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Radiation Protection Dosimetry

QUALITY CONTROL AND RADIATION PROTECTION OF THE PATIENT IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE

Proceedings Editors: G. Contento . Wall . Schibilla D. Teunen

CON F 930967 ISBN 1 870965 37 X EUR 15257 EN RADIATION PROTECTION DOSIMETRY Published by Nuclear Technology Publishing

Vol. 57, Nos. 14,1995

QUALITY CONTROL AND RADIATION PROTECTION OF THE PATIENT IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE
Proceedings of a Workshop held in Grado, Italy September 29 to October 1 1993 Co-organised by: Commission of the European Communities and Unita' Sanitaria Locale n. 7, Udine Co-sponsored by: The World Health Organisation

Proceedings Editors G. Contento . Wall . Schibilla D. Teunen


CONF 930967 ISBN 1 870965 37 X EUR 15257 EN RADIATION PROTECTION DOSIMETRY Vol. 57 Nos. 1 - 4 , 1995 Published by Nuclear Technology Publishing

DATA ANALYSIS IN QUALITY CONTROL AND RADIATION PROTECTION OF THE PATIENT IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE. Grado, Italy, September 29 to October 1 1993

Co-organised by the Commission of the European Communities and the Unita' Sanitaria Locale n. 7, Udine, and co-sponsored by the World Health Organization.

British Library Cataloguing in Publication Data A catalogue record of this book is available at the British Library LEGAL NOTICE Neither the Commission of the European Communities nor any person acting on behalf of the Commission is responsible for the use which may be made of the following information.

ECSC-EEC-EAEC Brussels-Luxembourg (1995) Publication No EUR 15257 EN of the Commission of the European Communities, Dissemination of Scientific and Technical Knowledge Unit Directorate-General Telecommunications Information Industries and Exploitation Research, Luxembourg

Radiation Protection Dosimetry


ISSN 01448420 EditorinChief: Dr J.A. Dennis, Consultant Editors: Dr G. Dietze, Germany Prof. Y. Horowitz, Israel Dr J. Rundo, USA

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EBRPDJ N12

Radiation Protection dosimetry


INSTRUCTIONS TO AUTHORS
SCOPE: The scope of this journal covers all aspects of personal and environmental dosimetry and monitoring for ionising and non-ionising radiations, including biological aspects, physical concepts, external personal dosimetry and monitoring, environmental and workplace monitoring and dosimetry related to protection of patients. Animal experiments and ecological sample measurements are not included. Scientific or Technical Papers should be full papers of a theoretical or practical nature with comprehensive descriptions of the work covered. Scientific or Technical Notes should be brief, covering not more than 4 printed pages (one page contains about 800 words or equivalent in figures) and are likely to cover work in development or topics of lesser significance than filli papers. Letters to the Editor should be written as letters with the authors' names and addresses at the end and should be marked 'For Publication'. LANGUAGE: All contributors should be in English. 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An Introduction to Medical Physics. William Heineman Medical Books Ltd (London). ISBN 0 433 003502. (1983) 4. Duftschmid, K.E. TLD Personnel Monitoring Systems - The Present Situation. Radial. Prot. Dosim. 2(1) 2-12 (1982). All the authors' names and initials (unless there are more than 10 authors), the title of the paper, the abbreviated title of the journal, volume number, page numbers and year should be given. Abbreviated journal titles should be in accordance with the current World List of Scientific Periodicals. If all of this information is not available the reference should not be cited. PROOFS will be sent to any nominated author for final proof reading and must be returned within 3 days of receipt using the addressed label which will be provided. Type-setting or printer's errors should be marked in red. Any other changes should be marked in green but if they are significant they may be charged to the authors. Authors' changes marked in red may not be accepted. 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1NST-J-RPD 4

DATA ANALYSIS IN QUALITY CONTROL AND RADIATION PROTECTION OF THE PATENT IN DIAGNOSTIC RADIOL OGY AND NUCLEAR MEDICINE.

PROGRAMME COMMITTEE L. Arranz, Madrid (E) and CGC Radiation Protection H. Bergmann, University Wien (A) L. Dalla Palma, University Trieste (I) and EAR P. Elsakkers, University L eiden (NL ) and ISRRT G. Hanson, WHO, Geneva J. L iniecki, University L odz (PL ) and ICRP C. Maccia, CAATS, Cachan (F) R. Padovani, USL N.7, Udine (I) D.P. Pretschner, University Hildesheim (D) W. Puschert, IEC, Hamburg (D) F.E. Stieve, GSF, Neuherberg (D) O.H. Suleiman, CDRH, Rockville MD (USA) D. Teunen, CEC, L uxembourg (L ) J. Valentin, SSI, Stockholm (S) A. Wambersie, UCL Brussels () and ICRU

SCffiNTIFIC SECRETARIAT G. Contento, USL N.7, Udine (I) H. Schibilla, CEC, Brussels () SESSION CHAIRPERSONS L. Dalla Palma G. Drexler G. Hanson W. L eitz C. Maccia B.M. Moores R. Padovani . Petoussi D.P. Pretschner H. Schibilla F.E. Stieve A. Talbot REFEREES M.G. Alm Carlsson . Bauer . Bergmann .. Busch M. Chevalier G. Contento F. Corlob L. Dalla Palma D.R. Dance G. Drexler S. Ebdon-Jackson P. Elsakkers A. Ferro de Carvalho M. Fitzgerald E. Guibelalde O. Hjardemaal K.A. Jessen R. Klausz H.M. Kramer W. L eitz S. L evialdi C. Maccia M.R. Malisan J.F. Malone S. Mattsson B.M. Moores P. Moran V. Neofotistou J.W. Oestmann R. Padovani M. Paganini-Fioratti W. Panzer N. Petoussi D.P. Pretschner M.L. Ramsdale V. Roberto P.J. Roberts H. Schibilla T. Schmidt K. Schneider A. Servomaa P.C. Shrimpton F.E. Stieve O.H. Suleiman A. Talbot D. Teunen .A.O. Thijssen G. Tosi J. Valentin E. Vano Carruana B.F. Wall A. Wambersie D. White J. Zoetelief D. Teunen J. Valentin E. Vano Carruana B.F. Wall

RADIATION PROTECTION DOSIMETRY


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EXOELECTRON EMISSION AND ITS APPLICATIONS 166 pp, Softback, Proceedings of the VHth International Symposium, Strasbourg, March 1983, Price 35.00 INDOOR EXPOSURE TO NATURAL RADIATION AND ASSOCIATED RISK ASSESSMENT 440 pp, Softback, Proceedings of an International Seminar, Anacapri, October 1983, Price 70.00 MICRODOSIMETRIC COUNTERS IN RADIATION PROTECTION 120 pp. Softback, Proceedings of a Workshop, Hamburg/Saar, May 1984, Price 25.00 RADIATION PROTECTION QUANTITIES FOR EXTERNAL EXPOSURE 166 pp, Softback, Proceedings of a Seminar, Braunschweig, March 1985, Price 35.00 MICRODOSIMETRY 400 pp, Softback, Proceedings of the Ninth Symposium on MicrodosimeUy, Toulouse, May 1985, Price 70.00 DOSIMETRY OF BETA PARTICLES AND LOW ENERGY X RAYS 134 pp, Softback, Proceedings of a Workshop, Saclay, October 1985, Price 30.00 ENVIRONMENTAL AND HUMAN RISKS OF TRITIUM 192 pp, Softback, Proceedings of a Workshop, Karlsruhe, February 1986, Price 40.00 ETCHED TRACK NEUTRON DOSIMETRY Proceedings of a Workshop, Harwell, May 1987, ACCIDENTAL URBAN CONTAMINATION Proceedings of a Workshop, Roskilde, June 1987, 130 pp, Softback, Price 25.00 192 pp, Softback, Price 40.00 SKIN DOSIMETRY - RADIOLOGICAL PROTECTION ASPECTS OF SKIN IRRADIATION (ISBN 1 870965 12 4) 212 pp, Hardback, Proceedings of a Workshop, Dublin, May 1991, Price 60.00 DOSIMETRY IN DIAGNOSTIC RADIOLOGY (ISBN 1 870965 II 6) 316 pp, Hardback, Proceedings of a Seminar, Luxembourg, March 1991, Price 80.00 AGE DEPENDENT FACTORS IN THE BIOKINETICS AND DOSIMETRY OF RADIONUCLIDES (ISBN 1 870965 15 9) 254 pp, Hardback, Proceedings of a Workshop, Schloss Elmau, November 1991, Price 60.00 GUIDEBOOK FOR THE TREATMENT OF ACCIDENTAL INTERNAL CONTAMINATION OF WORKERS (ISBN 1 870965 22 1) 50 pp, Softback, A Joint Publication for the CEC and the USDOE, Price 20.00 NEUTRON DOSIMETRY (ISBN 1 870965 16 7) 486 pp, Hardback, Proceedings of the Seventh Symposium on Neutron Dosimetry, Berlin, October 1991, Price 80.00 THE NATURAL RADIATION ENVIRONMENT (ISBN 1 870965 14 0) 800 pp, Hardback, Proceedings of the Fifth International Symposium, Salzburg, September 1991, Price 120.00 RADIATION EXPOSURE OF CIVTL AIRCREW (ISBN 1 870965 13 2) 140 pp, Hardback, Proceedings of a Workshop, Luxembourg, June 1991, Price 30.00 TEST PHANTOMS AND OPTIMISATION IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE (ISBN I 870965 26 4) 416 pp, Hardback, Proceedings of a Workshop, Wurzburg, June 1992, Price 80.00 MICRODOSIMETRY (ISBN 1 870965 21 3) 500 pp, Hardback, Proceedings of the Eleventh Symposium on Microdosimetry, Gadmburg, September 1992, Price 90.00 DECISION MAKING SUPPORT FOR OFF-SITE EMERGENCY MANAGEMENT (ISBN I 870965 25 6) 320 pp, Hardback, Proceedings of a Workshop, Schloss Elmau, October 1992, Price 60.00 INTAKES OF RADIONUCLIDES - DETECTION, ASSESSMENT AND LIMITATION OF OCCUPATIONAL EXPOSURE (ISBN 1 870965 28 0) 370 pp, Hardback, Proceedings of a Workshop, Bath, September 1993, Price 80.00 INDIVIDUAL MONITORING OF IONISING RADIATION - THE IMPACT OF RECENT ICRP AND ICRU PUBLICATIONS. (ISBN 1 870965 29 9) 232 pp, Hardback, Proceedings of a Workshop, Villigen, May 1993, Price 45.00 INDOOR RADON REMEDIAL ACTIONS -THE SCIENTIFIC AND PRACTICAL IMPLICATIONS. (ISBN 1 870965 30 2) 400 pp, Hardback, Proceedings of a Workshop, Rimini, Italy, June 27 to July 2 1993, Price 90.00 FUTURE PUBLICATIONS ADVANCES IN RADIATION MEASUREMENTS - APPLICATIONS AND RESEARCH NEEDS IN HEALTH PHYSICS AND DOSIMETRY (ISBN 1 870965 33 7) 450 approx pp, Hardback, Proceedings of a Workshop, Chalk River, October 1994, Price 90.00

NEUTRON DOSIMETRY 498 pp. Softback, Proceedings of the Sixth Symposium on Neutron Dosimetry, Neuherberg, October 1987, Price 75.00 NATURAL RADIOACTIVITY 560 pp, Softback, Proceedings of the Fourth International Symposium on the Natural Radiation Environment, Lisbon, December 1987, Price 85.00 BIOLOGICAL ASSESSMENT OF OCCUPATIONAL EXPOSURE TO ACTINTOES 400 pp. Softback, Proceedings of a Workshop, Versailles, May 1988, Price 65.00 IMPLEMENTATION OF DOSE-EQUTVALENT QUANTITTES ESTO RADIATION PROTECTION PRACTICE (ISBN 1 870965 03 5) 166 pp, Softback, Proceedings of a Seminar, Braunschweig, June 1988, Price 35.00 IMPLEMENTATION OF DOSE-EQUIVALENT METERS BASED ON MICRODOSIMETRIC TECHNIQUES (ISBN 1 870965 04 1) 156 pp, Softback, Proceedings of a Seminar, Schloss Elmau, October 1988, Price 30.00 MICRODOSIMETRY (ISBN 1 870965 05 X) 460 pp, Softback, Proceedings of the Tenth Symposium on Microdosimetry, Rome, May 1989, Price 80.00 STATISTICS OF HUMAN EXPOSURE TO IONISING RADIATION (ISBN 1 870965 08 6) 280 pp, Hardback, Proceedings of a Workshop, Oxford, April 1990, Price 60.00 RESPIRATORY TRACT DOSIMETRY (ISBN 1 870965 09 4) 268 pp, Hardback, Proceedings of a Workshop, Albuquerque, July 1990, Price 60.00

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EEC-PUB.J 05.12.94

Radiation Protection Dosimetry Vol. 57, Nos. 1 - 4 , pp. vii viii (1995) Nuclear Technology Publishing

Editorial
Data Analysis in Quality Control and Radiation Protection in Diagnostic Radiology and Nuclear Medicine
The Workshop on 'Data Analysis in Quality Control and Radiation Protection of the Patient in Diagnostic Radiology and Nuclear Medicine' was conceived as a forum for the evaluation of ten years of effort in these fields. For the co-organisers, the Department of Medical Physics of the Hospital Santa Maria della Misericordia, Udine, the World Health Organization and the Commission of the European Communities, this evaluation was seen from different points of view. The research group of Udine, as probably did most of the participants, wanted to check on progress since the seminar on 'Criteria and Methods for Quality Assurance in Medical X ray Diagnosis' held ten years ago in Udine and on which their current studies in the evolution of the field were based. For the World Health Organization the Workshop should help to identify means for the achievement of the overall goal good quality of medical services for everybody. The Commission of the European Communities hoped to assess the effectiveness of quality assurance measures in implementing the requirements of the Council Directive on the radiation protection of the patient (84/466 EURATOM, 4 September 1984). About 100 papers involving some 300 research workers addressed detailed objectives of the Workshop including: - overviews of trends and evolution in the past decade, - intercomparisons of dose reduction concepts, methods and practices, - definition of procedures for optimisation of radiation protection, as regards the clinical, equipment and organisational aspects as well as training, - analysis of the relationship between cost, risk and benefit, - perspectives of transfer of know-how to the user. For a greater coherence of the subject areas dealt with, the various contributions have been grouped slightly differently in these Proceedings from that occurring during the Workshop, thus emphasising the following main topics of interest, namely Guidance, European and Multi-national Trends and Activities, Image Quality, Computer Applications, (subdivided into knowledge based systems, and models and tools), Quality Control, (subdivided into instruments and methods, and surveys), Radiation Protection of the Patient, (subdivided into dose evaluation methods, dose reduction and surveys). For a research area that is in full evolution it was evident that for every question answered, two new ones emerged. The chairpersons of the Workshop sessions had therefore been invited to guide the session discussions in a way that answers to the following questions could be formulated: - What radiation protection strategies should be defined for diagnostic radiology and nuclear medicine? - What optimisation strategies can be recommended? - What is the practical relevance of the assessment of doses to the patient? - What socio-economic factors (health care concepts and spending, industrial activities etc) should be incorporated in radiation protection strategies? - What are the education and training priorities in radiation protection in diagnostic radiology and nuclear medicine? - What are the most important specific research priorities in all these items? The discussions taking place in the various Workshop sessions have been summarised by the chairpersons with these questions in mind and are reproduced in the penultimate section, followed by the final discussion and conclusions of the Workshop. The final discussion emphasised the need for better understanding of some specific components of radiation protection during radiological imaging procedures. In particular, since the reduction of patient dose is constrained by the need to obtain images of sufficient diagnostic content, it is necessary to understand the relationship between diagnostic content, physical measures of image quality and patient dose. There was a consensus that this task requires a multidisciplinary approach in order to lay down explicit links between the medical and the radiation protection requirements. Quality assurance programmes, which include periodic patient dose measurements and comparison with reference doses, can provide an essential feedback mechanism on the level of protection achieved. The CEC initiative to define, develop and test practical image quality and patient dose criteria at a European level vii

EDITORIAL for common examinations01, was considered to be a valuable effort in this direction. It was encouraging to find that this conceptual framework for optimisation, including quality criteria and technical performance requirements, is being dealt with from different points of view at the local, regional, and national level, as well as by the various competent professional bodies and international organisations such as ICRP, ICRU, WHO and UNSCEA R. It was the wish of the organisers of the Workshop that the evaluation of the data collected during the last decade on quality control and radiation protection become a milestone in the field of quality assurance in diagnostic radiology and nuclear medicine, against which further progress can be evaluated. A s with the preceding six European Workshops dealing with quality assurance in medical radiology, this one has also contributed towards a common terminology and provided fertile ground in which future research can be rooted. It is hoped that these Proceedings will consolidate this purpose. REFERENCE . CEC. Quality Criteria for D iagnostic Radiographic mages. Working Document CEC 7173/90, Commission of the European Communities, Brussels, June 1990. 2nd Edition, G. Contento . Wall . Schibilla D. Teunen

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Radiation Protection Dosimetry Vol. 57, Nos. 1 - 4 , pp. ix-xv (1995) Nuclear Technology Publishing

Contents
Contents Opening Address J. Sinnaeve GUIDANCE Referral Criteria for Selection of Patients and Diagnostic Procedures L. Dalla Palma, C. Ricci and S. Magnaldi (INVITED PAPER) The Scientific Work-Up of Radiographie Image Quality Now and a Decade Ago - The Radiologist's Approach J.W. Oestmann (INVITED PAPER) Trends in X Ray Diagnosis and Nuclear Medicine F.E. Stieve (INVITED PAPER) Interlaboratory Comparison of Imaging Devices in Nuclear Medicine H. Bergmann (INVITED PAPER) WHO and Rational Reduction of Patient Dose G. Hanson (INVITED PAPER) EUROPEAN AND MULTINATIONAL TRENDS AND ACTIVITIES Initiatives, Achievements and Perspectives with regard to the Council Directive of September 3 1984 laying down Basic Measures for Radiation Protection of Persons undergoing Medical Examination or Treatment D. Teunen and National Experts: A. Wambersie (Belgium), O. Hjardemaal (Denmark), A. Costa (France), B. Bauer (Germany), D. Panagiotis (Greece), G. O'Reilly (Ireland), F. Mazzei andM. Paganini Fioratti (Italy), C. Back (Luxembourg), T. Zoetelief (the Netherlands), A.F. Carvalho (Portugal), E. Vano (Spain), and S. Ebdon-Jackson (United Kingdom) (INVITED PAPER) 33 Initiatives of EFOMP in the Field of Radiation Protection and Quality Assurance A. Del Guerra (INVITED PAPER) Radiation Protection Education and Training of Radiographers P. Elsakkers (INVITED PAPER) 73 77 1

9 13

21 27

Practical Impact of the Evolution and Changes of ICRP Recommendations on Radiological Protection in Medicine S. Mattsson and A. Almn (INVITED PAPER) 79 UNSCEAR Data Collections on Medical Radiation Exposures: Trends and Consequences J. Valentin (INVITED PAPER) IEC Projects and Achievements in the Field of Quality Assurance in Diagnostic Radiology W. Puschert (INVITED PAPER)
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CONTENTS Results of the IAEA-CEC Co-ordinated Research Programme on Radiation Doses in Diagnostic Radiology and Methods for Reduction P. Ortiz, C. Maccia, R. Padovani, E. Vano, G. Alm Carlsson and H. Schibilla The United States Experience in Patient Dose and Image Quality .H. Suleiman, B.J. Conway, F.G. Rueter, J.L. McCrohan, R.J. Slayton andR.G. Antonsen (INVITED PAPER) IMAGE QUALITY CEC Quality Criteria for Diagnostic Radiographic Images - Basic Concepts B.M. Moores (INVITED PAPER) The 1991 CEC Trial on Quality Criteria for Diagnostic Radiographic Images C. Maccia, M. Ariche-Cohen, X. Nadeau and C. Severo (INVITED PAPER) Evolution of Quality Assurance in Paediatric Radiology K. Schneider (INVITED PAPER) Quality Control and Image Quality Criteria in Computed Tomography J. Albrechtsen, J. Hansen, L.C. Jensen, K.A. Jessen and A.G. Jurik Patient Dose and Image Quality for Computed Tomography in Several Dutch Hospitals J. Geleijns, J.J. Broerse, J. Zoetelief, D. Zweers and J.G. van Unnik Image Quality and Dose Distribution in Multiscan and Fast Ring CT Systems F. Levrero, G.L. Coscia, A. Pilot, F. Cavagnetto and E. Zucchi Image Quality Criteria Applied to Digital Radiography HP. Busch, K. Faulkner and J.F. Malone Standard Tools for Analysis of Image Quality in Digital Imaging N. Meier and M. Fiebich A Novel View on Detail Perception and on the Influence of the Film System Parameters R. Bollen Optimisation of Image Quality in Mammography K.J. Robson, C.J. Kotre and K. Faulkner Impact of Several Recommended Actions for Improving the Image Quality in Mammography M. Chevalier, P. Moran and E. Vano Quality Assurance and Patient Dosimetry in Mammography: a Retrospective I.A. Castellano, D.R. Dance, R. Davis, S.H Evans, C.H. Jones and C.A. Parsons Survey of Mammographie Image Quality in the UK K.C. Young, M.L. Ramsdale and A.G. Rust Image Quality and Patient Dose in Diagnostic Radiology D. Saure, G. Hagemann and H. Stender 163 167 119 125 105

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CONTENTS Assessment of Image Quality for Chest Radiography in the West Midlands H.M. Warren-Forward and J.S. Millar COMPUTER APPLICATIONS Knowledge Based Systems Data Analysis and Information Modelling: Objects, Codes, Concepts D.P. Pretschner (INVITED PAPER) Knowledge Based Approach to Quality Control in Diagnostic Radiology G. Contento, R. Padovani, V. Roberto, O. Varin, and C. Della Giusta (INVITED PAPER) 171

175 185

Knowledge Acquisition, Representation and Reasoning in a Gamma Camera Quality Control Expert System P.J. Slomka, T.D . Cradduck and L.A. Chudziak 191 Models and Tools Medical Devices Quality Assurance Services A. Talbot, M. Kragsholm, A. Mnsson and S.S. Nielsen Quality Control in Mammography B ased on Automatic Acquisition of Exposure Parameters T.P. Walderhaug, G. Einarsson, S. Kristinsson, S.M. Magnusson and B.F. Sigsson Computer Applications in Radiation Protection P.R. Cole and B.M. Moores Optimisation of the Design of Antiscatter Grids by Computer Modelling D.R. D ance, M. Sandborg, G. Alm Carlsson and J. Persliden Results from an Optimisation of Grid Design in Diagnostic Radiology M. Sandborg, D.R. D ance, G. Alm Carlsson and J. Persliden Computer Model for RiskBenefit Analysis of Mammographie B reast Cancer Screening J.Th.M. Jansen and J. Zoetelief QUALITY CONTROL Instruments and Methods In Field Testing of a New Instrument for Quality Control in Mammography M. Gambaccini, M. Marziani, CG. Candini, E. D e Guglielmo and C. Bertaggia 221 A Noninvasive Method to Control the Tube Current Calibration of Diagnostic Radiology Equipment N.J. Uys, C.P. Herbst, A. van Aswegen, M.G. Latter, M.A. Sweetlove and J.F.K. de Villiers 227 A Compound Hard Tissue Phantom in Radiologic Diagnostic Optimisation O. Eckerdal, E. Helmrot and G. Aim Carlsson Optimisation of Radiographic AEC System Performance J. U pton, B. Moran and J.F. Malone 217

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CONTENTS Quality Assurance Programme Applied to Mobile X Ray Equipment B. Tuohy, G. Tuohy, P. Cooney, B. Moran and J.F. Malone Contrast-Detail Testing Techniques for Modern X Ray Image Intensifier Systems CJ. Kotre, N.W. Marshall and K Faulkner 241 245

A Review of the Background to the Decision to Write-off Fluoroscopy Equipment in 15 Instances, - and the Impact of Patient Dose and Image Quality in Practice J.F. Malone, P. Cooney, HP. Busch and K Faulkner 249 A Simple Test for X Ray Tube Filtration R.E. Gallini, S. Belletti, V. Berna, U. Giugni and G. Prandelli Determination of the Speed of Medical Radiography Screen-film Systems F.R. Verdun, F. Bochud, J.F. Valley and O. Lm Thanh

253 257

A Practical Approach to a Quality Assurance Programme for Radiography at the Constancy Check Level B. Moran, J. Upton, P. Cooney and J.F. Malone 263 Automatic Exposure Control in Fluoroscopic Imaging P. Cooney, D. M. Marshand J.F. Malone Measurement of Wiener Spectra in Digital Systems D.M. Marsh, P. Cooney, B. P. McMahon and J.F. Malone An Assessment of the Variations in Image Quality with Multiformat Cameras D.M. Marsh, J.F. Malone and P. Cooney Pitfalls in the Use of Flood Sources "Co E. Busemann Sokole, A. Kugi and H Bergmann 269 273 277 281

NIR: A Database of All X Ray Units in Use in Lower Saxony to Improve Radiation Protection and Quality Control H. Brggemeyer and T. Siewert Surveys Some Results from a Diagnostic Radiology Optimisation Programme in the Madrid Area E. Vano, L. Gonzales, E. Guibelalde, J.M.Fernndez, A. Calzado and M.J. Ruiz Quality Control in Conventional Diagnostic Radiology in Greece V. Neofotistou, M. Molfetas and N. Panagiotakis Quality Control and Patient Dose for X Ray Examinations in Some Hospitals in Estonia A. Servomaa, S. Rannikko, T. Parviainen, P. Holmberg, E. Kuus, T. Mrsepp and V. J rv What is the True Film-Screen Sensitivity H.M. Warren-Forward Survey of Image Viewing Conditions for X Ray Film P. Cooney, C Davis, J.B.Y. Chua, W. vander Putten and J.F. Malone 285

289 293 297 301 305

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CONTENTS A Quality Assurance Programme for Medical X Ray Diagnostic Units Carried Out in Belgium D. Godechal, J. Delhove, C Mambour, J. CoomansandA. Wambersie Quality Control in the Radiological Departments of the Florence General Hospital C. Gori, G. Belli, S. Calvagno, L. Capaccioli, A. Guasti, G. Span and G. Zate Ui The RTI DIGI-X Plus QA System in Routine Practice M. Princivalli, L. Stea, P.L. Ordonez, L. Bussoli and C Marchetti Quality Control in Mammography: the Pilot Campaign of Breast Screening in the Bas-Rhin Region C Maccia, X. Nadeau, R. Renaud, S. Castellano, P. Schaffer, R. Wahl, P. Haehnel, G. Dale and B. Gairard Analysis of the Results of a QC Project on Mammography in Greece A. Flioni-Vyza, S. Xenofos, G. Panagiotakis, E. Giakoumakis and B. Proimos Quality Control in Computed Tomography Performed in Portugal and Denmark A.F. Carvalho, A.D. Oliveira, J. Alves, J. V. Carreiro, L.C. Jensen and KA. Jessen Radiation Protection Problems with Dental Radiological Equipment P. Cooney, G. Gavin, J. Rajan and J.F. Malone Daylight Film Processor/Loader Systems - Aspects of Performance and Distribution J. Upton, B. Moran, M. Duggan and J.F. Malone

309 315 317

323 329 333 339 343

Implementation of a Quality Control Programme at the Departments of Radiology and Nuclear Medicine of the Netherlands Cancer Institute (NKI-AvL) S.H Muller 347 Quality Control of Nuclear Medicine Instruments in Argentina M. Levi de Cabrejas and C. Giannone RADIATION PROTECTION OF THE PATIENT Dose Evaluation Methods National Patient Dose Measurement Protocols: an Investigation on Behalf of ICRU P.J. Roberts (INVITED PAPER) Patient Dose Protocols and Trends in the UK B.F. Wall and P.C. Shrimpton Dose-Area Product and Body Doses N. Petoussi-Hen, W. Panzer, M. Zankl and G. Drexler A Comparison of Two Methods for Estimating Effective Dose in Abdominal Radiology N.W. Marshall, K Faulkner, HP. Busch, D.M. Marsh and H Pfenning Effective Doses for Different Techniques Used for PA Chest Radiography F.W. Schultz, J. Geleijns and J. Zoetelief Computed Tomography Dose Assessment - a Practical Approach W. Leitz, B. Axelsson and G. Szendr
xiii

351

355 359 363 367 371 377

CONTENTS A Comparison of Measured and Calculated Organ Doses from CT Examinations A. Calzado, S.R. Sanz, M. Melchor and E. Vano Dose Profile and Dose Index Analysis in Computed Tomography A.D. Oliveira, J. G. Alves, A.F. Carvalho and J. V. Carreiro Organ Doses for Children from Computed Tomographic Examinations M. Zankl, W. Panzer, N. Petoussi-Hen and G. Drexler Calculation of Air Kerma to Average Glandular Tissue Dose Conversion Factors for Mammography J. Zoetelief and J. Th.M. Jansen Comparison of Dose Measurement Protocols in Mammography K.C Young An Investigation into Variations in the Estimation of Mean Glandular Dose in Mammography K. Faulkner and K Cranley 381 387 393 397

401 405

Physiologically Based Pharmacokinetics Model for Estimating Urinary Excretion of Short Half-life Nuclides in Nuclear Medicine K. Akahane, M. Kai, E. Konishi, T. Kusarna and Y. Aoki 409 Dose Reduction The Increasing Importance of X Ray Computed Tomography as Source of Medical Exposure P.C. Shrimpton and B.F. Wall 413

Intensive Care Department: Evaluation of the Radiological Activity and Criteria for Reduction of Patient and Worker Exposure S. Magri, S. Arisi, S. Camerini, M. Nolli, P.U. Marini and G. Rozzi 417 An Initial Report on the Investigation of High Patient Doses for the Lateral Lumbosacral Projection in the Lumbar Spine Examination B. Moran, J. Upton, M. Rafferty, G. Boyle and J.F. Malone 423 Recommended Actions for Reduction of Breast Doses in the Area of Madrid. An Evaluation. P. Moran, M. Chevalier and E. Vano Evaluation of Radiation Exposure to Personnel in Cardiac Angiography B. Axelsson, T. Cederlund and B. Svane Surveys Comparison of Entrance Surface Doses and Radiographic Techniques in the West Midlands (UK) with the CEC Criteria, Specifically for Lateral Lumbar Spine Radiographs E.A. McNeil, D.E. Peach and D.H. Temperton Patient Dosimetry During Chest Radiography H.M. Warren-Forward Patient Dose Measurement and Dose Reduction in East Anglia (UK) J.P. Wade, KE. Goldstone and P.P. Dendy 429 433

437 441 445

XIV

CONTENTS Patient Doses and Radiation Risks in Filmscreen Mammography in Finland A. Servomaa, T. Parviainen and T. Komppa 449

Level and Distribution of the Radiation Dose to the Population from a Mammography Screening Programme in New Zealand S.M. Bulling and J.J. Nicoli 455 Intestinal Biopsy in Children with Coeliac Disease; a Swedish National Study of Radiation Dose and Risk J. Persliden, H.B.L. Pettersson and K. FlthMagnusson 459 Dose Distribution in Children at Chest Radiography A. Almn and S. Mattsson Computed Tomography Practice in Sweden. Quality Control, Techniques and Patient Dose G. Szendr, B. Axelsson and W. Leitz Data Analysis on Patient Exposures in Cardiac Angiography J.C Huyskens and A.W. Hummel

463

469

475

Radiation Risk and Exposure of Radiologists and Patients during Coronary Angiography and Percutaneous Transluminal Coronary Angioplasty (PTCA) J. Karppinen, T. Parviainen, A. Servomaa and T. Komppa 481 Radiation Exposure of Patients by Using Modern Digital Fluoroscopy Systems J. Kopp, W. Maier and C Losereit Absorbed Dose to the Skin in Radiological Examinations of Upper and Lower Gastrointestinal Tract G. Zonca, A. Brusa, M. Bellomi, G. Cozzi, A. Severini, . Somigliano, C. Pasqualotto and A. Sichirollo . 489 Discussions by Session Chairpersons Final Discussion and Conclusions Author Index List of Participants 493 503 507 508

487

Radiation Protection Dosimetry is abstracted or indexed in APPLIED HEALTH PHYSICS ABSTRACTS


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Radiation Protection Dosimetry Vol. 57, Nos. 1-4, pp. 1-2 (1995) Nuclear Technology Publishing

OPENING ADDRESS
J. Sinnaeve Commission of the European Communities Radiation Protection Research Action The Commission of the European Communities organised its first Workshop on Quality Assurance in Diagnostic Radiology not far from here in Udine, in 1984, the famous year of Orwell's visions of the future. One way of evaluating the achievements in Quality Assurance in Diagnostic Radiology is to assess whether the objectives of 10 years ago have been realised. We were therefore very pleased that we could convince the Udine team of the Servizio di Fisica Sanitaria to co-organise a Workshop with us once more. I am particularly grateful to them and especially to Dr Gilberto Contento who has shouldered the enormous amount of work involved in the organisation of the Workshop. I thus have great pleasure in welcoming you to the Workshop which will analyse and evaluate the data that have been produced in the past decade on Quality Control and Radiation Protection of the Patient in Diagnostic Radiology and Nuclear Medicine. The objective is to define together what are the most appropriate methods for both analysis and evaluation, and to check how far the achievements have fulfilled our objectives. The Commission's services are periodically requested to evaluate the scientific and practical value of the research programmes of the CEC and our experience is that this stimulates creative criticism and opens up new ways of thinking. The Commission's Radiation Protection Actions have been and continue to be evaluated by external experts, who have recognised the need to deploy special efforts on radiation protection of the patient; but up to now we have not called upon the various professionals involved that is to say radiologists, radiographers, medical physicists, radiation protection surveyors and teachers, health authorities and manufacturers, as well as international organisations to evaluate together our efforts, our achievements and our objectives in this important field of radiation protection, related to the medical use of ionising radiation. This part of radiation protection research and legislation concerns every member of the public as a potential patient. The coherence of our work and its results should therefore be ensured all over Europe and contribute to worldwide coherence. We have also come together here in order to look for ways and means to improve this coherence. The seven Workshops and Seminars organised by the Commission demonstrate clearly where our main interests lay over the past decade. We started with the possibilities for dose reduction in diagnostic radiology; we defined concepts for quality assurance programmes; we evaluated the technical and physical parameters for quality control; we established quality criteria for diagnostic radiographic images and their link to radiographic techniques and doses to the patient, in particular with respect to certain conventional and digital radiographic procedures; we discussed the role of dosimetry as well as test objects and phantoms for quality control measures' '~7). The conclusive discussions of all of these events highlighted the achievements and requirements formulated for future actions and research efforts. It is an instructive read I can recommend it to all of you if we wish to find out whether our aims were realistic, whether we concentrated on the most relevant items and whether we succeeded in proposing the most appropriate radiation protection means and measures for the use of ionising radiation in medicine. There is, however, some discrepancy between the radiation protection measures that have been recommended and the public concern over radiation hazards linked to the medical use of ionising radiation and radionuclides. Several newspapers and magazines have recently denounced the possible dangers involved after accidents had occurred due to human errors and equipment failure. In this context our evaluation should also examine: (i) Whether the knowledge available of radiation protection measures is being properly applied? (ii) Whether this knowledge is suitable for medicalclinical priorities and circumstances? (iii) What else we need to know in order to control the true situation? We must establish and seek agreement on the criteria that will enable us to study these questions. At the end of the Book of Abstracts a series of Open Questions is listed for the Final Discussion. The answers that we might find together here should guide us in the effort to establish those criteria and also to establish the strategies needed to facilitate their application. I would like to stress how serious these questions are also for the definition of our future goals for research and legislation, including the revision of the Council Directive laying down basic measures for the radiation protection of persons undergoing medical examination or treatment. Research and Training on radiation protection for the medical use of ionising radiation and radionuclides must

J. SINNAEVE certainly concentrate more on the efficiency of radiation protection measures established so far, on their compati bility with medical requirements and on their links to overall optimisation of diagnosis and health care. For the definition of future priorities for radiation protection we must therefore study the ways and means by which the criteria for Quality A ssurance and Quality Control can be improved; with special emphasis on the defi nition of image quality in a most objective way: this might be achieved in promoting new lines of research, such as imaging sciences, the creation of new branches of radiological sciences and the development of new radiological methods and diagnostic tools. We will not, of course, be able to find answers to all these questions, nor will we have the necessary financial means to follow up all suggestions. However, at a moment where everybody is being invited worldwide to think more rationally about the use of resources and manpower, we must coordinate our efforts in order to define rational strategies on how to fulfil the most urgent tasks, even if this can only be done in small steps. I am impressed by the number of presentations that will take place: about 120 oral and poster communi cations, involving more than 300 research workers, will give a picture of the research results available in some 20 European and nonEuropean countries. They will contribute to the definition and analysis of radiation pro tection problems. They will also provide the material for the training programmes of the coming generation and that is one of the most rewarding aspects of all our efforts, in my opinion. We must recognise our responsi bility in transmitting our commitment in this field of research to young scientists. The CEC understands that one of its main tasks in research is to prepare the ground for sound research work to be carried out and guarantee the continuity of European expertise in selected pri ority areas. I very much welcome the organisation of the Round Table of the national experts who will review the achievements in radiation protection of the patient in their countries, indicate which research areas are being concentrated on and show how the implementation of radiation protection is facilitated on a more individual basis, so that we can learn from each other with the aim of approaching the optimum level. In addition, a number of international bodies will summarise their concepts and goals concerning the various aspects of radiation protection in medicine and will thus add new criteria for the evaluation of the outcome of the current research work. We have progressed in this field to a point where we are now closer to the possible standardisation of quality assurance and quality control measures in practice. Standardised measures will enable us to evaluate the efficiency of radiation protection of the patient. With this in mind I would like to invite you to benefit from this three day meeting by creating new links across the various professions, subject areas and geographical distances.

REFERENCES 1. Patient Exposure to Radiation in Medical Xrays Possibilities for Dose Reduction. Proceedings of a Seminar jointly organ ised by the CEC and the Gesellschaft fr Strahlen und Umweltforschung, MunichNeuherberg (FRG), 2730 April 1981. Eds G. Drexler, H. Eriskat and H. Schibilla. Report EUR 7438 EN (1981). 2. Criteria and Methods for Quality Assurance in Medical Xray Diagnosis. Proceedings of a Scientific Seminar organised jointly by the CEC and the Centro di Ricerca Applicatae e Documentazione, held in Udine, (I), 1719 April 1984. Eds G. Drexier, H. Eriskat and H. Schibilla. Report EUR 9255 EN, BIR Suppl. 18 (1985). 3. Technical and Physical Parameters for Quality Assurance in Medical Diagnostic Radiology: Tolerances, Limiting Valu Appropriate Measuring Methods. Proceedings of a Workshop organised by the CEC, held in Brussels (B), 2325 February 1988. Eds B.M. Moores, F. E. Stieve, H. Eriskat and H. Schibilla. Report EUR 11620 EN, BIR Report 18 (1989). 4. BIR. Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Proceedings of a Workshop organised jointly by the CEC and the National Radiological Protection Board Chilton, held in Oxford, (UK), 2729 September 1988. Eds B. M. Moores, . F. Wall, . Eriskat, . Schibilla. Report EUR 11842 EN, BIR Report 20 (1989). 5. D osimetry in Diagnostic Radiology. Proceedings of a Seminar, jointly organised by the CEC, the PhysikalischTechnische Bundesanstalt, Braunschweig (FRG), the World Health Organization and the International Commission on Radiation Units and Measurements held in Luxembourg (L), 1921 March 1991. Eds H. M. Kramer and K. Schmier. Report EUR 14180 EN. Radit. Prot. Dosim. 43(14) (1992). 6. D igital Radiography: Quality Assurance and Radiation Protection. Proceedings of a Workshop jointly organised by the CEC, the Klinikum Mannheim and the European Association of Radiology, held in Mannheim (FRG), 79 May 1992. Eds H. P. Busch and M. Georgi (SchnetztorVerlag GmbH, Konstanz) EN (1992). 7. Test Phantoms and Optimisation in Diagnostic Radiology and Nuclear Medicine. Proceedings of a Workshop jointly organise by the CEC, the Forschungszentrum fr Umwelt and Gesundheit, Neuherberg (FRG), the International Commission on Radi ation Units and Measurements and the European Federation of Organisations for Medical Physics, held in Wrzburg (FRG), 1517 June 1992. Eds B. M. Moores, . Petoussi, . Schibilla and D. Teunen. Report EUR 14767 EN. Radial. Prot. Dosim. 49(13) (1993).

Radiation Protection Dosimetry Vol. 57, Nos. 14, pp. 38 (1995) Nuclear Technology Publishing

REFERRAL CRITERIA FOR SELECTION OF PA TIENTS A ND DIAGNOSTIC PROCEDURES


L. Dalla Palma, C. Ricci and S. Magnaldi Universit degli Studi di Trieste, Istituto di Radiologia Ospedale di Cattinara, 134149 Trieste, Italy INVITED PAPER Abstract In order to maximise the benefits of modem diagnostic procedures and to minimise costs both for the health service and the individual, criteria for selecting patients undergoing diagnostic procedures must be carefully established. This review analyses the main factors (related both to patients and technology) which should influence our diagnostic choices. The general meaning of efficacy, efficiency, cost and benefits in a radiological milieu is defined and then applied to a number of highly practical situations where new technologies (ultrasonography, computed tomography and magnetic resonance) have revolutionised diagnostic approaches in the past decade. The review emphasises that referral criteria must be founded on a 'first priority' basis so that decisions as to diagnostic protocol are taken on the basis of clinical features, epidemiological data and simple laboratory tests; the consequent steps in diagnostic protocols are influenced by a priori knowledge of efficacy, efficiency, prognostic and therapeutic value of the diagnosis and cost considerations. INTRODUCTION The increasing number of radiological examinations in the population as a whole, the increasing cost for health care and the advent and most appropriate use of new technologies which do not use ionising radiations are important issues in radiology today. Prior to any discussion of this topic it is useful to single out some keywords which help in understanding how to draw up guidelines for optimal use of imaging modalities. Accuracy: often used as a synonym of efficacy this term represents the ratio between actual and ideal diag nostic performance'". In diagnostic imaging it can be defined as the ability to diagnose correctly true positive (TP) and true negative (TN) cases and is given by the following ratio: TP + TN 100/grand total. It is, how ever, also useful in modern diagnostic protocols in order to characterise the role of a given modality, to define other parameters such as sensitivity (TP/TP+FN) and specificity (TN/TN + FP)(2>. Efficiency may be defined as the ratio between the resources which should ideally be employed and those which are actually used"1. Referred to diagnostic imag ing it represents the ratio between accuracy and cost. The modality which offers the highest accuracy at the lowest cost is highly efficient. Cost is an increasingly important factor which is some times difficult to quantify unless we consider purely financial cost, usually expressed as cost/exam/year and is related to initial investment for the technology and to break even point. In reality, there is an additional optional cost regarding initial and inservice training of personnel. Biological cost is considered separately because it is one of the most important issues in modern diagnostic imaging, involving both radiologists and patients. This factor is mainly related to exposure to ionising radi ations of many categories of subjects but particularly children, pregnant women and adults of reproductive age. Whereas this cost is ideally zero for modalities such as ultra sonography (US) and magnetic resonance (MR), it can be only estimated for modalities like conventional radiology, CT and digital subtraction angiography (DSA). In recent years US has enabled this cost to be reduced in diagnostic imaging, by replacing X rays in several situations (for guiding diagnostic and therapeutical manoeuvres as in biopsies of abdominal organs, drain age of abscesses, percutaneous nephrostomies and gas trostomies, and even portosistemic shunts). Recently, US has also become an important tool for studying dynamic phenomena in areas where the reduction of dose is crucial, such as the female pelvis. There is a further biological cost in the risk associated with the use of contrast media (quantifiable in terms of probability of adverse reaction/number of subjects/ year). Finally there is abiological cost associated with tolerability, a subjective parameter which is therefore difficult to quantify. In other words, even noninvasive modalities, like US or MR, may have a biological cost (small) related to risky manoeuvres or to the use of con trast media. Availability is related to the diffusion of a given tech nology: it may be expressed in terms of average time to have access to a given technology and may vary widely, depending on the local situation. Benefits are the final results we wish to obtain by using imaging modalities in terms of influence on the patients' final outcome. Naturally they are linked to

L. DALLA PALMA, C. RICCI and S. MAGNALDI cost; subsequently, no approach to diagnostic imaging modality can fail to consider the so-called cost-benefit ratio. A number of sub-categories of benefits can be singled out. (1) Benefits affecting the quality of life: diagnostic information which leads to avoidance of further diagnostic procedures and/or useless therapies, enhances the quality of life. (2) Benefits affecting therapeutic decisions means useful information for identifying the most appropriate therapeutic approach (medical, surgical, guided by diagnostic imaging itself) (3) Purely diagnostic benefits are obtained when imaging modalities supply data for solving diagnostic problems generated by diagnostic imaging itself (especially when benign or malignant lesions are discovered incidentally). The above factors should all be considered by the decision maker when drawing up the guidelines for optimal use of imaging protocols. A practical approach to the problem is examined for different clinical situations regarding diagnosis of the central nervous system (CNS) and abdominal field. REFERRAL CRITERIA FOR SELECTION OF PATIENTS AND DIAGNOSTIC PROCEDURES IN CNS DIAGNOSTICS As with US in abdominal diagnostics, the introduction of MRI as a neuroradiological tool has greatly reduced biological cost. Despite its high cost and its still limited availability, this modality is replacing CT more and more; coupled with high diagnostic accuracy, it uses safe contrast media and no ionising radiations. Brain tumours MRI is a superb method of studying brain tumours by virtue of its excellent contrast resolution, easy multiplanar imaging and absence of artefacts. MRI and CT are roughly equivalent for detection of most brain tumours but MRI is superior at the vertex, in the posterior fossa, near the wall of the middle fossa, at the base of the skull and in the orbit'3"5'. The criterion for selecting patients is based upon clinical features (accurate neurological examination, evaluation of electrical brain activity in basal conditions and after stimuli). In these cases the first imaging diagnostic step should be MRI despite its high financial cost since it is the most accurate and gives important benefits affecting therapeutic decisions. The only limiting factor is availability; thus, the criteria to select patients are the following: Clinical features EEG Brain evoked MRI (if available) otherwise CT if negative MRI potentials Acute and chronic brain ischaemia Within a few hours of vascular occlusion, detection and localisation of cerebral infarction is possible with MRI while CT often yields equivocal or negative results in the first 24 or 48 hours and MRI is still superior to CT in subacute and chronic stages'36-7'. As in brain tumours this would suggest employing MRI in all circumstances but MRI is less widely available than CT, especially for monitoring development of the disease. Furthermore, patients with severely impaired CNS function may require a complex anaesthesiological surveillance which is much more compatible with CT technology. The following criterion can be suggested: Clinical MRI (if available) follow-up features otherwise CT CNS trauma It is important to remember that in clinical practice patients undergo a plain film of the skull. This is for legal reasons although it has been shown that fractures of the skull not associated with specific clinical findings are very rarely responsible for brain lesions'8"10'. This shows how an apparently low cost modality has an unfavourable cost-benefits ratio in practice and should not even be considered for selecting patients to undergo more expensive modalities such as CT or MRI. In head trauma, MRI has proved to be useful in detection of all types of intracranial haemorrhage, including haemorrhagic contusions and shearing injuries. In recent reports MRI shows a higher accuracy than CT. During the first one to three days after injury, however, CT may be preferable not only because it is better tolerated by patients but also because haemorrhage at this point may be more reliably demonstrated by CT' 3 " 12 '. The referral criteria are therefore the same as those suggested for ischaemic lesions. REFERRAL CRITERIA FOR SELECTION OF PATIENTS AND DIAGNOSTIC PROCEDURES IN ABDOMINAL DIAGNOSTICS Liver tumours Primary liver tumours The role played by diagnostics and therapy of hepatocellular carcinoma (HCC) has become increasingly important; in this field particularly diagnostic protocols must be carefully chosen in order to limit costs and enhance benefits. Patient recruitment must be clinical since categories of patients 'at risk' can be singled out CT

REFERRAL CRITERIA on a clinical basis (patients with postnecrotic cirrhosis and/or abnormal serum level of alphafeto protein). The sensitivity of various imaging modalities"315' shows that a certain gain occurs when using modalities of a considerably higher cost (both financial and biological). For this reason, it is worthwhile employing US as a first diagnostic imaging step in patients recruited on a clini cal basis. This allows us to create different categories of patients for whom different selection criteria must be considered in order to obtain the most favourable cost benefit ratio. (A) Clinical recruitment US (+biopsy) extensive involvement stop

FOR PATIENT SELECTION US and confirmed by CT, DSA and LCT, and/or associ ated with general conditions which preclude surgical treatment, patients can be selected for CEA T or PEI as an alternative, at lower biological cost. Secondary liver tumours As in primary tumours, patients at risk for metastatic disease should be first selected on the basis of clinical criteria. Diagnostic efforts should be mainly concen trated on patients who have a primary tumour which is well treatable and possibly curable and in whom treat ment of an early stage of metastatic disease can signifi cantly change the medium to longterm survival rate; for example, metastases from breast, colon and kidney. The sensitivity of diagnostic imaging is related to lesions size"6"19' and, although high levels of sensitivity are reached by more expensive modalities like CT or MRI, US remains, by virtue of its low cost and wide availability, the first tool in diagnostic protocols. A sug gested criterion can therefore be the following; Clinical recruitment US * multiple lesions Stop \ single lesion CT single lesion > US or CT guided biopsy

In this situation US'reveals the presence of a large neo plasm (occupying more than 50% of the liver volume) and therefore the oncological stage overcomes the thera peutic possibilities regardless of the clinical stage of cir rhosis. The gain offered by this flowchart in reducing costs (financial and biological) as well as increasing benefits, in terms of quality of life is clearly evident, also when considering the complex protocol involving patients with early stage of the disease. (B) Clinical recruitment CT early US early stage stage (+biopsy) DSA early stage (digital subtraction angiography) LCT early stage (lipiodol computed tomography) \ advanced stage In this second situation, an early stage of the focal dis ease at US examination associated with an early stage of the diffuse disease (cirrhosis), it is important to define the actual early stage of the HCC as accurately as poss ible. This is usually achieved by employing sequen tially three modalities which, at increasing costs, ensure high sensitivity and therefore enable the most appropri ate treatment (surgical or nonsurgical) to be set. The increased costs (both financial and biological) are offset by improved treatment and good results.

Liver haemangiomas The most common benign focal lesions of the liver are generally asymptomatic. They are accidentally dis covered in patients undergoing US examination for a variety of reasons. When they show a typical US pattern there is no diagnostic problem but when the pattern is atypical and in patients likely to have a metastatic dis ease they deserve a more careful evaluation. US, CT and DSA have a comparably high sensitivity but MRI and nuclear medicine (NM) are definitely more sensitive'202". Therefore, the use has been suggested, in ambiguous cases, an association of these modalities'22' by applying the following criterion: US incidental discovery ambiguous pattern or at risk patients

/ \

CT MRI (if available) NM

This criterion bears out the idea that modalities which have high financial cost but low biological cost (MRI (C) and NM) can be used to solve problems created by other Clinical US (+biopsy) locally CT DSA imaging modalities avoiding more invasive and costly recruitment advanced steps (DSA ). / LCT * \ no treatment CE A T (chemo embolisation arterial transcatheter) PEI (percutaneous ethanol injection) Jaundice When the clinical onset and laboratory tests are ambiguous in determining the aetiology of the jaundice, US has been seen to be very accurate in differentiating obstructive from nonobstructive forms. Unfortunately,

In this situation, a locally advanced disease revealed by

L DALLA PALMA, C. RICCI and S. MAGNALDI CT (+ staging) for anatomical and physical reasons, its accuracy is not Clinical US positive or equally high in detecting the site and nature of the feature suspicious obstruction. US features are nevertheless useful in selecting patients who must undergo more expensive and invasive procedures like CT or percutaneous transhepReno-ureteral colic atic cholangiography (PTC)'23-28'. The gain, in terms of financial and biological cost, is In this clinical situation IVU remains a reference tool evident when using the following criterion: by virtue of its superior spatial resolution. Both the Clinical US non-obstructive stop feature \ obstructive Laboratory > site/nature undetected CT or PC or ERCP (if therapeutic approach) Cholelithiasis Until ten years ago this disease, affecting a large population in the west, was diagnosed by means of oral cholecystography (OC) which uses both ionising radiation and contrast media but whose accuracy average is lower in comparison with US' 29-35 '. Moreover it is not able to depict the gallbladder wall and is rather time consuming when a functional evaluation of the gallbladder wall is required. For these reasons, as it is more sensitive and at least as specific as OC, US has now replaced this modality. However, if the clinical feature suggests that a stone or stones have moved to the choledochal duct (recent biliary colic with onset of jaundice) US accuracy decreases'36' for the above mentioned reasons (see above protocol for jaundice) and a different approach should be considered. Clinical feature (pain, dyspepsia) US see protocol for jaundice

excretory pathway and small stones are usually depicted with great accuracy. However, it has recently been proven that a plain film (PF) of the abdomen (which requires a small fraction of IVU exposure to X rays) combined with US examination of kidneys and distal ureters is almost as accurate as IVU'4243'. This represents a considerable gain in biological cost and enables us to select a limited number of patients for IVU, avoiding exposure of the genital area in sometimes very young patients. Clinical PF + US negative follow-up or IVU feature

Prostatic carcinoma There is increasing interest in this pathology due to the fact that it may be cured when it is still confined within the gland borders (B or T2 stage). Once the disease has been detected by the urologist and histologically proven it is not useful to employ ionising radiations to stage it since CT has a rather poor accuracy compared to MRI'44"47'. In this case, however, a second clinical-epidemiological criterion must be applied in order to obtain maximum benefit from staging; only subjects with life expectation of at least ten years and in good general condition should undergo staging with MRI. The composite criterion will therefore be: Clinical Histological (US if clinical MRI feature guided) diagnosis- condition Laboratory grading satisfied

Clinical feature (biliary colic, jaundice, fever) Kidney Renal tumours

Although accuracy of conventional intra venous urography (IVU), in expert hands, may be rather high, new modalities have dramatically increased the possibilities of detecting the disease in early stages' 37-4 "; US in particular, being a very diffuse modality, often allows recognition of this pathology when it is still asymptomatic. As in liver metastases, accuracy is related to tumour size and to its echo pattern. However CT is most accurate and must be used for integrating US data and for staging. IVU plays a minor role and this once again leads to a reduction in biological cost for the whole population since more costly modalities are dedicated to fewer well defined cases in which the US pattern is suspicious or atypical. The criterion for selecting patients and procedures is therefore:

CONCLUSIONS A few examples show that criteria for selecting patients and imaging modalities must be adapted to each clinical situation. The 'first priority' level is always based upon clinical data, epidemiological data, and laboratory tests. Diagnostic modalities are chosen on the basis of composite considerations in which the costbenefits ratio must play the main role. In other words, this implies a priori knowledge of the efficacy of all modalities in each clinical situation and of benefits to be obtained. A clear trend towards a reduction in biological cost is evident in modern diagnostic imaging protocols.

REFERRAL CRITERIA FOR PATIENT SELECTION REFERENCES 1. Lucertini, M. and Telmon, D. Benchmarking: valuatazione e miglioramento delle prestazioni aziendali (in press). 2. Inouye, S. K. and Sox, H. C. Standard and Computed Tomography in the Evaluation of Neoplasms of the Chest: a Compara tive Efficacy Assessment. A nn. Int. Med. 105, 906924 (1986). 3. Orrison, W. W., Stimac, G. K., Stevens, . ., Lamasters, D. L., Espinosa, M. C , Cobb, L. and Mettler, F. A. Comparison of CT, LowField Strength MR Imaging, and HighField Strength MR Imaging. Radiology 181, 121127 (1991). 4. Schoerner, W., Schubeus, P., Henkes, H., Rottacker, C , Hamm, . and Felix, R. intracranial Meningiomas; Comparison of Plain and Contrastenhanced Examinations in CT and MRI. Neuroradiology 32, 1218 (1990). 5. Tampieri, D., Moumdjian, R., Melanson, D. and Ethier, R. Intracerebral Gangliogliomas in Patients with Partial Complex Seizures; CT and MR Imaging Findings. Am. J. Neuroradiol. 12, 749755 (1991). 6. Bryan, R. N., Levy, L. M., Whitlow, W. D., Killian, J. M., Preziosi, T. J. and Rosario, J. A . Diagnosis of Acute Cerebral Infarction: Comparison of CT and MR Imaging. A m. J. Roentgen. 157, 585594 (1991). 7. Seiderer, M., Krappel, W., Moser, E., Hann, D., Schmiedek, P., Buell, V., Kirsch, C. M. and Lissner, J. D etection and Quantification of Chronic Cerebrovascular D isease: Comparison of MR Imaging, SPECT, and CT. Radiology 170, 545548 (1989). 8. Bell, R. and Loop, J. The Utility and Futility of Radiographic Skull Examination for Trauma. New Engl. J. Med. 284, 236239 (1971). 9. Masters, S. J. Evaluation of Head Trauma: Efficacy of Skull Films. A m. J. Roentgenol. 135, 539547 (1980). 10. National Study by the Royal College of Radiologists. Cost and Benefits of Skull Radiography for Head Injury. Lancet 2, 791795 (1981). 11. Gentry, L. R., Godersky, J. C , Thompson, B. and Dunn, V. D. Prospective Comparative Study of Intermediatefield MR and CT in the Evaluation of Closed Head Trauma. Am. J. Neuroradiol. 9, 91100 (1988). 12. Hesselink, J. R., Dowd, C. F., Healy, M. E., Hajek, P., Baker, L. L. and Luerssen, T. G. MR Imaging of Brain Contusions: A Comparative Study with CT. Am. J. Neuroradiol 9, 269278 (1988). 13. Choi, B. I., Park, J. H., Kim, B. H., Kim, S. H., Han, M. C. and Kim, C. W. Small Hepatocellular Carcinoma: Detection with Sonography, Computed Tomography (CT), Angiography and LipiodolCT. Br. J. Radiol. 62, 897903 (1989). 14. Takayasu, K., Moriyama, ., Muramatsu, Y., Makuuchi, M., Hasegawa, H., Okazaki, N. and Hirohashi, S. 77ie Diagnosis of Small Hepatocellular Carcinomas; Efficacy of Various Imaging Procedures in 100 Patients. A m. J. Roentgenol. 155, 4954 (1990). 15. Takashima, T., Matsui, O., Suzuki, M. and Ida, S., Diagnosis and Screening of Small Hepatocellular Carcinomas. Radiology 145, 635638 (1982). 16. Matsui, O., Takashima, T., Kadoya, M., Suzuki, M., Hirose, J., Kameyama, T., Choto, S., Konishi, H., Ida, M. and Yamaguchi, A. Liver Metastases from Colorectal Cancers: Detection with CT during Arterial Portography. Radiology 165, 6569 (1987). 17. Stark, D. D., Wittenberg, J., Butch, R. J. and Ferrucci, J. T. Hepatic Metastases: Randomized, Controlled Comparison of Detection with MR Imaging and CT. Radiology 165, 399^*06 (1987). 18. Vlachos, L., Trakadas, S., Gouliamos, ., Lazarou, S., Mourikis, D., Ioannou, R., Kalovidouris, A . and Papavasiliou, C. Comparative Study Between Ultrasound, Computed Tomography, IntraArterial Digital Subtraction Angiography, and Mag netic Resonance Imaging in the D ifferentiation of Tumors of the Liver. Gastrointest. Radiol. 15, 102106 (1990). 19. Wemecke, K., Rummeny, E., Bongartz, G., Vassallo, P., Kivelitz, D., Wiesmann, W., Peters, P. E., Reers, ., Rieser, M. and Pircher, W. D etection of Hepatic Masses in Patients with Carcinoma: Comparative Sensitivities of Sonography, CT, and MR Imaging. A m. J. Roentgenol. 157, 731739 (1991). 20. Stark, D. D., Felder, R. C. and Wittenberg, J. Magnetic Resonance Imaging of Cavernous Hemangioma of the Liver; Tissue Specific Characterization. Am. J. Roentgenol. 145, 213220 (1985). 21. Engel, . ., Marks, D. S., Sandler, M. A . and Shetty, P. D ifferentiation of Intrahepatic Lesions with 99m TcRed Blood Cell Imaging. Radiology 146, 777782, 1983. 22. Nelson, R. C. and Chezmar, J. L. D iagnostic Approach to Hepatic Hemangiomas. Radiology 176, 1113 (1990). 23. Baron, R. L., Stanley, R. J., Lee, J. K. T., Moehler, R., Melson, L., Balfe, D. M. and Weyman, P. J. A Prospective Comparison of the Evaluation of Biliary Obstruction using Computed Tomography and Ultrasonography. Radiology 145, 9198 (1982). 24. Dalla Palma, L., Maffessanti, M., Bazzocchi, M., Rizzatto, G., PozziMucelli, R. S. and Brizzi, F. Combined Use of Ultrasono graphy and Transhepatic Percutaneous Colangiography in Obstructive Jaundice. Eur. J. Radiol. 2, 281289 (1982). 25. Dalla Palma, L., Rizzatto, G., Bazzocchi, M., PozziMucelli, R. S., Brizzi, F. and Maffessanti, M. L'ecografia nella valuta zione del paziente itterico: attendibilit su 246 pazienti controllati. Radiol. Med. 67, 615622 (1981). 26. Gibson, R. N., Yeung, E. and Thompson, J. N. Bile D uct Obstruction: Radiologie Evaluation of Level, Cause and Tumor Resectability. Radiology 160, 43^*7 (1986). 27. Pedrosa, C. S., Casanova, R Lezana, A . H. and Fernandez, M. C. Computed Tomography in Obstructive Jaundice. Part II: The Cause of Obstruction. Radiology 139, 635645 (1981). 28. Pedrosa, C. S Casanova, R. and Rodriguez, R. Computed Tomography in Obstructive Jaundice. Part I: The Level of Obstruc tion. Radiology 139, 627634 (1981).

L D ALLA PALMA, C. RICCI and S. MAGNALDI 29. Coopenberg, P. L. and Burhenne, M. Z. Real Time Ultrasonography: Diagnostic Technique of Choice in Calcious Gallbladder Disease. New Eng. J. Med. 302, 12771279 (1980). 30. Crade, M., Taylor, K. J. W., Rosenfield, A . T., Capper, S., DeGraaf, F. and Minihan, P. Surgical and Pathological Correlation of Cholescistosonography and Cholecistography. Am. J. Roentgenol. 131, 227229 (1978). 31. De Lacey, G., Gajjar, B. and Towomey, B. T. Should Colecistography or Ultrasound be the Primary Investigation for Gallbladder D isease? Lancet i, 205207 (1980). 32. Klingensmith, W. C. and Eckhout, G. V. Cholelithiasis in the Morbidly Obese: Diagnosis by US and Oral Cholecystography. Radiology 160, 2728 (1986). 33. Krook, P. M., Allen, F. M., Bush, W. M., Maimer, G. and MacLean, M. D. Comparison of the Real Time Cholecystosonogra phy and Oral Cholecystography. Radiology 135, 145148 (1980). 34. Wolson, A. M. and Goldberg, B. B. Gray Scale Ultrasonic Cholecystography, a Primary Screening Procedure. J. Am. Med. Assoc. 240, 20732075 (1978). 35. Mcintosh, D. M. F. and Pennali, M. F. Gray Scale Ultrasonography as a Screening Procedure in the Detection of Gallbladder Disease. Radiology 136, 725727 (1980). 36. Mitchell, S. E. and Clark, R. A . A Comparison of Computed Tomography and Sonography in Choledocolithiasis. A m. J. Roentgenol. 142, 729733 (1984). 37. A mendola, . ., Bree, . L., Pollack, H. M., Francis, I. R., Glazer, G. M., Jafri, S. Z. H. and Tomaszewski, J. E. Small Renal Cell Carcinoma: Resolving a Diagnostic D ilemma. Radiology 166, 637664 (1988). 38. Bazzocchi, M., PozziMucelli, R. S, Zanella, F. and Ricci, C. D iagnostica 1985 delle neoplasie renali. In: Radiourologia 1985, pp. 8194 (Lint, Trieste) (1985). 39. Mobilio G., Cavalli, A . and Bianchi, G. Choice between US and CT in the Radiological Approach to the Renal Masses. Diagn. Imaging 51, 3238 (1982). 40. Plainfoss, M. C , Delecoeullerie, G. and Vital, J. L. 165 Renal Carcinomas, Accuracy of Imaging for D iagnosis and Spread cost Efficiency. Eur. J. Radiol. 3, 132137 (1983). 41. Smith, S. J., Bosniak, . ., Megibow, A. J., Hulnick, D. H., Horii, S. C. and NageshRaghavendra, B. Renal Cell Carcinoma: Earlier D iscovery and Increased D etection. Radiology 170, 699703 (1989). 42. Bazzocchi, M., Stacul, F., Cressa, C. and Dalla Palma, L. L'ecografia nella colica renale. Radiol. Med. 76, 7882 (1988). 43. Dalla Palma, L., Stacul, F., Bazzocchi, M., Pagnan, L., Festini, G. and Marega, D. Ultrasonography and Plain Film versus Intravenous Urography in Ureteric Colic. Clin. Radiol. 47, 333335 (1993). 44. Biondetti, P. R., Lee, J. K. T., Ling, D. and Catalona, W. J. Clinical Stage Prostate Carcinoma: Staging with MR Imaging. Radiology 162, 325329 (1987). 45. Emory, T. H., Reinke, D. B., Hill, A. L. and Lange, P. H. Use of CT to Reduce Understaging on Prostatic Cancer: Compari son with Conventional Staging Techniques. Am. J. Roentgenol. 141, 351354 (1983). 46. Morgan, C. L., Calkins, R. F. and Cavalcanti, E. J. Computed Tomography in the Evaluation, Staging and Therapy of Carcinoma of the Bladder and Prostate. Radiology 140, 751761 (1981). 47. Pontes, E., Eisenkraft, S., Watanabe, H., Ome, H., Saiton, M. and Murphy, G. P. Preoperative Evaluation of Localized Prostatic Carcinoma by Transrectal Ultrasonography. J. Urol. 134, 289291 (1985).

Radiation Protection Dosimetry Vol. 57, Nos. 1-4, pp. 9-11 (1995) Nuclear Technology Publishing

THE SCIENTIFIC WORK-UP OF RADIOGRAPHIC IMAGE QUALITY NOW AND A DECADE AGO: THE RADIOLOGIST'S APPROACH
J. W. Oestmann Diagnostische Radiologie I Klinikum der Georg-August-Universitt Robert-Koch-Strae 40 Gttingen, Germany INVITED PAPER Abstract The past decade has seen a number of efforts to increase image quality and decrease examination hazards to the patient in medical imaging. A comparison of image quality studies in the early 1980s with those of the early 1990s shows that the amount of scientific publications on the topic as well as their sophistication has grown. The concept of diagnostically relevant structures as well as the observer performance test with receiver operator characteristics (ROC) analysis has been well received. On the basis of our own experience in projection radiography a three-step approach to the evaluation or optimisation of new imaging modalities is proposed: (1) base evaluation applying adequate physical parameters; (2) subjective optimisation of the system with the diagnostic objectives in mind (i.e. the diagnostically relevant structures in radiographic studies) to generate a set of alternative hypotheses; and (3) comparison of these hypotheses with clinically oriented observer performance tests.

INTRODUCTION The past decade has seen a number of scientific and political efforts to increase image quality and decrease examination hazards to the patient in medical imaging. On the political side, national radiation protection laws and international and EEC initiatives led to the development and further improvement of technical standards and to the formation of local authorities which survey the quality of radiographic imaging with special attention to dose and diagnostic quality. On the scientific side, the advent of new modalities spawned interest in methodologies which permit a reliable and reproducible determination of diagnostic value. In conventional radiographic technique, dose reducing combinations of films with rare earth screens and high and low latitude films had to be tested. The introduction of commercial digital radiography systems in the early 1980s made imaging scientists search for subtle yet relevant differences between digital and conventional images. The post-processing capabilities of these systems could only be optimised with sophisticated tools. The rapid development and spread of CT, ultrasound and MRI required scientifically based decisions on the diagnostic value of each modality. The rise and fall of thermography was seen as an expensive example of a failed scientific evaluation. The importance of these efforts was enhanced by increasing cost constraints in national health programmes and the international economy. This paper is intended to describe briefly how image quality has been described scientifically and how we think image quality should be evaluated. An analysis of

scientific publications of the past decade will show how interest and sophistication of methodology have improved. THE RADIOLOGIST'S DEFINITION OF IMAGE QUALITY The radiologist's view of image quality is dominated by his or her professional task: the detection or exclusion of pathology as well as the differential diagnosis and localisation of detected abnormalities. A good detectability of disease is achieved if the conspicuity of a lesion is high, i.e. if the perceptual difference between the lesion and the anatomical background is large"-2). If the characteristics of the abnormality are quite different from normal anatomical structures (such as an enhancing neurofibroma in MRI), the documentation of normal anatomical structures is of lesser importance for the detection task. If the abnormality is, however, similar in imaging characteristics to physiological structures (such as pulmonary nodules and pulmonary vessel intersections), these structures must also be optimally imaged. This is of particular importance for the differential diagnosis and localisation of lesions. The image quality of a given modality is thus defined by its ability to demonstrate disease with a high level of conspicuity and to delineate anatomical structures relevant for detection, differential diagnosis and localisation. Radiologic image quality in our view is always a relative parameter. It defines itself in comparisons of different imaging modalities (such as CT and MRI) or different protocols of one imaging modality (such as different

J. W. OESTMANN dose levels or postprocessing algorithms in digital radiography (DR)). (FSS) and computed tomography (CT) were in the cen tre of scientific interest in the early 1980s. In the early 1990s magnetic resonance imaging (MRI) and digital radiography (DR) were the subjects of a large number EVALUATION OF IMA GE QUA LITY IN THE of studies. Partially due to new developments in CT LAST DECA DE (spiral CT) and in conventional radiography (A MBER) An analysis of the medical literature over the past but also as part of comparative studies including MR decade with the help of a computer database literature and DR, research on CT and FFS continued at a high search using the keywords 'image quality' and Observer level. For ultrasound and Doppler techniques combined, performance' shows that the number of publications on interest remained similar. Papers also were classified image quality issues has grown continuously (Figure 1 ). according to methodology following these definitions: A separate analysis of papers published in one major (1) Undefined or nonsystematic studies made no English language (Radiology, sample size: 330 papers) apparent effort to define a 'gold standard' of diag and one major German language (Rfo, sample size: 182 nostic truth. Their methodology failed to support papers) radiological journal in 1982 and 1992 supports their conclusions. Studies stating sensitivity as sole this statement: In Radiology the percentage of papers on parameter of image quality were also included in the topic rose from approx. 12 to 17% while this per this group. The relevance of the generated data was centage grew from approx. 6 to 24% in Rfo. There felt to be questionable. seems to be a certain lag time between publications on the topic in the English language and the German langu (2) Subjective rating studies had observers evaluate the visualisation of normal anatomy and/or the conspi age journal. Such papers were considered for further cuity of pathology with the help of visibility scores. study that made a statement on the comparative image The problem with this methodology was felt to be quality of imaging modalities as defined above. The its vulnerability to observer bias and the inability to analysis according to imaging modalities for both jour generate false positive results. nals (Figures 2 and 3) shows that filmscreen systems (3) Physical parameter studies looked at imaging 200 aspects such as contrast, latitude, speed or dose, modulation transfer function (MTF), signaltonoise ratio or as frequently seen in papers on MRI lesiontoparenchyma ratio. The clinical relevance Q. (0 of the generated data was the crucial point in these studies. 100 (4) Sensitivity/specificity studies were classified at face -Q value. Such studies have to define a certain 'gold E standard' of diagnostic truth as precondition. They need to include controls in an adequate case sample size. Tests should ideally be performed by a group of observers. This methodology does not take into 82 83 84 85 86 87 88 89 90 91 92 93 (18) account varying observer thresholds, which change Year the sensitivity/specificity ratio without a parallel change in image quality. Figure 1. Scientific publications on image quality in the medi cal literature between 1982 and 1992. For 1993, only the first (5) Receiver operator characteristics (ROC) analysis eight months could be analysed.
50
40 a. ra
O

30 20 10 1982 1992

1982 B 1992

E
3

Total

FS

DR

CT US/ MR Angio. Nucl. Dop.

Total FS

DR

CT

US/ MR Angio.NucI Dop.

Figure 2. Number of image quality papers according to imaging modalities in Radiology in 1982 and 1992.
10

Figure 3. Number of image quality papers according to imaging modalities in Rfo in 1982 and 1992.

THE SCIENTIFIC WORKUP OF RADIOGRAPHIC IMAGE QUALITY NOW AND A DECADE AGO studies were also classified at face value. They need due to new imaging modalities which needed to be to fulfil the same preconditions as for scientifically evaluated. The institutional and govern sensitivity/specificity studies but they incorporate mental initiatives concerning image quality and re the observer threshold in their calculations. The area duction of patient hazards as well as the financial under the ROC curve is taken as equivalent of the restrictions which are increasingly felt in the national diagnostic performance of a specific modality. health systems have certainly accelerated and intensified Between ROC areas generated by groups of work in this area. The knowledge of adequate method observers for different modalities, significant differ ologies for evaluating image quality has apparently ences can be calculated. These studies require good increased. This is reflected by the lower number of stud methodological planning and specific software in ies in 1992 which had to be classified as nonsystematic or undefined. Our experience in the field has led us to order to be executed with acceptable speed'141. practice and propose a threestep evaluation of image The analysis according to these criteria shows a trend quality. This includes ( 1 ) a preliminary evaluation using towards more sophisticated methodologies in the early physical parameters that are relevant to the pathology 1990s (Figures 4 and 5). A gain, there seems to be a to be detected and the anatomical structures to be docu certain lag between the two journals. The increase in mented, (2) a subjective optimisation to develop hypo physical parameter studies for 1992 is partially due to theses for further analysis and (3) a final test of hypo the large amount of MRI studies looking at signal inten theses with a wellplanned diagnostically oriented ROC sities. study. The methodological approach should be sound but also reasonable. Subtle differences certainly need sophisticated methods. Dose reduction studies, film DISCUSSION A ND CONCLUSIONS screen system comparisons or the optimisation of digital Independent of its classification in the context of this radiography will have to deal with those kinds of subtle analysis every paper must certainly be scrutinised indi differences in image quality. For some imaging vidually for its inherent methodological weaknesses and modalities the differences may turn out to be obvious. strengths. This was beyond the scope of this study. The However, a sound methodology will always increase the number of publications with interest in image quality credibility of the data and the researcher. has grown over the past decade. This is in some part

1982 a 1992

1982 0 1992

Total Undef. Subj. Phys. Sens./ ROC Spec.

Total Undef. Subj. Phys. Sens./ ROC Spec.

Figure 4. Number of image quality papers according to evalu Figure 5. Number of image quality papers according to evalu ation methodology in Radiology in 1982 and 1992. Several ation methodology in Rofo in 1982 and 1992. Several method methodologies may have been used. ologies may have been used. REFERENCES 1. Kundel, H. L., Nodine, C. F., Thickman, D., Carmody, D. and Toto L. Nodule D etection with and without a Chest Image. Invest. Radiol. 20, 9499 (1985). 2. Revesz G., Kundel, H. L. and Graber, M. A. The Influence of Structured Noise on the Detection of Radiologic Abnormalities. Invest. Radiol. 9, 479^186 (1974). 3. Metz, C. E. Basic Principles of ROC Analysis. Semin. Nuc. Med. 8, 283298 (1978). 4. Metz, C. E. ROC Methodology in Radiologic Imaging. Invest. Radiol. 21, 720733 (1986).

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Radiation Protection Dosimetry Vol. 57, Nos. 1-4, pp. 13-20 (1995) Nuclear Technology Publishing

TRENDS IN X RAY DIAGNOSIS AND NUCLEAR MEDICINE


F.-E. Stieve Institute for Radiation Hygiene Federal Office for Radiation Protection P.O. Box 1108 D-85758 Oberschleiheim, Germany INVITED PAPER Abstract The trend of the diagnostic process in diagnostic radiology and nuclear medicine is influenced by several factors in all countries with optimal health care. It is mainly attributable to changes in the structure of the population, to the disease frequency in relation to age, available diagnostic procedures, therapeutic possibilities and, also, to the trends in diagnostic techniques. Such tendencies are also of major influence on radiation exposure, including efficacy and efficiency measures of the diagnostic and therapeutic process and, of course, of the underlying disease,finallyresulting in better health care and in higher life expectancy. The main reasons for changes in diagnosis are considered in this paper. Data collected in several countries, mainly in Europe, illustrate the different trends which, generally speaking, still increase the total number of examinations and, in spite of better radiation protection, reducing certain examinations methods, are still increasing die frequency of examinations in general as well as the estimated collective population dose per year. INTRODUCTION According to periodic surveys in most of the member states of the European Communities, the number of X ray and nuclear medicine examinations is still increasing'". In 1990, the total frequency of diagnostic radiology examinations was in the range of about 500 to 1300 per 1000 persons in the 12 member countries. While the increase is slowing to about 2-5% per year, with an average of about 3% over the decade 1980 1990, the trend is still significant. The same tendency is observed in nuclear medicine, where the frequency is in a range of 7 to 40 examinations per 1000 people per year. Together with the rise in the frequency of examinations, the levels of exposure to which individuals are subjected commonly expressed as the 'average' per caput effective dose equivalent and calculated for the individual resident country are also increasing. There are several reasons why the trends are still progressing in spite of multiple directives, regulations and international and national standards recommending the avoidance of unnecessary medical exposures and the keeping of all necessary medical exposures as low as possible. The most significant reasons will be discussed here. MAIN FACTORS INFLUENCING TRENDS IN THE FREQUENCY OF RADIATION EXPOSURE IN X RAY DIAGNOSIS AND NUCLEAR MEDICINE The principal elements of change in the frequency of examinations and in patient exposures that influence the health of the population and the timely diagnosis of pathological conditions are connected with the provision of adequate health care. Even within such a relatively 13 demographically homogeneous region as Europe, there are significant differences in health care between and sometimes also within the countries. This overview presents only a general picture without going too deeply into detail. Further information on factors influencing the pattern of health care are found in several demographic and health statistics collected by the World Health Organization, Regional Office for Europe'21, the statistical office of the European Communities'31 and in health reports containing data from European nations (e.g. Ref. 4). According to this information, the following factors are of major importance: Demographic trends in population structures and their health implications The composition of the population depends on trends in fertility, morbidity, mortality and, in some cases, population movement. In Europe low levels of mortality and fertility lead to a high proportion of elderly persons, i.e. older than 65 years. The lower birth rate and the declining mortality of the elderly contribute to the accentuation of ageing within the European Community. In 1991, about 20% of the population were over 65 and 3.5% over 80 years of age. Due to the lower mortality rate, 4.7% of females and 2.2% of males were older than 80 years at the time of death. With a decreasing mortality, the life expectancy at birth is extended. The applied measure of mortality is the life expectancy which summarises the current age pattern of mortality in the form of a single index independent of the population age structure. Trends expressed by this measure over the past 40 years in the nations of the European Communities are shown in Figure 1. The lengthening of life is the result of an intensively applied health care

F.E. STIEVE policy. However, together with the increasing percent with a shift to older age groups and a slight age of persons older than 65 and 80 years, the disease reduction during the past decade in males and frequency per person and the required medical treatment females (Figure 2), are both much higher in this group than in younger (ii) an increase of malignant neoplasms from 1960 to groups and in the working population. The average 1990 to about 150%, mainly with an increase of number of diseases that require medical treatment in a neoplasms of the respiratory system, a slight population aged 65 and over is estimated to be about increase in breast carcinomas as well as colon and 2.5 per person'5'. In a careful clinical examination, an rectum and a distinct decrease in carcinomas of average of about nine diseases was found in such a the stomach. group of elderly persons'61. Malignant neoplasms and circulatory diseases are the According to our assessments, the number of examin two major causes of death, together accounting for ations involving ionising radiation in German hospitals about three quarters of the total number. Both diseases is about 10 times higher in the older and in the working are often diagnosed and controlled by diagnostic X rays population groups than in the younger population'71. and nuclear medicine methods. Although the mortality rate for infants less than 1 year old is dramatically decreasing, the percentage of the group under age 15 has dropped and represents a Reduction of specific infectious diseases decline of about 35%. This implies a reduction of the From the general incidence of infectious diseases in average child expectancy from 2.61 in 1960 to 1.5 in the European region, only a few are of greater import 1990 and hence a decrease of the genetically significant ance, mainly Enteritis infectiosa (Salmonellosis), men dose, without considering changes in doses to the gon ingitis and tuberculosis. From those diseases salmonel ads, of about 58%. Jointly with the declining birth rate, losis has increased between 1960 and 1990, the the average age of women giving birth for the first time incidence of meningitis has decreased and tuberculosis rises from 24.5 years in 1970 to about 28 years in 1990. also declined'81. While enteritis and meningitis are dis The percentage of births by mothers older than 45 years eases occurring mainly in the young population, with a dropped from 1.0 in 1960 to about 0.5 in 1990. This maximum between ages 1 and 5, active tuberculosis is indicates that the reproductive age for women is now nowadays an illness of the older population with a pre lowered to about 16 to 45 years of age. sent maximum per 1000 inhabitants between age 70 Finally the flow of migration increased during the and 85. past decades the net migration per 10,000 popu The percentage of deaths from the total incidence per lation in 1991 was about 198<3). Changes in the course of disease from the perspective of morbidity and mortality The majority of diseases in the elderly is due to degenerative and chronic conditions. The efforts made in the treatment of circulatory and infectious diseases manifest themselves in low levels of mortality or in higher mortality age rates. The age standardised mor tality rates by cause of death in the European region are demonstrating (i) an increase in diseases of the circulatory system
(b) (a) Female
^ Circulator system Malignant neoplasm

l i Pneumonia ^ Accidents

Male
Circulatory system ^ Malignant neoplasm

f H Pneumonia ^Accidents

1950 1960 1970 1980 1990 Figure 1. Life expectancy in the European member states. 14

1960 1970 1980 1990 Figure 2. Changes in the course of disease demonstrated as causes of death: (a) males, (b) females.

TRENDS IN X RAY DIAGNOSIS AND NUCLEAR MEDICINE 1000 population of all infectious diseases amounts to average hospitalisation time in special departments'91. about 6%. Here, too, the percentage of the older group The general in-patient time is reduced to about one is predominant, probably caused by pneumonia in older third. The reduced in-patient time also furthers the availpersons. Also, this form of infection needs regular diag- ability of beds, which is continuously decreasing. Marknostic control and is one of the main reasons for the edly increased is the frequency of admissions to hospihigh frequency of X ray examinations in intensive tals. In 1965, an average of about 130 patients out of 1000 inhabitants had to be treated in hospitals, in 1991 care units. about 175. This increase in hospitalisation is also due to the state of health of the elderly. Accidents Accidents, in general, account for about 5% of all deaths. Here males seem to have nearly twice as many accidents as females. The age distribution differs between the total frequency of accidents and traffic accidents, as shown in Figure 3. While, for the general number of accidents, the frequency of deaths is at a maximum in the age group of about 75, the maximum of traffic accidents occurs in the age group between 16 and 35. The frequency of traffic and occupational accidents is decreasing. The frequency of 'domestic' accidents is slowly increasing. Hospitalisation Finally the reduced hospitalisation time is remarkable. The average hospitalisation time in Germany has declined from about 25.4 days to 13.1 days in 1965 in general hospitals or from 19.4 days to 11.3 days in special hospitals for acute diseases. Table 1 lists the 3530
Accidents general 1 9 7 4 ^ Accidents general 1989 iTratfic accidents 1974 g | Traffic accidents 1989

Modification of diagnostic procedures Numerous diagnostic procedures have been introduced or improved during the process of developing an accurate and timely diagnosis of pathologic processes, attempting to minimise the risk, discomfort and, sometimes, also costs to the patient. The goal of reducing risk, costs and discomfort must always be balanced against the principal goal of a diagnosis, namely to be useful for patient treatment. Our knowledge about normal and abnormal changes has, in general, considerably increased and treatment methods in actual practice have improved. Prognostication has become much more precise and, in certain aspects, treatment is more efficient. However, the abundant possibilities of diagnostics often mislead the practitioner into ordering or performing unnecessary diagnostic procedures which may make the diagnosis clearer and put it on a more positive basis but do not improve the method of treatment. Every diagnostic procedure should, therefore, be evaluated by the referring physician, including history, physical examination and, if necessary, the results from laboratory tests, before medical imaging procedures are requested. In complicated circumstances, the best approach is that of discussion between the imaging physician (radiologist or nuclear medicine physician) and the clinician. The communication is most effective when both parties are well informed about the available options. New examination methods have nevertheless changed diagnostic procedures (Table 2). In some cases, a conventional radiological examination was replaced by alternative methods (Figure 4). For certain indications, the diagnosis should best be performed by other imaging methods. In neurology, cerebral angiography or nuclear brain scan has been nearly completely replaced by computed tomography or nuclear magnetic imaging. Myelography, an uncomfortable method for the patient, has likewise been nearly replaced by computed tomography and nuclear magnetic imaging. In skeletal metastases, the nuclear bone scan with technetium labelled phosphate components is the best screening method for occult skeletal metastases. Only for symptomatic bone metastases with a known primary tumour, is radiography and, in some cases, conventional tomography usually the imaging method to be initially recommended.
15

5-15 ^26-35
16-25

36-45 56-65 Age (y)

46-55

66-75

76-85

>85

Figure 3. Age distribution of accidental death (1974 and 1989) for Europe: (a) males, (b) females. Table 1. Average time of hospitalisation for specialised treatment 1965-1990 (Germany).
Department Surgery Gynecology and obstetrics Internal medicine Pediatrics Orthopaedics Tuberculosis 1965 15.5 11.3 28.0 23.6 38.3 175.6 1970 15.6 11.6 24.2 20.2 37.5 134.1 1980 13.3 7.6 21.1 11.4 24.7 45.8 1990 11.8 7.5 13.6 8.8 16.2 33.8

F.-E. STIEVE In special cases, the diagnosis should best be perfor- from studies on efficacy and efficiency are therefore med by new invasive radiological imaging methods. needed. With all these invasive methods, complications may increasingly occur in comparison with conventional Trends in therapeutic procedures and their radiographic methods. The radiologist must know the influence on radiation exposure benefits, risks, complications and appropriate alternative examinations. The procedures should only be performed Many therapeutic procedures found acceptance durafter the referring physician has consulted with the radi- ing the past decades. The principal goals are: ologist. Both must understand the indication of the proposed examinations and all special circumstances that (i) to prolong life at optimal conditions, including good health and an improved quality of life; may increase the risk. Efforts should be made to avoid (ii) to restore or improve functional abilities; examinations that will not change the treatment. Results (iii) to lessen the patient's discomfort caused by the disease and during diagnostic and therapeutic proTable 2. Examples for modified diagnostic procedures. cedures; and (iv) to alleviate the course of the illness, if recovery 1. Replacement of conventional radiologic examinations by is impossible. alternative methods Many therapeutic procedures are associated with diaggastro-intestinal tract barium endoscopy nostic imaging: for example, the treatment of a femoral gall ducts and bladder cholegraphy ultrasound neck fracture which is a frequent injury occurring in kidney urography ultrasound elderly persons, especially in older women. The method hip dysplasy (children) X ray ultrasound of nailing the fractured femoral neck has reduced the in-patient time to about 7 days and also the complication 2. Diagnosis by other radiological methods rate, due to the shorter confinement in bed. Nevertheless, death from a fractured femoral neck still contribangiography CT, NMR brain utes by about 0.7% to the overall mortality rate"01. myelography CT, NMR spinal cord Special therapeutic procedures connected with invasX ray nuclear med. vertebral column (metast.) ive diagnostic techniques are performed by various imaging methods that were improved by the recent 3. Introduction of new radiological examination methods development of digital image processing. These techniques are known as invasive or interventional radipercutaneous needle biopsy ology. The methods are often associated with high doses fine needle cholangiography to the patient and radiologist; they include: percutaneous transhepatic cholangiography endoscopic retrograde cholangiopancreatography (i) percutaneous transluminal angioplasty; (ii) therapeutic vascular radiology, e.g. embolisation, 4. Diagnostic procedures in combination with therapeutic different forms of infusion techniques and treatmeasures ment of vasospastic disorders; (iii) percutaneous lithotripsy""; percutaneous transluminal angioplasty (iv) biliary stone basketing; and therapeutic vascular radiology (v) foreign body extraction. percutaneous lithotripsy removal of foreign bodies While most of those procedures were relatively rarely applied in most institutions, the performance of percutaneous transluminal angioplasty, mainly transluminal Barium meal coronary angioplasty, has grown considerably since its introduction in 1977. In the United States, more than 133,000 procedures were performed in 1986"2). In 1990, therapeutic procedures had doubled and by now are in common practice. Numerous publications report that in all groups studied after a successful bypass operation or angioplasty, there was a significant survival rate taking the risks from surgery or angioplasty into account. Generally, the risks from percutaneous transluminar angioplasty are lower than from surgery, in spite 1960 1963 1966 1969 1972 1975 1978 1981 1984 1987 1990 of the high level of radiation exposure involved. AngioYear plasty requires less hospitalisation time, allows for outFigure 4. Percentage of diagnostic examinations as a function patient care and usually does not disturb existing collateral vascular pathways. Data on radiation exposure of years. 16

TRENDS IN X RAY DIAGNOSIS AND NUCLEAR MEDICINE show that sometimes the radiation exposure from these approach to procedures that will ensure a maximum special procedures is rather high, due to the fluoroscopic level of performance by the physician as well as the part of treatment. This procedure requires about 15 min imaging facility, requires much time until the maximum of fluoroscopy and 5 to 10 s of cinematography. Gray"31 possible benefit to patient care is achieved in practice. reported an average fluoroscopic time for angioplasty of (3) Dose constraints. ICRP recommended in 1990'211 31.3 min and for laser angioplasty of 43.8 min. Accordto introduce dose constraints in diagnostic radiology. ing to relevant reports, the dose from fluoroscopic and The philosophy is extensively discussed in several radiographic components varies between procedures and publications, such as the HHS recommendations to hospitals. The procedure involves mainly fluoroscopy evaluate the radiation exposure from radiodiagnostic for extensive and precise manoeuvring of the catheter examinations'221 and the working document on quality which, according to our own assessments, requires an criteria for diagnostic radiographic images, annexed average fluoroscopic time of about 15 min but, in comguidelines on radiation dose to the patient'231. The introplicated cases, up to 100 min and more. Average radiduction of dose measurements, as for example recation exposure doses are also reported by several ommended by the UK Institute of Physical Science in authors, for example in the cardiac dosimetry study by Medicine together with NRPB and the College of 41 Gray" . Radiographers'241 is, however, very difficult since there Special attention must be focussed on the correct indi- is a lack of knowledge in dosimetry on the part of physcation for diagnostic exposure prior to employment and icians and supporting staff and a lack of general stanon health programmes designed to reduce the level of dards for controlling radiation exposure sufficiently in health impairment in special occupational groups. most member states of the community. Trends in radiation exposure The radiation dose is usually based on the measured entrance skin dose or calculated integral dose. Detailed comparisons between many studies are hampered because of differences in dose measurement techniques and differences in calculation models used to derive skin exposure doses. Only overall exposure trends observed during the past decades are presented here. Average factors of influence on radiation exposure are: (1) Indication. Pursuant to the recommendations of the International Commission on Radiological Protection, unnecessary examinations tend to be avoided. During the 1970s and early 1980s several studies on efficacy had been performed. The results are reflected in several international and national recommendations. The most important are technical reports from WHO on a rational approach to radiodiagnostic investigations"51, the rational use of diagnostic imaging in paediatrics"6' and the effective choices for diagnostic imaging in clinical practice"71. Although these publications are still timely, it is nevertheless extremely necessary to continue with such reviews. Still, after about 10 years, many procedures continue to be performed in spite of evidence that proves their futility. (2) Quality control measures. WHO in its reports on efficacy and efficiency is underlining the need for quality assurance and quality control. The organisation has published several reports during the early 1980s, for example Quality Assurance in Diagnostic Radiology"81 and Quality Assurance in Nuclear Medicine"91. The obligation for quality control at regular intervals is stated in the medical directive of the Commission of the European Communities'201. However, as is the case with all programmes, the concept of providing a systematic
17

The following is a general review of some trends and efforts to reduce the radiation exposure to patients. The major factors influencing radiation exposure are: ( 1 ) The dose from modern image recording systems by introducing new film-rare earth screen systems or recording the radiographic pattern by image intensifier systems (photofluorospot films and cine films). The typical film-screen entrance dose and image intensifier dose should now be in the range of 0.1-0.4 Gy, depending on the speed class of the film-screen system or the image intensifier size and film speed requirements'251. The entrance exposure is often much higher, due to other than optimised conditions. (2) The dose from computed tomography units. Also in this area, the growth and importance of diagnosis makes it necessary to elaborate on guidelines for referai criteria and the performance of examinations. Examples are given in the guidelines of the German medical board on quality assurance in X ray diagnostics'261 and in computed tomography'271. The exposure to the patient is strongly influenced by the applied technique. CT is a potentially high patient dose source'281. (3) Dose from certain digital imaging methods. The exposure due to digital subtraction angiography depends on the radiographic unit used, the time of the radiographic examination, the entrance dose rate used at the image intensifier and the type of unit. This examination technique may also be a potentially high dose source'29,301. (4) Dose to the patient from fluoroscopic systems. The standard fluoroscopic exposure rate, measured as the dose in front of the image intensifier should be within the range of 0.17 Gy.s-1 for adults and 0.087 Gy.s- | for children. Data from exposure rate measurements show that this value is exceeded in most cases'311.

F.-E. STIEVE (5) Finally, the photographic quality of the recording systems. Several publications report that the radiographic speed varies within a range of four and more due to processing conditions132"341. This accounts for the general requirement that 'all installations in use must be kept under strict surveillance with regard to radiological protection and the quality control of applicants' (CEC directive of 3 September 19841201). Great variations also exist in the assessment of the radiograph. The retake analysis depends on many factors sometimes on those not related to quality but to the personal clinical experience of the viewer and, sometimes, there are financial considerations. The German legislature on radiation protection contains a paragraph stating that not only the installation needs to be controlled but also the diagnostic quality of the resulting radiographs produced by the physician or radiographer1351. The results from such independent screening of radiographs are shown in Table 3. The analysis demonstrates that about 4% of the radiographs submitted to the Commission are considered as unsuitable or useless for diagnostic purposes'361. Important objections are errors in exposure, positioning, resolution and radiation protection. Such evaluations result in the decision to put an installation not meeting the specified criteria out of operation and for the physicians to withdraw the license to perform radiographic examinations. One problem seems to remain unsolved and probably inhibits any change in the decision on the use of a desired diagnostic technology. It is that of a great number of practising physicians performing their own radiodiagnostic or nuclear medicine diagnostic procedures on self-referred patients. Also, in other fields of medicine the evidence has accumulated that self-referral may be associated with the over-use of both diagnostic procedures and therapeutic interventions'371. This may also explain differences in the frequency of radiological procedures within the European nations. In countries where those procedures are principally performed by specialists, for example by radiologists, the frequency is much lower than in countries where the indication for an examination is decided by physicians performing their own procedures. Table 3. Results of quality control of radiographs according to the regulations in the German X ray Ordinance.
Analysis judgement 1989 1992

Training and education The International Commission on Radiological Protection emphatically recommends that 'no person shall operate radiological equipment without adequate technical competence or perform radiological procedures without adequate knowledge of the physical properties and harmful effects of ionising radiation'138'. This calls for an adequate theoretical and practical training in radiation protection and in indicated techniques applied in medical diagnostic radiology and nuclear medicine. It is often overlooked that in most European countries a great number of examinations are performed on the responsibility of general practitioners who may have sufficient knowledge and experience in their field but are not competent in radiation protection, radiobiology or in appropriate radiographic techniques. The same situation applies also to the operators, radiographers, technicians and often to persons operating the equipment in private offices and also in hospitals. Such persons could be untrained or self-trained, using the equipment and having little or no understanding of the criteria applying to diagnostic imaging methods. It should not be overlooked that a relatively high percentage of examinations are performed by the physician himself. This means that physicians must also be trained in radiographic exposure, in positioning, in quality assurance and in quality control. Quality assurance programmes are meant to optimise the diagnosis and thus patient treatment. Teaching programmes should be developed and training aids provided in the local language in order to help in the education of radiation operators. The manuals from the World Health Organization are a good example of training aids1391. The main groups to be trained and educated are listed in Table 4. CONCLUSIONS In evaluating trends in X ray and nuclear medicine diagnosis, it is important to be aware of the growing life expectancy, characterised by low mortality and low fertility rates, by changes in the state of health and the cure of diseases. New and promising technologies Table 4. Training and education of all persons who work with radiation in the medical profession. 1. Radiologists and other practitioners qualified to perform medical radiological and nuclear medical examinations. 2. Medical or health physicists. 3. Radiographers and medical technical assistants. 4. Users without qualification. 5. Nurses. 6. Qualified experts, engineers and maintenance workers.

(%)
Without objections Minor objections Grave objections Unsuitable No analysis 51.9 28.5 12.1 6.4 I.I 62.7 22.0 9.8 4.0 1.4

18

TRENDS IN X RAY DIAGNOSIS AND NUCLEAR MEDICINE applied in the care of patients with different and possibly fatal diseases have greatly expanded the diagnostic and therapeutic instrumentation for preventing, diagnosing and treating diseases or for alleviatmg the course of disease. Nevertheless, it is prudent to ranonahse the medical care system by identifying what has proved to be effective and beneficial for the patient and the community and what is not advantageous and is unproductve Many physicians believe that the complication rate and risk from the examination itself for example in arteriography and therapeutic vascular radiology from the introduction of foreign substances into the various body organs and tissues is much higher than the risk from the radiation exposure. The consequences may be that the radiation risk is neglected. ICRP in its 1990 recommendations 12 " summarises thus: 'Less attention has been given to the optimization of protection in medical exposure than in most other applications of radiation sources. As a result, there is a considerable scope for dose reductions in diagnostic radiology. Simple, low cost measures are available for reducing the dose without loss of diagREFERENCES 1. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR). Sources and Effects of Ionizing Radiation. UNSCEAR 1993 Report to the General Assembly, with Scientific Annexes (New York: United Nations) (1993). 2. World Health Organization, Regional Office for Europe. Copenhagen. Demographic Trends in the European Region. WHO Regional Publications, European Series No. 17 (Geneva: World Health Organization) (1984). 3. Statistical Office of the European Communities. Demographic Statistics 1993. (EUROSTAT, Luxembourg/Brussels) (1993). 4. Bundesministerium fr Gesundheit. Daten des Gesundheitswesens. Ausgabe 1991 (Nomos Verlagsgesellschafl, BadenBaden) (1991). 5. Bayerisches Staatsministerium des Inneren und fr Arbeit, Familie und Sozialordnung. Bericht ber das bayerische Gesundheitswesen fr das Jahr 1991. 99. Band (Bayerisches Landesamt fr Statistik und Datenverarbeitung. Mnchen) (1993). 6. Brckcl, K. W. Krankheit und Aller. In: Grundzge der Geriatrie (Munich-Berlin-Vienna: Urban & Schwarzenberg) (1975). 7. Kalimo, E. et al. Health and Health Care of the Elderly Population in Finland. In: Geron XXII Yearbook 1978-1979 (Societas Geronlologica Fennica, Helsinki) (1980). 8. Statistisches Bundesamt. Statistisches Jahrbuch 1993 (Metzler. Poeschi. Weisbaden) (1993). 9. Bayerisches Staatsministerium des Inneren und fr Arbeit und Sozialordnung. Bericht ber das bayerische Gesundheitswesen fr das Jahr 1977. 85. Band (Bayerisches Statistisches Landesamt Mnchen) (1978). 10. Statistisches Bundesamt. Statistisches Jahrbuch 1992. Pos. 820 (Metzler. Poeschi. Weisbaden) (1992). 11. Chaussy C. H., Brendl. W. and Schmiedl. E. Extracorporallv Induced Destruction of Kidney Stones b\ Shockwaves. Lancet 11, 1265-1267 (1980). 12. King III. Sp. B. and Talley, J. D. Coronary Arteriography and Percutaneous Transluminal Coronary Angioplasty. Circulation 79 (Supplement I) 19-23 (1989). 13. Gray. J. E. Fluoroscopic Systems Control. Evaluation and Performance. In: Proc. ACR/FDA Workshop on Fluoroscopy. Washington. DC. pp. 14-15 (1992). 14. Gray. J. E. Cardiac Dosimetry '91 in Fluoroscopic System Control. Evaluation, and Performance. In: Proc. ACR/FDA Workshop on Fluoroscopy. Washington. DC. pp. 101-106 (1992). 15. World Health Organization. A Rational Approach to Radiographic Investigations. Technical Report Series 689 (Geneva: WHO) (1983). 16. World Health Organization. Rational Use of Diagnostic Imaging in Paediatrics. Technical Report Series 757 (Geneva: WHO) (1987). 17. World Health Organization. Effective Choices for Diagnostic Imaging in Clinical Practice. Technical Report Scries 795 (Geneva: WHO) (1990). 19 nostic information. But the extent to which such measures are used varies widely.' T h e p r e s e n t a t i o n o f t r e n d s d e m 0 n s t r a t e s that there are em d o s e b a fac. sti|, a d t e m e a n s t r e d u c e t h e t o r o f ( w 0 Qr m o r e T h e m a i n f a c t o r s m ^ j ^ . rad
ation exposures are:

(') (") ("0

('v>

(v)

evaluation of efficacy and efficiency studies and their subsequent use in diagnosis and therapy; g e n e r a l introduction of quality assurance programmes; development of guides for an effective choice and rational use of diagnostic imaging in clinical practice including all management practices instituted Dv m e imaging physician; recommendation of methods for patient dose measurement suitable for use in radiographic and fluoroscopic X ray examinations and in diagnostic nuclear medicine; continued education and training of all persons employed in the performance of radiological examnations with the goal of minimising errors and maintaining a high level of criteria that determine the diagnostic quality and the dose to the patient.

F.E. STIEVE 18. World Health Organization. Quality Assurance in Diagnostic Radiology (Geneva: WHO) (1982). 19. World Health Organization. Quality Assurance in Nuclear Medicine (Geneva: WHO) (1982). 20. European Communities. Council Directive of 3 September 1984, laying down basis measures for the radiation protection of persons undergoing medical examination or treatment. Off. Journal L. 265 Vol. 27, 5 Okt (1994). 21. International Commission on Radiological Protection. 1990 Recommendations of the International Commission on Radiologi cal Protection (Oxford: Pergamon Press) (1991). 22. Center for Devices and Radiological Health. Recommendations for Evaluation of Radiation Exposure from D iagnostic Radi ology Examinations (US Department of Health and Human Services) HHS Publication (FDA ) 858247 (1985). 23. Commission of the European Communities. Quality Criteria for D iagnostic Radiographic Images. Working Document, 2nd Edn. June 1990. CEC, GD XII/D/3. (1990). 24. Institute of Physical Sciences in Medicine, National Radiological Protection Board, College of Radiographers. National Protocol for Patient D ose Measurements in Diagnostic Radiology. NRPB, Chilton, Didcot, Oxon (1992). 25. Stieve, F.E. Messtechnische Anforderungen an die Patientendosimetrie: In: Strahlenschutz: Physik und Messtechnik, 26. Jahrestagung des Fachverbandes fr Strahlenschutz Karlsruhe, 24. bis 26. Mai 1994 pp. 6991 (Kln: TV Rheinland) (1994). 26. Bundesrztekammer. Leitlinien der Bundesrztekammer zur Qualittssicherung in der Rntgendiagnostik. Deutsches rztebl. 86: C. 12591266 (1989). 27. Bundesrztekammer. Leitlinien der Bundesrztekammer zur Qualittssicherung in der Computertomographie. Deutsches rz tebl. 89: C23672375 (1992). 28. National Radiological Protection Board. Protection of the Patient in Xray Computed Tomography. Documents of the NRPB 3(4) (1992). 29. Busch, H. P. and Georgi, M. (eds) D igital Radiography. Clinical Experiences with D igital Image Intensifier and Storage Phosphor Radiography (Berlin: Blackwell Wissensch) (1992). 30. Zeitler, E. and Schmidt, Th. Strahlenexposition bei der D igitalen Subtraktionsangiographie (Berlin: Springer) (1987). 31. Schfer, . ., Eder, . Wahl, . and Vrana, E. Unnecessary Exposure due to Incorrect Use of Radiological Equiment. In: Patient Exposure to Radiation in Medical Xray Diagnosis. Eds. G. Drexler et al. Commission of the European Communities EUR 7438 EN: 217226 CEC (Luxemburg: CEC) (1981). 32. Gray, J. E. and Stevens, E. Ch. Photographic Quality Assurance in Diagnostic Radiology, Nuclear Medicine and Radiation Therapy. Volume I. HEW Publication (FDA ) 768043 (US Department of Health, Education and Welfare, Rockville, USA) (1974). 33. Gray, J. E. Volume 2: Photographic Processing Quality Assurance and Evaluation of Photographic Material. HEW Publi cation (FDA ) 778028 (1978). 34. Hjardemaal, E., Sorensen, E. and Westergaard, . Investigation of the Connection between D ose to the Patient and the Developing Process in Xray D epartments. (National Institute for Radiation Protection, Bronshoj. Dnemark) (1987). 35. Verordnung ber den Schutz vor Schden durch Rntgenstrahlen (RntgenverordnungRV) vom 8. Januar 1987. Bundesges. BLI: 114 1133 vom 14. Januar 1987 (1987). 36. Reindl, P. and Boer, S. Ergebnisse und Erfahrungen der Qualittskontrolle (19801987) nach den Bestimmungen der KV Bayerns. In: Bildqualitt in der Rntgendiagnostik. Eds. H. St. Stender and F.E. Stieve pp. 11571160 (Deutscher rztever lag, Kln) (1990). 37. Reiman, A .S. 'Selfreferral': What's at stake? . Engl. J. Med. 327, 15221524 (1992). 38. International Commission on Radiological Protection. Protection of the Patient in D iagnostic Radiology. ICRP Pubi. 34 (Oxford: Pergamon Press) (1982). 39. World Health Organization. World Health Organization Basic Radiological System; Manual on Radiographic Technique (Geneva: WHO) (1986).

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Radiation Protection Dosimetry Vol. 57, Nos. 1-4, pp. 21-26 (1995) Nuclear Technology Publishing

INTER-LABORATORY COMPARISON OF IMAGING DEVICES IN NUCLEAR MEDICINE


H. Bergmann Department of Biomedical Engineering and Physics Vienna University Hospital, Waehringer Guertel 18-20, A-1090 Vienna, Austria INVITED PAPER Abstract Inter-laboratocy comparison studies (proficiency testing) are primarily used to review internal quality control programmes. A useful side effect is to stimulate me inter-convertibility of data from different laboratories. Imaging devices are compared either by evaluating physical performance parameters characterising imaging quality or by comparing test images made of suitable test objects (phantoms). Thefirstapproach is used when comparing imaging devices with closely matching performance, a situation usually found only when selecting equipment. The latter method is used when comparing imaging devices with considerably varying performance, which is me situation encountered in proficiency testing. A major difficulty is the need to compare and rank objectively the quality of the test images produced. An accepted method is based on ROC methodology and has been employed successfully in the field of nuclear medicine for inter-laboratory comparison studies of the performance of gamma cameras. More recently analysis software used for digital image processing in medicine has been identified as an area where inter-laboratory comparison studies are needed. Here the most promising approach is to analyse representative patient studies (software phantoms) by the software to be tested and to compare die results obtained with either true values, if known, or by statistical methods. Difficulties that still need to be resolved are the transfer of patient studies between dissimilar computer systems or to define methods for identifying studies that are representative for a given type of procedure and disease. The latter problem is closelyrelatedto standardisation. A European scientific project named COST B2 was created exclusively for producing such software phantoms and other tools to enable proficiency testing of software used to analyse medical images. INTRODUCTION The quality management system (QMS) of a medical diagnostic system consists of several components, all of which contribute to the final quality of the outcome of the diagnostic test. These include referral practice of the referring physicians, training of the personnel carrying out the tests, and technical factors involved in a test. The technical components of a test in nuclear medicine typically contain the following items: (i) instrumentation, (ii) radiotracer, (iii) acquisition protocol including patient preparation and data collection, (iv) data analysis, and (v) presentation of results. While all of these components contribute to the overall quality of the technical part of a study, the first two have attracted most attention, since they have the biggest influence on the quality of a test. The need for quality control (QC) has been early recognised in the development of nuclear medicine (NM) instrumentation. A survey of imaging instruments carried out by the British Institute of Radiology in 1972, in which a test phantom containing a radioactive solution, the Williams phantom, was imaged with scintillation cameras or rectilinear scanners, revealed gross differences in the performance of the instruments"1. These and similar findings from surveys of activity meters in the United States'21 have been responsible for an early interest in the nuclear medicine community to find methods to ensure the adequate function of the imaging instruments used.
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Routine quality control of an imaging device consists of: (a) internal quality control procedures, usually performed by the user, and (b) external quality control or proficiency testing, usually taking the form of an inter-laboratory comparison study and performed by an organisation independent of the participants. Internal quality control has been the subject of numerous scientific papers and is at present well documented in several guidelines and standards published by both national professional organisations'3-71 and international standards' organisations'81. At least one country, Germany, issued legislation which requires that internal quality control for complex equipment in nuclear medicine and diagnostic radiology be performed regularly and compulsorily'91. External quality control is used to review periodically the efficiency of internal quality control programmes. An important side effect is to demonstrate and bring into continued awareness the usefulness of an internal QC programme to all staff members involved. An accepted method for external review is the regular participation of a laboratory in inter-laboratory comparison studies. The first to develop systematic survey programmes for imaging equipment was the College of American Pathologists (CAP), which through its nuclear medicine resource committee chaired by Dr N. Herrera, has car-

H. BERGMANN

ried out such surveys in the field of nuclear medicine since 1971'" 1 " 1 . Inter-laboratory comparison studies outside the United States started essentially with studies stimulated by the WHO as a result of a recommendation during a meeting dealing with quality assurance in nuclear medicine in 1981" 2 '. The first pilot studies were carried out in Europe with the help of the CAP in 1984"31 and jointly with the IAEA in 1987"4', which were then extended over large parts of the world"51. There are two methods for comparing the quality of imaging devices. The first one is based on the measurement of a set of typical performance parameters of an imaging device such as spatial resolution and distortion, uniformity, signal-to-noise ratio, etc. A comprehensive evaluation of the quality of an imaging device using performance parameters usually requires sophisticated methods using special test equipment and procedures. Due to the expenses involved in terms of time, expertise and material resources it is therefore regarded as being of limited usefulness for regular inter-laboratory comparison studies. The other method uses the image of a total performance phantom. Characteristic features of the test image are then evaluated in order to assess the quality of a particular imaging device. It is the latter method which is by far the preferred one for inter-laboratory comparison studies. METHODS AND RESULTS Basic considerations An inter-laboratory comparison study of imaging equipment is based on the acquisition and evaluation of images of a test object obtained with the devices under investigation. The test object (phantom) contains a structure unknown to the participants of the study but known to the organiser (administrator) of the survey. Test objects and structures of a variety of designs have been used. The devices participating in a study are used to produce images of identical phantoms. Each image is evaluated, usually by the participant, following accurately defined criteria. An index of performance is then calculated for each instrument based on the data of the evaluation of the test image. The calculation requires knowledge about the internal structure of the phantom. It is therefore carried out by the organiser of the test. The index of performance is ideally a number increasing strictly monotonously with image quality, so that it can be used to compare the quality of imaging devices against each other. Image quality and radioactivity in the object to be imaged are closely related. It is therefore necessary to use an experimental set-up in the inter-laboratory comparison study mimicking the clinical imaging situation, since the latter is always characterised by a compromise between the administered dose and the radiation dose to
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the patient. This has been achieved by suitable design of the emission phantoms, i.e. by use of amounts of radioactive material comparable to the amounts present in a patient, and by requesting that the acquisition parameters for imaging the phantom should be chosen similarly to those of a clinical study. Early studies The first systematic attempts described by Herrera et al used various emission type phantoms, in which targets were generated using long-lived radioactive material such as "Co"" 1 . The next generation of phantoms contained absorbing structures but no radioactivity. Images were produced by placing the phantom between the gamma camera and a uniform source containing radioactive material. Phantoms with a variety of targets differing in size, location and contrast were readily produced by using different absorbing materials"113"161. As an example, the structure of the simulated anatomical liver phantom (SALP) used in the joint IAEA/WHO survey of 1985 is shown in Figure 1 together with a typical test image of the SALP obtained by a gamma camera. Both emission and transmission type phantoms were designed as either simple geometric structures or as anthropomorphic phantoms, the latter trying to simulate a clinical imaging situation. The desired outcome of an inter-laboratory comparison study is a ranking of the performance of the imaging devices participating in the study. This requires extraction of an index of performance from an image of the test object. All methods used rely on the evaluation of the test image by the participant. The evaluation task essentially consists of detecting targets in the image. Early evaluation methods were based on simply counting the number of true positive findings. Participants with the same number of true positive values were further ranked according to the number of false positive findings in the image"31. This method cannot account for varying decision thresholds of different observers, meaning that no useful distinction can be made between a conservative report with both few true positives and few false positives and a lenient report with many more true positives and at the same time necessarily many more false positives. ROC analysis An established technique to account for different decision thresholds is to generate a receiver operating characteristic (ROC) curve. The typical conventional ROC curve is obtained as a plot of true positive fraction against false positive fraction in a detection task in which a decision about the presence or absence of a target has to be made. Individual points of the curve correspond to individual observers with different decision thresholds"7'. The area under the ROC curve

INTERLABORATORY IMAGING DEVICES INTERCOMPARISON lies between 1 (or 100%) indicating perfect detection Figure 2 shows the evaluation result of a test image and 0.5 (or 50%) indicating real guess work. obtained from the SA LP. ROC methodology was employed successfully in sev Using the 'rating method'"71 it is then possible to eral more recent interlaboratory comparison construct an ROC curve for each such test image. Com studies" 5 "'"* 1 '". The evaluation task used in these stud putation of the area under the ROC curve for which ies consisted not only in detecting the targets, but also several methods have been proposed12"211 then produces in assigning to each area of a test image a rating an index of performance for a particular test image, reflecting the probability of the presence or absence of which is free from observer bias. a target. To this end, the test image was divided by a ROC curve analyses of test images based on the coordinate grid into small squares. For each of the graded rating method were shown to produce perform squares a graded decision had to be made. Most fre ance indices useful for the purposes of an interlabora quently four grades were assigned: I target definitely tory comparison"1". It should be emphasised that ROC not present, 2 target probably absent, 3 target curve values are well suited not only to characterise probably present and 4 target definitely present. individual imaging devices but also to analyse the performance of groups, as demonstrated in several publications"516191.
x~ A B C D E F G H

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Liver outline

Data analysis and presentation An essential feature of interlaboratory comparison studies is the feedback to the participant. This is achieved by firstly revealing the structure of the phan tom together with the results of the participants' evalu ation (Figure 2) and secondly by ranking the perform ance index achieved by the participant's imaging equipment against the ranking statistics of all parti cipants. This is conveniently done by displaying the per formance of a group as a frequency histogram, in which the participants' result is specifically marked (Figure 3). Group analysis of image quality data provides other useful statistical information. A s an example. Table I displays group ROC curves of different countries parti cipating in the IA EA /WHO interlaboratory comparison study"5'. A part from the fact that considerable differ

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Figure I. Internal structure of simulated anatomical liver phan tom (SA LP) showing position and absorbance values of the circular targets (a), and representative image of the SA LP obtained by a gamma camera, also indicating the coordinate grid used for image evaluation according to ihc graded rating method (b).
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Figure 2. Result of the evaluation of a lest image as obtained by participant. Individual rating values arc printed on the struc ture of the phantom. Sheet is returned to the participant.

H. BERGMANN enees between group ROC areas of individual countries are clearly noticed it is also obvious that some geographical regions perform on average better than others. These findings constitute useful information for future planning of activities by pinpointing regions of poor performance. In addition to the evaluation of the performance of the devices under study an inter-laboratory comparison study includes a questionnaire, which asks technical details of the imaging device used and other information relevant to the assessment of the quality management system. The latter information typically contains questions about the frequency of routine quality control procedures carried out in the participating laboratory, details of the acquisition procedure for obtaining the phantom image, representative phantom and QC images and so forth. Two examples of useful results, again taken from the IAEA/WHO inter-laboratory comparison study, are given in Figures 4 and 5. Dynamic studies and software quality The introduction of new imaging modalities and techniques in nuclear medicine required additional types of total performance phantoms. The special case of ECG

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Area under ROC Curve (%)

Figure 3. Histogram of ROC areas of participants of European region of IAEA/WHO inter-laboratory comparison study. A total of 242 gamma cameras have been evaluated. Crosshatched pattern marks position of ROC area for image evaluation of Figure 2. Sheet is returned to participant.

Daily

Weekly

Monthly

Never

Other

Table 1. Areas under ROC curve for participating countries in IAEA/WHO survey. Countries are identified by numbers to ensure anonymity. Areas are given in per cent. Europe Asia Latin America Mediterranean/ Middle East

Figure 4. Frequency of uniformity testing classified according to geographical regions of IAEA/WHO survey. The data were collected from a total of 331 laboratories (Asia 114, Europe 151, Latin America 61, Middle East 5).

Country No 1 95.0 2 91.8 3 91.6 4 90.3 5 89.7 6 89.2 7 89.1 8 87.7 87.4 9 10 86.8 86.4 11 12 83.5 80.9 13 14 78.8 15 76.9

91.1 90.8 90.8 89.0 87.5 86.3 86.2 84.4 76.4 73.7

85.6 85.5 84.0 83.8 82.3

84.7 81.8 51.8

Tc-flood

Co-flood

Tc-point

Figure 5. Source used for uniformity testing classified according to geographical regions of IAEA/WHO survey.
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INTER-LABORATORY IMAGING DEVICES INTERCOMPARISON triggered gated acquisition of the motion of the cardiac the results of the analysis on the positioning of regions, blood pool gave rise to the production of several on the severity of disease or on the location of abnordynamic cardiac phantoms such as the Vanderbilt phan- malities which are difficult to compare quantitatively tom*, the Jake phantom*, the Veenstra phantom* and have not yet been investigated systematically. Nevertheless, even the global figures for ejection fraction clearly the Danbury heart phantom'221. Another development at present going on in nuclear showed large variations for one and the same study or medicine is the use of so-called software phantoms for phantom not only for analysis programs of different 271 inter-laboratory comparison studies. Software phantoms manufacturers' , but even for different versions of an 1281 are representative patient studies taking the form of digi- analysis program of the same manufacturer , thereby tal images. They can be used in a variety of ways to indicating the need for further improvements. test reconstruction and analysis software. A special European project was created in 1988 under the name CONCLUSIONS COST B2, where COST stands for Co-operation in SciInter-laboratory comparison studies permit us to ence and Technology. The project is entitled 'Quality assess objectively and compare imaging systems which 23 241 Assurance of Nuclear Medicine Software'' . One main objective is to produce organ-based software phan- are of the same type. The use of total performance phantoms, i.e. representative patient studies. At present re- toms requires no special instrumentation. Some presentative patient studies in the areas of functional additional training of the participant regarding the renal studies, gated cardiac blood pool studies, SPECT evaluation task may be required. The feedback given to studies of the myocardium, SPECT studies of the brain the participant demonstrates his position within the peer and bone scintigrams are being collected under carefully group. It helps to identify poor performance of an instrumonitored clinical conditions (see e.g. Ref. 25). Another ment and thereby helps in improving performance by main aim of the project is to design and implement proper service or by replacing the device. Also, it methods for inter-laboratory comparison studies using increases the motivation to perform internal quality consuch software phantoms. The main challenge here is to trol. Finally, health authorities obtain valuable statistical distribute and use the phantoms in a form accepted by information for planning purposes. Some problems are still associated with inter-laborathe different computer systems used in nuclear medicine. To this end a standard file transfer format called tory comparison studies using test images from test Interfile, which is specially suited for digital nuclear phantoms. It is difficult to distinguish clearly between the quality of the imaging device and the performance medicine images, was developed'261. of the person evaluating the test image. It is safe to Up to now dynamic phantoms and software phantoms assume, however, that experienced persons perform the have been used primarily to validate analysis software evaluation with the same degrees of accuracy, so that of gated cardiac blood pool studies. Comparisons were when taking into account removal of the observer bias made by looking at the values of the ejection fraction by the ROC method, it is in fact the performance of the obtained from the phantom study by a particular proimaging device which is the subject of the comparison. gram or computer system. More detailed aspects of a Another criticism is that the evaluation task differs from particular analysis software such as the dependence of the clinical situation. Finally, follow-up studies to estimate the precision of the test cannot be made with cur*Vanderbilt phantom, Amersham Corp., UK. Jake phantom, rent phantom technology. For such studies a series of ADC Medical, USA. Veenstra phantom, Veenstra Instru- phantoms with slightly different structures would be needed. menten, The Netherlands.

REFERENCES 1. Rogers, R. T. A Survey of Images of a Phantom Produced by Radioisotope Scanners and Cameras. Special Report No 9 (London: British Institute of Radiology) (1976). 2. Hauser, W. The 1972 Nuclear Medicine Survey. Am. J. Clin. Pathol. 61, 943-946 (1974). 3. AAPM. Computer-aided Scintillation Camera Acceptance Testing. American Association of Physicists in Medicine Report No 9 (New York: American Institute of Physics) (1981). 4. AAPM. Rotating Scintillation Camera SPECT Acceptance Testing and Quality Control. American Association of Physicists in Medicine Report No 22 (New York: American Institute of Physics) (1987). 5. IPSM. Quality Control of Gamma Cameras and Associated Computer Systems. IPSM Report No 66 (York, England: Institute of Physical Sciences in Medicine) (1992). 6. DIN. Quality Control of Nuclear Medicine Instruments; Single Crystal Gamma Camera used in Planar Scintigraphy. Normenausschuss Radiologie im Deutschen Institut fr Normung e.V. Report 6855-3 (Berlin: DIN) (1992). 7. DIN. Quality Control of Nuclear Medicine Instruments; Test Conditions for Anger Type Gamma Cameras with Rotating Detector Heads used in Single Photon Emission Tomography. Normenausschuss Radiologie im Deutschen Institut fr Normung e.V. Report 6855-2 (Berlin: DIN) (1993). 25

H. BERGMANN 8. IA EA . Quality Control of Nuclear Medicine Instruments. IA EA TECDOC602 (Vienna: International A tomic Energy Agency) (1991). 9. Verordnung ber den Schutz vor Schden durch Rntgenstrahlen (Rntgenverordnung RV). Germany, BGBl. I S.1I4 (1987). 10. Hermann, G. ., Herrera, . E. and Hauser, W. Rationale. Techniques and Results of a Quality Control Program of Imaging Procedures. In: Medical Radionuclide Imaging, STI/PUB/440 (Vienna: IA EA ) pp. 5565 (1977). 11. Herrera, . E., Hermann, G. ., Hauser, W. and Paras, P. College of American Pathologists Program Series X Survey Program. In: Medical Radionuclide Imaging 1980 (Vienna: IA EA ) STI/PUB/564, pp. 177181 (1981). 12. World Health Organisation. Quality Assurance in Nuclear Medicine. Guide prepared following a workshop, 1721 November 1980, Heidelberg (Geneva: WHO) (1982). 13. Volodin, V., Souchkevitch, G., Racoveanu, N., Bergmann, H., BusemannSokole, E., Delaloye, ., Dermentzoglou, F., Geor gescu. G., Herrera, . E., Jasinski, W., Kasatkin, Y., Paras, P. and Mould, R. World Health Organisation Interlaboratory Comparison Study in 12 Countries on Quality Performance of Nuclear Medicine Imaging D evices. Eur. J. Nucl. Med. 10, 193197 (1985). 14. Souchkevitch, G. N., Asikainen, M., BumI, ., Bergmann, ., BusemannSokoke, ., Carlsson, C , Delaloye, ., Dermentzo glou, F., Herrera, ., Jasinski, W., Karanfilski, B., Mester, J., Oppelt, ., Perry, J., Skretting, ., van Herk, G., Volodin, V., Wegst, A . and Mould, R. F. The WHO and IAEA Second Interlaboratory Comparison Study in 16 Countries on Quality Performance of Nuclear Medicine Imaging D evices. Eur. J. Nucl. Med. 13, 495501 (1988). 15. Bergmann, ., Wegst, A . V., Ganatra, R. and Souchkevitch, G. N. Interlaboratory Comparison Study of Nuclear Medicine Imaging Devices Results of a Joint IAEA/WHO Quality Control Sun>ey in 43 Countries. In: Medical Physics '87. Ed. H. Bergmann. Proc. A nn. Sci. Meeting OeGMPDGMPEFOMP, Innsbruck 1987, pp. 579589 (1987). 16. Skretting, ., Strandmayr, E. and Lindegaard, M. W. A Norwegian Nationwide Quality Assurance Project in Nuclear Medi cine: Total Performance in Bone Scintigraphy Measured with a New Transmission Phantom. Eur. J. Nucl. Med. 17, 1014 (1990). 17. Metz, C. E. Basic Principles of ROC Analysis. Semin. Nucl. Med. 8, 283289 (1978). 18. Hermann, G. ., Herrera, . and Sugiura, H. T. Comparison of Interlaboratory Survey Data in Terms of Receiver Operating Characteristic (ROC) Indices. J. Nucl. Med. 23, 525531 (1982). 19. Bergmann, H., Hoebart, J. and Kugi, A . External Quality Control of Gamma Cameras Results of an Interlaboratory Comparison Study in Austria. Eur. J. Nucl. Med. 16, 2328 (1990). 20. Dorfman, D. D. and Alf, E. Jr MaximumLikelihood Estimation of Parameters of SignalDetection Theory and Determination of Confidence IntervalsRatingMethod D ata. J. Math. Psychol. 6, 487496 (1969). 21. Hanley, J. A. and McNeil, B. J. The Meaning and Use of the Area under a Receiver Operating Characteristic (ROC) Curve. Radiology 143, 2936 (1982). 22. Herrera, ., Paras, P., Hermann, G. and Marymont, J. Quality Control For Dynamic Studies: the Interlaboratory Comparison Approach for Scintillation CameraComputer Systems. In: Proc. Int. Symp. on A pplications of Dynamic Functional Studies in Nuclear Medicine in Developing Countries. Vienna, 1519 August 1988. (Vienna: IA EA and WHO) pp. 517524 (1989). 23. Britton, K. E. and BusemannSokole, E. COST B2: Why and Wherefore. Eur. J. Nucl. Med. 19, 563568 (1992). 24. Britton, K. E. and Vauramo, E. COST B2: the Quality Assurance of Nuclear Medicine Software. Eur. J. Nucl. Med. 20, 815816 (1993). 25. Bourguignon, M. H., BusemannSokole, E., Jones, B. and van der Wall, E. Protocols for the Selection of Cardiac Radio nuclide Studies for Use as a Data Base of Normal Studies and Typical Patterns of Diseases (COST B2 Working Group II, in association with relevant working/task groups of the European A ssociation of Nuclear Medicine and the European Society of Cardiology). Eur. J. Nucl. Med. 20, 5965 (1993). 26. ToddPokropek, ., Cradduck, T. D. and Deconinck, F. A File Format for the Exchange of Nuclear Medicine D ata: a Specification of Interfile Version 3.3. Nucl. Med. Commun. 13, 673699 (1992). 27. BusemannSokole, E Cradduck, T. D. and Erickson, J. J. Experience with Gated Cardiac Software Phantoms for Quality Control of Applications Programmes. Eur. J. Nucl. Med. 17, 106110 (1990). 28. Vera, P., Gardin, I. and Bok, B. Comparative Study of Three Computer Programs of Left Ventricular Ejection Fraction Evaluations. Eur. J. Nucl. Med. 20, 989 (A 684) (1993).

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Radiation Protection Dosimetry Vol. 57, Nos. 1-4, pp. 27-32 (1995) Nuclear Technology Publishing

WHO AND RATIONAL REDUCTION OF PATIENT DOSE


G. Hanson Radiation Medicine World Health Organization CH-1211 Geneva 27, Switzerland INVITED PAPER Abstract WHO activities aimed at reducing patient dose, while maintaining satisfactory image quality, include rational use of diagnostic imaging, effective choices for examinations, equipment design and specification, quality assurance, and guidance for regulatory authorities and radiological personnel. To assist its Member States in developing a rational policy concerning imaging services WHO provides guidance through publications, its network of Collaborating Centres, and its expert advisers. Because approximately 2/3 of the world's population lacked diagnostic imaging services, early in the 1960s WHO became concerned with basic radiology. After several unsuccessful approaches WHO concentrated on development of the Basic Radiological System (WHO-BRS). Following a workshop held in Neuherberg, Germany, a guide for Quality Assurance in Diagnostic Radiology was published by WHO in 1982. A similar guide for Quality Assurance in Nuclear Medicine was also published in 1982. In collaboration with other international organisations WHO is preparing revised editions of both the Basic Safety Standards for Radiation Protection, and thefive-volumeManual on Radiation Protection in Hospitals and General Practice. Regarding future needs, within any health care system these is a spectrum of imaging requirements ranging from the most essential to the most complex. Issues to be resolved involve the clinical decision-making process through which diagnostic imaging examinations are produced and the optimum mixture of imaging modalities. INTRODUCTION Background The World Health Organization (WHO), a specialised agency of the United Nations, experienced a substantial change in its programme emphasis as a result of the International Conference on Primary Health Care in Alma Ata, USSR, in 1978. The Conference determined that the health of a large portion of the world was unacceptable and concluded that the primary health care approach was imperative"1. Primary health care is essential health care based on practical, scientifically sound and socially acceptable methods and technology. It is concerned with the main health problems in the community and provides services accordingly. Later, the strategy of 'Health for All' was adopted. This is not a single finite target but rather a process leading to the progressive improvement of the people's health. The efforts of WHO, in collaboration with its 189 Member States, to improve access to, and the quality of, essential health care in the developing world are involved with the commonest medical problems. Communicable diseases continue to cause a large percentage of disability and death, but non-communicable diseaes such as cardiovascular diseases and cancer as well as accidents and injuries resulting from mechanisation and industrialisation are becoming a serious cause of morbidity and mortality. Many of the diseases and clinical conditions responsible for the disease burden, e.g. tuberculosis, cancer,
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bronchitis and pneumonia, infections and intestinal diseases, and fractures and other traumatic injuries, could be diagnosed using X rays. However, about two-thirds of the world's population does not have access to the most essential radiodiagnostic services. The fundamental principle of 'Health for All', which is equity, demands that this precious diagnostic tool be made available, and the primary care approach, which advocates that health care be brought as close as possible to where people work and live, if successfully applied to diagnostic radiology, could mean less transport expense, shorter hospitalisation, a quick and accurate diagnosis, prompt return of the patient to home or the workplace and, most importantly, less pain and suffering. Equity must be accompanied by efficacy and efficiency in order to assure that the noble goal of providing equal access does not result in ineffective health care. Hence the need for quality assurance, radiation protection, and the rational use of X rays as well as the rational employment of methods to reduce patient dose. RATIONAL USE OF RADIODIAGNOSTIC PROCEDURES History The concern for unjustified radiological investigations started in the early fifties, when medical irradiation was recognised to be the major source of population exposure to man-made ionising radiation. This continues to be of major concern to many national and international bodies when analysing the

G. HANSON data on X ray investigations and attempting to develop measures to limit their use and consequently to decrease the population dose. Patient and population protection is directly implied when the radiologic investigations are limited only to those clinically justified. Efficacy and efficiency Industrialised countries, which currently carry out between 320 and 1290 X ray examinations per 1000 population per year, differ very little in terms of major health indicators. In some countries where radiological procedures are used in a more restricted way, such as the United Kingdom, no signs of a lower quality of health care have been shown compared with countries where these procedures are used more freely such as Germany and Switzerland'21. WHO has been greatly concerned with the more efficacious use of diagnostic radiology for the following reasons: (1) the escalating use and cost of diagnostic imaging throughout the world, for which there has been no objective justification in terms of health outcome; (2) the rapid changes in imaging technologies, which are increasingly being introduced into practice before a proper evaluation of their overall efficacy, and their effectiveness in terms of an appropriate health care infrastructure, has been made; (3) the very restricted resources which the majority of WHO Member States are able to devote to diagnostic radiology, making its more efficacious use of vital importance. WHO recommendations WHO has played a catalytic role in promoting efficacy studies by organising a number of scientific meetings and issuing in 1983 a publication entitled 'A Rational Approach to Radiodiagnostic Investigations' (TRS 689). This report'31 contains brief and clear recommendations on the clinical indications for major diagnostic X ray investigations and also indicates when radiological investigations are not justified for clinical or epidemiological reasons. The recommendations of WHO TRS 689'31 are directed towards increasing the disease prevalence in the group of patients referred for X ray investigations. By defining clinical signs symptoms indicating a higher probability of obtaining diagnostic information which will affect patient management the report offers a practical means of increasing the predictive value of radiological investigations. The WHO report covers a number of radiodiagnostic investigations such as: (i) those which are most frequently used; (ii) those used for screening (mass chest X ray, mammography, etc.); 28 (iii) those involving a high cost or an increased risk for the patient. It gives clear recommendations on how to rationalise the use of radiodiagnostic investigations in the following areas: chest, skeleton, abdomen. Some examples are given below: Chest X ray Two main categories are considered: (1) Routine chest radiographic examinations such as: (i) on admission to hospital; (ii) of pregnant women; (iii) pre-operative; (iv) mass chest survey of unselected populations; (v) routine survey of selected populations. The recommendations for the chest X ray categories including (i) and (ii) above, are to restrict such examinations to areas where a particular epidemiological condition exists, i.e. high incidence of clinically silent chest diseases. Regarding the pre-operative chest X ray, a careful clinical examination should decide if there is a real need for such an investigation. Since 1974 WHO has recommended the abandonment of mass miniature photo-fluorography as a screening procedure for tuberculosis, and the WHO TRS 689 endorses this policy. Routine chest X rays in selected populations are also unproductive, with the exception of subjects occupationally exposed to respiratory hazards, where the chest X ray could play an important role in detecting early lung changes. (2) Chest examinations in patients for: (a) Tuberculosis In active tuberculous cases, chest X ray should be done when the clinical condition demands and not following an arbitrary time schedule. Failure to complete the drug therapy may be an indication for further chest X ray. Old or chronically ill people should have a chest radiograph before admission to long-term care facilities, but repeated radiographs afterwards are not recommended in the absence of clinical symptoms. (b) Malignant disease Periodic chest radiographs have not shown significant benefits for early detection of lung cancer in symptomfree individuals. In patients with known malignant disease the followup chest radiography should be carried out at intervals determined by the natural history of the primary tumour rather than by an arbitrary time schedule. (c) Children

WHO AND RATIONAL REDUCTION OF PATIENT DOSE There is no evidence that chest X rays are of any Mammography assistance in the care of sick children when there is no The report recognises the usefulness of mammoclinical evidence of cardiopulmonary diseases. graphy, mentioning that the technique should be well controlled. As a screening procedure, this report stated (d) Adults that mammography is justified only in areas with a high Without any evidence of chest disease and in the incidence of breast cancer and only for women over 50 absence of fever, it is unlikely that a chest radiograph years of age. will produce any evidence of significant chest disease After the Scientific Group met, two studies were pubin patients of any age. lished in the United States, the Netherlands and Sweden, indicating that in the age group 40-50 years a large (e) Post-operative number of unpalpable tumours with a definite prognosis Post-operative chest radiography should not be per- can be found. formed as routine in patients with no cardiopulmonary surgery. Obstetric examinations (f ) Cardiovascular disease Due to radiation hazards to mother and embryo or Hypertension, angina and myocardial infarction are fetus, such examinations should be limited to patients better evaluated by clinical investigation rather than with specific clinical indications. Ultrasound is the best chest X rays. method to determine fetal size and maturation, malpositioning, and intrauterine fetal death. Obstetric (g) Acute pneumonia radiography should not be the technique which is used Chest radiographs are indicated only when the patient first, when ultrasound is available. When valid indications exist for obstetric radiography, the examination does not progress satisfactorily. should be restricted to the third trimester and not (h) Chest fluoroscopy repeated. Chest fluoroscopy has very limited clinical use and cannot replace a PA chest radiograph; its indications remain to confirm movement of the diaphragm in the absence of ultrasound, localise foreign bodies or lesions that cannot be adequately identified on PA or lateral films. Chest fluoroscopy produces a much higher patient dose and has a much lower information yield than radiographic images. Skeletal examinations (1) Skull radiography Skull radiography following minor head injuries yields a very low amount of clinically useful information. In adults with recent minor head trauma, asymptomatic or with mild signs and symptoms, no skull radiography is required, but careful observation for an appropriate period should be performed. In infants and children, the greatest risk is for the infant and toddler (0-2 years); the risk diminishes gradually from 2 to 8 years and after 10 years is similar to an adult. A skull radiograph in mild head trauma could, therefore, be indicated in infants, young children and in intoxicated persons. (2) Computed tomography Skull radiography is usually unnecessary prior to CT examination. Headache as the only symptom is not a valid indication for skull radiography. 29 EFFECTIVE CHOICES OF IMAGING PROCEDURES Having accepted that diagnostic imaging is justified, the next issue for consideration is how to choose and conduct the imaging procedures in an optimum manner. Optimum, for the purpose of this deliberation, is defined as: 'A condition, degree, amount, or compromise that produces the best possible result'151. Therefore.within the imaging department a concerted effort must be made to make optimum choices regarding the imaging method, selection of equipment, and protection of the patient, the staff and the public. In addition to guidance on the rational use of radiodiagnostic procedures, WHO has provided guidance on effective choices for diagnostic imaging procedures in clinical practice. This guidance is found in the report, 'Effective Choices for Diagnostic Imaging in Clinical Practice', Technical Report Series 795'61. The objective of this report is to provide clear advice on the sequence for imaging the most common clinical problems taking into account the wide range of professional skills and facilities available in the world. The report is structured on an anatomical basis covering the chest, abdomen, head, the cardiovascular, musculoskeletal, and central nervous system, plus obstetrics, gynaecology and trauma. Nearly 500 published references were utilised by the WHO Scientific Group to produce this authoritative guide. It is realised that the choice of the most effective imaging method is often difficult and frequently it is controversial; that the imaging sequence varies with

G. HANSON many factors: equipment, skills, expected quality of results, quality of interpretation, and the local treatment capabilities. The principle that no patient should be exposed to unnecessary radiation (meaning ineffective or clinically useless exposures) was kept foremost in view in determining the recommended sequence of imaging methods. Three levels of imaging capabilities, ranging from standard radiography to magnetic resonance imaging (MRI) were identified and considered, and standard radiography and general purpose ultrasonography (identified in the report as Level I) were recommended as the minimum acceptable for good patient care. EQUIPMENT DESIGN AND SPECIFICATION Conventional radiography Because approximately two-thirds of the world's population lack diagnostic imaging services, WHO concentrated on development of the Basic Radiological System (WHO-BRS) during the period 1975-1985. The WHO-BRS consists of three training manuals, periodic supervision, and a deceptively simple X ray unit which is rugged and incorporates designed-in features for the production of high quality radiographs and little maintenance. Although WHO had worked on the problem since the early 1960s, attempts to develop an X ray machine that was more suitable to the needs of developing countries than the X ray machines currently available were unsuccessful and by 1970, the consensus of expert opinion was that a more basic X ray unit was required. The broad spectrum of requirements for an essential radiological system was considered, and specifications for a simple, high quality X ray machine were prepared'71. Succinctly, regarding the hardware: the BRS X ray apparatus consists of a high quality X ray generator and X ray tube, together with a high quality focused grid, and a unique tube stand; all of which are linked together in a sophisticated manner to produce an optimum and simple X ray system. The WHO-BRS also includes three training manuals which are an integral part of the system: - Manual of Radiographic Technique'81 - Manual of Darkroom Technique191 - Manual of Radiographic Interpretation General Practitioners'"11. Department of Radiology, serves as a focal point for development of the WHO-BRS. In a recent assessment made by the Department of Health and Social Security of the UK National Health Service, a WHO-BRS type X ray machine was compared with the installed conventional X ray equipment in an 800 bed hospital. The radiologists were not given any indication of which films were from the WHO-BRS type unit as they evaluated radiographs of the chest, abdomen, skull (sinuses and facial bones), spine, pelvis, knee, shoulder, and extremities. Over this wide range of examinations, the images produced by the BRS were judged to be excellent in 20% of the cases as against only 6% for the conventional X ray equipment"". Other evaluations, such as the joint evaluation of the WHO Basic Radiological System by the SIMAVI Foundation, WHO, and the equipment manufacturer have shown that the system performs very well in the environment for which it was produced"21. This on-site evaluation was conducted in 8 out of 13 countries in Africa for which SIMAVI had provided BRS units because it was decided that the only way to obtain reliable information about the performance of the BRS was to visit the local hospitals where it was being used. Quoting from the conclusion of the report of this evaluation: 'This SIMAVI project has clearly shown that there can no longer be any doubt that the WHO/BRS is ideally suited to do the work for which it was designed. The real question is not whether it should be available, but how long it will be before it is available everywhere'. Such a conclusion prompts one to ask what experience has been observed in the industralised countries. Sweden, with easy access to the best technology and equipment available in the marketplace has now installed WHO-BRS type X ray units in more than eight small primary care centres. Over the past 10 yeas more than 400,000 radiographs have been made in about 100,000 patients examinations. To quote from Dr Thure Holm of the Lund University Clinics: 'I have seen many university centres with the same image quality, but none with better image quality than we have with these WHO-BRS machines'. The experiences mentioned above as well as the paradoxical selection of the WHO-BRS by the military medicine services in a number of industralised countries clearly show that the design conceived for the Third World's problems has proven to be the equipment of choice in countries with ample resources but where value for purchase price is an important criterion. Currently the WHO-BRS is produced by several leading manufacturers in the industralised countries and approximately 1000 units are installed in some 60 countries. Efforts are also being made by WHO in collaboration with the United Nations Industrial Development Organization (UNIDO) to promote the manufacturing of the WHO-BRS type X ray machine in developing countries.
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for

In 1980 a testing laboratory for prototype BRS X ray machines was established at the Lund University Clinics (St Lars Roentgen) under the direction of Dr Thure Holm. This laboratory, which is part of the WHO Collaborating Centre for Continuing and General Radiological Education established at the Lund University

WHO AND RATIONAL REDUCTION OF PATIENT DOSE At a Consultation between WHO advisers, represen- Quality Assurance tatives of professional societies, and equipment manuConsidering that better diagnostic imaging should facturers held at the WHO Collaborating Centre for General and Continuing Radiological Education in lead to more accurate diagnoses and better informed Lund, Sweden, in June 1993, the past decade of equip- decisions concerning treatment, the Institute of Radiment development, testing and experience with the ation Hygiene of the Federal Health Office and the WHO-BRS was reviewed and new technical specifi- Society for Radiation and Environmental Research of cations were developed for the improved 'WHO Radio- the Federal Republic of Germany, in collaboration with graphic Unit' (WHIS-RAD) as part of the WHO WHO, organised a workshop on quality assurance Imaging System. Suggestions by radiographers were which was held in Neuherberg in October, 1980. The incorporated to provide simple modifications so that the organisers believed that it was time for a concerted WHIS-RAD would be more suitable not only in the international effort towards a systematic approach and developing world but also in the developed world. specialists from various countries and different backThese included the possibility for angulation of the tube grounds (diagnostic radiology, medical physics and pubhead to facilitate radiographs of patients in traction and lic health administration) were brought together to in the emergency room as well as a standard light-beam exchange views and provide solid recommendations for collimator and a cassette holder capable of accepting routine application in radiologic diagnostic departments. Use by national quality assurance programmes was any standard format. recognised as being necessary for three main objectives: first the improvement of medical diagnostic imaging, secondly cost containment, and thirdly the reduction of Ultrasound and computed tomography radiation exposure. The participants at this meeting identified four specUltrasound and computed tomography are the subific areas where the efforts of international organisations jects of a WHO report entitled 'Future Use of New such as the World Health Organization and the ComImaging Technologies in Developing Countries, Technimission of the European Communities would be effeccal Report Series 723'13). tive: first the collection and publication of comparative This report discusses each technique and outlines the information, secondly recommendations for quality promain clinical indications for their use and specifies the tocols, thirdly training, and fourthly the establishment particular areas where the most benefit can be obtained. of internationally accepted guidelines/criteria for Caution is suggested in view of the limitations of both image quality"41. ultrasound and computed tomography regarding the common diseases of the developing world and it is emphasised that they are an addition to, and not a substi- GUIDANCE FOR REGULATORY AUTHORITIES tute for conventional radiological systems. AND RADIOLOGICAL PERSONNEL The importance of planning, education, and supporting infrastructure (clinical specialists and supporting The International Basic Safety Standards for technical staff, maintenance, and resources for ongoing Protection Against Ionizing Radiation and for the expenses) are emphasised. Neither technique should be Safety of Radiation Sources considered if the necessary resources and staff are not In 1990, an Inter-agency Committee on Radiation available. Regarding ultrasound, at present these units have Safety was established for the direct exchange of inforbecome smaller, less expensive and easier to use, and mation among international organisations concerned diagnostic ultrasound has become increasingly popular with radiation safety. At present, one of the primary at different levels of the health care system. This diag- objectives of the Committee is the revision of the Basic nostic technique has replaced a large number of X ray Safety Standards for Radiation Protection in light of the International Commission and nuclear medicine procedures such as obstetric radi- 1990 recommendations of the 61 ology, liver scanning, and cholecystography. In many on Radiological Protection" . The current edition of the developing countries, diagnostic sonography may find Basic Safety Standards (BSS) for Radiation Protection an important application in a number of parasitic dis- which was jointly sponsored by IAEA, ILO, NEAand WHO, was published as IAEA Safety Series eases such as amoebiasis, schistosomiasis, tumours and OECD 7) No. 9" . A new draft of the revised BSS has been preother lesions located in the abdomen. The usefulness of any ultrasound machine largely pared and is now being circulated for comments. depends on the skill and experience of the operator. According to the WHO report, a general practitioner Manual on Radiation Protection in Hospitals and should perform a minimum of 200 obstetric and abdominal examinations with a general purpose General Practice machine before he or she can be considered to be able The original 'Manual on Radiation Protection in Hosto interpret the studies with any reliability. pitals and General Practice' was published by WHO on
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G. HANSON behalf of the joint sponsors (ILO, IAEA, WHO) during the period 1974-1980 in five volumes (1, Basic Protection Requirements; 2, Unsealed Sources; 3, X ray Diagnosis; 4, Radiation Protection in Dentistry; 5, Personnel Monitoring Services)" 81 . The new, more stringent, 1990 Recommendations by the International Commission on Radiological Protection as well as advances in radiological technology have led to the conclusion that the Manual must be revised, Five organisations have agreed to co-sponsor the new edition (CEC, IAEA, ILO, PAHO, WHO). It is anticipated that the revised edition will be in use during the next 10 to 15 years. . J raising many issues in developing countries. The collaboration of institutions that have special expertise for planning of services and facilities, training, quality assurance, and evaluation of images and results will be invaluable. A related area in which collaboration among centres in developing countries may be more important than with developed countries, involves the rationalisation and optimisation of the mixture of diagnostic imaging modalities. Within any health care system, there is a spectrum of imaging requirements and the need for associated equipment ranging from the most essential such as the WHO-BRS to the most complex such as computed tomography or magnetic resonance imaging. The issues to be resolved are the clinical decision-making process through which diagnostic imaging examinations are produced and the optimum mixture of diagnostic imaging modalities within a health care system.

The new imaging modalities such as ultrasound, computed tomography, and magnetic resonance imaging are REFERENCES

1. WHO/UNICEF. Primary Health Care. Report of Int. Conf. on Primary Health Care, Alma-Ata, USSR, 6-12 September 1978. 2. UNSCEAR. Sources and Effects of Ionizing Radiation. United Nations Scientific Committee on the Effects of Ionizing Radiation. Report to the General Assembly with Scientific Annexes (New York: United Nations) (1993). 3. WHO. A Rational Approach to Radiodiagnostic Investigations. Technical Report Series 689 (Geneva: WHO) (1983). 4. WHO. Rational Use of Diagnostic Imaging in Paediatrics. WHO Technical Report Series 757 (Geneva: WHO) (1987). 5. Collins Dictionary of the English Language, 2nd edn (London and Glasgow: Collins) (1982). 6. WHO. Effective Choices for Diagnostic Imaging in Clinical Practice. Technical Report Series 795 (Geneva: WHO) (1990). 7. WHO. Technical Specifications for the X-Ray Apparatus to be Used in a Basic Radiological System (updated version of January 1985), RAD/85.1, (Geneva: WHO) (1985). 8. Holm, T., Palmer, P. E. S. and Lehtinen, E. Manual of Radiographic Technique (Geneva: WHO) (1986). 9. Palmer, P. E. S. Manual of Darkroom Technique (Geneva: WHO) (1985). 10. Palmer, P. E. S., Cockshott, W. P., Hegedtis, V. and Samuel, E. Manual of Radiographic Interpretation for General Practitioners (Geneva: WHO) (1985). 11. Department of Health and Social Security (United Kingdom). Clinical Evaluation of Siemens Vertix Stand and Polyphos 30 R Generator. NHS Procurement Directorate Report STD/87/1 (London: HMSO) (1987). 12. Agenant, D. M. A. The SIMAVI BRS Project: A Successful WHO Approach. (SIMAVI, Haarlem) (1991). 13. WHO. Future Use of New Imaging Technologies in Developing Countries. Technical Report Series 723 (Geneva: WHO) (1985). 14. WHO. Quality Assurance in Diagnostic Radiology (Geneva: WHO) (1982). 15. WHO. Quality Assurance in Nuclear Medicine (Geneva: WHO) (1982). 16. ICRP. 1990 Recommendations of the International Commission on Radiological Protection. Publication 60 (Oxford: Pergamon Press) (1991). 17. IAEA. Basic Safety Series for Radiation Protection. Safety Series No. 9 (Vienna: IAEA) (1982). 18. WHO. Radiation Protection in Hospitals and General Practice. Volume 1, Basic Protection Requirements (1974). Volume 2, Unsealed Sources ( 1975). Volume 3, X-ray Diagnosis ( 1975). Volume 4, Radiation Protection in Dentistry ( 1977). Volume 5, Personnel Monitoring Services (1980). (Geneva: WHO) (1974-1980).

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Radiation Protection Dosimetry Vol. 57, No. 14, pp. 3371 (1995) Nuclear Technology Publishing

ROUND TA BLE ON INITIATIVES, A CHIEVEMENTS AND PERSPECTIVES WITH REGA RD TO THE COUNCIL DIRECTIVE OF 3 SEPTEMBER 1984 LAYING DOWN BA SIC MEA SURES FOR THE RA DIA TION PROTECTION OF PERSONS UNDERGOING MEDICAL EXA MINA TION OR TREA TMENT
D. Teunen Commission of the European Communities Directorate General Environment, Nuclear Safety and Civil Protection, Radiation Protection and invited contributors from the Member States: A. Wambersie (B), O. Hjardemaal (DK), A. Costa (F), B. Bauer (D), P. Dimitriou (GR) G. O'Reilly (IRL), F. Mazzei and M. Paganini Fioratti (I), C. Back (LUX) J. Zoetelief (NL), A. Ferro de Carvalho (), E. Van (E), S. Ebdon Jackson (UK). INVITED PAPER INTRODUCTION Experts from the 12 Member States will present their experiences with the implementation and the impact of the Council Directive of 3 September 1984* on the pro tection of the patients and further prospects. In revising and updating the Directive setting the Basic Safety Standards for the protection of the general public and of workers in 1980, the Commission became increasingly aware of the need for protection for the third point of the radiation protection triangle as ident ified by the ICRP the patient. Radiation protection of the first two groups the general public and workers was considered as being satisfactory, but the protection of the patient clearly needed specific meas ures to be taken. After a lengthy period of consultation and discussion, a Council Directive on the protection of persons undergoing medical examination or treatment involving ionising radiation was adopted in 1984. The lynchpin of this Directive is that 'all medical exposures must be medically justified and kept as low as reasonably achievable', a requirement based on the principles of justification and optimisation laid down in ICRP Publication 26. The main requirements of the Directive are: (3) establishment of criteria of acceptability for radio logical and nuclear medicine installations; (4) the monitoring of all installations in use with regard to radiological protection and the quality control of appliances; (5) a qualified expert in radiophysics must be available to sophisticated departments of radiotherapy and nuclear medicine; (6) discouragement by Member States of any unnecess ary proliferation of equipment.

What are the consequences of this Directive for the radiological protection of the individual citizen in the European Union (EU)? The Directive by definition is addressed to governments of Member States and is bind ing only as regards the results to be achieved, so that national competent authorities have discretion to decide, in view of their national legal and administrative struc tures, how this.can most effectively be accomplished. The ultimate date for complying with the Directive was 1 January 1986. In general terms, it can be said that the implemen tation of the Directive in national regulations is satisfac tory. Numerous legislative and administrative initiatives have been taken throughout the EU. However, the major ( 1 ) for doctors, acquirement of competence in radiation merit of this Directive, in spite of its general nature and protection and training in techniques used in the dif its limited scope, is to have largely contributed, directly ferent disciplines; for medical staff, appropriate or indirectly, to a better awareness for the need to pay instructions in the techniques applied and in suitable attention to radiation protection aspects in the use of ionising radiation for medical purposes. Its very exist radiation protection procedures; (2) the drawingup of an inventory of radiological ence has brought about an evolution in the way of think ing of many of the professionals and legislators equipment and nuclear medical installations; involved. It could even be said that it is now possible to consider enlarging its scope, beyond what was poss ible at its inception ten years ago. In some Member States, however, implementation of the Directive has 84/466/EURATOM, OJ No L265, 5.10.1984, p. 1.
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INITIATIVES. ACHIEVEMENTS AND PERSPECTIVES not been entirely satisfactory and infringement procedures have been opened, resulting in one case in a judgement by the Court of Justice that the Member State had failed to fulfil its obligation. The major problems encountered in the interpretation of the Directive were the following: (1) Determining the responsibilities of the medical doctor, the physicist, if present, and the assistants. (2) Member States often have different ways of implementing the organisation of training for the staff; sometimes leaving it to professional organisations, sometimes trusting it to universities. (3) Often the inventory of radiological equipment and nuclear medicine installations is limited to a list of authorisations and is seldom used to control, for example, the unnecessary proliferation of equipment. (4) The definition of technical criteria for acceptability for installations created problems. In the framework of this Directive, the Commission of the European Communities (CEC) took several initiatives to assist towards implementation by Member States. For example, regarding the criteria of acceptability, it organised consultative meetings with competent authorities to discuss a proposal for harmonised technical criteria for radiodiagnostic installations. It also organised several training courses for professionals in the medical and dental fields on radiation protection and quality control aspects. It also developed the quality criteria concept for binding clinical requirements in relation to technical performance and patient dose. Apart from this, it also produced videotapes for training of medical and paramedical personnel and several other informative documents on quality assurance and quality control in the different disciplines. In the light of the experience gained with the 1984 Directive, and the new recommendation published in ICRP 60, the CEC has this year taken the initiative to start the procedure to update and extend the 1984 Patients Directive in order to strengthen its provisions, in close coordination with the ICRP Committee 3 on medical exposures. In a working party, established for this purpose by the scientific experts of the Article 31 group, a first brainstorming session has taken place. Many items, some of them already quoted before, have been discussed and have resulted, among others, in the following proposals: (1) to introduce an article with definitions of key terms, such as quality assurance programmes, quality control, complex installations, etc; (2) to have an extended article on justification, including its relation to the different types of persons undergoing examination or treatment; (3) an extended article on optimisation, including a technical part and a part on the examination itself;
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(4) an article on dose control, including the principle of dose constraint; (5) an article on medical and technical competence or responsibilities, including training; (6) an article on surveillance, making a distinction between the local level (quality control) and inspection by competent authorities; (7) also to accord special attention to paediatric examinations and new technologies. If things progress smoothly the new directive could be developed in 2-3 years. In any case, it is the firm intention of the CEC to follow up this aspect of radiation protection closely to ensure a permanent improvement of radiation protection standards. The experts from the Member States have been invited to answer the following list of problems: (i) (ii) (iii) (iv) (v) (vi) establishment of statistical data on frequency of examination, number of films and contribution to population doses, etc.; dose assessment and evaluation; quality assurance programmes, quality control protocols; acceptance auditing or optimisation strategies; organisational aspects; special problems.

Contributions from Member States are presented as appendices in the following order: 1. Belgium, 2. Denmark, 3. France, 4. Germany, 5. Greece, 6. Ireland, 7. Italy, 8. Luxembourg, 9. Netherlands, 10. Portugal, 11. Spain, 12. United Kingdom. CONCLUSIONS (1) The so-called Patients Directive has brought about several legal initiatives in all Member States. However, only a few Member States have fully implemented the Directive. There are several reasons for this: (a) The implementation in national legislation is highly dependent on the organisational structure of health care in the Member States. Unfortunately there is no harmonisation on an EU level. (b) The text of the Directive is very general and this sometimes creates interpretation problems to the Member States. (c) It was a first extension of radiation protection towards a new category of persons: patients. It took some time to promote this concept. Some Member States faced an infringement procedure for not having fully implemented the Directive after the date of January 1986. (2) The Directive certainly evoked a greater awareness of the need for radiation protection and, in practically applying the Directive and other CEC and

ROUND TABLE PRESENTATIONS

international recommendations, many Member States introduced Quality Assurance and Quality Control programmes. The organisation of training of medical personnel in radiation protection is getting better and better organised in Member States. However, since it is organised in different ways, there is room for further European initiatives for harmonisation. Several Member States have also taken measures to avoid unnecessary spread of radiological equipment. (3) Future options regarding the Patients Directive lie in

a revision of the Directive where, in order to avoid confusion, policy and procedures to be followed should be more explicit. New concepts such as dose constraint can also be introduced. Special attention should be given to specific domains of medical examinations, in particular in paediatrics and interventional radiology. The CEC and the Member States should continue to concentrate their efforts on the harmonisation of training of medical personnel and on improvement of procedures for applying ionising radiation in the medical field.

APPENDIX 1. RADIATION PROTECTION AND QUALITY CONTROL IN DIAGNOSTIC RADIOLOGY: SITUATION AND EVOLUTION IN BELGIUM
P. Smeesters, J. P. Samain and A. Wambersie INTRODUCTION Traditionally in Belgium, as well as in the other European countries, the problem of quality assurance in diagnostic radiology was approached mainly in terms of the quality of the images and of their contribution to the clinical diagnosis. Indeed the education of the radiologists was orientated primarily towards the understanding of the different pathological situations and the role of radiology in improving the diagnosis. In that respect, since the discovery of X rays by Roentgen in 1895, the contribution of radiology to better diagnoses and, as a result, to better selected treatments cannot be questioned. This has to be added to the credit of the radiological 'schools' and traditions in the different countries. In parallel, but quite independently, efforts were orientated continuously towards the improvement of the equipment. The efforts of the radiological companies, often in collaboration with dynamic radiological teams, have resulted in more reliable equipment, safer for the staff as well as for the public, and allowing for more accurate and complex radiological investigations. In this paper, the situation in Belgium and its evolution will be reviewed. Three points will be considered: (i) education; (ii) actual achievements in the field of quality assurance programmes; and (iii) new types of relations with professional organisations. EDUCATION The education programme for the radiologists In line with the CEC Directive of 3 September 1984, the Arrt Royal of 7 September 1993, signed by the new King Albert II and published (Moniteur Belge) on
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15 October 1993 imposes on radiologists a specific training of 75 hours (45 h theoretical and 30 h practical teaching courses) involving: (i) the physics of radiations; (ii) dosimetry; (iii) radiobiology; (iv) radiological techniques and quality assurance; and (v) radiation protection (including legislation). It is important to note that this teaching programme is imposed not only on the radiologists but also on all the specialists, in different disciplines, who are using radiology as a diagnostic tool in the frame of their specialty. It is hoped that this regulation could contribute to preventing accidents such as those mentioned during this workshop in cardiology.

Recognition of qualified experts in radiophysics A proposition has been recently submitted to the Belgian advisory board on radiation protection (CSH, Conseil Suprieur d'Hygine) for the education and the recognition of 'Qualified Experts in Radiophysics' in Belgium. Three orientations ar identified: (i) radiation therapy; (ii) nuclear medicine; and (iii) diagnostic radiology. The training involves at least 600 hours (theoretical and practical courses of university level), followed by a term of at least 12 months in a clinical department in one of the three orientations. In the field of diagnostic radiology, the responsibility of the qualified experts in radiophysics is orientated mainly towards radiation protection of the patient and quality assurance. Belgium is thus rapidly catching up other more advanced countries in the EU in the field of education of diagnostic radiology.

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES Education and radiographers Efforts have been made for the education of radiographers, especially orientated towards radiation protection and quality assurance. These efforts were initiated by some universities, but they are still at the level of private initiatives. QUALITY ASSURANCE PROGRAMMES From a more practical point of view, several quality assurance programmes have been initiated and are presently running. The Belgian Society of Medical Physics has established two working groups The radio diagnostic group has three main programmes: (1) It offers a 'no cost' service to radiological departments for performing quality control of the equipment (significant errors concerning tension (kV), automatic exposure and filtration were actually discovered). (2) In the frame of 'Europe Against Cancer', it collaborates in the breast screening programme sponsored by the CEC. The European protocol for the technical aspects of Quality Assurance is applied. (3) It contributes to the Radiation Protection Programme of the CEC in diagnostic radiology e.g.: (i) the European study on quality criteria for the diagnostic images; and (ii) the CEC cooperative project for determining the doses delivered for some frequently performed radiological examinations; e.g. hernia in lumbar spine, renal carcinoma. Although some activities include routine measurements, they aim mainly at data collection, and the final goal remains research on the topics covered by this workshop. The nuclear medicine group is involved in the calibration of pit chambers (well chambers) in collaboration with the Belgian Nuclear Energy Centre of Mol. A Quality Assurance programme in diagnostic radiology A QA programme, mainly orientated towards the control of the radiological equipment, has been initiated in collaboration by the Universit Catholique de Louvain and the Company AIB-Vinotte-Controlatom. Some results have been presented during the workshop (see Godechal, proceedings). Delhove and Wambersie, these

THE PROFESSIONAL ORGANISATIONS Serious difficulties are encountered today in Belgium, as in other countries of the EU, in diagnostic radiology concerning: (i) education and training; (ii) recruitment of young radiologists; (iii) regulations (at the national and European level); and (iv) critical financial situation (e.g. reimbursement rates). Therefore, several organisations (e.g. Association of Radiologists, Royal Belgian Society of Radiology and professional organisations) have established a study Committee to discuss the future of radiology (CESAR: Comit d'Etude Sur l'Avenir de la Radiologie). In its programme, the CESAR Committee has recognised that education, quality assurance and radiation protection are priority orientations. Such an agreement is important since any quality assurance programme cannot be made to run on a large scale without the full collaboration (a freely accepted collaboration) of a large part of the radiological community. CONCLUSION Belgium has followed the orientations and recommendations of the CEC concerning QA and radiation protection in diagnostic radiology. First of all, an effort has been made for education at the level of the radiologists and the qualified experts in radiophysics. Specific training programmes on QA and radiation protection have been set up and added to the traditional education programmes in radiology. An effort has still to be made to integrate better the two types of training which ideally should influence each other. The quality assurance programmes initiated in Belgium either locally or in the frame of the CEC are listed above. These QA programmes keep within the 'technical aspects' of radiology. Quality assurance programmes concerning more 'medical' aspects of diagnostic radiology are still missing and nevertheless needed (indications for an X ray examination, choice of the technique: conventional X rays, CT, NMR, ultrasound, use of contrast media, position of the patient, etc.). It is recognised that quantitative data and clear conclusions will certainly be more difficult to reach when dealing with the 'medical' aspects than with the .'technical' aspects of QA in radiology.

36

ROUND TABLE PRESENTATIONS

APPENDIX 2. AN OVERVIEW OF RADIATION PROTECTION AND QA IN DIAGNOSTIC RADIOLOGY AT NATIONAL LEVEL IN DENMARK
O. Hjardemaal INTRODUCTION Findings from NIR on diagnostic X ray equipment relating mainly to patient dose or image quality are presented together with the annual number of X ray examinations. A survey of mammography installations has been carried out and the mean dose was evaluated. The speed of screen-film systems for lumbar spine examinations has been measured in a number of X ray departments. Protocols for acceptance and constancy tests have been established and are being tested in a hospital. Finally, dose measurements have been performed on 1200 dental X ray sets for intra-oral use and large dose variations have been found. GENERAL FINDINGS There are about 1500 diagnostic X ray devices in Denmark and a further 4500 dental X ray sets are used by dentists. As reported earlier" ' diagnostic X ray equipment is checked each year by a commercial undertaking and every five years by the NIR, whereas dental X ray equipment is checked by the NIR only every ten years. Some findings from the NIR checks on diagnostic X ray equipment with a strong bearing on patient dose or image quality are mentioned below. The rounded percentages quoted show the percentage of the devices checked which had defects, over the period 1980-1990. (N.B. the findings for image quality in the fluoroscopy mode are from 1987-1992.) Coverage of light and radiation fields in relation to light beam diaphragms Indication of exposure factors etc. Alignment of tube and image intensifier Beam limitation in the fluoroscopy mode Level of contrast in fluoroscopy measured with TOR test object not visualising disc No 10 Level of resolution in fluoroscopy measured with TOR test object not visualising 1.12 line pairs/mm :10% defects : 5% defects : 5% defects : 5% defects :10% defects :30% defects image quality of the image intensifier/TV systems. The problem is not with new installations but with older ones that are not properly adjusted or have simply worn out. FREQUENCY OF DIAGNOSTIC X RAY EXAMINATIONS Once a year X ray departments report the number of X ray examinations to the National Board of Health. For a number of years the annual frequency has been very close to 2.4 million, corresponding to 470 examinations per 1000 inhabitants. Since 1991 reporting has been based on a 4-digit classification system comprising some 500 different examinations where the first digit specifies the topographic target, the second the type of procedure, and the last two the type of examination. To give an example in code 3046: 3 stands for extremities 0 stands for non-invasive examination 46 stands for right elbow Although it is a 4-digit system, only the first two digits are used for reporting to the National Board of Health. However, more than 30% of the X ray departments have computerised systems making use of all four digits. This information would form a good basis for estimating the number of different types of X ray examinations carried out each year nationwide. NIR plans to introduce a dose measurement programme in the near future which, in addition to the above mentioned information, will enable the population dose from diagnostic X ray activities to be calculated. MAMMOGRAPHY In 1985 the NIR completed an examination of all 38 mammographie X ray units in use in Denmark at that time. In terms of image quality and performance, approximately 40% of the X ray sets were found to be unsatisfactory. The absorbed dose in mammary gland tissue varied from 0.7 mGy to 6.7 mGy per radiograph, with a mean dose 2.3 mGy (see Figure A2.1 ). In 1990 the radiation protection authorities in Denmark, Finland, Norway and Sweden issued recommendations concerning quality assurance in mammography'2'. These recommendations are today used as a guideline when procuring equipment for
37

As can be seen from the findings the rather low-tech problems of beam coverage, limitation and centring still exist for the light beam diaphragms although the latter are checked and adjusted annually. Another outstanding problem revealed is the poor

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES

screening activities in Denmark. The NIR has perfor med acceptance tests on the screening installations in service in accordance with these recommendations and demonstrated compliance. SPEED OF SCREENFILM PROCESSING SYSTEMS The speed of the screenfilm system used for X ray examinations as well as the processing conditions have a major effect on dose to the patient. Consequently, the speed of screenfilm combinations in cassettes used for lumbar spine examinations in 25 Danish X ray depart ments has been examined under field conditions, i.e. the actual processing conditions will influence the speed measured'3'. The cassette is exposed in seven steps at a focus film distance of approximately 1.8 m at 90 kV with an aluminium absorber of 29 mm in the beam in addition to the filtration of tube and light beam diaphragm of around 3 mm aluminium equivalent. Prior to the exposure a monitoring chamber close to the light beam diaphragm is calibrated. When exposing the film the air kerma in the plane of the film is calculated from the monitor reading. The speed is calculated as 1 mGy multiplied by the reciprocal of the air kerma in mGy in the plane of the film needed to produce a net density of 1.0. Figure A 2.2 shows that systems having a speed of
Bi 5
to
<*-

between 100 and 650 are used for the lumbar spine A P projection. In its guidelines on quality criteria for diag nostic radiographic images'", the CEC recommends a speed class of 400 for this projection. A s can be seen from the figure only three of the systems, corresponding to 12% of the total, meet these recommendations. The findings show that large dose savings can be obtained if slow systems are replaced, and this can be done at a fairly low cost per unit dose. PROTOCOLS FOR A CCEPTA NCE A ND CONSTANCY TESTS ON DIA GNOSTIC X RAY EQUIPMENT As mentioned earlier, tests on diagnostic X ray equip ment are performed on a yearly basis according to legal provisions issued by the NIR. However, this is not a complete scheme of acceptance and constancy tests. The NIR therefore started a project in 1992 in order to estab lish a national protocol for testing diagnostic X ray equipment. A working group has now established a protocol for acceptance tests on generators. It covers the following aspects: reproducibility, linearity, high voltage, ex posure time, current time product, and nominal power. A protocol for acceptance tests on associated equip ment for radiography has also been prepared. It covers: overall consistency of A EC, consistency of A EC between chambers, consistency of A EC with change in tube voltage, consistency of AEC with change in patient thickness, focus size, and total filtration. Finally, the group has drawn up a protocol for con stancy tests on generators and associated equipment for radiography, covering: radiation quality (test object), congruence of field, cassettes, viewing conditions, vis ual evaluation of image quality, film rejection analysis, and darkroom conditions. Preliminary tests using the protocols are being carried out in collaboration with the University Hospital at rhus. After a certain period of time the procedures and the findings will be evaluated, and the protocols will be amended where necessary. This should ensure that the protocols are fit for use when made available to all X ray departments. Once this work has been completed, it is planned to draw up protocols for other types of X ray equipment. DENTAL EQUIPMENT For intraoral examinations two different types of X ray films are used: ISO speed group D and E'5'. Table A2.1 shows the speed range in reciprocal roentgens for the respective groups. A s can be seen, E films are more sensitive than D films and thus to be preferred with regard to patient dose. Dose measurements have been performed on 1200 dental X ray sets for intraoral use inspected by NIR since the end of 1990. During the inspection the medical

without grid with grid

22 1 0

1 1 1 1 l
1 2

nu
3 4

7 (mGy)

Figure A2.1. Absorbed dose in mammary gland tissue per radiograph for 38 X ray sets.

100 150 200 250 300 350 400 450 500 550 600 650
Measured speed

Figure A2.2. Measured speed for 25 screenfilm systems with indication of the speed recommended by the CEC for systems used for lumbar spine examinations.
38

ROUND TABLE PRESENTATIONS staff are asked questions about the speed group used, the exposure time and focusskin distance applied for a mandibular incisor. A TL dosemeter calibrated at the NIR secondary standards laboratory is exposed freein air in accordance with these data. The results for dental films of speed class D are shown in Figure A 2.3 and, for films of speed class E, in Figure A 2.4. For D films the mean air kerma is 4.9 mGy, with an SD of 4.3 and the upper quartile is 6.3 mGy. For E films the mean air kerma is 3.2 mGy, with an SD of 3.6, and the upper quartile is 3.5 mGy. Table A2.1. ISO speed groups. ISO speed group ISO speed range* (in reciprocal rntgens) 6.0 12.0 24.0 48.0 to to to to 12.0 24.0 48.0 96.0 For mean air kerma a reduction of 35% is obtained when using films of speed group E; however, this sensi tive film was only used in 20% of the cases. Reference 6 recommends that the kerma to the skin of the patient should be lower than 7 mGy for D films. This value is quite close to the upper quartile of 6.3 mGy found in this study. The upper quartile is in some instances used as a dose constraint and measure ments performed at the two Danish dental colleges also confirm that this is a reasonable constraint for practical purposes as they were not far below this limit with their optimised systems. CONCLUSION The findings presented show that although X ray installations are checked regularly, and the defects found rectified, doses are still unnecessarily high due to maladjusted light beam diaphragms, insensitive image recording devices, etc. A s regards image quality, the findings point to a poor image quality in intensifier/TV systems. It is believed that a more widespread use of acceptance and constancy tests could improve the situ ation, combined with a purposeful effort by the NIR.

C D E F

*The upper limit of each ISO speed range shall be excluded from that range.

500
2
150

100

so

3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 Air kerma (mGy)

12 15 18 21 24 27 30 33 Air kerma (mGy)

Figure A2.3. Kerma freeinair at focusskin distance for 980 dental X ray sets using films of speed group D. REFERENCES

Figure A2.4. Kerma freeinair at focusskin distance for 195 dental X ray sets using films of speed group E.

1. Hjardemaal, O. A Review of Quality Control in Diagnostic Radiology in the Scandinavian Countries. In: Technical and Physical Parameters for Quality A ssurance in Medical Diagnostic Radiology. Eds B. M. Moores et al. BIR Report 18 (London: British Institute of Radiology) pp. 5659 (1985). 2. Radiation Protection A uthorities in Denmark, Finland, Iceland and Sweden. Mammography. Series of Nordic Reports on Radiation Safety, No 1 (1990). 3. Hjardemaal, O. and Westergaard, H. Speed of Medical X ray ScreenFilm Processing System in D anish Hospitals. Radit. Prot. Dosim. 42(2), 115119 (1992). 4. CEC. Quality Criteria for D iagnostic Radiographic Images. Working document No XII/173/90, 2nd edn (June 1990). 5. ISO 3665. Photography IntraOral D ental Radiographic Film Specifications. 6. Finnish Centre for Radiation and Nuclear Safety. Survey of D enial Radiographic D oses in Finland. A cta Radiol. 29, 481 485 (1988).

39

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES

APPENDIX 3. FRENCH NATIONAL OVERVIEW OF INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES IN QUALITY ASSURANCE AND RADIATION PROTECTION IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE
A. Costa INTRODUCTION Council Directive 84/466/Euratom of 3 September 1984, on the radiation protection of persons undergoing medical examination or treatment is widely applied in France. The French national health authorities (Ministre de la Sant) have been, and are, engaged in numerous activities designed to reinforce the radiation protection of patients. At the same time, professional associations of medical physicists are involved in quality assurance and radiation protection initiatives. LEGISLATION AND REGULATIONS Diagnostic radiology First of all, equipment was standardised and the national inventory of facilities Was drawn up and enforced. Since 1962, prior approval has been required for the refunding of medical expenses by the national insurance administration. Approval for a facility is issued under several criteria of acceptability: (1) Conformity and official approval of X ray tubes, generators and limiting devices. (2) Facilities constructed in accordance with current safety and technical standards. (3) Operation in accordance with regulations. to scintillation cameras: 1 scintillation camera per 140,000 inhabitants and 1 more per 2500 hospital beds are allowed. The mandatory attendance of a qualified expert in radiation physics (linear accelerators, 1969 (1)24/03/94) was extended to nuclear medicine departments by an NHA order of 8 August 1988'". At the present time, 6 full-time and 28 part-time medical physicists are employed in this work in 168 nuclear medicine departments (including 33 private facilities). Radiation protection The French regulations for qualified experts in radiation protection (Personnes comptentes en radioprotection) were issued by the NHA in a decree of 2 October 1986'". EDUCATION The Paul-Sabatier University in Toulouse which, together with Paris-Sud University and the Institut Gustave-Roussy at Villejuif is responsible for the training of medical physicists in France was asked to increase the number of students trained: 32 students graduated in medical physics in June 1990.

Licences for the use of equipment are only given for OTHER ACTIONS ten years and cannot be issued for equipment more than The NHA have organised campaigns to inform the 25 years old. public about new regulations'2'. In connection with EC Fluoroscopy equipment is being progressively with- initiatives, other measures have been taken by the NHA drawn from service: 15,000 devices were in use in 1973, together with the French Medical Physicists' Associcompared with just 1900 now. Only qualified physicians ation (Socit Franaise des Physiciens d'Hpital, may use them. SFPH) and radiologists in diagnostic radiology departIn the Hospital Outline Law, the national health auth- ments. orities (NHA) have defined an equipment/population ratio for sophisticated medical facilities using radiations or radioactive substances: 1 CT per 110,000 inhabitants European intercomparison and 1 more per 1500 hospital beds are allowed. A European intercomparison of diagnostic dosemeters with the PTB (Dr Kramer), SCPRI and SFPH was carried out in 1990. In our country, ten dosemeters were Nuclear medicine intercompared in order to obtain information on the 1 In the field of nuclear medicine, permission to supply errors of dosemeters at present used in quality control' '. is given only after the facility in question has been approved. 1991 trial The equipment/population ratio for sophisticated medical facilities (Hospital Outline Law) is also applied In 1991 a trial was organised by the CEC on quality
40

ROUND TABLE PRESENTATIONS criteria for diagnostic radiographic images'4'. Nine radi- installation, use and maintenance of this type of apparatus. ology departments were involved (see appendix). Daily involvement Medical physicists are required each day for dose evaluation of radiological examinations of pregnant women and also for dose measurement surveys. Working groups Apart from implementation of and compliance with these regulations, the French Medical Physicists' Association has done-useful work in the field of radiation protection and quality assurance. The following committees and task groups have been set up within this organisation: A Diagnostic Radiology Committee (physicists), A Quality Assurance in Mammography task group (physicists, radiologists and biomedical engineers), A Quality Assurance in CT Scans task group (physicists), A Quality Assurance in Conventional Diagnostic Radiology task group (physicists and external organisation: CAATS, Cachan), A Quality Assurance in Nuclear Medicine task group (physicists). Publications These groups have published the following booklets and papers. (1) Evaluation of doses in diagnostic radiology examinations, booklet (1988)'5', Radioprotection (1988)'6' Journal de Radiologie (1991)'7'. The purpose of these documents is to provide radiologists with a simple and realistic means of assessing the individual dose delivered to a patient undergoing radiological examination, in the region under investigation and in any other sensitive organs. Fourteen types of examinations were considered, based on studies of radiological examinations carried out in France in 1982'8'. A suggested calculation model was given for dose estimation in other types of examinations. (2) Evaluation of CT performance and quality control (1990). Published by the Digital Imaging Committee this document reviews the available methods for evaluation and QC and contains general information on principles and technology. In view of the increasing use of scanner images in diagnosis and treatment planning for radiation therapy, all the factors relating to this application are reviewed. The last section, dealing with calls to tenders and installation requirements, is useful for the purchase, 41 (3) Responsibilities and needs of medical physicists in nuclear medicine departments (1992). (4) Evaluation of performance and quality control of scintillation cameras (1992). (5) Quality control in conventional diagnostic radiology. This booklet'9', to be published later this year, is a practical guide for radiologists, physicists, engineers and technicians involved in carrying out quality control in conventional diagnostic radiology. Meetings and training courses The following meetings and training courses have been organised by the SFPH in the field of diagnostic radiology, digital imaging and nuclear medicine. (1) Meetings: Physics of Diagnostic Radiology, 1984, Nice Digital Imaging, 1990, Lille. (2) Training courses: Physicists in Digital Imaging, 1985, Toulouse. Quality Control in Medical Imaging, 1991, Nancy. Medical Physicists in Nuclear Medicine, 1992, Lille and Kremlin-Bictre. Technology and Quality Control of Radiological Equipment, 1993, Issy-les-Moulineaux. Training of qualified experts Training courses for qualified experts in radiation protection have been taking place since 1988 (Nice'"", Marseille, Paris, St Cloud), each annual course having involved thirty persons. Standards committees Medical physicists from the SFPH have taken part in the work of IEC, European and national standards committees. Local initiatives Radiation protection training based on local initiatives has been given to medical staff and physicians (1990-1993, Nice"") and to medical physicists in the field of quality assurance (1991, Nancy" 213 '). Training of radiologists and technicians Physicists are involved in the training of radiologists and technicians. At the request of professionals in diagnostic radiology, 22 regional cooperative groups work-

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES ing on quality assurance are being set up, bringing together radiologists, physicists, engineers and tech .". o * r J o
n i f i cine

(1) The maintenance of equipment _, ,.,, ., j n e maintenance of X ray equipments raises the ques
/ ! !

... .', , Finally QC tratmng in mammography scheduled over the next few months in _ , . , , , , , , ., , October), Nantes (1213 November), .. . . ,w . . , . November) and Marseille (December).

, , has been Pans (12 . ,,n Pans (19

tions of what types of checks should be performed. The ,99Q ^ ^ ^ ^ N H A o r d e r J* ]m& Q( r . . . ... .. , . . safety rfor workers and the surrounding area, but not rtor ,. . ~, ... . . . . ,, . .. patients. The rpatients are mainly protected by J the elim .. , .. , . . . . . J r . . . ,. . c . mation of the dntts. The NHA are thinking of requiring the supplier to maintain equipment. interventional procedures t e c hnique is rapidly increasing and represents t h e l a r g e s t contribution to individual exposure of pali e n t s a n d o f p e r s o n s working in diagnostic radiology. In t n s a r e a t s essential that equipment be regularly main t a i n e d T n e a p p r o v a l of this equipment would be made conditional on maintenance by the supplier,
(2) This

Future initiatives A training course (SFPH) for medical physicists and biomedical engineers, entitled 'Technology and Q.C. of Radiological Equipment', is to be held in Nice on 12 14 January 1994. A summer school (EFOMP, CEC, SFPH, Centre AlexisVautrin) on 'Radiophysics in Diagnostic Radi ology' is scheduled in Nancy, June 1994. DISCUSSION Three points must be emphasised:

(3) Mammographie screening for breast cancer Realistic QC protocols are being drawn up with the effective help of the NHA and the involvement of physi cists and biomedical engineers.

APPENDIX French Radiology Departments Participating in CEC Trial on Quality Criteria for Diagnostic Radiographic Images (1991) Centre Centre Centre Centre Centre Centre Institut Institut Centre RenGauducheau, Nantes, Dr Digabel, M.D., and A . Lisbona, Ph.D.; Hospitalier Universitaire, Nantes, Dr Dupas, M.D., and A . Lisbona, Ph.D.; A ntoineLacassagne, Nice, Pr J.N. Bruneton, M.D., and A . Costa, Ph.D.; A lexisVautrin, Nancy, Dr Stines, M.D., and A . Nol, Ph.D.; Hospitalier Gnral, Chambry, Dr TruHong, M.D., and A . Choulet, Ph.D.; Hospitalier Gnral, Bonneville, Dr M. C. Casile, M.D., and M. Page, Ph.D.; GustaveRoussy, Villejuif, Pr. J. Chavaudra, Ph.D.; Curie, Paris, G. Gaboriaud, Ph.D.; Hospitalier Universitaire, Hpital Bretonneau, Tours, Pr Rouleau, M.D., and H. A get, Ph.D.

REFERENCES 1. Journal Officiel de la Rpublique Franaise. Protection contre les Rayonnements Ionisants. Brochure 1420. (1992). 2. Comit franaise d'Education pour la Sant. La Radioprotection en Milieu Hospitalier. 133 (1990). 3. Juran, R., Nol, A . and Olerud, H. M. Performance of the Intercomparison Programme. Radit. Prot. Dosim. 43(14), 8186 (1992). 4. Maccia, C , A richeCohen, M., Severo, C. and Nadeau, X. 77ie 1991 Trial on Quality Criteria for D iagnostic Radiographie Images. Draft Report of CEC contract BI7.0075 (1993). 5. Commission de Radiodiagnostic SFPH. Evaluation des D oses D livres au Cours d'Examens Radiologiques (1988). 6. Radioprotection, special issue, 23, 937 (1988). 7. Journal de Radiologie 72, 89, 403^120 (1991). 8. L'Activit Radiodiagnoslique en France en 1982. Evaluation de lu Dose Collective et de la Dose Gntiquement Significative. CEPN no 68. CEE BIO444F(S.D.) (1983). 9. A get. H., Costa, ., Lisbona, ., Page, M. and Maccia. C. Commission Imagerie SFPH. Groupe de travail. Assurance Qualit en Radiologie Conventionnelle. Prsentation du "Guide Pratique de Matrise de la Qualit en Radiodiagnostic'. A ctes: Congrs de la SFPH, Poitiers. France (June 1993). 10. La Radioprotection en Milieu Hospitalier. A ctes: Enseignement PostUniversitaire, Formation de la personne comptente. Centre A ntoineLacassagne, Nice, France (1988). 11. La Radioprotection en Milieu Hospitalier. A ctes: Enseignement PostUniversitaire. Formation des cadres et mdecins du travail. Centre A ntoineLacassagne. Nice. France (19901993).
42

ROUND TABLE PRESENTATIONS 12. Nol, ., Stines, J. and Pugin. J. M. Contrle de Qualit et Mesure de D ose en Mammographie. Aspects Thoriques et Pratiques. A ctes: Enseignement postuniversitaire. Centre A lexisVautrin, Nancy, France (2123 March 1991). 13. Contrle de Qualit en Imagerie Mdicale. A ctes: Enseignement postuniversitaire. Centre A lexisVautrin, Nancy, France (2123 March 1991).

APPENDIX 4. INITIATIVES, A CHIEVEMENTS A ND PERSPECTIVES IN QUA LITY A SSURA NCE A ND RA DIA TION PROTECTION IN DIA GNOSTIC RA DIOLOGY, BOTH ON THE LEGAL A ND PRA CTICA L LEVEL IN GERMA NY
B. Bauer and R. Veit INTRODUCTION Statistical data were gathered on the frequency of examinations, film consumption and radiation dose. In West Germany, 99 million X ray examinations per year were carried out, resulting in an annual average of 1.5 examinations per resident. (For the former German Democratic Republic, see A nnex.) An assessment of doses from radiography was done by measuring the dosearea products in several hospi tals and medical practices and by also adding external data. The legal provisions concerning diagnostic radi ology deal primarily with the technology of radiological equipment, the qualifications of physicians and non medical staff as well as the quality control during the diagnostic procedures. Important institutional panels for acceptance auditing are committees which request X ray films of patients subjected to all types of diagnostic procedures from all physicians and hospitals and offer advice on the improvement of image quality. ESTABLISHMENT OF STA TISTICA L DA TA ON FREQUENCY OF EXA MINA TIONS, NUMBER OF FILMS A ND CONTRIBUTION TO POPULA TION DOSES Statistical data on the frequency of examinations, film

Table A4.1. Frequency of X ray examinations per year in West Germany (65 million inhabitants) averaged over the period of 1990 to 1992. Organ systems Outpatients (106) 7 . 8
17.0

In hospital (10") 8 . 9 2 . 6 0 . 9 0 . 8 1 . 0 0 . 6 0 . 2 0 . 1 0 . 1 0 . 6 0 . 5 0 . 2 1 . 5 0.1 0 . 2 0 . 2


18.4

Others (10") 1 . 2

Total (10")
17.9 19.6

Per 1000 Inhabitants 275 302 148 97 144 34 18 5 4 31 16


64'2

Chest Extremities Spine Pelvis/hips Skull Abdomen Upper GI tract Lower GI tract Cholecystogr. Urinary tract Angiography Mammogr.1" CT" Dental Osteodcnsitometry Others Total

8 . 7 5 . 5 8 . 4 1 . 6 1 . 0 0 . 2 0 . 2 1 . 4
(1.5

3 . 9 2 . 0
17.5

9 . 6 6 . 3 9 . 4 2.2 1 . 2 0 . 3 0 . 3 2 . 0 1 . 0 4 . 1 3 . 5
17.5

0 . 8 1 . 3
77.8

1.5""

1 . 0 3 . 0
98.9

54 270 15 46
1,523

2 . 7

' ' 'Each breast examined counts as one examination. '^'Corresponding to 147 examinations per 1,000 women over 15 years of age. '"All fields 1992. '4'Nonclassilicd examinations.
43

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES consumption and dose distribution among the general public were compiled by a step-by-step process, after which they were reported to UNSCEAR'" and published in Germany'2'. Frequency of examinations Since the health services in East and West Germany were completely different, most of the data presented below apply to West Germany. The frequency of X ray examinations is shown in Table A4.1, classified by organs and the examining physicians/centres. Averaged over the period of the years between 1990 to 1992, a total of 99 million X ray examinations were carried out in West Germany on 65 million inhabitants, resulting in an average of 1.5 examinations per inhabitant per year. The most frequent X ray examinations were those of the extremities, followed by chest radiography and dental examinations. Film consumption The film consumption in 1992 was 13.3 IO6 m2 for Eastern and Western Germany, of which 9.7 IO6 m2 were used for direct radiography. The use of green sensitive films accounted for about 2/3 and that of blue sensitive films to about 1/3 of the total. Approximately 420,000 m2 of mammography films were sold, corresponding to 9.8 million films in the standard size of 18 x 24 cm2 (7 10 in2). In relation to the 4.3 million mammographies performed (the number refers to the number of organs examined and not to the number of patients), this corresponds to an average of 2.3 exposures per organ examination. For chest radiography, a mean value of 1.8 films per examination was found; in other words two projections (PA and LAT) were required in 80% of all cases. Additional fluoroscopy as a complementary examination to chest radiography was considered to be necessary in about 20%. Chest fluoroscopy as an exclusive examination is obsolete. DOSE ASSESSMENT AND EVALUATION An assessment of doses from radiography was conducted by measuring the dose-area products in several hospitals and medical practices and also by collecting external data on the dose-area product. Conventional radiography For selected examinations the results obtained are given in Table A4.2. The dose-area product as a unit of measurement was selected for several reasons: it can easily be measured by any practitioner who has measuring equipment available; it is the only way of measuring patient exposure during complex examinations involving fluoroscopy. It also provides information on radi44

ation exposure in X ray examinations of the extremities. Although these make only a small contribution to the effective dose, they cannot be neglected because of their frequency. Computed tomography For computed tomography the dose-area product cannot be assessed. Therefore the effective dose resulting from these diagnostic procedures was assessed based on the values of the effective dose calculated in the UK by Shrimpton et al\ The values are given in Table A4.3. In Germany the number of slices per examination as well as the normalised dose free-in-air has increased over the past few years due to the use of new equipment. There has also been a considerable absolute and relative increase in the number of CT examinations over the past few years. The 3.5 million examinations per year represent 3.6% of all X ray examinations but make a contribution of 34.4% to the collective effective dose. QUALITY ASSURANCE AND QUALITY CONTROL The legal provisions concerning diagnostic radiology deal mainly with the technology of radiological equipment, the qualifications of physicians and non-medical Table A4.2. Mean dose-area product (DAP) and effective dose in patients per X ray examination.
DAP (Gy.cm2) Chest Lumbar spine Pelvis Skull Abdomen Stomach Small intestine Colon Phlebogr. (leg) PTCA 1.13 9.79 3.68 0.92 3.68 35.93 66.40 64.42 11.06 109.49 Eff. dose (mSv) 0.2 1.5 0.8 0.03 1.1 11.5 21.3 20.6 2.3 21

Table A4.3. Mean effective dose and relative frequency of CT examinations. Eff. dose Slices (mSv)
Head Chest Abdomen Spine Extremities 2.6 20.5 27.4 9.0 1.0 23 40 40 30

(mA.s) Frequency (%) (outpat.)


440 350 400 550 35 7 21 34 3

ROUND TABLE PRESENTATIONS staff, and quality control during the diagnostic pro- stancy tests on X ray equipment and processing machines to be submitted and give advice in case the cedures. image quality was found to have decreased. Another, even more important task of the committees Quality assurance is to request X ray films of patients subjected to all types The X ray Ordinance'4' prescribes that all radiological of diagnostic procedures, which are submitted to several equipment must be thoroughly inspected by the manu- members for their joint judgement. The results of these facturer and an expert prior to starting up. As a result, examinations are communicated to the physicians but more than 50% of the equipment was found to be older also to the hospital authority. In cases of moderate or than 10 years of age and numerous defects were found poor image quality, e.g. lacking collimation, wrong which were either remedied or the unit was put out of screen, wrong exposure voltage, the physicians are operation. The transitional period for full implemen- given advice for improvement of the image quality. tation of the X ray Ordinance, which started in 1988, Cases of repeated inadequate image quality are reported has now expired and all radiological equipment is in to the state authority, which may initiate disciplinary good condition. Technical inspections are repeated actions. The positive effect of this committee is threeevery 5 years and it is no longer permitted to perform fold: fluoroscopy on man without an image intensifier. Another quality assurance measure concerns the (1) Almost all physicians wish to achieve good image quality and appreciate the value of advice for image qualification of the staff. Only physicians with a special quality improvement. qualification in both the medical field and radiological protection are permitted to use X rays and are eligible (2) The report to the hospital authority and, if necesfor establishing the indication. This qualification is sary, to the supervisory state authorities makes all acknowledged by the medical board in the respective physicians strive for good image quality in order not federal states. All other physicians as well as radiograto lose face with their employers or the authorities. phers and auxiliary medical staff are allowed to take action only upon instruction and under supervision. (3) The efforts made by the responsible physicians to However, they must also possess medical knowledge bring their medical-technical staff to produce good and are obliged to attend a course in radiological protecradiographs are considerably increased in force by tion, albeit on a lower level. comments from an objective external authority indicating, what is bad and how it could be improved. Quality control Quality control is done by performing phantom X rays once a month with all X ray machines. These are then compared with the first phantom X ray so that any changes in image quality can be rapidly detected. The functioning of the processing machines is also subject to regular controls which are normally performed on a daily basis and at least once a week. For this purpose, films with a standard step wedge are exposed and subsequently processed. The processed film is then measured using a photodensitometer, which allows the optical density, the contrast and the base plus fog to be seen. ACCEPTANCE AUDITING Medical authorities An important institution for acceptance auditing in Germany consists of 'medical authorities', which are committees appointed by the medical board. Most of the senior radiologists are members of these committees, assisted by some other physicians also performing diagnostic radiology, such as orthopaedics, surgeons, internal medicine specialists and urologists as well as medical physicists. These committees request from all physicians and hospitals the radiographs of the con45 (a) Characteristic image criteria (e.g. for the chest: symmetric visualisation, sharp visualisation of the blood vessels, heart contour and diaphragm, visualisation of the apices of the lung and of the basal pleural sinus). (b) Important image details (e.g. structures of 0.31 mm) must be visible. (c) Critical structures (e.g. small roundish structures in the periphery of the lung, retrocardiac lung segments). Guidelines of the Federal Medical Board for quality assurance in diagnostic radiology These guidelines encompass conventional radiology15' and computed tomography'6' and describe how to conduct the standard examinations, such as chest, skeleton (precisely subdivided), biliary, GI and urinary tracts, mammography, teeth and computed tomography. The guidelines distinguish between medical and technical requirements. Medical requirements

INITIATIVES. ACHIEVEMENTS AND PERSPECTIVES Technical requirements (a) Exposure voltage. (b) Total filtration. (c) Focal spot size. (d) Focus-to-film distance. (e) Maximum exposure time, (f ) Antiscatter grid. (g) Sensitivity of the film-screen combination. One example of the efficiency of these guidelines can be shown. In 1990 the amount of green-sensitive film used (connected with the use of dose-reducing rare-earth screens) was the same as that of blue-sensitive film (as REFERENCES ratio of 1:1). By 1992, as mentioned above, twice as much green-sensitive film was used as blue-sensitive film (a ratio 2:1). These guidelines do not specify which image quality is required, as this varies in each individual case and depends on what information the treating physician needs. SPECIFIC PROBLEMS A special feature of the German health care system is that diagnostic radiology procedures are carried out not only by radiologists but also by other physicians, such as ENT specialists, internal specialists, urologists, orthopaedics and surgeons, who perform about 50% of all X ray examinations, at least in the outpatient sector. These physicians have detailed knowledge of specific disorders, but have received a less detailed postgraduate training in general radiological problems.

1. UNSCEAR. Sources and Effects of Ionizing Radiation (New York: United Nations) (1993). 2. Bauer, B. and Tsavachidis, C. Hufigkeit von Rntgen- und Alternativuntersuchungen. Rntgenpraxis 46. 25-30 (1993). 3. Shrimpton, P. C, Jones, D. G., Hillier, M. C, Wall, B. F., Le Heron, J. C. and Faulkner. K. Survey of CT Practice in the UK. NRPB-Report R249 (London: HMSO) (1991). 4. Verordnung ber den Schulz vor Schden durch Rntgenstrahlen (Rntgenverordnung-RV). Bundesgesetzblatt (BGBl.) p. 114 (1987) and BGBl. I p. 2949 (1990). 5. Leitlinien der Bundesrztekammer zur Qualittssicherung in der Rntgendiagnostik. Dl. rzlcbl. 86. B-I437-B-1444 ( 1989 6. Leitlinien der Bundesrztekammer zur Qualittssicherung in der Computertomographie. Dt. rztebl. 89. C-2367-C-2375 (1992).

ANNEX Developments and Trends in X-ray Diagnostic Procedures in the Former German Democratic Republic between 1955 and 1989 an Analysis of More Than 300 Million Examinations
W. Angerstein and I. Barth Bundesamt fr Strahlenschutz Waldowallee 117, D-10318 Berlin, Germany In the former German Democratic Republic the total number of X ray films and types of film format used were exactly known; and the same was true for all types of contrast media. There were also official standards on how to carry out the more frequent types of examination. Since 1984 in some larger districts with more than 3.6 million people all examinations were registered statistically. Figure A4.1 shows the film consumption in East Germany between 1955 and 1989, which was proportional to the number of examinations. After 1974 the fluctuations in the graph are connected with the delivery rather than with different frequencies (storage in the departments). By evaluating some millions of examin46

ations an average of 2.2-2.4 films per examination was found. After 1983 the influence of ultrasound, CT and endoscopy resulted in declining numbers of X ray examinations. This decrease was compensated to a great extent by growing numbers of other examinations, mainly of the skeleton. The technical parameters of the examinations and especially the numbers of exposures in normal cases were regulated by official standards. This was thought to be a valuable tool for quality assurance and also a requirement for the evaluation of the population dose. The number of photofluorographs of the chest made in connection with mass screening reached, in the six-

ties, nearly 10 million. In the seventies the number decreased sharply because the separation of two exam inations was now 2 years instead of 1. After 1984 the number of mass screenings decreased somewhat but the technique was increasingly used instead of 'normal' films in the hospitals. The total sum of photo fluorographs remained at nearly 4 million. The whole situation, and especially the changes after the reunification, demonstrate that the EC Council direc tives 80/836 (1980) and 84/467 (1984) had no immedi ate regulating effect on the number of examinations, the
x106

ROUND TABLE PRESENTATIONS amount of X ray equipment and the methods used in East Germany. New techniques (e.g. US, CT, MRI) should diminish the use of conventional X rays; but in reality there is no such an effect. Since reunification of Germany the number of examinations in East Germany is growing as in West Germany. Reasons for the growing numbers of X ray examin ations are: (1) Increasing numbers of medical doctors cause greater numbers of examinations. (2) Increasing items of equipment are looking for amortisation. (3) The easier a special X ray examination can be car ried out, the greater the frequency. CONCLUSIONS In East Germany the number of exposures per exam ination, the film formats and other technical parameters to be used, and in some cases the fluoroscopies, were regulated by official standards as an effective measure of quality assurance. The situation after reunification shows that the amount of X ray equipment has increased, the number of X ray departments has grown, and the number of examinations has increased.

^***^
n

70 75 80 85 90 Year Figure A4.1. X rayfilmconsumption in the GDR, 19551989.

55

60

65

BIBLIOGRAPHY Angerstein, W. Daten ber die Rntgendiagnostik in der ehem. D D R. Bericht fr das Bundesamt fr Strahlenschutz, Salzgitter (Mai 1993). Angerstein, W. Strahlenexposition der Bevlkerung durch die Rntgendiagnostik. I. Die Hufigkeit der einzelnen Untersuchung arten in der ehemaligen D D R. Rntgenpraxis 47, 108115 (1994).

APPENDIX 5. RADIATION PROTECTION IN DIA GNOSTIC RADIOLOGY A ND NUCLEAR MEDICINE THE SITUA TION IN GREECE
P. Dimitriou RADIATION PROTECTION REGULA TIONS In Greece, the first law on the handling of radiation sources for medical purposes was established in 1974. Radiation protection regulations were introduced in 1972 and published in 1978. These regulations underwent a major revision in 1991, when they were brought into line with the Euratom Directives (836/80, 466/84 and 467/84), as required under the Euratom Treaty. They were also extended to cover new issues such as radioactive waste management, the safe trans port of radioactive material and all applications of ionis ing radiation.
47

According to these regulations, the authority respon sible for the implementation of radiation protection regulations in Greece is the Greek Atomic Energy Com mission (GA EC). Under existing regulations, all medical applications of ionising radiation are subject to licensing by the Min istry of Health, which only issues licences after the GAEC has given its approval. This approval is based on the proposal of an expert who inspects the instal lations. The following documents concerning radiation protection, prepared by a medical physicist, are also required for the issue of this licence: (a) a report prescribing, and ensuring the adequacy of the radiation shielding; (b) a quality control report, ensuring the

INITIAT1VES, ACHIEVEMENTS AND PERSPECTIVES

appropriate performance of all apparatus installed; (c) a hazard report.

DIAGNOSTIC RADIOLOGY Four categories of licences are issued for diagnostic radiology installations, according to the number of X ray units in operation. These licences have to be renewed every five years. For large diagnostic laboratories, equipped with more than two X ray generators and CT scanners, the employment of a medical physicist is compulsory. The medical physicist has a key role in the implementation of radiation protection measures and monitors all installations for quality control purposes. However, this measure has not yet been fully implemented. The following information outlines the current situation in the field of diagnostic radiology in Greece. It is estimated that some 800 diagnostic radiology laboratories (450 private and 350 state owned), operating about 1700 X ray tubes, are in use. There are also in use 130 CT scanners (20 state owned, 110 private) and 90 X ray bone densitometers (7 state owned, 88 private), 80% of which were installed in Greece within the last five years. The number of new or renewed licences for radiology installations, issued by the authorities has shown a significant increase over the past three years. Post-1991, 690 radiology installations (representing a large portion of the total number) were subjected to quality control measures according to the new regulations in force which provide for upgrading of medical installations. The area of X ray films sold in the Greek market over the past few years, and in particular CT films has shown a large increase. The upward trend translates into an increased collective radiation dose to the population from medical applications. This fact led the relevant authorities, on 1 February 1993, to suspend the issue of new licences in order to introduce new justification criteria so as to avoid the unnecessary proliferation of radiological installations (this measure is in compliance with the Article 4 of Directive/84/466/Euratom). In addition, all installations using direct fluoroscopic screens, as well as those which do not meet specified criteria will be taken out of service or replaced within the next year. For the time being they are operating under licences issued for a limited period. With regard to the initiatives for reliable quality control measurements, a central laboratory for the calibration of apparatus has been installed at the GAEC and will be ready to operate within the next few months. In addition, a secondary-standard dosimetry laboratory is being set up. In addition, the Greek Association of Medical Physicists (GAMP) has issued quality control protocols for diagnostic radiology installations, which are applied by its members. The criteria of acceptability of the per48

formance characteristics are based on the recommendations of international organisations. Results obtained when these protocols were applied to 400 X ray tubes are presented at this conference'". Another paper'2', dealing with dose assessment quality control of mammographie equipment based on a protocol prepared by the authors, is also presented. As far as the radiation dose from diagnostic radiology is concerned, no official assessment exists. However, the new thermoluminescence dosimetry laboratory installed at the GAEC will enable an assessment to be made. On the other hand, several interesting studies concerning quality control and dose assessment results from Greek diagnostic installations have recently been published'-1"6'. Furthermore, Greece is now participating in a series of research programmes dealing with quality control and assessment of the risk from (a) dental X ray units, (b) radiology and (c) mammography.

NUCLEAR MEDICINE As far as nuclear medicine laboratories are concerned, regulations provide for four different types of licences, relating (a) to the maximum permissible quantities of radioactivity that can be used, and (b) to the medical procedures applied. Licences are renewed every two years, after inspection of the laboratories by the competent authority to ensure compliance with regulations. The therapeutic use of radionuclides is restricted to public or private hospitals. The supply of radioactive materials is centrally controlled by the GAEC. Radiation physicists are employed as qualified experts in laboratories where in vivo administration of radionuclides is carried out. Regulations also provide for quality assurance programmes and quality control protocols. At present, a group of experts from the GAMP and the GAEC are working on the preparation of these protocols. As with diagnostic radiology, the number of nuclear medicine departments has significantly increased over the last few years. This has been accompanied by qualitative improvements in this field, due to the updating of the equipment used in the new departments. This, together with the use of more advanced diagnostic techniques, explains the remarkable increase in 99Tcm activity used in Greece in 1993. As regards the radiation risk from diagnostic nuclear medicine procedures, no official estimate exists though there is a relevant programme under preparation. A recent study'7', based on 50,000 examinations and carried out in northern Greece over the period 1988-1992, deals with the assessment of the collective effective dose from nuclear medicine procedures. This study has been submitted for publication.

ROUND TABLE PRESENTATIONS data were obtained from the GAEC's central dosimetry laboratory (film dosimetry). In spite of the increased use of medical applications This is an encouraging result which reflects how of ionising radiation in Greece over the last few years, much has been done by the people involved in improv a yearbyyear gradual reduction in the mean individual ing radiation protection in Greece (authorities, doctors, dose to workers in the health sector is occurring. The physicists and technicians). OCCUPATIONAL RA DIA TION EXPOSURE REFERENCES 1. Neofotistou, V., Molfetas, M. and Panayiotakis, N. Quality Control in Conventional Diagnostic Radiology in Greece. Radit. Prot. Dosim. 57(14), 293296 (1995) (This issue). 2. FlioniVysa, ., Xenofos, S., Giakoumakis, E., Panayiotakis, G. and Proimos, V. Analysis of the results of a quality control project on mammography in Greece. Radit. Prot. Dosim. 57(1^1), 329332 (1995) (This issue). 3. Xenofos, S., Panayiotakis, G., Giakoumakis, E. and FlioniVyza, A. Quality Control of Mammographie Equipment in Greece. Abst. Book. p. 175. 7th International Congress on Senology. Rhodes, Greece (1992). 4. Maccia, C, A richeCohen, M., Severo, C. and Nadeau, X. (Eds). The 1991 CEC Trial on Quality Criteria for Diagnostic Radiographic Images. Draft Report of CEC Contract No BI70075 (1993). 5. Lyberis, C, Efstathopoulos, E., Manetou, A. and Poudridis, G. Automatic Film Processors' Quality Control Test in Military Hospitals. Eur. J. Radiol. 16, 246249 (1993). 6. Okkalidis, D. Assessment of Radiology Installations in Macedonia, Greece. Eur. J. Radiol. 12, 177181 (1991). 7. Hatzioannou, K., Hatziyiannaki, ., Molyvda, E., Sioundas, ., Kostaki, P. and Psarrakos, K. Effective Dose from Diagnostic Nuclear Medicine Procedures in Northern Greece (submitted) (1993).

APPENDIX 6. QUALITY A SSURA NCE A ND RA DIA TION PROTECTION IN IRELA ND


G. O'Reilly INTRODUCTION There has been considerable progress in quality assur ance and radiation protection in recent years. One of the most encouraging features of this progress has been the growing recognition of their value and importance. However, from a practical viewpoint the extent of pro gress in this area has been constrained to a certain extent by the limited resources available. From a legal perspective, most of the requirements of the Council directives concerning ionising radiation have been implemented in Irish legislation. Require ments for radiation protection and quality assurance have been incorporated into the legal framework. There are, however, some important omissions. For example, some aspects of the requirements of the Council Patient Directive in the quality assurance area have not yet been fully implemented in Irish legislation. There are also difficulties of interpretation in and con flicts between some existing pieces of legislation with regard to the control of use of ionising radiation in medicine. The responsibility for this has not been clearly allocated. 49 ORGANISATIONAL FRA MEWORK The Radiological Protection Institute of Ireland (RPH); this Institute has statutory obligations in relation to radiological protection. The Medical Council; this Council was established under the Medical Practitioners Act (1978). The Council regulates the activities of the medical profession. The Dental Council; this Council was established by the Dentists A ct (1985). The function of the Council is the registration and control of persons engaged in the practice of dentistry. The Department of Health; this department has overall control of the services provided by the health authorities throughout the country. In addition, the department reviews existing services and initiates proposals for new services.

LEGAL FRA MEWORK The use of ionising radiation for medical purposes in Ireland is controlled by several pieces of legislation. The principal legal documents which apply are as follows:

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES 1. The Radiological Protection Act (1991); this act established the Radiological Protection Institute of Ireland (RPH) and conferred upon it responsibilities in the area of radiological protection. The RPH replaced the Nuclear Energy Board (NEB). 2. S.I. No 151 (1993); under this order, which was made under the RPH Act (1991), activities involving exposure to ionising radiation are prohibited save under licence issued by the RPH. This instrument replaced S.I. No 166 (1977). 3. The Safety, Health and Welfare at Work Act (1989); this act established the National Authority for Occupational Safety and Health and made provision to secure the safety, health and welfare of persons at work. 4. S.I. No 189 (1988); this order partly implements the EC Directive on the protection of the patient (84/466/Euratom). 5. S.I. No 43 (1991); this order implements the Council Directive on the protection of the public and workers (80/836/Euratom as amended by 84/467/Euratom) and partly implements 84/466/Euratom. It is of interest that the dose limits for workers and members of the public set out in S.I. No 43, derive not from either 80/836/Euratom or 84/466/Euratom but from ICRP 60, and are thus more restrictive than those required by the Council Directives, which are, however, under revision. REGULATIONS AND GUIDELINES In addition to the legal documents listed, there exist several important supporting documents. One of the most important of these was issued in 1983 by the Department of Health as an administrative circular. It set out detailed organisational arrangements that should be implemented in hospitals using ionising radiation. Included in the guidelines were the recommendations that each hospital, or group of hospitals, should establish a radiation safety committee and appoint a Radiation Protection Advisor (RPA) and a Departmental Radiation Safety Officer (RSO). Appropriate responsibilities for both the committee, the RPA and the RSO were specified. The requirement for appointing an Approved Medical Officer was also emphasised. The Department of Health required notification of these appointments. Furthermore, any activity involving a hazard from ionising radiation was to be reported to the Radiation Advisory Committee (a Committee of the Nuclear Energy Board acting on behalf of the Department of Health). In accordance with Article 5 of the Council Directive 80/836/Euratom, prior authorisation was required from the Department of Health for the administration of radioactive substances to persons for diagnostic or other purposes. Finally, in order to ensure compliance with the recommendations of the circular, it was stipulated that each hospital would be subject to inspection arranged by the Department of Health. 50 Another document issued by the Department of Health was the 'Code of Practice for Radiological Protection in Dentistry'"'. This document contains a detailed code dealing with aspects of radiation protection. It defines responsibilities with regard to radiation protection, lists rules of good practice and outlines criteria of acceptability for imaging equipment. This document is currently being revised. The Nuclear Energy Board (which was replaced by the RPH in 1992) circulated two important documents relating to medical use of ionising radiation. The first of these, issued in 1988, was a code of practice entitled 'The Design of Diagnostic Medical Facilities Using Ionising Radiation''2'. The document is intended as a guide to architects and works departments concerned with the design, construction and modification of such units. It contains detailed advice on specific design features. This document is currently under revision. Another document issued by the Nuclear Energy Board in 1988 was entitled 'Guidelines for Approved Medical Officers on Health Surveillance of Radiation Workers''3'. This document outlines the role of the Approved Medical Officer and provides information to assist in this work. In 1992, the Medical Council established a Permanent Advisory Committee to advise the Council on the requirements of the Council Patient Directive. Following this initiative, all hospitals were requested by the Council to ensure that practitioners engaged in the use of ionising radiation had completed a course in radiation protection. The initiative led to the establishment of regular courses on radiation protection in many of the large teaching hospitals. The Dental Council are also addressing the question of training in radiation protection and quality assurance for dentists. Another instrument used to regulate practice in the use of ionising radiation is the licence. Under S.I. No 151, activities involving exposure to ionising radiation are prohibited save under licence issued by the RPH. Furthermore the RPH may attach to any licence such conditions as it deems necessary. This can be a very effective method of further regulating practices. The use of ionising radiation is tightly controlled in Ireland. The legislation in this area is intended to ensure the protection of workers, the general public and to a lesser extent the patient. In general this objective is realised. However, a closer examination of the legislation does reveal some difficulties, particularly in the area of medical use.

CONTROL OF USE OF IONISING RADIATION IN MEDICINE In Ireland there is a division of control responsibility between the general use of ionising radiation and its medical use. While, broadly speaking, the RPH has overall responsibility for the control of use of ionising

ROUND TABLE radiation in most areas, its role is limited in the area of medical use. In this area the existing legislation is not entirely consistent. The difficulties in the present system may be due to the fact that the various items of legislation do not all stem from a common source. Responsibility in this area is divided between the RPH, the Medical and Dental Councils and the Department of Health. More importantly there are areas of the use of ionising radiation in medicine which fall between these bodies and are not controlled at all by statute, even though their control in practice may be satisfactory. The exact division of responsibility is not at all clear as the existing legislation does not make provision for the specific allocation of responsibilities in relation to the control of use of ionising radiation in medicine. The role of the Medical and Dental Councils is defined in S.I. No 189. This statutory instrument prohibits exposure in the practice of medicine or dentistry, unless the practitioner has completed a course of training giving him competence in radiation protection techniques to the satisfaction of the Medical or Dental Council. However, there is a conflict between S.I. No 43 (1991) and the RPH Act (1991). In the area of medical use of ionising radiation, S.I. No 43 (which implements the EC Council Directives on the protection of the public and workers) envisages the Institute controlling the use of ionising radiation in medicine as it does in industry and other areas. However, in relation to medical use, the Institute is required by S.I. No 43 to act in conjunction with an officer of the Minister for Health. Notwithstanding this, under the RPH Act (section 7 (2)), the role envisaged for the Institute is more restricted, as its functions under this Act are limited to the area of custody, maintenance and calibration of irradiating apparatus used in medicine. The difficulty that arises, therefore, is that there is no provision in existing legislation to allocate the balance of responsibilities in the area of medical use to any organisation. This leaves an unsatisfactory situation where no organisation has responsibility for the control of use of ionising radiation in medicine. LEGAL BASIS FOR QUALITY ASSURANCE The legal basis for quality assurance is well established. It is addressed in several pieces of Irish legislation S.I. No 43, the RPH Act and it is also required as a condition of the licence. In particular, the RPH Act requires that proper calibration and maintenance be carried out on any irradiating apparatus or nuclear device. This requirement is intended both to minimise effects on property and persons other than the patient and to maximise accuracy and safety. S.I. No 43 also addresses the question of quality assurance. It requires environmental surveillance such 51

PRESENTATIONS that doses, dose rates and activities are monitored and the results recorded. It also requires that new installations are examined and accepted from the perspective of radiation protection. Furthermore, it requires the regular checking of the effectiveness of protective devices and techniques. Finally it requires that measuring instruments are serviceable and correctly used. However, while many of the requirements of the EC Council Directives for quality assurance have been incorporated into Irish legislation, there are some aspects that have yet to be implemented. S.I. No 189, which implements the EC Council Patient Directive, makes no reference to quality assurance. The Directive requires that the competent authorities shall establish and enforce criteria of acceptability for radiological and nuclear medical installations. It also requires that all installations in use must be kept under strict surveillance with regard to radiological protection and the quality control of appliances. A further requirement is that the competent authorities shall ensure that all installations which no longer meet the criteria of acceptability are taken out of service or replaced. S.I. No 189 does not address any of these requirements. There is, therefore, a need to address some of the specific requirements of the EC Patient Directive, particularly those contained in Article 3 of this Directive. A further omission from legislation is the absence of a system of recognition and training for qualified experts. This is required by 80/836/Euratom, but so far it has not been addressed either in legal or practical terms although S.I. No 43 refers to qualified experts and recognises their role. Furthermore, the Council Patient Directive requires that a qualified expert in radiophysics shall be available to sophisticated departments of radiotherapy and nuclear medicine. This has not yet been explicitly addressed. As noted previously, S.I. No 151 prohibits activities involving exposure to ionising radiation save under licence issued by the RPH. In the conditions attached to such licences, there is a requirement that all imaging devices be subjected to appropriate quality assurance testing as detailed in the WHO guidelines on quality assurance in diagnostic radiology and nuclear medicine'45'. However, as the role of the Institute is constrained by the RPH Act (1991) to certain very limited aspects of the medical use of ionising radiation, there is some uncertainty over what matters may be properly considered by the Institute. The effect of this conflict in the existing legislation is to make enforcement of the licence conditions difficult. Most of the requirements of the Council Directives have already been incorporated into Irish legislation. The difficulties that remain in existing legislation may be summarised as follows: ( 1 ) Responsibility for the control of the use of ionising radiation in medicine is not clearly allocated to any organisation or body.

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES (2) The requirements of the Council Patient Directive for quality assurance have not yet been fully implemented in Irish legislation. (3) Those requirements for quality assurance that have been incorporated into Irish legislation may not be enforceable because of anomalies in allocation of responsibilities. (4) The requirement for a qualified expert in radiophysics to be available to certain types of departments has not yet been explicitly addressed. It is clear, therefore, that reform of the legislation is required. QUALITY ASSURANCE AND RADIATION PROTECTION IN THE HEALTH SERVICE Hospitals in Ireland fall into two categories: health board hospitals, which are administered by eight regional health boards and financed by the state, and voluntary hospitals, which operate under a board of management and are also substantially state financed. Each health board has one or a number of committees concerned with radiation protection. Each committee looks after aspects of radiation protection in the group of hospitals for which it is responsible. The committees include among their members an administrator from the health board's executive and a Radiation Protection Advisor (RPA) appointed by the regional health board. The RPA may provide services on a part-time basis and it is not unusual to have the same RPA advising a number of health boards. Each health board develops and implements its own radiation protection programmes through its radiation protection committees. In addition to their role in general radiological protection, the individual committees are charged with the responsibility of implementing and overseeing quality assurance programmes. The stage of development of the different programmes of quality assurance varies from region to region and in fact even in individual health board regions there can be significant differences in approaches between different committees. Each voluntary hospital has its own radiation protection committee and RPA. In the larger hospitals, which have their own physics support, the RPA is usually a member of staff. In the case of small voluntary hospitals which do not have a physics department the RPA would typically be a physicist drawn from one of the larger hospitals. QUALITY ASSURANCE IN DIAGNOSTIC IMAGING The stage of development of quality assurance programmes in the different areas of diagnostic imaging varies. Therefore the areas of general radiology, nuclear medicine, dental radiology and mammography will be discussed separately.
52

General radiology The Department of Health is very clear in its commitment to quality assurance and radiation protection. This is evident in the approach followed when equipping new installations. Patient dosimetry is regarded as an important consideration in equipment selection. It is also the policy to purchase the equipment necessary for QA at the same time as new imaging equipment is installed, provided it has been requested by the user. Furthermore, the Department of Health is a strong advocate of training, education and research in the areas of radiation protection and quality assurance. Annual courses in quality assurance and radiation protection are held for radiographers, physicists and radiologists. The last national survey on diagnostic radiology carried out in Ireland (NEB (1981))"" concluded that very few X ray units were subjected to adequate quality assurance assessment. The situation has changed since then with a growing recognition of the importance of QA. However, there are still areas that need some improvement. A well-developed QA programme should have at least the following elements in place: equipment specification, acceptance testing, constancy checking, routine QA measurements and the writing-off of equipment. In general the first three elements of this programme are in place in most regions. Similarly, the procedures to write off and decommission equipment, the performance of which is judged unacceptable, are also well established in most regions. However, the routine performance evaluation of imaging equipment is inadequate in some QA programmes. Part of the problem stems from inadequate resources both in terms of staffing and equipment. Many hospitals operate without any physics support other than that provided by the RPA. This makes routine implementation of comprehensive QA difficult. Fluoroscopy rooms are usually subjected to QA assessment either by a resident physicist (when there is one) or by the visiting RPA. In general, mobile X ray units tend to be neglected from a QA point of view. Nuclear medicine In the area of nuclear medicine, quality assurance programmes are better established. Part of the reason for this may be that many nuclear medicine departments have a physicist whose responsibilities include the implementation of a quality assurance programme. The most recent survey of nuclear medicine departments in Ireland, which was carried out in 1985'7', found that all nuclear medicine departments operating in the country at that time carried out some quality assurance assessment. It was apparent in the survey, however, that most checks were done on an 'as required basis'. It is likely that the more comprehensive programmes were to be found in those departments which had some form of

ROUND TABLE physics support. In 1985, 46% of nuclear medicine departments were operating without proper physics support. At that time there were eleven nuclear medicine departments in operation. There are now sixteen departments in operation, 57% of them operating with fulltime physics support.

Dental radiology The public dental service is managed by the regional health boards. The structure for radiation protection, therefore, is similar to that for hospitals. Dentists are represented on the Radiation Committee and participate in its work. In private practice the individual dentist is responsible for radiation protection. In the last few years there has been a major initiative to evaluate the current status of imaging equipment in the public dental service with a view to replacing equipment judged to be unacceptable. There has been a considerable amount achieved in several regions, with most of the equipment which was judged unacceptable, already having been replaced. There is also a general recognition of the need to implement equipment specification and acceptance testing for all new imaging equipment. At present, the main limitation on the further development of these initiatives is one of lack of resources. The dental profession in the public service relies on the services of either the RPA for the region or a representative from the RPH and this places some limitation on the amount that can be achieved. There is, however, a clear commitment by the Department of Health to advance the work already in progress. This should lead to completion of the equipment audit and the subsequent replacement of equipment. At that stage a proper quality assurance programme can be implemented. REFERENCES 1. 2. 3. 4. 5. 6. 7.

PRESENTATIONS Mammography The most recent survey (NEB (1989))'8' focused on breast doses and image quality in mammography in Ireland. The survey found that although no unit delivered excessively high doses, there was an unacceptable spread in values. It also found that routine quality assurance programmes were not generally in place. It would seem that the situation has improved somewhat in the intervening years. Most units are now subjected to regular quality assurance. There is still, however, considerable room for improvement in this area which can only come with the allocation of adequate resources. CONCLUSIONS There has been considerable progress in the areas of quality assurance and radiation protection in Ireland in recent years. The legal basis for both of these has been well established by the implementation of the Council Directives concerning ionising radiation. While there have been many positive developments, there are still some unsatisfactory aspects in the present situation. The difficulties that remain may be summarised as follows: (1) Some of the requirements of the Council Patient Directive (84/466/Euratom) have not yet been fully implemented in Irish legislation. (2) Current legislation is inadequate for the proper control of the use of ionising radiation in medicine. (3) The further development and implementation of routine quality assurance has been limited by lack of resources. Although these difficulties are of a serious nature, they must be viewed in the light of the significant developments that have already taken place. A review of both the legal and practical initiatives in this area shows that there is a serious commitment to both radiation protection and quality assurance in Ireland and it is hoped that this will lead to resolution of the current problems.

Code of Practice for Radiological Protection in Dentistry (Dept of Health) (1988). The Design of Diagnostic Medical Facilities Using Ionising Radiation (NEB) (1988). Guidelines for Approved Medical Officers on Health Surveillance of Radiation Workers (NEB) (1988). Quality Assurance in Diagnostic Radiology (World Health Organization, Geneva) (1982). Quality Assurance in Nuclear Medicine (World Health Organization, Geneva) (1982). Survey of Diagnostic Radiology in the Republic of Ireland (NEB Report) (1988). O'Donovan, N., Hone, C. and Turvey, F. J. Survey of Nuclear Medicine Practice in Ireland. Irish J. Med. Sci. 157(10), 310315 (1988). 8. A Survey of Breast Doses and Image Quality in Mammography in Ireland (NEB Report) (1989).

53

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES

APPENDIX 7. INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES CONCERNING RADIATION PROTECTION OF THE PATIENT IN ITALY
F. Mazzei and M. Paganini Fioratti LEGAL AND REGULATORY ASPECTS Over the last ten years the problem of radiation protection for the patient has been the subject of numerous discussions and symposia organised, in particular, by scientific and professional bodies. It can safely be assumed that most physicians and their assistants are now aware of the main purposes of radiation protection for patients. However, this increased awareness has not been accompanied by progress in the regulatory field. In fact, no effective regulations for the diagnostic and therapeutic use of ionising radiation exist in Italy at present. Presidential Decree No 185 (DPR 185) of February 1964, which is still the sole legal instrument governing the use of ionising radiation covers medical applications and radiation protection of the patient only in an indirect way. Two articles (97 and 98) are of particular relevance; these require practitioners working with radiation to have specific qualifications and to record the type and amount of the radionuclides administered. It should be mentioned that in 1984, coinciding with the adoption of Council Directive 84/866/EURATOM the Ministry of Health issued Circular No 62'". This pointed out the need to: (a) justify individual and collective examinations and in particular, mass screening programmes, whose effectiveness should be assessed by a risk-benefit analysis; (b) facilitate the circulation of examination results; (c) train both practitioners and members of staff in radiation protection; (d) plan, clearly identify and monitor radiological installations. In its second section the Circular made technical suggestions concerning radiation protection of the patient in both diagnostic radiology and radiotherapy. However, the timely publication of Circular No 62 was not followed by the adoption of more effective provisions. As the Circular itself was not binding, it has been applied in a haphazard way in our country through regional regulations. A draft proposal has been prepared by the Ministry of Health to implement the Council Directive 84/866/EURATOM. This proposal is still under discussion and has not yet been adopted. Its main points are as follows: (a) the clinical use of radiation must be justified; (b) the quality of medical applications must be improved by training medical and other staff in 54 radiation protection of the patient and by regulating equipment quality control procedures. A complete data recording system that will enable an evaluation of the contribution of medical examinations to effective dose is also being considered. QUALITY CONTROL PROGRAMMES Over the last 10 years many Health Physics Services have been carrying out studies and programmes on quality control in radiology. Many of these were presented and discussed at the conferences organised by the CEC during this period'2-4'. Where resources allow, these programmes have been based on criteria derived from the main literature sources and from CEC initiatives and documents. An exhaustive review of the published reports on the programmes would take up too much space. However, a great deal of useful work has been done in this field, which is important for the application of the optimisation criteria in radiation protection of the patient. It should be stressed, however, that these programmes do not cover the whole of Italy. At some facilities, the most sophisticated measurements and checks are performed, while at others X ray apparatus is wrongly operated without any control whatsoever. The same pattern can be recognised in inspection work, depending on the training, time and technical support available to the inspection body. In any event checks carried out during inspections of X ray equipment should be exclusively aimed at ascertaining that worker radiation protection is ensured. Quality control programmes have been carried out over the last few years for Nuclear Medicine facilities and CT scanners'56'. THE NEXT PROGRAMME The NEXT programme was presented at a meeting in Levico in 1975. It ran from 1978 to 1990, and was sponsored by the National Health Institute (Istituto Superiore di Sanit, ISS) and the Italian National Agency for New Technologies, Energy and Environment (ENEA). The NEXT programme aimed at collecting all available information on the different techniques used when performing 12 selected examinations. Parameters such as voltage, current and time were simply recorded, while source-to-film distance, exposure at a fixed distance, exposures with three increasing aluminium thicknesses and beam size were meas-

ROUND TABLE PRESENTATIONS

ured directly. Halfvalue layer, skin entrance exposure and organ dose indexes were then calculated. The programme was limited by the fact that some technical parameters, such as voltage, were simply recorded and not directly measured. Nevertheless, it was an honourable compromise and enabled useful infor mation on doses and procedures to be collected in a short time. The introduction of the NEXT programme was closely related to a reorganisation of the National Health Service. Many tasks concerning radiological and radi ation protection aspects were assigned to regional and local health administrations and some of them, especially in Umbria and Emilia Romagna, used the programme to obtain more information on specific areas. The programme was then used as an overall sur vey in a field where not even the number of working devices was known. Thus, the NEXT programme was a useful tool to analyse the Italian situation in this field and constituted the only national programme on radio logical exposure. The entrance exposures for chest, abdomen and den tal examinations decrease considerably from the first NEXT survey in Italy to the last group of surveys performed'7'. A s regards the 1447 radiological projec tions analysed in the survey performed between 1986 and 1989, it should be stressed that the variation in tech nical parameters is still too wide: from 40 kV to 141 kV, from 1 mA.s to 120mA .s for chest PA . Surprisingly, the beam area to film area ratio ranges from 0.51 to 7.02. The maximum ovarian dose of 50 5 is found for chest PA . The same remarks apply to the other projections covered by the programme. The testis dose for abdomen AP, for example, ranges from 5 5 to 2460 5, while for the skull LA T the thyroid dose ranges from 10 5 to 2230 5. As for HVL values, the techniques used in the above mentioned projections were compared to the values rec ommended in ICRP Publication 34; the level of agree ment ranged from 12% to 74%. Bearing in mind the limitations mentioned, these results indicate that a great deal of work still has to be done.

GSD IN ITA LY IN 1974 In 1974 the ISS and ENEA carried out a study'9' on the genetically significant dose (GSD), arising from medical exposures in X ray diagnosis and nuclear medi cine; the GSD received by the Italian population from X ray examinations was estimated to amount to 300 \S\. However, this estimate was subject to certain limi tations, in that organ doses were obtained from the literature and the total number of radiological examin ations and their frequency related to only a small sample of facilities. Furthermore, the data were provided on a voluntary basis. Nevertheless, it was this study that drew the attention of the relevant authorities and scientific organisations to the problem of patient protection. COLLECTIVE DOSE IN FRIULIVENEZIA GIULIA In the years 19831985 a major research project was carried out in the FriuliVenezia Giulia region by the Health Physics Service of the Udine Local Health Administration in cooperation with the University of Trieste and the CRA D of Udine, supported by the CEC'10'. This study, relating to the method used by the NRPB in the UK to evaluate the collective dose to the popu lation due to X ray exposure, could become a model for all new programmes in this field. The Emilia Romagna region is now planning a research project modelled on the one mentioned above. DOSE EVA LUA TION IN NUCLEA R MEDICINE Radiation exposure due to radiopharmaceuticals administered in nuclear medicine procedures has been monitored in Italy since 1974. In the seventies the GSD was estimated to be around 6 5"". In the years between 1982 and 1989, it ranged from 0.9 8 to 1.5 5; in the same period the effec tive dose equivalent ranged from 26.6 8 to 42.7 8"". CONCLUSIONS A number of quality control programmes for X ray equipment have taken place in Italy, although their national distribution has been uneven. Great attention is being paid to mammography and adequate controls exist for nuclear medicine. The importance of the NEXT pro gramme lies in the fact that its results clearly show that a great deal remains to be done to control and optimise the main source of exposure for the Italian population. The difficulties facing national programmes for the evaluation of collective doses and the definition of com mon criteria for quality assurance in radiology are quite similar to those discussed in sections 2 and 3, but they are hugely magnified when related to Italy as a whole
55

THE DQM PROGRA MME The Dose and Quality in Mammography Italian sur vey was carried out by the Society for Radiology and Nuclear Medicine (SIRMN) in cooperation with the University of Ferrara and the National Health Institute. The main purpose of this programme was to obtain good quality radiographic images with a dose reduction through the checking of several technical parameters, dose measurement and image quality evaluation. This programme ran for five years and analysed about 300 equipment sets distributed throughout the country'*'.

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES and are the main reason why a national research pro gramme on collective doses in radiology has not yet been carried out in Italy. These difficulties can be summarised as follows: (1) A lack of legal provisions laying down precise guidelines and responsibilities for the authorities and bodies involved. (2) Uncertainties connected with the delayed implementation of the Council Directives. (3) A lack of information about the total number of working X ray equipment sets, the total number and REFERENCES 1. Ministero della Sanit. La Radioprotezione del Paziente nelle Indagini Diagnosliche e nei Trattamenti Terapeutici di Radiolo gia e di Medicina Nucleare. Circolare n 62, DGSIPDIV V (1984). 2. Gal lini. R., Belletti, S. and Giugni, U. Cost Benefit Evaluation in a Quality Control Programme for Conventional Radiodi agnosis. In: Technical and Physical Parameters for Quality A ssurance in Medical Diagnostic Radiology: Tolerances, Limiting Values and A ppropriate Measuring Methods. Eds B. M. Moores, F. E. Stieve, H. Eriskat and H. Schibilla. BIR 18 (London: British Institute of Radiology) pp. 4950 (1985). 3. Francescon, P., Occhialini, L. and Benini, A. Theoretical and Practical Considerations on Xray Quality Control Measure ments. In: Technical and Physical Parameters for Quality A ssurance in Medical Diagnostic Radiology: Tolerances, Limiting Values and A ppropriate Measuring Methods. Eds B. M. Moores, F. E. Stieve, . Eriskat and . Schibilla. BIR 18 (London: British Institute of Radiology) pp. 8183 (1985). 4. Gaiba, W., Rossi, ., Vianello Vos, C , Giacomelli, G., Galletti, S. and Rimondi, E. Quality Control in the Radiological Examinations of Paediatric Patients. In: Technical and Physical Parameters for Quality A ssurance in Medical Diagnostic Radiology: Tolerances, Limiting Values and A ppropriate Measuring Methods. Eds B. M. Moores, F. E. Stieve, H. Eriskat and H. Schibilla. BIR 18 (London: British Institute of Radiology) pp. 129130 (1985). 5. Pedroli, G. and Buraggi, C. / Controlli di Qualit in Medicina Nucleare. A tti del Convegno Nazionale sui processi di ottimizzazione nella diagnostica medica con radiazioni ionizzanti: situazione attuale e prospettive future. Serie Simposi ENEA, pp. 149161 (1983). 6. Borasi, C , Granata, M. and Guglielmo, D. Dose e Controllo di Qualit nella Tomografia Computerizzala. Atti del Convegno Nazionale sui processi di ottimizzazione nella diagnostica medica con radiazioni ionizzanti: situazione attuale e prospettive future. Serie Simposi ENEA , pp. 149161 (1983). 7. Calicchia, ., Mazzei, F., Indovina, P. L., Dobici, F. and Paganini Fioratti, M. Patient Exposure from D iagnostic and Dental Xray Examinations. Phys. Med. 5, Suppl. 1, 264268 (1989). 8. Benassai, S., Dobici, F., Susanna, ., Indovina, P. L., Pugliani, L. and Salvadori, P. Some Results on Radiation Exposure of the Italian Population due to Medical D iagnostic Examinations in 1974. Health Phys. 32, 403^13 (1989). 9. Rimondi, O., Gambaccini, M., Candini, G. C , Indovina, P. L. and Rosati, A. A Survey of Radiation Dose and Image Quality in Mammography: an Ongoing Program in Italy. Health Phys. 52(4), 437441 (1987). 10. Padovani, R., Contento, G., Fabretto, M Malisan, M. R., Barbina, V. and Gozzi, G. Patient Doses and Risks from D iagnostic Radiology in North Italy. Br. J. Radiol. 60, 155165 (1987). 11. Dobici, F., Susanna, A . and Wells, J. Radiation Exposure of the Italian Population due to Nuclear Medicine Examinations. J. Int. Fed. Med. Biol. Eng. 29, Suppl. 2, 10021005 (1991). distribution of examinations, the age and sex distri bution of the population receiving X rays. Infor mation concerning limited geographical areas is available but it is not suitable for a national pro gramme. (4) Insufficient support by the relevant central organis ations owing to the uncertainty surrounding their tasks and duties. It is hoped that the forthcoming new legislation will help to bring about a considerable improvement in the situation. The hard and detailed work carried out over many years will then have been worthwhile.

56

ROUND TABLE PRESENTATIONS

APPENDIX 8. OVERVIEW OF INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES IN QUALITY ASSURANCE AND RADIATION PROTECTION IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE IN LUXEMBOURG
C. Back LEGISLATION Under a law enacted in 1983'", detailed practical rules were laid down in a regulation issued in 1987'231. The main consequences of this regulation are: (a) Medical and auxiliary staff must prove that they have received education and training in radiation protection and radiology. Most radiological examinations are carried out by radiologists or under their supervision. (b) Minimum performance criteria are laid down for X ray equipment for the different types of X ray examinations: thus, for each type of examination, the power of the X ray generator, the maximum dimensions of the focus and other relevant components of the X ray equipment must be appropriate. As a result, radiological examinations in private practices outside hospitals are decreasing due to the high cost of adapting existing equipment to the required legal standards and radiology is becoming increasingly restricted to hospitals. Since the law was introduced, very few doctors have applied for a licence and purchased X ray equipment for their private practices. It is estimated that more than 90% of all X ray examinations (except dental X ray examinations) are carried out in hospitals. All nuclear medicine examinations are carried out in hospitals. (c) Dose reduction and optimisation techniques have to be used. Since 1989 only rare earth intensifying screens may be used. This has produced an important diminution in dose to the patient. (d) The use of fluoroscopic equipment without image intensifiers is forbidden. Fluoroscopic examinations of the heart have been mainly replaced by ultrasound examinations. (e) Each patient is issued with a radiological record card in which all radiological examinations have to be entered. It was hoped that the adoption of this system would reduce repeated examinations and so reduce the dose to the patient. However it did not have the desired effect, as no reduction of the number of X ray examinations has taken place in the last 5 years. The reasons are manifold. is not laid down in a law or regulation. There is no law that requires regular technical quality control of radiological equipment, e.g. routine control of film processors. However, the radiation protection division of the Ministry of Health is carrying out acceptance testing. Periodical, non-regular quality controls on existing equipment are carried out by our division; our main interest at the moment is the control of the image receptor (intensifying screens, image intensifiers) and the chemical processing of films. Generally speaking, our conclusions are accepted and the suggested improvements are carried out. Quality assurance has been introduced at a national level, and for the first time in our health system, through a mammography-based screening programme for breast cancer that started in 1992. The main features concerning quality assurance are: (a) Technical quality assurance: the programme has to comply with the European protocol for the quality control of the technical aspects of mammography screening141. Our division is responsible for establishing such a technical quality assurance programme: (i) positioning of the patient, training of technical assistants takes place periodically; (ii) mammograms are read a second time by an outside radiologist who is an expert in mammography and who is also taking part in the technical quality assurance programme. All major radiological centres are participating in this programme, so that by now all radiological departments are used to the idea of quality assurance. STATISTICS All persons living in Luxembourg are enrolled in our national social security system. This allows us to establish statistical data on frequency of examinations and to estimate the contribution of medicine to the dose to the population. Table A8.1 gives statistics (number of X ray examinations per 1000 inhabitants) for certain doseintensive X ray examinations'5' carried out in our country. The following conclusions may be drawn: (a) The frequency of barium enema, barium meal and IVU examinations is slowly decreasing. (b) The frequency of CT and mammography examinations is increasing very rapidly (about 40% in a 2 57

QUALITY ASSURANCE Quality assurance in radiology and nuclear medicine

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES year period). The rapid increase in CT examinations is of concern. In particular, we should look at new, highly doseintensive CT techniques which are becoming popular (spiral CT) or are being developed (CT angiography). (c) The frequency of abdomen examinations shows a slow increase. (d) The frequency for all X ray examinations (excluding dental X ray examinations) is about 1000 in statistical terms. This means that each inhabitant of Luxembourg is examined once a year. This fre quency is still rising. FUTURE WORK Future work should include the following: (1) Technical quality assurance has to be further pro moted in all fields of radiology and nuclear medi cine. (2) Individual dosimetry of the patient should be pro moted in the fields of interventional radiology and CT examinations. (3) Inservice training of all participants has to be increased. This includes training of those who pre scribe examinations using ionising radiation. We recommend that our Ministry, in collaboration with radiologists should draw up a document like 'Mak ing the best use of a department of radiology, guide lines for doctors'' 6 '. (4) The implications of the organisation of our health and social security systems in terms of radiation protection of the patient should be further investi gated. Our Ministry, in collaboration with the Min istry of Social Security, should investigate what incentives could be introduced to further promote radiation protection of the patient as well as quality assurance, among radiologists, radiographers and hospital managements.

Table A8.1. Luxembourg statistics on number of examinations per 1000 inhabitants (source: Social Security data). 1988 Computer tomography Skull Body Angiography Phlebography Interventional radiology Barium enema IVU Abdomen Mammography Total (excluding dental X rays) Population 1990 1992 (90/92) (%)

11.3 13.9 11.1 9 . 9


20.1

19.9 28.0
13.3

26.1 38.9
15.2

+35 +44
+ 14

7 . 7
17.3 11.6 25.9 1020 378000

5 . 9
15.7 12.4 35.9 1070 390000

23 9
+ 11

8 . 6
15.6

+43 +5

918
371000

REFERENCES 1. Loi du 10 Aot 1983 concernant l'Utilisation Mdicale des Rayonnements Ionisants. Memorial 'A ', No 69 (31 A ugust 1983). 2. Rglement Grandducal modifi du 17 Fvrier 1987 portant Excution de la Loi du 10 Aot 1983 concernant l'Utilisation Mdicale des Rayonnements Ionisants. Memorial 'A ', No 16 (23 March 1987). 3. Kayser, P. Recent Progress in Luxembourg on Quality Assurance in Medical Xray D iagnosis. In: Technical and Physical Parameters for Quality A ssurance in Medical Diagnostic Radiology. Eds B. M. Moores et al. (London: British Institute of Radiology) BIR 18 (1985). 4. CEC. European Guidelines for Quality Assurance in Mammography Screening and Appendix: European Protocol for the Quality Control of the Technical Aspects of Mammography Screening. CEC V/775/92, Report EUR 14821 (1992). 5. Wall, B. F., Harrisson, R. M. and Spiers, F. W. Patient dosimetry techniques in diagnostic radiology, IPSM Report No 53 (York: IPSM) (1988). 6. Making the Best Use of a D epartment of Clinical Radiology, Guidelines for D octors (The Royal College of Radiologists, Great Britain) (1993).

58

ROUND TABLE PRESENTATIONS

APPENDIX 9. QUALITY ASSURANCE AND POPULATION DOSE IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE IMAGING: STATE OF THE ART IN THE NETHERLANDS
J. Zoetelief, L. B. Beentjes, J. J. Broerse, H. W. Julius and E. Busemann-Sokole INTRODUCTION Optimisation procedures in diagnostic radiology and nuclear medicine imaging should be directed at obtaining the diagnostic information required to provide the best care to the patient at the smallest effective dose to both patient and personnel. There is increased understanding that comprehensive Quality Assurance'" (QA) programmes are required to ensure that diagnostic radiology and nuclear medicine imaging are operating at a satisfactory level of performance. QA encompasses the total process from the original decision to carry out the diagnostic procedure, the procedure itself, to the report and follow-up. Quality control"' (QC) protocols are essential links within the QA chain covering monitoring, evaluation and maintenance at optimal levels of all characteristics of performance that can be defined, measured and controlled. Certification, or accreditation, is considered a realistic means of achieving overall QA in health care. The concept of hospital accreditation was initiated in North America12'. The main features of the North American accreditation system are the definition of QA standards, self-assessment by departments for compliance with these standards, and periodic, independent and objective evaluation surveys by a central accreditation body (JCAH'3', CCHA'4'). Radiation protection of the patient is essential in the medical application of radiation. The Commission of the European Communities (CEC) has, therefore, laid down basic measures for the radiation protection of persons undergoing medical examination or treatment in Council Directive 84/466/EURATOM of 3 September 1984'5'. In addition, the CEC has formulated quality criteria for diagnostic radiographic images'6' and performed trials on quality criteria for diagnostic images in which both image quality and dose were assessed. In this contribution the present situation in the Netherlands with respect to legislation, certification, QA programmes and QC protocols is summarised. In addition, information is provided on Dutch participation in international trials on image quality and dose. Finally, information is given on the frequency of diagnostic examinations and related doses in the Netherlands. LEGAL SITUATION AND RELATED ACTIVITIES Council Directive 84/466/EURATOM'5' regarding the radiation protection of persons undergoing medical examination or treatment was recently transposed into Dutch law. This was achieved by an amendment, dated 25 May 1993, to the Dutch Decree on Radiation Protection of 10 September 1986. In an annex to this amendment, technical criteria are included for nuclear medicine installations and equipment used for diagnostic radiology. In addition to the formal introduction of the CEC patient directive, the Dutch Ministry of Welfare, Health and Cultural affairs (WVC) is promoting various activities to help implementation of the legal provisions. With the support of WVC, research programmes on patient dose due to diagnostic procedures have been initiated at several university hospitals and at the Netherlands Organization for Applied Scientific Research (TNO). These activities include the implementation of computer models of radiation transport for the calculation of organ doses in diagnostic radiology'781, the development of computer models for dose calculations in nuclear medicine, and experimental determination of organ doses in angiography'9', chest'10' and CT examinations. At the end of 1990, cooperation between WVC and TNO in the area of radiation protection for medical applications was formalised. Activities within this framework, the so-called 'covenant', include an analysis of the legislation in other European countries in connection with the CEC patient directive, the formulation of criteria to issue licences for diagnostic radiology, the development of QC protocols and quality criteria for equipment used for medical applications of ionising radiation, and research on reference values for patient dose in relation to image quality for diagnostic examinations. Under the auspices of WVC, the Dutch professional societies involved in medical applications of ionising radiation prepared a document to structure responsibilities with respect to the radiation protection of patients. On the initiative of WVC, the Dutch professional societies involved in medical applications of ionising radiation are planning, with the assistance of the TNO, to start the development of QC protocols and quality criteria for equipment used in diagnostic radiology. More generally, quality in health care is being addressed on a national level by WVC. Certification is considered to be a realistic means of helping to attain quality in health care. A pilot project for developing an accreditation scheme for hospitals in the Netherlands (PACE) has been started" ". It is based on the principles of the Canadian system for hospital accreditation'4' and the ISO 9000 standard series on quality assurance. Uniform methods for developing Q A standards were adopted for analysing and describing processes. These 59

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES methods aimed at clarifying organisational links and procedural processes by describing daily activities in a schematic form. They also helped to determine where procedural protocols, measurement standards and action criteria are appropriate"2'. A set of 21 standards has been developed" ", and is currently being validated at a national level through the professional societies. for inspection of X ray departments"8', which is being used in a pilot study. This protocol also includes radi ation protection aspects. For the Dutch breast cancer screening programme, a national reference centre has been established at Nijmegen. A QA protocol"9' for mammography was developed which includes acceptance tests for mam mography equipment. This protocol served as a basis for the European protocol for the quality control of the technical aspects of mammography screening'2'". Con cerning the dosimetric aspects of mammography, the Netherlands Commission on Radiation Dosimetry (NCS) has published a report'2" which includes a code of practice for the determination of average absorbed dose in glandular tissue. Other NCS reports deal with radiotherapy applications. PARTICIPATION IN INTERNA TIONA L TRIA LS ON IMA GE QUA LITY A ND PA TIENT DOSE The World Health Organization (WHO) organised three European interlaboratory comparison studies for nuclear medicine imaging in the periods 19811983'22', 19841986'23' and 19871990'24'. In the first study, four phantoms were used simulating brain and liver. The second study employed phantoms simulating thyroid and liver. The two studies assessed image quality and routine imaging techniques used for static, planar imag ing of these organs. The third study was performed with a dynamic heart phantom which simulated a gated blood pool examination to assess hardware and software rou tinely associated with assessing left ventricular (LV) wall motion and LV ejection fraction. The Netherlands participated in these studies with 12, 18 and 19 depart ments, respectively. It was concluded'24' that results and imaging techniques in the Netherlands showed a wide range, but were, in general, similar to those in Europe as a whole. Continued, more frequent proficiency testing is advocated on a national and international level. QC practices have improved but QC is not always perfor med as frequently as recommended internationally. A new study is in progress using a skeletal phantom. Under the auspices of the CEC, a European inter comparison of dosemeters used in diagnostic radiology was performed in 1990. A mong the 162 participants from 18 countries were 13 institutions from the Nether lands. In comparison with the European results'25', the Dutch measurement values'26' showed a good level of performance, especially for mammography, as shown in Figure A 9.1. It was concluded that the majority of the Dutch participants achieved results with a deviation of less than 10% from the reference value. No Dutch parti cipants reported values significantly (above 30%) in error. There is, however, room for improvement parti cularly for measurements at the higher tube voltages used. In 1987, a Study Group of the CEC Radiation Protec tion Programme initiated a project on the establishment
60

QA PROGRAMMES AND QC PROTOCOLS


Within the Netherlands, QA committees have been established within the Netherlands Society for Nuclear Medicine (NVNG) and the Netherlands Society for Diagnostic Radiology (NVRD). The NVNG QA committee's initial task was to develop national protocols for clinical procedures and for the QC of instrumentation and pharmaceuticals"4'. These have recently been published and take the form of national recommendations"51. A t present, the NVNG has prepared protocols for approximately thirty types of nuclear medicine examinations. The framework for the contents of each of these protocols is shown in Table A9.1. NVNG QC protocols available for equipment used in nuclear medicine are given in Table A 9.2. The protocols will be subject to continuous review, update and expansion. In future, recommendations for radio nuclide therapy will be included. The NVNG has also finalised protocols"5' for patient dosimetry based upon ICRP Publications 53" 6 ' and 62" 7 '. The NVRD QA committee has prepared a protocol Table A9.1. The content framework for each nuclear medicine imaging procedure of the NVNG QC clinical protocols"5'. Principles of specific examinations Indications to perform examination Medical data available when examination is requested Radiopharmaceutical and amount of radioactivity employed Patient prestudy preparation Additional technical aids required Performance of the examination Gamma camera and computer technique Reporting on the examination Interpretation and pitfalls Relation to other diagnostic examinations References to important literature

Table A9.2. Available NVNG QC protocols for equipment in nuclear medicine imaging"5'. Gamma camera planar Gamma camera wholebody scanning Gamma camera used for SPECT Dose calibrator Radiation protection monitors

ROUND TABLE PRESENTATIONS of quality criteria for diagnostic radiology images. The met about 90% of the image quality criteria. The avermain goal of this project was to provide practitioners age doses for each examination were rather low for the with a provisional list of both radiological and technical Dutch participants, but showed a considerable variation, requirements (including entrance surface dose). To as can be seen in Table A9.3. The increased Dutch parevaluate the suitability of these requirements, a trial was ticipation indicates an increasing awareness of the need conducted on six common types of examinations' 2 7 '. for dose reduction and QA. Only one Dutch X ray department participated. As a result of the 1987 initiative, a C E C working FREQUENCY OF EXAMINATIONS AND DOSE document' 6 ' was issued and circulated among the most ASSESSMENT important professional radiological associations in EurAn estimate of the effective dose equivalent due to ope. T o validate and demonstrate the usefulness of such a document on a much broader scale, a second trial was nuclear medicine procedures in the Netherlands in 1984 carried out in 1991 on the initiative of the C E C , has been made by Beekhuis'29'. He assumed an annual specifically for chest, lumbar spine and breast examination frequency of 200,000, corresponding to an examinations' 2 8 '. In this trial, 83 X ray departments annual per capita examination frequency of 0.013, and from 16 countries participated, including 5 Dutch X ray employed conversion factors relating effective dose departments. The main conclusions were that no statisti- equivalent to unit of administered radioactivity as pubcally significant correlation was found between patient lished by Johansson et /' 3 " 3 ". By combining these condose and image quality and that on average all films version factors with data from Dutch hospitals on the number of patients diagnosed using a particular radiopharmaceutical and the amount of radioactivity usually 60-1 administered per examination, Beekhuis arrived at an effective dose equivalent per capita per annum of 50 37 5. Use of the ICRP"61 effective dose equivalent Mammography per unit administered radioactivity values results in a all participants Dutch participants value of 40 5 (Table A9.4). 40 Another study of Beentjes and Timmermans'32' was based on information obtained from insurance compaE 30nies for sex and age specific data concerning nuclear medicine procedures performed in the Netherlands in 20 1984. Their derived annual per capita examination frequencies in nuclear medicine are 0.012 for males and 0.011 for females, resulting from an annual number of 10nuclear medicine procedures of 165,000 14,000. The effective dose equivalent per capita per annum calculated from somatic effective dose equivalent (SED) and 0J genetically significant dose equivalent (GSD), and thus 20 30 40 10 50 60 corrected for the skewed age distribution of the group Deviation (%) Figure A9.1. Histograms of European and Dutch results for mammography X rays in the European inlercomparison of dosemeters used in diagnostic radiology126'. Given are the number of deviations from the reference value in classes of 10% width. Per participant only the result with the largest deviation from the reference value is included. Table A9.3. Average entrance surface dose values (mGy) for diagnostic examinations in five Dutch hospitals (A-E) participating in the 1991 CEC trial121".
Type of examination Lumbar spine PA Lumbar spine LAT Breast CC Breast LAT Chest PA Chest LAT A 5.5 12.6 1.4 3.5 5.8 4.5 C 6.5 10.3 7.0 8.5 D E

Table A9.4. Annual frequency of examinations, F and population dose, H, in nuclear medicine imaging in the Netherlands (ICRP"6' conversion factors and ICRP133' weighting factors). F (106)
1984"" 1984'1" 1988"'' 1988"" 0.200 0.165 0.240 0.177

F HE HE (per caput) ( per caput) (person.Sv)


0.013 0.011 0.016 0.012
40 34 49 36

580 490 730 530

0.18 0.44

15.0 15.5 0.09 0.39

7.4 7.0 0.09 0.29

""Ref. 29 ""Ref. 32 lcl Ref. 34 for examination frequency; Refs 29 and 32 for average effective dose per examination. ""Ref. 32 for examination frequency in 1984; Ref. 34 for increase in examination frequency between 1984 and 1988; Refs 29 and 32 for average effective dose per examination. 61

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES of nuclear medicine patients compared to the population as a whole, amounts to 31 8. Use of the ICRP'33' weighting factors results in a value of 34 5 (Table A9.4). In the studies of Beekhuis'29' and Beentjes and Timmermans'32', the effective dose equivalents per capita per annum, adjusted for the examination frequency and use of ICRP weighting factors and ICRP effective dose equivalent per unit radioactivity administered, are similar (i.e. 33 5 and 34 8, respectively, at an annual examination frequency of 165,000). In a more recent survey of the NVNG'34' covering the period 1984-1988, in which 6 out of the 8 university hospitals and 32 out of the 70 non-university hospitals participated, the total number of nuclear medicine examinations was assessed to be approximately 220,000 and 240,000 per annum in 1984 and 1988 respectively. Based upon 240,000 annual examinations, an effective dose equivalent per capita per annum of 49 5 and a collective effective dose equivalent of 730 person Sv per annum were estimated for the Netherlands in 1988 (Table A9.4). When the increase in examination frequency between 1984 and 1988 of Bakker'34' is applied to the frequency derived by Beentjes and Timmermans'32' for 1984 lower values result (Table A9.4). Future surveys and dose estimates should be easier following implementation of the Dutch national clinical protocols for nuclear medicine procedures, which include recommendations for the amounts of radioactivity to be administered. Trends in X ray examination frequencies between 1967 and 1987, not including dental radiography by Table A9.5. Annual frequency of examinations, F and population dose, H, in diagnostic radiology in the Netherlands (excluding dental radiography by dentists).
(106) (per caput) ( per caput) (person.Sv) 1980'" 1984'"' 1986"" 1987"" 1988""

HE

HE

9 . 0 7 . 7 7 . 7 7 . 7 7 . 7

0.64 0.54 0.53 0.53 0.53

_
450 420 440 440
6400 6100 6400 6400

dentists and examinations performed in mass screening programmes, have been presented by Beentjes and Timmermans'35'. The annual per capita frequency of dental examinations by dentists can be derived from Velder's data'36', it was 0.42 in 1984. The observations on examination frequencies are mostly based on data from radiologists'37' and combined data from the Dutch specialists' bureau and insurance companies'3538'. The data from the various sources are in good agreement. The frequency of examinations shows an increase up until 1980, reaching a maximum value of about 0.64 per caput per annum'35', followed by a decrease to a value of 0.54 in 1984, as shown in Table A9.5. This decrease is mainly due to the ending of the mass screening programme for tuberculosis. An analysis by Beentjes and Timmermans'39' of data collected by Van Kempen'40' resulted in examination frequencies per capi/i for the years 1986, 1987 and 1988 of 0.518, 0.513 and 0.521 respectively for conventional radiography, and 0.012, 0.012 and 0.013 respectively for computed tomography (CT). The annual collective somatic effective dose equivalent per caput in the Netherlands in 1984 was estimated to be 0.51' 35 ' (Table A9.5). Analysis'39' of data collected by Van Kempen'40' resulted in annual collective effective dose equivalents for the years 1986, 1987 and 1988 as shown in Table A9.5. The decrease in annual collective dose between 1984 and 1986 can be attributed to the replacement of conventional X ray examinations of the abdominal region by ultrasound. The increasing number of CT scans'3537', however, will most likely result in higher collective doses in the Netherlands. This increase will be augmented by an increased dose per scan dependent on the type of examination. Beentjes and Timmermans135' reported values in the order of 3 mSv per CT scan, whereas Geleijns et /14" measured effective dose values of 0.7 mSv for CT head scans, 11 to 17 mSv for CT thorax, and 15 to 24 mSv for CT abdomen examinations. These data emphasise the need for more specific and up-to-date dose assessments in diagnostic radiology. ACKNOWLEDGEMENT The preparation of this paper was supported in part by the Dutch Ministry of Welfare, Health and Cultural affairs.

'"'Reference 35 ""Reference 39

REFERENCES 1. WHO. Quality Assurance in Nuclear Medicine (World Health Organization, Geneva) (1982). 2. Roberts, J. S., Coale, J. G. and Redman, R. R. A History of the Joint Commission on Accreditation of Hospitals. J. Am. Med. Assoc. 258, 936-940 (1987). 3. JCAH. Accreditation Manual for Hospitals (Joint Commission on Accreditation of Hospitals, Chicago, Illinois, USA) (1988). 4. CCHA. Guide to Accreditation of Canadian Health Care Facilities. (Canadian Council on Hospital Accreditation, Ottawa, Ontario, Canada) (1986). 5. CEC Council Directive of 3 September 1984 (84/466/EURATOM) laying down Basic Measures for the Radiation Protection of Persons Undergoing Medical Examination or Treatment. Official J. Eur. Communities No L 265 (1984).
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ROUND TABLE PRESENTATIONS 6. CEC. Quality Criteria for D iagnostic Radiographic Images. CEC Working Document XII/173/90 (1990). 7. Jansen, J. T. M., de Wit, N. J. P. and Zoetelief, J. Comparison of Measured and Calculated Inphantom DepthDose Distri butions for Mammography. Radit. Prot. Dosim. 43, 245249 (1992). 8. Schultz, F. W., Geleijns, J. and Zoetelief, J. Calculation of Dose Conversion Factors and for PosteriorAnterior PA Chest Radiography of Adults with a Relatively High Energy Xray Spectrum. Br. J. Radiol. 67, 775785 (1994). 9. Kicken, P. J., Kemerink, G. J., Vaessen, P. J. and A ckermans, J. J. An Automated Measurement System for Characterisation of Patient Exposure during Angiography. Radit. Prot. Dosim. 43, 165169 (1992). 10. Geleijns, J., Broerse, J. J., Julius, H. W., Vrooman, . ., Zoetelief, J., Zweers, D. and Schultze Kool, L. J. AMBER and Conventional Chest Radiography: Comparison of Radiation D ose and Image Quality. Radiology 185, 719723 (1992). 11. Bunnik, G. S. J. Proefproject PACE. Vooronderzoek en plan van aanpak. Onderzoeksrapport nr. MTD/89.047 (Medisch Technologische Dienst TNO, Leiden) (1989). 12. BusemannSokole, E., Royen, E. A . van. Lagerwaard, ., Kraus, J. and Bunnik, G. S. J. Establishing National Quality Standards for Nuclear Medicine Services. Eur. J. Nucl. Med. 19, 637 (1992). 13. Kraus, J. Kwaliteitsborgingsnormen, proefprojekl PACE (1993). 14. NVNG. Stralingsbescherming van de patint in de nucleaire geneeskundepolicy statement. Nederlandse Vereniging voor Nucleaire Geneeskunde (1989). 15. NVNG. Aanbevelingen nucleair geneeskundige diagnostiek. Nederlandse Vereniging voor Nucleaire Geneeskunde (Delft: Eburon) (1993). 16. International Commission on Radiological Protection. Radiation Dose to Patients from Radiopharmaceuticals. ICRP Publi cation 53 (Oxford: Pergamon Press) (1988). 17. International Commission on Radiological Protection. Radiological Protection in Biomedical Research. Addendum to ICRP 53, Radiation D ose to Patients from Radiopharmaceuticals. ICRP Publication 62 (Oxford: Pergamon Press) (1993). 18. NVRD. Commissie Kwaliteitsbevordering, Visitatie van maatschappen. Nederlandse Vereniging voor Radiodiagnostiek (1993). 19. Thijssen, M. A . O., Bijkerk, K. R. and Hendriks, J. H. C. L. The Dutch Protocol for Quality Assurance in Mammography Screening. Radit. Prot. Dosim. 43, 273275 (1992). 20. CEC. European Guidelines for Quality Assurance in Mammography Screening + Appendix. European Protocol for the Quality Control of the Technical Aspects of Mammography Screening. CEC V/775/92, Report EUR 14821 (1993). 21. Zoetelief, J., Aalbers, A. H. L., Beentjes, L. B., Broerse, J. J., Julius, H. W. and Zuur, C. Dosimetric Aspects of Mammography. Report 6 of the Netherlands Commission on Radiation Dosimetry (1993). 22. Volodin, V., Souchkevitch, G. N., Racoveanu, S., Bergmann, H., Busemann Sokole, E., Delaloye, B., Dementzoglou, F., Georgescu, G., Herrera, ., Jasinski, W., Kasatkin, Y., Paras, P. and Mould, R. F. World Health Organization Interlaboratory Comparison Study in 12 Countries on Quality Performance of Nuclear Medicine imaging D evices. Eur. J. Nucl. Med. 10, 193197 (1985). 23. Souchkevitch, G. N., Asikaainen, M., Bauml, ., Bergmann, ., Busemann Sokole, E., Carlsson, S., Delaloye, B., Dementzo glou, F., Herrera, N., Jasinski, W., Karanfilski, B., Mester, J., Oppelt, ., Perry, J., Skretting, ., Van Herk, G., Volodin, V Wegst, A. and Mould, R. F. The World Health Organization and International Atomic Energy Agency Second Interlaboratory Comparison Study in 16 Countries on Quality Performance of Nuclear Medicine Imaging D evices. Eur. J. Nucl. Med. 13, 495501 (1988). 24. BusemannSokole, E. Quality Assurance in Nuclear Medicine Imaging: Hardware and Software Aspects. PhD Thesis, Univer sity of A msterdam (CIP) (1990). 25. Clark, M. J., Delgado, ., Hjardemaal, O., Kramer, . M. and Zoetelief, J. European Intercomparison of Diagnostic Dosemet ers: Results. Radit. Prot. Dosim. 43, 8791 (1992). 26. Zoetelief, J., de Wit, N. J. P. and Jansen, J. T. M. Europese Vergelijking van dosismeters voor radiodiagnostiek: de Neder landse resultaten. Gamma 41, 299304 (1991). 27. Maccia, C , Wall, . F., Padovani, R., Shrimpton, P. and Husson, B. Results of a Trial set up by a Study Group of the Radiation Protection on Programme of the CEC. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores, B. F. Wall, H. Eriskat and H. Schibilla. BIR Report 20, pp. 242246 (1989). 28. Maccia, C , A richeCohen, M., Severo, C. and Nadeau, X. The 1991 Trial on Quality Criteria for D iagnostic Radiographic Images. Radiation Protection Research A ction CEC, draft A pril 1993 (1993). 29. Beekhuis, H. Population Radiation Absorbed Dose from Nuclear Medicine Procedures in the Netherlands. Health Phys. 54, 287291 (1988). 30. Johansson, L., Mattson, S. and Nosslin, B. Radiation Absorbed Dose from Radioactive Substances in Medical Use (Swedish National Institute of Radiation Protection, Stockholm, Sweden) (1981). 31. Johansson, L., Mattson, S. and Nosslin, B. Effective D ose Equivalent from Radiopharmaceuticals. Eur. J. Nucl. Med. 9, 485489 (1984). 32. Beentjes, L. B. and Timmermans, C. W. M. Age and Sex Specific Population Doses (SED and GSD) due to Nuclear Medicine Procedures in the Netherlands. Nucl. Med. Biol. 17, 261268 (1990). 63

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES 33. International Commission on Radiological Protection. Recommendations of the International Commission on Radiological Protection. ICRP Publication 26 (Oxford: Pergamon Press) (1977). 34. Bakker, W. H. In-vivo nucleaire geneeskunde in Nederland 1984-1988. Nucl. Geneesk. Bull. 12, 1988-1989 (1990). 35. Beentjes, L. B. and Timmermans, C. W. M. Age and Sex Specific Radiographie Examination Frequency in the Netherland Br. J. Radiol. 63, 691-697 (1990). 36. Velders, X. L. Patient Exposure due to Bitewing Radiography. Thesis, Free University, Amsterdam (1989). 37. Valois, J. C. de Radiologie in Nederland: facts andfigures.In: Rntgenfysica-techniek en Stralenbescherming. Nederlandse Vereniging voor Radiodiagnostiek, Syllabus no 6, pp. 72-75 (1989). 38. Beentjes, L. B. and Glas, J. A. An Estimate of the Somatically Effective Dose in the Netherlands during 1976-1980. Heal Phys. 47, 299-304 (1984). 39. Beentjes, L. B. and Timmermans, C. W. M. Note added in proof to: Patient Doses in the Netherlands. Radit. Prot. Dosim. 36, 265-268 (1991). 40. Kempen, R. J. van Pattern of Diagnostic Procedures in Radiology in the Netherlands. Radit. Prot. Dosim. 36, 257-259 (1991). 41. Geleijns, J., Unnik, J. G. van, Zoetelief, J., Zweers, D. and Broerse, J. J. Comparison of Two Methods for Assessing Patient Dose from Computed Tomography. Br. J. Radiol. 67, 360-365 (1994).

APPENDIX 10. RADIATION PROTECTION OF THE PATIENT IN PORTUGAL


A. Ferro de Carvalho and J. Vaz Carreiro INTRODUCTION In Portugal X rays began to be used for medical purposes during the year 1896 and in 1900 radiography departments had been established in the most important hospitals of Lisbon and Coimbra. In 1907 radium mining started in the central region of the country but only in 1931 did a law refer to the harmful effects of radiation. In 1932 the Law No 1942 was published by the Portuguese government where the workers' rights to get financial compensation and medical assistance in case of accident or professional disease originated by the action of X rays or radioactive substances was recognised. The 1958 OECD Recommendations concerning general principles for radiation protection and dose limits for workers and population were transposed to national law in 1961 through Decree law No 44060, which was replaced in 1989 and 1990 by the decrees Decree Law No 348/89'" and Decree Reg. No 9/90'2', following the Council Directives 80/836 and 84/467/Euratom. Present legislation assigns to the Ministry of Health (General Directorate of Health) regulatory responsibilities in the field of radiation protection, while the Ministry of Internal Administration (Civil Protection Service) is responsible for civil protection in the case of major accidents, the Ministry of Employment is responsible by inspection of working places and the Ministry of the Environment (Radiation Protection and Safety Department) is responsible for the environmental radioactivity surveillance and research in radiation protection.
64

FREQUENCY OF MEDICAL EXAMINATIONS WITH USE OF IONISING RADIATION Portugal is a country with a population of nearly 10 millions where the level of health care throughout the country presents great differences and private medicine plays an important role. Distribution of staff by sectors of activity is shown in Table A 10.1, making clear the small number of physicists involved in the application of radiation in medicine. The amount of diagnostic radiology carried out in public hospitals, and in private hospitals and offices, is approximately the same. Overall frequency of examinations per year is about 950 per thousand inhabitants, including 30 computed tomography examinations. The frequency of other examinations is shown in Table A 10.2. The annual frequency increase of diagnostic radiology is about 9%, while computed tomography and Table A10.1. Population and staff statistics (1991). Staff Physicians Radiologists Radiotherapists Nuclear medicine specialists Medical physicists Population (with islands of Azores and Madeira) No per million of inhabitants 2870 44 8 2 2 9.86 million

ROUND TABLE mammography have a higher increase rate of the order of 16 to 20%. The average effective dose-equivalent per caput was estimated as 0.71 mSv and the annual collective effective dose-equivalent was estimated as 6000 man.Sv. Diagnostic nuclear medicine is restricted to 11 laboratories in hospitals and other centres, the majority being public services, while it was estimated that private centres were responsible for not more than 10% of diagnostic nuclear medicine examinations. The overall frequency of nuclear medicine examinations per year is 4 per thousand inhabitants. PATIENT PROTECTION LEGISLATION The legal framework for radiation protection of the patient is Regulatory Law No 9/1990 which transposed Council Directive 84/466/EURATOM to Portuguese legislation and also establishes that the use of ionising radiation in medicine shall be restricted to trained staff and that radiotherapy and nuclear medicine premises should include in their staff a physicist with training in radiation protection and in the appropriate medical physics field. A technical regulation defining the minimum requirements for acceptability of radiology equipment was approved by the Ministry of Health on 15 July 1993 and will be published in the official journal by the end of 1993. There are no other legislation or regulations applicable to the medical uses of ionising radiation. Quality Assurance and Quality Control are therefore not mandatory in the field of medical uses of ionising radiation. PROGRESS AND ACHIEVEMENTS IN PATIENT PROTECTION Radiation protection of the patient has been improved in Portugal in the last years through: (1) co-operative research carried out under contract with CEC; (2) demonstration actions; (3) routine programmes related mainly to quality control. Research was done under a contract between the CEC Radiation Protection Programme and the DPSR, Radiation Protection and Safety Department (formerly in Table A10.2. Frequency of diagnostic radiology (1991). Total annual frequency of examinations per 1000 inhabitants (screening not included) Computed tomography Mammography Dental (1 exam= I film) 950 30 20 100

PRESENTATIONS LNETI, the National Laboratory for Engineering and Industrial Technology and presently in the Ministry of the Environment). Research was carried out on radiology patient dosimetry and national surveys were carried out by DPSR on patient doses in conventional radiology'3' as well as in dental radiography'4', computed tomography'5' and mammography'6'. In these surveys image quality in mammography and computed tomography was also assessed. Demonstration actions were mainly carried out in the field of mammography and dental radiography by optimisation of technical aspects, which has led to improvements in image quality and reduction of patient doses. Participation of few Portuguese radiology departments in 'The 1991 CEC Trial on Quality Criteria for Diagnostic Radiographic Images' led in some cases to demonstration actions which have contributed to protection of patients. Routine programmes of quality control (QC) of equipment used in diagnostic radiology and nuclear medicine have been set up by the initiative of physicists, radiologists and specialists in nuclear medicine in a few public hospitals and private centres and offices. QC of diagnostic radiology equipment is performed mainly for film processors used in mammography (optical sensitometry), while in nuclear medicine QC is applied mainly to scintillation cameras (tests of uniformity, resolution and precision on estimation of rotation's centre). A complete programme of Quality Assurance has been applied in a breast cancer screening in the central region of Portugal which is promoted by Nucleo Regional do Centro da Liga Portuguesa Contra o Cancro with the support of the CEC 'Europe Against Cancer' Programme and the Portuguese Government. The programme was applied in the three mobile screening units and in the central reading office; Quality Control involved all technical aspects. During 1992, QC was done according to a Portuguese protocol'7' that was replaced in 1993 by the 'European Protocol for the Quality Control of the Technical Aspects of Mammography Screening''8'. Main results of this QC programme were higher stability of image quality and a reduction of 40% in the entrance breast dose. PERSPECTIVES FOR THE FUTURE The evolution of patient radiation protection can not be forecast because it will be conditioned by the following: (i) a revision of the Council Directives, (ii) the national policy of recruitment and training of new physicists. In what concerns the Council Directives, it is believed that they could be an important element in the progress of patient protection if they were not restricted to defining principles, but if they also established mandatory rules and included report or inspection procedures to confirm accomplishment by member states.

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INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES At a national level it is believed that this would be essential for a change in the governmental policy of employment in order to promote the recruitment and training of new physicists to deal with the radiation pro tection of the patient.

REFERENCES 1. DecretoLei No 348/89, Dirio da Repblica, No 235, pp. 44474450 (12 Aug. 1989). 2. DecretoRegul. No 9/90, Dirio da Repblica, No 91, pp. 18531903 (19 April 1990). 3. Serro, R., Carreiro, J. V., Galvo, J. P. and Reis, R. Population Dose Assessment from Radiodiagnostic in Portugal. Radit. Prot. Dosim. 43(14), 6568 (1992). 4. Carvalho, . F., Oliveira, A. D., Amaral, E. M., Carreiro, J. V. and Galvo, J. P. Dental Radiographic Exposures in Portugal. Radit. Prot. D osim. 43(14), 6163 (1992). 5. Carvalho, . F., Oliveira, A. D., Amaral, E. M., Carreiro, J. V. and Galvo, J. P. Assessment of Patient D oses and Image Quality in Computed Tomography. LNETI/DPSR report (1991). 6. Carvalho, . F., Rocha, M. P., Alves, J. G., Carreiro, J. V. and Galvo, J. P. Radiation Doses from Mammography in Portugal. Radit. Prot. Dosim. 36(24), 261263 (1991). 7. Protocol of Quality Control in Mammography (in English). LNETI/DPSR (1991). 8. CEC. European Protocol for the Quality Control of the Technical Aspects of Mammography Screening. In: European Guid lines for Quality Assurance in Mammography Screening. CEC V/775/92, Report EUR 14821 (1992).

APPENDIX 11. INITIATIVES, A CHIEVEMENTS A ND PERSPECTIVES IN SPA IN CONCERNING QUA LITY ASSURANCE A ND RA DIA TION PROTECTION IN DIA GNOSTIC RADIOLOGY A ND NUCLEAR MEDICINE
E. Van, L. Gonzlez and M. Bezares INTRODUCTION Over the last few years, a major effort has been made in Spain to improve patient protection in medical prac tices involving diagnostic imaging. Considerable pro gress has been made in the diagnostic radiology (DR) field, because of its higher impact on the collective dose. Studies on DR examination rates and patient dose esti mations have been carried out in the Madrid area. The results have been extrapolated to Spain as a whole, using data from the National Institute of Health (INSALUD). UNSCEA R reports already include some of these data (see Table A l 1.1). Council Directive 84/466/Euratom was transposed into Spanish law by Royal Decree 1132/1990 (Ministry of Health and Consumer A ffairs (MHCA )), which lays down basic measures for the radiation protection of per sons undergoing medical examination and treatment. Later, in January 1992, a Royal Decree (No 1891/1991) on the installation and use of X ray devices for medical diagnostics was issued. Nuclear medicine installations had already been governed from 1972, by Decree 2869/1972 on nuclear and radioactive installations. At present, it has not yet been decided how the health authorities will supervise patient protection. For this 66 reason, amongst others, Spain has received a reasoned opinion from the CEC concerning its failure to incorpor ate certain aspects of Directive 84/466 into Spanish law. In fact, the Spanish Ministry of Health planned some years ago a pilot programme of quality control (QC) in diagnostic radiology as a first step, to gain experience, with the intention of extending it later to radiotherapy and nuclear medicine installations. The programme was not started at that time, but a similar programme might be organised in the next few years. THE SPA NISH PROTOCOL ON QUA LITY CONTROL IN DIA GNOSTIC RA DIOLOGY In 1991, the Spanish Society for Medical Physics (SSMP) and the Spanish Society for Radiological Pro tection (SSRP) agreed to sponsor the preparation of a protocol on the technical aspects of QC in diagnostic radiology. The technical committee created for this pur pose has completed an initial version of the document (presented at the recent Spanish National Congress on Medical Physics, held in September 1993), and suggests that it be applied on an experimental basis for one year, before it becomes an official protocol recommended by these societies.

ROUND TABLE The committee has proposed two action levels in the protocol, being aware of the current status of Spanish diagnostic radiology installations and of the lack of a tradition of quality assurance (QA) and QC programmes. One of them is basic and would be applied immediately, the other one would be applied after a transitional period; the latter is comparable to action levels in protocols used in other countries with a longer tradition and greater experience in the quality control of diagnostic radiology installations. THE SPANISH PROTOCOL ON QUALITY CONTROL IN NUCLEAR MEDICINE In 1991 the SSRP decided to sponsor the preparation of a Spanish protocol on QC for nuclear medicine instrumentation. A working group consisting of members of the SSRP, the SSMP and the Spanish Society for Nuclear Medicine was set up for this purpose. A draft version of the protocol is already available for internal use, and it is hoped to issue a provisional text in September 1994 for public distribution, in order to elicit suggestions and comments. Apart from the usual objectives in this kind of document, the draft attempts to encourage the use of QC in nuclear medicine instrumentation and resource optimisation, and features some innovative aspects compared to other protocols. MEASURES SUPPLEMENTING REGULATORY ACTION During 1992, the MHCA appointed an expert group on medical physics and radiology to draw up a report dealing with quality criteria for the radiation protection of the patient in diagnostic radiology, to facilitate the implementation of the Royal Decree 1132/1990 (and the Council Directive 84/466/). The expert group organised meetings with, and consulted members of the Spanish Society of Medical Radiology (SSMR) and representatives of companies associated with X ray and radiographic film equipment, after which a draft version was produced. Copies were then circulated among individual experts, scientific societies and public bodies [SSMP, SSRP, INSALUD and the

PRESENTATIONS Nuclear Security Council (CSN)], for comments. The final report to the MHCA was then drawn up. It therefore represents a degree of consensus between the medical physics specialists (experts in QC) and the radiologists, and incorporates some of the suggestions made by the companies and the authorities themselves. The main recommendations in the report were as follows: (a) An annual basic QC programme should be carried out for 5 years. Simultaneously, diagnostic radiology installations should gradually implement QA programmes. (b) The basic QC programme could consist of the evaluation of image quality parameters and the measurement of dose parameters among real samples of patients. If a malfunction is indicated by deviations from the reference levels (both in image quality and in higher dose values), the owner of the installation should command a more exhaustive QC programme with a view to taking appropriate corrective actions. Radiologists on the expert group considered that the basic QC programme could be applied straight away. It is also accepted that parameters regarded as basic (image quality and dose, evaluated on real patient samples) are the only ones which provide effective information in order to improve the radiation protection for the patient, since other checks on the generator or the image chain are not sensitive enough to detect bad practices (i.e. unsuitable generator parameter setting) in the examination protocols. PROGRAMMES OF THE COMMISSION OF THE EUROPEAN COMMUNITIES (CEC) WITH SPECIAL RELEVANCE TO SPAIN The experience gained by Spain through its participation in the CEC radiation protection programme and in the two European trials on quality criteria for diagnostic radiographic images and patient doses has been of inestimable value. In fact, the proposals made by the expert group mentioned above, advising to the Spanish Ministry of Health on future nationwide QC actions, are based on this experience.

Table All.l. Significant parameters of diagnostic radiology in Spain (1986-1990). Thousands of inhabitants Number of radiologists Number of general DR facilities (performing over 1000 examinations a year) Dental DR equipment Annual rate (xlOOO) of general DR exam, (excluding military, legal and occupt.) Annual rate (xlOOO) of dental DR examinations Examinations per year per 1000 inhabitants (excluding dental) Effective dose equivalent per patient (mSv) due to DR, estimated for 1985-86 Effective dose equivalent per inhabitant (mSv) due to DR, estimated for 1985-1986 Collective dose (person.Sv), estimated on 1985-86 38558 1645 9000 18000 22 290 9000 570 31 100
1.4 0.8

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INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES VALUE is another CEC programme that touches on radiation protection in diagnostic radiology. During 1991 and 1992, VA LUE supported a project designed to determine the objectives of training in radiation pro tection and QA for radiologists and radiographers. The initial working group, coordinated from Spain, included experts from France, Italy and the UK. In Spain, the SSMR and the Spanish A ssociation of Radiology Tech nicians made a special contribution. Both societies have explicitly endorsed the contents of the documents pre sented to the CEC. As both the ICRP and the WHO have stressed the importance of radiation protection training for medical staff, a number of optional radiation protection courses are being included in the new syllabus for the Spanish medical schools. This may bring about a significant improvement in radiation protection of the patient. In November 1992 the CSN has issued an instruction about radiation protection training for staff operating diagnostic radiology installations. A part from estab lishing criteria for the contents of radiation protection training programmes, it provides for the direct licensing of radiologists and radiographers, on condition they pos sess sufficient knowledge of radiation protection. ANALYSIS OF THE CURRENT SITUA TION A ND FUTURE PROSPECTS REGA RDING QUA LITY CONTROL DIA GNOSTIC RA DIOLOGY IN SPA IN Despite the efforts devoted to QC in diagnostic radi ology over the past few years, a clear and widespread BIBLIOGRAPHY conviction of its necessity and benefits does not yet appear to exist. Regarding QC merely as an administrat ive requirement that installations be adapted so as to comply with regulations is potentially harmful and may result in all the human and financial resources put into implementing the QA programmes being wasted. Accordingly, it seems advisable that initial control steps should involve simple checks, without a signifi cant economic impact on the user, designed to detect and correct abnormal findings, moving on later to equip ment constancy and status tests, thus gradually evolving a comprehensive QA programme. To sum up, in diagnostic radiology Spain has already carried out patient dose studies and radiation protection optimisation programmes (with the valuable support of the CEC) and a provisional national QC protocol which is being introduced this year. Apart from this, the Span ish Ministry of Health has a technical report endorsed by radiologists and radiophysicists which describes how global parameters of patient dose and image quality can be measured in order to check the level of patient pro tection and the effectiveness of the optimisation pro grammes. Such a system cannot be introduced unless the political will exists and appropriate funding is pro vided. ACKNOWLEDGEMENT The authors thank Mrs M. Tllez for her helpful information about the Spanish protocol on QC in nuclear medicine.

Calzado, ., Van, E., Moran, P., Castellote, C, Ruiz Sanz, S. and Gonzlez, L. Estimation of Doses to Patient from 'Complex' Conventional Xray Examinations. Br. J. Radiol. 64, 539546 (1991). Ruiz, M. J., Gonzlez, L. Van, E. and Martnez, A. Measurements of Radiation Doses in the most Frequent Simple Examination in Paediatric Radiology and its Dependence on Patient Age. Br. J. Radiol. 64, 929933 (1991). Van, E., Gonzlez, L. and Bezares, M. Patient Protection. Implementation of Community D irectives in Spain. In: Medical Radiation Practice within the EEC, pp 3337 (London: British Institute of Radiology) (October 1991). Van, E., Gonzlez, L., Moran, P., Calzado, ., Delgado, V., Fernndez, J. M. and Ruiz, M. J. Patient Dose Reference Values in Diagnostic Radiology Examinations. Radiologa 34(1), 2731 (in Spanish) (1992). Van, E., Gonzlez, L., Calzado, ., Moran, P. and Delgado, V. Some Indicative Parameters on Diagnostic Radiology in Spain. First Dose Estimations. Br. J. Radiol. 62, 2026 (1989). Van, E., Gonzlez, L., Calzado, ., Delgado, V. and Moran, P. Some Results of a Patient Dose Survey in the Area of Madrid. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology (London: British Institute of Radiology) Report 20, pp 180185 (1989).

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ROUND TABLE PRESENTATIONS

APPENDIX 12. UK NATIONAL OVERVIEW OF INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES IN QUALITY ASSURANCE AND RADIATION PROTECTION IN DIAGNOSTIC RADIOLOGY AND NUCLEAR MEDICINE
S. Ebdon-Jackson

BACKGROUND
The profile of radiation protection of the patient in diagnostic radiology and nuclear medicine has increased over the past 5 years in the UK. This is due to the impact of legislation made: The Medicines (Administration of Radioactive Substances) Regulations 1978, The Ionising Radiations Regulations 1985 and The Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988. This legislation is enforced by the Health and Safety Executive (HSE) and the four Health Departments respectively of England (DH), Scotland, Wales and N. Ireland. The National Radiological Protection Board (NRPB) was established in 1970 with functions concerning the protection of the UK population from radiation hazards. It is an independent statutory body which advises Government but does not produce or enforce legislation. Several professional bodies have an immediate interest in radiation protection, as follows. The Royal College of Radiologists (RCR) provides input from the medical profession, the Institute of Physical Sciences in Medicine (IPSM) from medical physicists and the College of Radiographers (COR) represents radiographers. The British Institute of Radiology (BIR) has members from all these professions and provides a multi-disciplinary forum for discussion, as does the British Nuclear Medicine Society (BNMS). The Regulatory Authorities (HSE and Health Departments of the four Home Departments) have provided a legislative framework and professional bodies have worked together to produce publications and practical initiatives for radiation protection, particularly over the past 5 years. Both of these approaches have involved extensive consultation and cooperation. There is a clear understanding of professionals' responsibility within medicine and a belief that initiatives from professional groups, in support of legislation, are most likely to influence diagnostic practice with resulting benefits to the patient. Most diagnostic radiology and nuclear medicine in the UK are carried out within the National Health Service but the legislation also applies to the Private Sector and military hospitals.

REGULATORY AUTHORITIES Legislation and associated guidance The Medicines (Administration of Radioactive Substances) Regulations 1978"' implement Article 5a of Council Directive 76/579/Euratom'2' which required prior authorisation for administrations of radioactive substances to persons. These regulations established the Administration of Radioactive Substances Advisory Committee (ARSAC). The statutory role of this Committee is to advise the Health Ministers on the granting of certificates to doctors and dentists to enable them to administer radioactive medicinal products, and general aspects of prior authorisation. It provides non-statutory advice on matters associated with the practice of nuclear medicine. Detailed Notes for Guidance'3' give advice on topics such as scaling of activities for children, diagnostic administrations to breast feeding mothers and maximum usual activities for most routine examinations. The Ionising Radiations Regulations 1985'4' and the Approved Code of Practice (1985)'5' largely implement Council Directive 80/836/Euratom. Most of these regulations are designed to protect employees and other persons in the vicinity, but Regulation 33 provides for the radiation protection of persons undergoing medical exposure. Employers must ensure that equipment used for medical exposures is designed, installed, calibrated and maintained to achieve medical exposures which are as low as reasonably practicable, compatible with the clinical purpose or research objective. Employers must notify HSE of radiation doses much greater than intended due to equipment malfunction or failure. Further advice is available in the HSE Guidance Note PM77'6'. The Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988'7' largely implement Council Directive 84/466/Euratom. Regulation 4 states that medical exposures should conform to accepted practice and that doses should be kept as low as reasonably practicable (ALARP). The Guidance Notes for the Protection of Persons Against Ionising Radiation Arising from Medical and Dental Use (1988)'8' were produced by HSE, NRPB and the Health Departments after wide consultation with professionals. This guidance supports the legislation outlined and gives extensive advice on compliance with regulations and good practice. 69

INITIATIVES, ACHIEVEMENTS AND PERSPECTIVES To enforce legislation, both the HSE and the Health Departments have Inspectorates. These actively promote the principle of ALARP and the importance of quality assurance and procedures to ensure safe delivery of medical exposures. Other initiatives Throughout the last 10 years officials from the Health Departments and from HSE have participated on IEC Standards Committees. They have also operated a system of defect reporting through DH and HSE which has alerted users to problems with medical equipment. Appropriate liaison with manufacturers has helped to modify equipment in specific circumstances. DH supports work at the medical physics department at the University of Leeds. This group assesses radiological system performance, and in particular digital image forming systems. Similar establishments in London assess X ray and CT equipment. The DH has also funded projects which have demonstrated radiation protection possibilities. Many of the approaches are being adopted throughout England including the use of Total Quality Management. The DH regularly produces guidance to the National Health Service' 9 ""' on practical issues which give advice on purchasing X ray equipment, running diagnostic departments and compliance with legislation. These include guidance on dose reduction strategies. Activity in nuclear medicine and diagnostic radiology is monitored by annual returns to the Health Departments. These give a clear indication of numbers and less detailed information on the types of examination carried out throughout the National Health Service in the UK. The National Health Service Breast Screening Programme was established in 1987. Thus the UK was the first member state to launch a nationwide breast screening programme on computerised call and recall. The programme has set-up costs of 70 million and covers women aged 50-64. It is expected to save over 1250 lives per year. The programme set out expected detection rates and dose targets which have been met throughout its implementation. The programme incorporates rigorous quality assurance aspects. NRPB AND PROFESSIONAL BODIES Between 1983 and 1985 the NRPB undertook a National Patient Dose Survey for routine X ray examinations"2'. This has provided the basis for many of the estimates throughout Europe of the contribution of medical exposures to the radiation dose of populations. In nuclear medicine, a survey of UK Nuclear Medicine Departments"3' during 1989/90 was undertaken by IPSM and BNMS. This identified a 22% increase in imaging studies and decline (30%) in non-imaging
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studies since 1982. Numbers of studies per 1000 inhabitants remained below that of many member states. There have been a number of areas of practical research carried out over the last 5 years and this is reflected in the journal 'Nuclear Medicine Communications' which is widely read throughout Europe. Quality assurance is now practised in most nuclear medicine departments and its impact is being formally evaluated in larger centres. The IPSM has produced a number of valuable publications"4'51 covering radiation protection and quality standards. In 1990 the RCR and NRPB produced a joint report on patient dose reduction in diagnostic radiology"6'. This included 21 recommendations covering referral criteria, radiological procedures, equipment and training. This report has had considerable impact and has led to further joint initiatives. In 1991 the NRPB produced its document on radiation dose from CT" 7 ' which identified that whilst CT accounted for only 2% of examinations it resulted in 20% of the dose from medical examinations. This document has contributed to the increased awareness of high CT dose in Europe as a whole and recent purchases of CT equipment in the UK have included minimisation of radiation dose to the patient as an important specification. In 1990 the BIR produced a report on the use of rare earth screens"8' in the UK. This recognised method of major dose reduction is now in use in 96% of all examinations. In 1992 the NRPB, IPSM and COR produced a National Protocol for Patient Dose Measurements in Diagnostic Radiology"9'. This has been distributed to every radiology department in the UK and DH funds are supporting a national database of dose measurements. In 1992 the NRPB also produced its response to ICRP 60'20'. Production of this document involved professionals and officials from HSE and DH and demonstrates the cooperation established in the UK. 1993 has seen the publication of the second edition of the RCR's 'Making the Best Use of a Department of Clinical Radiology. Guidelines for Doctors'' 2 ". This document is a practical guide and associated research has demonstrated reductions in numbers of patient examinations, and hence dose, in departments following publication of the guidelines. Throughout the last 10 years the IPSM has made major contributions to patient dose reduction through its Topic Groups, meetings and publications. These include the Report 32 series'22' on measurement performance (to be updated in the next 2 years) and Report 59'23) on mammography. FUTURE INITIATIVES Following the 1990 NRPB/RCR report on patient dose reduction, initiatives have commenced concerning cost effective methods of dose reduction and

ROUND TABLE PRESENTATIONS testing/frequency of testing of X ray equipment. These involve NRPB, IPSM, COR, BIR and HSE. This work should complement the awaited CEC initiative on guidance for 'criteria of acceptability' and IEC documents on QA. CONCLUSION Cooperation between regulatory authorities and proREFERENCES 1. The Medicines (Administration of Radioactive Substances) Regulations 1978 (SI 1978 No 1006) (London: HMSO) (1978). 2. Council Directive 76/579 EURATOM laying down the Basic Safety Standards for the Health Protection of the General Public and Workers against the Dangers of Ionizing Radiation, OJ No L 187, p. 1 (12 July 1976). 3. DoH. Notes for Guidance on the Administration of Radioactive Substances to Persons for Purposes of Diagnosis, Treatment or Research. Administration of Radioactive Substances Advisory Committee 1993 (London: Department of Health) (1993). 4. The Ionising Radiations Regulations 1985 (SI 1985 No 1333) (London: HMSO) (1985). 5. Approved Code of Practice, The Protection of Persons against Ionising Radiation arising from any Work Activity. The Ionising Radiations Regulations 1985 (London: HMSO) (1985). 6. Fitness of Equipment used for Medical Exposure to Ionising Radiation. Guidance Note PM77 from the Health and Safety Executive (London: HMSO) (1992). 7. The Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 (SI 1988 No 778) (London: HMSO) (1988). 8. Guidance Notes for the Protection of Persons Against Ionising Radiation Arising From Medical And Dental Use (London: HMSO) (1988). 9. HSG(91 ) 11. Health Services Guidelines. Patient Dose Reduction. Purchasing Radiology Equipment. NHS Management Executive (1991). 10. Health Equipment Information No 98. Management of Medical Equipment and Devices (London: Department of Health) (1990). 11. Health Circular HC(89)18. Health Service Use of Ionising Radiations (London: Department of Health) (currently under revision) (1989). 12. NRPB. A National Survey of Doses to Patients Undergoing a Selection of Routine X-ray Examinations in English Hospitals. NRPB-R200. Eds P. C. Shrimpton et al (London: HMSO) (1986). 13. Elliott, A. T. and Shields, R. A. UK Nuclear Medicine Survey, 1989/90. Nucl. Med. Commun. 14, 360-364 (1993). 14. IPSM. Radiation Protection in Nuclear Medicine and Pathology. Eds K. E. Goldstone, P. C. Jackson, M. J. Myers and J. D. Simpson. IPSM Report 63 (York: IPSM) (1991). 15. IPSM. Quality Standards in Nuclear Medicine. Eds G. C. Hart and A. H. Smith. IPSM Report 65 (York: IPSM) (1992). 16. Patient Dose Reduction in Diagnostic Radiology. The National Radiological Protection Board/Royal College of Radiologists Report. Documents of the NRPB 1(3) (1990). 17. NRPB. Protection of the Patient in X-ray Computed Tomography. P. C. Shrimpton. Documents of the NRPB 3(4) (1992). 18. Preliminary Report of the Rare Earth Screens Working Party (1991). British Institute of Radiology Bulletin (June 1991). 19. NRPB. National Protocol for Patient Dose Measurements in Diagnostic Radiology. Institute of Physical Sciences in Medicine/National Radiological Protection Board/College of Radiographers (NRPB, Chilton) (1992). 20. NRPB. Board Statement on the 1990 Recommendations of ICRP. Documents of the NRPB 4(1 and 2) (1993). 21. RCR. Making the Best Use of a Department of Clinical Radiology. Guidelines for Doctors. Royal College of Radiologists, London (1993). 22. IPSM. Measurement of Performance Characteristics of Diagnostic X-Ray Systems. IPSM Report 32 Parts I-VI (York: IPSM) (1980-1984). 23. IPSM. Commissioning and Routine Testing of Mammographie X-Ray Systems. IPSM Report 59 (York: IPSM) (1989). fessionals has raised awareness and produced improvements in radiation protection of the patient. The involvement of professional bodies has ensured the transfer of information to practitioners and a commitment to patient dose reduction has been established in the diagnostic use of ionising radiation.

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Radiation Protection Dosimetry Vol. 57, No. 1-4, pp. 73-76 (1995) Nuclear Technology Publishing

INITIATIVES OF EFOMP IN THE FIELD OF RADIATION PROTECTION AND QUALITY ASSURANCE


A. Del Guerra Department of Physics, University of Ferrara and INFN, Sezione di Ferrara via Paradiso 12, 1-44100 Ferrara, Italy INVITED PAPER Abstract The initiatives of EFOMP in the field of radiation protection and quality assurance are presented, with a particular emphasis on the activities of the Scientific Committee and the Education, Training and Professional Committee. EFOMP STRUCTURE, AIMS AND PURPOSES The European Federation of Organisations for Medical Physics (EFOMP) was inaugurated in London in 1980. Much of the credit goes to Professor John Clifton, who managed to convince the Council of the Hospital Physicists' Association (UK) in early 1978 to host the first preparatory meeting of European medical physicists for launching this new organisation. At the time of the original constitution (1980) there were fourteen founder members: Austria, Belgium, Finland, France, Germany (Federal Republic), Italy, The Netherlands, Norway, Spain, Sweden, Switzerland, Turkey, United Kingdom, Yugoslavia. The following additional members have since been accepted: Germany (Democratic Republic), Greece and Israel in 1981; Denmark in 1982; Bulgaria in 1983; Czechoslovakia, Ireland (Republic) and Portugal in 1984; Hungary in 1986; Poland in 1987; Cyprus in 1990; Romania, Russia and Moldavia the latter two jointly represented by the Association of Medical Physics of Russia (AMP) in 1991; Croatia in 1993. As at the end of 1993 there is a total of 25 members, after the political changes of the unification of Germany and of the cancellation of the states of Yugoslavia and Czechoslovakia. EFOMP works in collaboration with the International Organisation of Medical Physics (IOMP), which represents the medical physics associations from all over the world. There are discussions within IOMP to organise itself on a regional basis: in this event EFOMP may be asked to act as the European regional chapter. The administration of EFOMP is held by the Council and by the officers. The Council is formed by two delegates from each member organisation and meets once
*From its inauguration, the presidents of EFOMP have been: J. Clifton (UK) 1980-83; J. Chavaudra (F) 1984-86; H. K. Leetz (D) 1987-89; P. Inia (NL) 1990-92; K. A. Jessen (DK) 1993-95. 73

a year. The officers are: the President*, the Immediate Past President, the Secretary General, the Treasurer and the Chairman of the Scientific Committee, the Chairman of the Education, Training and Professional Committee (ETP), and the Chairman of the Publication Committee. The officers are nominated for a 3 year term by the EFOMP Council. At the EFOMP Council meeting in August 1985, the revised constitution of EFOMP was approved: some excerpts from Article 4 of importance to the matter presented here are reported below: " Article 4 The aims and purposes of the Federation include: d) proposing guidelines for education, training and accreditation programmes; e) making recommendations on the appropriate general responsibilities, organisational responsibilities and role of workers in the field of Medical Physics..." EFOMP pursues these aims mainly by means of publication of documents called 'Policy Statements', which will be briefly discussed in the next section. EFOMP POLICY STATEMENTS The following Policy Statements have been issued by EFOMP: in 1984: 'The Roles, Responsibilities and Status of the Clinical Medical Physicist'"' and 'Medical Physics Education and Training: the present European Level and Recommendations for its Future Development''2' in 1988 (after the release of the EC Council Directive 84/466 Euratom): 'Radiation Protection of the Patient in Europe: the

A. DEL GUERRA training of the Medical Physicist as a Qualified Expert in Radiophysics'13' in 1991: 'Criteria for the Number of Physicists in a Medical Physics Department''4' in 1992: 'Departments of Medical Physics: Advantages, Organisation and Management''5' Some topics and recommendations will be illustrated. In its first policy statement'", EFOMP introduced for the first time its strategy for the education of a medical physicist: ' . . . Education of a medical physicist can be divided into three stages: . . . ' 'First stage: An entrant to Medical Physics training should have at least a Bachelors degree in physics or equivalent. Second stage: Education in Medical Physics should follow as a formal course of lectures, seminars, tutorial work and practical work. A minimum of 1-2 years is required.' 'Third stage: In-service training should be done under the supervision of a medical physicist at senior level . . . The length of the in-service training should be 2 years or longer.' In the policy statement issued in 1988'3', EFOMP gives its definition of a Qualified Expert in Radiophysics, QE(R), as introduced by Article 5 of EC Council Directive 84/466 Euratom of September 1984: 'A Qualified Expert in radiophysics shall be available to sophisticated departments of radiotherapy and nuclear mediTable 1. Radiodiagnosis (from Reference 3). 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Physical principles and technical features of diagnostic radiology facilities. Control of diagnostic radiology facilities including specification of protection measures and conduct of room and equipment surveys. Imaging techniques and their effect on the radiation exposure of the patient. Optimisation of exposure and alternative diagnostic methods. Quality control. Measurement and calculation of doses to patients, including those following irradiation of an undisclosed pregnancy. Selection of calibration, monitoring and test equipment. Radiation protection of staff. Instruction in the event of accidents or incidents. Special legal requirements and guidelines. Technical rules. cine'. If the expression 'sophisticated department' is to be interpreted as a department 'in which complex radiological methods and procedures requiring special protection of the patient are undertaken', EFOMP underlines that the same concept should also be extended to many departments of diagnostic radiology. According to EFOMP the QE(R) is defined as 'an experienced Medical Physicist working in a hosptial or in a recognised analogous institution, whose knowledge and training in radiation physics are required in services where the quality of the diagnostic image or the precision of treatment is important and the doses delivered to the patients undergoing these medical examinations or treatments must be strictly controlled'. EFOMP also clarifies that the expression 'shall be available' is to be interpreted not as permanently present, but a daily relationship should exist between the expert and the patient environment, in particular the medical staff. In the same policy statement of 1988'3' the formal part of training required for a QE(R) is also indicated: 'The Qualified Expert should firstly have an education in physical sciences that provides an adequate scientific basis in radiation physics of a masters degree or its equivalent'. Then a curriculum of Basic Courses and Special Courses must be followed. The special Courses are differentiated according to the fields of application, e.g. Radiation Therapy, Radiodiagnosis, Nuclear Medicine. As an example Table 1 shows the proposed special courses for the field of Radiodiagnosis. As for the assessment and recognition of training, EFOMP proposes that 'appropriate arrangements should be made for assessTable 2. Description of the first three competency levels of a career in medical physics (adapted from Reference 6). Competency level Training experience

1. Adequate knowledge in a relevant scientific discipline to a level normally expected of a university degree or equivalent diploma in physics. 2. Adequate span of theoretical knowledge to current state of the art; able to apply this knowledge with reasonable skill under supervision; able to explain problems to other specialists and discuss response with appropriate vocabulary. 3. Adequate span of practical knowledge plus a demonstrated capacity for interpreting the state of the art to non-specialist clients, professionals in related disciplines, students, enforcing authorities or administrators; able to perform given or routine professional tasks without supervision; able to estimate project budgets, manpower costs and delivery schedules.

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INITIATIVES OF EFOMP IN THE FIELD OF RADIATION PROTECTION AND QUALITY ASSURANCE ment and certification of Qualified Experts either by of Section' and 'Head of Department', respectively. the competent national authorities or by the national Examples of competency level description for various professional organisations for medical physics. The fields can be found in Reference 6. certificate awarded on successful completion of the It is worth noting that the EFOMP strategy is towards designated training should be formally recognised by a recognition of the European Medical Physicist. For the competent national authority as indicating a this purpose the EFOMP proposal is to encourage a Qualified Expert in Radiophysics'3'.' registration scheme (on a voluntary basis) as opposed to a regulation scheme (as imposed by law). The main policy of EFOMP is to give the guides and In the 1991 Policy Statement'4' EFOMP analyses the the guidelines for an harmonised training of the QE(R) needs for the number of Physicists in a Medical Physics and to assess the various levels of competence to be Department. The minimum staffing required to support achieved during the career structure of the medical radiNuclear Medicine and Diagnostic Radiology is shown ation physicist. Table 2' 6 ' presents the description of the in Tables 3 and 4, respectively. first three of the five competency levels in which EFOMP subdivides the career. Each competency level is attached to a certain step in the career: having a level OTHER INITIATIVES 1 of competence corresponds to the entrance level Many other initiatives have been developed by required to enter the training programme; level 2 means EFOMP in the field of education, training and a completion of the training course, and level 3 means accreditation programmes. having completed the 'in service' training. At this stage Summer Schools in Radiophysics have been (and will the training of a QE(R) is completed. Levels 4 and 5 be) held in various European locations, as described in pertain to higher responsibility degrees, such as 'Head Table 5. The typical duration is one week. The 'Advanced School in Medical Physics' was Table 3. Minimum staffing of the Medical Physics support established in 1991 and the first course on 'Metabolism Studies using Magnetic Resonance Spectroscopy and of Nuclear Medicine (adapted from Reference 4). Positron Emission Tomography' was held in Como (Italy) in 1992'7', within the framework of the 'Scuola In all departments there must be at least one medical Superiore di Fisica Biomedica' of the Italian Associphysicist who is QE(R) with experience in nuclear medicine ation of Biomedical Physics (AIFB). physics. If the department has responsibilities related to therapy with radionuclides a second qualified expert may be The EFOMP scientific meetings are held every three necessary. years in connection with the scientific meeting of the host national organisation of medical physics: in 1987 General guidelines: in Innsbruck (Austria), in 1990 in Oxford (UK), in 1993 0.5 wte physicist 1 gamma camera in Tenerife (Spain) and in 1996 it will be held in 0.5 wte physicist 5000 examinations per annum Trieste (Italy). 500 dynamic studies involving significant data processing by a Various international scientific journals have been0.25 wte physicist physicist per annum sponsored by EFOMP: Physics in Medicine and Biology 250 studies involving SPECT per (Institute of Physics, UK) Physiological Measurements 0.25 wte physicist annum (Institute of Physics, UK) and Physica Medica (Giardini 50 new courses of treatment per Editori e Stampatori in Pisa, Italy). The Federation annum 0.25 wte physicist maintains representatives and collaborates with other scientific organisations, such as the International Elecwte = whole time equivalent trotechnical Commission (IEC), the European Society for Therapeutic Radiology and Oncology (ESTRO), the Table 4. Minimum staffing of the Medical Physics support European Society for Engineering and Medicine of Diagnostic Radiology (adapted from Reference 4). (ESEM), the International Radiation Protection Association (IRPA), the International Organisation of Medical All departments using complex equipment or carrying out Physics (IOMP), the American Association of Physicists complex radiological procedures should have available to in Medicine (AAPM), the European Association of them the services of at least one medical physicist who is Radiology (EAR), etc. QE(R) with experience in diagnostic radiological physics. Finally, European Medical Physics News, which is For a diagnostic radiology department utilising a full range distributed by EFOMP to all member organisations, of techniques, including, e.g. digital radiology, computed ensures a prompt transmission of information to the tomography, dedicated mammography to a population of medical physics community in Europe. 500,000, 1.0 whole lime equivalent physicist would be appropriate. ACKNOWLEDGEMENTS Physics input to diagnostic imaging technique using nonionising radiation is not considered. Many thanks are due to Dr Philip Dendy for useful discussions.

A. DEL GUERRA Table 5. Summer Schools in Radiophysics by EFOMP. Year Location Subject Participants + Lecturers 33 + 9 3 0 + 15 44+15 Countries represented 17 12 13

1991 1992 1994 (June) 1995 (Autumn) 1997

Dublin Seville Nancy Trieste Nice

Nuclear Medicine Radiotherapy Diagnostic Radiology Diagnostic Radiology in conjunction with AAPM

REFERENCES 1. EFOMP Policy Statement. 77ie Roles, Responsibilities and Status of the Clinical Medical Physicist (1984). 2. EFOMP Policy Statement. Medical Physics Education and Training: The Present European Level and Recommendations for its Future Development (1984). 3. EFOMP Policy Statement. Radiation Protection of the Patient in Europe: The Training of the Medical Physicist as a Qualified Expert in Radiophysics (1988). 4. EFOMP Policy Statement. Criteria for the Number of Physicists in a Medical Physics Department ( 1991 ). 5. EFOMP Policy Statement. Departments of Medical Physics: Advantages, Organisation and Management (1992). 6. Dendy, P. P. Work of the European Federation of Organisations of Medical Physics (EFOMP) in Establishing Uniform Standards of Radiation Protection in Health Care in Europe. Radioprotection 28(2), 153-161 (1993). 7. Molho, . (ed.) Proceedings of the 1992 Advanced School on Medical Physics Metabolism Studies using Magnetic Resonance Spectroscopy and Positron Emission Tomography, Como, Italy, May 1992. Physica Medica VIII(4), Supplement 1 ( 1992).

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Radiation Protection Dosimetry Vol. 57, No. \^, pp. 77-78 (1995) Nuclear Technology Publishing

RADIATION PROTECTION EDUCATION AND TRAINING OF RADIOGRAPHERS


P. Elsakkers Department of Radiology, University Hospital Rijnsburgerweg 10, 2333 AA Leiden, Netherlands INVITED PAPER Abstract The International Society of Radiographers and Radiological Technicians (ISRRT) is an international non-governmental organisation in official relationship with die World Health Organization. Over 50 countries are members of the ISRRT. The ISRRT encourages and facilitates communication between radiographers throughout the world. The ISRRT has produced several documents, e.g. 'The Role of the Radiographer in Europe'. The ISRRT has also done research and developed initiatives to analyse the quality of training of radiographers in the different member states of the EC. Research was done in die member states to analyse the efforts in the field of quality control. An extended study was performed on the current level of education in radiation protection in the European member states. The ICRP recommends in its publications the need of good training and continuing education for all radiographers. An important part of the basic training of radiographers should focus on the performance of radiation protection and quality control tests. Good daily practice can decrease patient dose in many ways. The ISRRT (International Society of Radiographers and Radiological Technicians) is a non-governmental organisation in official relationship with the World Health Organization. Among its objectives the ISRRT aims to achieve the following: (1) To encourage and facilitate communication between radiographers throughout the world. (2) To advance the science and practice of radiography and allied subjects. (3) To identify the needs of national groups of radiographers. In this paper some activities of the ISRRT will be discussed. ISRRT The ISRRT has done research and developed initiatives to analyse the quality of the training of radiographers in the different member states of the EC. In 1988 a combined CEC/ISRRT meeting took place in which the implementation of the patient directive (Euratom/84/466), the role of the radiographer in Europe and the professional training were discussed'". In 1988 the board of the ISRRT requested two radiographers to investigate the organisation of the education of radiographers in the different member states. The socalled 'Clarijs survey' demonstrates the similarities and differences between the member states in qualifications required to enter the education programme, in the duration of the training, in the location of practical training (hospital, skills lab), in recommended books and so on. The Clarijs survey was presented in a combined meeting of the CEC and the ISRRT in Luxembourg in 1990 and
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on the basis of this survey much discussion took place regarding the education of radiographers in the 12 member states with the specific goals: (1) To establish a common professional profile. (2) To harmonise training objectives and the duration of professional training. (3) To come to reciprocal recognition of diplomas and other certificates. Another subject of extensive research was a survey conducted to find out in which countries the Patient Directive has been implemented and in which way. The subject of quality assurance has also been researched. The aim was to investigate what was going on in the field of quality assurance and quality control in radiography in Europe. Evaluations of the results of questionnaires sent to all member states led to the compilation of a list of quality control tests currently carried out by radiological departments. In January 1992 a European subcommittee of the Europe-Africa region of the ISRRT finalised the document: 'The Role of the Radiographer in Europe.' The aims set out in this document are: (1) To obtain general agreement in the countries of Europe on the role of the radiographer. (2) To clarify the responsibilities resting upon the radiographer as a member of the Health Care team. (3) To facilitate the formulation of professional education programmes. (4) To form a basis for the consideration of common European standards of qualification. Regarding quality assurance the document says: 'The radiographer must be a full member of the team that

P. ELSAKKERS

develops, maintains and monitors the quality standards of the department'. During the years 1991-1993 another subcommittee of the ISRRT did research on the education of radiographers in radiation protection. The group defined recommendations based on a close inventory of the current levels of education in safe radiation practice in the different countries. These recommendations should be taken as advice on the required level of education. Radiographic education centres can compare their own programmes with the ISRRT recommendations. The recommendations will be discussed in a future CEC/ISRRT meeting. At this moment the ISRRT is working on a common professional profile, based on the professional profiles defined by each separate member country.

for all personnel. It is of great importance to set up and perform quality control programmes. The ISRRT publishes information in a Newsletter about all aspects of radiation protection. In many European countries and also in the Netherlands several postgraduate courses are being organised on the subject of quality control. In these courses attention is paid to theoretical knowledge. In the first place, however, students learn to perform different practical tests. Part of the courses call for the student to do research on a subject concerning quality control or dosimetry. Studies are done on subjects such as retake analysis, status tests, dosimetry, image quality, mammography and film processing. In many studies recommendations were made to improve the image quality, to do investigations to solve eq.uipment problems and to change daily practice in order to decrease the patient dose. CONCLUSION AND RECOMMENDATIONS Radiographers, physicists and diagnostic radiologists should work together to define programmes in which each profession can contribute. The central governments and the European Community should promote the determination of technical criteria for equipment used in diagnostic radiology. A structure of responsibilities for the people who perform tests, the registration of the results and maintenance of equipment should be introduced. The criteria, the test methods and test conditions should be described and agreed upon. Radiographers should be able to perform quality control tests and dosimetry. An important part of the training should focus on the performance of quality control tests. The role of an educated radiographer is indispensable.

POSTGRADUATE TRAINING In its publications the ICRP recommends the need of good training. ICRP 57 states that adequate education and practical training in radiation protection should be provided for all who apply ionising radiation in the medical, dental and associated professions. They do not only require initial training in radiation protection but also continued education throughout their professional lifetime. This education should include a broad knowledge of radiation biology, dosimetry and radiation physics. The World Health Organization also puts emphasis on the need of training. During the combined CEC/ISRRT meeting in 1990 in Luxembourg Prof. Stieve presented a paper 'Desirable teaching and training programme for radiographers and radiological technicians'. The ISRRT emphasises his point of view about the necessity of continual education

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Radiation Protection Dosimetry Vol. 57, No. 1-4, pp. 79-84 (1995) Nuclear Technology Publishing

PRACTICAL IMPACT OF THE EVOLUTION AND CHANGES OF ICRP RECOMMENDATIONS ON RADIOLOGICAL PROTECTION IN MEDICINE
S. Mattsson and A. Almen Department of Radiation Physics, Lund University Malm General Hospital, S-214 01 Malm, Sweden INVITED PAPER Abstract The International Commission on Radiological Protection (ICRP) has given recommendations concerning the radiological protection of the patient in diagnostic radiology, nuclear medicine and radiation therapy, as well as of the worker in medicine and dentistry. In spite of these earlier recommendations, the situation in medicine is far from optimal showing a wide distribution of patient doses among various departments and hospitals without any similar variation in diagnostic information. There is a special need to emphasise such areas, which have the potential of high patient dose and/or highrisk,e.g. interventional radiography, computed tomography, and paediatric radiology. For medical exposures, ICRP (Publication 60) still indicates that if the practice is justified and the protection optimised, dose limits should not be applied. However, it does recommend the development of reference levels as a quantitative guide to optimisation. Consideration should also be given to potential accidents and intervention. INTRODUCTION The medical use of ionising radiation, which has an enormous benefit to the patients, also contributes significantly to the radiation exposure of individuals and populations"2'. Diagnostic radiology is the largest manmade source of ionising radiation, although more than three-quarters of the world's population have no chance of receiving any radiological examination, regardless of what disease they might have'". In the field of diagnostic radiology, the potential for reducing the absorbed dose to patients is well established13'. Unnecessary exposures may be clinically unjustified as well as non-optimised (which implies that doses can be reduced by improvements in procedures or equipment). The opinion of the ICRP is that radical measures should be taken to reduce unnecessary exposure, especially since this can be done without any sacrifice of diagnostic benefit'4'. It is not clear if the same potential exists for nuclear medicine investigations, which are less frequent but for the individual patient may give an exposure of the same order of magnitude as an X ray investigation. In radiation therapy, the situation is very different from the diagnostic one, since the adequate irradiation of the target volume is therapeutic and the wish to give low doses to volumes just outside the treated volume is an essential part of the process. In external beam therapy, doses to distant parts of the body may, however, be significantly influenced by, for example, the various types of field shaping devices used. When discussing protection in medicine, one must also consider the irradiation of members of the staff, remembering that more than 90% of the persons occu79

pationally exposed to radiation world-wide belong to the medical field. CURRENT ICRP RECOMMENDATIONS ON RADIOLOGICAL PROTECTION IN MEDICINE The International Commission on Radiological Protection (ICRP) has a special connection with medicine due to its roots in the International Society of Radiology. It has even a special committee on 'Protection in Medicine' (Committee 3) and has issued a series of documents'5"7' for the medical field: ICRP Publication 34 deals with Protection of the Patient in Diagnostic Radiology, Publication 52 with Protecion of the Patient in Nuclear Medicine (diagnostic and therapeutic) and Publication 44 is about Protection of the Patient in Radiation Therapy. There is a special report, Publication 57, on the Protection of the Worker in Medicine and Dentistry^'. Publication 53, Dose to Patients from Radiopharmaceuticals1^, is also an important document for nuclear medicine. Since these documents were written, ICRP has published new general recommendations in Publication 60'"", which replaces Publication 26 from 1977"". There is now an urgent need to implement and apply the ideas of Publication 60 in the medical field. A first attempt to do so was the updating of the Summary of the Current ICRP Principles for Protection of the Patient in Diagnostic Radiology, which is included in the recently printed Publication 62 from 1993"2'. A similar publication covering the field of nuclear medicine was distributed at the International Congress of Radiology in Singapore at the beginning of 1994. The main part of Publication 62 deals with Protection of Humans in

S. MATTSSON and . ALMEN Biomedical Research. There is also an addendum to Publication 53 Dose to Patients from Radiopharmaceut icals in that publication. WHAT DOES ICRP PUBLICA TION 60 SA Y ABOUT RA DIOLOGICA L PROTECTION A ND SAFETY IN MEDICINE? New data and new interpretations of old data indicate that the risk associated with ionising radiation is about four times higher than estimated a decade ago. The increased knowledge about the variation of risk by age 'at exposure also has implications for our clinical radi ation protection efforts, which should establish priorities for newborn, children and pregnant women. The main principles for radiological protection still state that practices causing exposure should be justified. The new recommendations point out that together with the justification at the broad level of practices, it is necessary to justify with respect to the individual pa tient. Protection arrangements should be optimised. Dose limits should be applied to workers but not to medical exposures of patients. However, ICRP now rec ommends that consideration should be given to the use of reference dose levels for application in some common diagnostic procedures. They should be applied with flexibility to allow higher doses when indicated by sound clinical judgement. The use of such dose con straints is a part of the optimisation procedure. A s a new principle, potential exposure (accidents) as well as interventions after an accident are to be treated in the same way as planned exposure. Moreover ICRP Publi cation 60 points out the need to control whether the system used for optimisation (or justification) is good enough (assessment of effectiveness). An important task for ICRP is to clarify how the rec ommended system of radiological protection should be applied in medicine. A major point to be clarified is how the A LA RA principle should be applied at investi gations of patients, how reference levels should be applied to medical exposures and constraints to occu pational exposure and for members of the public. Other tasks include the implications of the new dose limits for occupational exposure, potential exposures and inter vention. In addition, the procedures for assessment of effectiveness of the system of radiological protetion will be developed. There is also a need to review the quan tities used for dose and risk assessment in medical examinations. WHICH PA RA METERS CA N BE USED TO DESCRIBE THE RA DIA TION RISK FOR PATIENTS? One parameter is the mean absorbed dose to the whole body. It is the energy imparted (e) divided by the weight of the person. In diagnostic radiology, the energy imparted can be estimated using measurements with a
80

transmission ionisation chamber. This is the simplest way to get an individual dose estimate and can separate contributions from various projections and procedures. To obtain a better estimate of the risk, the distribution of the absorbed dose among different organs and tissues in the body has to be known. This gives the possibility of calculating the mean absorbed dose to organs/tissues and combining those with risk figures for each organ (tissue). The use of mean absorbed doses to organs and tissues is a simplification as the heterogeneity of absorbed dose in the tissue is not taken into consideration. In diagnos tic radiology organs are often only partly irradiated or there is a sharp dose gradient within organs. Sharp dose gradients are also present at interfaces, e.g. between bone and soft tissue, contrast media and soft tissue. In nuclear medicine there is often a heterogeneous uptake of the radionuclide in organs and tissues and even in cells. There is often insufficient information on organ doses to calculate the effective dose (E). Attempts to estimate effective dose or effective dose equivalent (HE) in diag nostic radiology normally rely on a limited number of Monte Carlo calculated organ doses for standardised phantoms"315'. A lmCarlsson and Carlsson"6', Huda and Bissessur"7' and Le Heron"8' used such data and calculated effective dose values for a number of typical investigations and gave a relation to dosearea product, mean absorbed dose or entrance dose. Experimentally, using measurements on phantoms, various groups have estimated the relation between HE and e or E and e (e.g. Mnsson et /"9', A lmn and Mattsson'20'). In nuclear medicine, calculations of organ doses and effective dose (equivalent) have been carried out for a number of radiopharmaceuticals'92" mainly using the MIRD formalism'22'. There is a large uncertainty in dose data mainly due to insufficient information on biokinetic data. It is also well known that there are considerable differences in biokinetics from patient to patient. Chil dren, who often show different kinetics from adults, constitute a special problem. There is also a need to establish reliable biokinetic data for new radiopharma ceuticals. Effective dose (equivalent) for patients? The use of the quantity effect dose for patients has been criticised'2324'. MIRD accepts the use of effective dose equivalent for volunteers entering investigational protocols, but not for patients'23'. The alternative pro posed is the absorbed dose to various organs and tissues, for which specific risk factors can be applied. According to the authors' opinion, the effective dose is of great value if one wants to characterise and communicate on patient doses. It should not be taken as an exact value of the risk. The effective dose, however, gives a relative number and thereby a possibility to compare techniques used at various places and laboratories. NRPB'25' has

EVOLUTION AND CHANGES OF ICRP RECOMMENDATIONS ON RADIOLOGICAL PROTECTION IN MEDICINE quantified levels of risk for two broad groups of pa'dose-area product meter' (transmission ionisation tients, namely paediatric and geriatric, for which the detchamber). In this respect there is a strong need for riment per unit effective dose is a factor of about 2 an international agreement on quantities to be meashigher and at least 5 lower, respectively, than for the ured, calibration to be used and on a uniform data general population. For patients of any age between presentation. Factors to convert data on dose-area these two groups, the detriment per unit effective dose product into energy imparted, organ doses and is close to the ICRP Publication 60 value for the geneffective dose should be given. eral population. There is a need for further advice and a protocol for The effective dose takes only the stochastic effects periodic patient dose measurements. UK has got such a (lethal cancer and hereditary effects) into consideration. protocol128' and ICRU is tackling the problem'29'. Today, there are new reasons to consider the risk for Methods for carrying out automated dose surveys'30' deterministic effects in diagnostic radiology again. should be stimulated. Based on patient dose surveys Locally high absorbed doses to the skin can be reached CEC and UK have suggested guideline dose levels in for example in digital radiography in connection with terms of entrance surface dose for routine radiographs, interventional studies. The doses are sometimes at a based on the third quartile value of the observed dose level where they result in skin erythema and epilation. distributions'253". The ease with which new equipment can give the patient high doses, stresses the need to create routines DIAGNOSTIC RADIOLOGY which react when certain investigation levels are overThe potential for reducing the exposure of the popu- drawn! lation from medical X ray examinations is well established through a number of local, national and international patient dose surveys. It is generally accepted How can image quality be described? that the lowest possible dose should be delivered conThere are various ways to describe the image quality: sistent with the clinical purpose of the investigation. A problem is to guarantee that these aspects are considered (1) Imaging standard test phantoms for determination of physical parameters (contrast, resolution). in practice. Radiation protection has often a low priority (2) Imaging phantoms with diagnostically relevant in the busy clinical practice. structures (subject optimisation) or patients of equal It is important to include patient exposure as well as size (group mean weight with 70 5 kg). Observer image quality in the quality management system, which performance tests (ROC) can then be done on the should be in operation at every department of diagnostic images. radiology. The manufacturers have a central role in building radiological protection into the system design. (3) Specification of the visibility3 of defined anatomical structures in patient studies' ". The WHO-Basic Radiological System (BRS)'26' is a good example of such a design! Relation between image quality and absorbed dose? How can patient exposure be monitored in the clinic? There are several methods used together with the more simple estimates based on the mA.s product. The need differs considerably for various types of equipment. CT is standardised and the mean absorbed dose in the scan is similar from patient to patient, if the same unit is used. There are, however, considerable differences between units'27' as in the number of scans used. At other investigations there is a need for more detailed studies of the large variation of doses. This can be done by: (1) Measurement of the primary beam air kerma using an ionisation chamber. (2) Measurement of entrance surface absorbed dose by TLD (lithium fluoride, lithium borate) on patients or on phantoms simulating the clinical situation. (3) Assessment of total energy imparted to the patient by direct measurement of the product of the kerma in air and the area of the patient exposed using a 81 There are fundamental difficulties in understanding the relation between measured physical parameters and what the radiologist can see in an image. This is one of the most challenging field of research related to diagnostic radiology and nuclear medicine today. If we could make some progress in this field, our work to optimise the relation between dose and image quality will be much simplified. Reference dose levels and image quality criteria have to be set by professional and advisory bodies after consideration of the information content gained and the ranges of average doses delivered. Need of methods for risk comparison It is important to be able to put the radiological risks into perspective. We also need to know the risk for the patient if the investigation is not carried out. We need better methods for risk comparison, e.g. between radiation and amount of X ray contrast agents in diagnostic

S. MATTSSON and . ALMEN radiology, and also between risks associated with X rays and with MR, ultrasound, etc. One problem for ICRP is that this organisation works solely with ionising radiation. Which priorities should be given today in radiological protection in diagnostic radiology? These priorities, of course, differ from country to county. However, in most developed countries, the high dose/high risk investigations are paediatric investigations, interventional radiology, CT and other digital techniques. The effective dose at CT investigations is 5-10 times higher than at ordinary X ray images. CT, which in many European countries typically stands for 2% of the investigations, gives 20% of the total population dose from diagnostic radiology'27'. There is an increasing unintentional misuse of modern technology. This may be connected to a wish to increase the patient throughput from the user's side. For example, using helical scan CT it takes shorter time to scan 60 cm along the body with covering scans in 30 s than to take only the necessary 10 scans at various positions. The misuse may also be connected to insufficient knowledge about the dose contribution from long time fluoroscopy. NUCLEAR MEDICINE Nuclear medicine differs from diagnostic radiology in respect that the radiation source term, the administered activity, is well known. ICRP recommends that this should be recorded for every patient. Patient doses can then be estimated using data in ICRP Publications 53 and 62. One problem is that uptake and retention, and thus the absorbed dose, may differ considerably from patient to patient. As part of the optimisation process the activity, which provides an appropriate level of diagnostics but still ensures radiological protection aspects, has to be determined to be in accordance with proposed reference levels. Paediatric applications should receive special attention in this regard and recommendations should be given for selected body-weight intervals. There may be a need for differentiation, so that lower activity and longer measurement times are used for young patients (provided that patient movement can be controlled) and higher activity and shorter measurement times for older persons. Relevant methods for dose reduction should be used'7'. Except for forced diuresis and thyroid blocking using stable iodine, this is not much used in the clinical practice. It is important that quality control procedures are employed to monitor the performance of all equipment used for clinical measurements. With regard to occupational exposure, exposure of
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workers, who are engaged in labelling, synthesis and preparation of radiopharmaceuticals and in patient handling, is the main concern. Exposure of the public during the patient's travelling back home and when he/she is back at home with family members has to be assessed, as well as the appropriate handling and disposal of the radioactive waste. Unintended situations such as misadministration of radiopharmaceuticals or administration of certain radiopharmaceuticals to pregnant and nursing women have to be addressed. RADIATION THERAPY Optimisation regarding irradiation of target volume and risk organs is a part of the radiotherapy procedure itself. Underexposure of the target volume can have as serious health consequences for the patient as overexposure. However, the dose to distant organs (uterus, second breast etc.) can be significantly influenced by the treatment technique (wedges or not, extra collimation, shielding of organs, leakage radiation etc.) and there is no reason to treat this differently from other types of radiological protection problems. In radiation therapy, the main emphasis has to be given to the potential (accidental) exposures. Even if radiotherapy is the area of medicine which has the longest traditions of quality control and safety, a number of accidents and misadministrations have occurred during recent years. In spite of improved safety systems accidents continue to occur. The type of accidents range from one single fraction up to the whole treatment of a large number of patients. There is a combination of equipment failure, a wide range of human errors as well as communication problems. High dose rate brachytherapy systems create special problems from the safety point of view. ICRP will hopefully transfer the experiences of accidents and malfunction into recommendations for authorities, manufacturers and users. The recommendations are proposed to cover design of equipment, responsibilities and programmes for education and training. As regards safety, the interlocks associated with the equipment and the facility will be reviewed and for the protection of staff and public, consideration will be given to the practical application of dose constraints. Potential exposures to the public from decommissioned radiation sources should be minimised. Procedures to assess the effectiveness of the safety measures have also to be considered. IMMEDIATE PRACTICAL IMPACTS In spite of the fact that the work to translate ICRP Publication 60 into the medical field has recently started, there are several points which follow earlier ICRP recommendations that are quite obvious. The work to improve radiological protection in medi-

EVOLUTION AND CHANGES OF ICRP RECOMMENDATIONS ON RADIOLOGICAL PROTECTION IN MEDICINE cine has to be done in close cooperation between all ventional radiology and other types for digital radiology categories of staff involved in the work. The responsi- is concerned. Today most digital radiography systems bility of the operator of the various pieces of equipment are adjusted by the manufacturers to guarantee good used should be increased. Various persons have to be image quality for very different patients, giving too aware of their responsibilities. They should actively sign much exposure to the large majority. This guarantees when and why levels for dose constraints are over- best image quality in every situation, which is the selling argument number one. For most modern CT, one drawn. The continuous dialogue between experts in diagnos- should be able to reduce the exposure (mA.s) to half tic radiology and medical physics and people from vari- the recommended value without any observable degraous medical professions, including the practitioners who dation of image quality for almost all patients. Too little send the patients for a diagnostic investigation, is essen- attention has hitherto been given to the patient dose aspects when designing new CT scanners'27'. tial and has to be improved. Education and training of all physicians, medical The new economic system for health care, where the income depends on how many investigations are carried physicists, radiographers, assistants, nurses and other out, does not stimulate optimisation and there is a risk staff members working in radiology and nuclear medithat the justification for a certain investigation is not cine should be intensified. Complementary training for always discussed as it should be. There is therefore an those who are not specialised (training in new methods) increasing need for clear referral criteria. It is important is also important. 'Drivers licences' for equipment and that the responsibility in each situation is given to those methods should be given when training is fulfilled. who have the professional knowledge. A competent and Courses in radiological protection in medicine should active local radiation protection organisation is needed, be given for all medical students. Examinations in radioincluding an experienced radiation protection commit- logical protection should be carried out for specialists tee. It is important that this organisation is asked for in Diagnostic Radiology, Nuclear Medicine, Radiation advice, e.g. when new equipment is purchased. A cen- Oncology and Medical Physics. Active research in the tralised organisation and a joint laboratory, a diagnostic field of radiation protection and the relation between house or centre, for all patient imaging, may be one way patient doses and image content should be stimulated. to simplify the optimal choice of imaging technique as well as the contacts with the practitioners. ACKNOWLEDGEMENTS The manufacturers of equipment for X ray diagnosThis paper is partly intended to reflect some of the tics and nuclear medicine have to be more actively involved in the discussions, programmes and planning current discussion in ICRP Committee 3. However, than at present. The situation is far from optimal. This ICRP should not be made responsible for any part of is particularly problematic as far as equipment for inter- the document. REFERENCES

1. UNSCEAR. Sources, Effects and Risks from Ionising Radiation. Report to the General Assembly (New York: United Nations) (1993). 2. Valentin, J. and Webb, G. Medical Uses of Radiation: Retaining the Benefit but Recognising the Harm. SSI Report 93-07 (Swedish Radiation Protection Institute, Stockholm) (1993). 3. Wall. B. F. and Hart, D. The Potential for Dose Reduction in Diagnostic Radiology. Radit. Prot. Dosim. 43, 265-268 ( 1992). 4. Liniecki, J. Radiological Protection in Medicine Current and Prospective Work of the ICRP. In: Proc. 8th Int. Congress of the International Radiaron Protection Association, IRPA-8, Montral, Canada, 17-22 May 1992. 5. ICRP. Protection of the Patient in Diagnostic Radiology. Publication 34, Ann. ICRP 9(2-3) (Oxford: Pergamon) (1982). 6. ICRP. Protection of the Patient in Radiation Therapy. Publication 44, Ann. ICRP 15(2) (Oxford: Pergamon) (1985). 7. ICRP. Protection of the Patient in Nuclear Medicine. Publication 52, Ann. ICRP 17(4) (Oxford: Pergamon) (1987). 8. ICRP. Radiological Protection of the Worker in Medicine and Dentistry. Publication 57, Ann. ICRP 20(3) (Oxford: Pergamon) (1989). 9. ICRP. Radiation Dose to Patients from Radiopharmaceuticals Publication 53, Ann. ICRP 18(1-4) (Oxford: Pergamon) (1987). 10 ICRP. 1990 Recommendations of International Commission on Radiological Protection: Publication 60, Ann. ICRP 21(1-3) (Oxford: Pergamon) (1991). 11 ICRP. Recommendations of the International Commission on Radiological Protection; Publication 26, Ann. ICRP 1(3) (Oxford: Pergamon) (1977). 12 ICRP. Radiological Protection in Biomedical Research. Publication 62, Ann. ICRP 22(3) (Oxford: Pergamon) (1991). 13. Drexler, G., Panzer, W., Widenmann, L., Willimas, G. and Zankl, M. The Calculation of Dose from External Photon Exposures using Reference Human Phantoms and Monte Carlo Methods, Part III: Organ Doses in X-ray Diagnosis. G Bericht 11/90 (GSF-Forschungszentrum fr Umwell und Gesundheit, Mnchen) (1990). 83

S. MATTSSON and . ALMEN 14. Jones, D. G. and Wall, . Organ Doses from Medical Xray Examinations Calculated using Monte Carlo Techniques. Report NRPBR186 (NRPB, Chilton, Didcot, Oxon) (1985). 15. Rosenstein, M. Handbook of Selected Tissue Doses for Projections Common in Diagnostic Radiology. (Bureau of Radiological Health, U.S. Department of Health, Education and Welfare, Rockville, MD, USA ) (1988). 16. A lmCarlsson, G. and Carlsson, C. Relations between Effective Dose Equivalent and Mean Absorbed Dose (Energy Imparted) to Patients in Diagnostic Radiology. Phys. Med. Biol. 31, 911921 (1986). 17. Huda, W. and Bissessur, K. Effective D ose Equivalents, HE, in Diagnostic Radiology. Med. Phys. 17, 9981003 (1990). 18. Le Heron, J. C. Estimation of Effective Dose to the Patient D uring Medical Xray Examination from Measurements of the DoseArea Product. Phys. Med. Biol. 37, 21172126 (1992). 19. Mnsson, L. G., Wallstrm, E. and Mattsson, S. Relations between Effective D ose, Effective Dose Equivalent, AreaKerma Product and Energy Imparted in Chest Radiography. Radit. Prot. Dosim 49, 421431 (1993). 20. A lmn, A . and Mattsson, S. D ose D istribution in Children at Chest Radiography. Radial. Prot. Dosim. 57,(1 4), 463^t67 (1995) (This issue). 21. Johansson, L., Mattsson, S., Nosslin, . and Leide, S. Effective Dose to the Patient from Radiopharmaceuticals Calculated with the New ICRP Tissue Weighting Factors. In: Proc. 5th Int. Radiopharmaceutical Dosimetry Symp., Oak Ridge, Tenn., 710 May 1991 (Internal Dose Information Center, Oak Ridge, Tenn., USA ) (1992). 22. Loevinger, R. and Berman, M. A Revised Schema for Calculating the Absorbed D ose from Biologically D istributed Radio nuclides. MIRD Pamphlet No 1 (Revised) (The Society of Nuclear Medicine, New York, USA ) (1976). 23. Poston, J. W. for the MIRD Committee. Application of the Effective Dose Equivalent to Nuclear Medicine Patients. J. Nucl. Med. 34, 714716 (1993). 24. Drexler, G., Panzer, W., Petoussi, N. and Zankl, M. Effective Dose How Effective for Patients. Radit. Environ. Biophys. 32, 209219 (1993). 25. NRPB. Occupational, Public and Medical Exposure: Guidance on the 1990 Recommendations of ICRP. Doc NRPB 4(2), 4374 (1993). 26. Holm, T., Hanson, G. P. and Sandstrm, S. High Image Quality and Low Patient D ose with WHOBRS Equipment. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores et al. BIR Report No 20 (British Institute of Radiology, London) pp. 153155 (1989). 27. Leitz, W., Szendr, G. and A xelsson, B. Computed Tomography Practice in Sweden Quality Control, Techniques and Patient D ose. Radial. Prot. Dosim. 57(1^1) 469473 (1995) (This issue). 28. IPSM/NRPB/CoR (Institute of Physical Sciences in Medicine, National Radiological Protection Board and College of Radio graphers, UK) National Protocol for Patient D ose Measurements in Diagnostic Radiology. (NRPB, Chilton, Didcot, Oxon OX11 0RQ) (1992). 29. Roberts, P. J. Patient D osimetry in Diagnostic Radiology. ICRU News pp. 1013 December 1992. 30. Chappie, C.L. and Faulkner, K. Unpublished data. 31. CEC Study Group. Quality Criteria for D iagnostic Radiographic Images. A ppendix to: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores et al. BIR Report No 20 (British Institute of Radiology, London) pp. 271280 (1989).

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 85-90 (1995) Nuclear Technology Publishing

UNSCEAR DATA COLLECTIONS ON MEDICAL RADIATION EXPOSURES: TRENDS AND CONSEQUENCES


J. Valentin Swedish Radiation Protection Institute S-171 16 Stockholm, Sweden INVITED PAPER Abstract UNSCEAR evaluates medical radiation frequencies and effective doses (E) or effective dose equivalents (HE) at four health care levels (I = industrialised countries, IV = poor developing countries). The 1993 Report is fairly complete for levels I and II. Effective doses for specific procedures may differ from effective dose equivalents by a factor of 2, but for entire practices E and HE are similar. For most X ray examinations, doses at level I decrease but computed tomography (CT) doses are increasing, resulting in an overall annual per caput HE of 1 mSv. Doses at levels II, III and IV are 0.1, 0.1 and 0.04 mSv (worldwide average 0.3 mSv). For nuclear medicine, the annual per caput HE is 0.09, 0.008, 0.008 and 0.008 mSv at levels I-IV (worldwide average 0.03 mSv). For diefirsttime, UNSCEAR now also estimates effective doses in radiotherapy (excluding dose to target). These are 0.7, 0.2, 0.03 and 0.02 mSv annually per caput at levels I-IV (average 0.3 mSv) for tele- and brachytherapy, much less for therapeutic nuclear medicine (average 0.002 mSv). These doses cannot be directly compared to diagnostic doses, but therapy should not be disregarded in dose statistics. UNSCEAR draws no radiation protection conclusions. However, its data suggest that attention should be paid to CT, to paediatric X ray examinations, to repeated X ray examinations of small subsets of populations, tofluoroscopyand to choice of diagnostic radiopharmaceuticals in developing countries. INTRODUCTION Medical use of radiation is the biggest source by far of man-made exposure of the human population to ionising radiation. However, medical radiation differs from other man-made exposures in that the exposed individuals and populations are almost entirely the same ones who also receive in return the direct benefits of the practice. Nevertheless, there is a continuing need to analyse frequencies, doses and trends of medical radiation procedures worldwide. Such information permits evaluation of differences in medical radiation usage, comparisons with other sources of radiation, identification of areas of concern and estimation of presumed detriment. The United Nations Scientific Committee on the Effects of Atomic Radiation, UNSCEAR, has repeatedly assessed exposures from medical uses of radiation"-7'. The objectives are, for example, to determine trends in doses and practices; to assess how new techniques, radiation protection measures or quality assurance programmes affect these trends; to evaluate dose variations for procedures and practices as well as the reasons for such variations; and to study age and sex distributions of patients. In this way, UNSCEAR supplies bodies involved in radiation protection with the necessary raw material for their conclusions. Unfortunately, statistics on medical exposures are not available in all countries. The UNSCEAR 1988 Report'6' demonstrated a good correlation between the number of X ray examinations per unit population, and the number of physicians per unit population. The number of physicians is a more widely available statistic. Therefore, worldwide diagnostic X ray examination frequencies could (according to UNSCEAR) be estimated by extrapolation from a limited number of countries. Other medical radiation usage is treated similarly, although little formal analysis has been performed to support the extrapolation. For this purpose, countries were categorised in the UNSCEAR 1988 Report'6' as to level of health care. In countries of level I, there is at least one physician per 1000 population; level II, one physician for 10003000 population; level III, one for 3000-10,000 population; and level IV, one for more than 10,000 population. This categorisation is retained in the UNSCEAR (1993) Report. The total population residing in countries of levels I, II, III and IV is 1.35, 2.63, 0.85 and 0.46 billion. For its 1993 Report, UNSCEAR'7' undertook a survey of medical radiation usage and exposures in 140 countries, over 50 of which responded. With additional published data, the UNSCEAR 1993 Report provides at least some information for about 95 countries. However, these are unevenly distributed over health care levels. Data for levels I and II come from countries representing about 75% of the population concerned, while data for level III represents some 20% and for level IV some 2% of the population concerned. However, it may be assumed that countries of levels III and IV contribute little to the worldwide collective dose from medical radiation usage.

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DOSE EVA LUA TION In its 1982 and 1988 reports, UNSCEAR' ' used the effective dose equivalent, HE, to express patient doses. This was done in full and clearly stated awareness of its limitations as applied to medical radiation pro cedures. HE was defined for a population of healthy adult workers, while patients may be younger or (more often) older than an average worker, and are by defi nition not healthy. Thus, doses cannot be directly trans lated into detriment using the conventional risk factors or detriment probability coefficients of ICRP'89'. How ever, several studies indicate that, on average, a HE to a patient of 1 mSv from diagnostic X ray examinations would result in the same detriment as 0.60.7 mSv to a worker'"". For diagnostic nuclear medicine, 1 mSv to a patient would correspond to 0.5 mSv to a worker, and for radiotherapy, 1 mSv to a patient would correspond to0.25mSv"". Currently, HE is being superseded by the effective dose, E, of ICRP'9'. A veraging over all examinations and patients, studies summarised in the UNSCEA R 1993 Report'7' show that E probably does not differ from HE by more than, say 10%. However, for individ ual procedures, one of these measures could turn out to be at least twice the other measure. In consequence, UNSCEAR'7' prudently distinguishes between E and HE for medical radiation exposures. DIAGNOSTIC X RA Y EXA MINA TIONS The average annual frequencies of X ray examin ations in countries of health care levels I, II, III and IV are 890, 120, 67 and 8.8 per 1000 population for 1985 1990. Thus, as expected, there are more examinations in richer countries. However, Figure 1 reveals substantial variation between individual countries at each level of health care. Much of this variation would be difficult to explain in terms of medically relevant factors. Figure 2 illustrates the time trends of these fre quencies for different health care levels. At health care level I, worldwide X ray examination frequencies have remained fairly constant since the 1970s. Nevertheless, the pattern of different types of examinations has changed completely. In particular, chest examinations are decreasing in level I countries, while computed tom ography (CT) is increasing. The introduction of alterna tive diagnostic modalities, such as ultrasound and endoscopy, has also reduced the frequencies of certain examinations. At lower health care levels, the frequencies of X ray examinations, including chest examinations, are gener ally increasing, while CT is available at negligible fre quencies only. The age distribution of patients in common X ray examinations in 19851990 is shown in Figure 3. The average age of patients is highest in level I countries, the difference being statistically significant. The greater
86
5 6

proportion of children in the populations of countries of health care levels IIIV is reflected in a higher share (compared to level I) of children among examined patients'6'. The differences in population age structure appear to be sufficient to explain the differences in pati ent age. Figure 4 shows sex distributions of patients for 1985 1990. There are consistently fewer female patients in level II and level III countries than in level I countries. Since no obvious medical explanation is at hand, this
Belgium Canada FR Germany France Russian Federation Chechoslovakia Finland Luxembourg USA Kuwait Portugal Poland New Zealand Cuba Spain Australia Netherlands Norway Sweden Denmark Romania Malta

Turkey
Barbados China India Brazil Ecuador Nicaragua Peru Dominica St. Lucia Philippines Vanuatu

Belile
Thailand Cape Verde Sudan Myanmar Rwanda

200 400 600 800 1000 12001400 Number per 1000 population Level I m Level II H Level lllIV

Figure 1. Frequency of X ray examinations in different coun tries, 19851990. Sorted by Health Care Levels, where Level I = less than 1000 population per physician, Level II = 1000 3000, Level III = 300010,000 and Level IV = more than 10,000 population per physician.

1000 800 Number per 600' 1000 population 400 19851990 19801985 19701980 Level lllIV

Figure 2. Variation of X ray examination frequency with time at different Health Care Levels (Levels as in Figure I ).

UNSCEAR DATA ON MEDICAL RADIATION USAGE may reflect social/cultural differences between coun Figure 6, the frequency scale of which is logarithmic to tries. accommodate the huge variation. Again, it is difficult to Average effective dose equivalents at health care find medical reasons for such a large variation between level I for some common X ray examinations are otherwise similar countries. depicted in Figure 5 for two time periods. Typically, The frequencies of some nuclear medicine examin doses for specific examinations are decreasing with ations are given in Figure 7. For lack of information, it time. However, CT doses are increasing. The frequency is not possible to demonstrate time trends here, but it of CT examinations is also increasing, and CT is now may be assumed that diagnostic nuclear medicine fre the most important component of the per caput dose quencies were generally higher during the 1980s than from diagnostic X rays, contributing some 20% to the during the 1970s. collective dose from X ray examinations in several Figure 8 shows the mean ages of patients in 1985 countries'"". 1990 for common types of nuclear medicine examin The 19851990 average annual per caput HE for diag ation. On average, the population examined is not only nostic X ray examinations amounts to 1, 0.1, 0.04 and older than the population in general, but also older than 0.04 mSv at health care levels I, II, III and IV. The col those receiving X ray examinations. The proportion of lective doses were 1.3, 0.29, 0.04 and 0.02 million man children among examined patients is higher in countries Sv. The average annual per caput dose for the entire of health care levels IIIV than at health care level I, world is 0.3 mSv (collective dose 1.6 million man Sv). but the difference between health care levels is smaller Dental X ray examinations contribute only about 1 % to than for X ray examinations. A gain, the higher pro portion of children in the general population of countries the average and collective doses listed above. of levels IIIV explains the excess of children among patients from these countries. DIAGNOSTIC NUCLEA R MEDICINE The sex distributions of nuclear medicine patients in The average annual frequencies of nuclear medicine 19851990, given in Figure 9, show no consistent dif examinations in countries of health care levels I, II, and ference between levels of health care. It was speculated III are 16, 0.5 and 0.3 per 1000 population for 1985 above that a deficit of females among diagnostic X ray 1990. There is a conspicuous variation between coun patients at health care levels IIIV could reflect cultural tries within each level of health care. This is shown in differences between countries. Such differences appar ently do not apply to diagnostic nuclear medicine.
Chest radiography Chest photof Uterography Chest fluoroscopy Chest radiography Chest photofluorography Chest fluoroscopy

20 30 40 Mean age (y) Level I ESLevelll HLevel III

80 100 40 60 Females (%) Level I ESLevelll HLevel III

20

Figure 3. Mean age of patients subjected to some common X ray examinations, 19851990. Sorted by Health Care Levels (Levels as in Figure 1). 87

Figure 4. Percentage of females among patients subjected to some common X ray examinations, 19851990. Sorted by Health Care Levels (Levels as in Figure 1).

J. VALENTIN Nuclear medicine is costly and available only to a small subset of the population, so it is not impossible that a difference exists between diagnostic X rays and diag nostic nuclear medicine. Average effective dose equivalents for some common
GI lower Angiography

!:!:!:!:!:!:!:!:!:i:5

nuclear medicine examinations in 19851990 are shown in Figure 10. Lack of information precludes adding a time dimension to the diagram. However, many of the examinations listed can be performed with different radiopharmaceuticals, causing vastly different doses. Hence, two values of average dose are given for each examination. The 19851990 average annual per caput H E for Bone Cardiovascular Lung perfusion Thyroid scan Liver/spleen Renal Lung ventilation

:::v:v::::::::::::::::::::::::::::::::::::::x:x::::::::::::::::::::::: *S:?SS??i Urography Lumbosacral Cholecystography Pelvis Abdomen Mammography Chest fluoroscopy Hip/femur Chest photo fluorography Skull Chest radiography Extremities

" ' " " " " "

nMHMU

8 4 6 He(mSv) SLevel I HLevel I 19701980 19801990

1 2

,
10

Thyroid uptake Brain 0.001 0.01 0.1 1 Number per 1000 population 10

Figure 5. Mean effective dose equivalent (HE) to patients sub jected to some common X ray examinations in countries of Health Care Level I (Levels as in Figure 1). Sorted by time period.
FR Germany Belgium USA Luxembourg Czechoslovakia Denmark Kuwait Canada Sweden Argentina Netherlds Norway Japan Australia New Zealand Italy France Yugoslavia Romania Turkey Jamaica Brazil Iraq Barbados Tunisia Ecuador China India Peru Egypt Sudan Thailand Myanmar Ethiopia

Level I HLevel II Level III Figure 7. Frequency of some common nuclear medicine exam inations, 1990. Sorted by Health Care Levels (Levels as in Figure 1). Bone Brain Cardiovascular Liver/spleen Lung ventilation Lung perfusion Renal Thyroid scan Thyroid uptake

0.01

10 0.1 1 Number per 1000 population Level I

100 I Level I

20 30 40 Mean age (y) LULevel II HLevel ! Figure 8. Mean age of patients subjected to some common nuclear medicine examinations, 19851990. Sorted by Health Care Levels (Levels as in Figure I).

3Level II HLevel lllIV

Figure 6. Frequency of nuclear medicine examinations in dif ferent countries, 19851990. Sorted by Health Care Levels (Levels as in Figure 1).

UNSCEAR DATA ON MEDICAL RADIATION USAGE diagnostic nuclear medicine as a practice amounts to effective dose to radiotherapy patients, calculated from 0.09, 0.008, 0.008 and 0.008 mSv at health care levels doses in nontarget organs. These calculations are based I, II, III and IV. The collective doses are 0.13, 0.02, on extensive work of Williams et al02) as summarised 0.006 and 0.004 million man Sv. The average annual by ICRP<13). The numerical results are somewhat tenta per caput dose for the entire world is 0.03 mSv tive, but indicate the order of magnitude of the doses. (collective dose = 0.16 million man.Sv). In other words, The 19851990 annual average effective doses per the impact of diagnostic nuclear medicine is about 10% caput from tele and brachytherapy are estimated to be of that of diagnostic X rays. 0.73, 0.18, 0.03 and 0.02 mSv at health care levels I, II, III and IV. The collective doses are 1, 0.5, 0.03 and 0.01 million man.Sv. The worldwide average is 0.3 mSv RADIOTHERAPY corresponding to 1.5 million man.Sv. In other words, Radiotherapy differs from diagnostic medical radi the average dose from radiotherapy is similar to that ation uses in that delivering a dose to the patient is not from diagnostic X rays and an order of magnitude big a means but the objective. Quite high doses are given ger than that from diagnostic nuclear medicine. Thera to kill cancer cells. Relatively high doses occur also out peutic nuclear medicine adds negligibly to these figures. side the tumour being irradiated. Thus, patients surviv The annual average per caput effective dose must be ing after treatment run a tangibly increased risk of iatro interpreted keeping the sharply bimodal dose distri genic cancer. bution in mind. No patient gets a dose which is even Alternative treatment regimes are also potentially remotely similar to the arithmetical per caput average lethal and, in the case of chemotherapy, carcinogenic. of therapy patients and untreated persons. In the absence of any treatment at all, the patient would face almost certain death. Nevertheless, there are reasons to try to assess the deleterious side effects of CONCLUSION radiotherapy. One reason is the very success of cancer The current annual average effective dose per caput therapy: with increasing survival times for cancer pati due to medical exposures worldwide is some 0.6 mSv. ents, second cancers become manifest more frequently. Half of this dose comes from brachy and teleradiother Even if this is an unavoidable result of indispensable apy. The remainder, from diagnostic procedures, is treatment, it is of interest to compare doses with those dominated by X ray examinations, with nuclear medi encountered in other situations. cine examinations contributing a few per cent to the For these and other reasons, UNSCEAR has decided for the first time to include in its 1993 Report'7' the

Bone Brain Cardiovascular Liver/spleen Lung ventilation Lung perfusion Renal Thyroid scan Thyroid uptake 20 I Level I 80 40 60 Females (%) OLevel II SLevel 100 Thyroid uptake 0 10 20 HE (mSv) HLow HE 30 40

HighH E

Figure 9. Percentage of females among patients subjected to some common nuclear medicine examinations, 19851990. Sorted by Health Care Levels (Levels as in Figure I). 89

Figure I0. Mean effective dose equivalent (HE) to patients sub jected to some common nuclear medicine examinations in countries of Health Care Level I (Levels as in Figure 1). 'Low HE' = using radiopharmaceuticals causing low doses; 'High HE' = using radiopharmaceuticals causing high doses.

J. VALENTIN total. The worldwide average conceals variation spanning two orders of magnitude in that annual per caput doses range from 1.8 mSv for countries of health care level I to 0.07 mSv for level IV countries. The detriment associated with these doses cannot be directly derived using the conventional risk factors of ICRP (8 - 9) , and UNSCEAR (7) provides no alternative calculation of detriment. However, it is in principle possible to calculate a suitably adjusted detriment. For diagnostic examinations, this will be of the order of 6 0 - 7 0 % of the detriment that a worker would have suffered from a similar occupational dose. For radiotherapy, the detriment could perhaps be of the order of 25% of that connected to a similar occupational dose. In the author's opinion, dose surveys are important REFERENCES 1. UNSCEAR. Report of the United Nations Scientific Committee on the Effects of Atomic Radiation. Official Records of the General Assembly, Thirteenth Session, Suppl 17 (A/3838) (New York: UN) (1958). 2. UNSCEAR Report of the United Nations Scientific Committee on the Effects of Atomic Radiation. Official Records of the General Assembly, Seventeenth Session, Suppl 16 (A/5216) (New York: UN) (1962). 3. UNSCEAR. Ionizing radiation: Levels and Effects. United Nations Sales Publication E.72.IX.17 and 18 (New York: United Nations) (1972). 4. UNSCEAR. Sources and Effects of Ionizing Radiation. United Nations Sales Publication E.77.IX.1 (New York: UN) (1977). 5. UNSCEAR. Ionizing Radiation: Sources and Biological Effects. United Nations Sales Publication E.82.IX.8 (New York: UN) (1982). 6. UNSCEAR. Sources, Effects and Risks of Ionizing Radiation. United Nations Sales Publication E.88.IX.7 (New York: UN) (1988). 7. UNSCEAR. Sources and Effects of Ionizing Radiation. United Nations Sales Publication E.94.IX.2 (New York: UN) (1993). 8. ICRP. Recommendations of the International Commission on Radiological Protection. ICRP Publication 26 (Oxford: Pergamon) Ann. ICRP 1(3) (1977). 9. ICRP. 1990 Recommendations of the International Commission on Radiological Protection. ICRP Publication 60 (Oxford: Pergamon) ICRP 21(1-3) (1991). 10. Valentin, J. and Webb, G. A. M. Medical Uses of Radiation: Retaining the Benefit but Recognising the Hann. In: Radiation Protection on the Threshold of the 21st Century. Proceedings of an NEA Workshop. Ed. O. Ilari, pp. 105-122 (OECD, Paris) (1993). 11. Beentjes, L. B. and Timmermans, C. W. M. Patient Doses in the Netherlands. Radit. Prot. Dosim. 36(2/4), 265-268 (1991). 12. Williams, G , Zankl, M. and Drexler, G. The Calculation of Dose from External Photon Exposures using Reference Human Phantoms and Monte Carlo Methods 4. Organ Doses in Radiotherapy. GSF-Report S-1054 (1984). 13. ICRP. Protection of the Patient in Radiation Therapy. ICRP Publication 44 (Oxford: Pergamon) ICRP 15(2) (1985). because they provide a standard to which doctors, departments, hospitals or countries may compare their own results. Audits based on such comparisons permit identification of problems, planning of remedial action and sometimes even immediate rectification of the situation. The quick growth of computed tomography in conjunction with the increasing doses per examination indicates that more responsibility may have to be placed on those proposing or introducing new techniques to assess the level of exposure in advance, and accompany the introduction of the technique with appropriate measures to ensure that it is used only when clinically justified and that the resulting doses are as low as reasonably achievable.

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Radiation Protection Dosimetry Voi. 57, Nos 1-4, pp. 91-94 (1995) Nuclear Technology Publishing

IEC PROJECTS AND ACHIEVEMENTS IN THE FIELD OF QUALITY ASSURANCE IN DIAGNOSTIC RADIOLOGY
W. Puschert Philips Medizin Systeme Rntgenstrae 24 DE-22331 Hamburg, Germany INVITED PAPER Abstract Since its foundation in 1968, IEC Technical Committee 62 'Electrical equipment in medical practice' and its subcommittees have issued about 60 publications, most of them dealing with safety requirements for equipment. These safety requirements cover all aspects of safety, not only as often supposed, electrical and mechanical safety. For example, requirements for protection against excessive temperatures, abnormal operation and fault conditions as well as protection against hazards from unwanted or excessive radiation are also included. Two main parts of these comprehensive activities will be presented: (1) Radiation protection by preventive measures incorporated into medical electrical equipment. For patients or occupationally exposed persons, exposure to ionising radiation may exceed tolerable limits established for a member of the public, therefore the following measures have to be considered: (a) adequate provisions have to be made to protect patient, operator and other persons; (b) tolerable limits for equipment intended to emit radiation are specified in Collateral and Particular Standards; and (c) tolerable limits for equipment emitting unwanted X radiation are specified in a General Standard and in Particular Standards. (2) Quality assurance programmes which describe methods and provide guidelines for individual items of equipment or systems of equipment used in medical imaging departments. Test methods to be carried out on the user's responsibility will be described to achieve and maintain: (a) radiological information of adequate quality for medical diagnostic purposes; (b) minimum radiation dose to patients and medical staff, compatible with adequate quality of the radiological information; and (c) maximum cost containment by minimising wastage of time and resources (e.g. by reducing the number of rejected radiograms). Special emphasis will be placed on mutual effects between these main parts. RADIATION PROTECTION Means for radiation protection are often incorporated into medical electrical equipment. In the following, other aspects of radiation protection will also be included. Within medical electrical equipment, the high voltage generator is a first component in the imaging chain necessary for the generation of X radiation. Very important for secondary radiation protection aspects is that its safety related performance, especially the accuracy of operating data, is within required tolerance levels, and that it is well protected against incorrect output. These requirements, including linearity and reproducibility, are given in the Particular Standard IEC 601-27 ( ". The next component in this imaging chain will be the X ray tube. For both quality assurance and radiation protection, a good knowledge of the relevant performance like characteristics of focal spots, electrical, thermal and loading characteristics as well as the maximum symmetrical radiation field is a pre-requisite and described in IEC 336(2>, IEC 613 ,3) and IEC 806(4). The X ray tube housing and the beam limiting device complete the X ray source assembly, together with the high voltage generator described above complete the X ray generator. Now, if X radiation can be produced, the requirements of the future Collateral Standard IEC 60191 l-3<5), General requirements for radiation protection in diagnostic X ray equipment, are applicable. This standard will partly (not for thereapeutic equipment) supersede IEC 407(6) and was circulated as Draft International Standard (DIS) 62B (Central Office) 111. As this DIS has been accepted, IEC 601-1-3 will be published soon. The object of this Collateral Standard is to establish general requirements for protection against ionising radiation in medical diagnostic X ray equipment, in order that the dose equivalent to the patient, the operator and other staff can be kept as low as reasonably achievable. The requirements in this Collateral Standard apply mainly in respect of X radiation after its generation. Requirements for the control of the electrical energy used to generate X radiation, which is also an important aspect of radiation protection, are included in the General Standard IEC 601-1(7) and in Particular Standards for the safety of the equipment concerned, as described before. Within this very important Collateral Standard, all aspects are covered concerning: (i) radiation quality, (ii) limitation and indication of the extent of the X ray beam, (iii) relationship between X ray field and image reception area,

W. PUSCHERT (iv) leakage radiation, (v) focal spot to skin distance, (vi) primary protective shielding, and (vii) protection against stray radiation. Aspects such as inherent filtration and antiscatter grids are described in IEC 522l8) and IEC 627(9). More direct radiation protection aspects are related to protective clothing, protective glass plates and the determination of the attenuative properties of materials, extensively developed in document 62B (Central Office) 70<IO>. The last step related to radiation protection aspects is the high efficiency detection of the X ray pattern, either in radioscopy or radiography mode. As expressed earlier, an excellent knowledge of all performance characteristics of the detector system is indispensable, given in the International Standards IEC 520' n) , IEC 572' l2) , IEC 573<,3) and IEC 858(l4>, superseded soon by the IEC 1262-series05', describing in seven parts the characteristics of electro-optical X ray image intensifiers for radioscopy, and in IEC 406" 6) and IEC 658 (l7) as accessories for radiography. A new work item proposal circulated recently deals with interventional radiology, especially with the need to minimise absorbed dose by using digital storage techniques and cine-view of radiological images. To test the performance, the protective characteristics and the quality of all these items of equipment, standardised radiation qualities and conditions are needed. These conditions are contained in the future IEC 1267(,8), at present 62B (Central Office) 110. Only the most important aspects of radiation protection in the diagnostic imaging chain could be noted here. Nevertheless, relevant requirements of about 20 IEC Standards were cited for testing compliance with them. After manufacturing all these items of equipment with high quality and in compliance with the applicable standards, the installed and assembled medical electrical system will be delivered up to the responsibility of the user or operator. All the necessary actions following this step are described in the next section on quality assurance. QUALITY ASSURANCE In recent years, quality assurance programmes have been initiated in several countries mostly on a local basis, sometimes on a national level with the purpose of accepting a radiological installation or either maintaining or improving the quality of daily operations in diagnostic X ray departments. In so far as these operations depend on the use of equipment, and as part of an international effort towards a more uniform approach in this field, the IEC issues General and Particular Publications within the IEC 1223 series"9' (part 1 for general aspects, part 2 for constancy tests and part 3 for acceptance tests), which describe 92 the methods and provide the guidelines for establishing quality assurance programmes for individual items of equipment or systems of equipment in a diagnostic X ray department. An effective quality assurance programme will help to achieve and maintain: (a) radiological information of adequate quality for medical diagnostic purposes; (b) minimum radiation dose to the patient and medical staff, compatible with adequate quality of the radiological information; and (c) maximum cost containment by minimising wastage of time and resources. Benefits arise also through the enhancement of the professional and public reputation of the department. The Particular IEC Publications describing guidelines for establishing effective quality assurance programmes are concerned with test methods for monitoring the imaging performance of equipment. To encourage the adoption of these test methods, in a large number of diagnostic X ray departments, emphasis is placed upon test methods suitable to be carried out by operators involved in the daily use of the equipment. Effective activities for quality assurance depend on quality administrative elements as well as on quality control techniques. Quality administrative elements ensure that (a) testing is done by qualified personnel to an effective schedule; (b) test results are analysed to determine whether problems exist; and (c) appropriate corrective action is undertaken where necessary. Quality control techniques comprise physical testing and monitoring of the functional performance of the equipment in order to determine whether or not corrective action is needed to adjust the equipment to maintain the desired quality of the radiological information. The user is responsible for preventive and corrective maintenance of the equipment in the diagnostic X ray department. A quality assurance programme involves a continuous evaluation of the adequacy and effectiveness of quality control. Both the quality assurance programme and quality control should be reviewed and adjusted as appropriate to maintain continued effectiveness. The technical report IEC 1223-l(l9), 'General aspects', applies to equipment and sub-assemblies forming those constituent components of diagnostic X ray installations that generate, influence the propagation of, and detect the X radiation, and process, store and present the radiological information. It presents the concept of quality assurance in diagnostic X ray departments and introduces a series of test methods to be carried out under the responsibility of the user. The test methods introduced here are solely concerned with monitoring

QUALITY ASSURANCE IN DIAGNOSTIC RADIOLOGY the constancy of functional performance of equipment The results of all subsequent constancy tests are comand associated equipment by means of test instrumen- pared with these baseline values. Each result of a constancy test is related to estabtation and test devices that are simple to use. The test methods are not intended to deal with aspects of safety, lished criteria. Taking into account the foreseen applisuch as mechanical and electrical safety, except where cation of the equipment, applicable legal requirements, the intended function of the equipment or devices is to and the guidance in the Particular International Stanprovide safety. The individual test methods for quality dards, the user has to establish: control are described in, and published as, separate (a) the administrative measures to be followed; Particular IEC Publications. The individual tests carried (b) the values of the functional parameters to be used; out in a diagnostic X fay department shall be linked to and those aspects of a quality assurance programme which (c) other conditions to be observed for carrying out the are described in this technical report. constancy tests. It is not intended to cover matters of clinical judgeFollowing practical experience, established criteria ment in the management of the patient. may have to be adjusted in order to be more appropriate Within the broad field of quality assurance, quality control and quality administration, there is increased under given conditions. The established criteria concern and awareness among users, manufacturers and employed may vary with the type of equipment involved. Action shall be taken when results do not meet competent authorities of the need for optimal use of the established criteria. resources and for ensuring that radiological information of adequate quality is produced in a diagnostic X ray department, taking the radiation dose to the patient into CONCLUSION account. Part 2 of IEC.1223 series"91 emphasises quality As demonstrated, design, construction and manufaccontrol techniques and activities that monitor the con- turing of medical electrical equipment or systems is stancy of the functional performance of the equipment. covered by many IEC Standards, the most important These techniques and activities should be carried out being IEC 601-1(7) with all applicable Collateral and after the user is satisfied that the functional performance Particular Standards. of the diagnostic X ray installation is acceptable (e.g. After assembly and installation of equipment, conthat it complies with the contractual specification, see stancy tests according to part 2 of IEC 1223"9) will part 3 of IEC 1223"9') Prior to starting a series of con- maintain or improve the quality of daily operation in stancy tests, the functional status of a diagnostic X ray diagnostic X ray departments. installation has to be established and documented. The Acceptance tests according to part 3 of IEC 1223([9) results of the initial constancy test, or of the first series indicate the point of intersection between the interests of initial constancy tests, constitute the baseline values. of users and manufacturers.

REFERENCES

1. IEC 601-2-7. Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High-voltage Generators of Diagnostic X-ray Generators (1987). 2. IEC 336. X-ray Tube Assemblies for Medical Diagnosis Characteristics of Focal Spots (1993). 3. IEC 613. Electrical, Thermal and Loading Characteristics of Rotating Anode X-ray Tubes for Medical Diagnosis (1989). 4. IEC 806. Determination of the Maximum Symmetrical Radiation Field from a Rotating Anode X-ray Tube for Medical Diagnosis (1984). 5. IEC 601-1-3. Medical Electrical Equipment Part I: General Requirements for Safety 3. Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment ( 1994). 6. IEC 407. Radiation Protection in Medical X-ray Equipment 10 kV to 400 kV (1973). 7. IEC 601-1. Medical Electrical Equipment Part 1: General Requirements for Safety (1988). 8. IEC 522. Inherent Filtration of an X-ray Tube Assembly (1976). 9. IEC 627. Characteristics of anti-scatter grids used in X-ray Equipment (1978). 10. IEC 62B (Central Office) 70. Protective Devices (1987). 11. IEC 520. Entrance Field Sizes of Electro-optical X-ray Image Intensifiers (1975). 12. IEC 572. Determination of the Luminance Distribution of Electro-optical X-ray Image Intensifiers (1977). 13. IEC 573. Measurement of the Conversion Factor of Electro-optical X-ray Image Intensifiers (1977). 14. IEC 858. Determination of the Image Distortion of Electro-optical X-ray Image Intensifiers (1986). 93

W. PUSCHERT 15. IEC 1262. Medical Electrical Equipment Characteristics of Electro-optical X-ray Image Intensifiers Part 1: Determination of the Entrance Field Size (1994). Part 2: Determination of the Conversion Factor (1994). Part 3: Determination of the Luminance Distribution and Luminance Non-uniformity (1994). Part 4: Determination of the Image Distortion (1994). Part 5: Determination of the Detective Quantum Efficiency (1994). Part 6: Determination of the Contrast Ratio and Veiling Glare Index (1994). Part 7: Determination of the Modulation Transfer Function (to be published). 16. IEC 406. Radiographic Cassettes (1975). 17. IEC 658. Radiographic Intensifying Screens for Medical Use Dimensions (1979). 18. IEC 1267. Medical Diagnostic X-ray Equipment Radiation Conditions for Use in the Determination of Characteristics (1994). 19. IEC 1223. Evaluation and Routine Testing in Medical Imaging Departments Part 1: General Aspects (1993). Parts 2: Constancy Tests (1993, 1994). Parts 3: Acceptance Tests (to be published).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 9599 (1995) Nuclear Technology Publishing

RESULTS OF THE IA EA CEC COORDINA TED RESEA RCH PROGRAMME ON RA DIA TION DOSES IN DIA GNOSTIC RADIOLOGY A ND METHODS FOR REDUCTION
P. Ortiz'", C. Maccia<2), R. Padovani"', E. Va(4', G. A . Carlsson5' and H. Schibilla'6'* '"International A tomic Energy A gency, Wagramerstrasse 5 PO Box 100, A1400 Vienna, A ustria (2 'Centre de d'A ssurance de Qualit des A pplications Technologiques dans le Domaine de la Sant INSERM Unit 240, A v. A ristide Briand 165, F94230 Cachan, France "'Instituto de Fisica Santaria, Ospedale Sta. Maria della Misericordia USL7, 133100 Udine, Italy '"Ctedra de Fsica Mdica, Facultad de Medicina Universidad Complutense, 28040 Madrid, Spain "'Department of Radiation Physics, Faculty of Health Sciences Linkping University, S581 85 Linkping, Sweden l6 'Commission of the European Communities Directorate General XII, Radiation Protection Research A ction Rue de la Loi 200, 1049 Brussels, Belgium Abstract In 1991, a Coordinated Research Programme on assessment of radiation doses in diagnostic radiology and studying methods for reduction was started in IAEA Member States in cooperation with the CEC Radiation Protection Research Action. It was agreed to carry out a pilot exercise consisting of assessing patients' Entrance Surface Doses, followed by: analysis of the relevant parameters; quality control and corrections, and reassessment of doses where applicable. The results show that dose reduction was achieved without deterioration of the diagnostic information of the images, by applying simple and inexpensive methods. INTRODUCTION Radiation doses from diagnostic radiology are the largest contribution to the collective dose from all man made sources of radiation'". Because most procedures causing medical exposures are clearly justified and because the procedures are usu ally for the direct benefit of the exposed individuals, less attention has been given to the optimisation of pro tection in medical exposures than in most applications of radiation sources (ICRP 60)'2'. In addition to this expression of concern by ICRP, two other statements are essential to an understanding of the subject'2': (1) Dose differences of up to two orders of magnitude for the same type of examination have been reported in diagnostic radiology. (2) Consideration should be given to the use of dose constraints, or investigation levels, selected by the appropriate professional or regulatory agency, for application in some common diagnostic procedures and that they should be applied with flexibility to allow higher doses where indicated by sound clini cal judgement. The first statement suggests that there must be large scope for dose reduction not necessarily associated with high investments. Simple, low cost, methods for dose reduction can be used without loss of diagnostic infor mation: by reviewing the parameters influencing the dose, a list of these methods is easily obtained. In prac tice, the variety of combinations of these parameters, and differences in the equipment, films and film pro cessing conditions available in each particular X ray room, justify a casebycase exercise. The second statement suggests comparing actual doses with some guidance or reference levels, and to investigate their applicability to different countries under different conditions. This action is relevant to the establishment of general recommendations. Such a review process can provide 'knowhow' and first hand experience to the participants and create awareness and motivation in the radiology staff involved. In addition, a number of requests for IA EA 's Technical Cooperation projects as well as for research contracts on dose assessment, dose reductions and quality control in diagnostic radiology have been received by the IA EA from its Member States during recent years. For all these reasons, it was considered convenient to optimise efforts and resources by conducting a Coordi 95

*In collaboration with: J. Skvarca (Argentina), A. M. Campos de A rajo (Brazil), O. Kodl and I. Zacharisov (Czech Republic), W. Mengesha (Ethiopia), C. Schandorf (Ghana), M. Sohrabi (Iran), C. Milu (Romania), A . Benini (IA EA ), B. M. Moores (UK), W. Panzer (Germany).

P. ORTIZ, C. MACCIA, R. PADOVANI, E. VANO, G. A. CARLSSON and . SCHIBILLA nated Research Programme on Radiation Doses in Diagnostic Radiology and Methods for Reduction and to include this pilot study in the IAEA's programme. Since 1987, the CEC, under its Radiation Protection Research Action, had been running a number of projects on dose assessment (some examples in Refs 3-6) and developing dose reference levels and image quality criteria for common diagnostic examinations'7-"", which provided good background material for the programme. Therefore, the Coordinated Research Programme (CRP) was launched in cooperation between the IAEA and the CEC. In future projects, it is expected that this cooperation will be extended to other agencies. The fact that most radiological examinations (70%) are performed in health care level I countries"" (WHO classification), does not reduce the usefulness of the exercise in developing countries. Dose reduction without loss of diagnostic information implies a successful process of optimisation and quality assurance which leads to an improved used of the available X ray equipment and film. METHODOLOGY The exercise has been completed in seven countries: Argentina, Brazil, Czech Republic, Ethiopia, Ghana, Iran and Romania. It was restricted to the most common examinations: one single field size and projection per examination was chosen as a common part for all participants: chest and abdomen (abdomen simple, pelvis, LS). Mammography and others were studied in only some of the countries. For each examination, only a few rooms per participant were selected which were not included in any previous quality control programme. The indicator used for comparison and assessment of dose reduction was the patient entrance surface dose (ESD) with backscatter. The absorbed dose was calculated for striated muscle (except for mammography, where the ESD is referred to air), so as to be consistent with the reference values of patient entrance surface dose used by the CEC for patients of 70 3 kg. Those values are 0.3 mGy for chest PA and 10 mGy for the abdominal region /AP'9'. The value of 7 mGy for ESD for mammography given in Ref. 9 is currently under revision. There is a trend to use absorbed dose in air (or air kerma) as an indicator instead of absorbed dose to muscle as TLDs are usually calibrated in a manner which is traceable to a primary standard of air kerma"2': however, the numerical differences are not significant for this exercise in dose reduction. The measurements were made with a TLD stuck on the patient at the centre of the beam entrance. The TLDs were calibrated at the laboratory of the National Institute of Public Health of Prague, being exposed to different beam qualities (25, 60, 80, 120W and l37Cs) and different air kerma (0.1, 1, 5 and 50 mGy). The procedure for assessing the dose reduction was 96 simple: initially, a first set of measurements of the ESD was made and the relevant parameters were collected. All these data were analysed and compared with the CEC reference values. This exercise allowed the participants to identify the major problems. Secondly, a quality control programme was performed followed by modifications of the parameters, where appropriate and possible. Finally, a second set of measurements allowed for the evaluation of the reduction in the ESD, where applicable. In order to ensure that the reduction of the ESD did not result in a deterioration of the diagnostic information of the image, the CEC Quality Criteria for Diagnostic Radiographic Images were used by the field radiologists to perform a score of their own images. RESULTS AND DISCUSSION Calibration of the TLDs The results of the calibrations of the TLDs influence the selection of a threshold for the dose differences to be considered as real changes. At the level of 1 mGy the standard deviation was <15%, while it increased to 33% (in one case up to 54%) at the level of 0.1 mGy (chest). In addition to that, it was not possible to achieve the required uniformity in patient weight and thickness. For these reasons, dose differences lower than 20% between the first and second set of measurements were not considered as real reductions. Values of patient entrance surface dose The final results show reductions in 33 of the cases (rooms and/or examination type) between 21 and 84% in patient entrance surface dose. These average reductions, broken down by causes, are summarised in Table 1. More detailed results on dose reduction classified by X ray room and type of examination are given in the Appendix. It is worth noting that not all methods for reduction Table 1. Results of different dose reduction actions.
Method for dose reduction used % of X ray Average rooms where the reduction of the ESD (%) method for reduction was used 15 30 30 6 51 54 48 57

Increased filtration Increased tube potential Increased screen-film sensitivity Reduced mA.s*

*When the optical density of the film was too high.

lAEA-CEC COORDINATED RESEARCH PROGRAMME of the entrance surface dose influence the effective dose Comparison of the measured ESD with the dose in the same proportion. From this point of view, the reference levels methods can be grouped into two categories: With regard to the worldwide applicability of Refer(1) Methods leading to a pure reduction of the mA.s ence Values for ESD, it is of interest to show the perwithout modification of the beam quality (e.g. centage of rooms/examinations in which the ESD values improving the film developing conditions, reducing were below the Reference Values used in the present the optical density of the film or increasing the sen- work. This is shown in Table 2. The second column sitivity class of the film-screen combination). In shows the percentage of cases before the quality control these cases, the reduction of the entrance surface exercise and the third column shows the percentage dose implies a reduction of the effective dose by the after QC. same factor since the relative dose distribution does It appears that for examinations in the abdominal not change. area, the compliance with the reference levels can be (2) Methods leading to a modification of the dose distri- achieved easily in all participating X ray departments bution within the patient by modifying the beam of the different countries. The same applies for mamquality (kV and/or filtration). In these cases, the mography in the two countries where this examination penetration and scattering inside the patient are was studied. changed and, therefore, the reduction of the In the case of chest PA, the Reference Value for ESD entrance surface dose does not imply a reduction in of 0.3 mGy was defined for 'high kV technique', (which effective dose by the same factor. In addition, a is considered well established and advisable for chest large variation of the distance from the X ray tube examinations) and therefore for high penetration of the to the patient also modifies the dose distribution. A X ray beam. Most of the hospitals participating in this shorter distance leads to a higher ESD, (given the exercise used 'low kV technique' thus leading to a same optical density to the film), which becomes higher entrance surface dose even after quality control. critical when the focus-patient distance decreases In summary, it seems that it is possible to develop down to 50 cm or less. reference values for wide application for common Conversely, the effective dose can be influenced examinations and use them as investigation levels. For by the field size without necessarily modifying the the chest it is necessary to specify that the reference ESD once the field size is large enough to reach values apply only for 'high kV technique' and will often saturated scatter condition. be exceeded when the 'low kV technique' is used. With regard to mammography, the gland dose can also be used as an indicator and for comparison with reference values. Conversion factors from ESD to gland dose for different beam qualities and breast thickness are given in Rosenstein et /"3'. Since, for this exercise, the CEC indicators and reference values were taken (referred to 4.5 cm compressed breast), the actual thickness is to be taken into account when compared with the reference values. As an example, the average thickness in Iran, hospital/room number 2/2, was only 3 cm. Image quality assessment The CRP exercise also included an evaluation of the image quality through the use of the image quality criteria defined in the CEC working document. For practical reasons, it was not possible to get and analyse centrally either individual radiographic films or the individual answers provided by the field radiologist for each examined patient. (However, the images produced

Table 2. Compliance with CEC dose reference value.


First set of measurements Examination type X-ray rooms complying with CEC dose reference value for ESD (%) 20 100 29 75 0 Second set of measurements CEC reference values for ESD (mGy) X-ray rooms complying with the reference value for ESD

(%)

Lumbar spine (PA) Pelvis Chest (PA) Abdomen Breast

75 100 36 100 100

10 10 0.3 10 7*

*Dose measured with grid.


97

P. ORTIZ. C. MACCIA, R. PADOVANI. E. VANO, G. A. CARLSSON and . SCHIBILLA in each X ray department were scored by the field radiologists according to these criteria.) Therefore, general considerations are made hereafter concerning the image quality evaluation and their compliance with the image quality criteria, based on this score. The field radiologists used a qualitative rating: poor, satisfactory and good. Such a rating system was applied to each image criterium for each examination type and was mostly performed after the second set of measurements. Almost all images were declared by the field radiologists as satisfactory and fulfilling most of the criteria. Concerning chest examinations, two specific criteria were particularly difficult to be seen. (Criterion 5: Reproduction of the vascular pattern in the whole lung, particularly the peripheral vessels. Criterion 6: Visually sharp reproduction of (a) the trachea and proximal bronchii, the borders of the heart and aorta, and (b) the diaphragm and costo-phrenic angles.) It is interesting to note that the same finding was obtained in the 1991 CEC image quality criteria trial and this confirms the need for improving the wording of these two criteria in order to avoid any ambiguity in their interpretation. This exercise has demonstrated that it is possible to achieve significant reduction of the ESD without introducing deterioration of the diagnostic information of the image as appreciated by the radiologists by scoring with the CEC quality criteria for diagnostic examination. CONCLUSIONS The exercise has confirmed that there is, in general, considerable scope for dose reduction in diagnostic radiology in any place, and that simple and low cost methods can be used to achieve significant dose reductions, without loss of diagnostic information of the X ray images. Reference doses values can be valid worldwide for common examinations. Furthermore, it has been shown that it is possible and advisable to choose investigation levels which can be widely applicable, if they are frequently exceeded for standard sized patients. The exercise has proven to be valuable as a self-learning process for those taking part and has provided them with hands-on experience, which can also add effectiveness to practical training programmes. This kind of pilot exercise could be considered a good and cost effective start for national projects on radiation protection and quality assurance in diagnostic radiology. Awareness gained through these pilot exercises should contribute to a better use of TC assistance and improve the safety and duration of X ray equipment, all of which is particularly essential for developing countries. In conclusion, despite some practical limitations inside the pilot project, and the obvious difficulties connected to the starting of a new programme in countries from different continents and with different levels of radiological and radiation protection infrastructures, the results have shown that it is possible to achieve dose reduction at little or no cost. The basis has been established for a wider approach to the problem of patient dose reduction in diagnostic radiology.

APPENDIX Dose Reductions achieved by Country, Hospital, Room and by Examination Type
Country Hospital/Room Argentina 1/1 Examination and Projection Chest Method Reduction Country Hospital/Room Brazil 2/6 Examination and Projection Method Reduction

(%)
Increased filtration Increased filtration + increased kV Screen-film with higher sensitivity Increased kV Increased kV 29

(%)
47

Argentina 2/3 Czech 2/2 Ethiopia 1/1 Ethiopia

Chest Chest Chest Chest

28 72 26 75

Czech 2/1 Czech 3/1 Argentina 1/4 Brazil 1/3

Lumbar spine Screen-film AP/PA with higher sensitivity old-new Lumbar spine Screen-film with higher AP sensitivity Lumbar spine Screen-film with higher sensitivity Increased Abdomen filtration Abdomen Screen-film with higher sensitivity

56 56 35 22

98

lAEACEC COORD INATED RESEARCH PROGRAMME Country Hospital/Room Ghana 5/1 Ghana 6/1 Iran 1/1 Iran 1/2 Iran 1/3 Romania 1/1 Czech 2/1 Czech 3/1 Czech 3/2 Brazil 1/8 Examination and Projection Chest Method Reduction Country Hospital/Room Brazil 2/10 Brazil 3/2 Iran 1/1 Iran 1/2 Iran 1/3 Iran 2/4 Romania 1/4 Argentina 3/5 Argentina 3/6 Iran Examination and Projection Abdomen Abdomen Abdomen Abdomen Abdomen Abdomen Abdomen Breast Breast Breast Method Reduction

(%)
49 58 79 65 74 23 38 51 48 70

(%)
Increased filtration Increased filtration Increased kV Increased kV Increased kV Increased kV Reduced mA.s* Screenfilm with higher sensitivity Screenfilm with higher sensitivity Increased kV 60 84 43 27 65 28 50 32 37 21

Screenfilm with higher sensitivity Chest Screenfilm with higher sensitivity Chest Increased kV Increased kV Chest Increased kV Chest Increased kV Chest Screenfilm Pelvis A P with higher sensitivity Pelvis A P Screenfilm with higher sensitivity Pelvis A P Screenfilm with higher sensitivity Lumbar spine Screenfilm AP/PA with higher sensitivity oldnew

*Reduced mA .s due to too high optical density of the film.

REFERENCES 1. United Nations. Scientific Committee on the Effects of Atomic Radiation (UNSCEAR). (New York: UN) (1988). 2. International Commission on Radiological Protection (ICRP). 1990 Recommendations of the International Commission of Radiological Protection, Publication 60 (Oxford: Pergamon Press) (1991). 3. Commission of the European Communities (CEC). Radiation Protection Progress Report 19851989. Rep. EUR 13268, Vol.3, pp. 31833347 (1991). 4. Commission of the European Communities (CEC), Radiation Protection Progress Report 19901991. Rep. EUR 14927, pp. 12911400 (1993). 5. Van, E., Gonzlez, L., Calzado, ., Delgado, V. and Moran, P. Some Results of Patient Dose Survey in the Area of Madrid. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores, B. F. Wall, . Eriskat and . Schibilla. BIR Report 20, pp. 180185 (London: British Institute of Radiology) (1989). 6. Van, E Gonzlez, L., Calzado, ., Delgado, V., Moran, P., Chevalier, M., Gulbelaide, E., Ortiz, P., Marin, M. and Ruiz, M. J. Optimization of Protection in Medical D iagnostic Radiology. Final Report. Progress Report Radiation Protection Pro gramme, 198589, Vol.3, pp. 33473357, CECEURA TOM, EUR 13268 (Brussels: CEC) (1991). 7. D osimetry in Diagnostic Radiology. Proceedings of the Seminar, jointly organised by the CEC, the PhysikalischTechnische Bundesantalt, Braunschweig (FRG), the World Health Organisation and the International Commission on Radiation Units and Measurements held in Luxembourg (L), 1921 March 1991. Eds H. M. Kramer and K. Schnuer. Report EUR 14180. Radit. Prot. Dosim. 43(14) (1992). 8. Maccia, C , Moores, . M., Nahrstedt, U., Padovani, R. and Wall, B. CEC Quality Criteria for D iagnostic Radiographic Images and Patient Exposure Trial (1988), Report EUR 12957 (1990). 9. Quality Criteria for D iagnostic Radiographic Images. Working Document, CEC XII/173/90 (June 1990). 10. Quality Criteria for D iagnostic Radiographic Images in Paediatrics. Working Document, CEC XII/307/91 (June 1992). 11. United Nations. Scientific Committee on the Effects of Atomic Radiation (UNSCEAR). (New York: UN) (1993). 12. National Radiological Protection Board. National Protocol for Patient Dose Measurements in Diagnostic Radiology (Institute of Physical Sciences in Medicine, National Radiological Protection Board and College of Radiographers, Chilton, Didcot, United Kingdom) (1992). 13. Rosenstein, M., A ndersen, L. W. and Warner, G. G. Handbook of Glandular Tissue Doses in Mammography. Presentation at the Twentyninth Meeting of the Health Physics Society, New Orleans, LA (1984).
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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 101-104 (1995) Nuclear Technology Publishing

THE UNITED STATES EXPERIENCE IN PATIENT DOSE AND IMAGE QUALITY


O. H. Suleiman, B. J. Conway, F. G. Rueter, J. L. McCrohan, R. J. Slayton and R. G. Antonsen United States Food and Drug Administration Center for Devices and Radiological Health (HFZ-240) 5600 Fishers Lane, Rockville, Maryland 20857, USA. INVITED PAPER Abstract In the United States the Nationwide Evaluation of X-ray Trends (NEXT), a cooperative federal-state survey programme, measures the average radiation air kerma associated with several specific diagnostic X-ray examinadons. Chest radiography was surveyed in 1984 and 1986, the abdomen-L/S spine in 1987 and 1989, computed tomography in 1990, and dental radiography in 1993. Since 1984, patient exposure equivalent phantoms have been used for each annual survey. Three examinations, mammography (1985, 1988, 1992);fluoroscopy(1991), and dental radiography (1993) have incorporated image quality test objects. The surveys are comprehensive, collecting data such as screen and film type, whether a grid is used, selected Xray tube potential, measured beam quality, the measurement of processing speed, and entrance air kerma. The trend in mammography, which has been observed for three separate surveys, shows an overall decrease in the average examination dose during this period of time, while image quality has improved. The main reason for the reduction in dose is the elimination of xerography relative to screen-film mammography. Within screen-film mammography an improvement has been observed infilmprocessing, an improvement in beam quality, and an increase in die use of grids. These changes have contributed to the observed improvement in image quality and associated increase in mean glandular dose for screen-film systems. Thefluoroscopysurvey showed an average air kerma of 43 Gy.min-'. The image quality evaluation showed 87% of surveyed facilities able to resolve at least the 20 wire mesh (equivalent to 0.8 lp.mm-1); while 51% of facilities had a per cent contrast sensitivity greater than 4%.

INTRODUCTION In the United States the only national programme which performs a trends analysis for diagnostic X ray examinations on an ongoing basis is the programme known as the Nationwide Evaluation of X-ray Trends (NEXT). Each year an annual survey to determine the radiation air kerma for specific diagnostic X ray examinations is conducted. The programme is a voluntary programme conducted jointly between the federal government's Food and Drug Administration and the state radiation control agencies. The formal relationship is handled through the Conference of Radiation Control Program Directors (CRCPD), the umbrella organisation for the state and local radiation control agencies. Technical assistance is provided by the federal government and the actual programmatic decisions are made by a CRCPD committee consisting of state and federal members. NEXT was originally established in 1973 to assess the population dose from diagnostic X ray examinations. It became obvious that comprehensive national X ray exposure surveys similar to the 1964 and 1970 X ray exposure studies"-2' could no longer be conducted either efficiently or in a timely manner, and an ongoing survey programme, such as NEXT, would allow such information to be collected and analysed more quickly. In 1984 Quality Assurance (QA) tests became part of the NEXT survey, and the survey was limited to one diagnostic examination each year. This decision ensured

that a good statistical sample was surveyed. Although participation is voluntary, eighty per cent of the state and local programmes consistently participate. Patient exposure measurements were performed using standard patient-equivalent phantoms'3'. The use of a standard phantom ensured that the patient exposure data was obtained using a very precise survey protocol. The second unique and essential piece of data, which related to processing QA, was the measurement of film processing speed using an empirical test known as the sensitometric technique for the evaluation of processing (STEP)'4'. Film processing speed refers to the filmchemistry-processing system activity, not the screenfilm speed, nor the processor cycle time. MAMMOGRAPHY In 1985 the selected diagnostic examination was mammography. The phantom selected was a standard, commercially available phantom. This phantom represented a typical female breast and was used to perform air kerma measurements. The mean glandular dose was then calculated using knowledge of the X ray beam quality and the air kerma. In addition to the determination of dose, image quality was assessed using a set of image quality test objects. Image quality and dose problems identified by this survey stimulated other organisations, primarily the American College of Radiology (ACR), to establish a Mammography Accreditation programme (MAP). Although the ACR is
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O. H. SULEIMAN, . J. CONWAY, F. G. RUETER. J. L. McCROHAN, R. J. SLAYTON and R. G. ANTONSEN not a government agency, its MAP has become the stan dard for mammography quality. The MA P not only requires comprehensive QA tests for mammography equipment and facilities, it also has criteria which apply to the physicians reading the mammography films. The mammography survey was repeated in 1988 and 1992 using essentially the same protocol. The image receptor effect on dose One of the more significant changes observed is that screenfilm mammography is the primary technique used today. A s screenfilm mammography increased, xeroradiography decreased from 38% in 1985, to 17% in 1988, and finally 1% in 1992. Because xeroradiogra phy is a higher dose technique than screenfilm mam mography, elimination of this technique has resulted in an overall reduction in dose. Image quality Image quality was evaluated along with dose using a standard, commercially available mammography phantom'5'. The phantom is equivalent to a 4.7 cm com pressed breast (50% adipose and 50% glandular tissue). Image quality test objects within the mammography phantom consisted of specks (0.54 mm to 0.16 mm diameter), fibres (1.56 mm to 0.40 mm diameter), and masses (2.00 mm to 0.25 mm thick). A n acceptable image score was noted using the A merican College of Radiology criteria of radiographic visualisation of the 0.32 mm diameter speck group, the 0.75 mm diameter fibril and the 0.75 mm thick mass. In 1985 64% of all surveyed mammography units met A CR image quality standards, although these standards were not established until 1987. In 1988 81% of surveyed facilities met these standards, and in 1992 86% of facilities met these stan dards. Grids The increasing use of grids is apparently one of the main reasons for this improvement in image quality. It also is one of the major reasons for the increase in dose for screenfilm mammography (Figure 1 ). Beam quality Beam quality has continued to improve with the shift toward dedicated mammography systems. Lower tube potentials have been observed, 28.7 kVp in 1985 to 26.8 kVp in 1992, and lower HVLs, 0.44 mm Al in 1985 to 0.35 mm A l in 1992. Film processing Acceptable film processing has improved from 82% of all mammography facilities surveyed in 1985, to 93%
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of all facilities in 1988, to 95% of observed facilities in 1992. Film processing in mammography is generally much better than practised in general radiography (Figure 2). Acceptable processing speed is defined as a processing speed which is 100 plus or minus 20, or 80 to 120'6*. FLUOROSCOPY For the 1991 NEXT fluoroscopy survey, entrance air kerma rates were measured using a standard phantom'7'. The average air kerma, freeinair, was 43 mGy.min'' (Figure 3). In addition to the air kerma, image quality was also evaluated. Low contrast test objects were visualised dur ing the study from the video monitor. Per cent contrast values were calculated from knowledge of the beam quality and relative attenuation of the phantom and low contrast test objects, (Figure 4) ' 8 9 ' . A pproximately half of the tested systems could image test objects corre sponding to a 4% contrast or lower, although a signifi cant number of fluoroscopy systems could not image even relatively large signals. Seventeen (17%) of

1985

1988 Survey year

1992

Figure 1. Mean glandular dose for screenfilm mammography systems.


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Figure 2. Film processing by facility type.

US EXPERIENCE IN PATIENT D OSE AND IMAGE QUALITY observed fluoroscopy systems could not image an 8% contrast signal. Spatial resolution was evaluated by imaging high contrast wire mesh. Eightyseven percent (87%) of all facilities could image 20 lines/inch wire mesh (equivalent to 0.8 lp.mm" 1 ) or better (Figure 5). This is considered to be acceptable for standard television systems'"".
25 > 20

CONCLUSIONS In our experience, the use of a standard, patient equivalent phantom, for the measurement of radiation air kerma enables comparison of these data. The collec tion of patient dosimetry data using hundreds of patients is labour intensive and does not always ensure that the observed dose is comparable to other reported data, since patient populations vary. This standard phantom can also be used for routine quality control measure ments. The assessment of image quality is also an essential QA component of the survey. Dose needs to be evalu ated with knowledge of the associated image quality. Although the assessment of image quality is a complex task, using a standard image quality test object has proven to be very useful. Although the assessment of dose and image quality is critical, the collection of additional technical infor mation, such as the type of film, screen, presence of a grid, beam quality (kV p and HVL), and processing speed is also important. These additional data allow a comprehensive evaluation of the reasons for the observed dose and image quality. These should be rou tinely collected as part of any comprehensive survey.

" 15
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1019 2029 3039 4049 5059 6069 Air kerma rate (mGy.min 1 )

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Figure 3. Entrance air kerma rates for fluoroscopy systems.

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60

Figure 4. Low contrast test objects visualised, converted to minimum detectable signal as a per cent contrast (n = 351). REFERENCES

Figure 5. High contrast test objects visualised; in lines per inch (n = 351).

1. Gitlin, J. N., Lawrence, P. S. et al. Population Exposure to Xrays U.S. 1964. A Report on the Public Health Service Xray Exposure Study. Public Health Service Publication No. 1519 (1966). 2. BRH73. Population Exposure to X rays. U.S. 1970. A report on the Public Health Service Xray Exposure Study. DHEW Publication (FDA ) 738047 (Washington, DC) (November 1973). 3. Conway, B. J., Suleiman, O. H., Rueter, F. G and McCrohan, J. L. Patient Equivalent Attenuation Phantoms. Radit. Prot. Dosim. 43(1), 123125 (1992). 4. Suleiman, O. H Rueter, F. G., Antonsen, R., Conway, B. J. and Slayton, R. J. The Sensitomelric Technique for the Evaluation of Processing (STEP). Radial. Prot. Dosim. 49(1/3), 105106 (1993). 5. Conway, B. J., Suleiman, O. H., Rueter, F. G., A ntonsen, R. G. and Slayton, R. J. National Survey of Mammographie Facili ties in 1985, 1988 and 1992. Radiology 191, 323330 (1994). 6. Suleiman, O. H., Conway, B. J., Rueter, F. G. and Slayton, R.J. Automatic Film Processing: Analysis of 9 Years of Obser vations. Radiology 185, 2528 (1992). 7. Suleiman, O. H. Assessing Fluoroscopy Performance. In: Proc. ACR/FDA Workshop on Fluoroscopy (Strategies for Improve ment in Performance, Radiation Safety and Control). Washington D.C. 16 and 17 Oct. 1992. 8. Wagner, A . J. and Barnes, G T. Private communication.
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O. H. SULEIMAN, . J. CONWAY, F. G. RUETER, J. L McCROHAN, R. J. SLAYTON and R. G. ANTONSEN 9. Quinn, P. Private communication, FDA. 10. Gray, J. E., Winkler, N.T., Stears, J. and Frank, E. D. Quality Control in Diagnostic Imaging (University Park Press, Baltimore) (1983).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 105110 (1995) Nuclear Technology Publishing

CEC QUA LITY CRITERIA FOR DIA GNOSTIC RA DIOGRA PHIC IMAGES BASIC CONCEPTS
B. M. Moores Integrated Radiological Services Unit 188 Century Building Brunswick Business Park, Liverpool L3 4BJ, UK INVITED PAPER Abstract The basic concepts of the Quality Criteria are discussed and the role of image quality in radiation protection strategies highlighted. The need for consistency between the clinical, technical and scienfic aspects of die Quality Criteria is discussed in terms of the interrelationships which exist between diese three aspects. Future areas for research and development which can help to strengthen die overall framework, and applicability of the Quality Criteria are considered.

INTRODUCTION Diagnostic radiology is a major worldwide activity within the health care domain. In Europe roughly 250 million X ray examinations are performed annually and these give rise to some 160,000 man.Sv. of population exposure. The scope and practice of radiology vary enormously both within Europe as well as throughout the world' ". There is no clear consensus amongst differ ent countries as to the most desirable and/or necessary level of radiological activity. For example, the fre quency of radiological examinations expressed as the number per 1000 of population varies by roughly a fac tor of 3:1 amongst the developed nations. The United Kingdom (UK) performs roughly 460 examinations per 1000 of population whereas in Japan this number is almost 1200. Similarly the collective effective dose delivered per million of population varies by almost a factor of 5. In 1979 the cost of radiological services in the United States of A merica was estimated at approximately 7 IO'2 ECU per year'2'. A t today's costs and allowing for growth this implies annual costs of over 15 10' 2 ECU per year with a similar figure applying to Europe. In the UK radiological services probably cost in the region of 1.3 IO12 ECU per year or on average 1230 ECU per radiograph. Similar radiographic costs have also been noted in the Federal Republic of Germany'3'. Throughout Europe there are about 400,000 medical radiation workers'4'. Industries which support diagnostic radiology in Europe may employ another 100,000 or more in manufacturing, sales and service functions. Throughout Europe there are probably more than 100,000 X ray units both fixed and mobile with a capital value in excess of 15 IO12 ECU. The infrastructure costs of building, education and training of new and existing staff will also be extensive.

Diagnostic radiology is a major industry. It provides a high level of employment in Europe and is a sizeable vehicle for the application of a wide spectrum of modern technologies and services as well as financial investment. The supporting industries also play an important role in the socioeconomic infrastructure of many member states. These aspects alone provide sig nificant justification for diagnostic radiology when viewed in a modern industrial context, particularly when the sociological impact of diagnostic radiology is com pared to a multitude of other accepted industrial and commercial activities. The radiation exposure resulting from diagnostic radi ology may be viewed as a form of pollution. A s pol lution goes it is extremely clean and relatively non toxic. Nonetheless, like all pollutions, every effort should be made to control and/or reduce the levels incurred. However, justification for so doing must take into account the widest spectrum of factors. The role, function and most effective framework for radiation protection in diagnostic radiology must, therefore, be viewed within a modern industrial and social context. Also, the most effective radiation protection strategy should apply equally to all nations whether they be highly developed or developing nations and whether they have high or low levels of radiological activity, for whatever reason. FUNDAMENTAL BA SIS OF RA DIA TION PROTECTION IN DIA GNOSTIC RA DIOLOGY The very foundation of radiation protection in diag nostic radiology concerns the level of information gained from an examination. This information in fact represents the 'product specification' and forms the basis of clinical justification. It has two components; the quality of (a) the image and (b) its interpretation. Unfor tunately, almost 100 years after the establishment of the
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. . MOORES

radiological process it is still impossible clearly and unequivocally to define the quality of 'the product of service' resulting from such a widespread activity. What is, perhaps, even more surprising is the fact that all those agencies, government or otherwise responsible for the provision of radiological services on behalf of the general public, have never required detailed specification of performance, even though the costs of these services are extremely high. Image and interpretative quality should constitute a known result for all radiological examinations. Once the required image quality has been defined it should be possible to stipulate those combinations of technical factors which can routinely produce the desired outcome. Coincidentally, this then provides a logical basis for choosing the 'best or most desirable combination' where choice may depend upon patient dose, economic factors or a combination of both. Once the required technical factors are defined it is important to know that they are accurately reproducible to within prescribed limits, both consistently and routinely. Similarly those radiographers/ technicians responsible for performing an examination should be capable of selecting and utilising the most appropriate factors also routinely and consistently. Making the necessary adjustments to accommodate variation in patient size and weight as well as making sure that the patient is positioned correctly. The dose delivered to a patient will then be determined by the outcome of these three stages; (i) Choice of image quality. (ii) Establishment of required technical factors. (iii) Correct and consistent implementation. Having produced an image of acceptable quality it must be interpreted correctly. Inaccurate or false interpretation can and does contribute to non-productive costs and exposure. For example, studies have shown that more than 30% of lung tumours less than one centimetre in diameter are not reported on the initial reading of chest films even though they are visible when films are reviewed'5-6'. The aim of any X ray examination should be to produce an outcome that will meet defined standards for the anatomical site and clinical indications. Such standards must include the quality of the clinical image. Since a high proportion of examinations will involve negative findings, then logically any quality standards should be expressible in terms of normal anatomy. Negative radiological findings play a vital role in patient management strategies and an acceptable true negative detection capability is often equally as important, from the point of view of cost-risk-benefit, as any true positive capacity. The need to place imaging performance centrally within the radiation protection framework for diagnostic radiology has been highlighted on numerous occasions. In 1964 during a meeting on 'The Reduction of Patient Dose by Diagnostic Radiologic Instrumentation'

held in Chicago'7', G. M. Ardran stated: 'The evaluation of a method of determining image quality is essential before one can deal with the speed of systems, since the speed must be stated for given image quality'. During a meeting held in 1971 on Reduction of Radiation Dose in Diagnostic X-ray Procedures and organised by the Bureau of Radiological Health"" G. H. Chamberlain stated: 'The final evaluation of its (diagnostic radiology) worth, however, will depend on its practical feasibility in clinical practice, the medical purposes to which it is applied, and its influence on the yield of diagnostic information . . . It seems appropriate, therefore, to lift our thoughts to the plane of efficient and wise use of radiation rather than confining the perspective to dose reduction alone'. During a meeting held in 1974 in Columbia, Maryland, on Quality Control in Diagnostic Radiology'9' D. J. Goodenough stated: 'It seems unreasonable, however, that each new imaging system should undergo a process of trial and error on the patient population without system designers having first made every possible effort to optimise their system for the detection of the particular diagnostic signal(s) under consideration'. During a later meeting on quality control in diagnostic radiology'"" J. R. Cleeveland stated: 'Although the community of physicists and radiologists agree that adequate definition of the specific clinical performance requirements necessary for accurate diagnosis does not yet exist, to my knowledge no unified effort has been initiated to convert this mysterious art into a specific science'. In 1982 the World Health Organization"" published guidance on quality assurance in diagnostic radiology. This document presented essential elements of a quality assurance programme which included criteria and test methods. It stated: 'Criteria and test methods must be established.... The criteria should include consideration of at least the following elements: (1) identification of imaging requirements; (2) performance and characteristics of radiological equipment related to image quality and patient exposure During a Scientific seminar held in Udine in 1984"2' M. Davison indicated that the International Commission on Radiation Units and Measurements (ICRU) Committee members had 'suggested that there was a need first of all to define what was meant by image quality', and 'For the future the prime needs for international support can be summarised in terms of the provision of training programmes, the publication of statistical data and the development of image quality standards'.
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CEC QUALITY CRITERIA FOR DIAGNOSTIC RADIOGRAPHIC IMAGES BASIC CONCEPTS During the same meeting M. Cohen stated: (v) Represent an overall forward planned strategy for examinations. '.. . we need as a measure of urgency, the develop(vi) Establish common standards as a basis for radioment of methods for routine measurement or logical audits. indexing of image quality or diagnostic quality. It is ironic when you come to think that we are talking However, to be fully effective the Quality Criteria must about quality assurance of diagnosis and have no themselves fulfil certain criteria. These include: method of saying in a simple way that can be (a) Presentation within a rational framework. applied routinely within departments what the (b) Consistency. quality of an image and of the subsequent diagnosis (c) Employment of rigorous terminology. should be'. (d) Incorporation of tolerances and limiting values. In order to address this long standing and fundamen- (e) Acceptable to the radiological community. tal radiation protection problem, the Commission of (f) Capable of widespread implementation. European Communities produced a set of Image Quality Criteria for six common X ray examinations"3'. These Quality Criteria are also being extended to include other RATIONAL FRAMEWORK radiological procedures. A rational framework for the Quality Criteria is preQUALITY CRITERIA FOR DIAGNOSTIC RADIOGRAPHIC IMAGES The rationale, structure and content of the Quality Criteria have been discussed previously"4"17'. Similarly, two European-wide trials of the Quality Criteria have been evaluated and the results of the first trial were made available throughout Europe"8', whilst preliminary results from the second, more extensive, trial will be presented at this Workshop"9'. One of the main purposes of this Workshop is to review the possible impact or otherwise of radiation protection measures pursued throughout Europe during the past decade. Therefore, it is worthwhile attempting to review the basic concepts of the Quality Criteria themselves in the light of past experience in order to try to define fundamental criteria which the Quality Criteria themselves might need to meet, in order to be more effective, logical and practical. However, before so doing it is worthwhile trying to define clearly the aims of adopting a Quality Criteria approach to radiation protection in diagnostic radiology. The Quality Criteria should provide a logical framework for radiation protection initiatives which links the desired or acceptable outcome, in terms of image quality, of a radiological examination, to the radiographic technique required to produce this outcome and the patient dose which should be achievable. The overall aim of the Quality Criteria is to help improve radiation protection in diagnostic radiology throughout Europe. This overall aim comprises a number of more specific possibilities which include: (i) Standardisation of radiological practice. (ii) Foundation for optimisation which incorporates image quality. (iii) Framework for education and training of both radiologists and radiographers. (iv) Indicate technical requirements for X ray equipment.
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sented in Figure 1. The Quality Criteria provide guidance on four aspects of radiographic practice, namely: (1) The structures which should be present in a particular radiograph expressed in terms of normal anatomy image criteria. (2) Important image detail which should be capable of reproduction. (3) Example of good radiographic technique. (4) Entrance surface dose for a standard-sized patient.

The clinical structures which are reproduced on any radiograph are not solely dictated by the technical factors employed. A primary requirement for an acceptable image is the correct positioning of a patient. Thus the

CLINICAL STRUCTURES TECHNICAL FACTORS

EDUCATION AND TRAINING

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Figure I. Quality criteria framework.

. . MOORES Quality Criteria should clearly define those clinical structures appearing in the image criteria which are predominantly dependent upon positioning of the patient and those which are dependent upon technical factors. Obviously some criteria will depend upon both. The ability to assess whether the technical image quality is being achieved or not is embodied in the important image detail which should be capable of representation. It is impractical, however, to assess technical imaging performance routinely by assessing abnormal radiographs for the presence or absence of important image detail. This assessment could be made by imaging test phantoms which either reproduce directly, or mimic the image criteria in order to verify technical performance. This approach should enable the purely technical performance of the X ray equipment to be assessed separately from the human or operator aspects of performance. However, the correct technical factors must be correctly chosen by the radiographers/technician so that here also there exists a human element. Factors may be incorrect because of poor choice or because of erroneous calibration or equipment fault. The radiographic technique provides guidance on the most desirable technical factors to employ. Certain technique factors may be considered to be primary factors in that they have an influence on the outcome of an examination when taken in isolation. The kilovoltage employed and use of carbon fibre products may be taken as examples. On the other hand there may need to be secondary considerations whereby more than one combination of factors may produce a desired outcome. For example focal spot size, focus-film distance (FFD) and exposure time are such a combination. The focal spot size may be increased, the FFD increased and the exposure time decreased, due to higher power loading of the tube. This could lead to increased resolution without affecting patient dose. The criteria needs to include this type of flexibility, which can have an impact of cost implications. After all the Quality Criteria are concerned with the achievement of realistic standards at acceptable cost. The patient dose expressed as the entrance surface dose to a standard-sized patient is a simple and relevant quality control measurement. Unfortunately this does not take into account one of the fundamental aims of radiation protection which concerns the protection of the individual as well as mankind and future generations. It is quite possible to have entrance surface dose values for a particular examination which fulfil dose guidelines for an average-sized patient, or alternatively average values which do so, but still have a large spread of doses when considering all patient sizes. Since the overall aim of the Quality Criteria is to help improve all facets of radiation protection in diagnostic radiology, then this aspect cannot be ignored. Guideline dose values for different sizes of patients are desirable. One advantage of this might be the development of a meaningful definition of patient size, in a radiological sense. CONSISTENCY One of the main aims of the European-wide trials undertaken to date has been to try and check the overall consistency of the Quality Criteria. That is, to assess whether or not the image criteria can be met when applying a particular radiographic technique whilst meeting the dose guidelines. But procedures for running the trials and evaluating the results are themselves still under development. Consequently the relevant consistency of the Quality Criteria may not as yet always be evaluated. An example may help to indicate future considerations. In the Quality Criteria for the chest, a kilovoltage range of 100-150 kV is stated. Such a Quality wide kV range will obviously lead to a wide variation in image contrast and, therefore, image quality. There is a need to verify that the Quality Criteria can be applied consistently over this kV range. It. has also been shown that for constant film blackening'2'. mA.s x (kV)5 = constant Since the X ray output itself varies roughly as (kV)2, the entrance surface dose varies roughly as (kV)3 for constant film density. Substituting the recommended kV range presented in the Criteria indicates that constant film density can be achieved with a range of entrance surface doses of approximately 3.4. That is to say that an image produced at 150 kV will employ a dose roughly 3.4x lower than one employing 100 kV. However, both will fulfil the radiographic technique criteria, but possibly not the dose guidelines. TERMINOLOGY The terminology employed in the Quality Criteria must be understood with the minimum of dubiety, for example, the speed class is not a well understood quantity itself. However, the only reference to screen-film imaging requirements is expressed solely in terms of this quantity. Speed is related to resolution and noise for screen-film combinations and depends upon the combination of screen and film employed. There is a real need to ensure that wherever possible, fundamental radiographic parameters are employed rather than factors which hide a variety of other important quantities. It would be useful also to define imaging requirements in terms of objective measures such as resolution and threshold contrast which can supplement quantities like speed class. TOLERANCES The examples of good radiographic technique provide guidance on the technical aspects of a radiographic 108

CEC QUALITY CRITERIA FOR DIAGNOSTIC RADIOGRAPHIC IMAGES BASIC CONCEPTS examination. There is no indication whether the values ity Criteria initiative it is worthwhile discussing this quoted are manufacturer's specified values or values separately. measured as part of a quality assurance programme. If realistic tolerances are applied to all the radiographic factors quoted, then enormous dose variations can result (perhaps as much as 100:1) whilst still employing the QUALITY CONTROL AND RADIATION recommended radiographic technique. Exactly this PROTECTION problem was encountered in the United States during the 1970s and will be discussed more fully later. HowThroughout the 1970s the US Bureau of Radiological ever, there is a need for those who use X ray equipment Health, later to become part of the Federal Drug Adminto establish meaningful discussions with the manu- istration (FDA) funded a major programme for facturers in order to develop an understanding of the developing and implementing patient dose reduction cost implications associated with maintaining particular strategies in diagnostic radiology. The Nationwide tolerances for equipment performance. If, at the end of Evaluation of X-ray Trends (NEXT) programme formed the day, the purchaser of radiological services can only part of these initiatives'23'. The NEXT programme afford equipment manufactured to certain tolerances involved the assessment of doses to a standard patient then image quality and patient dose and variations ther- for a number of common examinations performed on a ein will be dictated by these costs. However, if there large number of X ray units throughout the US. The exists scope for improvements within existing budgets, results of this study highlighted: then this needs to be highlighted. (1) The extremely large variations in patient doses which existed. (2) The dynamic nature of the variations over a period of time where high dose units could give low doses at a later date and vice versa. (3) The reasons for these variations were multi-faceted and could not be directly ascribed to particular A number of conclusions were drawn from this study. Firstly in order to contain and reduce dose variations comprehensive quality assurance programmes needed to be established in which allowable variations in performance standards should be clearly stipulated. Secondly, the administrative/management framework for running such a programme should be established prior to its implementation. Thirdly, supporting education and training initiatives and appropriate test methods needed to be made available. Without such programmes it is impossible to determine whether long-term dose reductions are a viable proposition. If Europe is not merely to repeat the USA experience twenty years later, then effective radiation protection strategies based upon existing practices in diagnostic radiology must develop acceptable definitions of and methods for assessing image quality in clinical radiographs. The technical factors required to produce the required level of image quality need to be clearly stated and quality control programmes implemented which verify consistent performance. Education and training of radiographers should be directed towards the establishment of consistent performance standards and mechanisms for auditing this performance. Similarly the efficacy of the interpretation of diagnostic images needs to be placed on a more objective footing. All of these different facets constitute components of an effective medical radiation management system. 109

ACCEPTABILITY The Image Quality Criteria will only be acceptable to the radiological community if they are seen to provide a rational operational scientific basis for medical imaging strategies. Over the past 40 years there have been literally thousands of scientific publications worldwide dealing with imaging science, optimisation strategies, dose reduction techniques, does measurement surveys, risk assessment etc. It is valid, within a workshop such as this to ask: what if any has been the impact of all of this work on radiological practice, in particular those aspects which directly concern radiation protection? Unfortunately the answer may well be, not a lot. Most technical developments which have an impact on radiation protection, for both good and bad, seem to have originated from the activities of the manufacturers of X ray equipment.

IMPLEMENTATION If the Quality Criteria are to be effective, then they must be capable of widespread implementation throughout Europe. This will require investment of money and resources not only to develop further the Quality Criteria themselves but also to educate and train radiographers and radiologists in their use. Of prime importance also is the need to develop the necessary tools and instrumentation which will enable the Quality Criteria be implemented easily, effectively and with the minimum of disruption to existing practice in an integrated fashion. An example of such tools concerns the development of integrated computer based systems'22' for quality control programmes and other associated functions. Since quality control forms an integral part of the Qual-

. . MOORES REFERENCES 1. UNSCEA R. Sources and Effects of Ionising Radiations. (New York: UN) (1977). 2. Linton, 0. W., Properzio, W. S. and Steele, J. P. Quality Assurance. An Idea whose Time has Come. A m. J. Roentgenol. 133, 989992 (1979). 3. Rehm, H. J. Private communication (1993). 4. NRPB. Document M445 (to be published). 5. Muhm, J. R., Miller, W. E. and Fontana, R. S. Lung Cancer Detection during a Screening Program using Four Month Chest Radiographs. Radiology 148, 609615 (1983). 6. Heelan, R. T., Flehinger, B. J. and Melamed, M. R. Non Small Cell Cancer. Result of the New York Screening Programme. Radiology 151, 289293 (1984). 7. Mosely, R. D. and Rust, J. H. 77ie Reduction of Patient D ose by D iagnostic Radiographic Instrumentation. Springfield, Illinois: Charles C. Thomas (1964). 8. DHEW. Reduction of Radiation Dose in Diagnostic Xray Procedures. Publication No. (FDA) 738009. Bureau of Radiologi cal Health, Rockville, Maryland 20852, USA (1972). 9. SPIE. Proc. Society of PhotoOptical Instrumentation Engineers, Vol. 56. Medical Xray and PhotoOptical Systems Evalu ation (Box 1146, Palos Verdes Estates, California 90274, USA ) (1974). 10. SPIE. Proc. Society of PhotoOptical Instrumentation Engineers, Vol. 96. Application of Optical Instrumentation in Medicine V (Box 1146, Palos Verdes Estates, California 90274, USA ) (1976). 11. WHO. Quality Assurance in D iagnostic Radiology. A guide prepared following a Workshop held in Neuherberg (World Health Organization, Geneva (1982). 12. Davidson, M. Criteria and Methods for Quality Assurance in Medical Xray D iagnosis. Eds G. Drexler, H. Eriskat, H. Schibilla, J. Haybittle and L.F. Secretan. BIR Supplement 18 (British Institute of Radiology London)(1985). 13. CEC. Quality Criteria for D iagnostic Radiographic Images. Commission of European Communities. Working Document 2nd edition XII/173/90 (1990). 14. Moores, . M. European Standards in Diagnostic Radiology: the Euro Xray. In: Optimisation of Image Quality and Patient Exposure in Diagnostic Radiology. BIR Report 20 (British Institute of Radiology, London) (1989). 15. Stieve, F. E. Radiological Requirements for the Specification of Image Quality Criteria. In: BIR Report 20, pp. 221238 (British Institute of Radiology, London) (1989). 16. Wall B. F. and Shrimpton, P. C. Patient Exposure Criteria. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology, BIR Report 20, pp. 239241 (British Institute of Radiology, London) (1989). 17. Moores, . M. Scientific Basis for Standardisation in Diagnostic Radiology. In: Medical Radiation Practice within the EEC. Eds M. Fitzgerald and J. M. Courades (BIR, London) pp. 4751 (1990). 18. Maccia, C , Moores, . M., Nahrstedt, U., Padovani, R. and Wall, B. F. CEC Quality Criteria for D iagnostic Radiographic Images and Patient Exposure Trial. Report EUR 12952, DGX1 lD3 (CEC, Rue de la Loi 200, B1049 Brussels) (1990). 19. Maccia, C. CEC Trial on Quality Criteria for D iagnostic Radiographic Images. Radit. Prot. Dosim, 57(14) 111117 (1995) (This issue). 20. Bierman, A . and Boldingh, W. H. The Relation between Tension and Exposure Times in Radiography. In: Xray Research and Development (N.V. Philips Gloeilampenfabrieken, Eindhoven). (A lso A cta Radiol. XXXV, 22 (1951)) (1951). 21. Boercke, E. Speed and Speed Classes of FilmScreen Systems. D etermination and Practical Application. In: Technical and Physical Parameters for Quality Assurance in Medical Diagnostic Radiology. Eds B. M. Moores et al. BIR Report 18, pp. 9 1 92 (British Institute of Radiology, London) (1989). 22. Cole, P. and Moores, . M. Computer Applications in Radiation Protection. Radit. Prot. Dosim. 57(14), 203206 (1995) (This issue). 23. Vucich, J. J. Quality Assurance: a Fundamental whose Time has come. Proc. Society of PhotoOptical Instrumentation Engineers, Vol. 70. (Box 1146, Palos Verdes Estates, California 90274, USA ) (1975).

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Radiation Protection Dosimetry Vol. 57, No. 14, pp. 111117(1995) Nuclear Technology Publishing

THE 1991 CEC TRIA L ON QUA LITY CRITERIA FOR DIAGNOSTIC RA DIOGRA PHIC IMA GES
C. Maccia, M. A richeCohen, X. Nadeau and C. Severo Centre d'A ssurance de Qualit des A pplications Technologiques dans le domaine de la Sant (CAATS) 165 A v. A ristide Briand, 94230 Cachan, France

INVITED PAPER Abstract In 1987 a project for the establishment of quality criteria for diagnostic radiographie images in adult diagnostic radiology was initiated within the framework of the Radiation Protection programme of the CEC (DG XII). Six common examin ations were considered (chest, skull, lumbar spine, pelvis, urinary tract and breast) and afirsttrial was conducted in 24 European X ray departments. A s a result of this initiative, a CEC working document was issued and circulated to the most important professional radiology associations in Europe. In order to validate and demonstrate the usefulness of such a document, a second trial was carried out in 1991 specifically for chest, lumbar spine and breast examinations. This paper reports on (a) the collection of information relating to 83 X ray departments which participated in the trial and provided about 2000 films associated with more than 1100 patients; (b) the methodology followed for the evaluation of the data collected related to each examination type and to each patient; (c) the overall statistical results relating to the patient dosimetry and radiographic techniques; and (d) the comparison between the image quality as directly assessed by the field radiologists and as assessed by a group of independent experts. INTRODUCTION In 1987, a project for the establishment of quality cri teria for diagnostic radiographic images was initiated within the framework of the activities of the Radiation Protection Programme of the Commission of the Euro pean Communities (DG XII). The main objective of this project was to provide practitioners with a provisional list of radiological, technical and dosimetric criteria helpful in determining the quality of radiographs rou tinely undertaken in adult diagnostic radiology. Six common examinations were considered (chest, skull, lumbar spine, pelvis, urinary tract and breast) and an initial trial was conducted in twentyfour European X ray departments'". As a main result of this initiative, a CEC working document was issued and circulated to the most im portant professional radiology associations in Europe'2'. In order to validate and demonstrate the usefulness of such a document on a much broader scale, a second trial was carried out in 1991, under the initiative of the DGXII, specifically for chest, lumbar spine and breast examinations. METHODOLOGY Data collection To be able to carry out the second Trial, different practical problems were to be solved and a welldefined protocol was to be respected.
Ill

Figure 1 summarises the overall framework relating to the organisation of data collection. Three different questionnaires, one for each type of examination, were prepared and sent out by the CEC DGXII services to the national level coordinators in various European countries who previously had established contact with local X ray departments. A t the same time, three Euro pean dosimetry laboratories, namely, the Forschungs zentrum in Germany (GSF), the National Radiological

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Figure I. Organisational framework of the CEC Quality Criteria Trial.

C. MACCIA, M. ARICHE-COHEN, X. NADEAU and C. SEVERO Protection Board (NRPB) in the UK and the Unit Sanitaria Locale (USL No 7) in Italy, sent thermoluminescence dosemeters (TLDs) to all participating X ray departments. These dosemeters were to be used for measuring, for each projection type and for each patient, the entrance dose received during the examination. For each examination, the following data were gathered: image criteria, type and make of X ray equipment used, filtration, focal spot sizes, type of grid, type of film, type of cassette and film processor, patient thickness in the centre of the beam, peak applied potential, focus-to-film distance, film size, exposure time, patient dose, tube current, speed class of film-screen combination and film acceptability for diagnosis. Once the field survey was completed, all information, including the original X ray films, dosemeters and questionnaires, were sent to the dosimetry laboratories which then prepared the readout of the TLDs. Finally, the questionnaires, together with the original films and dose measurement results, were centralised at the Centre d'Assurance de Qualit des Applications Technologiques dans le domaine de la Sant (CAATS) in France for evaluation. Expert review In order to provide an independent analysis of the image quality of these examinations for comparative purposes, a group of fifteen European expert radiologists met in Paris for one week. Five experts were assigned to each examination type. Their mission was to review all collected films using the same quality criteria and questionnaires as were used by the field radiologists. Each expert, working separately, received sets of films which were reorganised randomly between each reading. The experts completed as many readings as possible within the week, with the aim of eventually reviewing all collected films in their specialty. Thus, each film was checked once on a local level and two to five times by the independent experts. Data analysis Concerning the analysis of the collected data relating to a given type of examination, Figure 2 shows the different steps followed in the quality criteria trial. Out of the total number of collected films and questionnaires, a small percentage of the overall number of the original radiographic images which were considered by both the field radiologists and the experts as unacceptable for diagnostic use, were excluded. Accepted films were viewed and scored by the group of independent expert radiologists, five for each type of examination. Those films which were seen by all members of the examination-related group were taken into consideration in the subsequent image quality analysis. This analysis only dealt with those radiographic techniques described in the CEC Quality Criteria document. Therefore, an additional small number of films was excluded from the final group analysis. Finally, the experts' opinions were compared with those directly made by the field radiologists who performed the original examinations. Trial characteristics Table 1 gives the general characteristics of this CEC trial carried out in 1991. These figures give a quantitative overview of the size of the project and of the scope of the work performed. Almost all western European countries, as well as one Southern American country, participated in this initiative. More than 80 radiological departments provided approximately 2000 X ray films which were checked by the fifteen expert radiologists. Three laboratories provided thermoluminescence dosemeters (TLDs) to each participating hospital for measuring the patient entrance skin dose received during the examinations. Each laboratory also read out the 700 doses from the TLDs it had distributed. The intention for recruitment for each projection type was 10 patients from each hospital. Nearly, all participating countries were able to survey a sufficient number of patients for each of the three examinations considered, as requested by the trial instructions. A higher number of breast examinations were included in the

Figure 2. General methodology for the CEC Trial data analysis. Table 1. General information describing the CEC Trial (1991). Number of countries Number of X ray departments Number of patients Number of films Number of dose measurements Number of expert radiologists Number of dosimetry laboratories 83 1108 2088 2136 15 3
16

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DIAGNOSTIC RADIOGRAPHIC IMAGES study, compared to the other two types of examinations settings for specific examinations to be considered (429 breast, 366 chest and 313 lumbar spine reliable and usable. respectively). For the examination considered, information quality Concerning the individual workloads completed by was verified using the response rates to questions each of the fifteen experts (five for each examination concerning technical equipment-related parameters type) during the week of review, the task was theoreti- included in the questionnaires. Two categories of paracally to check the whole set of collected radiographic meters were created: the first concerning overall X ray films, that is, to view from 600 to 800 films according production (filtration, focal spot size, type of generator, to their specialty. Within the allocated time period, such automatic exposure control (AEC) and antiscatter grid) an ideal goal could not be attained. Nevertheless, a high and the second relating to formation and processing of percentage of films was actually seen by each radiol- the image (age of intensifying screen, speed class of ogist. For breast films, between 72% and 95% were film-screen combination, processing time and develreviewed by all experts. For chest films and lumbar oper temperature). spine films, these figures ranged from 65% to 82% and Not surprisingly, among the five parameters included from 73% to 87% respectively. in first category, filtration and focal spot size were less Finally, each day's work consisted, for each radiol- frequently reported (50% on average), probably due to ogist, in visualising, checking, and reporting infor- the relative inaccessibility of this type of information. mation on an average of 121 films for breast, 97 films Nevertheless, all parameters considered, a fairly high response rate (80% on average) was obtained. As far as for chest or 123 films for lumbar spine examinations. the second category of parameters is concerned, a slightly lower response rate for the breast examination Rejected films was obtained. Such high response rates demonstrate an acceptable level of reliability of the equipment-related Before proceeding with a more detailed analysis of data and allowed further detailed analysis to be made. the trial data, one must discuss the films which were rejected by the field radiologists as not suitable for diagnosis and evaluate what fraction of the total number of General results for patient dose collected films they represent. In general, the analysis provided in this paper places The percentage of films considered by the field radiolemphasis on mean values for each hospital, rather than ogists as not acceptable for diagnosis varied from 0.5% individual values related to specific patients. This trial (1 film out of 267 for chest lateral projection) to 8.1% has attempted to gather information concerning average (13 films out of 161 for lumbosacral joint projection). use of specific equipment within the participating hospiAlthough such findings are lower than those generally tals. Therefore, while some information is given in the 3 4 observed in routine practice' ', and may suggest that following section on the range of individual patient particular attention was paid to performing the radiovalues, it is the comparison between average values for logical examinations, one must keep in mind that each the entire group of patients examined in each hospital hospital only provided a series of 10 patients to the trial. which is the most pertinent indicator of compliance with These samples cannot, therefore, be considered as repCEC quality criteria requirements. resentative of either the departments' normal activity or Table 2 indicates the number of dose measurements the technical reliability of the imaging equipment used. Thus, the exact causes for the low number of rejected actually carried out, together with their corresponding statistical range (minimum, mean, third quartile and films were unknown. maximum values), by type of X ray projection. Depending on the type of examination considered, ratios between maximum and minimum dose values Equipment-related data ranged from 40 (breast craniocaudal projection) to 400 In diagnostic radiology, a large number of publi- (chest PA projection). Wide distributions of doses were cations have highlighted the fact that the same type of found. Standard deviation values, which approximate, image can be obtained using a wide variety of tech- or even exceed, the corresponding mean dose value, niques and patient doses'5-6'. Apart from problems clearly confirm this finding. Although many reasons related to patient characteristics (in particular, may be invoked to explain these differences (type of X thickness), two aspects are responsible for variations in ray equipment used, patient size, radiographic techpractice: personnel training and radiological equipment nique, quality control, etc.), they are unacceptably large, performance. Within this study, an attempt was made to and it is clear that harmonisation of radiological pracdetermine to what extent participating staff had tices in this area is essential. adequate knowledge of their equipment. A relatively Table 2 permits a comparison between third quartile high level of knowledge is necessary in order for dose values and their corresponding CEC reference reported information concerning general operating doses. In general, trial results seem to be consistent with characteristics of equipment and concerning technical CEC references, except for breast examinations. 113

C. MACCIA, M. ARICHE-COHEN, X. NADEAU and C. SEVERO The dose reference value for breast examination was derived under experimental conditions from a breast phantom of 4.5 cm thickness. This value cannot therefore easily be compared to collected breast dose data, which include a wider range of breast thicknesses. However, if one restricts the comparison to the patient population of 4 cm to 5 cm breast thickness, the resulting third quartile dose value is 8.6 mGy, a lower value than that indicated in the table for all breast thicknesses. The value for the 4-5 cm group is close to the CEC reference dose level. Table 3 presents data concerning the overall compliance with CEC dosimetric requirements for the entire group of participating X ray departments. As the fourth column of this table shows, from 13.8 to 69% of hospitals have mean dose levels in excess of CEC reference doses. As noted above, the largest number of excess mean doses comes from breast examinations. It is possible that the CEC dose reference value of 7 mGy is too restrictive. Nevertheless, relatively few hospitals (maximum = 12.9% for the lumbar spine AP or PA projection), have all dose values in excess of CEC reference doses. More than 70% of hospitals' mean dose values were in compliance with CEC dose requirements for chest and lumbar spine examinations. It was more difficult to respect such levels for breast examinations; only about 40% of doses are in the acceptable range. The fifth column of the table shows the percentage of hospitals whose mean dose value complied with the CEC reference dose, but whose maximum value exceeded it. The last column shows the number of hospitals in which even the maximum dose value is inferior to the CEC reference value. Comparison of these two columns gives, implicitly, an impression of the variation of dose values within each hospital. The fact that up to twice as many hospitals have maximum values exceeding the CEC reference dose, means that the range of all their dose values is larger than the range of, values in the Column 6 hospitals. The percentages in the two columns might, at best, be equal, meaning that the range of values in all hospitals had been reduced. The global aim for doses should be the reduction of mean doses for all projections in hospitals to compliance with CEC reference values. Only after this goal is achieved should hospitals try to reduce the range of all dose levels to within two standard deviations, or to another reasonable goal. Experts review: inter-rater reliability As described above, during the expert review week,

Table 2. Dose statistics by examination and projection type (mGy).


Projection PA Number of measurements Minimum Mean 1 SD Maximum Third quartile CEC reference 354 0.03 0.360.75 11.99 0.39 0.3 Chest Lat 257 0.13 1.31 2.9 37.94 1.22 1.5 CC 369 1 7.85.4 41.8 10.04 7 Breast Lai 408 0.5 9.27.3 54.5 11.99 7 AP or PA 301 0.5 7.86.8 63.9 9.99 10 Lumbar spine

Lat
308 0.9 18.713.3 68.5 26.49 30

L5-S1 139 2.7 34.620.3 119.9 45.7 40

Table 3. Compliance rates with the CEC dose requirements. Examination type Projection Hospitals in which all dose values exceed CEC dose level (%)
11.7 3.4 7.9 9.5 12.9 6.1 11.1

Hospitals whose mean dose exceeds CEC dose level (%)


29.4 13.8 52.6 69.1 25.8 15.2 33.4

Hospital mean Hospitals with all dose equal to or doses less than less than the CEC the CEC dose dose level (%) level (%)
70.6 86.2 47.4 30.9 74,.2 84.8 66.6 41.2 72.4 15.8 11.9 29 60.6 33.3

Chest Breast Lumbar spine

PA Lateral CC Lateral AP or PA Lateral L5-S1

114

DIAGNOSTIC RADIOGRAPHIC IMAGES each expert worked independently on a separate view ible. Fewer films were able to meet these criteria, and box. Each received a packet of films in random order the experts agreed less between themselves on what which were to be viewed and scored using the same constituted an adequate image. Viewers 3 and 4 appear type of questionnaires and the same scoring system for to have been particularly strict in their scoring of Crieach criterion (0 = no; 1 = yes) as had been completed teria 2, 3, 4, and 8. Criterion 8 shows that the experts by the field radiologists. One criterion, concerning film had two different levels of acceptability for the visualblackening, had three possible scores: too light, optimal, isation of these anatomical features. or too dark. In this case, too light or too dark was counFor film blackening (see Figure 4), Viewer 3 was ted as 0, while optimal counted as 1. Thus, each film much more critical than the others. For this examination received six readings in all, five from the experts and in general, a clearer film gives a potentially higher level one previously from the field radiologist. of diagnostic information than does a darker film. In order to test the inter-rater reliability of the experts, Therefore, non-optimal scores tend to be in the too comparisons were made between their five readings of dark category. As shown in Figure 5, field radiologists consistently each projection. Ideally, to have perfect inter-rater reliability, all raters checking the same film indepen- scored films as acceptable more often than did the dently should rate the film in exactly the same manner. experts. The greatest level of disagreement was for CriTwo factors are of critical importance to this ideal terion 2, symmetrical reproduction of the thorax. The result. First, the rating criteria must be carefully defined. only two criteria for which there was agreement were The terms used in the definition must be unambiguous. Nos 1 and 6. The good correlation between the groups The categories of possible answers must be exclusive; of answers for No 1 result from the explicit definition that is, there must be no possibility of two correct of the criterion, which included a decision rule (see the answers. Second, the raters must be trained to apply the six anterior ribs or ten posterior ribs). criteria and must believe implicitly in their relevance. It is particularly interesting to note that the field radiFurthermore, it must be possible to apply the criteria to ologists gave positive scores from 10 to 25% more often the films, that is, the technical environment necessary for Criteria 3 and 8. Criterion 3 is highly dependent to rating must be provided and of high quality. In this upon patient positioning. Criterion 8, however, has a case, new viewboxes were provided. In the section unique problem, because the definition contains two below, an overview of the inter-rater reliability for chest elements of different anatomical density which result in AP projection type is provided. the non-exclusivity of the responses. A yes answer Conclusions are drawn for the criteria on which the might mean that the viewer sees both structures, or it experts disagreed as discussed to determine which factor might mean that the viewer sees only one of them. of reliability was involved: explicitness of definition of the criterion, or the feasibility of applying it. Vertical CONCLUSION bar charts show the experts' scores for each criterion. Image criteria for chest examination (PA projection) Figure 3 compares the responses of each expert for each criterion. There was only a high level of agreement on one third of the criteria: Nos 1, 5, and 6. Criterion 1 concerns the positioning and cooperation of the patient, while the other two are related to the radiographic technique itself. For the other criteria, however, there was up to 100% disagreement on certain criteria. Nevertheless, two types of problems are found in the criteria over which the experts disagree. Criteria 2 and 4 concern judgements of symmetry and completeness. Criterion 2 demands a score on the symmetry of the thorax image, without giving a measurement technique or decision rule. For Criterion 4, it is clear that Viewer 3 appeared to interpret the definition in the opposite sense to the others, or applied a decision rule which was extremely severe. Criteria 3, 7, and 8 are more difficult criteria to meet, because the anatomical structures require a combination of technical prowess, good positioning and good choice of kVp and exposure time in order to be sufficiently visThe CEC Quality Criteria Trial was designed to examine the CEC guidelines set for radiographic technique, patient dose, and image quality. The results show that the set of criteria defined for evaluating the quality of diagnostic films for the breast, chest, and lumbar spine examinations can be applied consistently by both field radiologists and international experts. Furthermore, the trial has shown that the criteria represent an improvement in determining film acceptability over the subjective definitions of individual radiologists acting alone. The following detailed observations can be made: ( 1 ) Radiographic practices vary excessively for several parameters such as kVp, applied focal spot size, focus-to-film distance, speed class of film-screen combination and use of automatic exposure control. Harmonisation of practice is necessary. (2) Radiographers appear to have insufficient knowledge about the current operating condition of their equipment. Training of radiographers on the importance of these elements should be developed. (3) As in many previous studies, this trial has shown that patient dose varies markedly for all projection
115

C. MACCIA, M. ARICHECOHEN, X. NAD EAU and C. SEVERO


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116

DIAGNOSTIC RAD IOGRAPHIC IMAGES types. However, more than fifty per cent of hospital mean doses by projection are lower than the CEC reference dose value. (4) Concerning the image quality criteria, seven out of the 29 failed to meet validation requirements for interrater reliability. There were three types of weaknesses: first, four criteria were too vaguely defined, using words such as 'full' and 'symmetric' without providing limits of acceptable deviation or a measurement technique. Second, two criteria were nonexclusive, that is, the response categories could be interpreted in at least two ways. Finally, the response categories for the film blackening criterion were completely subject to individual interpretation and produced highly variable scores for all projec tions. Despite these minor problems, the image quality criteria system was shown to be acceptable and applicable by both the field radiologists and the international experts. A fter minor improvement, they may be used to optimise image quality in these three diagnostic radiological examinations, while avoiding unnecessarily high radiation doses to patients.

Too dark 13 Too light Optimal

C3 C4 C5 C6 Field radiologists HI Expert radiologists Figure 4. Criterion No 9: film blackening (chest PA projection). REFERENCES

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Figure 5. Field radiologists and experts average responses for each image quality criterion: chest projection.

1. Maccia, C , Moores, . M., Nahrstedt, U., Padovani, R. and Wall, . M. CEC Quality Criteria for D iagnostic Radiographic Images and Patient Exposure Trial. Report EUR 12952 (Commission of European Communities, Rue de la Loi 200, 1049. Brussels, Belgium) (1990). 2. CEC. Quality Criteria for D iagnostic Radiographic Images. Working Document XII/173/90 2nd edn (Commission of European Communides, Rue de la Loi 200, B1049. Brussels, Belgium (1990). 3. Goldman, L. W. Analysis of Retakes: Understanding, Managing and Using an Analysis of Retakes Program for Quality Assurance. HEW Publication (FDA ) 798097 (US Department of Health and Human Services, Washington, DC) (1979). 4. Rogers, K. D., Matthews, I. P. and Roberts, C. J. Variation in Repeat Rates between 18 Radiology Departments. Br. J. Radiol. 60, 463 (1987). 5. Contento, G., Malisan, M. R., Padovani, R., Maccia, C , Wall, B. M. and Shrimpton, P. C. A Comparison of D iagnostic Radiology Practice and Patient Exposure in Britain, France and Italy. Br. J. Radiol. 61, 143152 (1988). 6. Vano, E., Velasco, ., Moran, P., Ganzalez, L. and Alvarez Pedrosa, C. S. Evolution of Diagnostic Radiology in a Big Hospital during a 5 year Period, and the Collective Dose. Br. J. Radiol. 66, 892898 (1993).

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Radiation Protection Dosimetry Vol. 57, No. 1-4, pp. 119-123 (1995) Nuclear Technology Publishing

EVOLUTION OF QUALITY ASSURANCE IN PAEDIATRIC RADIOLOGY


K. Schneider Rntgenabteilung im Dr. von Haunerschen Kinderspital Innenstadt-Kliniken der Universitt Mnchen Lindwurmstr. 4, 80337 Mnchen Federal Republic of Germany INVITED PAPER Abstract Quality assurance in diagnostic radiology has become increasingly important over the last 10 years. It is vital, especially in paediatric radiology, to make therightselection of radiographic examinations and their proper sequence and, furthermore, to adapt the radiographic technique to the special requirements of paediatric patients. As part of a quality control programme, several field study surveys were conducted and the X ray equipment was evaluated in a total of 180 clinics and doctors' offices in Germany in the period between 1988 and 1992. For this purpose, measurements of the entrance surface dose (ESD) using a patient equivalent Teflon phantom were taken for seven frequent X ray examinations in infancy. The dose values varied extensively in all examinations. Similar variations were found for general radiologists and other physicians who X ray children, but the mean doses were three times higher than the mean doses found for paediatric radiologists. An initiative of the Commission of the European Communities (CEC) led to the definition of image quality criteria and parameters for good radiographic technique for frequent X rays as part of the development of Quality Criteria in Paediatrics (Working Document of the CEC). This allowed a direct evaluation of the relation between the measured ESD and image quality. The analysis from two European Communitywide surveys in about 90 children's clinics showed similarly wide dose variations as in the above mentioned national surveys. The Commission of the European Community now has the responsibility to make use of these results to induce effective quality assurance programmes in its member states.

INTRODUCTION Quality assurance programmes and quality control initiatives in general diagnostic radiology have been developed in several European countries in the past 10 years""3'. However, the need for special quality assurance programmes for paediatric patients were first realised early in the 1980s145'. The main goals were to improve the diagnostic information and to reduce the patient dose to a minimum the ALARA principle'6'. The efforts towards quality assurance in paediatric radiology were at first dominated by the principle of justification and also by the concepts of 'efficacy/efficiency''78'. The WHO Report 757 compiled such principles for a number of common diseases in paediatrics and emphasised the term 'rational use of diagnostic imaging'19'. CEC INITIATIVES The development of the Document 'Quality Criteria for Diagnostic Radiographic Images in Paediatrics'1"" by a group of paediatric radiologists (the Lake Starnberg Group), medical physicists and the CEC services in addition to an earlier developed document for adults"" was an important step exemplifying the second important principle of 'optimisation'"2'. It served as a sound basis for the evaluation of good radiographic technique and image quality for frequent X ray examin-

ations in research projects. Because infants were investigated with X rays more frequently than older children"3', these young patients were chosen for national phantom studies as well as EC-wide dosimetric surveys. NATIONAL STUDIES IN GERMANY Table 1 lists a breakdown of the 180 clinics and private practices in Germany which participated in the series of national surveys in the period from 1989-1992. All measurements were made using the same Teflonabsorber ('euro-baby') and recording device (DAVID: a dose and peak-voltage measuring and computing Table 1. Breakdown of clinics and private practices participating in dosimetric phantom studies on X ray examinations in infants in Germany (1988-1992). Paediatric radiologists General radiologists Paediatricians Private practices general radiologists paediatricians orthopaedic surgeons surgeons (n = 66) (n = 26) (n = 28) (n = 21) (n = 20) (n= 11) (n = 8)

119

K. SCHNEID ER device" '). Questionnaires were used to survey equip ment and radiographic technique. Seven frequent X ray examinations (three types of chest, skull, abdomen, hip, and spine) in infants (1000 g to 10 kg) were studied. Direct measurements were made for entrance surface dose (ESD), kVp, total filtration and exposure time. In addition, the test plate exposures were examined for col limation, optical density and perpendicularity. There were wide variations in X ray equipment, exposure tech nique as well as differences between exposure settings and the corresponding measurements"5'. The highest deviations were found in exposure time (Figure 1) which varied by a factor of 1:350 (the minimum value was 1.4 ms, the maximum 565 ms). Thirtyfive per cent of the clinics/hospitals headed by paediatric radiologists operate at the recommended exposure times 10 ms; of those headed by paediatricians and radiologists only 15% and 5%, respectively, were within this range. Con siderable deviations between set and measured peak voltage values were also found, whereby the largest dif ferences were found when comparing paediatric radiol ogists in clinics with paediatricians and general radiol ogists (Figure 2). The sensitivity of filmscreen combinations varied similarly by a factor 1:16. Looking at the chest X ray examinations studied, there were wide differences in
paediatric radiologist (n = 66) paediatricians (n = 28) raradiologists (n = 26)
4

exposure technique as well as in the measured dose within and between different physician groups. Wide deviations of image quality parameters were also found when test plate films (Wellhfer Phantom) were exposed using the individual radiographic tech nique of the radiology departments or practises"6'. In Figure 3 the discrepancy between light and X ray fields for both the bucky table (skull) and stands (chest) is percentually graphed. The light visor corresponded well with the beam field in twothirds of the units studied. The light field was too small in 15%, too large in another 15% and very much too large in 10% of the units studied. Close to 70% of skull and 50% of chest films have good alignment (deviation between 0.5 to +1.0 cm). Seven per cent of skull and 18% of chest films were misaligned (deviation > 1.5 cm or were cut off). Deviations in the perpendicularity of the beam were also often found"6'. The results of the phantom ESD measurements showed variations within and between different clinics and private practices (Figure 4). Table 2 lists the small est and highest mean values for different radiographic parameters for the groups shown in Figure 4. There are large variations in radiographic technique which nat urally determine the ESD. DOSIMETRIC SURVEYS IN THE EUROPEA N COMMUNITY Two surveys in the Member States of the European Community were carried out parallel to the national phantom studies in Germany; a third Europewide sur vey is presently in progress. The first two studies meas ured the ESD for common X ray examinations of infants using calcium fluoride crystal thermoluminescence dosemeters (TLDs) in about 90 children's clinics. The first study examined the same seven X ray examinations studied in the national surveys; the second concentrated only on the chest X ray examinations. Basic data on X ray equipment, auxiliary devices and radiographic technique were collected by questionnaires and the orig inal X ray films were evaluated for image quality. The dosemeters were measured by medical physicists of the

30 t 25 20 15 10 5 0

10 20 30 40 50 75 100125150>150

Exposure time (ms) Figure 1. Variation of exposure time for the stationary chest AP/PA, 10 month infant in children's clinics and general hospi tals headed by different physician specialists.
paediatric radiologists paediatricians radiologists

Q.

> <
6pulse 12pulse Converter Direct current generator too small 051.0 cm >1.5 cm 0.55.0 cm 1.01.5 cm misaligned I Skull Chest

Figure 2. Deviations of the measured kVp from the set kVp in children's and general hospitals headed by different physician specialists. Chest AP/PA, 10 month infant.

Figure 3. Alignment between X ray and lightfieldin the verti cal axis for skull and chest X rays. 120

EVOLUTION OF QUALITY ASSURANCE IN PAED IATRIC RADIOLOGY National Radiation Protection Board in Chilton (United Kingdom), of the Unit Saniteria Locale No 7 in Udine (Italy) and of the GSF Forschungszentrum fr Umwelt und Gesundheit in Neuherberg (Germany). It was possible during the course of these surveys to develop and refine the image quality criteria of the Working Document for paediatric X ray examin ations" 0 '. These were used in evaluating the radio graphs of the two TLD surveys. The data analysis from both studies showed extremely wide variations in ESD 500
CD

>

400

300 200 100

Q (
LU

^ - "
Mean

_I__L

paed rail (W) paediatricians radiologists

doctors off. paed.radio.(E)

I SD

Freehand exposure

1500 1250

J 1000
i
(

(results of the first TLD survey are shown in Table 3). The ratio between minimum and maximum dose values for the given standard aged infant varied between 1:15 and 1:76. The questionnaire data revealed a surprisingly high proportion of clinics using outdated generators, low speed or incompatible filmscreen combinations and absence of additional filtration"7'. The image quality rated by a panel of eight paediatric radiologists (Lake Starnberg Group) using the image quality criteria specified in the CEC Document surpris ingly showed no correlation with the entrance surface dose (Figure 5). Examples for good image quality for X rays of the skull and chest were recently reported" 8 '. The data analysis was made anonymously and the participating clinics received feedback in the form of an individual percentile profile of both dose and image quality. The clinics varied in terms of their optimisation of radiographic technique of both dose and image qual ity, ranging from one end of the scale with low dose and good image quality to the other end with high dose and poor image quality. The experience with these TLD surveys, especially with respect to the recognition of specific critical struc tures was incorporated into the CEC Working Docu ment. A n expert group of paediatric radiologists and medical physicists met to provide recommended maximum values for patient dose for conventional paed iatric X rays (at least 7 5 % of the clinics in the first TLD Table 3. Basic statistics for entrance surface dose on seven frequent X ray examinations in infants. ESD in (>.

750 500 250

rfn ~
I SD

+1
Mean

I . I
doctors Ott. paed.tadio.(E)

Examination Abdomen Skull AP Chest AP/PA Spine Pelvis Chest, mob. newborn Chest, mob. infant

Min. 77 152 21 107 18 11 34

Max. 3210 4514 979 4351 1369 386 718

Mean 650.5 1252.7 131.3 112.8 401.1 67.8 128.5

Median Ratio Total 440 926 74 875 2745 435 90 1:42 1:30 1:47 1:41 1:76 1:35 1:21 45 57 69 31 50 64 37

paed radioi (W} paediatricians radiologists

Automatic exposure Figure 4. Mean entrance surface dose and standard deviations for die stationary chest X ray in different clinics (paediatric radiologists, paediatricians, radiologists) and private doctor's offices. (W) = West Germany; (E) = East Germany. Chest AP/PA, 10 month infant. Table 2. Lowest and highest group means found in the national surveys. Comparison of phantom measurements; chest A P/PA , infant of 10 months. Smallest and highest mean values of the groups studied: Antiscatter grid Automatic exposure control Exposure time (ms) Peak voltage Total filtration Focusfilm distance Filmscreen speed none: 34.193.5% none: 34.993.5% with A EC: 20.356.1 without A EC: 26.7153.8 6166 kV 2.73.0 mm A l 141159 cm 161244

1 2 3 4 5 6 No of criteria fulfilled: chest AP/PA, 10 month ESD D Image Quality Figure 5. Impact of good radiographic technique on both entrance surface dose and image quality of stationary chest X rays. 121

K. SCHNEIDER study had a measured dose lower than the 'reference' dose listed in Table 4); they also defined easily 'achievable' lower dose values based on the data of these surveys and on their experience and judgement. Reference values for X rays of the spine were not included because the data were not sufficient to provide reliable numbers for this comparatively rare examination in infants. One other decisive factor for entrance surface dose is the collimation of the beam, whereby poor collimation plays a more significant role than defects in the light visor system. The tolerance values ( 2 cm) for collimation as defined by the CEC Document were followed only in 10 to 20% of the clinics studied (Figure 6). Only one (!) clinic had an ideal field size. Of chest films, 10 to 20% were collimated within a 2 cm tolerance range for both upper and lower edges (total 4 cm). There was poor collimation in 70 to 85% of the films, i.e. they exceeded this tolerance but were below 200% of the ideal field size. Of the premature chest films, 20% were very poorly collimated ( > 2 0 0 % of ideal field size) 0 9 '. The criteria for good radiographic technique defined in the CEC Document were used in an analysis of the data and dose measurements of the German phantom studies. Only a relatively low percentage of the children's clinics in Germany fulfilled the CEC criteria for good radiographic technique for X rays of the newborn chest (Table 5). It is alarming that only about 20% of the clinics operate with doses below the recommended achievable dose (Figure 7) |2( ". For the 15% of the clinics which exceeded the reference dose, the cause(s) for these increased doses must be identified and actions taken. CONCLUSION The national and EC-wide surveys have shown that quality assurance in paediatric radiology is presently lacking in many children's clinics in Europe. To make matters worse, the national studies in Germany have shown that much higher levels of patient irradiation are to be expected in general hospitals and private practices. This situation must be urgently improved. The quality criteria and dose recommendations presented in the Working Document of the CEC ensure a significant dose reduction without negative effects on image quality. Quality criteria recommendations are now also being developed for computed tomography and fluoroscopy in paediatric patients. ACKNOWLEDGEMENT Table 4.'Reference' and 'achievable' dose values for different X ray examinations in infants. ESD in (. Examination Abdomen Skull AP Chest AP/PA Pelvis Chest, newborn, mob. Reference dose 1700 150 80 700 200 Achievable dose 800 70 30 400 50 Table 5. Per cent of clinics fulfilling the CEC criteria for good radiographic technique for X rays of the newborn chest. Exposure time kVp-setting Beam filtration Focus-film distance Film-screen sensitivity (speed) 12% 21% 30% 67% 66% 13/94 21/100 26/106 71/106 66/100 . M. Kohn (Munich) gave great assistance in the preparation of this paper.

Reference dose fulfilled by 75% of those surveyed. Achievable dose a rough estimate of an 'easily achievable' dose.

(%)
100 80 60 40 20 0
ideal CEC (+4 cm) Poor

(%)
80 60 40 value

reference

Aw
Extreme 1 kg 10mon,stat.m i 10 mon. mobi le

20 0

-/^Liffl^^
=30 &0> >80

Figure 6. Collimation of the X ray field in chest X rays in infants from both EC-wide surveys.
122

Figure 7. Per cent of clinics in Germany fulfilling the CEC recommendations for 'achievable' and 'reference' dose, and those exceeding these values.

EVOLUTION OF QUALITY ASSURANCE IN PAED IATRIC RADIOLOGY REFERENCES 1. BK. Leitlinien der Bundesrztekammer zur Qualittssicherung in der Rntgendiagnostik. Deutsches rzteblatt 86, 1437 1444 (1989). 2. DIN 6868/1. Sicherung der Bildqualitt in rntgendiagnostischen Betrieben; Allgemeines (Beuth Verlag GmbH, Berlin) (1985). 3. Stender, H.S. and Stieve, F.E. Praxis der Qualittskontrolle in der Rntgendiagnostik (Gustav Fischer Verlag, Stuttgart New York) (1986). 4. Fendei, H., Schneider, K., Schfer, H., Bakowski, C. and Kohn, M. M. Optimisation in Pediatric Radiology: Are there Specific Problems for Quality Assurance in Pediatric Radiology? In: Technical and Physical Parameters for Quality A ssurance in Medical Diagnostic Radiology: Tolerances, Limiting Values and A ppropriate Measuring Methods. Eds B. M. Moores et al. BIR 18 (London: British Institute of Radiology), pp. 159165 (1985). 5. Fendei, H. Symposium: The Status of Paediatric Radiology in Europe. The Principles for Rational Use and Optimization of Diagnostic Imaging in Paediatrics. 27th Congress of ESPR, Munich (1990). 6. ICRP. Recommendations of the International Commission on Radiological Protection. Publication 26 (Oxford: Pergamon Press) (1977). 7. Fendei, H., Schneider, K., Bakowski, C. and Kohn, M. M. D ie Auswirkung (Efficacy) diagnostischer Strahlenanwendungen in der Kinderheilkunde. 1. Bericht (Bonn: Bundesministerium des Innern) (1985). 8. Fendei, H., Schneider, K., Bakowski, C , Glas, J., Drews, K. and Kohn, M. M. The Efficacy of D iagnostic Radiation in Paediatrics. 2nd Report (Bonn: Bundesministerium fr Umwelt, Naturschutz und Reaktorsicherheit) (1986). 9. World Health Organization Study Group. Radional Use of D iagnostic Imaging in Pediatrics. WHO Technical Report Series 757 (Geneva: WHO) (1987). 10. CEC. Quality Criteria for D iagnostic Radiographic Images in Paediatrics. Working Document No. XII/307/91 (June 1992). 11. CEC. Quality Criteria for D iagnostic Radiographic Images. Working Document No. XIV173/90, 2nd edn (June 1990). 12. Fendei, H., Schneider, K., Bakowski, C. and Kohn, M. M. Specific Principles for Optimization of Image Quality and Patient Exposure in Pediatric D iagnostic Imaging. Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores et al. BIR 20 (London: British Institute of Radiology) pp. 91110 (1989). 13. Fendei, H. Radiation Problems in Roentgen Examinations of the Chest. In: Progress in Pediatric Radiology. Ed. H. J. Kauf mann, Vol. 1, pp. 1832 (Basel: KargerVerlag) (1967). 14. Schfer, I. DAVID Gert zur Bestimmung des Aluminiumgleichwerts won Rntgenstrahlen; Kurzbeschreibung (Zomeding bei Mnchen) (1980). 15. Fendei, H., Schneider, K., Bakowski, C , Burtscher, S., Kohn, M. M., Kellner, M., Schweighofer, K., Pehe, J. and Weisbach, M. Resultate der Studie: Gerteoptimierung der konventionellen Rntgenaufnahmeeinrichtungen fr Kinder. In: Kaufmann H. J. (Hrsg): Pdiatrie A ktuell, Band 2, Neue bildgebende Verfahren in der Pdiatrie, S. 101105 (Mnchen Bem Wien San Francisco: Zuckschwerdt Verlag) (1989). 16. Horwitz, A . E., SchweighoferBerberich, ., Schneider, K., Kohn, M. M., Bakowski, C , Stein, E., Freidhof, C. and Fendei, H. Selected Image Quality Parameters in a Survey using a Test Phantom in Radiological D epartments and Offices in the FRG. Radit. Prot. Dosim. 49, 7982 (1993). 17. Schneider, K., Fendei, H., Bakowski, C , Stein, E., Kohn, M. M., Kellner, M., Schweighofer, ., Cartagena, G., Padovani, R., Panzer, W., Scheurer, C. and Wall, . Results of a D osimetric Study in the European Community on Frequent Xray Examinations in Infants. Radit. Prot. Dosim. 43, 3136 (1992). 18. Schneider, K., Kohn, M. M Bakowski, C , Stein, E., Freidhof, C , Horwitz, A . E., Padovani, R., Wall, B., Panzer, W. and Fendei, H. Impact of Radiographic Imaging Criteria on D ose and Image Quality in Infants in an ECwide Survey. Radit. Prot. Dosim. 49, 7376 (1993). 19. Fichtner, C , Schneider, ., Freidhof, C , Endemann, ., Horwitz, A . E., Kohn, M. M. and Fendei, H. Critical Analysis of Field Size in Chest Xrays of Infants a ECwide Survey in Children's Clinics. Eur. Radiol. Suppl. 3, 389 (1993). 20. Zeiler, M., Weisbach, M., Weigel, ., Kohn, M. M., Schneider, K. and Fendei, H. Patient Exposure and Radiographie Technique in Neonatal Chest Radiography a Survey in Germany. Eur. Radiol. Suppl. 3, 85 (1993).

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QUALITY CONTROL A ND IMA GE QUA LITY CRITERIA IN COMPUTED TOMOGRA PHY


J. A lbrechtsent, J. Hansen^, L. C. Jensent, K. A . Jessenf and A . G. Jurikf Department of Radiology and ^Department of Medical Physics Aarhus University Hospital, DK8000 rhus C, Denmark Abstract Technical and diagnostic quality assurance are particularly important in computed tomography due to the complexity of the technology and the variability of scan parameters. The effect of the scanning parameters on image quality and patient dose has been assessed quantitatively by phantom measurements on seven CT systems in Denmark brought into clinical operation during recent years. Image quality criteria have been formulated for the mediastinum and retroperitoneum. These criteria are a modified version of the criteria defined by die German Federal Chamber of Physicians which have been tested in a prefatory pilot study. A total of 190 examinations for the two types have been evaluated by an expert radiologist trained in CT and a mean score given for fulfilment of the selected pure anatomical criteria equally weighted. The doses for the examinations are defined by the measured multislice average dose (MSA D) multiplied with the number of slices and the slice thickness, giving a value related to the volume dose. For the same type of examination a variation up to a factor of five in dose is registered without any significant improvement of the image quality or diagnostic information. There seems to be a need for optimisation of the dose value and the number of slices for each examination protocol. The new fast scanners with high capacity of the X ray tube invites an unnecessarily high patient exposure. More detailed calculations of effective doses will be performed.

INTRODUCTION Image quality in computed tomography is affected by many parameters, some of which are called scanning parameters as given below and can be controlled by the operator and should be selected using clinical and ana tomical considerations about the examination and pati ent in question. In order to obtain an adequate image quality and to ensure optimal radiation protection in computed tomography, it is therefore necessary to have a precise medical indication, to select the examination Table 1. Image quality criteria for the mediastinum. QC indicate pure anatomical criteria. A. Characteristic image freatures 1. Sharp repro, of the pleuromediastinal border. 2. Sharp repro, of the anterior mediastinum. 3. Sharp repro, of the thoracic aorta. 4. Visual, of die arteria pulmonalis with main branches. 5. Sharp repro, of die trachea and main bronchia. 6. Visual, of enlarged lymph nodes ( a 15 mm). 7. Visual, of lymph nodes lesser than 15 mm. 8. A dministration of intravenous contrast medium. 9. Visual, of die oesophagus and paravertebral space. 10. Sharp repro, of die diaphragm and costophrenic angles. B. Critical image elements 1. Presence of small mediastinal thickenings. 2. Visual, of the wall of the vessels. 3. Visual, of density differences in the vessels. 4. Sharp repro, of the trachea and paratracheal tissue. 5. Sharp repro, of the carina and lymph node area. C. 'Diagnostic' image quality 1. Optimal quality 2. A rtefacts due to movement or beam hardening. 3. A rtefacts due to contrast medium.

technique specifically according to the information which it was desirable to obtain, and to minimise the radiation exposure to the patient. The image quality primarily depends on two types of scanning parameters. One which is dose related and one that is related to the processing of the image. Dose related parameters are: kV and mA .s setting, slice thick ness, number of slices, measuring time, table increments. Processing parameters are such as: field of view (FOV), reconstruction matrix size, reconstruction algorithms, window settings for the organ concerned and number of projections. The effect of these para meters on image quality and patient dose can be assessed quantitatively by phantom measurements and this is essential information for formulating the quality criteria about the clinical information wanted in the images. The measures taken for technical and diagnostic qual ity assurance are particularly important if the aim is to

100 90 80 ^ 70

1b 1a 2a 5 _ 7 2b

b 60 O 50 O 40 30 20
10

500

1000 1500 2000 2500 MSAD T n (mGy.cm)

3000

3500

Figure 1. The mean yes score (QC) as function of the 'volume' dose for examinations of the mediastinum for individual scan ners (17). The a and b indicate different protocols for the same scanner. 125

J. ALBRECHTSEN, J. HANSEN, L. C. JENSEN, K. A. JESSEN and A. G. JURIK obtain a sufficient amount of medical information with a justifiably low level of dose to the patient. ANATOMICAL A ND PHYSICA L IMA GE QUALITY CRITERIA The image quality criteria in computed tomography are basically of two different types: anatomical and physical image quality criteria. The anatomical image quality criteria include the medical quality requirements with the aim of providing answers to specific questions. A s proposed by the German Federal Chamber of Physicians the quality cri teria for the images can be based on two components related to anatomical structures: the characteristic image features and the critical elements'". Characteristic fea tures are related to the anatomical structures of the region concerned and the critical elements to differences in density which are essential for the detection of dis crete pathological changes. A modified version of the criteria defined by the German Federal Chamber of Physicians was used by inclusion of sharp reproduction and not just visualisation of anatomical structures, this being essential for the diagnostic value. The set of diag nostic criteria for the mediastinum is given in Table 1.
100 90 80 70 60 50 40 30 20 10

In addition, an evaluation of the general 'diagnostic' image quality is included, based on disturbing artefacts and graded in perfect and less optimal image quality. The physical image quality criteria are based on the physical image quality parameters measurable by objec tive means and on definitions given by several national and international documents12" specifying routine tests for image quality parameters such as picture element noise, spatial resolution, linearity, homogeneity and stability of the CT numbers, slice width and dose. Some of the parameters can be combined to the socalled Figure of Merit13'.

Table 3. The mean yes score of the image quality criteria in percentage for the individual scanner (17) for examinations of the mediastinum.
Images criteria 1 Al A2 A3 A4 A5 A6 A7 A8 A9 AIO Bl B2 B3 B4 B5 Cl C2 C3 61 39 35 100 65 26 83 4 100 82 30 61 0 44 39 48 44 22 2 25 25 31 94 56 50 88 0 100 56 75 50 0 19 13 50 44 13 Scanner identication 4 50 50 57 93 50 50 64 100 100 57 64 50 14 7 7 71 21 50 5 50 0 100 100 100 50 100 50 100 50 100 100 0 0 0 100 0 50 6 0 0 0 100 67 33 67 67 100 67 100 67 0 0 0 33 0 33 7 60 20 40 100 60 20 70 30 100 60 60 60 0 20 30 100 20 0

1c

5a. 2c .2a 1a .1b

5b "7
3

.4b 4a .2b

o.

500

1000 1500 2000 M S A D x T n x Z (mGy.cm)

2500

Figure 2. The mean yes score (QC) as function of the 'volume' dose for examinations of the retroperitoneum for the individual scanners (17). The a, b and c indicate different protocols for the same scanner.

QC = (A 1+A 2+A 3+A 5+A 7+A 9+A 10+B4+B5V9

Table 2. Typical scanner settings and physical image quality parameters for scanning protocols for the mediastinum. Noise (S), Spatial resolution (R) and Figure of Merit (Q) are given.
Identification and name of scanner Scanner settings MAS Slice T UA CC (mA.s) (mm) (kV) 1. Somatom Plus S 2. Somatom Plus S 3. Somatom HiQ 4. Picker 2000 PQ 5. Tomoscan SR 6. Tomoscan LX 7. Tomoscan LX 420 275 240 300 250 332.5 332.5 10 8 10 10 10 10 10 120 137 133 130 120 120 120 S R Q (CTDI/MAS) (MSAD/MAS)Mean slice 'Volume' xlOO number. dose xlOO (freeinair) (phantom) vlSADxTxT T (mGy/mA.s) (mGy/mA.s) (mGy.cm) 10.7 16.1 19.5 33.8 22.2 19.7 20.4 9.7 14.8 18.5 23.1 14.6 13.5 13.9 20.7 30.4 34.7 46.9 28.5 47.7 26.1 842.5 989.8 1540.7 3245.5 1043.1 2146.5 1208.4

(%)
0.7 1.6 1.1 1.2 1.6 1.2 1.5

(mm) (mm2.Gy') 1.9 1.2 0.82 0.83 0.78 0.79 0.85 0.41

1.2 1.2 1.3 1.8

126

QUALITY CONTROL AND IMAGE QUALITY CRITERIA IN CT been evaluated by an expert radiologist trained in CT RESULTS AND DISCUSSION and the score yes/no has been given for the fulfilment A survey has been carried out in Denmark on seven of the individual criteria for each examination. The of the newest CT systems. For four weeks all the scan- mean of the 'yes' score is given as a percentage in Table ning parameters, number of slices etc., have been 3 for the CT systems used for examinations of the recorded for each examination together with relevant mediastinum. If only the criteria related to the pure anainformation on the patient (size, sex etc.). The physical tomical image quality are taken given below the image parameters have been measured for all systems table and weighted equally to get a mean total 'yes' by a standard phantom from RMI, model 461 A. The score for all examinations of the specific type, this value dose descriptor used is the multi-slice average dose can be compared directly to the measured dose value. (MSAD) measured on the surface of a 20 cm Perspex The mean total yes score combined with the mean dose phantom with a pencil shaped ionisation chamber for a for the mediastinum examinations for the seven CT syssingle slice'4'. The total dose for the specific examin- tems are given on Figure 1. There seems to be no correation is obtained as the MSAD value multiplied by the lation between the quality assessed and the dose. The number of slices and the slice thickness in cm. This same procedure has been used for the examinations of value can be related to the volume dose given to the the retroperitoneum. There seems to be a slight correpatient disregarding any overlap or spacing between lation as presented on Figure 2 between dose and the slices. The computed tomography dose index (CTD1) mean score of image quality but still a great variation was calculated from dose profile meaurements free-in- in dose. air at the centre of rotation by TL dosemeters. In Table The wide variations in dose between different depart2 results are given for typical scan parameters for exam- ments are related to the type of scanner but also to the inations of the mediastinum. Differences in MSAD and scan protocols. CTDI are seen for scanners with shaped filters. In conclusion, this type of analysis is recommended Before the image quality criteria were formulated as before a final protocol is set up for a specific examingiven for the mediastinum in Table 1 a pilot study was ation. Many departments follow the protocol given by performed on the two types of examination (23 in the the manufacturers. Especially for the new and fast scanmediastinum and 30 in the retroperitoneum) based on ners there is a tendency to increase the number of slices. the criteria recently produced by the German Federal More detailed conclusions of effective doses are in proChamber of Physicians'". These criteria predominantly gress and then risk estimates will be possible. indicate anatomical and physiological features. Criteria related to the basic image quality such as the presence ACKNOWLEDGEMENTS of artefacts, disturbing noise and spatial resolution were The authors are grateful to all departments involved missing. Therefore a modification of the German Cri- and for the help and assistance from the staff. This work teria was made and all the examinations of the two was financially supported by the CEC Radiation Protectypes, 190 examinations in all, from survey period have tion Programme, contract FI3P-CT920020. REFERENCES 1. Guidelines of the Federal Chamber of Physicians on Quality Assurance in. Computed Tomography. Translation by the CEC Services doc. XII/354/92-EN (Private communication). 2. IEC 62B. X-ray Equipment Operating up to 400 KV, Part 2-6: Constancy Tests of Equipment for Computed Tomography (1992). 3. Hospital Physicist's Association. Measurements of the Performance Characteristics of Diagnostic X-ray Systems used in Medicine. Part III Computed Tomography X-ray Scanners. TRG-32 (London: ) (1981). 4. Shope, T. B., Gagne, R. M. and Johnson, G. C. A Method for Describing the Doses Delivered by Transmission X-ray Computed Tomography. Med. Phys. 8, 488-495 (1981).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 129133 (1995) Nuclear Technology Publishing

PATIENT DOSE A ND IMA GE QUA LITY FOR COMPUTED TOMOGRAPHY IN SEVERA L DUTCH HOSPITA LS
J. Geleijnsf, J. J. Broersef, J. Zoetelief, D. Zweerst and J. G. van Unnikt ("University Hospital Leiden Departments of Clinical Oncology and Diagnostic Radiology, P.O. Box 9600, NL 2300 RC Leiden, The Netherlands $OLVG Hospital A msterdam and Medical Biological Laboratory TNO Rijswijk, The Netherlands Abstract In several Dutch hospitals a survey of computed tomography (CT) techniques was performed at 14 CT scanners. In this survey the computed tomography dose index (CTDI) was measured freeinair with a pencil type ionisation chamber. These measurements yield dose values related to a single CT scan of one slice whilst radiation exposure of patients due to a complete CT examination should preferably be expressed in terms of organ and tissue doses or effective dose. Organ and effective doses were derived by application of published organ dose conversion factors. Effective doses varied from 0.7 mSv to 2.2 mSv for head scans, from 6.0 mSv to 13 mSv for chest scans and from 7.1 mSv to 21 mSv for standard abdomen scans. The survey also included the assessment of parameters related to image quality, i.e. high contrast resolution and noise (standard deviation, , of Hounsfield units) associated with the CT scanners and protocols at the different locations. Image quality in terms of noise or resolution and effective dose did not reveal a significant correlation for the different CT scanners. INTRODUCTION Studies carried out in different countries have shown a relatively high radiation burden to the patient due to CT examinations and revealed important variations in absorbed dose. Shrimpton et al\ concluded that for the population of the United Kingdom a major contribution to the collective dose from diagnostic X rays is due to CT examinations, owing to the relatively high doses incurred and the increasing frequency. In other countries CT examinations might also contribute significantly to the collective dose. In the past decade, dose reduction has received atten tion but there is still a potential for optimisation of CT techniques. This implies that the procedures followed yield images of a good diagnostic quality at the lowest possible radiation dose to the patient. Recent infor mation on patient dose due to CT in the Netherlands is lacking. Therefore a survey of routine CT examinations at a limited number of CT scanners in different hospitals has been performed. INSTRUMENTS A ND METHODS Dosimetric concepts available for computed tomography Different quantities can be used to quantify patient dose due to CT. Quantities involved are tubecurrent exposuretime product (mA .s) for one CT slice, surface dose, computed tomography dose index (CTDI), mul tiple scan average dose (MSA D), equivalent dose in an organ or tissue (further referred to as organ or tissue dose) and effective dose. The tubecurrent exposuretime (mA .s) product of a CT scan gives information on the radiation exposure as it is proportional to dosimetric quantities such as surface dose, CTDI and effective dose. This quantity can be used only as a relative measure of radiation exposure at a specific type of CT scanner and should therefore not be used for comparing different types of CT scanners. It can, for example, be used for comparing different techniques at the same CT scanner12"5'. Surface doses at a phantom or the skin of a patient can be measured, e.g. with thermoluminescence dose meters (TLD)'6"10'. In Figures 1 and 2 surface dose pro files are shown measured with TLD employing a cylin drical water phantom for a CT scan of seven contiguous slices with a slice thickness of 10 mm. It is concluded that surface dose is rather inhomogeneous and cannot be obtained from a single measurement.

45

90

135

180 225

270 315 360

Angle (deg)

Figure 1. Surface dose profiles measured at the surface of a cyl indrical water phantom during a CT scan that consisted of seven contiguous slices with a slice thickness of 10 mm; dose profile along the circumference of the phantom. 129

J. GELEIJNS, J. J. BROERSE. J. ZOETELIEF, D. ZWEERS and J. G. VAN UNNIK The CTDI (computed tomography dose index) and the MSAD (multiple scan average dose) are concepts developed especially for CT"". The CTDI, measured during a single CT scan, is defined as: CTDI D(z)dz instruments. Furthermore it should be possible to make estimates of organ and tissue doses from these dose measurements. Measurements with anthropomorphic phantoms have the disadvantage that they are time consuming. Surface dose measurements at patients or phantoms or determination of tube-current exposure-time products (mA.s) can be performed rapidly but are not directly correlated with organ doses. In the present survey CTDI was measured free-in-air for a limited number of CT scanners. Measurements of CTDI were performed with a Capintec 3 cm' pencil type ionisation chamber (sensitive length 102 mm) connected to a Keithley 617 programmable electrometer at different tube voltages, slice thicknesses, filters and all possible focus to centreof-rotation axis distances. Organ doses were estimated from measured CTDI values employing conversion factors published elsewhere"24'. Mathematical phantoms are defined in a coordinate system with their longitudinal axis parallel to the axis of rotation of the CT scanner. This axis is used to define the boundaries of the CT scan. For the mathematical phantom of Shrimpton for example the coordinate '0 cm' on the longitudinal axis is assigned to the bottom of the trunk and '94 cm' at the top of the head. For a CT head scan the boundaries of the scan were chosen between the longitudinal coordinates 80.5 cm and 93.5 cm, for a CT chest scan between 41.5 cm and 69.5 cm and for a CT abdomen scan between 13 cm and 44 cm. Organ doses were calculated for various CT scanners by combining the measured CTDI values with organ dose conversion factors. Most organ dose conversion factors were derived from Shrimpton et /'" but in this publication no organ dose conversion factors for the Siemens CT scanners operating at a high tube potential of 137 kVp are given. For this type of scanner organ dose conversion factors of Zankl et al were used124'. Image quality
(3
k

where D(z) is the dose as a function of position along the rotation axis of the CT scanner and is the selected nominal slice thickness. The MSAD differs from CTDI as it takes into account the distances between successive slices (the increment, I), it can simply be derived from the CTDI"": MSAD = CTDI CTDI can be measured, e.g. with a pencil type ionisation chamber or with an array of TLDs. It can be measured at a specific depth inside a phantom such as the cylindrical PMMA (polymethylmethacrylate) standard head or body phantoms with diameters of 16 or 32 cm respectively"2-14' or free-in-air at the centre of rotation of the CT scanner"5"16'. Organ and tissue doses (HT) can be measured inside anthropomorphic phantoms employing TLDs at the locations of the selected radiosensitive organs'8917"23' or can be calculated from CTDI free in air values using conversion factors"'52425'. Subsequently a comparison of the radiation burden to patients from different CT techniques can be achieved by using the effective dose concept'26'. Dosimetric method selected for the survey During a survey doses should preferably be measured in a short period of time using simple transportable

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Position (cm) Figure 2. Surface dose profiles measured at the surface of a cylindrical water phantom during a CT scan that consisted of seven contiguous slices with a slice width of 10 mm: dose profile parallel to the axis of rotation of the phantom.

Amongst other aspects image quality of CT scans is related to noise (standard deviation of Hounsfield units) and spatial resolution (high contrast resolution)'27'. Noise is associated with low contrast resolution and was measured in a region of interest in the centre of images of two different cylindrical homogeneous water phantoms. These images were obtained from CT scans according to the clinical protocols actually used at the scanners concerned. For body techniques a cylindrical water phantom with a radius of 30 cm was used, for head techniques a water phantom with a radius of 16 cm was used complemented by a PVC ring simulating the attenuation of the skull. High contrast resolution was assessed with a test pattern of a CT performance phantom consisting of eight arrays, each with five cavities with diameters and separations of respectively 1.75, 1.50, 1.25, 1.00,0.875,0.75, 0.625, and 0.50 mm. The number of arrays for which

130

CT DOSE AND IMAGE QUALITY IN DUTCH HOSPITALS all cavities could be recognised separately was used to For some CT scanners organ doses could be derived quantify resolution (for example six recognisable arrays from the CTDI values and organ dose conversion fac would respond to separate depiction of the array cavities tors. It was, however, not possible to calculate organ with a diameter of 0.75 mm). doses for all scanners included in the survey as organ dose conversion factors were not available for some types of scanners. From the organ doses, effective dose RESULTS was assessed. Effective doses for some of the CT proto In Table 1 the make, type and number of the CT scan cols from Tables 2, 3 and 4 and for the corresponding ners that were included in the survey are listed. A t the CT scanners are listed in Table 5. participating hospitals different protocols may be used In Figures 3 and 4 effective doses for CT abdomen for CT examinations. The protocols used routinely for CT examinations of the head (brain scan), chest and Table 3. The CT protocols routinely used at the participat abdomen are compiled respectively in Tables 2, 3 and ing hospitals and related noise and dose: CT chest scan. 4. A lso included in these tables are the results on dose, noise and high contrast resolution measurements. Some Scanner Thickness Incre (mA.s) (kV) Noise Rsolu CTDI of the CT head and chest protocols of Table 2 and 3 (mm) ment of tion (mGy) include more than one technique. In this case these dif (mm) HU No ferent techniques are used for different parts of the head of or chest. arrays Table 1. Type and number of CT scanners included in the survey. GE PACE GE Sytec 3000 Philips Tomoscan 350 Philips Tomoscan LX Siemens Somatom Plus Siemens Somatom Plus S Toshiba TCT 600 HQ Toshiba TCT 900 S
A B B C D D E F G H I J K L M M 10 10 5 10 12 6 10 10 10 10 10 10 10 10 9 9 10 10 5 10 12 6 10 10 10 10 10 10 10 10 9 9 333 260 320 255 434 240 300 260 252 333 210 333 150 252 530 240 120 120 120 137 120 120 120 120 120 120 120 120 140 120 120 120
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7.0 8 . 8
12.6 11.6 14.2 11.2 10.9 12.0

Table 2. The CT protocols routinely used at the participat ing hospitals and related noise and dose: CT head scan. Scanner Thick ness (mm) Incre (mA .s) (kVp) Noise Rsolu CTDI ment of tion (mGy) (mm) HU No of arrays
10 10 10 5 10 363 390 320 480 420 120 120 120 120 120 3.5 3.3 4.4 2.8 6 6 6 6 71 173 142 214 49

7 . 2 9 . 6

65 115 142 41 39 91 121 101 49 63 26 57 57 63 58 59

Table 4. The CT protocols routinely used at the participat ing hospitals and related noise and dose: CT abdomen scan.
Scanner Thickness Incre (mA.s) (kV) Noise Resolu CTDI of tion (mGy) (mm) ment HU No of (mm) arrays

A B B

B C D E E F F G H I J K L M N

10 5 5 2 10

9 10 5 2 10 10 5 5 5 5 10 9 9

9 10 5 5 10 10 10 7 10 10 10 9 9

180 500 650 480 390 440 435 420 435 400 440 180 180

120 120 120 120 120 120 120 120 120 140 120 120 120

2 . 9 1 . 8

5 6


2 . 3 3 . 2 4 . 6 3 . 7 5 . 4 3 . 9 2 . 6 3 . 4 3 . 5


6 6 7 6 7 6 7 6 6

29 202 265 146 151 86 83 54 75 161 110 34 33

A B C D E F G H I J K L M

10 10 10 12 10 10 10 10 10 10 10 10 9

10 10 10 12 10 10 10 10 10 10 10 10 9

380 260 255 362 300 390 420 333 210 380 400 420 240

120 120 137 120 120 120 120 120 120 120 140 120 120

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12.6

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75 115 41 53 121 151 82 63 26 65 152 105 59

131

J. GELEUNS, J. J. BROERSE, J. ZOETELIEF, D . ZWEERS and J. G. VAN UNNIK are graphically compared with the noise and high con trast resolution respectively. DISCUSSION A ND CONCLUSION During the survey attention was focused on the absorbed dose and image quality met in daily practice at the participating hospitals. The methods employed proved to be practical and could be performed within less than two hours. CTDI values for different CT examinations showed variations by about a factor 56. For head examinations some high CTDI values, in excess of 200 mGy, were
30 1 20

measured. Radiation dose to the patient due to CT expressed as effective doses varied from 0.7 mSv to 21 mSv. Especially for CT body scans effective doses are high compared to, for example, effective doses from conventional radiography. For a specific examination such as CT scans of the head, chest or abdomen effective doses varied by a fac tor of 23. Variations in CTDI values are larger than variations in effective dose. This indicates that CTDI freeinair is not the most suitable parameter for esti mations of the radiation risks and it illustrates the importance of applying CT scanner specific organ dose conversion factors. In the survey of CT scanners no strong correlation was found between effective dose and image quality quantified as noise or high contrast resolution although a weak correlation is suggested, for example in Figure 3, except for scanner D. The lack of correlation might be due to differences in the characteristics of the CT scanners regarding sensitivity of the detector elements or due to differences in the selected radiation quality or image reconstruction algorithms. Variations in noise and high contrast resolution were modest for the different locations. Noise levels were, for example, at the differ ent locations for CT head 3.4 0.9 HU, for CT chest 12.1 3.8 HU and for CT abdomen 9.2 3.4 HU. ACKNOWLEDGEMENTS This research was supported by the Dutch ministry of Welfare, Health and Cultural A ffairs and by the J. A. Cohen Institute, Leiden, the Netherlands. Table 5. Effective doses calculated for some scanners from CTDI.
Scanner CT head Effective dose. E (mSv) CT chest 11 13 9.2 Il 11 6 10 9.5 CT abdomen 15 16 12 9.8 21 13 7.1 13 11

L H E (mSv)

Noise (HU)

Figure 3. CT abdomen examinations: effective dose (E) and noise () in the centre of an image of a 30 cm cylindrical water phantom.
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Figure 4. CT abdomen examinations: effective dose (E) and high contrastresolution(No. of arrays). REFERENCES

A C D F H I J M N

1.5 1.3 1.5 0.7 2.2 0.9 1.2 0.8 0.8 0.8

1. Shrimpton, P. C. Jones, D. G., Hillier, M. C, Wall, B. F., Le Heron, J. C. and Faulkner, K. Survey of CT Practice in the UK. Part 2: Dosimetric Aspects, NRPBR249 (1991). 2. Naidich, D. P., Marshall, C. H., Gribbin, C, A rams, R. S. and McCauley, D. I. Low D ose CT of the Lungs: Preliminary Observations, Radiology 175, 729731 (1990). 132

CT DOSE AND IMAGE QUALITY IN D UTCH HOSPITALS 3. Babbel, R., Hamsberger, H. R., Nelson B., Sonkens, J. and Hunt, S. Optimization of Techniques in Screening CT of the Sinuses. A m. J. Roentgenol. 157, 10931098 (1991). 4. Marmolya, G, Wiesen, E. J., Yagan, R., Haria, C. D. and Shah, A . C. Paranasal Sinuses: LowD ose CT. Radiology 181, 689691 (1991). 5. Zwirewich, C. V., Mayo, J. R. and Mller . L. Lowdose Highresolution CT of Lung Parenchyma. Radiology 180, 413 417(1991). 6. Lund, E. and Halaburt, H. Irradiation Dose to the Lens of the Eye during CT of the Head. Neuroradiology 22, 181184 (1982). 7. Jones, K. R. and Garett, J. H. Patient Absorbed D ose for Philips Tomoscan 300 CT Scanner, Br. J. Radiol. 58, 365 367 (1985). 8. Murphy, F. and Heaton, B. Patient D oses received during Whole Body Scanning using a Eliscint 905 CT Scanner. Br. J. Radiol., 58, 11971201 (1985). 9. Evans, S. H., Davis, R., Cooke, J. and Anderson, W. A Comparison of Radiation Dose to the Breast in Computed Tomography Chest Examinations for Two Scanning Protocols. Clin. Radiol. 40, 4546 (1989). 10. Mayo, J. R., Jackson, S. A . and Mller, . L. Highresolution CT of the Chest. Am. J. Roentgenol. 160, 479^81 (1993). 11. Shope, T. B., Gagne, R. M. and Johnson, G. C. A Method for D escribing the D oses D elivered by Transmission Xray Computed Tomography. Med. Phys. 8, 488495 (1981). 12. Mayo, J. R, Webb, W. R., Gould, R., Stein, M. G, Bass, I., Gamsu, G. and Goldberg, H. I. Highresolution CT of the Lungs: An Optimal Approach. Radiology 163, 507510 (1987). 13. McCrohan, J. L., Patterson, J. F., Gagne, R. M. and Goldstein, H. A. Average Radiation Doses in a Standard Head Examin ationfor 250 CT Systems. Radiology 163, 263268 (1987). 14. Conway, B. J., McCrohan, J. L., A ntonsen, R. G, Rueter, F. G., Slayton, R. J. and Suleiman, O. H. Average Radiation Dose in Standard CT Examinations of the Head: Results of the 1990 NEXT Survey. Radiology 184, 135140 (1992). 15. Panzer, W., Scheurer, C. and Zankl, M. Dose to Patients in Computed Tomographic Examinations: Results and Consequences from a Field Study in the Federal Republic of Germany. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores et al (London: British Institute of Radiology) BIR Report 20, pp. 185187 (1989). 16. Christensen, J. J., Jensen, L. C , Jessen, . ., Jrgensen, J., Petersen, J. and Sorensen, E. W. D osimetric Investigations in Computed Tomography. Radit. Prot. Dosim., 43, 233236 (1992). 17. Brsch, R.C. and Cann, C E . Computed Tomographic Scanning in Children: II An Updated Comparison of Radilion Dose and Resolving Power of Commercial Scanners. A m. J. Roentgenol. 138, 127133 (1982). 18. Wagner, L. K., Archer, B. R. and Zeck, O. F. Conceptus Dose from Two Stateoftheart CT Scanners. Radiology 159, 787 792 (1986). 19. Fearon, T. and Vucich, J. Normalized Pediatric OrganAbsorbed D oses from CTExaminations, A m. J. Roentgenol. 148, 171174 (1987). 20. Sager, . M., Skretting, A . and Lindskld, L. Absorbed D ose Resulting from a Specially D esigned Computer Tomography Technique for Examination of the Urinary Bladder. A cta Radiol. 30, 5760 (1989). 21. Vano, E., Gonzales, L., Calzado, ., Moran, P. and Delgado, V. Some Indicative Parameters on D iagnostic Radiology in Spain: First D ose Estimators. Br. J. Radiol. 62, 2026 (1989). 22. Nishizawa, K., Maruyama, T., Takayama, M., Okada, M Hachiya, J. and Furuya, Y. Determinations of Organ Doses and Effective D ose Equivalents from Computed Tomographic Examination, Br. J. Radiol. 64, 2028 (1991). 23. Tweed, J. J., Davis, M. L., Faulkner, K., Rawlings, D. J. and Foster, E. Patient Dose and Associated Risk due to Radiological Investigation of the Internal Auditory Meatus. Br. J. Radiol. 64, 447451 (1991). 24. Zankl, M., Panzer, W. and Drexler, G. The Calculation of D ose from External Photon Exposures using Reference Human Phantoms and Monte Carlo Methods. Part VI: Organ D oses from Computed Tomographic Examinations. GSFBericht 30/91 (1991). 25. Panzer, W. and Zankl, M. A Method for Estimating Embryo D oses Resulting from Computed Tomographic Examinations. Br. J. Radiol. 62, 936939 (1989). 26. ICRP. 1990 Recommendations of the International Commission on Radiological Protection. Publication 60 (Oxford: Pergamon) A nn. ICRP 21(13) (1991). 27. McCullough, E. C , Payne, J. T., Baker, H. L., Hattery, R. R., Sheedy, P. F., Stephens, D. H. and Gedgaudus, E. Performance Evaluation and Quality Assurance of Computed Tomography Scanners, with Illustrations from the EMI, ACTA and D elta Scanners. Radiology 120, 173188 (1976).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 135138 (1995) Nuclear Technology Publishing

IMAGE QUA LITY A ND DOSE DISTRIBUTION IN MULTISCA N AND FAST RING CT SYSTEMS
F. Levrero, G. Coscia, A . Pilot, F. Cavagnetto and E. Zucchi Servizio di Fisica Sanitaria, Ospedale S. Martino v. le Benedetto XV, 10, 16132 Genova, Italy Abstract Modem CT systems allow examinations with both multiscan and volumetric techniques. This study on image quality and dose distribution was carried out varying die operating conditions (step and slice thickness) for each technique. To describe the physical image quality two basic parameters were taken into account: spatial resolution and noise. The measurements were performed using an acrylic phantom, which includes a series of inserts for the response to spatial frequencies and a uniform insert for noise evaluation. The phantom images recorded on the film by a multiformat laser printer were acquired with a TV digitiser system and processed with a customised software package. Dosimetric evaluations were performed along the longitudinal axis using an air density equivalent phantom holding the TL dosemeters at the desired location. INTRODUCTION The relationship between image quality and dose in computerised tomography was investigated referring to the Esaote Biomedica A.TOM XR Fast Ring equipment. This system offers the facility to carry out CT examin ations in both volumetric and multiscan modes. The volumetric acquisition corresponds to continuous data collection and related images are reconstructed through interpolation processes at the desired spacing in the ana tomical region being analysed. Because the acquisition techniques are quite different in normal or volumetric mode, it is important to com pare the two methods varying the operating and recon struction conditions. The following parameters were taken into account: dose along longitudinal axis, single scan dose profiles, image spatial resolution and noise along transversal and longitudinal axes. The aim of the work was to evaluate the scanning parameters in each single examination, taking into account the real diagnostic requirements and the possi bility of reducing dose to patients. MATERIALS A ND METHODS A.TOM XR Fast Ring CT Scanner The system considered is a thirdgeneration continu ousrotation scanner"' with Fan = 47.1 and xenon detectors, equipped with a Varan GS 2070 CT X ray tube (400 mA , 130 kV). In normal mode scan times are 0.6, 1, 2 and 4 s, with slice thicknesses of 1, 2, 3, 5 and 10 mm. Scans can be performed at 100, 120 and 130 kV, with tube currents up to 400 mA. The volumetric CT option offers slice thicknesses of 2, 5 and 10 mm, with a 1 s rotation time and all avail able kV settings. Volumetric scans can be performed with a duration of up to 50 s (50 continuous rotations with continuous table movement and continuous data acquisition). The table speed can be varied from 1.5 to 20 mm.s"1. Image quality The measurements performed were restricted to spa tial resolution and noise'23'. Both values were obtained from a 20 cm diameter phantom including a region of inserts for the resolution measurement and a uniform region for the noise measurement. Spatial resolution is the capability of the system to reconstruct small size, high contrast details. The spatial resolution of the system in the various examination techniques is described using the modulation transfer function (MTF) which represents the contrast depen dence on spatial frequency. The phantom region referring to the spatial resolution measurement was composed of four spatial frequencies (0.05, 0.1, 0.2, 0.5 line pairs per mm (lp.mnr 1 ), any of which was achieved using a set of acrylic planes of corresponding thickness and spacing. The reconstructed
0.20

10

15

20

25

Table index (mm)

Figure I. Volumetric mode, transverse plane, MTF ( I lp.mm ') plotted against table index for each slice thickness: ( ) 2 mm, 175 mA.s; (A) 5 mm, 200 mA.s; () 10 mm, 200 mA.s.

135

F. LEVRERO, G. COSCIA, A. PILOT, F. CAVAGNETTO and E. ZUCCHI image presents the spatial frequencies pattern. The hardcopy film produced by the laser printer was acquired by a TV digitiser connected to a PC. A customised software package developed in C language fits the data to give the MTF function of the system under the specific conditions. Noise was measured by acquiring a laser printer hardcopy of the uniform region of the phantom. The distribution of the grey level is observed in 10 regions and as noise measurement the variance of the optical density distribution was assumed. Thermoluminescence dosimetry In order to investigate dosimetric delivery'4"8' LiF rods were used (0.1 0.6 cm2) and sensitivity factors obtained with l37Cs irradiation (1.5% uncertainty on the source exposure). The same source was used for the dose-response curve (from 8.76 mGy to 87.6 mGy). The X ray beam energy was investigated by HVL measurements. The experimental energy correction factor referring to the X ray beam used (120 kV, Eeff = 54 keV) was 1.082 + 0.004, in good agreement (about 2%) with published values. For each slice thickness and table index, 16 contiguous rods, held in an air-equivalent phantom and oriented along the longitudinal axis, were exposed three times to obtain multiscan average dose values for a fixed scan length, excluding rising and falling contributions to the multiscan dose profiles. RESULTS Both for image quality and dosimetry, the measurements were carried out at 120 kV, 200 mA and 1 s scan time. The current set in 2 mm slice thickness was 175 mA depending on the X ray tube small focal spot employed. Image quality All image quality measurements were performed with the abdomen standard reconstruction filter and 512 512 reconstruction matrix. Table 1 and Figures 1 and 2 show MTF measurements in normal mode and volumetric mode in the transverse and longitudinal plane respectively. The transverse values both in normal and in volumetric mode are similar (about 10% at 1 lp.mm"1), depending on the fact that transverse resolution is independent of

Table 1. Results summary table (in the DOSE column SD are indicated except for asterisked cases in which SD are replaced by standard errors).
Volumetric mode Slice thickness (mm) 2 Table index (mm) 1.5 2 3 3 5 10 5 10 20 Dose (mGy) Long.MTF(%) (0.2 lp.mm-') Tr.MTF(%) (1 lp.mm -1 ) Long.noise (xlO"3) Tr.noise (xl0~ 3 ) Long.S/N Long.S/N Dose 67.2 76.2 51.7 10.6 6.9 0.5 <0.3 <0.6 <0.8

33.7 0.8 26.3 1.0 16.5 1.9 57.4 2.1 34.5 1.1 17.2 0.9 70.8 1.4 34.9 1.0 18.4+ 1.6

53 52 41 23 14 4 <4 <4 <4

10 11 11 9 10 11 10 10 10

1.24 0.4 1.35 0.5 1.97 0.8 0.87 0.4 0.82 0.4 1.78 0.3 0.80 0.2 0.82 0.4 1.13 0.4

10.2 2.6 8.99 3.4 9.54 2.5 2.2 0.4 2.3 0.6 2.3 0.6 1.0 0.3 1.3 0.2 1.3 0.2

2265 2003 853 608 239 9 <20 <20 <14

10

Normal mode 2 1.5 2 3 3 5 10 5 10 20 38.1 1.7 28.0 0.8 18.3 0.5 59.3 2.1 37.4 0.9 18.8 3.6* 73.5 + 1.3 37.0 1.6 19.2 2.5* 11 11 11 10 10 10 1.6 0.5 1.6 0.5 1.6 0.5 1.1 0.2 1.1 0.2 1.1 0.2

10

136

IMAGE QUALITY AND DOSE DISTRIBUTION IN CT SYSTEMS longitudinal parameters (thickness, table index, scan Dosimetric evaluation number). The values referred to longitudinal reconstruc Dose delivery was investigated for each slice tion decrease with table index and slice thickness thickness employing prepatient collimation (2, 5 and increment. 10 mm). A s the number of scans contributing to the Table 1 and Figures 3 and 4 relate to noise measure multiple scan dose profile was increased, the average ments in the same MTF operating conditions. In all scan dose of the profile reached a limiting value, called multi modes noise decreases with slice thickness increment; scan average dose (MSA D). This limiting value was in volumetric mode, while for the transverse plane it is reached when the first and the last scan of the series independent of table index, for longitudinal reconstruc were sufficiently separated from the central scan of the tion it increases together with table index. series so that they did not contribute any significant dose to the region of the central scan. MSAD was chosen as a comparison index for doses 0.6 delivered by normal and volumetric mode. It is seen that a distance of at least 5 cm is sufficient to reach the limit 0.5 ing value. In the volumetric mode, for each slice thickness, the table indexes were chosen so that it was possible to have 0.4 _ either overlapped or contiguous or separate zones. The normal mode tests were performed using the same com 0.3 binations between slice thickness and table index. Q. The relationship between MSA D and table index for v each slice thickness are shown in Figures 5 and 6. 0.2 Numerical data are indicated in Table 1.
0.1
v

CONCLUSIONS
4 6 8 10 12

Table index (mm)

Figure 2. Volumetric mode, longitudinal plane MTF (0.2 lp.mm"') plotted against table index for each slice thick ness: ( ) 2 mm, 175 mA.s; (V) 5 mm, 200 mA.s.

In Table 1 the results relating to image quality analy sis and dosimetry are presented. A s expected, dose values are lower in volumetric mode than in the normal one. Furthermore, in volumetric mode dose decreases when the table index rises. As a first attempt to match dose with image quality, the ratio between signaltonoise and dose is expressed, where SN ratio is MTF2/noise. Only longitudinal image x10"3 3.0
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137

Figure 4. Volumetric mode, longitudinal plane, noise plotted against table index for each slice thickness: ( ) 2 mm, 175 mA.s; (V) 5 mm, 200 mA.s; (T) 10 mm, 200 mA.s.

F. LEVRERO, G. COSCIA, A. PILOT, F. CAVAGNETTO and E. ZUCCHI quality measurements are taken into account, since the transverse component remains almost constant. For each slice thickness, a table index that optimises the SN/dose ratio is expected. This is confirmed for 2 mm slice thickness, where the maximum SN/dose ratio is reached for 2 mm table index. To verify the same result for 5 and 10 mm slice thickness, further investigations are necessary referring to a smaller table index. ACKNOWLEDGEMENTS The authors are grateful to the medical team of the Cattedra di Radiologia R of the University of Genoa, particularly to Dr Giuseppe Cittadini, and to the techni cal team of Esaote Biomedica, Genoa.

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10 15 Table index (mm)

Figure 5. Volumetric mode, MSA D as function of table index. Slice thickness: () 2 mm, 175 m.A.s; () 5 mm, 200 mA.s; (A) 10 mm, 200 mA.s. REFERENCES

Figure 6. Normal mode, MSA D as function of table index. Slice thickness: ( ) 2 mm, 175 mA.s; (V) 5 mm, 200 mA.s; (T) 10 mm, 200 mA.s.

1. Steenbeek, J. C. M. Principles and Applications of Volumetric CT. Medicamundi 38(1), 2029 (1993). 2. Borasi, G., Castellani, G., Domenichini, R., Franchini, M., Granata, M., Torresin, A . and Tosi, G. Image Quality and Dose in Computerized Tomography: Evaluation of Four CT Scanners. Med. Phys. 11(3), 321325 (1984). 3. MaueDickson, W., Trefler, M. and Dickson, D. R. Comparison of D osimetry and Image Quality in Computed and Conven tional Tomography. Radiology 131, 509514 (1979). 4. Spkas, J. J. D ose D escriptors for Computed Tomography. Med. Phys. 9(2), 288292 (1982). 5. Gagne, R. M. Geometrical Aspects of Computed Tomography: Sensitivity Profile and Exposure Profile. Med. Phys. 16( I ), 2937 (1989). 6. Shope, T. B., Gagne, R. M. and Johnson, G. C. A Method for D escribing the Dose Delivered by Transmission Xray Computed Tomography. Med. Phys. 8(4), 488494 (1981). 7. McCrohan, J. L., Patterson, J. F., Gagne, R. M. and Goldstein, H. A. Average Radiation Doses in a Standard Head Examination for 250 CT Systems. Radiology 163(1), 263268 (1987). 8. Shope, . ., Morgan, T. J., Showalter, C. K., Pentlow, K. S., Rothenberg, L. N., White, D. R. and Speller, R. D. Radiation Dosimetry Survey of Computed Tomography Systems from Ten Manufacturers. Br. J. Radiol. 55, 6068 (1982).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 139140 (1995) Nuclear Technology Publishing

IMAGE QUA LITY CRITERIA A PPLIED TO DIGITA L RADIOGRAPHY


H. P. Buscht, K. Faulkner! and J. F. Malone fBrderkrankenhaus, Trier, Germany ^Newcastle General Hospital, Newcastle, UK St James's Hospital Dublin, Ireland Abstract Filmscreen radiography has been replaced more and more by digital imaging methods. The aim of this development is the extension of diagnostic capabilities and the reduction of patient discomfort and side effects such as radiation dose. For digital image intensifier radiography and luminescence radiography the image quality and the dose value can be adapted to the diagnostic problem in a broad range. Capabilities of digital radiography have changed the strategy of imaging. To decrease the dose value image quality has to be chosen to be not as good as possible but as good as necessary to answer the diagnostic question. Digital image intensifier radiography, for example, allows a dose reduction to 10% in comparison with film screen for special diagnostic problems. Digital radiography increases the diagnostic information and gives, additionally, the chance to lower the dose values significantly. In recent years conventional filmscreen radiography has been more and more replaced by Digital II radio graphy for fluoroscopic examination units. For Digital II radiography the image of the intensifier output screen can be directed to a spot film or 100 mm camera or to a video camera by a light distributor. Video signals go directly to a video monitor or for digitalisation to an image processing system. The main characteristics of Digital II radiography in comparison to filmscreen radiography are: (i) (ii) (iii) (iv) wide dynamic range; spatial resolution limited by a matrix 1024 1024; immediate availability of images; new possibilities of postprocessing, storage and data transfer. (iii) signaltonoise ratio; (iv) dynamic range by measuring the numerical values of attenuation step wedge. Semiquantitative parameters are spatial resolution and contrast detectability, measured by phantoms. For high image quality it is important that the whole imaging chain has a high performance level, including documentation and film processing. Different para meters can be quantified directly by numerical values or by subjective comparison of image quality. Parameters which can be determined in numerical form are the sig nal as a mean value, the noise, the signaltonoise ratio and the dynamic range. Imaging of test phantoms allows determination of parameters like the spatial resolution, and object detectability on the monitor or after docu mentation on films. Of course the measurement of dose is an important parameter to grade image quality. Digi tal test patterns, which are stored in the computer, can be used to control the quality of image demonstration on the monitors or documentation on films. For digital radiography, dose can be selected in a broad range (Figure 1). This means that the radiation dose for the patient can be adapted to the diagnostic problem. By automatic control the image brightness is

Storage phospor radiography or luminescence radio graphy came into clinical application 10 years ago. In storage phosphor radiography special imaging plates are used instead of conventional X ray films. A central pro cessing unit reads the imaging plates using a laser beam and stores the image information digitally in a 2000 2000 matrix. A final homogeneous light emis sion deletes the image information. The imaging plate is now ready for new exposures. The imaging capabili ties of storage phosphor radiography are characterised by: (i) (ii) (iii) (iv) wide dynamic range; limited spatial resolution by a 2000 2000 matrix; automatic image optimisation; new possibilities of postprocessing, storage and data transfer.

Digital radiography offers new possibilities to quan tify image quality by numerical values. Digital para meters are: signal by the mean value within a region of interest; (ii) noise by the standard deviation; (i)

ft
14 cm B V

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20 cm B V 28 cm BV 40 cm BV

Figure I. Preselectable entrance dose values for digital image intensifier radiography. 139

1 J

H. P. BUSCH, K. FAULKNER and J. F. MALONE nearly independent of the dose. This contrasts with film-screen radiography, but due to physical laws a lower dose is connected to a lower signal-to-noise ratio. It is thus necessary to answer the question: What is the lowest dose necessary for special diagnostic problems? The following examples will give an impression of the wide range of necessary image quality and of dose values. In Figure 2 a double contrast examination of the stomach with high image quality is demonstrated; in Figure 3 a functional examination of a newborn is shown. In this case the diagnostic problem of gastrointestinal abnormalities had to be evaluated and a much lower signal-to-noise ratio and a much lower dose value was needed. For a high quality image the selected dose was about 40% of a film-screen combination speed 200, for an image with lower quality it was about 3% of a 200 film-screen system. As a summary, digital radiography gives new possibilities of imaging. The numerical form of image information leads to new parameter for image quality like signal-to-noise ratio. But the different possibilities of postprocessing makes the evaluation of image quality more complex than for conventional film-screen, radio-

Figure 2. Image of a stomach after surgery. REFERENCES

Figure 3. Image of a stomach of a newborn.

1. Busch, H. P.. May, S., Wrtche, R. and Lehmann, K. J. Test Phantoms in Digital Radiography. Radit. Prot. Dosim. 49(1/3), 261-264(1993). 2. Busch. H. P. and Lehmann K. J. Quality Assurance in Digital Radiography. In: Technical and Physical Parameters for Quality Assurance in Medical Diagnostic Radiology. Eds B. M. Moores et al. BIR Reprot. 18, pp 117-120 (London: British Institute of Radiology) (1989). 3. Lehmann, K. J.. Busch, H. P. and Georgi, M. Digitale Bildverstrker-Radiographie welche Aufnahmedosis fr welche klinische Fragestellung1} Akt. Radiol. 2, 11-15 (1992). 4. Busch. H. P. and Georgi M. Digital Radiography Clinical Experience with Digital Image Intensifier and Storage Phosphor Radiography (Berlin: Blackwell Wissenschaft) (1992).

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Radiation Protection Dosimetry Vol. 57, Nos 1^1, pp. 141143 (1995) Nuclear Technology Publishing

STANDARD TOOLS FOR A NA LYSIS OF IMA GE QUA LITY IN DIGITAL IMA GING
N. Meier and M. Fiebich Institute of Clinical Radiology AlbertSchweitzer Strae 33, D48129 Mnster, Germany Abstract Increasing numbers of images in radiology and nuclear medicine are digital images. Various methods for quality analysis in digital imaging are studied. Images from two different digital luminescence systems and a computer tomograph are analysed by testing signaltonoise ratio, modulation transfer function and Wiener spectra. The influence of different analytical methods is also described. The reproducibility of the measurements under specified conditions and analytical methods is shown. The results vary over a wide range and demonstrate the need for standardised experimental setup and numeric analysis. Compar ability of methodologies is important for determining and improving image quality in digital imaging, especially in view of patient dose reduction. INTRODUCTION The system under investigation is a prototype by Eastman Kodak. The system includes three components: a reading station for storage phosphor plates (Kodak Ektascan Storage Phosphor Reader, KESPR), a work station for rough quality checks (QCW), and a second workstation for reporting (Patient Display Station, PDS). For documentation purposes a laser imager (Kodak, XLP) is used. The KESPR and QCW is installed directly in the Intensive Care Unit (ICU). The second workstation PDS and the laser imager XLP are located 16 floors below the ICU in the Department of Radiology. A ll components are part of a fibre optic net work (Figure 1). If such systems are introduced, they will be compared to existing systems already on the market. The compa nies themselves usually (reluctantly) give information about system performance if asked; however, instal lations in hospitals do not work under laboratory con ditions and therefore perform differently. Comparing physical parameters to existing data in literature is a tedious (if not impossible) process in many cases, since authors do not disclose information about how the data was acquired or calculated. A s we will only look at physical image quality here, parameters such as costs, organisational impact, and influence on reporting and reporting time will not be discussed. METHODS Among the physical parameters tested were the sig naltonoise ratio (SNR), the modulation transfer func tion (MTF), and the Wiener spectrum (WS), as these are the main tools determining the quality of the investi gated digital system. The basis for all these measure ments are images produced with an X ray device. In agreement with a protocol given by the German Institute of Standardization (DIN), the following exposure con ditions were used: The image plate cassette (IP) was exposed with 70 kVp and 5.0 Gy in the film plane using a (patient equivalent, focus near) square alu minium block of 21 mm thickness. It is known that MTF is largely independent of dose in the film plane, therefore these typical settings were chosen for MTF analysis. It is necessary that a high contrast edge is depicted in the image. For this purpose a square wave Pb grid showing 0.2510.00 cycles per mm was placed on the cassette. The Wiener spectrum can be calculated from a homogeneously exposed square in the centre of the same image. For SNR evaluation several images with different X ray exposures are necessary. Exposure was measured using a calibrated dosemeter (PTW DALi). Images with 2.5, 5, 10, and 20 Gy dose in the film plane were taken, corresponding to 400, 200, 100, and 50 class conventional systems respectively. The MTF, SNR, and WS were determined using the raw data and a personal computer running IMA GE 1.47 (National Institutes of Health, NIMH) modified to calcu late MTF, SNR, and WS. The X ray device has a middle frequency converter type generator (Philips S80 CPD).
141

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Floor 19 Intensive Care Unit Floor 03 Institute of Clinical Radiology Thinwire Ethernet

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Figure I. Installation in Mnster. KESPR and QCW are placed directly in the ICU on Floor 19. Catheter control can be evaluated almost online on the QCW. Reporting is only poss ible at the PDS or on film both installed in the Department of Radiology on the third floor.

N. MEIER and M. FIEBICH For comparison, raw data of two different digital luminescence systems were used. Kodak, KESPR and Siemens, Digiscan, using image plates of the type SO 237 (Kodak) and STIII (Siemens) under identical exposure conditions. MODULATION TRA NSFER FUNCTION The M T F " is calculated by measuring the amplitude at 0.25 cy.mrn"' and the relative damping of higher fre quencies up to 4.0 cy.mrn"1 or the maximum theoretical resolution yielding the contrast transfer function M T (r) for the square wave grid, which is transformed into MTF based on a sinusoidal grid by the relation , , W , N , M T (3r) M s (r) = I M T (r) + F = M T (nr) M T (5r) + +F. t= m t * m Spatial frequency (cy.mrrr1) Figure 3. Comparison of modular transfer factors in KESPR and Digiscan. In the low frequency domain they are identical within the error limits. In the high frequency area (>1 cy.mrn"') Digiscan shows better characteristics (both curves were averaged). 100 80 60 The numbers for mean and standard deviation calcu lated from the raw data have to be logarithmically trans formed into mean dose and standard deviation of dose. The SNR can otherwise not be taken for comparison of the two systems since they have a different logarithmic offsets. This is done by fitting a curve to the data and calculating the dose values corresponding to the mean (number) and standard deviation (number) using a trans

(lHlM
0

where m is the number of primes into which n can be broken down, t the number of different primes in n, and r the spatial frequency. The series was discontinued at n = 15. The amplitudes M T (r) were determined by plac ing a rectangular region of interest perpendicularly across the image of the square wave linegrid. The width of the rectangle was chosen to be 5 mm (~30 pixels) which was averaged to reduce noise in the data (Figure 2). Results show that the MTF of the investigated digital system differs slightly at 20% amplitude from the Digis can system used for comparison, with 1.9 cycles per mm and 2.3 cy.mrn" 1 respectively (Figure 3). In the low frequency region there was no difference between the two systems within the error limits; however there was an overall tendency towards lower performance in the KESPR. SIGNALTONOISE RA TIO The signal to noise ratios"^" were calculated using the ratio of the mean value in a defined square region 20,000 pixels in size and the standard deviation. SNR = Mean St.dev.

Kodak Siemens

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Figure 4. Signaltonoise ratios of KESPR and Digiscan. The curves termed S/N were calculated using mean and standard deviation. The other curves (S/N dose) were calculated trans forming into the dose domain. These results are comparable since they are invariant to linear transformations.

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Figure 5. Qualitative plot of different noise sources.

STANDARD TOOLS FOR ANALYSIS formation function (linear regression) obtained directly by measuring the raw data value against the dose in the film plane (for Digiscan this can be calculated from S and L values on the image). The results show great differences for the two systems (Figure 4), again with the investigated system performing slightly less efficiently than the system used for comparison. WIENER SPECTRUM A homogeneously exposed image still shows local differences in intensity due to quantum noise and noise introduced by the imaging system including detector, photomultiplier, etc. (Figure 5). The spectrum of frequencies and amplitudes comprising the noise can be described by the noise power density spectrum called the Wiener spectrum W(u,v), or the noise amplitude spectrum N(u,v) given by(5) N(u,v) = V[W(u,v)] W(u,v) can be determined by Fourier transformation of the spatial intensity variance found in an infinitely long thin slit taken from the image along a given analysis axis. The finite boundaries actually taken only approximate to this function. With sufficient slit length N this approximation becomes acceptable. In digital images W(u,v) is given by W(u,v) : MN exp

OF IMAGE QUALITY IN DIGITAL IMAGING the direction along the frequency axis u a slice is cut out of the two-dimensional spectrum. The width of this slice is given by the slit length ( = 1/M). The Wiener spectrum is a representation of the slice along frequency axis u. The frequency resolution Au is determined by the scan length along this axis Au = 1/(*). For comparison, raw data values of the different systems have to be transformed into dose values (analogous to the calculation of the signal-tonoise ratio). The results are shown in Figure 6. SUMMARY It is of central importance that image acquisition, exposure conditions, and calculation methods be disclosed in full to the user and, for comparison purposes of new and different digital systems, that they are standardised to dose values.
x10-!

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. /ux
-21 M
+

0.5

1.0 1.5 2.0 2.5 Spatial frequency (cy.mrrr1)

3.0

where is the length and M the width of the slit. In REFERENCES

Figure 6. The Wiener spectra of KESPR and Digiscan. The spectrum is a measure of the frequency characteristics of the noise. Slit dimensions M = 32, = 3, =1, and = 512 (pixels).

1. Giger, M. L. and Doi, K. Investigation of Basic Imaging Properties in Digital Radiography. 1. Modulation Transfer Function Med. Phys. 11(3), 287-295 (1984). 2. Moran, P. R. A Physical Statistics Theory for Detectability of Target Signals in Noisy Images. I. Mathematical Background Empirical Review, and Development of Theory. Med. Phys. 9, 401-413 (1982). 3. Wagner, R. F. Towards a Unified View of Radiological Imaging Systems. Part II: Noisy Images. Med. Phys. 14(5), 279-296(1987). 4. Wagner, R. F. and Brown, D. G. Unified SNR Analysis of Medical Imaging Systems. Phys. Med. Biol. 30, 489-518 (1985). 5. Giger, M. L., Doi, . and Metz, C. E. Investigation of Basic Imaging Properties in Digital Radiography. 2. Noise Wiener Spectrum. Med. Phys. 11(6), 797-811 (1984).

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 145-149 (1995) Nuclear Technology Publishing

A NOVEL VIEW ON DETAIL PERCEPTION AND ON THE INFLUENCE OF THE FILM SYSTEM PARAMETERS
R. Bollen Agfa-Gevaert NV Seplestraat 27 2640 Mortsel, Belgium Abstract A perception technique, called the perception probability curve (PPC) technique, is presented. It is based on the determination of the perception chance of details of different contrast, and on the plotting of the chances along a cumulative probability scale for each detail contrast. Psychometric data obtained for industrial and medical radiographic systems according to this technique support a perception model which has been developed for it. INTRODUCTION When perception or detection is a result of pattern recognition, pattern transfer must be a main issue in the imaging process. In regular imaging the conversion of the scenery or object into, for example, light or X radiation patterns may be considered as a logarithmic process. Intensity patterns may vary according to the illumination level of the light or X ray source. The pattern of the logarithm of the intensities or the density pattern, however, remains independent of the illumination level. It is therefore not surprising that nature has provided man with an almost logarithmic visual detector. During transfer, image patterns may degrade by imperfect transfer of some spatial waves according to T(m), by generation of noise or superposition of artefact patterns. The best known effect of degradation by MTF lowering is the loss of sharpness due to poor transfer of the high spatial frequencies. The best known effect of degradation by noise is crenation of the detail's edges and mottling, like a Swiss cheese within structures. Most details in scenery or an object have a lot of abundance in their power spectrum and can suffer a lot of degradation during transfer before becoming another image. Once becoming faint, however, even a minor degradation may render a whole detail or part of it not perceptible or may make it resemble something else. Guessing and taking the risk of being wrong is then all that is left to the observer. Noise itself can rarely compose a shape pattern suggesting a specific detail except for detail with a very primitive pattern. By application of the well-known psychometric receiver operating characteristic (ROC) technique"' the balance of such guessing can be determined and expressed in terms of true and false positives, true and false negatives. Practical reasons, however, often make the ROC technique hard to apply, especially for routine evaluation. Therefore, a hybrid method is mostly applied by which the observers are asked to indicate how sure they are about their positive or negative diagnosis. According to the psychometric technique presented in this paper the chance of perception according to the contrast of the details is determined. By plotting the data on a suitable diagram ROC characteristics are also obtained. Because this plotting is fundamental to the new technique, before the experimental data are presented, appeal is made to a perception model. PERCEPTION MODEL Suppose a homogeneous exposure of identical details is made. The observer counts the number of details he perceives and calculates the percentage against those actually present. The percentage describes the perception chance of the detail. The same procedure is repeated for details with same shape and projection size but different physical contrasts. The curve obtained when plotting the perception probability along a cumulative probability scale against the density contrasts ADp0 of the details is called a perception probability curve (PPC). Figure 1(a) shows what PCC may be expected by a noiseless image. All details generating a AD lower than the density contrast threshold for perception ADp0 have perception probability 0%, all details generating a density contrast higher than ADp0 have a probability 100%. The PPC is a vertical line at detail contrast ADp0. Internal noise of the human visual system, which some people suggest will be present, would tilt the line clockwise around the 50%pp point. The psychometric tests done in that respect proved, however, that if no tilting was occurring, then internal noise was not present or, if any, it must be low. Instead the tests showed that already, after about 10 min of perception, fatigue starts shifting ADp itself to higher levels. Therefore, when setting up psychometric tests, duration of the perception sessions has to be short. Obviously the density contrasts in discussion here are the contrasts as experienced in the observer's eye. When expressed, e.g. in film density contrast, values will differ 145

R. BOLLEN pp

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146

according to the MTF of the observer's visual system Tv(m), contrast lowering by parasitic light entering the eye(2), etc. For simplicity of the model these parameters will not be taken into account. By the psychometric tests themselves, however, they must, since they may strongly influence the results. ADp0 may differ strongly between observers. The psychometric results suggest that, although sometimes specified otherwise even in psychometric method standards'3', raw perception data obtained from different observers may never be added together to get mean perception data. The difference in perception threshold between observers, e.g. because of different Tv(m), is a noise on the psychometric evalu ation. Its effect may exceed by far the difference in noise between the imaging system in evaluation. Pro ceeding according to A STM E746<3), which prescribes addition of perception scores, made it seem that the mean density contrast level for 50% perception prob ability of all film systems for NDT was noise independent<4). In reality, the noise generated by adding the data of the different observers overshadowed all other noise sources. Image quality evaluation has to be considered as a personal experience with respect to the imaging systems being evaluated. The rankings of dif ferent observers may be averaged, not the raw percep tion data themselves. Suppose one and another similar noise pattern could be superimposed on all details. Since spatial noise distri bution is identical on all details, all detail pattern will be mottled in the same way and to the same amount. As experienced in the psychometric testing, the PPC shifts to a higher AD value, leaving the slope unchanged as illustrated in Figure 1 (b). In order to avoid the unde sirable influence of the density increase by superim posing the noise film, the luminance of the view box was adjusted. Finally suppose that, instead of superimposing one and another similar noise pattern, a random noise is gen erated in the image. A clockwise rotation around the 50%pp point may now be expected, as illustrated in Fig ure 1(c). Notice that random noise lowers the perception chance of the details with density contrasts higher than the former A Dp of Figure 1 (b), but gives to details with density contrasts lower than A Dp a certain perception probability, be it lower than 50%. Reason for that becoming perceptable is that while the mean density contrast of these details remains unchanged, the positive tops of the density fluctuation of the noise bring part of the detail above the perception threshold. Of course, these detail images will be strongly mottled but will have now a chance of being detected. The closer their contrast to the former A Dp, the higher the perception gain. In the psychometric tests, medical and industrial, it has been found that the PPCs of all observers, although they showed large differences in A Dp5rre, have a slope proportional to (ADp5(wADp) and a shape factor. This shape factor is determined by detail type and decreases

DETAIL PERCEPTION AND INFLUENCE OF THE FILM SYSTEM PARAMETERS with the complexity of the detail's shape. When quant ified by the ratio of the density contrast requested for a 84% perception probability (1) to the density contrast requested for a 50% perception probability, it has been found that this factor was about 1.13 for lineshaped details and 1.37 for holeshaped details. Summarising previous reasoning, Figure 2 shows how PPC may be expected to evolve according to noise level. From a vertical curve at level A Dp0 in absence of noise, the curves shift, when noise increases, to higher ADp values and lower their slope according to (ADp50%ADpo) and the shape factor of the detail. When performing psychometric tests it is often easier and also more meaningful to the radiologist to express detail contrast not by the density contrasts they generate, but either by the radiation contrast (A logK) they gener ate or by their physical contrast (Tph) in the object, e.g. depth of hole. The transformation then to be performed can be outlined by: AD = TD(m) G AlogK = TD(m) G 0.43 (1) (2)

TD(m) being the MTF of the imaging system for density patterns, and G the sensitometric gradient of the imag ing system. When such contrast parameters are plotted along the
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147

R. BOLLEN detail contrast axis it may be clear that the PPCs will Figure 4 shows the PPCs obtained for the STRUCshift and change slope accordingly. TURIX D7p film system by one observer at densities Figure 3 reveals the relation between PCC and the 1.00, 1.50 and 2.00. The shape factor for the holeROC characteristics, i.e. true positive, false negative, shaped details is about 1.37. ADp5(re varies profalse positive and true negative. With the PCC technique portionally to D" \ That means that the signal-to-noise no blanks are requested, since false positive and true ratio for that perception score remains constant, since by negative scores correspond to the pp value for zero such film systems noise varies proportionally to D" s l5). detail contrast, which may be obtained by extrapolation These findings also agree with the perception model, of the PPC. Details with a high shape factor will yield since the shifting and rotation of the PCCs are exactly a higher false positive score than details with a low as expected according to the model. (For people familiar shape factor. Details of low complexity are more prone with such non-destructive test film systems: notwithto be suggested by noise pattern than the more com- standing noise increases with density it is worthwhile plex ones. making high density images, since the sensitometric gradient increases almost proportionally to D. Hence, the perceptibility of the physical details in the object EXPERIMENTATION AND COMMENTS will increase approximately proportionally to D\) The perception model is based on PPCs obtained for: Figure 5 shows the PPCs obtained for the screen-film system CURIX Ortho HTU/CURIX Ortho Medium at 1 (1) lp.mm" line patterns, each producing in projection densities 0.9 and 2.2 by three observers. The shape facan image within an area with a diameter of 8 mm tor for the line-shaped details is 1.13 for all observers and having different silver content, for 80 kVp and both densities. Observer 1 performs much better exposures on CURIX medical screen-film systems, than observer 3 at low density, but not at high density. which cover a speed range from 130 to 550 1/mGy. Notice also how close the experimental points fit the (2) Hole-type details with diameters of 0.5-0.6 and PPCs notwithstanding the large density contrast scale. (31 0.7 mm, as described in ASTM E746 , for 200 kVp The human visual system must be extremely sensitive exposures on STRUCTURIX industrial film types, which cover a speed range from 50 to 400 1/mGy. Presentation of all PPCs is beyond the scope and available space of this paper.

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Figure 4. PCCs for one observer for STRUCTURIX D7p at densities 1.0. 1.5 and 2.0 for hole-shaped details.
148

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3

as it is capable of differentiating by perception chance evaluation on a noisy image density contrast differences less than 0.001! A t net density 1.0, PCCs when plotted against the density contrast A D of the details, for each observer, all coincided; when plotted against the radi ation contrasts A logK of the details PCCs for the higher speedfilm systems shifted to higher A logK values in proportion to T ( l ) , the MTF at spatial frequency 1 mm" 1 . These results confirm the results obtained by means of another psychometric technique, i.e. percepti bility curve technique 161 . By this technique the number of perceptible density and/or radiation contrast steps within a radiation range can be determined. The study proved that all these screenfilm systems, notwithstand ing their large differences in speed, provided the same number of perceptible density contrast steps, but that the number of perceptible radiation contrast steps or the number of differentiable details in an object, were dif ferent according the differences in MTF 17 '. A ll these screenfilm systems yield an almost equal RMS noise but have different noise spectra. The low frequency noise components mainly affect the line pattern along their length and render parts of them notperceptible; the high frequency components mainly affect the line pattern perpendicular to the lines and crenate them. CONCLUSION By introducing the PPC technique which is based on the determination of the perception chance of details of different contrast, and on the plotting of the perception chances along a cumulative probability scale for each detail contrast, a new experimental world for image quality evaluation has been opened. The corresponding perception model brings a better understanding of the phenomena involved.

REFERENCES Swets, A . Assessment of ND T Systems Part 1: The Relationship of True and False D etection. Materials Evaluation (October 1983). Bollen, R. and Vranckx, J. The Influence of Ambient Light on the "Visual" Sensitometric Properties and D etail Perception on a Radiograph. In: SPIE Proc. Vol. 273, A pplication of Optical Instrumentation in Medicine IX (1981). ASTM. Standard Method for D etermining Relative Quality Response of Industrial Radiographic Film. ASTM E74680 ( 1980). Bollen, R. and Perdieus, P. D er Zusammenhang zwischen der Bildqualitt und den Filmsystemparametern nach D IN/EN 5841 zur Klassifizierung von Filmsystemen. Proceedings Jahrestagung DGZfP. Fulda (1992). Bollen, R. and Borcke, E. D ie Theoretische Begrndung eines neuartigen Systems zur Bestimmung der Bildqualitt (QWS) am Beispiel des D iagrammes: Filme und optische D ichte. In: Proc. 3rd European Conf. on Nondestructive Testing Florence (1984). De Belder, M., Bollen, R. and Van Esch, R. A New Evaluation Method of Radiographic Systems. In: SPIE Proc. Medical Xray Photooplical Systems Evaluation. Vol. 56 (1975). Bollen. R Blenl. C , Kierdorf. M. and Frey tag. K.H. Psychometric Evaluation of the Information Capability (ITC) of Radio graphic Screen Film Systems; Correlation of ITC with Image Quality Parameters and Viewing Conditions. Radiology (submitted).

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 151-154 (1995) Nuclear Technology Publishing

OPTIMISATION OF IMAGE QUALITY IN MAMMOGRAPHY


K. J. Robson, C. J. Kotre and K. Faulkner Regional Medical Physics Department Newcastle General Hospital, Westgate Road Newcastle-upon-Tyne NE4 6BE, UK Abstract In mammography it is particularly important that the maximum amount of diagnostic information is obtained from each radiograph. One of the factors influencing image quality is the optical density of the film. In this work the Newcastle contrast-detail test object was used to establish the optimum optical density value for onefilm-screencombination. Films taken using various mA.s values were developed in a nominally optimised film processor to mimic the real situation. The films were then viewed under optimum conditions on a variable brightness lightbox and the threshold contrast for each disc size calculated. Threshold contrast was plotted against optical density for each disc size and a curve fitted through the points. The optimum optical density, taken as being the point at which the threshold contrast is a minimum varied little with disc size. Averaged over all disc sizes the value of optimum density for this particular case was found to be 1.71 OD. INTRODUCTION It is important in any radiological examination that the maximum amount of information is obtained from the radiograph. This is especially true of a breast screening programme where the purpose of the examination is to detect by radiographic means, lesions which would otherwise be occult. In order that this may be achieved, the whole system should be fully optimised. One area that has not been addressed is the determination of the optimum optical density (O.D.). Most mammograms are taken under automatic exposure control (AEC), the purpose of which is to maintain the same film density on a radiograph regardless of the size or composition of the breast. At present no recognised target optical density exists in the UK and a recent publication"' showed that the film density obtained when a 4 cm Perspex block is exposed using the AEC varied greatly across the country (ranging between 0.5 and 2.5 OD). Clearly, not all these units can be operating at the optimum optical density. One of the recommendations of the report was the adoption of a standard target OD. A target OD of 1.0-1.5 has been recommended by the Commission of the European Communities (CEC)'2'. What is required is some way of finding the optimum optical density and a straightforward way of setting the system up so that it operates at this optimum. The total noise on a radiograph is made up of film granularity, quantum mottle and structure mottle from the screen. It is a difficult task to separate out each of these individual contributions as each component has its own noise power spectrum which will, in general, be a complex function of exposure level and optical density'3'. In practice, if a screening unit wanted to change the optical density of the films, this would be achieved by adjusting the AEC i.e. altering the dose rather than the nominally optimised film processor. Since this will cause a complex change in the noise, it is difficult to predict the response of the signal-tonoise ratio. A proven method of assessing imaging performance is by the use of threshold contrast-detail diameter tests'45'. In this work, contrast-detail measurements are used to find the optimum density level. METHOD The Newcastle contrast-detail test object has been described previously'6'. Radiographs of the test object were taken on a Siemens Mammomat 2 mammography unit with a realistic spectrum obtained by using Perspex attenuation to simulate soft tissue. Because the spectrum used in this study is different to that for which the test object was originally designed, it was necessary to recalculate the contrasts. The recalculation of the contrasts assumed scatter-free conditions, an assumption whose validity was verified experimentally. The test object was placed at the bottom of a stack of Perspex whose total thickness was 37 mm, approximately the thickness of the standard breast phantom'7' and a series of exposures at different mA.s values were made to provide radiographs of different optical densities. A Kodak MinR-2 cassette was used with Min-RE film and the film processed in Kodak X-Omat chemistry on a 3 min cycle at 36C. The air kerma in the plane of the film behind the Perspex was measured by placing an ionisation chamber in the cassette holder and the output calculated in Gy/mA.s. The dose to each of the test object films was then calculated from a knowledge of the mA.s and the output. The optical density measured off the test object films at a reference point near the chest wall side of the film was plotted against the dose to give the film-screen characteristic curve. The radiographs of the test object were read out on variable brightness lightbox over a wide range of lightbox luminances under optimum viewing conditions by two experienced observers. The area of the lightbox around the film was blanked off so as to reduce glare and the room lights dimmed. The films were read in

151

A V . 7. ROBSON, C. J. 077 aw/ A". FAULKNER 10

9 mm discs

10-,

5 m m discs

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0.1 0

0.5

1.0

1.5

2.0

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3.0

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0.1 4 0 10

1 0.5

Optical density

1 1 1 1 1.0 1.5 2.0 2.5 Optical density

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3.5

- 4 mm discs

2 o .c 0 10 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Optical density 1 2 m m discs
1

3 m m discs

'

0.1 i

0.5

1.0

1.5

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2.5

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3.5

Optical density 1.5 m m discs

2 o

-C

0.1 0 _ 10-,

0.1 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Optical density 100 0.5 m m discs

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Optical density 1 m m discs

o o

1 2 o

10-

0.1 0

11 1 1 1 1 1 1

0.5

1.0 1.5 2.0 2.5 Optical density

3.0

3.5

05

1.0

1.5 2.0 2.5 Optical density

3.0

3.5

Figure l. Series of graphs showing the relationship between threshold contrast (CT) and optical density for each disc size. The curves are second order polynomial fits and the error bar is a standard error of 18%.

152

OPTIMISATION OF IMAGE QUALITY IN MAMMOGRAPHY random order and half marks were awarded if there was Figure 1. Because of the heel effect, the density falls doubt as to whether a disc was present or not and the off towards the nipple side of the film. Due to the design average of two viewing sessions taken. The threshold of the test object, this effect is greater for the largest contrast was calculated for each disc size, plotted discs as they are towards the nipple side. In order to against optical density and a second order polynomial compensate for this, for each reading, the optical density fitted through points. The error on the threshold contrast was measured near to where the final disc was seen. was calculated according to the method of Cohen et allS) These values of optical density were used in the plots which for two observers and one film is 18%. of threshold contrast against optical density. The error bar shown on each graph represents a stan dard error of + 18% calculated according to the method RESULTS A ND DISCUSSION of Cohen et /'8'. The optimum OD will be that at which The family of curves of threshold contrast plotted the signaltonoise ratio is a maximum, i.e. threshold against optical density for each disc size are shown in contrast is a minimum. The position of the minimum threshold contrast was calculated and found to vary only slightly with disc size. A cross the range of disc sizes, the optimum optical density lay between 1.631.80 OD with a mean value of 1.71 optical density units. The mean glandular dose to the standard breast for an optical : 3 density of 1.71 was calculated according to the IPSM CD method'9' and found to be 1.06 mGy. E E The characteristic curve for the filmscreen combi 2: nation was plotted and a sigmoid curve fitted to the points using a commercially available software package o (FigP, Durham, NC, USA). This equation was then dif Q. ferentiated and expressed as a function of optical den sity. The differential of the characteristic curve is the point gamma (y) and for a given input contrast, the sig 0 I > |r-i r-i(-' I I nal will be greatest at the point of maximum gamma. Plotting gamma against optical density gives the curve 0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 shown in Figure 2 which has a maximum at an optical Optical density density of 1.71 OD. It was found that above a luminance of about Figure 2. Plot of point gamma () against optical density. The 2 points shown represent the optical densities of the radiographs 200 cd.m" the effect of lightbox brightness on contrast detail performance was small compared with the influ used in the study. ence of optical density. This result agrees with that of 10 Guibelalde et al00' who show that lightbox brightness has little effect on 'contrast sensitivity' above a thres hold luminance of approx 250 cd.m"2. Contrastdetail curves for three luminances are shown in Figure 3. CONCLUSIONS
c o u
]3 O -C
(

>

-C

0.1
0.1 10 Detail size (mm)

100

Figure 3. Contrastdetail curves for three lightbox luminances: (D) 170 cd.m"2, () 600cd.m"2 and (V) 2800 cd.m"2. Again, the standard error is 18%.

The optimum optical density for one filmscreen combination under particular processing conditions has been determined on the basis of contrastdetail measurements to be 1.71 OD. This optimum value is found to lie at the point at which the point 7 of the film screen combination is a maximum. The significance of this result is that for this particular system, despite the complex noise functions, the optimum optical density is that at which the instantaneous slope of the filmscreen characteristic curve is a maximum. This result shows that the 'perceived noise' is relatively constant over a range of optical densities surrounding the optimum point. However, this is not a general result. If the same experiment were performed but the processing speed, for example, was different, the relative contributions of the noise sources would be different and would not in
153

K. J. ROBSON. C. J. KOTRE and K. FAULKNER general result in the 'perceived noise' being a flat funetion of density. This would result in the optimum OD from SNR (contrast-detail) measurements being shifted with respect to the peak in the y against OD curve. The demonstration of the optimum optical density by contrast-detail measurements confirms the value of quantitative image quality test objects and signal-toREFERENCES 1. NHS BSP. Review of Mammography Equipment and its Performance. NHS BSP Publication 24 (1992). 2. Commission of the European Communities. European Protocol for the Quality Control of the Technical Aspects of Mammography Screening, V/775/92(2) (Brussels: CEC) (1992). 3. Barnes, G. T. and Chakraborty, D. P. Radiographic Mottle and Patient Exposure in Mammography. Radiology, 145, 815821 (1982). 4. Burger, G. C. E. Phantom Tests with X-Rays. Philips Tech. Rev. 11(10), 291-298 (1950). 5. Cohen, G, Wagner, L. K., Amtey, S. R. and DiBianca, F. A. Contrast-Detail-Dose and Dose Efficiency Analysis of a Scanning Digital and a Screen-Film-Grid Radiographic System. Med. Phys. 8(3), 358-367 (1981). 6. Faulkner, K. and Thompson, S. R. Optimisation of a Dedicated Mammographie Film Processor using a Test Phantom. Radit. Prot. Dosim. 49(1/3), 213-215 (1993). 7. Dance, D. R. Monte Carlo Calculation of Conversion Factors for the Estimation of Mean Glandular Breast Dose. Phys. Med. Biol. 35(9), 1211-1219 (1990). 8. Cohen, G., McDaniel, D. L. and Wagner, L. K. Analysis of Variations in Contrast-Detail Experiments. Med. Phys. 11(4), 469^*73 (1984). 9. IPSM. Commissioning and Routine Testing of Mammographie X-ray Systems. Report 59. York: IPSM (1989). 10. Guibelalde, E., Van, E. and Llorca, A. L. Quality Assurance of Viewing Boxes: Proposal for Establishing Minimum Requirements and Results from a Spanish Quality Control Programme. Br. J. Radiol. 63, 564-567 (1990). noise ratio in optimisation. On the basis of the results presented here, for the mammography system studied, the recommendation by the CEC on OD' 2 ', is inconsistent with the optimisation of contrast-detail performance. The extension of this technique to other filmscreen combinations and a more detailed analysis of the noise is currently being investigated.

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Radiation Protection Dosimetry Vol. 57, Nos l^t, pp. 155-158 (1995) Nuclear Technology Publishing

IMPACT OF SEVERAL RECOMMENDED ACTIONS FOR IMPROVING IMAGE QUALITY IN MAMMOGRAPHY


M. Chevalier, P. Moran and E. Vano Grupo de Fsica Mdica, Departamento de Radiologa Facultad de Medicina, Universidad Complutense, 28040 Madrid, Spain Abstract The dose/image quality relationship of mammography in the area of Madrid was studied during the period 198991. As a conclusion, several actions were recommended to the facilities and its impact was evaluated during the period 199293. The results showed that die replacement of the old X ray units with modem ones provided the major improvement in the image quality. Conversely, the breast doses were increased due to the presence of a grid (64%). However, this increase was balanced by the major improvement found in image quality. The replacement of the image receptors by high contrast screenfilm combinations did not produce a noticeable variation in die image quality. However, this action was important in reducing the breast doses (62%). Overall the actions resulting from quality control recommendations slightly improved the image quality but the doses were reduced by 41%. INTRODUCTION Breast doses and image quality produced by seventeen X ray units in the area of Madrid were evaluated during the period 1989-91. The mammography centres consisted of four private and ten public (seven hospitals and three outpatient centres) facilities. In addition, basic quality control procedures were introduced for checking the kV accuracy, half value layer (HVL) and tube output of each X ray unit, in addition to the film processors performance. The study pointed out that the main factors which dramatically affected the breast dose and image quality were the use of inadequate radiographic factors (too low or too high tube tension, inappropriate Al filtration), the lack of accuracy of the kV, inadequate image receptors and malfunctions of both automatic exposure control (AEC) or processors giving too low optical density values. Also, approximately half of the units belonged to the first generation of dedicated mammographie units (old units) and, in consequence, their features (broad focus, short source-image distance, without grid) limited the image quality'". The results derived from this first study were reported to each facility and several actions recommended in order to overcome the detected faults. In addition, the resulting mean values of both phantom surface air kerma (henceforth called air kerma) and image quality, together with the reference breast entrance surface dose proposed by a CEC expert group'2', were also reported for the sake of comparison with the values achieved at each facility. The impact of these actions on breast dose and image quality was one of the aims of a second study which was carried out during the period 1992-93. The results concerning the air kerma values are presented in another contribution13'. In this work the variations in image quality are analysed and compared with the mean air kerma values obtained in both periods. Thus, the benefit of the action is derived from the image quality/breast dose relationship. METHODS AND MATERIALS The facilities surveyed were identical to those in the first study although several old X ray units have been withdrawn from service or replaced by modern ones. A total of sixteen X ray units were investigated: eight units were from General Electric-CGR (one Senographe DMR, three Senographe 600 T, two Senographe 500 T, one Senographe and one Senomax), three from Philips (models Mammo Diagnosi E, U and U-M), three from Siemens (models Mammomat, Mammomat 2 and Mammomat III), one from Instrumatic Corporation (model Alpha III) and one from Toshiba (model MGU-10A). The features of the X ray units playing an important role in the image quality are summarised in Table 1. The single screen Kodak Min-R was employed at all the sites with the exception of one facility using the single screen Agfa Mamoray MR Detail. Nine facilities employed Kodak films (seven Min-R MA, one Min-R H, 1 Min-R E), three facilities employed Agfa Mamoray MR3-II film and two facilities used Dupont Cronex Microvision film. The Agfa screen was combined with Dupont film. All the processors were automatic with standard cycles between 90 s and 120 s. The most frequent developer temperature was 35C. In order to ensure that the variations in air kerma and image quality measurements were basically due to the actions or developments at each facility, both parameters were evaluated with the same methods as followed in the previous study. Breast doses and image quality were assessed by means of the Leeds TOR (MAX) mammographie phantom which consists of a semicircular test plate of 1 cm thickness and an attenuator stack of acrylic semicircular plates (five of 1 cm thickness plus two of 0.5 cm). In this study, the test plate was on top of an attenuator stack 3.5 cm high which is equivalent to the 5 cm compressed average breast thickness for the population in the area of Madrid"'. The test plate contains several details evaluating high and low contrast resolution (lp.mm -1 ), small
155

M. CHEVALIER, P. MORAN and E. VANO detail visibility and low contrast sensitivity, as well as objects providing densitometric measurements. A full description of the phantom can be found elsewhere'45'. Five exposures were made by selecting the radiographic factors (kV, filter, AEC) clinically used for breasts 5 cm thick and average composition, which are equivalent to the phantom. The straight edge of the phantom assembly was always positioned aligned with the breast table edge closest to the chest wall. The AEC chamber was always positioned under the area containing the low contrast details to avoid the high absorption of the high contrast resolution gratings. The five images were independently scored by the same two observers following the same scoring method used in the previous study. In the score a full point was assigned to each test detail if it was clearly seen and half a point if it was less clearly seen. The scores from the observers were subsequently combined according to the criteria proposed by Kirkpatrick'6', assigning confidence levels of 1, 0.5 or 0 to each detail of the test objects. The combined scores were summed to obtain the score for each phantom image. Since the phantom contains two perpendicular test gratings for determining high contrast resolution, the average value was taken. The mean values of both overall score and high contrast resolution were calculated for the five phantom images. The optical densities within the phantom images were measured at a point approximately 15 mm from the film edge corresponding to the chest wall and centred laterally, according to the manufacturer's recommendations. The densitometer used was the Digital Densitometer II (Model 07-424) from Victoreen with an accuracy of + 0.02 OD. RESULTS The developments at the facilities with major influence on image quality were the replacement of some old mammography units with modern ones and the replacement of image receptors. In addition, changes in radiographic factors, such as changes in the kVp selected or in the background optical density, and the improvement in the film processor performance, also affected image quality. In most cases, several changes occurred simultaneously making it difficult to isolate their effects on image quality. It should be remembered that the sensitivity of the Leeds TOR (MAX) phantom to changes in the imaging system is limited'5'. For instance, variations in the kVp less than 2 kV were reported not to produce any noticeable variation in the quality of the phantom image. Table 2 shows the three actions that were considered as the main causes of the variations in image quality and the mean values of the image quality parameters (high contrast resolution and score) obtained in each study. With regard to the score values, the figures given were obtained by subtracting the number of details (20) which were always clearly seen in all phantom films, thus stressing the differences between the image quality achieved. In order to make more apparent the benefit of particular actions, the mean air kerma values corresponding to each study are also given. Four older units (four CGR Senographe) were replaced while a new unit was installed in five facilities. As expected, the mean value of the high contrast resolution is significantly higher (96%) as a consequence of the smaller focus size and the longer source to image distance of the modern units. In addition, the reduction in the geometric unsharpness, together with the improvement in the image contrast derived from the use of a grid, improves the overall image quality significantly (62%). The increase in the mean air kerma value (64%) ascribed to the use of a grid is balanced by the remarkable improvement in the image quality. In 75% of the X ray units the image receptor was replaced, but only in 50% of these cases was the replacement considered the main cause of the variations in image quality. In some instances, the image receptor replacement produced an inferior image quality. For example, the use in four cases of a faster and high contrast combination (Min-R/Min-R MA) in place of a less noisy and slow speed combination (Min-R/Min-R) increased the threshold values of both the small detail visibility and the low contrast detection. The mean score reduced its value by 30% while the mean high contrast resolution did not experience a significant variation (7%). Nevertheless, the worse image quality obtained in this case was offset by the important reduction (63%) found in the air kerma value. Conversely, the use in one case of high contrast combinations (Kodak Min-R/MinR MA) instead of the faster but too noisy double screen/double emulsion combination (Kodak Min-R-

Table 1. Summary of the X ray units' features. Study No of units Mo/Mo


1989-91 1992-93

Target/Filter Mo/Mo-Al 7 Mo-Rh/ Mo-Rh-Al


1

Nominal focus size (mm) Grid AEC


0.6 <0.6

SID (cm) <60 >60 10 1 3

17 16

10 6

7 4

10 1 2

8 1 2

1 1 1 4

7 3

156

EFFECT OF ACTIONS TO IMPROVE IMAGE QUALITY Min-R Fast/TMAT-MII) provided the major image quality score value increased by approximately 24% improvement, since lower threshold values for the small while no significant difference between the values for detail visibility and the low contrast sensitivity could be the high contrast resolution were found. In addition, the achieved. In this case, the score and the high contrast reductions in the mean air kerma value were signifiresolution values increased from 5 to 18.5 (270%) and cant (42%). from 11.3 to 15.5 lp.mm"' (37%) respectively and, as it was expected, the air kerma values also increased from DISCUSSION 3.6 to 8.4 mGy (133%). Less noticeable variations in The results show that the developments at the differthe image quality were achieved when the screen-film ent facilities have improved noticeably the quality of combinations were replaced by combinations of similar mammography in the area of Madrid. The most remarkcontrast and speed characteristics. Summarising, the able benefit was related to the introduction of modern improvements in the image quality achieved in some mammographie X ray units, since they produced high cases were offset by the inferior quality obtained in quality images with more useful diagnostic information. other instances. Thus, as it is shown in Table 2, the It is also noticeable that a more uniform image quality image receptor replacement produced slight increases in was provided by the replacement of the old units, as the overall mean values of the high contrast resolution can be seen in the narrower range of both high contrast and score (7.5% and 10%, respectively) with respect to resolution and image quality score (Table 2). Neverthethose values obtained in the previous study. However, less, there were also significant differences between the the reduction in the mean air kerma value (62%) means type of X ray units, image receptors, radiographic techan important dose saving. niques, processor performances, etc. As regards dose, The QC group includes different actions recom- the range of air kerma values is narrower than in the mended to the facilities as a consequence of the findings previous study which indicates that the actions have had obtained in the quality control procedure developed in major impact on dose reductions. the previous period (grid not well focused, incorrect The feedback to the centres has played an important adjustment in either the AEC or in the developer tem- role. Most of the facilities did not know their doses and perature, roller marks in the films, inadequate radio- image quality performance. The comparison between graphic factors, etc.). The improvements achieved were these values and the reference one proposed by the mainly related to the increase in the optical densities of CEC'2', together with the information also given in the images, which provided lower threshold values for relation to the possible causes of the anomalous values, the low contrast sensitivity, and higher limiting values have partly motivated the necessary developments for the low contrast resolution. Thus, the overall image within the facilities. Table 2. Mean values of high contrast resolution (lp. mm ') and score for the two studies. Mean air kerma values in both studies (S stands for standard deviation). Action Cases Mean high contrast resolution S (lp.mm"1) (range) 1989-91 X ray unit replacement Image receptor replacement Quality control 5 8 5 7.6 3.4 (6-14.3) 11.9 3.1 (7.8-18.3) 11.6 2.6 (7.1-13.4) 1992-93 14.9 1.5 (12.5-16.6) 12.83.4 (7.1-16.6) 12.4 3.1 (7.1-14.6)
Mean score S (range) 1989-91 11.1 4.5 (6-18.3) 13.8 4.4 (8-21) 14.4 5.0 1992-93 18.0 6.0 (8.0-21.5) 15.2 5.9 (3 - 20.7) 17.8 3.0 Air kerma mean values S (mGy) (range) 1989-91 5.3 3.9 (1.0-10.4) 12.6 14.4 (3.1-46.1) 5.8 3.0 1992-93 8.7 5.8 (5.5 - 8.9) 4.8 2.7 (0.9 - 8.4) 3.4 0.7

(8.5-22.0) (13.3-21.7)

(3.2-10.4)

(2.4-4.1)

REFERENCES 1. Moran, P., Chevalier, M. and Van, E. Comparative Study of Dose Values and Image Quality in Mammography in the Area of Madrid. Br. J. Radiol. 67(798), 556-563 (1994). 2. Commission of the European Communities (CEC). Quality Criteria for Diagnostic Radiographic Images. 2nd edn. Working Document CEC, D.G XII, ref. XII/73/90 (Brussels: CEC) (1990). 3. Moran, P., Chevalier, M. and Van, E. Recommended Actions for Reduction of Breast Doses in the Area of Madrid. An Evaluation. Radial. Prot. Dosim. 57(1-4), 429^132 (1995) (This issue). 157

M. CHEVALIER, P. MORAN and E. VANO 4. Cowen, A . R. and Coleman, J. D esign of Test Objects and Phantoms for Quality Control in Mammographie Screening. In: Physics in Diagnostic Radiology, IPSM Report No 61 (York: Institute of Physical Sciences in Medicine) (1990). 5. Moran, P., Chevalier, M., Contento, G. and Van, E. Evaluation of the Sensitivity of the Leeds TOR (MAX) Mammographie Phantom. Radit. Prot. Dosim. 49(1/3), 163166 (1994). 6. Kirkpatrick, . E. and Law, J. A Comparative Study of Films and Screens for Mammography. Br. J. Radiol. 60, 7378 (1987).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 159162 (1995) Nuclear Technology Publishing

QUALITY A SSURA NCE A ND PATIENT DOSIMETRY IN MAMMOGRAPHY: A RETROSPECTIVE


I. A. Castellanot, D. R. Dancef, R. Davisf, S. H. Evanst, C. H. Jonesf and C. A. Parsons* Departments of tPhysics and Radiology, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ, England Abstract The study of the breast using mammography commenced at this major cancer centre in the late 1960s. Clinically useful images werefirstobtained using a Xerox system in the early 1970s. The development of quality assurance phantoms since this time is described, also research into the evaluation of breast dose and optimisation of the imaging chain. Physical and biological phantoms were used to evaluate available imaging configurations, and examples of the parameters investigated target material, choice of image receptor are given. A number of Monte Carlo programs have been developed to quantify image quality parameters and patient dose. They have been used to optimise available imaging configurations for a wide range of breast thicknesses and radiographic parameters. Examples of studies into dose reduction by the addition of filtration, choice of kVp, and the use of grids are given. INTRODUCTION It is easy to understand what is meant by quality assurance in the context of wellestablished technology; specifications exist for the equipment, and the clinical requirements are well understood. However, in the situ ation of rapid change, any advances in quality assurance techniques are driven by the requirement to evaluate new technology. This paper outlines how experimental and computational methods were developed to address this need. HISTORICAL PERSPECTIVE The study of breast disease using mammography commenced at this hospital in the late 1960s. In 1967 interest shifted from direct exposure film radiography towards xeroradiography, as the edge enhancement fea ture of this technique promised improved visualisation of soft tissue structures. In addition, advances in the Xerox process, and the greater availability of the special plates required for X ray work, made the technique more accessible. Pioneering work in xeromammography was performed in the UK by Boag, Stacey and Davis"2' at the Royal Marsden Hospital. The first European Xerox 125 system was brought into clinical use in 1971. Xeroradiography remained the technique of choice for mammography at this hospital for over a decade. Its use was justified over that of direct exposure film in terms of image quality and lower radiation exposure to the patient13'. However, the introduction of mammo graphie screenfilm combinations achieved a significant reduction in the patient dose associated with film mam mography. This advantage over the Xerox process was maintained despite the introduction of a grid into the imaging chain in the early 1980s; the increase in dose resulting from the presence of the grid was offset by the improving sensitivity of the screenfilm combination. In spite of lowering the breast dose associated with xero mammography by increasing tube filtration'4', screen film radiography superseded xeromammography at our hospital in 1985. DEVELOPMENT OF PHYSICA L A ND BIOLOGICAL PHA NTOMS By the early 1970s, masses, calcification and spic ulation had been identified as the primary features of malignant breast disease'56'. The performance of the systems available could be compared according to how well these details could be visualised. The easiest method involved constructing a breast phantom simulat ing these features. Such a phantom was used as part of an evaluation of xeromammography systems undertaken at seven centres in Germany, Italy and Spain'7' (Figure 1 ). Unfortunately it was not possible to discrimi nate between the units in terms of image quality, although large variations in physical parameters would have suggested that the techniques used in these centres were far from optimised. This exercise highlighted the difficulties associated with designing physical phantoms. The possibility of introducing a bias towards one technique as a conse quence of phantom construction also needed to be con sidered. This was particularly critical whilst both Xerox and film techniques, where the imaging mechanisms were based on two distinct physical processes, were in
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Figure I. Diagram of the phantom used by Stacey and Davis'7'. The test objects are embedded in Temex, which simulates glandular tissue. 159

/. A. CASTELLANO, D. R. DANCE, R. DAVIS, S. H. EVANS, C. H. JONES and C. A. PARSONS use. It was therefore decided that, in order to achieve a fair comparison, the shape and density of test objects must be the same as those in breast lesions. The argument for a biological test object was overwhelming. An initial study was performed on the discrimination of calcifications by the imaging techniques available at the time, namely molybdenum and tungsten target tubes combined with direct exposure film, screen-film combination or Xerox detectors. A suitable histological section of breast tissue sandwiched in 5 cm of polythene to simulate adipose breast tissue was used as the test object'8'. A number of observers identified the calcifications visible on the image. The performance of the tungsten target-film receptor system was deemed to be clinically unacceptable. A detection threshold of 100 for calcifications was demonstrated for the Xerox system with either target, whereas the equivalent figure for a molybdenum target with a film system was 400 . This work was expanded to evaluate system performance as a function of calcification size.'9' The chosen specimen was cleared and stained so as to count and classify the calcifications by size, and then radiographed as above. The performance of the various systems is summarised in Figure 2. The superiority of the molybdenum target-Xerox receptor system was again demonstrated in the size range 100-300 , which was deemed to be most significant clinically. A similar result was obtained in a study of the discrimination of spiculation'"". Biological phantoms were instrumental in evaluating the performance of the mammography techniques available at the time. However, they were not suitable for quality assurance because of their short life-span and lack of reproducibility. In the late 1970s commercial physical phantoms were introduced. Their performance was poor, and it was evident that the problems of image scoring and of the observer's familiarisation with a static pattern had not been fully addressed. A new phantom was developed at the Royal Marsden Hospital to meet these requirements. It consisted of paraffin/beeswax cubes containing a range of test objects; nylon was used to represent nodules and spiculation, and foraminifera to simulate calcifications"". The cubes were individually identified and arranged randomly to form an aggregate test object. A phantom of similar construction was marketed by Pitman Ltd. During the late 1980s, the Leeds TOR(MAX) phantom came into wide circulation and was adopted as a national standard. However, a deep dissatisfaction remained with a quality assurance tool that did not address the performance of the observer in the clinical situation. A phantom with realistic breast structure was proposed, where natural sponge was used to simulate the collagen structure of the breast"2'. Unfortunately, difficulties were experienced in making and stabilising it, and progress has been slow. PATIENT DOSE ESTIMATION The radiation detriment to the breast is a principal parameter in the evaluation of an imaging system. Initial estimates were made in terms of skin exposure, or skin absorbed dose, which are not comparable between mammography techniques. Boag et al0) suggested that a more appropriate quantity was the total energy absorbed in the breast per unit cross-sectional area. They calculated conversion factors to translate skin exposure into this quantity for both molybdenum and tungsten target tubes over a limited range of tube potentials. Monte Carlo techniques were subsequently adopted to demonstrate that a reduction in total integral dose could be achieved in xeromammography by the introduction of aluminium filtration in the beam"3'. A reduction in skin exposure had already been observed'4'. Furthermore, and most importantly, it was demonstrated 100 200 300 400 500 750 that, for simple spectra (i.e. those in use at the time), the 1000 Mean diameter of calcifications () conversion factors were a continuous function of beam quality, and hence were universally applicable"4'. m Figure 2. Discrimination of calcifications (from Tonge et al ). In the late 1980s mean glandular dose was accepted The performances of four Xerox modes, one direct exposure film system (PE 4006), and two screen-film combinations are as the most appropriate indicator of detriment. The InstiSciences in Medicine defined a standard illustrated. The cleared specimen curve shows the number of tute of Physical breast"5' based on the simple model used by Hamcalcifications present in the phantom. 160

QUALITY ASSURANCE AND PATIENT DOSIMETRY IN MAMMOGRAPHY merstein et /" 6 ' to enable estimates of this quantity to decade, extensive work in this field has been undertaken be made. A measurement protocol was adopted in which by this hospital. the exposure incident on a 4 cm block of Perspex was In order to obtain a satisfactory conventional radio measured. Monte Carlo techniques were again utilised graph, the energy absorbed in the image receptor should to convert this measurement to exposure incident on the be the same regardless of the chosen technique. With standard breast, and conversion factors were calculated Monte Carlo methods it is possible to investigate how to obtain mean glandular dose for a range a beam the absorbed energy to the breast varies with photon qualities"7'. This technique has proved a powerful tool, energy in these circumstances. This exercise was under as it is possible to compare easily the dose delivered by taken for the Xerox plate" 4 ' and for Kodak's MinR different systems, and to set national reference doses in screen"91. Both computations demonstrated that, for a terms of this measurement. Further studies have also thicker breast, a heavy dose penalty is incurred if the been conducted to assess the influence of the model tube potential is not increased. However, this conclusion parameters upon the conversion factors"81. took no account of image quality. The authors chose the signaltonoise ratio (SNR) as the pertinent indicator of the latter. Of particular interest was the variation of the IMAGING CHA IN OPTIMISA TION SNR for a given mean breast dose as a function of pho The Monte Carlo model developed for the calculation ton energy. The results are illustrated in Figure 3 and of absorbed dose can be readily applied to the investi demonstrate a maximum SNR which is a function of gation of the imaging chain. The characteristics of the breast thickness. This result was important in that the pertinent parameters can be incorporated into the model model had, for the first time, considered a realistic and then varied at will to determine the effect on both receptor, used appropriate scattertoprimary ratios, and breast dose and image quality. The aim of this exercise referred to a satisfactory indicator of detriment. is to ascertain whether there is an optimum combination This optimisation work continued with assessments of the imaging parameters that will maintain image of the introduction of grids into the imaging chain. In quality whilst minimising patient dose. During the past this instance, the change in the scattertoprimary (S/P) ratio is a good indicator of how the image quality will improve when the scatter is removed. The dependence of the ratio upon the chosen detector and breast thick 30 ness was investigated by Dance and Day'2"'. The effect / \ 2 cm MinR o of magnification techniques, and the introduction of a o 25 grid was also explored. It was therefore possible to con S m duct comparisons between different grids in terms of the ( dose penalty associated with the improvement in con 20 trast achieved'2".

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CONCLUSION The quality assurance tools that we enjoy today in mammography have arisen from an improved under standing of the pertinent imaging criteria. It was only through the development of both biological and physical phantoms that the problems that needed to be addressed were identified. The application of Monte Carlo tech niques has been instrumental in providing a standard method for the assessment of the radiation detriment to the patient. The optimisation of the imaging chain, based on the computational models derived for dose cal culations, is an ongoing exercise that will aid users of mammography to produce optimum images at the low est possible patient dose.

REFERENCES 1. Boag. J. W Stacey, A. J. and Davis, R. Some Clinical and Experimental Applications of Xeroradiography. J. Photgr. Sci. 19,4548(1971). 2. Boag, J. W., Stacey, A. J. and Davis. R. Xeroradiographic Recording of Mammograms. Br. J. Radiol. 45, 633640 (1972). 3. Boag, J. W.. Stacey. A . J. and Davis. R. Radiation Exposure of the Patient in Xeroradiography. Br. J. Radiol. 49, 253261 (1976). 4. Baker. A . M.. Davis. R.. Dance. D. R. and Parsons, C. A . Reduction of Patient D ose in Xeromammography by Added Filtration. Br. J. Radiol. 52. 1010 (1979).
161

/. A. CASTELLANO, D. R. D ANCE, R. DAVIS, S. H. EVANS. C. H. JONES and C. A. PARSONS 5. A ckerman, L. V. and Gose, E. E. Breast Lesion Classification by Computer and Xerograph. Cancer 30, 10251035 (1972). 6. Fisher, E. R., Gregorio, R. M. and Fisher, B. A Syllabus D erived from Findings of the National Surgical Adjuvant Breast Project (Protocol no 4). Cancer 36, 184 (1975). 7. Stacey, A . J. and Davis, R. Radiation Exposure to the Patient and Image Quality in Xeromammography a Preliminary Account of a Survey at Seven Centres in Europe. Presented at the 1st European Symposium on Xeroradiography, Venice Lido (May 1979). 8. Millis, R. R., Davis, R. and Stacey, A . J. 77ie Detection and Significance of Calcification in the Breast: a Radiological and Pathological Study. Br. J. Radiol. 49, 1226 (1976). 9. Tonge, . ., Davis, R. and Millis, R. R. The Problem of Discrimination in Mammography. Arguments for using a Biological Test Object. Br. J. Radiol. 49, 678685 (1976). 10. Spencer, J. D., Tonge, K. A . and Davis, R. The Mammographie Demonstration of Malignant Spiculation. Br. J. Radiol. 50, 489^192 (1977). 11. Tonge, K. A. and Davis, R. A Phantom Designed to Compare the Quality of Various Mammographie Images. Br. J. Radiol. 51, 731733 (1978). 12. Jones, C. H., Davis, R., Dance, D. R., Evans, S. H. and Bradley, D. . Mammography Test Object with Simulated Breast Architecture. Poster presented at 44th A nnual Conference of the and IPSM, Liverpool (1987). 13. Dance, D. R., Baker, A . M., Davis, R. and Stacey, A . J. Monte Carlo Calculation of Absorbed D ose in Xeromammography. Paper presented at 5th Int. Conf. of Medical Physics and the 12th Int. Conf. on Medical and Biological Engineering, Jerusalem (1979). 14. Dance, D. R. The Monte Carlo Calculation of Integral Radiation D ose in Xeromammography. Phys. Med. Biol. 25. 2537 (1980). 15. Institute of Physical Sciences in Medicine. The Commissioning and Routine Testing of Mammographie Xray Systems. Topic Group Report 59 (York: IPSM) (1989). 16. Hammerstein, G. R., Miller, D. W., White, D. R., Masterson, . E., Woodard, H. and Laughlin, J. S. Absorbed Radiation Dose in Mammography. Radiology 130, 485491 (1979). 17. Dance, D. R. Monte Cario Calculation of Conversion Factors for the Estimation of Mean Glandular Breast D ose. Phys. Med. Biol. 35, 12111219 (1990). 18. A im Carlsson, G. and Dance, D. R. Breast Doses in Mammography: Evolution of Experimental and Theoretical Approaches. Radit. Prot. Dosim. 43, 197200 (1992). 19. Dance, D. R. and Day, G. J. Simulation of Mammography by Monte Carlo Calculation the Dependence of Radiation Dose, Scatter and Noise on Photon Energy. Proc. Symp. on Patient Exposure to Radiation in Medical Xray Diagnosis, Munich. Report EUR 7438 EN ( 1981 ). 20. Dance, D. R. and Day, G. J. 77ie Computation of Scatter in Mammography by Monte Carlo Methods. Phys. Med. Biol. 29, 237247 (1984). 21. Dance, D. R., Persliden, J. and A lm Carlsson, G. Calculation of D ose and Contrast for Two Mammographie Grids. Phys. Med. Biol. 37, 235248 (1992).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 163165 (1995) Nuclear Technology Publishing

SURVEY OF MA MMOGRA PHY IMA GE QUA LITY IN THE UK


K. C. Young, M. L. Ramsdale and A . Rust National Coordinating Centre for the Physics of Mammography Department of Medical Physics, St Luke's Hospital Guildford GUI 3NT, UK Abstract A previous report based on data collected from a large number of physicists found a wide range in image quality in the mammography systems used in the UK Breast Screening Programme (UKBSP). This paper is a preliminary report on direct measurements of image quality by one team of physicists on a representative sample of mammography systems in the UKBSP. Image quality was assessed using three mammography image quality test objects: TOR (MAX), TOR (MAM), and a contrast detail phantom. Many factors which affect overall image quality were also measured including kV, film density, focal spot size, spatial resolution, light and X ray sensitometry and mean glandular dose to the standard breast. The results on the 25 systems so far assessed is reported. INTRODUCTION A review of equipment performance in mammo graphy by Young et /'" appeared to show a large vari ation in image quality in the UK Breast Screening Pro gramme (UKBSP). However, this was based on the separate assessment of image quality by a large number of physicists throughout the country. In order to assess the image quality across the UKBSP, while minimising observer error and variations in technique, a study is being undertaken by one team of physicists using a single set of test equipment. This study is not yet com plete and this paper presents a preliminary analysis for 25 mammography systems. METHODS It has been agreed to assess the image quality of at least two systems used in the screening programmes in each of the 14 Regions of England and also Northern Ireland, Scotland and Wales. It is also planned to include some systems used for symptomatic work out side the Screening Programme. Image quality is being measured using three mammography test objects: TOR (MAX)'2, TOR (MAM)'3' designed by FA XIL in Leeds, and the contrast detail test object developed in Nijmegen'4'. In addition, a number of factors likely to affect image quality are being measured. The accuracy of the set kV was measured using an electronic kV meter (RMI 232), which has an accuracy of 1.0 kV and a reproducibility of 0.3 kV. The gross film densities of radiographs of a 4 cm thick Perspex block exposed under automatic exposure control (A EC) at clinical set tings were measured for each system on the midline at 4 cm from the chest wall edge. Using light sensitometry, contrast was measured as the gradient between a density of 1.0 and 2.0 above base and fog. A calibrated stepwedge was used to assess similarly defined contrast using X ray sensitometry. (The stepwedge created 10 increments of approximately 0.11 in the log of the exposure). Focal spot size was measured using a slit camera on a reference axis passing through a point on the midline of the breast support table and 5 cm from the chest wall edge as described in the Department of Health Guidance Notes'5'. High contrast spatial resol ution was measured using the TOR (MAX) test object on top of 4 cm of Perspex. The dose to the standard breast was assessed using the IPSM protocol'6'. A ll systems were assessed under standard conditions, i.e. using a bucky grid and at 28 kVp with exposure under AEC control.

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Figure 2. Film densities (including base and fog) of a radio graph of a 4 cm Perspex block exposed under A EC control at clinical settings. 163

K. C. YOUNG, M. L. RAMSDALE and A. RUST RESULTS The results of the measurements of the various factors expected to affect image quality are shown in Figures 1 to 7. kV accuracy was generally very good with the exception of one symptomatic set (Figure 1 ). The gross film densities resulting from exposure under A EC con trol at clinical settings are shown in Figure 2, and were generally in the range 1.2 to 1.6. Measurements of the gradient of the light and X ray sensitometry curves are shown in Figures 3 and 4. When the gradients measured by light and X ray sensitometry were compared there was a linear regression with a correlation coefficient of

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0.89 (Figure 5). A number of the systems were meas ured to have focal spot lengths in excess of 0.5 mm (Figure 6). Measurements of high contrast resolution parallel to the tube axis are shown in Figure 7. The image quality scores for the TOR (MA M) films for the 25 systems are shown in Figure 8. The measurements of the mean glandular dose to the standard breast were all below the currently recommended limit of 2 mGy' 71 (Figure 9). A scatter plot of the mean glandular dose to the standard breast against the image quality score using the TOR (MA M) test phantom is shown in Figure 10. The assessment of image quality using the contrast detail test object is not yet completed and will be pre sented later. DISCUSSION A ND CONCLUSIONS As yet this study is incomplete, but some preliminary

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Figure 8. Image quality measurements using TOR (MAM) lest object. 164

SURVEY OF MAMMOGRAPHY IMAGE QUALITY conclusions can be reached. A fairly wide range in overall image quality was observed, with the few symptomatic systems being noticeably poorer than the screening systems. The accuracy of the set kV was generally excellent, and film densities were more consistent than found previously'". The variation in overall image quality may be partly explained by the underlying variations in contrast as measured by sensitometry. The good correlation between the gradients measured by light and X ray sensitometry suggests that light sensitometry may be sufficient for quality control purposes in monitoring radiographic contrast. The variation in high contrast spatial resolution measurements noted in our original survey"' is confirmed and will also lead to a variation in overall image quality score. Dose levels for the standard breast were satisfactorily below recommended levels and comparable to those reported previously' ' '. The lack of a correlation between image quality and dose suggests that it may be possible to optimise these systems further. Overall, one can conclude that among the systems examined to date there were substantial real variations in overall image quality, partly as a result of of variations in spatial resolution and contrast. 90 o 80 S 70 60 ' 50 g. 40 > 30 ?20 E 10 0

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0.6 0.8 1 1.2 1.4 1.6 1.8 2 2.2 2.4 2.6 2.8 3 Mean glandular dose to the standard breast (mGy) gure 9. Measurements of mean glandular dose to the standard breast for each mammography system. REFERENCES

0 0.50 1.00 1.50 2.00 Mean glandular dose to the standard breast (mGy]

Figure 10. Scatter plot of image quality score using TOR (MAM) and mean glandular dose to the standard breast for each system.

1. Young, K. C , Ramsdale, M. L. and Horton, P. W. Review of Mammography Equipment and its Peiformance. NHSBSP publi cation No 24 (l 992). 2. Cowan, A . R. and Coleman, N. J. D esign of Test Objects and Phantoms for Quality Control in Mammographie Screening. In: Physics in Diagnostic Radiology, IPSM Report 61 (York: IPSM) (1990). 3. Cowan, A . R., Brettle, D. S.. Coleman, N. J. and Parkin, G. J. S. A Preliminary Investigation of the Imaging Performance of Photostimulable Phosphor Computed Radiography using a New D esign of Mammographie Quality Control Test Object. Br. J. Radiol. 65, 528535 (1992). 4. Bijkerk, . R., Lindeijer. J. M. and Thijssen, M. A. O. 77ii CDMAMPhantom: A Contrast D etail Phantom Specifically for Mammography. Radiology 185, 395 (1992). 5. DoH. Revised Guidance Notes for Health Authorities on Mammographie Xray Equipment Requirements for Breast Cancer Screening. Medical Devices Directorate Report STD/90/46 (London: Department of Health) (1990). 6. Fitzgerald, M., Dance, D. R., Fisher, K, Lawinski, C. P. and Ramsdale, M. L. Commissioning and Routine Testing of Mammo graphie XRay Systems. IPSM Report 59 (York: Institute of Physical Sciences in Medicine) (1989). 7. NHS. Objectives for the Breast Screening Programme. NHS Breast Screening Programme (1993).

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Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 167170 (1995) Nuclear Technology Publishing

IMAGE QUA LITY A ND PA TIENT DOSE IN DIA GNOSTIC RADIOLOGY


D. Saure, G. Hagemann and H. S. Stender rztliche Stelle Niedersachsen Berliner A llee 20, 30175 Hannover, Germany Abstract The results of quality assurance procedures performed by 3500 sets of radiological equipment were reviewed by the 'rztliche Stelle' (quality evaluation panel) of Lower Saxony from 1988 to 1993. Of 95,000 examinations reviewed, 7000 patient studies were selected and analysed in terms of technical and diagnostic quality and patient dose. For this report the emphasis was put on parameters of special relevance for radiation exposure and image quality such asfilmscreensystem (FSS), tube voltage and film processing. The average FSS speed (S) has gone up. The percentage of FSSs with a speed of 400 or higher has increased from 8% in 1984 to 30% in 1993. A reduction in detector dose from an average 9.2 Gy to 5.4 Gy has thus been achieved. In 1989 55% of the examinations were performed with tube voltages in accordance with the guidelines issued by the German Medical Association and the European Commission, while this was 72% in 1993. High speed FSS and high tube voltage yield a good image quality at low patient dose. Especially in the abdomen, a reduction in dose to 25% or less of the 1984 values can be achieved without loss of information. INTRODUCTION In the Federal Republic of Germany the Rntgen verordnung (XRay A ct 1987, RV) requires a quality assurance standard which must be checked, according to paragraph 16.3 RV, at intervals of one to two years by quality evaluation panels composed of radiologists, medical physicists and radiographers. The carrying out of acceptance tests by manufacturers or suppliers of the X ray equipment, supplemented by constancy checks by the operators and the application of optimised radio graphic examination techniques are intended to ensure high quality images at acceptable levels of patient dose. The diagnostic requirements and optimised radiographic examination techniques are set out in the 'Guidelines for High Image Performance' published by the BK (German Medical A ssociation) and the working docu ment 'Quality Criteria for Diagnostic Radiographic Images' issued by th European Commission""4'. MATERIAL A ND METHOD patient dose'5 7'. In selected cases, the entrance surface dose was measured with an anthropomorphic phantom (skull, pelvis)'689'. The diagnostic image quality was divided into three categories: (1) Standard quality. The image criteria and anatomic details are substantially represented and clearly re cognisable. Medium optical density, optical density range and visual sharpness of the structures permit a clear assessment. (2) Limited image quality. The image criteria and ana tomical details are only partially or not clearly re presented and only recognisable to a limited degree. Medium optical density and optical density range deviate significantly from the standard category, and the structures are partially blurred. Only a limited assessment is possible. (3) Unsatisfactory (poor) quality. Many of the image criteria and anatomic details are not represented and cannot be recognised. Medium optical density and optical density range do not fall within standard limits. The structures are visually blurred. The image cannot be assessed.

The results of the acceptance tests and the constancy checks for one year, and at the same time the patient radiographs from X ray examinations typical of practice usually sixteen per body region were The assessments of diagnostic image quality are made requested from the X ray installation operators. The on the basis of BK guidelines by four radiologists. dose Ks of the applied filmscreen system for the pro About 90% of their results fell into the same category. duction of the net optical density 1.0 (DIN 6867, part The review of the constancy check on film processing 1 ), and the measured values of the dose at the receptor was carried out using densitometry of the sensitometer KB ^ G y ) , which were determined at 80 kVp behind strips provided. Base and fog, sensitivity index and con 25 mm of A l (DIN 6868, part 50), were evaluated. The trast index were measured, as well as the maximum den speed of the FSS and the measured dose at the receptor sity. (KB) before and after consultation with the quality Up until the present time, the Lower Saxony's quality evaluation panel were compared. evaluation panel has investigated around 3500 X ray The tube voltages (kVp) for the various organ exam installations, more than 70% of which were located in inations were taken from the case notes of the radio outpatient practices. A total of no less than 95,000 logists ( 28 RV). The radiographs were evaluated in examinations were evaluated. terms of the technical and diagnostic quality and for the For the following report 9870 examinations randomly 167

D. SAURE, G. HAGEMANN and H. S. STENDER selected from 780 X ray installations were assessed. The main emphasis was on the influence of the speed of film-screen systems, tube voltage and film processing on image quality and patient dose. FILM-SCREEN SYSTEMS The significant increase in FSS intensifying factor from 1984 to 1993 is shown in Table 1. During this period, it was possible to reduce both the detector dose and the patient dose by more than half. In addition, the detector dose for abdomen radiographs was estimated just for the year 1993. Taking into consideration the various different organ examinations but with the exception of the upper intestines, the proportion of high intensifying FSSs (speed class 200 or 400) was doubled (Table 2). Parallel to this, the proportion of unsatisfactory radiographs where high intensifying FSS was used fell. This documents the efforts of the radiologists to optimise radiation protection and image quality simultaneously. The high speed FSS (S = 400 or more) provide trunk radiographs of the same diagnostic quality as systems of lower speed"" 1 ". TUBE VOLTAGE Tube voltage plays an important role in reducing the patient dose. From 1989 to 1993 there was a significant Table 1. Percentage of speed class of film-screen systems (FSS) used at examinations of the trunk and estimated average dose at the receptor (KB) in (, especially at examinations of the abdomen in 1993. Speed class s s 100* 100 < S = 200 200 < S < 400 KB tGy) *4/5 S = 100 1/5 S = 50 Table 2. Percentage of speed class of FSS (S) used at various organ examinations in a comparison between the years 1988 and 1993. Organ Chest Urinary tract Pelvis Lumbar spine Upper intestine Lower intestine >200 >400 >400 >400 a400 a400 1988/89 (%) 1992/93 (%) 64 32 26 31 56 32
92 66 53 59 52 66

increase in the voltage values applied during examinations of lumbar spine, pelvis and urinary tract. In 1988/89, more than 90% of thorax examinations were already being carried out using a tube voltage of over 100 kV p (Table 3). FILM PROCESSING Film processing also plays an important role in maintaining diagnostic image quality and in the control of radiation exposure. Base and fog (max. 0.25 optical density) and sensitivity index tolerance (0.2) were considered to be important criteria. The contrast index was not taken into account. In 1990, at least at times, 30% of the sensitometer strips showed base and fog over the limiting value of 0.25. In contrast, in 1993 only 2 1 % exceeded the limit. In 1990, 4 3 % and in 1993 6 1 % of operators conformed to the sensitivity index tolerance over a period of at least six months. The percentage of processing machines which exhibited unsatisfactory development results only occasionally decreased between 1990 and 1993 from 36% to 2 3 % . In contrast, the proportion of processing machines which frequently delivered unacceptable results remained virtually unchanged, sinking Table 3. Tube voltage (kVp) used at various organ examinations in a comparison of the years 1988/89 and 1992/93 (% of all examinations). Organ Standard value (kV )* a 100 75 >75 &75/90 >90 >90 1988/89 (%) 93 31 39 34 82 68 1992/93 (%) 97 56 47 55 81 80

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168

IMAGE QUALITY AND PATIENT DOSE from 21% in 1990 to 16% in 1993. A major cause of ogists, it was considered necessary to conduct second this is a low examination frequency and a consequent checks after an interval of from three to six months in low utilisation of the processor. The proportion of radi cases of serious deficiencies in technical or diagnostic ologists who achieved unsatisfactory results in the con image quality. As an outcome of this, the results of 1324 stancy checks on account of methodological errors also examinations carried out at 95 X ray installations were analysed in 1993. remained almost the same, 20% against 18%. Film processing showed that more than half of the operators now achieved standard results and more than IMAGE QUA LITY 30% had improved their constancy. The image quality The evaluation is based on the set of parameters laid was now at a standard level in more than 50%, down by the BK and EC (Table 4) with regard to both improved in 30% and unfortunately still unsatisfactory the technical quality (projection, optical density in a in 14% of all examinations. A s a whole, examination range between 0.6 and 2.2, contrast and visual techniques were at a standard level in 80% of all cases. As a result of recommendations from the quality sharpness) and the diagnostic image criteria. For exam inations of the trunk, sufficient diagnostic image quality, evaluation panel, the tube voltage was raised by 48% without any information loss, is provided by the film and filmscreen systems with higher intensifying factors screen systems in the speed class 200 and 400"'". The were now used by 56% of the radiologists. same applies to examinations of the thorax. The evaluation of the diagnostic image quality in the CONCLUSIONS three categories described above for 1989 showed that In conclusion, our results show that on the basis of 6575% of examinations achieved a standard level, while 1726% only achieved a limited image quality the recommendations and of the BK and EC guide rating. The proportion of unsatisfactory examinations lines the patient dose was reduced in more than two was generally under 9%, not including examinations of thirds of the cases under consideration by the use of the stomach and colon, for which the figures were 38% filmscreen systems with higher speed, a higher tube and 16% respectively. The figures for 1993 were 70% voltage and more constant and optimised film pro to 83% standard rating, only 29% unsatisfactory. On cessing. It must be emphasised that high intensifying account of poor examination techniques, a large pro filmscreen systems of speed class 400 do not nega portion of the examinations of the gastrointestinal tract tively influence the image quality in the case of trunk examinations. were unsatisfactory (Table 5). The quality assurance measures carried out in the manner described above led to an improvement in the RENEWED CHECKS diagnostic image quality and to a reduction in patient Consequent upon the assessments of the four radiol dose. However, further efforts are still necessary. Table 5. Diagnostic image quality in three categories rated by four radiologists (n = 9135).
Organ n Standard (%) 1989 Skull Lumbar spine Extremities Pelvis Chest Urinary tract Upper intestine Lower intestine 556 1692 1440 1730 2128 543 644 402 70 65 75 72 70 73 26 48 1993 75 76 79 83 70 76 38 55 Reduced (%) 1989 23 26 17 21 23 23 36 36 1993 19 18 11 14 .24 20 37 28 Insufficient (%) 1989 7 9 8 7 7 4 38 16 1993 6 6 9 2 6 4 25 17

REFERENCES 1. Leitlinien der Bundesrztekammer zur Qualittssicherung in der Rntgendiagnostik. Dtsch. rzteblatt 86, 2021 (1989). 2. BIR. Quality Criteria for Diagnostic Radiographic Images, Working Document. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores, . F. Wall, . Eriskat and . Schibilla. BIR 20 (London: British Institute of Radiology) p. 271 (1989). 3. Stender. H. S. and Stieve, F. E. Image Quality Physical and Diagnostic Parameters. The Radiologist's Viewpoint. In: 169

D. SAURE, G. HAGEMANN and H. S. STEND ER Technical and Physical Parameters for Quality A ssurance in Medical Diagnostic Radiology: Tolerances, Limiting Values and A ppropriate Measuring Methods. Eds B. M. Moores, F. E. Stieve, H. Eriskat and H. Schibilla. BIR 18 (London: British Institute of Radiology) (1985). Stieve, F. E. Radiological Requirements for the Specification of Image Quality Criteria. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores, . F. Wall, . Eriskat and . Schibilla. BIR 20 (London: British Institute of Radiology) p. 231 (1989). Shrimpton, P. C , Wall, B. F., Jones, D. G., Fisher, E. S., Hillier, M. C , Kendall, G. M. and Harrison, R. M. D oses to Patients from Routine Diagnostic XRay Examinations in England. Br. J. Radiol. 59, 749 (1986). Wall, B. F. and Shrimpton, P. C. Patient Exposure Criteria. In: Optimization of Image Quality and Patient Exposure in Diagnostic Radiology. Eds. B. M. Moores, . F. Wall, . Eriskat and . Schibilla. BIR 20 (London: British Institute of Radiology) p. 239 (1989). Rainbow, A . J. and Cockshott, W. P. A 13Year Regional Survey of Patient Exposure in Diagnostic Radiology. In: Optimiz ation of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores, . F. Wall, . Eriskat and . Schibilla. BIR 20 (London: British Institute of Radiology) p. 177 (1989). Drexler, G, Panzer, W., Widenmann, L., Williams, G and Zankl, M. Organ D oses in XRay D iagnostics. GSFBericht 11/90 (1990). Hagemann, G D osisbedarf fr die Projektionsverfahren der Rntgendiagnostik. A kt. Radiol. 2, 123 (1992). Mller, R. D., et al. Tumornachsorge mit reduzierter Expositionsdosis durch hochverstrkende FilmFolienKombinationen zur Abbildung der Thoraxorgane. ROCAnalyse zur D etektion von Rundherden. Tumordiagn. Ther. 14, 16 (1993). Buhr, E., Herrmann, C. and Hoeschen, D. Correlation between Physical Image Quality Parameters and Visually Perceptible Image Quality in XRay Diagnosis. Presented at the Symposium 'Imaging the Future' of the Royal Photographic Society in Cambridge, UK, Sept. 1992.

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 171-174 (1995) Nuclear Technology Publishing

ASSESSMENT OF IMAGE QUALITY FOR CHEST RADIOGRAPHY IN THE WEST MIDLANDS


H. M. Warren-Forwardt and J. S. Miliari fRRPPS, Birmingham Medical Physics Services Queen Elizabeth Medical Centre, Birmingham 15 2TB, UK JWessex Neurosurgery Unit Southampton General Hospital Tremone Road, Southampton, UK Abstract Radiographic quality of chest radiographs has been assessed during a patient dosimetry programme. Radiographs from each of the centres involved were assessed by a radiologist from that centre and a sample of these were assessed by a control radiologist. A questionnaire was used by the radiologist at each centre to assess patient positioning, respiration and radiographic quality. A control radiologist assessed each radiograph in two ways. The first assessment was made using the questionnaire. The films were then reviewed a second time, in a single sitting, at which they were scored on an arbitrary scale of 1 to 5 in order to assess the immediate impression of the radiographic quality. Inter-observer variations were seen to be large, with a correlation r= 0.52. Much smaller variations in intra-observer observation were seen when assessing the samefilmsusing the two methods above, thus demonstrating that the control radiologist was consistent. The relationship between image quality and (a) dose and (b) applied potential was assessed using the quality scores obtained by the control radiologist using the questionnaire. There was a slight tendency to higher radiographic scores at lower patient doses (r = 0.36, = 0.13). There was a strong relationship between image quality and applied potential (r = 0.77, = 0.005). INTRODUCTION A good radiographic technique should produce an image containing all the essential information and cause the minimum possible dose to the patient. The amount of information that can be obtained by the attenuation of the X rays within the body, depends on the composition of the anatomical or pathological structures, the radiation quality and the transfer into an image suitable for interpretation. Diagnostic procedures require the justification by the clinician that the proposed radiological examination may be of net benefit to the patient and the optimisation of the procedure in order to obtain enough information, for diagnosis whilst keeping the patient's dose as low as reasonably achievable. The Royal College of Radiologists'" have produced a set of guidelines 'Making the Best Use of a Department of Radiology' to help non-radiologists decide when a particular procedure is justified. A Study Group of the Radiation Protection Programme of the Commission of the European Communities have produced guidelines for radiographic factors and techniques that might be employed to achieve radiographic images of good quality and acceptable dose. All patient dose surveys reported in the literature have had a wide variation in doses observed for nominally the same type of X ray examinations performed in different hospitals or on different patients'2-4'. This implies that all exposures are not being kept as low as possible. The causes of this variation are differences in patient size and pathology, differences in radiological technique (dictated by departmental policy and the training and skill of the operators) and differences in imaging equipment. Many of the measured doses in the upper end of the ranges may represent radiation levels that are unnecessarily high. It may also be true that many doses in the lower end of the ranges may result in poor image quality. The optimisation of chest radiography in the West Midlands has been investigated. Chest radiography was chosen for the study because of its high frequency, making it possible to sample a representative cross section of hospitals within the region, extending from cottage hospitals with only one tube to large general hospitals. Emphasis has been placed upon examining the potential for dose reduction resulting from possible impovements in technique and/or in equipment, while ensuring that there is no loss of diagnostic information from the resulting radiograph. MATERIALS AND METHODS Patient dosimetry Patient doses were measured to obtain an indication of the entrance surface dose that is being given to adult patients within the West Midlands, without discrimination of age, ethnic origin or size. Dose measurements were made using lithium borate thermoluminescence dosemeters (TLD) attached to the patient's skin in a position coincident with the central axis of the incident X ray beam. A minimum of twenty patients were measured on each X ray tube. Radiographic quality criteria In 1987 the Commission of the European Communi171

H. M. WARREN-FORWARD and J. S. MILLAR ties (CEC)' ' initiated a project on the establishment of quality criteria for diagnostic radiographic images. This provided a list of both radiological and technical requirements that could be useful to judge the quality of the radiographs routinely undertaken in diagnostic radiology. In order to assess the compatibility of the technical requirements set up in the document of the CEC with those routinely used in the West Midlands, results of a trial survey were evaluated' 6 '. The trial survey reported on dose information obtained on 20 X ray tubes, with the monitoring of approximately 600 patients. This exercise revealed the great differences in use of applied potential and use of grids between the two communities, and also highlighted the large variation in techniques used within the West Midlands. Owing to these differences in technique, the radiographic quality criteria used by the CEC needed to be assessed for suitability. A number of local radiologists were invited to comment on the important characteristic features of the 'normal' posterior-anterior and lateral chest radiograph. Each radiologist then checked the CEC quality criteria and commented on the relevance of each statement. In view of their comments several minor changes were made. No information was collected on the high and low contrast details to be found in the lung area or those out of the lung periphery. The questionnaire used was broken down into three different areas; patient positioning, state of respiration and the quality of the radiograph. Using the questionnaire, clinical assessments of the patient radiographs were made at each hospital by the department radiologists, on all the radiographs taken. To allow for observer variation, and again using the questionnaire, additional clinical assessment was made by a control radiologist on ten radiographs from each tube. The films were then reviewed by the control radiologist a second time, in a single sitting, where they were scored on an arbitrary scale of 1 to 5. A score of 5 was allocated for a perfect film and 1 where a repeat film would have been requested. This method assesses the immediate impression of the radiographic quality, since it provides a more realistic comparison to every day protocol than that of the detailed analysis. The consistency of the control radiologist could be assessed by comparing his two scores for each film.
5

RESULTS Patient doses Over 1400 patients have been monitored from 29 different hospitals incorporating 54 tubes. The spread of patient skin doses was characterised by a wide and positively skewed distribution with a mean value of 0.16 mGy and a median value of 0.14 mGy. The range factor of doses (the ratio of maximum to minimum dose) was found to be 46. The 75th percentile value was calculated to be 0.18 mGy. The range of mean doses between individual X ray tubes was 4. Preliminary results for patient doses have already been published' 71 . Radiographic quality Radiographs from twenty-three hospitals have also been assessed for radiographic quality. Comparison of techniques advocated by the CEC, and those currently being used in the West Midlands are summarised in Table 1. Each question in the questionnaire was weighted in order of importance. For example, the most important aspect of the radiograph was its optical density. A score of 4 was given if this was satisfactory. On the other hand, the clavicles being equidistant from the centre was not viewed to be essential and were given a score of 1. The difference between the radiographic quality assessed by the departmental radiologists and the control radiologist (both assessments carried out with the questionnaire) was studied. For each tube the mean scores obtained by the departmental radiologists was plotted against the mean scores obtained by the control radiologist (Figure 1). The control radiologist gave consistently lower quality scores than the departmental radiologists. The line shows the regression curve for a linear fit, resulting in a correlation coefficient of 0.52. The low coefficient indicates the large variability between radiologists throughout the region. Assessment of intra-observer reliability (i.e. the consistency of the control radiologist) was carried out by comparing the full questionnaire score with the quick assessment score for each film. The data can be represented in the form of a box plot (Figure 2). The dark line inside the box represents the median value of the

Table 1. Comparison of technique between CEC recommendation and use in the West Midlands for chest radiography. CEC criteria Filtration (mm Al) Film-screen speed Focus-film distance (cm) Radiographic voltage (kVp) Antiscatter grid Automatic exposure control >3.00 200-400 140-200 100-150 Use Use West Midlands use 2.2-3.8200-400 150-200 55-117 2 units only 5 units only % compliance with CEC criteria 68 100 100 3.4 3.4 8.5

172

IMAGE QUALITY ASSESSMENT IN CHEST RADIOGRAPHY variable. The top and bottom of the box mark the limits radiography. Increasing applied potential both improves of the first and third quartiles. Thus, each box enclosing image quality and decreases patient doses. Removing 50% of the data, shows clearly the differences in ques the single result using the high applied potential and tionnaire scores between adjacent quick assessment antiscatter grid reduces the coefficient slightly to 0.68, scores (especially between 2 and 3, and 3 and 4). The while increasing the gradient considerably. lines extending from the box mark the reliable minimum and maximum value. The circles are taken to be outliers from the distribution at each quality score. If the mean CONCLUSIONS questionnaire score is plotted against the quick assess Patient doses have been assessed on over fifty X ray ment score a regression coefficient of r = 0.98 is tubes throughout the West Midlands regional health obtained indicating that the control radiologist main authority. Twentythree of these have also been assessed tained uniformity with the criteria. for radiographic quality. As the consistency of the control radiologist has been Assessment of interobserver comparison shows the demonstrated, the relationship between radiographic large variations in scores between radiologists in the quality and dose was investigated using only the scores region, with a maximum variation of 54%. The control obtained by the control radiologist using the question radiologist scored lower than the departmental radiol naire. The mean quality scores plotted against the mean ogist in 86% of cases. entrance surface dose for each X ray set (Figure 3) pro The control radiologist scored the films by two duced a weak regression of r = 0.36 which increases to methods and showed excellent consistency. A regres 0.42, if the tube using high kVp technique with antiscat sion coefficient of 0.98 was obtained between the two ter grid is removed. methods. Using the control radiologist score the vari The variation of radiographic quality with applied ation of radiographic quality with patient dose and potential (Figure 4), showed a strong positive corre applied potential was assessed. There was a slight corre lation, with regression coefficient of r = 0.77. This lation between dose and quality, with increasing quality emphasises the conclusions of several reports'578' that at the lower patient doses. There was a strong corre higher applied potentials should be used for chest lation between applied potential and radiographic

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H. M. WARRENFORWARD and J. S. MILLAR quality highest scores were obtained with higher project funded by the West Midlands Regional Health applied potentials. A uthority; the authors are grateful for the continued sup port of the Regional Health A uthority. The authors ACKNOWLEDGEMENTS acknowledge the cooperation of all the staff at the RRPPS (past and present) for their help and support The work reported here is part of a 3 year research over the last few years. REFERENCES 1. The Royal College of Radiologists. Making the Best Use of a Department of Radiology Guidelines for D octors (The Royal College of Radiologists, 38 Portland Place, London) (1989). 2. Harrison, R. M., Clayton, C. B., Day, M. J., Owen, J. P. and York, M. F. A Survey of Radiation D oses to Patients, in Five Common Diagnostic Examinations. Br. J. Radiol. 56, 383395 (1983). 3. Padovani, R., Contento, G., Fabretto, M., Malisan, M. R., Barbina, V. and Gozzi, G. Patient Doses and Risks from D iagnostic Radiology in NorthEast Italy. Br. J. Radiol. 60, 155165 (1987). 4. Shrimpton, P. C , Wall, B. F., Jones, D. G., Fisher, E. S., Hillier, M. C , Kendall, G. M. and Harrison, R. M. A National Survey of D oses to Patients Undergoing a Selection of Routine Xray Examinations in English Hospitals. Chilton, NRPBR200 (London: HMSO) (1986). 5. Commission of the European Communities. CEC Quality Criteria for D iagnostic Radiographic Images and Patient Exposure Trial. Commission of the European Communities, Document XII/268/90 (1990). 6. WarrenForward, H. M. and McKeeney, D. B. Towards Reduction of Patient Exposure in Medical D iagnostic Radiology. Radit. Prot. Dosim. 43(1/4), 283286 (1992). 7. WarrenForward, H. M. and Bradley, D. A. A Pilot Study of Chest XRay Doses and Dose Variability within the West Midlands Regional Health Authority. J. Radiol. Prot. 13(4), 267274 (1993). 8. Huda, W., Sandison, G. ., Palser, R. F. and Savoie, D. Radiation D oses and D etriment from Chest Xray Examinations. Phys. Med. Biol. 34(10), 14771492 (1989).

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 175-184 (1995) Nuclear Technology Publishing

DATA ANALYSIS AND INFORMATION MODELLING: OBJECTS CODES, CONCEPTS


D. P. Pretschner Institute for Medical Informatics University of Hildesheim Samelsonplatz 1 D-31141 Hildesheim, Germany INVITED PAPER Abstract Acceptance, performance and usefulness of knowledge-based systems for quality control and radiation protection in diagnostic radiology and nuclear medicine depend on the technical competence of its developers and the medical, juridical and/or administrative relevance for its users. In promoting the efficient application of communication and information technologies the two groups of experts (developers, users) distinguished by overlapping domains of knowledge, objectives, subject fields and different concept, term and code systems have to be harmonised. On conceptual and methodological levels various strategies are discussed: conventional classification systems (Read Codes, ICD-9, SNOMED etc.), object-oriented analysis and design (e.g. NHS: CBS, CCPM), and standardised terminologies for international vocabularies, nomenclatures, encyclopaedias and thesauri according to ISO, CEN/TC 251, UMLS, AIM. Conceptual modelling using new terminological representation languages based on formal logic and semantics is proposed for the development of an open, unified concept and code system for the liberation of concepts from inadequate codes. It is assumed that work on well-formed terminologies promises more consistent and superior representation of expert knowledge for European information interchange, computer processing and quality assurance than (sometimes necessary) 'separatistic' and 'particularistic' solution islands. INTRODUCTION In order to understand, analyse, document and master selected physical, chemical and health care phenomena, one way of explicitly and reproducibly mapping parts of real world domains into mental awareness is achieved by modelling. Diagnostic radiology, nuclear medicine and radiation protection objectives are concerned, for example, with the phenomena of electromagnetic radiation and dose-effect relationships. Each of these phenomena can be mapped into two different models, so that one has reason to believe that one understands and is able to implement this understanding beneficially on computer systems. Propagation of electromagnetic radiation is described by the continuous wave model. Emission and absorption use the discrete quantum model. The concepts of physical quantities and their units such as energy, Planck's constant and frequency can be related using terminology which is accepted and easily understood worldwide: Ae = /iv. This arrangement of symbols and connectors explicitly designating different concepts and relations represents deep quantitative knowledge in shorthand. It presents a means for visualisation of a complex generic conceptual model and is an instance of a solution to a part of a well-structured problem. In comparison, dose effect relationships are explained by two other models, stochastic and non-stochastic. Concepts represented and pointed at by terms and signs are basic to modelling. Concepts are units of thought constituted through abstraction on the basis of properties common to a set of objects, related either hierarchically or non-hierarchically. They are used in systems of concepts as structured sets, each concept occupying a definite position""4'. Code values can be assigned to concepts, terms, and positions (concept-, term-, position-codes) to facilitate identification and computer processing (see Figure 5, later). Another example of a fundamental model or concept, code, terminology and sign system that is well-formed, is the periodic table with 109 elements, of which, at normal temperature and pressure, two (Br, Hg) are liquid and eleven gaseous (H, He, N, O, F, Ne, Cl, Ar, Kr, Xe, Rn). Nuclides with atomic numbers higher than 83 (Bi) are radioactive. Elements above 94 (Pu) have to be synthesised artificially. In physics and chemistry many exemplary problems have now become well structured. In medicine and health care, on the contrary, many problems are regarded as ill structured. From the point of view of realism, in order to justify and verify this hypothesis ontological arguments are put forward stating that it is the very nature of medicine and health care which is ill structured. From the point of view of nominalism, when an attempt is made to falsify the ill-structured domain hypothesis, the systems of concepts, terminologies and codes, the symbolic and linguistic representations are accused of being ill structured, but not the domain itself. The guiding principle in this contribution will be conceptualism as an intermediate between realism and nom175

D. P. PRETSCHNER

inalism. This should not imply that somehow the states of both realism and nominalism exist separately from conceptualisation. Both states are in continuous flux as our knowledge, understanding and conceptual framework changes. Today's realism may well be tomorrow's nominalism and vice versa. When applying new information technologies for the development of useful knowledge-based systems, and in order to harmonise technical competence and medical relevance, one prerequisite is work on formal conceptual and terminological models by means of well-formed concepts, roles and terms, with adequate coding for subsequent computer processing. The computer applications framework which exists today is based upon inadequate and limited concept systems developed by numerous individuals spanning fields as diverse as mathematical philosophy, solid state physics and software development which have evolved over many years. One should not expect interesting results from socalled 'information' storing, processing and visualising machines if the data (code sets) they so impressively manipulate represent inadequately and only in small parts the concept systems developed exclusively for human use. Computer illiterate end users can easily be satisfied by customised ad hoc applications and solution islands using sophisticated man-machine interfaces with conventional data bases. The desideratum for international, portable knowledge representation is not the 'it means what the system does with it' point of view, but the possibility that the system, by automatic logical inferences, is able to 'answer for the user questions beyond what was explicitly told to the system''5'. For future actions and research activities, therefore, the development of a natural-language-independent, formal concept representation system for quality assurance and knowledge-based systems in radiation protection is proposed with close relationships to corresponding ISO, CEN/TC251 and AIM activities'6"9'. DATA MODELLING; STATIC AND DYNAMIC ASPECTS Data modelling is the process and result of formally describing data and their relations. Traditional, semantic, and object-oriented data models can be distinguished. Concepts are the implicit or explicit content and meaning of data, terms and signs. It is the concept system which semantically and pragmatically modulates data, terms and their relations. Therefore, thorough and explicit conceptual modelling for the different sets of elements and mapping functions from the syntactic, semantic and pragmatic universes should precede data modelling (Figure 1). When using information processing machines the (different) code sets and coding schemes of the universes should be formalised explicitly. Syntactic and semantic models exist, formalising pragmatics may be difficult.

Traditional data models; relational data model Restrictions prescribed by real, commercial data base systems in contrast to semantic data models are basic to traditional data models. Traditional data models are implementation models differing in the representation of the relations of their data objects. In addition to the hierarchical and network model the relational data model has succeeded for some time in being a de facto standard""1". In a relational data base model entity types and their relations are represented by special tables. Rows are tuples u(A), corresponding to an entity type E of the entity-relationship model, and columns represent the values of attributes A. u(A) is injective, all tuples are different. A relation is valid if semantic conditions, formal dependencies of data, are fulfilled. Relations can be classified in normalised forms. A key consists of a subset of the set of attributes which determine a tuple. Dependencies of keys follow functional dependencies denoting semantic conditions. SQL (Structured Query Language) for instance is a relational language"". It is a mixture of a tuple orientated relational calculus with some text processing, arithmetic and algebraic elements. Traditional data models are record orientated. Many records have to be created in order to model complex objects of the real world. Their design and administration become difficult. Semantic data models; entity-relationship model A classical representative of the semantic data model is the entity relationship model"2'. In contrast to the traditional and object-oriented models, it is a pure design model in order formally to describe semantic aspects of the data. It is difficult to state explicitly the pragmatic aspects of the semantics of a syntactically well-structured data model. An example is the Arden Syntax with its MLM language (Medical Logic Modules). The Medical Entity dictionary contains medical terms with different attributes, such as NAME, KEY, SYNONYMS, DOMAIN, MAPPING, MODULE, and PROCEDURE"3'. The Arden Syntax is proposed as a knowledge representation language to be used for knowledge exchange between different institutes. It has to be shown in the future how medical knowledge regarding syntactics, semantics and pragmatics is explicitly extracted and coded. When being implemented, semantic data models are usually mapped onto traditional data models, e.g. the relational data model. However, during this manoeuvre they lose parts of their semantics. Entities e are objects of the real world belonging to a type, E e e E. r(e,,e2) denotes a relationship between entities e, and e2. A relationship has a complexity comp( ), which specifies the number of elements that can be, may be, or have to be related minimally (x) or maximally (y): comp(r, E,,E 2 ) = (x,y) x,y e N. In
176

DATA ANALYSIS AND INFORMATION MODELLING object-oriented data modelling the concept 'complexity' in 1987 in ISO 704: 'phenomenon of the outer or inner indicated by the term complexity is represented by the world which is observed (or can be observed) by a man term cardinality. at a given moment'. Three years later ISO 1087 defines Entity types E have attributes from set A with values an object as 'any part of the perceivable or conceivable of a domain. An entity e is fixed by the values of its world' with a note: 'objects may also be material (e.g. attributes. Entities, relationships and attributes have engine) or immaterial (e.g. magnetism)'"2'. their own graphical notations. Three different object models exist"4': Object-oriented data models The basic concept of an individual object was defined (1) value based, no object identity exists, the uniqueness of an object is based on its value;

Pragmatics navigational aids; structuring principles; targets, aims, goals; sense of meanings;

Semantics terminologies; taxonomies; partonomies; conceptions; meanings; dictionaries; encylopaedias; nomenclatures; vocabularies; thesauri;

patients; organs; radiation fields; medical procedures; illnesses; interventions;

"natural" images; paramtrica! images: 2D, 3D, 4D, nD; tools; programming languages; measured values; descriptions;

Figure 1. Three universes, syntax, semantics, pragmatics, with separate symbol (code) and mapping (coding schemes) systems (sets M mapping functions Fj) for information modelling.
177

D. P. PRETSCHNER

(2) identity based, every object in the system is associ ated with an identity, which is independent of the object's value; (3) hybrid, the designer specifies whether an attribute denotes a value or an object with identity. 'A ttri bute' here represents a part (e.g. instance, variable, field, element) of the structure of an object From the point of view of operationalising, values are bound to a type, an interval, an enumeration. They are clearly visible and can only exist permanently inside an object. Objects are instances of a class. They have an identity and a life cycle with appearance, changes, can cellation. A n unambiguous memory address is attached at every moment of their existence. Figure 2 shows an example of modelling partitive relations with regard to some characteristics of the con cept 'drug' using the notation of Coad and Yourdon"5'. Objectoriented concept and terminology systems as well as coding and data models are still under develop ment. Consortia of important industries, the Object Manage ment Group (OMG) with its subgroup Object Database Management Group (ODMG) are working successfully on the specifications of the standard CORBA (Common Object Request Broker A rchitecture)"617'. A t the moment objectoriented analysis and design of concept systems are supplying a well thought out model to oper ationalise and code sets of application concepts. 'Object oriented analysis is not an approach that models reality. Instead, it models the way people understand and pro

cess reality through the concepts they acquire' (Ref. 18, p. 233). Programming Two aspects are of importance, the static structure of data types and the dynamic behaviour of and with programmes that operate on these data. Regarding the current state of the art, it is rather difficult for an appli cation to combine the advantages of professional static data modelling with the advantages of adequate oper ational programming paradigms. Popular programming paradigms are: (a) (b) (c) (d) (e) imperative (C, FORTRA N, PA SCA L, A ssembler), functional (Lisp), declarative (Prolog), objectoriented (C++, Smalltalk), logicbased (KLONE families).

For the traditional relational data model, languages of relational algebra and of relational calculus can be distinguished"91. Programming with Smalltalk and C++ is common for the object oriented data model. Gem Stone and Ontos are examples of corresponding databases'202". The KLONE language families are addressed in the chapter on conceptual modelling. So called 4G systems (fourth generation languages) try to combine operational and descriptive paradigms of pro gramming and data base languages. In Radiology and Nuclear Medicine the imperative programming para digm (only) is, at the moment, in widespread use.

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Figure 2. Objectoriented modelling of wholepart structures of the concept "drug" with graphical notations according to Ref. 15. 178

DATA ANALYSIS AND INFORMATION MODELLING New technologies comprising synergistic combi- these static and descriptive instruments really will fulfil nation of the static and dynamic aspects assumed to be the far-reaching expectations. In this paper they are sub'killer technologies for software development' have sumed under data modelling although a clear distinction appeared"8'. They consist of CASE tools (Computer- between them and classification and coding systems Aided Software Engineering), code generators, visual does not exist. Strong aspects of conceptual modelling programming, repository-based methodologies, infer- are inherent, but not explicitly formalised and not operence engines, client-server technologies, class libraries ational. This is assumed to be the main difference in and object-oriented analysis and design"8'. Character- comparison with the ideas of conceptual modelling, ised by these 'slogans', some of the most ambitious Eur- with which automated classification, reasoning and opean R&D projects aim at laying the basis for the next dynamic simulation studies are expected to be feasible. generation of multilingual coding systems to integrate Figure 3 illustrates a part of the CCPM. In an attempt advanced medical information systems and clinical care to show extension possibilities and to give an example for Quality Assurance. These projects are to be found of consistent modelling, new entities and relations have with AIM (e.g. GALEN and GRAIL (Generalised been inserted to incorporate the model of anatomical Architecture for Languages, Encyclopaedias and knowledge for diagnostic classification from Read to Nomenclatures in Medicine, GALEN Representation MeSH'2930. And Integration Language), KAVAS-2 (Knowledge Acquisition, Visualisation and Assessment System), HELIOS II (Hospital Object Software Tools) and CLASSIFICATION AND CODING SYSTEMS CEN/TC251)'46-922'. Classification means two things. Firstly it is a formal, systematic structure of a set of concepts determined by terminology and logic. It could be compared with Minimum data set model; CBS; CCPM (NHS) terminological knowledge (T-Box-knowledge)'3". In 1985 a 'Charter on Data Modelling and Data Terminologically, this type of classification aims at Management' set out six policies (-F) for the develop- denoting essential characteristics and properties. Philoment of data modelling in the NHS (National Health sophically, it represents analytical sentences. Service)'23'. Policy A stated that data modelling should Secondly, classification means the empirical content always be used for information system projects where of a formal structure. This corresponds to extralinguisthe design stage is over 50 work days. Policy D, for tic, assertional knowledge about objects in the real instance, states that 'the NHS Common Data Model world domains (A-Box-knowledge) aiming terminologishould be used as the basis for all data modelling cally at denoting accidental properties or, philosophiactivity in the NHS'' 23 '. These policies and the NHS cally, at representing synthetical sentences'3". The difReview together with endeavours to realise these overall ferent representation of terminological and assertional plans resulted in the NHS Data Model, the CBS knowledge has been realised in the KL-ONE language (Common Basic Specification) Generic Model, their families (see chapter on Conceptual Modelling). mappings and the Cosmos Clinical Process Model 'The divergence between assertional and taxonomie (CCPM)'24-28'. These static and descriptive models are systems began with the earliest systems of logic. Aribeing developed and updated exemplarily in an attempt stotle was a taxonomist with his method of defining to define and structure knowledge precisely about data, new types by 'genus' and 'differentiae'. Each new events and activities in the NHS of the United Kingdom. type of species is defined by stating its genus or Object-oriented analysis concepts are used. The view is supertype and the properties or differentiae that discentralistic, dirigistic and very strongly managemental. tinguish it from other subtypes of the same genus. These great national efforts, investments and application Aristotle's method has formed the basis for all dicprojects are believed to be justified for the improvetionaries written in the past two millennia. Symbolic ment of logic takes the opposite extreme of emphasising assertions while ignoring the taxonomy of terms'' 32 '. (a) the information model mapping process, (b) specifying information requirements, Knowledge representation systems try to integrate both (c) standards for exchanging data across the new health terminological and assertional knowledge'3334'. care market, Beside generic subsumptions, the other possibility of (d) business and strategic planning, statistics and forehierarchical relations is of partitive nature. Frequent parcasting, titive intransitivities can be resolved by differentiating (e) clinical classifications used in audit and resource six different types of partitive relations'35'. The Nomina management, Anatomica are pure partitive hierarchies'36'. A termin(f) using and developing computer systems, ology is a set of terms representing the concept system (g) project management and control. of a particular subject field'2'. The totality of characterThe graphical notations of the CCPM are activity, event istics (properties) of a concept is named its intension and concept diagrams'28'. It has to be proved whether (idea, notion, definition, understanding). The broader
17')

D. P. PRETSCHNER (narrower) the intension of a concept is, the narrower and features of codes, data item representations and (broader) is its extension (law of reverse correlation). design of data codes. Uniform principles and methods The extension consists of the set of individual objects for the standardisation work of terminologies, essential to which the concept applies. A coding scheme is a col to all standardisation activities, are described in 40 lection of rules to represent items of one set with the ISO 10241' '. Terminological principles often are sacrificed when elements of another set. Figure 5 below shows the coded representation of the concept 'aneurysm' from combining (and confusing) concept systems directly with coding schemes, resulting in severe structural UMLS'3738). In determining the coding efforts and the coding rules restrictions and disadvantages: after analysis of the universe of discourse concerned, (a) concept relations are implicitly represented in the the information requirements are139': code, (b) generic and partitive relations are mixed in the (i) identification, same hierarchy, (ii) classification, and (c) hierarchical concept relations are represented by (iii) key to further information. hierarchical codes, Identification concerns precise terminology and data (d) hierarchical codes are fixed in depth, modelling. Figure 5 graphically compares two different (e) significant and nonsignificant codes are mixed, structures, Read Codes and MeSH (Medical Subject multiaxial systems use fixed combination codes, 29 3 Headings), as an example' "'. Classification in (f) (g) criteria of subsumptions are implicit, and TR 9789 of ISO/IEC is defined as a 'systematic (h) different characteristics on the same hierarchical arrangement of entities or attributes in groups or cat level, etc. egories based on the similarity of predetermined 39 In SNOMED 1984, for instance, sequential, mne characteristics'' '. In the same reference an overview can be found regarding the objectives of coding, types monic, combinatorial, group sequential and hierarchical

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Figure 3. Partial extract of the Clinical Process Model with extensions (black) for inclusion of new concept relations for example torepresentanatomical knowledge for diagnostic classification from Read to MeSH.
18

DATA ANALYSIS AND INFORMATION MODELLING codes are applied unsystematically at different code pos structured representation of the relations of semantic itions. In addition the composition of concepts is restric categories to which the concepts of the metathesaurus ted by only using tuples as the destination code, e.g. are mapped. General information about the biomedical n = 7, representing seven SNOMED axes. These are sources are contained in the information sources map. Two CDROMs contain the data of the third version structured like conventional enumerative schemes'4". In the future SNOMED may be structured using concep of UMLS: tual modelling. (1) disc UMLS92 (ISO 9660) with A SCii data of: A needs analysis and careful subject delimitation Meta1.2. in relational format have to be carried out when terminology standardisation Metathesaurus in nonrelational format (unit record projects are being prepared. For one project (without format) subprojects) the number of concepts should not exceed Semantic network in relational and nonrelational approximately 200 for reasons of avoiding inconsist format ency, omissions and inadequately reflecting new devel Information Sources Map in relational format opments of the subject field'40'. (2) disc UMLS8.92 (Macintosh HFS) with MetaCard, a HyperCard application of the Meta thesaurus Unified Medical Language System (UMLS) a browser for the semantic network. UMLS is one project and an example of interfacing different, machine readable biomedical classification Figure 5 shows an example of coding the concept 'aneu systems, nomenclatures, terminologies and controlled rysm'. The amount of A SCii data in relational format is vocabularies'37384243'. It aims at compensating for the terminological differences of its sources by means of a 460 Mbyte, in unit record format it is 132 Mbyte. unified interface between user and biomedical infor 130.137 concepts and 134 semantic categories have mation. UMLS consists of three components: meta been identified from 270.797 terms. The semantic types thesaurus, semantic network and information sources contain one hierarchical generic (is_a) and 4 main non map. The metathesaurus contains the central vocabulary hierarchical relations (without inheritance): with information about context, terms and relations of (9 subtypes) physically_related_to the concepts in a source. The semantic network is a (2 subtypes) temporarily_related_to (18 subtypes) functionally_related_to (13 subtypes) conceptually_related _to The hierarchical generic net is a tree from the point of view of graph theory. A ll nodes of the net model are a connected acyclic graph showing transitivity and inheritance. The root nodes consist of the concepts 'event' and 'entity' which bipartite to 'activity', 'phenomena or process' and 'physical object', 'concep tual entity'. The concept fields represented in the sources belong to the vocabulary of comprehensive information sys tems, classification of diagnoses, nomenclatures of medical terms and terminology of medical procedures (Table 1). The sources claim to dispose of a standard ised vocabulary for a limited medical domain. They dif fer considerably in data structures. From the sources listed in Table 1 only the terms of MeSH and DSM IIIR have been included in their entirety. CONCEPTUAL MODELLING Traditional 'concept systems' in medicine, such as the classification systems Read Clinical Classification, OPCS4, ICD9, ICD9CM, ICD10, SNOMED, ATC, ICPC, etc. are not pure'3044"19'. Their thesauri, nomenclatures and vocabularies are characterised by an indissoluble mixture of terminology, classification, and coding systems using different data models with inco herent and inadequate representation paradigms for con 1S1

Figure 4. Two different coding and classification structures with identical notations; Read (left), MeSH (right).

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Figure 5. Representation of a concept and unique identifiers in UMLS (C: concept, L: term, S: string).

D. P. PRETSCHNER cepts and roles. A change in representation of the same concept from one terminological system to another, transformation, for example from an ICD-9 rubric to a SNOMED analytic form is difficult' 4 50 '. Transforming concepts, roles (with domains and ranges) and characteristics in two terminological systems from source to destination may result in a loss of information because of different discreteness. The original concept may become subordinate but not distorted. In the mapping of concepts a shift of meaning is not excluded, whereas the conversion of concepts should not change meaning' 4 '. New developments for conceptual modelling and terminological representation languages are originating in formal terminological logic, conceptual graphs, research and standardisation projects such as GALEN and CEN/TC 251, WG 2,<4622'. Terminological logic together with predicate calculus are formalisms for defining concepts and roles with a formal semantics in order, for example, automatically to deduce subsumptions and partitive relations (classification). In KL-ONE language families logical operations, such as conjunction, disjunction, and denial, are only a primitive set of many other constructors for compositional concepts and roles' 33 34 51 52 '. Limits to the expressiveness of KL-ONE together with alternatives are discussed in Refs 5, 52 and 53. Conceptual graphs consist of concept and conceptual relation nodes for language-independent graphical notations of meaning' 54 55 '. Concepts and conceptual relations (roles) are defined by type and prototype Table 1. Sources of the UMLS vocabulary with number of adopted terms Index for Radiological Diagnoses AI/RHEUM COSTAR 1989 COSTAR 1992 Current Procedural Terminology (CPT) COSTART: coding symbols for thesaurus of adverse reaction terms CRISP thesaurus Diagnostic and statistical manual of mental disorders (DSM-III-R) DxPlain International Classification of Diseases: 1989 International Classification of Diseases: 9th revision, clinical modification (ICD-9-CM) Thesaurus Biomedical Franais Anglais Library of Congress subject headings, 12th ed. List of epidemiology terms Medical subject headings (MeSH) UMLS Metathesaurus Classification of nursing diagnoses Nursing interventions classification (NIC) Systematised nomenclature of medicine (SNOMED) Universal medical device nomenclature system 122 776 776 735 543 5.553 2.548 450 603 520 9.345 16.640 5.094 43 213.355 1.159 100 905 11.418 112 corresponding to definitional and assertional characteristics or, terminologically, essential and accidental '. The semantics of conceptual graphs is properties' based on predicate calculus. Canonical graphs and rules (copy, restrict, join, simplify) are at the base of automated classification' 56 57 '. Conceptual graphs are dealt with normatively by the Committee on Information Resource Dictionary Systems (ANSI X3H4) and the Interlingua Working Group for a Knowledge Interchange Format (KIF)' 58 59 '. KIF is analysed sceptically by Ginsberg' 6 '". One goal is the liberation of concepts from inadequate codes. Images in radiology and nuclear medicine are primarily aconceptual, though not aconceptional. Untrained individuals without adequate concept systems cannot arrive at any diagnostic or therapeutic deduction from perceiving scintigrams, CT or NMR pictures. These 2D matrices stand for results of a set of sophisticated measurements of physical and chemical quantities in time and space which are severely data-reduced and mapped to sets of pixels and voxels for human visual inspection only' 61 62 '. Useful interpretations of this (coded) pixel set then need transformations, algebraically quite unclear, to a set of concepts, roles and characteristics from a very complex concept system' 62 63 '. This consists of chemical notions together with physical, mathematical and metrologicai concepts such as spin, vector fields, probability, accuracy, etc. and is combined with medical ideas of anatomy, pathology, diagnosis, therapy, prognosis, etc. The expansion of existing classification systems and the development of conceptual modelling with liberation of concepts from inadequate codes will hopefully explicitly reveal structures in a form that is suited to subsequent adequate coding and computer processing e.g. for knowledge-based systems, not similar to alchemy, but well structured.

CONCLUSIONS (1) Work on well-formed terminological and concept systems of a specific subject field promises more consistent and superior representation of expert knowledge for information interchange, computer processing and quality assurance than 'separatistic' and 'particularistic' ad hoc solution islands. (2) Conceptual modelling and new terminological representation languages based on formal logic and semantics facilitate the composition of concepts, roles and characteristics with automated classification for the computer based exchange of knowledge: (3) Coherent entity and event modelling can be achieved by object-oriented analysis and design concepts. (4) In addition to necessary, individual ad hoc solutions, the coordinated development of a formal, natural-language-independent European concept system for quality control and radiation protec182

DATA ANALYSIS AND INFORMATION MODELLING tion in diagnostic radiology and nuclear medicine is proposed for future actions and research initiatives. (5) A sound concept, role and properties system open to extensions, regular amendments and national adaptations could be regarded as a solid base for future research, development, harmonisation and standardisation activities,

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Radiation Protection Dosimetry Vol. 57, Nos 1-1. pp. 185-189 (1995) Nuclear Technology Publishing

KNOWLEDGE BASED APPROACH TO QUALITY CONTROL IN DIAGNOSTIC RADIOLOGY


G. Contento4, R. Padovani4/, V. Roberto4:, O. Varint and C Delia Giustat tServizio di Fisica Sanitaria, Ospedale S. Maria della Misericordia USL n. 7, 1-33100 Udine, Italy Dipartimento di Informatica, Universit degli Studi via Zanon 6, 1-33100 Udine, Italy INVITED PAPER Abstract The design and prototype implementation of a Knowledge Based System (KBS) devoted to the Quality Control (QC) of X ray imaging (mammographie) equipment is briefly reported. Following the steps in KBS development reported in the Artificial Intelligence literature a conceptual analysis of the problem domain is first performed, identifying the relevant objects, concepts and their relations, as well as the tasks/goals involved in current practice. In particular, plans are individuated and explicitly represented that are sequences of relevant actions followed by the experts in QC practices. The computable form of plans constitutes the core part of the KBS. One of' the plans developed aims at diagnosing malfunctions of the mammographie equipment on the basis of the data which are daily collected during a routine QC programme, i.e. a performance test with a phantom and the sensitomelric strip. INTRODUCTION Artificial Intelligence (AI) techniques provide powerful and flexible tools to push the automation of current practices in radiological departments well beyond the current level. In particular, expert systems or knowledge based systems"'(KBSs) are computer programs encoding facts, relations, procedures, plans to assist the user in complex activities such as Quality Assurance (QA) in diagnostic radiology. This paper is mainly concerned with conceptual aspects: emphasis is put on introducing AI concepts and methods to non-specialists in an attempt to lay the foundations of future cross-disciplinary research. Basic concepts are introduced about KBSs and their impact in the domains of QA in diagnostic radiology; problems are identified for which the approach is expected to provide the most convincing results; an analysis is accomplished to identify concepts, objects, and actions involved in real-life situations, providing the conceptual grounds on which a KBS is being designed. STEPS IN KBS DESIGN The development of the KBS followed a general methodology consisting of three main steps'2'. Conceptual model An abstract and formal description of expertise results from cognitive modelling, i.e. systematical study of human behaviour in real cases. It is of interest to individuate facts, physical objects, concepts of the domain, as well as relations among them. For example, an X ray tube can be described as an object with attributes: focal spot size, target material, target angle, filtration, tube current and voltage and so on; a specific X ray tube can be identified by assigning appropriate values to its attributes. A relation is a link between objects (e.g. the X ray tube is a part of a mammographie equipment). In this way object structures become apparent. A common technique is reporting objects as nodes in a graph and relations as arcs connecting these nodes (semantic network). This knowledge must not only belong to the domain of interest, but must also be relevant to the problem (e.g. the colour of an X ray equipment is a feature not relevant to QC). Similarly, an analysis is carried out on the dynamics of object manipulations. The whole problem (task) is decomposed into simpler structures (sub-tasks), and so on, until sufficiently simple (elementary) steps are individuated. This kind of knowledge includes subtasks, strategies to pursue solutions of problems and constraints relating to the problem. It substantiates reasoning and problem solving activities. Control knowledge is also of concern: how the expert focuses his/her attention on relevant pieces of information: for example, by a priori planning sequences of actions, by monitoring the status of the progressing work, by rating priorities of co-occurring decisions. Design model The conceptual model of the real world, in conjunction with external requirements and constraints, is converted to a model for the KBS. The output is an architecture, i.e. a description of physical components of the system in terms of functionalities and structure. Knowledge representation techniques are used to map real 1 X 5

G. CONTENTO, R. PADOVANI. V. ROBERTO, O. VARIN and C. DELLA GIUSTA world objects to a form suitable to be coded in a computer. The knowledge base is now a structured collection of objects and tasks, strictly reflecting their conceptual counterparts. Detailed model The architecture of the KBS is further organised to determine a specific control and information flow. The system becomes an executable program. In the testing stage the system is evaluated. The results of tests are used in the refinement process of the system thus starting a cycle of testing and refinement phases. ELEMENTS OF A CONCEPTUAL MODEL FOR QC Identification and characterisation of the problem Identifying the problem environment is preliminary and crucial to any subsequent development of the KBS. The characteristics of the problem are identified by exploring the basic relationships between the radiological system and QC tests. The structure of QC tests and their interdependence are considered in view of defining appropriate operational contexts. QC includes a large set of tests, instruments and procedures regarding the whole radiology. Every operational context for QC is characterised by a radiological sector (conventional radiography, fluoroscopy, cine-imaging, mammography, dental radiography, conventional tomography, digital radiography, CT) and a phase of the process of formation of the radiological image (generating the X ray beam, producing the latent image, processing the image, visualising the image). Operational contexts pertaining to different radiological sectors may share a subset of QC tests. For example, in conventional radiography and fluoroscopy, the tests for the X ray tube and generator are basically the same. However, it is worth noting that QC tests for every sector of radiology are independent of those of the other sectors. The opposite is true for tests belonging to different phases of the imaging process in a given radiological sector. For example, some tests, though concerning a single phase of the radiological process, imply the use of films and are interconnected with the image processing system (e.g. tests for screen speed). Often, tests involve more phases of the imaging process (e.g. tests to check the efficiency of the image intensifier-TV system chain in fluoroscopic equipment, or tests for assessing image quality and patient dose). These interdependencies of tests along the phases of the radiological process cannot be neglected. In the knowledge representation it will be necessary to include relational links between different QC tests. The objectives of routine QC tests are to verify the permanence of optimised conditions of equipment and to give information on possible causes of malfunctions, though this information can be not conclusive. QC tests can achieve these objectives either by measuring some observables of the radiological system (e.g. kVp, mA, exposure time, developer temperature) and comparing the results with those obtained in optimised conditions (baseline reference values), or comparing one or more outputs of the subsystems that make up the radiological equipment with those obtained in optimised conditions (this output must be obtained using a test object). Objects and relations The QC test plays a central role in the domain. Its characterisation implies the specification of three main objects/properties: the radiological equipment, the operating environment and the test tool (Figure I). Every object/property can be further expanded to show more objects (subsystems, components), as it has been done for the radiological equipment in Figure 2 and the object film in Figure 3. The arrows in the figures represent relations, namely: ISA link (relation of

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Figure 1. Representation of objects and relations relevant in QC. The core part of the semantic network is based on the object TEST. The arrows in thefigurerepresentrelations,namely: ISA link (relation of inclusion) and HAS link (a property of the object). Only a few examples of objects belonging to each class are explicitly represented. 186

KNOWLEDGE BASED APPROACH TO QUALITY CONTROL inclusion), HAS link (a property of the object), PART- prototypical descriptions of the malfunctions are often OF link (a component of the object). It should be clear uncertain, approximate and able only to capture the that, for reasons of space, only a few objects among all most common characteristics exhibited by malfunctions. In the case of a test phantom the findings are repthose involved in QC are represented in the figures. Not only physical objects have their representation in the resented by the observables of the phantom image KBS, but also concepts and their properties can be rep- (densities and details). Every finding must be characterised by a number of attributes (properties): its value, its resented in the same manner. baseline value, limiting values and tolerances. As every KBS reasons on symbols not on numbers, numeric Relevant concepts in the diagnostic process values of findings must be converted to linguistic Expert diagnosticians tend to solve problems using values. This conversion knowledge is represented by a heuristic knowledge first, by directly associating obser- numeric-linguistic mapping: a set of linguistic values vations with diagnostic hypotheses. Since some data that provide evidence of variations of the variable conabout a system can be inaccessible, expensive or cerned with respect to its baseline value (unchanged, 5 dangerous to retrieve, observed data are often noisy and increased, decreased, and so on)' '. A prototypical repuncertain. They may include spontaneous manifes- resentation of a malfunction is given by a set of linguistations of the system, such as overheating of the X ray tic values of each finding of the phantom that are associtube, or the results of even complex measurement pro- ated with the malfunction, together with a numeric value cedures as is, for example, an image of a test phantom. that expresses the likelihood of such an association. For A diagnostic KBS, which mimics the expert's behav- example, a failure in the AEC control is considered iour, must be able to produce diagnoses by relating highly associated with a variation of the background those findings to a pre-enumerated set of possible mal- density from the baseline value. Instead, as far as high functions. This process is called heuristic contrast resolution is concerned, no relevant variation 5 classification'3' and aims at connecting the malfunctions is expected' '. to their typical manifestations. It is necessary then to As for the dynamics of objects' manipulations, the model the possible malfunctions in terms of their corre- whole QC activity has been structured according to a sponding manifestations so as to allow the KBS to three-level hierarchy: the plan level, the phase level and establish the relevant connections'4!. These models of the generic action level (Figure 4). The planning level

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Figure 2. Representation of objects andrelationsrelevant in QC. The expansion is of the node RADIOLOGICAL EQUIPMENT, included in the semantic network of the object TEST. The arrows in the figure represent relations, namely: ISA link (relation of inclusion), HAS link (a property of the object) and PART-OF link (a component of the object). Only a few examples of components of objects are explicitly shown. 187

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G. CONTENTO, R. PADOVANI, V. ROBERTO, O. VARIN and C. DELLA GIUSTA is the topmost level and represents the ability of humans to select the most appropriate set of actions to achieve a specified goal. In the QC domain, examples of plans are: executing routine tests, consulting the logbook, optimising the equipment performance. Every plan includes high level tasks, called phases of the plan. For example, in the plan execution of routine tests, phases are chosen so as to maintain a wide general scope, independent of the type of test under consideration: triggering of and assistance in test execution, input of data (finding values), validation of input data, analysis of data, diagnosis of possible malfunctions, suggestion of remedial actions, updating the logbook. If we focus on one of such phases, for example diagnosis of possible malfunctions, we find more specific activities, that determine the flow of generic actions performed during a diagnostic process (define symptoms, retrieve information from the logbook, establish trend of observables, generate hypotheses, etc.). THE PROTOTYPE The design and detailed models of a KBS to assist in the QC practices in mammography are currently being developed. Such steps are largely based on the conceptual analysis outlined in the present paper. The prototype is written in LISP code, is being coded by means of object-oriented programming techniques (detailed model) and runs on a PC 486 with 16 Mbytes of RAM. The prototype system makes use of the data obtained with a performance phantom and a sensitometric strip to evidence variations from the baseline performance of the radiological equipment and then infer hypotheses on causes of malfunctions. Although performance tests of the prototype are still in progress, some powerful features may be underlined. The prototype system is able to produce and rate sound diagnoses consistent with the symptoms observed. The prototype provides explanations of the steps followed to reach its conclusions. This is done by monitoring the system activity while crossing different plans, phases and generic actions and by a justification system involved in the diagnostic process. The architecture of the system allows an incremental development of the KB by adding malfunctions/symptoms descriptions or expanding the object/task structures. Work is in progress along these lines. Once the prototype has reached a stable configur-

PI.AN level

PHASE level

GENERIC ACTION level

Figure 4. The hierarchical organisation of QC activities. Tasks and actions are structured according to a three-level hierarchy: the topmost level includes high level tasks, the plan, that can be considered as an organised composition of activities of liner granularity, and the phases. Each phase, in turn, can be further detailed in a net of generic actions.

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Figure 3. Representation of objects and relations relevant in QC. The expansion is of the node FILM included in the semantic network of the object RADIOLOGICAL EQUIPMENT.

KNOWLEDGE BASED APPROACH TO QUALITY CONTROL ation, it is planned to start a systematic test of its behaviour, by comparing human with machine diagnoses REFERENCES 1. Jackson, P. Introduction to Expert Systems. 2nd edn (New York: Addison-Wesley) (1990). 2. Breuker, J. and Wielinga, B. Models of Expertise in Knowledge Acquisition. In: Topics in Expert Systems Design. Eds G. Guida and C. Tasso (Amsterdam: Elsevier Science Publishers) pp. 265-296 (1989). 3. Clancey, W.J. Heuristic Classification. Artif. Intell. 27. 289-350 (1985). 4. Moran. P.. Chevalier. M.. Van. E. and Contento, G. Evaluation of the Sensitivity of the Leeds TOR (MAX) Mammographie Phantom. Radial. Prot. Dosim. 49(1/3), 163-166 (1993). 5. Contento, G., Padovani, R., Varin, O., Castellano, S., Maccia, C , Chevalier, M., Fernandez, J. M., Moran, P., Van, E. and Roberto, V. The Use of Test Phantoms in Expert Systems for Diagnosing Malfunctions of the Radiological Equipment. Radit. Prot. Dosim. 49(1/3), 153-156 (1993). using worked-out examples, the input data being the results of routine QC tests.

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 191-194 (1995) Nuclear Technology Publishing

KNOWLEDGE ACQUISITION, REPRESENTATION AND REASONING IN A GAMMA CAMERA QUALITY CONTROL EXPERT SYSTEM
P. J. Slomkat, T. D. Cradduckt and J. A. Chudziakt tDepartment of Nuclear Medicine, Victoria Hospital 375 South Street, London, Ontario, Canada N6A 4G5 Institute of Computer Science Warsaw University of Technology ui. Nowowiejska 15/19, Warszawa, Poland Abstract Gamma camera quality control (QC) requires several test procedures which involve experienced staff. In an attempt to help medical personnel and automate these tasks, a prototype expert system was developed. A large database of faulty QC images and associated case histories was compiled. These cases were used in formulating object-oriented models for knowledge representation and reasoning. QC image features, artefacts and hypotheses are represented as hierarchical trees, with levels corresponding to the amount of detail in the description. This paradigm allows reasoning on various levels of abstraction. A small number of control rules derive appropriate conclusions using pattern matching techniques. Such a modular approach overcomes the complexity and maintenance problems often found in traditional rule-based systems. Preliminary studies of system performance suggest that it can be used as an intelligent QC assistant. It is hoped that the expert system can be helpful in centres lacking technical support, for example in third world countries. INTRODUCTION Gamma camera performance must be assessed frequently to ensure the acquisition of diagnostically reliable images. This is done by several quality control (QC) procedures. Most often QC tests use predefined phantoms containing radioisotopes placed in the scanning field to produce various distributions of photons. The most common gamma camera test is the assessment of the response to the uniform flux of radiation (floodfield uniformity). This test can be done under many conditions and thus provides valuable diagnostic information about camera function. Typically, a person with experience in instrumentation analyses the images and decides whether the camera performance is adequate. Standard numeric parameters are often not sufficient to characterise the fault and usually an informal verbal description is used. In addition, it is possible to diagnose certain camera problems by analysing the influence of differing acquisition parameters on the images. Guidance in such fault diagnosis can be found in various papers, books, and proprietary technical documentation"1; however, many practical diagnostic techniques are not documented at all. Hence, it would be beneficial to build an expert system, which would automate and standardise these tasks'2'. The main obstacles in creating an expert system for this application are the lack of precise documentation for troubleshooting methods, and the informal character of image description. To overcome these problems, the initial process of gathering the information was approached in an organised fashion. Hierarchical classifications were created of various concepts such as image features, artefacts, actions, problems and tests. This categorisation was implemented in the prototype expert system called QCMAN. Such an object-oriented approach allowed one to achieve high modularity of the software. In addition, the number of troubleshooting rules was significantly reduced compared with the conventional representation'31. The object-oriented technique allowed us to overcome problems of complexity often encountered in traditional rule-based expert systems'4'. METHODS Image-feature derivation Raw quality control images are not suitable for symbolic analysis by the system. Therefore, images had to be pre-processed. The pre-processing phase extracts values for various quality features. This allows symbolic description of the image, which is necessary for logical analysis. Several types of features were used such as uniformity indices, hot and cold area descriptions, asymmetry indices, edge distortion coefficients, object dimensions and statistical features (Poisson variation, etc.)'5'. Some features are calculated routinely during daily QC checks (e.g. uniformity indices). However, additional features were designed specifically for the expert system, for example the asymmetry coefficient, which describes the difference between the actual and expected shape. Image processing algorithms are written in C language. When the values of features are required by the reasoning module, the appropriate algorithms are executed. An example of an image is shown in Figure

191

P. J. SLOMKA. T. D. CRADDUCK and J. A. CHUDZIAK 1. Some selected features derived from the image are shown in Figure 2. Knowledge organisation A large database of gamma camera faults and associated case histories were collected, retrieved from old service logs and archived images. A complete fault case contains relevant quality control images with various artefacts, an informal description of the problem and action taken by the user. In order to compile an extensive database, it was necessary to survey many hospitals and camera systems from different manufacturers. Whenever possible, the original computer study was converted to the INTERFILE format, but most of the time it was only possible to obtain a hard copy of the images representing camera faults. The original computer acquired images were preferable to film images, but many hospitals did not archive their quality control images in the digital format. In particular, faulty images were rarely saved. These hard copy film images were digitized using a high resolution video camera. In total 217 quality control flood images, representing a variety of gamma camera faults were collected. When attempting to categorise images, it was found that conventional subjective interpretation of terms such as 'gridlike' or 'blotchy' caused difficulties in precise description. Hence, an attempt was made to classify various image features (Figure 3), artefacts (Figure 4) and gamma

FEATURE TREE

ASYMMETRY

Figure 1. An example of a quality control image with an artefact (floor contamination). number of pixels on edge := 0 coefficient poisson variation := 2.45 coefficient measured variation := .20 meancount:= 1677 uniformity integral := 48.78 uniformity differential := 5.23 central point coordinates := 32.17 33.50 central point offset := .17 1.50 coordinates of minimum value := 13 53 minimum count := 993 maximum count := 3209 size of cold spot := 1218.00 mean count in hot spot := 2279 size of hot spot:= 850.00 total distortion := 4.45 total counts := 5078376 asymmetry := 2.39

MINIMUM

MAXIMUM

Figure 3. A fragment of a hierarchical classification of features derived from QC images.

ARTEFACT TREE

REGULAR SHAPE

RANDOM PATCHINESS

VERTICAL

HORIZONTAL

Figure 2. Some features derived from the quality control flood image.
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Figure 4. A fragment of a hierarchical classification of image artefacts.

GAMMA CAMERA QUALITY CONTROL EXPERT SYSTEM camera problems. A structured classification of various with a technologist is required. If, as a result of an concepts was necessary for an objectoriented represen action, new images are acquired, the image features and tation of the data. The problems were categorised based artefacts are evaluated again. A new set of possible on their location (which component of the camera), and hypotheses is subsequently determined, taking into the type (user error, hardware defect). Specific types of account the previous results. This cyclic process stops problems are represented as subproblems of more gen when one of the hypotheses is confirmed. eral concepts. Similarly, all possible image artefacts and image features were organised hierarchically. The rea son for such specific classification of faults, features, RESULTS and artefacts during the knowledge acquisition stage was to provide data in a form suitable to be An example implemented in the objectoriented data structures'6'. To illustrate the QCMAN application, the case of iso Neuron Data NEXPERT OBJECT expert system shell tope spillage on the floor below the gamma camera is was used to represent this classification scheme. NEX considered. It results in additional activity being regis PERT OBJECT allows representation of the hierarchical tered during the test (Figure 1). The following is an trees as classes and subclasses. Subclasses inherit their informal description of the problem and the problem properties from classes they belong to. Subclasses rep solving methodology. During a daily QC check, the resent further specialisation of various concepts. image quality is found to be unacceptable. Specifically, uniformity is outside acceptable limits. Since a large area of higher intensity is noticed, isotope contamination Expert system reasoning strategy or some background radiation can be suspected. The The design of reasoning methods was influenced by next step is to move the gamma camera away and repeat the capabilities of the NEXPERT OBJECT shell. Com the test. During the second test there are no artefacts on bining rulebased technology with modular objectori the image. Therefore it was confirmed that, indeed, it ented inheritance techniques was attempted. Several was the isotope contamination of the floor. If the same techniques were utilised to implement different aspects artefact was still observed, it would suggest that the of the expert system reasoning. For instance, selfevalu problem was not external to the camera. ating data structures were created to compute image fea The QCMAN line of reasoning is illustrated in Figure ture values'7'. General control rules were used to find 5 and described below. In the first pass, the question Is the most probable set of initial hypotheses. camera usable? leads to the evaluation of image fea The general flow of information is represented in Fig tures. One of the features, specifically uniformity, is out ure 5. The reasoning process begins from the evaluation side of limits. Consequently, other features of the image of image features, which leads to the evaluation of the are calculated by the image processing component and artefact tree, if features are abnormal. Based on these linguistic interpretations based on simple threshold cri initial estimations the most probable preliminary teria are assigned. A n interpretation can be bad, alarm hypotheses are established. To confirm such preliminary ing, or OK. For purposes of this example certain fea findings, it may be necessary to perform a few tures are evaluated as follows: features are alarming, additional actions, which provide new data for improved asymmetry is OK, dimensions are OK, distortion is OK, diagnosis. During this process, evaluation of a gamma uniformity is alarming, hot area is big, hot area is pos camera history log, available resources and the feasi itioned on side. bility of various actions is performed, and interaction Based on these statements the system tries to detect the existence of various artefacts. One of the properties of the artefact class is a list of feature interpretations ACTIONS HISTORY LOG associated with the given artefact. Thus, a pattern camera moved move camera matching rule, which finds artefacts corresponding to evaluated features,.is fired. The evidence of an artefact HYPOTHESES floor contamination described as high count region on side is confirmed camera face contamination since it has the following features associated with it: eource contamination dimension is OK, uniformity is alarming, hot area is uniformity correction circuit big, hot area is definite, hot area is positioned on side. There are several hypotheses linked to this artefact, FEATURE EXTRACTION ARTIFACT namely, floor contamination, collimator contamination, EVIDENCE asymmetry OK camera fact contamination, source contamination and l high count dimenatone OK uniformity correction faulty. Each hypothesis has some region on tide 1) uniformity alarming 2) no artifacte initial evidence. There is a set of confirming conditions 2) uniformity OK associated with each hypothesis. If these conditions are 1 - FIRST PASS, 2 - SECOND PASS fulfilled then the hypothesis property confirmed becomes TRUE. First, a search is initiated to find a con Figure 5. An example of thereasoningpath. 193

P. J. SLOMKA, T. D. CRADDUCK and J. A. CHUDZIAK firmed hypothesis. If there are none, initial findings have to be verified through some user actions. These actions are listed in the verify actions property. Actions have a measure of feasibility. A pattern matching meta-rule finds a hypothesis with the most feasible confirming action. In the case of floor contamination an associated action move camera is initiated. After the user accomplishes the task a new QC image is acquired and its features are evaluated. In this second pass the feature interpretation property becomes OK. The action object has the property findings, which contains a list of linguistic concepts. In our example, the finding is spot disappeared, since image features are now OK. When the action is completed, a search for new confirmed hypotheses is initiated. This time the hypothesis floor contamination is established because all the confirming conditions are satisfied. These conditions are as follows: artefact high count region on side is present, action move camera is done, action finding is artefact disappeared. Preliminary evaluation of prototype In the current prototype only a subset of all possible faults has been tested. To evaluate the system performance, 30 flood images, which represented 10 different faults were selected from the 217 collected cases. The faults included: analogue to digital converter gains and offsets problems, contamination, photomultiplier defects and detuning, optical decoupling, overfilling the flood phantom, count overflow and pulse height analyser faults. The expert reasoning path and classification were analysed for each of these images as explained in the example. In 28 cases the diagnosis or suggested actions were correct. In two cases, the diagnosis was false due to wrong classification of features. It should be possible REFERENCES 1. IAEA. Quality Control of Nuclear Medicine Instruments. TECDOC-602 (Vienna: IAEA) (1991). 2. Todd-Pokropek, A. An Expert Aided System for Quality Assurance in Nuclear Medicine. In: Radioaktive Isotope in Klinik und Forschung, Band 18, Eds R. Hofer and H. Bergman (New York: Schattauer) (1988). 3. Slomka, P. J. and Cradduck, T. D. An Expert System for Gamma-Camera Quality Control. In: Radioaktive Isotope in Klinik und Forschung, Band 20. Eds R. Hofer and H. Bergmann (New York: Schattauer) (1991). 4. Debenham, J. K. Knowledge Systems Design. Advances in Computer Science Series (London: Prentice Hall) (1989). 5. Slomka, P. J. and Todd-Pokropek, A. A General Purpose Micro-computer Based Quality Assurance Package Designed to Used under an Expert System Shell. Eur. J. Nucl. Med. 16, 83 (1990). 6. Martin, J. Principles of Object Oriented Analysis and Design. (Englewood Cliffs, N.J. Prentice Hall) (1993). 7. Torasso, P. and Console, L. Diagnostic Problem Solving (New York: Van Nostrand Reinhold) (1989). to rectify such errors by improving the feature extraction algorithms. The total number of faults included in the fault tree was 62 and further testing and refinement of the system would be required to consider all these cases. CONCLUSIONS An attempt was made to build a prototype object-oriented expert system (QCMAN) for gamma camera quality control. Knowledge acquisition was approached in an organised fashion and a rigid classification of various concepts attempted; concepts which have been used previously in an informal way. Thus, an organised database was created consisting of quality control images representing various camera faults. Image processing algorithms for deriving features from images are incorporated in the system. The data representation is object-oriented, which provides modular structure, better control of the reasoning, and natural representation of knowledge. The QCMAN system can diagnose gamma camera malfunction, and judge if the fault can be corrected by the user. Whenever possible, it suggests the corrective action and then analyses the change in QC results. The system can be used not only for specific fault diagnosis, but also during routine QC tasks to verify camera status. Preliminary studies of system performance suggest that it could be employed successfully in the role of an intelligent QC assistant. It is hoped that it can be used in centres lacking experienced technical support. ACKNOWLEDGEMENTS The authors acknowledge active participation of nuclear medicine technologists Alice Yun Sang and Janice Stephenson in the knowledge acquisition process. This research was in part supported by NSERC Grant 0036853 and the KBN grant 507/032/277/1.

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 195-198 (1995) Nuclear Technology Publishing

MEDICAL DEVICES QUALITY ASSURANCE SERVICES


A. Talbot, M. Kragsholm, A. Mnsson and S. S. Nielsen Danish Centre for Medical Technology MTA 51111, Rigshospitalet Blegdamsvej 9 2100 Copenhagen East, Denmark Abstract The main objective of the two tools described herein is the support of Quality Assurance of Medical Devices. The first tool is named PANDA and was developed for quality control services for inspection of Medical Devices. PANDA is used directly in connection with inspection of a wide range of medical devices. It functions as a dynamic quality manual which is able to carry out inspection procedures and contains a log for each medical device containing measurement data and material used. Extended reuse of previous work and modular contraction assists in the construction and maintenance of the inspection procedures. The sequence of inspection instructions can be controlled by a logic language. Object oriented programming is also used throughout for the database. The tool is characterised by its ability to fully document the circumstances under which the inspection is performed. This makes PANDA a candidate for ISO 9000 work. The second tool is a European Database for Quality Assurance Data (EuroQADB). The purpose of the EuroQADB is the exchange of inspection procedures and inspection data gathered using PANDA. INTRODUCTION At the Danish Centre for Medical Technology, two software tools PANDA and EuroQADB to support Quality Assurance of Medical Devices are currently under development. This work is performed within the workpackage, Medical Devices Quality Control Service (MEDQAS) of project A2001 BEAM: 'Biomedical Equipment Assessment and Management' in the CEC AIM programme"'. Current available Medical Equipment Management Systems'23' are characterised by giving the highest priority to the economical and corrective maintenance functions. Lately, preventive maintenance functions have been included but normally with limited possibilities for structuring measurement results. The preventive maintenance procedures are described in text files and re-use of procedures within the system is not optimised. Most often, the users of the systems must themselves provide the procedures. This is time demanding and hospitals have problems with the implementation in a cost effective way. In the USA, an Inspection and Preventive Maintenance System'4' provides a complete set of procedures in software text files. In additon to the above mentioned general systems for medical device management many systems specialised for specific instruments have been developed'5'. In contrast to the conventional systems, the goal of MEDQAS tools is characterised by being modular to allow for adjustment and re-use of procedures. In addition, PANDA and EuroQADB are designed for quality management according to EN 29000/ISO 9000'6' (although it is not mandatory to apply ISO 9000 to use the tools). The concepts and terminology of ISO 9000 are applied'7'. Two basic requirements from ISO 9000 have had a significant impact on the requirements for PANDA and EuroQADB; the need for planned documented working processes and the quality loop. According to ISO 9000, the quality system for the department must include documented processes for all the functions and subfunctions. This is obtained by working out requirements for quality and a quality manual. These should be developed at each department with involvement from the individual employees since the process of working out the programme itself will result in a better level of quality and the involvement of the employees is important for the results. The documentation of the processes should be appropriate and controlled. For all functions, measurable quality parameters should be defined. The quality loop is a conceptual tool well suited for the central theme of continuous improvement. The phases in the quality loop are: (i) (ii) (iii) (iv) Planning defining requirements Implementation Evaluation Adjustment

For each medical device these phases must be addressed routinely. The quality system established for the devices must include documentation control. PANDA The main objective of the Panoptic Action Navigator and Data Administrator (PANDA)'8' is to support the quality control of the inspection of medical devices in the hospital. PANDA is designed for use with a wide range of medical devices. It is for use in the scheduling and execution of inspection procedures as well as in the administration of data acquired during inspection. Emphasis has been placed on making PANDA very flexible; it has a modular construction. For this reason, an object oriented software architecture has been applied. An important part of PANDA consists of 195

A. TALBOT, . KRAGSHOLM, A. MNSSON and S. SKOGSTAD NIELSEN

detailed and reusable setup functions assisting the pro cess of establishing the requirements for quality. The specification of inspection procedures is done in socalled PA NDA sessions, which contain the descrip tion of the inspection procedures. Each PA NDA session is built of a number of smaller modules PANDA activities that in turn are built of PANDA steps. The smallest structural units in the tool are the info elements, and they can reside in either PA NDA activi ties or steps. The infoelements accommodate the infor mation and the functionality necessary for interfacing with the user, the medical device under inspection and the measuring instruments. The latter two are relevant when measurements can be automated, avoiding manual input of data. This is the case for an increasing number of medical devices. A n example of a measuring instru ment that can be interfaced is leak current measuring equipment. The design is based on a tree structured organisation for both all the equipment and all PA NDA sessions, activities, steps and infoelements (Figure 1 ). A ll medi cal devices residing in a hospital can be organised according to the grouping specified in the BEAM classi fication. In PA NDA , this grouping is achieved by con struction of a tree with the device groups at highest level of the tree, the device models at the next level and finally the real devices at the sprigs of the tree. Due to this tree structure, it is possible to reuse already defined PANDA activities, steps and infoelements when editing a PA NDA session for a given device or group of devices. The principle is that the session, activity, step and infoelement reside on the most general level poss ible. If an activity is common to a whole device group it will be attached at the device group level of the tree. On the other hand, the activity will be attached at a sprig node of a tree if is relevant only for a specific device. During an inspection (i.e. execution of a PA NDA session) a number of different items must be stored in order fully to document the results and the conditions under which the results were acquired. This information

storage in PANDA is named the Device Log (Figure 2). The device log is made up of a list of every infoelement executed, the infoelement results and the 'address' of this infoelement, i.e. to which PA NDA activity or PANDA step the infoelement belongs. This also includes the person involved and the measuring instru ments, spare parts/consumables, accessories etc. used. For this logging purpose an object oriented database (VOSSObject Oriented DB'91) is integrated with PANDA. The point of integration between PA NDA and the database is at the device level, i.e. at the sprigs in the tree. The tree itself does not act as information storage, but only as organiser. Since a PANDA session may not always be straight forward in the sense that some special conditions may necessitate special actions or measurement results may point to, for example, readjustments, some form of logic is necessary (Figure 3). This has been provided as a simple programming language named P A CL A (PANDA Control Language). Calculations and con ditional branching will be possible at the PA NDA activity and step level. To assure easy and flexible access to the device log, a device log inquiry function has been designed (PA LA F, PANDA Device Log A ccess Facility). With PA LA F it is possible to build inquiries that explore the log accord ing to three selection criteria: (1) Results for medical devices belonging to a specific device group or model or one or more particular device(s). (2) Results from a particular PA NDA session or activity or step or infoelement. (3) Results from a particular time period, e.g. results from the last two years.
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Figure 2. Example of a log generated during execution of a PANDA session. Information is contained about the inspection results (e.g. measurement data), the names of the activities, steps and infoelements that were used and an execution time stamp for each element.
196

MEDICAL DEVICES QUALITY ASSURANCE SERVICES Reporting and calculations on this device log inforDifferent kinds of domains will be present as the datamation will be handled by a report builder. base is populated. First there are the data/information Similarly a function has been designed that can per- received from the various hospitals. This is the raw data form inquiries about the contents and structure of the from which various derived information can be PANDA tree (PATAF, PANDA Tree Access Facility). obtained. The derived information itself is also organWith PATAF inquiries about the location of some spec- ised in domains and attached to the tree in, for example, ific PANDA sessions, activities, steps and info-elements SIG work domains (see below) or a domain for standard as well as device group, device models or one specific PANDA sessions. device can be accomplished. The EuroQADB have most of the functions already For the purpose of planning of PANDA sessions a available in PANDA. However, these functions are calendar function has been designed (PAPLA, PANDA enhanced with functions that handle multiple hospitals Planning Facility). PAPLA is capable of planning and and for comparing many variations of PANDA sessions. booking the execution of PANDA sessions on the It is possible to implement basic statistical functions. In device level, including booking of staff and measuring addition, EuroQADB is able to handle PANDA sessions instruments required. without device specific information hereafter named generic sessions. EUROQADB The original information imported from the hospitals will be stored for each hospital as read-only copies. The The second tool in MEDQAS is a European Database original data contain a log (or part hereof) generated for Quality Assurance (EuroQADB). EuroQADB is during execution of sessions at a given PANDA site. closely related to PANDA. The objective of the EuroQADB is to provide for exchange of inspection From the log(s) the sessions, activities, steps and infoprocedures and the measurement results obtained using elements can be extracted during the studies of the origPANDA in the hospitals. The exchange of data between inal data. These extracted PANDA sessions will be PANDA and the EuroQADB will support the Clinical stored in the generic domain after refinement. The inforEngineer in his routine work with quality inspection. He mation from this generic domain is candidate for export will be able to take advantage of information from other to other local PANDA installations asking for generic experts dealing with the same special medical devices. PANDA sessions. For evaluations purposes another domain is used. The The EuroQADB is able to collect, refine and distribute information from and to individual PANDA statistical information derived from the original data systems. Therefore the EuroQADB has structures will be stored in a statistical domain together with the circumferencing the structures in the PANDA system. statistical procedures which derived them. This is managed by introducing a node-level above the Both PANDA and EuroQADB prototypes are topnode of the PANDA tree. This level is called the developed in a SMALLTALK-OS/2 environment. The Domain level. PANDA and EuroQADB prototypes will be tested in 1994.

Connections between SESSIONS | ACTIVITIES | STEPS | INFOELEMENTS In the PANDA-tree TOP VENIATOR DRAMER 6000

SPECIAL INTEREST GROUPS In the beginning, informal generic PANDA sessions will be the dominant data content of the EuroQADB. With time, emphasis will be extended to sessions based on peer reviewed procedures, sessions based on international standards as well as inspections results. We are currently looking for special interest groups (SIGs) that are interested in working with development and exchange of inspection procedures for specific devices, e.g. where quality aspects are of high priority such as mammography screenings'"". The experts in the SIGs will be asked to specify and test PANDA sessions and to perform selection and definition of quantities suitable as a basis for the exchange of information. The SIGs would benefit by getting opportunities for each multisite comparison of procedures and data obtained.

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Figure 3. Execution of a PANDA session named SERVOVENTILATOR for Device 191. It illustrates how the activity SERVOCALIB, the step STEP2 and the info-element BASICSET21 is activated within SERVOVENTILATOR. When logical decisions must be made during execution, PACLA statements (e.g. IFNOT .. . THEN . ..) are built into the steps and/or activities.

197

A. TALBOT, . KRAGSHOLM, A. MNSSON and S. SKOGSTAD NIELSEN REFERENCES 1. AIM 1993, Annual Technical Report on RTD: Health Care. STIG programme, Commission of The European Communities, DGXIII Information Technologies and Industries, and Telecommunications, 31 (1993). 2. MED EQ, et datoriserat system fr registrering och bearbetning av informationer om medicinteknisk utrustning, Spri rapport 121 (1983). 3. Lamberti, C , Carota, L., Giribona, P., Magliacca, F., Campajola, G. and Staree, G. D evelopment of a European Medical Equipment Management System. In: Proc. Clinical Engineering Workshop: Development, A ssessment and Maintenance of Medical Instrumentation, Trieste, September, 1993. 4. Medical D evices Inspection and Preventive Maintenance System, 2nd edn., ECRI (1990). 5. Cole, P. R. and Moores, . M. Computer Applications in Radiation Protection. Radit. Prot. Dosim., 57( 14), 203206 (1995) (This issue). 6. ISO 90042. Quality Management and Quality System Elements, Part 2: Guideline for Sen'ices ( 1991 ). 7. ISO/DIS 8402. Quality Management and Quality Assurance Vocabulary ( 1991 ). 8. Skogstad Nielsen, S., Mnsson, ., Seest, J., Olesen, D. E., Wistreich, . and Talbot, A. First PANDA Prototype, MEDQAS 4. Deliverable 22, BEA M project, A IM programme (1993). 9. VOSS Virtual Object Storage System for Smalltalk. V/PM, Logic A rts (1993). 10. Kirkpatrick, ., Tmberg, S. and Thijssen, . . . European Guidelines for Quality Assurance in Mammography Screening, CEC EUR 14821 (1992).

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Radialion Protection Dosimetry Vol. 57, Nos ^, pp. 199-201 (1995) Nuclear Technology Publishing

QUALITY CONTROL IN MAMMOGRAPHY BASED ON AUTOMATIC ACQUISITION OF EXPOSURE PARAMETERS


T. P. Walderhaugt, G. Einarssonf, S. Kristinssoni, S. M. Magnssonf and B. F. Sigfssont f National Institute of Radiation Protection, Laugavegi 188d, 150 Reykjavik, Iceland Icelandic Cancer Society, Skgarhl 8, 101 Reykjavik, Iceland Abstract A system for automatic acquisition of exposure parameters and radiation dose calculation in mammography is presented. Analysis of the parameters together with information on image quality can be utilised in optimisation of the radiographic procedure. Of special interest is the use of the compression force which is a parameter inaccessible with standard quality control procedures. Its influence on radiation dose is discussed. INTRODUCTION Recommended routine assessment of image quality and patient absorbed radiation dose in mammography is based on the use of specific test phantoms'". The image quality is then analysed in terms of the physical parameters of the imaging system alone, e.g. focal spot size, anode material or effectiveness of antiscatter grid. In addition, it is also of interest to study how the equipment is operated, since it may affect both the radiation dose and image quality considerably. This may be accomplished with a computer interface to the X ray unit, facilitating automatic acquisition of exposure parameters. Since film-screen mammography with dedicated systems involves one of the most standardised examinations in diagnostic radiology, the factors which influence the mage quality and radiation dose, apart from the physical properties of the imaging system itself, are few and their variation is normally limited to a narrow range. Most important are the breast thickness, compression force, the selected tube voltage and correction of the automatic exposure control. An analysis of the different parameters together with information of image quality and radiation dose may be used to optimise the radiographic procedure. The importance of the different parameters on the image quality and absorbed radiation dose must then be studied. An example is the compression force and its influence on radiation absorbed dose. Theoretical considerations imply that an increased pressure should reduce the dose, but an analysis of exposure parameters does not reveal such a simple relationship, due to the radiographers selective use of compression force with different breast thicknesses. METHOD In Iceland more than 90% of the mammography screening is performed on Soredex Mamex X ray units with molybdenum anode and filtration. All are equipped with an interface to computer or printer, and exposure parameters are automatically transferred with every exposure. A software program running on a desktop
199 Xray unit RS-232 serial

computer has been developed to perform the acquisition and store the parameters in a database. The computer also generates date and time of the examination, and the user, i.e. radiographer or radiologist, transfers information such as patient ID and examination type and view to the database. A schematic outline of the system is shown in Figure 1. A major aim when implementing the system was to enable calculation of radiation dose. It is performed according to standard methods by conversion of the exposure free-in-air at the breast entrance to average glandular tissue dose'23'. The relationship between the current time product for every tube potential and the exposure free-in-air is established at a reference point in the X ray field and made accessible to the computer. When the focus-film holder distance, the focusreference point distance and the breast thickness are also known, the exposure free-in-air at the breast entrance can be calculated. The conversion factor which is a function of the X ray quality, breast thickness and radiographic view is determined by linear interpolation in tables'3'. The accuracy of the dose evaluation is influenced by a number of factors, such as the accuracy of the assessComputer Generated by computer Keyboard/mouse User input X ray unit technical information Transferred from X ray unit Dose calculation Database record Date and time Patient/usar ID Examination View Type of filtration kVp and mA Dose Exp. time (ms) j Mode (auto/man.) Breast thickness Compr. force

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of exposure parameter system.

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T. P. WALDERHAUG, G. EINARSSON, S. KR1STINSSON, S. M. MAGNUSSON and B. F. SIGFSSON ment of the X ray unit high voltage and half-value layer, the accuracy of the breast thickness measurement device and the deviation of the mean of several measurements from the breast model. The accuracy of the breast thickness measurement device is of special concern due to the automatic measurement procedure adopted here. It is calibrated at a compression force of 130 N and investigations have shown that the measurements have a reproducibility better than 2 mm, or 0.2% of the distance from the X ray tube to the breast entrance. In addition, however, there is a systematic error from the distortion of the compression plate with increased compression force which, without correction, leads to an additional uncertainty of 4 mm. The uncertainty in the thickness measurements influence the dose evaluation both through the free-in-air exposure at the breast entrance and through the selection of the conversion factor to glandular tissue dose. These two factors together implicate a 7% uncertainty in the radiation dose evaluation for a medium thick breast. The accuracy of the compression force measurements has also been studied, revealing a considerable discrepancy from the true value, especially in the low and high compression force region. It was therefore necessary to

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1.5 2.5 3.5 4.5 5.5 6.5. 7.5 8.5 Mean glandular tissue dose (mGy) Figure 2. Distribution of glandular tissue doses for one unit. Mean value was 1.3 mGy with 0.7 mGy standard deviation. The glandular tissue dose, evaluated by standard methods at 28 kVp by simulating the breast with 45 mm polymethylmethacrylate (PMMA), was 1.1 mGy for this unit.

Figure 4. Variation of mean compressed breast thickness and mean radiation dose with compression force. The bars indicate two standard deviations of the mean. Only exposures with 28 kVp tube voltage were considered, and the radiation dose was corrected for differences in the correction settings of the automatic exposure control. In addition the breast thickness measurements were corrected for the error resulting from the distortion of the compression plate with increased pressure.

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09 11 01 03 05 07 09 11 01 03 10 12 02 04 06 08 10 12 02 04 Month (1990-1992)
15 20 25 30 35 40 45 50 55 60 Compressed breast thickness (mm) 65 Figure 5. Changes in the monthly average glandular tissue dose for one unit, for breast thicknesses of 24-36 and 48-60 mm. Values are relative to the mean of the whole period for each thickness interval. The influence of a change of the X ray unit software to increase the film density for thicker breast can be seen at time 1. At time 2 the automatic exposure control was adjusted to meet the sensitivity of a new film type. 200

Figure 3. Variation of mean glandular tissue dose with compressed breast thickness. Dashed lines indicate one standard deviation.

QUALITY CONTROL IN MAMMOGRAPHY BASED ON AUTOMATIC ACQUISITION OF EXPOSURE PARAMETERS correct those data before they were used in further up to approximately 70 N increased pressure decreases both breast thickness and subsequent radiation dose, as analysis. expected. Above 70 N, however, the mean breast thickness increases in spite of increased pressure and so does APPLICATION the radiation dose. This is an example of the radiograApart from being an easily available source of statisti- phers' discriminating use of compression force with difcal information, such as the dose distribution shown in ferent breast thicknesses and densities. Figure 2 and the radiation dose as a function of comWhen the radiographic procedure has been optimised, pressed breast thickness in Figure 3, the system is also the system may be developed to monitor the different a valuable tool in optimisation of the radiographic pro- exposure parameters. This may be of value both in fault cedure. One method is to relate the radiologists subjec- finding and in estimating influences from modification tive evaluation of the image quality with the actual of the equipment. An example of the latter is shown in exposure parameters and radiation dose, which in turn Figure 5 where the result from a specific change in the may lead to changes of the radiographic procedure. X ray unit software to increase the film density for thick The variations in tube potential and compression breast can be seen in the radiation dose. force and their influence on the radiation dose and image quality is of special interest. The relationship ACKNOWLEDGEMENT between compression force, compressed breast thickness and radiation dose is shown in Figure 4, revealing Financial support from the Icelandic Cancer Society a rather unexpected behaviour. For compression force is gratefully acknowledged. REFERENCES 1. The Radiation Protection Institutes in Denmark, Finland, Iceland, Norway and Sweden, Om mammografi. Nordisk rapportserie i strlskyddsfrgor, Nr 1. (in Swedish) (1990). 2. Rosenstein, M., Anderson, L. W. and Warner, G. G. Handbook of Glandular Tissue Doses in Mammography. HHS Publication FDA 85-8239 (US Dept of Health and Human Services, Rockville, Maryland) (1985). 3. Servomaa, A. and Tapiovaara, M. Glandular Tissue Dose in Film-Screen Mammography. Finnish Centre for Radiation and Nuclear Safety. Preliminary Report (1990).

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Radiation Protection Dosimetry Vol. 57, Nos \-A, pp. 203-206 (1995) Nuclear Technology Publishing

COMPUTER APPLICATIONS IN RADIATION PROTECTION


P. R. Cole and B. M. Moores Integrated Radiological Services Ltd Unit 188, Brunswick Business Park Liverpool L3 4BJ, UK Abstract Computer applications in general and diagnostic radiology in particular are becoming more widespread. Their application to the field of radiation protection in medical imaging, including quality control initiatives, is similarly becoming more widespread. Advances in computer technology have enabled departments of diagnostic radiology to have access to powerful yet affordable personal computers. The application of databases, expert systems and computer-based learning is under way. The executive information systems for die management of dose and QA data that are under way at 1RS are discussed. An important consideration in developing these pragmatic software tools has been the range of computer literacy within the end user group. User interfaces have been specifically designed to reflect the requirements of many end users who will have little or no computer knowledge. INTRODUCTION The integral parts of any quality assurance (QA) programme within diagnostic radiology are concerned with image quality and dose. Indeed patient dose is meaningless unless assessed together with image quality, and both are ultimately linked through the radiographic factors used for the examination. It is our experience, from running QA programmes and radiation protection services in the Merseyside region, that considerable amounts of data are generated. Taking mammography as an example, there will be daily measurements of fog, speed, contrast and temperature per processor plus daily measurements on image test phantoms. Also, weekly checks will be made on automatic exposure control (AEC), tube output and beam size. Together with reject analysis, this amounts to hundreds of data items per week. The clear implication is that effective management of this data and therefore the effective implementation of the Council Directives (80/836-EURATOM and 84/466EURATOM) would benefit from computer applications. This paper describes the software tools developed at 1RS to support the handling of quality assurance data together with patient dose assessment. this, or any other spreadsheet, in order to exploit its power through the application. Throughout, the software screens have been constructed so as to facilitate human-computer interaction (HCl). The spreadsheet-generated menu bars have been minimised, if not completely removed, and all functionality is only accessible through customised buttons (or menus on chart screens). The resultant user interface is simple and robust, thereby meeting the requirements of many end users who will have little or no computer knowledge. A flatfile database has been set up consisting of a number of tabulated data sheets. An individual sheet exists for each room or location and for this example the database has been populated with data that are the measurements from QC surveys of mammographie equipment. Any row within a datasheet refers to a specific date on which the QC readings were collected and the columns represent the type of reading, e.g. resolution and details detectable from the Leeds Test Object, output constancy measurements, AEC performance data for various thickness of Perspex, etc. Even though readings are collected daily, each sheet has the capacity for 10 years worth of data. It is possible from the main menu screen, to switch between data sheets and thereby handle data that only relate to a particular location. The QA data system is divided into two sections, both are reached from the main menu screen. Update section Measurements of equipment and processor performance in a local QA programme are made on a daily and a weekly basis. Consequently, two on-screen entry forms have been painted for the daily and weekly input of QA data, (see Figure 1). These screens have been designed so that they resemble the paper-based forms currently used by QA radiographers. Data is entered on to the forms by typing into the fields provided and posting to the database. Validation routines flag non203

QA DATA MANAGEMENT SYSTEM Implementation of meaningful radiation protection strategies requires that the data produced by QA programmes are effectively managed and that assessment of the quality of the image produced by departments is performed on an on-going basis. This stand-alone PC-based system aims to support the logging, analysis and interpretation of radiographic quality control data. It has been developed within a commercially available Windows-based spreadsheet package. However, the user interface has been carefully designed so that the end user requires no knowledge of

P. R. COLE and numeric inputs and request that these be altered. This validation routine can be extended to flag data falling outside tolerances, i.e. rogue data, and offer an 'investigation' into these deviations. Here 'investigation' denotes a rule-based logic tree that can provide advice and guidance. These forms allow the user to update and/or browse the database with no knowledge of its structure, indeed without ever bringing the relatively complicated datasheets into the foreground. Chart and analysis section Data is graphically represented as charts, a typical example of which is shown in Figure 2. Within this section all functionality is accessed via the menu bar at the top of each screen. From the 'charts' menu the user can toggle between any of the available charts. They are: 1. Fog Level.

. . MOORES 2. Speed Index 3. Contrast 4. mA .s delivered 5. Resolution 6. 0.25 mm details 7. 0.5 mm details 8. 6 mm details 9. Density Step 10 10. A EC performance optical density for 2, 4 and 6 cm sheets of Perspex. 11. Output constancy for various focuses and mA .s. 12. TLD breast dose measurement. Sensidensitometry readings.

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Figure 1. The update form within the data mangement system: (a) daily update, (b) weekly update.
204

It should be noted that the above formats are specific to QA in mammography, however they can be easily customised to any QA programme. The date interval over which data are displayed can be changed in one day steps from a minimum of two weeks up to a maximum of six monthbs. In this way it is possible to 'zoom in' on certain sections of data for a more detailed view, or 'zoom out' for the wider picture. An onscreen statistics report can be generated which currently details various parameters such as the mean and standard deviation of the displayed data set. Data target levels can be edited by the end user and then saved as default. Likewise the values for action and suspension tolerances can be changed as a percentage of the target and saved for future data analysis. Analysis takes the form of automatic 'rogue' (i.e. data outside tolerances) flagging and subsequent interpret ation aids. Once invoked, the rogue flagging routine checks the displayed data set in chronological order for any points that fall outside tolerances. If any are detected the system bleeps, highlights the offending data point on the chart and brings up a 'rogue report'. This report describes the rogue position and value, it also provides the opportunity to 'Continue' or 'Investigate'. By 'continuing' the current rogue is ignored and the system checks the remaining data set for further rogues. Alternatively, the system can investigate the current rogue by examining all related data within the database on that date and reporting as to whether it is above, below or within the tolerances. In this way the analysis assists the end user in identifying the possible causes of QA readings that are outside tolerances. Using rule based logic, this functionality is being extended so that the system will, using the results of the investigation, automatically list possible problems associated with a specific set of data conditions and suggest likely sol utions or further investigations. It is also desirable to examine the behaviour of data that are within tolerances as the detection of trends such as upwards/downwards drifts or periodic variations, may reveal nonstandard aspects of equipment perform ance and consequently act to predict rogues before they occur. Trend analysis for the QA data handling system is currently under development.

COMPUTER APPLICATIONS IN RADIATION PROTECTION It is envisaged that this data management system will The considerable amounts of reference data necessary not only facilitate the handling of large amounts of QA to perform dose calculations have been incorporated data but also, using data analysis and casebased logic, into the system as lookup tables. For example, by click act as an intelligent aid for QA radiographers. ing upon the 'Examination' field the user is able to sel ect from 22 commonly performed examinations plus appropriate field sizes, which refer to a comprehensive DOSE CA LCULA TION SYSTEM set of Monte Carlo tables. Likewise, through the 'Tubes' This software aims to provide a quick and robust field users can switch between several tubes for which method for the calculation of surface entrance doses and calibration data, i.e. output measurements per mA .s at organ doses from radiographic factors. It has been con one metre, are stored within the system. Values for the structed using the same Windowsbased spreadsheet inherent filtration of each tube are also contained within package as that used for the QA data management this table. software, and consequently both these systems are com patible. A s before, buttons and menus have been cus tomised, and screens have been carefully designed to Dose calculation facilitate HCl. The system calculates a surface entrance dose with At present most interaction occurs through the open backscatter for the selected projection and field size ing screen which contains a number of display fields. from the product of: These have been arranged into four groups according to (i) mA .s entered, the type of data that they hold. The groups are: (ii) tube output looked up from calibration tables for (i) Settings kVp, mA .s, FSD. the selected tube and kVp entered, (ii) Examination projection, field size, particular (iii) an inverse square correction for variations in FSD, tube or room, (iv) a backscatter factor looked up from Monte Carlo (iii) Patient patient size, tables for the selected examination, field size, kVp (iv) Dose calculates doses. and tube filtration. Online help is available to the user as descriptions of the data and ranges required within any particular group. Organ doses are calculated using the above surface entrance dose and data from the Monte Carlo tables.

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205

P. R. COLE and . . MOORES These Monte Carlo figures are normalised to surface entrance dose and have been previously calculated' ' ' for the standard MIRD hermaphrodite test phantom'2'. In an attempt to take account of the effects of patient size on organ dose the system provides five choices of size which cover the entire range of patients normally encountered'3'. Knowing the dimensions of the MIRD phantom, together with tables of percentage depth dose data'451 the program derives a 'scaling' factor which is used to modify the final value of organ dose that is cal culated. The calculated doses displayed on the opening screen can be transferred to a preformatted, cumulative report which can then be archived or printed. This software tool is currently being used inhouse for retrospective calculations of foetal doses which sup ports 1RS's radiation protection services to the Mersey side region. However, in the near future it will be used in a major regional study to compare the various methods for dose assessment. In the X ray department the dose system will provide radiographers with the means of calculating doses quickly before and/or after the examination. group as to their requirements of such computer sys tems. To this end customised versions of the software described here are currently being implemented in a number of X ray departments within the Merseyside region. Radiographers and radiation protection super visors will have the opportunity to evaluate the systems and to make comments. The feedback generated from these trials will allow modifications to be made, thereby ensuring that the user interfaces and functionality are radiologically viable. A further advantage of Windows is that it supports dynamic data exchange (DDE). This is a communi cations protocol that makes it possible for two or more applications to exchange data and issue commands to one another. DDE allows applications to be linked together to produce a system that takes advantage of the strengths of each individual component. A lthough, the software packages that have been developed function well as standalone applications, it is envisaged that linked together they will form the basis of a comprehen sive system for QA in radiology. When populated with dummy data or linked to teach ing practicis the packages, could also be viewed as computerbased training activities and consequently both could be incorporated into a CBL environment for radiographer training. In the near future, using similar communications technology, it is intended to establish a regional data network. This will provide individual X ray departments with the opportunity to transfer QA data, digitised images etc. to a central data management system for offsite processing. Data and services such as personnel monitoring information and training software could be transmitted to the users, via the network. The software tools described above will serve as a basis for this data network which can be extended to the national and international levels. In this way these tools can help develop European Standardisation in radiation protec tion practices in diagnostic radiology.

CONCLUSION In developing these software tools we have aimed to embed sophisticated functionality for the manipulation of radiographic data within a user friendly interface. The graphical operating system Windows is inherently user friendly and has proven to be an ideal development environment. Likewise, the software produced makes use of the power and flexibility offered by the Excel spreadsheet package. Functionality has been tailored to radiological prac tice and user interfaces carefully designed so as to optimise humancomputer interaction. However, 1RS recognise that it is essential to consult the end user REFERENCES

1. Jones, D. G. and Wall, B. F. Organ D oses from Medical Xray Examinations Calculated using Monte Carlo Techniques NRPB Rl86 (London: HMSO) (1985). 2. Snyder, W. S., Fisher, H. L., Ford, M. R. and Warner, G. G. Estimates of Absorbed Fractions for Monoenergetic Photon Sources Uniformly D istributed in Various Organisms of a Heterogeneous Phantom. J. Nucl. Med. 10, Suppl. 3, Pamphle 5 (1969). 3. Pheasant, S. Bodyspace Anthropometry, Ergonomics and Design (London: Taylor and Francis) (1988). 4. Harrison, R. M. Central Axis Depth D ose D ata for Diagnostic Radiology. Phys. Med. Biol. 26(4) 657670 (1981). 5. British Institute of Radiology. Central Axis Depth Dose Data for use in Radiotherapy. Br. J. Radiol. Supplement 17 (1983).

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 207-210 (1995) Nuclear Technology Publishing

OPTIMISATION OF THE DESIGN OF ANTISCATTER GRIDS BY COMPUTER MODELLING


D. R. Dancet, M. Sandborgi, G. Alm Carlsson^ and J. Perslideni tDepartment of Physics, The Royal Marsden Hospital, London SW3 6JJ, England. ^Department of Radiation Physics, University of Linkping, S-581 85 Linkping, Sweden Abstract A Monte Carlo computer program has been developed to model diagnostic radiological examinations, and has been used to study and optimise the design of antiscatter grids. This is important because the use of an inappropriate or poorly designed grid can lead to increased patient dose. Optimal grid parameters may be different for large and small scattering volumes. The program treats die patient as a rectangular block of tissue and takes account of the grid and image receptor. Image quality is measured in terms of contrast and signal-to-noise ratio and patient risk in terms of mean absorbed dose. Test objects of appropriate size and composition are used in the calculation of these image quality parameters. A new performance comparison and optimisation procedure has been developed, and the program has been used to study grid design in screen-film and digital radiology for small, medium and large scattering volumes. INTRODUCTION One of the fundamental objectives for the design of radiological imaging systems is to achieve an acceptable level of image quality with an associated absorbed dose in the patient which is as low as reasonable achievable. To achieve this design objective, it is necessary to consider the individual and combined optimisation of the components of the imaging system. In spite of the long history of technical developments in radiological imaging, design improvements with concomitant reduction of absorbed dose are still possible. This is illustrated in this paper and a companion paper"', which together summarise methods, results and applications from an extensive optimisation which has been made of antiscatter grid design. Such grids are used to remove scattered radiation from the radiation field after the patient, thus improving the contrast in the image but increasing absorbed dose in the patient because of the need to maintain the optical density on the film. The most detailed data on grid design previously published is that of Chan and Doi' 2 ' who used Monte Carlo methods to investigate performance for a range of grids, but at a very limited selection of tube potentials and scattering conditions. Their results were expressed in terms of contrast improvement factors and dose increase factors. However, contrast and absorbed dose can also be changed by varying the tube potential. It is not possible therefore to use these results as a basis for grid selection because of lack of data on variation with tube potential. In addition, it was felt important to study grid design for a range of scattering conditions. A different grid design may be preferred for a paediatric examination, where the patient thickness and scattering volume are small, compared to an adult lateral lumbar spine examination where the patient thickness and scattering volume may be large. The object of this work was therefore to investigate grid performance as a function of grid construction parameters, tube potential and scattering volume and to provide a basis for the optimisation of grid design. It was not practicable to carry out such a comprehensive study by direct measurement, and a Monte Carlo computer program was developed for this purpose. METHOD Imaging system model A simple geometrical model was used for the Monte Carlo calculations. The patient was treated as a rectangular block of tissue whose composition and thickness could be varied. The tissue block was irradiated by a rectangular beam with a cross-sectional area which could also be varied. The antiscatter grid was placed between the patient and the image receptor within a 4 cm air gap which was allowed for grid movement. The size of the air gap could be increased if required and the grid removed so that scatter reduction by the use of air gaps could also be studied. The geometric model and the Monte Carlo code are described in detail elsewhere' 3 '. Three patient sizes and tissue compositions were studied corresponding to adult chest and lumbar spine examinations and a pelvis for a 5 year old child. The image receptors modelled were chosen to simulate screen-film, image intensifier and digital (Fuji image plate) radiography. The antiscatter grid was constructed from highly absorbing lead strips which are intended to remove the scattered radiation and interspaces which should be constructed from material which offers low attenuation to the radiation beam. The lead strips were focused towards a line parallel to the receptor and passing through the tube focal spot. The grid had a top and bottom coyer to provide rigidity. In the optimisation studies the grid height and the strip and interspace width could be varied. It was convenient to specify the grid construction in terms of the lead strip width, the strip density (number of strips per cm) and the grid ratio (ratio of height to width of the interspace material) and the com207

D. R. DANCE, M. SANDBORG, G. ALM CARLSSON and J. PERSLIDEN position and thickness of the covers and interspaces. Both aluminium and low atomic number materials were used for these latter components of the grid.

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Monte Carlo technique The Monte Carlo code developed for the grid optimisation was a combination of earlier codes developed by the authors'4-7'. It used a collision density estimator to calculate quantities of interest at points in the image plane. The first stage of the program was the generation of the direction and energy of the photons emitted from the focal spot of the X ray tube. The photon direction was sampled isotropically within the rectangular field area defined for the examination being simulated. The photon energy was sampled from a tabulated X ray spectrum. A modified rejection technique was used which achieved a high efficiency by separating the bremsstrahlung from the characteristic X rays. Photon spectra were available at lOkV intervals between 50 and 150 kV for a tube with a tungsten target and 3 mm aluminium added filtration. The initial photon was tracked into the phantom block and its history followed from interaction to interaction using standard Monte Carlo techniques. In order to improve efficiency, the first interaction in the phantom was forced and all interactions were constrained to be either coherent or incoherent scatters. A weight function was used to correct for the bias this introduced according to the magnitudes of the scattering and photoelectric cross sections and the dimensions of the phantom where appropriate. The photon history was terminated when the photon left the tissue block. In addition, when the weight reached a low value, a biased technique known as Russian roulette was used to terminate most histories, with some histories being allowed to continue with an increased weight to compensate. Sufficient photon histories were generated to achieve a precision of 3% or better in all quantities of interest. The energy deposited at each interaction point in the phantom was recorded so that an estimate of the mean absorbed dose in the phantom could be made. The energy deposited per unit area at the point of interest in the image plane from primary photons was calculated from the product of the transmission of the photon through the phantom and the antiscatter grid and the energy deposited by a primary photon incident on the receptor. The transmission through the phantom and the grid were calculated analytically, the latter making use of the formula developed by Day and Dance'8'. The energy deposited in the receptor was estimated using a Monte Carlo simulation as discussed below. The energy deposited per unit area at the point of interest in the image plane from secondary photons was calculated using the collision density estimator'5'. This estimator receives a contribution from each interaction point of each photon history as follows:

The summations in this equation are over the photon histories simulated and the m interaction points per his tory. The quantities wi)C and , are the photon weights and the energy deposited in the receptor (see below), respectively, and aIK is the state vector for the ith history prior to the kth interaction in the phantom. The quantity T(aiic) is the probability per unit area in the receptor plane for the interacting photon to be scattered towards the point of interest and to reach it without further inter action in the phantom or grid. It was calculated analyti cally. A small correction was necessary to allow for scattered photons and characteristic X rays generated within the grid itself, and this was estimated using ana logue Monte Carlo simulation of the photon interactions within the grid. The energy absorbed in the image receptor from a given primary or secondary photon was estimated using straightforward Monte Carlo simulation but with the first interaction forced. Characteristic X rays with energy above 10 keV were followed within the receptor but those with energies below 10 keV were assumed to be locally absorbed. Measures of grid performance and optimisation strategies Grid performance was assessed in two ways. Firstly, the conventional approach of calculating contrast improvement and dose increase factors was followed to facilitate comparison of our results with the work of others and to provide a validation. Secondly, a task dependent approach was developed which also provided an optimisation strategy. Using this latter approach an imaging task was set and the grid parameters and tube potential were adjusted until the imaging task was achieved. The mean absorbed dose in the phantom block was used as a cost function for the optimisation. Two types of imaging tasks were set corresponding to screenfilm imaging and digital radiology. In both cases, a test object was selected with a size and compo sition appropriate to a particular radiographic projection such that the object was small but perceptible and corre sponded in size to structure identified in the quality cri teria guidelines developed by the CEC'9'. For screen film imaging a contrast level was set for the test object which could be achieved using the good technique para meters identified in the CEC document. For digital imaging, a signaltonoise (SNR) ratio was set. The contrast and/or SNR were then calculated for the projection and test object under consideration for a fixed grid and a range of tube potentials. The tube potential was selected (Ucq in Figure 1(a)) which gave the required value of the image quality measure and the mean absorbed dose in the phantom at that tube poten tial (U,.q in Figure 1(b)) deduced. By repeating this pro 208

OPTIMISATION OF GRID DESIGN BY COMPUTER MODELLING cedure for a large series of grid parameters, the optimal erating large amounts of scatter, the use of a high grid grid design could be found which achieved the desired ratio in combination with high tube potentials is favour level of the image quality parameter at the least possible able. When less scatter is generated, either the grid ratio dose in the patient. Figure 2 shows one stage of the or the tube potential can be varied to achieve the desired optimisation procedure: a study of the variation of contrast level. For paediatric radiology, the optimal absorbed dose for fixed strip width and grid ratio for grids require thinner lead strips (1020 ) than com the adult lumbar spine examination A P view. monly used today. APPLICATIONS A ND RESULTS The Monte Carlo program has been applied in three main areas which are outlined in the accompanying paper and discussed in more detail elsewhere"""121. In the first application, the program was used to quantify the advantage of grids with low atomic number covers and interspaces compared with grids which use alu minium for these components. This provided important data which can be used to give a quantitative justifi cation for the purchase of dosesaving grids (i.e. those with low atomic number covers and interspaces). In the second application, the performances of a range of com mercially available grids were compared in various imaging situations. In the third application the grid design was optimised for situations with small, medium and large scattering volumes. The last two studies showed that in many situations grids with widely rang ing strip densities (lines.cm"1) and grid ratios can offer good performance provided that they are used with appropriate strip width and tube potential. In some cases it was noted that commercially available grids did not have a welldesigned strip width. In examinations gen
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Figure 1. Contrast (a) and mean absorbed dose (b) in the phantom as a function of tube potential for a grid ratio of 12 and a strip width of 36 . A t a contrast level of 3% the contrast equivalent tube potential Ucq is 85 kV. The corresponding mean absorbed dose in the phantom is 0.071 mGy. The irradiation geometry is for an adult lumbar spine examination in the AP projection with a 1 mm contrasting bone detail and a 25 cm X 36 cmfieldat the entrance of the 20 cm thick soft tissue phantom.
209

D. R. DANCE, M. SANDBORG, G. ALM CARLSSON and J. PERSLIDEN DISCUSSION The Monte Carlo technique is a powerful tool which can find important application in situations where it is difficult to make direct measurements or where many different situations need to be studied. In the present case it has facilitated the investigation of a wide range of imaging situations and has led to the provision of information which will be of value in the specification of the imaging system. li is noted that the model used for the patient and for REFERENCES 1. Sandborg, M., Dance, D. R., Alm Carlsson, G. and Persliden, J. Results from an Optimisation of Grid Design in Diagnostic Radiology. Radit. Prot. Dosim. 57(1^1), 211-215 (1995) (This issue). 2. Chan, H.-P. and Doi, K. Investigation of the Performance of Antiscatter Grids: Monte Carlo Simulation Studies. Phys. Med. Biol. 27(6), 785-803 (1982). 3. Sandborg, M., Dance, D. R., Persliden, J. and Alm Carlsson, G. A Monte Carlo Program for the Calculation of Contrast, Noise and Absorbed Dose in Diagnostic Radiology. Comput. Methods Prog. Biomed. 42(3), 167-180 (1994). 4. Dance, D. R. and Day, G. J. The Computation of Scatter in Mammography by Monte Carlo Methods. Phys. Med. Biol. 29(3), 237-247 (1984). 5. Persliden, J. and Alm Carlsson, G. Calculation of the Small-angle Distribution of Scattered Photons in Diagnostic Radiology using a Collision Density Estimator. Med. Phys. 13, 19-24 (1986). 6. Dance, D. R., Persliden, J. and Alm Carlsson, G. Monte Carlo Calculation of the Properties of Mammographie Antiscatter Grids. Phys. Med. Biol. 37(1), 235-248 (1992). 7. Sandborg, M. and Alm Carlsson, G. Influence of Energy Spectrum, Contrasting Detail and Detector on the Signal-to-noise Ratio and Detective Quantum Efficiency in Projection Radiography. Phys. Med. Biol. 37(6), 1245-1263 (1992). 8. Day, G. J. and Dance, D. R. X-ray Transmission Formula for Ami-scatter Grids. Phys. Med. Biol. 28(12), 1429-1433 (1983). 9. Commission of the European Communities. Quality Criteria for Diagnostic Radiographic Images. In: Optimisation of Image Quality and Patient Exposure in Diagnostic Radiology. Eds B. M. Moores, B. F. Wall, E. Eriskat and H. Schibilla. BIR Report 20. pp. 271-280 (London: British Institute of Radiology) (1989). 10. Sandborg, M., Dance, D. R., Alm Carlsson, G. and Persliden, J. Selection of Antiscatter Grids for Different Imaging Tasks: the Advantage of Low Atomic Number Cover and Interspace Material. Br. J. Radiol. 66(792), 1151-1163 (1993). 11. Sandborg, M., Dance, D. R., Alm Carlsson, G. and Persliden, J. Monte Carlo Study of Grid Performance in Diagnostic Radiology: Factors which affect the Selection of Tube Potential and Grid Ratio. Br. J. Radiol. 66(792), 1164-1176 (1993). 12. Sandborg, M., Dance, D. R., Alm Carlsson, G. and Persliden, J. Monte Carlo Study of Grid Performance in Diagnostic Radiology: Task Dependent Optimisation for Screen-film Imaging. Br. J. Radiol. 67(793), 76-85 (1994). the imaging task were both very simple and the transfer of contrast and noise by the image receptor were negi e c t e d j t w i n b e o f considerable interest to extend the m o t jel by including some of these effects. ACKNOWLEDGEMENTS The authors are grateful to the CEC Radiation Protection Action (Contract Nos Bi7-0019-C(CD) and F13PCT92-0037) and the Swedish Radiation Protection Institute (SSI) for financial support.

210

Radiation Protection Dosimetry Vol. 57, Nos 14, pp. 211215 (1995) Nuclear Technology Publishing

RESULTS FROM A N OPTIMISA TION OF GRID DESIGN IN DIAGNOSTIC RA DIOLOGY


M. Sandborgt, D. R. Dancei, G. A lm Carlssonf and J. Perslidenf ("Department of Radiation Physics, Faculty of Health Sciences Linkping University, S581 85 Linkping, Sweden Department of Physics, The Royal Marsden Hospital, Fulham Road, London SW3 6JJ, England Abstract Results of an optimisation of grid design using a Monte Carlo model of the imaging chain are presented. Patient dose is significantly reduced by changing from aluminium to fibre grid covers and interspaces while keeping contrast constant. Numerous commercial grids have been investigated to identify superior designs. For optimal use, grids with high strip density require thinner lead strips and higher ratios than grids with low strip density. In paediatric radiology, grids with very thin strips (1020 ), or an air gap can be considered. In an adult lumbar spine examination, the optimal grid ratios are higher (greater than 15) than in commercial grids. This is particularly accentuated for grids with high strip density, fibre interspaces and in the lateral view. For a given imaging task, it is possible to identify grids of different design that have good performance, provided an appropriate strip width and tube potential are selected. INTRODUCTION In radiography, the adverse effect of scattered radi ation is reduced by using antiscatter grids which improve contrast but cause increased absorbed dose in the patient if film blackening is maintained. Strategies have been developed, using a Monte Carlo compu tational model"31, to optimise the design of grids for a wide range of X ray examinations. Monte Carlo methods have been used in the past'4' to study grids but in a limited range of imaging situations (tube potential and irradiation geometry). No study has previously been devoted to comparing patient absorbed dose at a con stant measure of image quality. This paper summarises the main results and con clusions from Sandborg et /'23'. The description of the methodology and the optimisation strategies employed are found in Sandborg etal' and Dance etal<5). The aim of this paper is to present results from three aspects of this work: firstly, a study of the effect on grid per formance of substituting aluminium with fibre materials in the grid covers and interspaces; secondly, a compari son of the performance of commercially available grids; and thirdly, an optimisation of the grid design para meters (strip density, lead strip width, grid ratio) and tube potential such that a specified level of image qual ity (contrast) is achieved at the lowest mean absorbed dose in the patient. The optimisation has been perfor med for both paediatric and adult examinations. METHOD Monte Carlo model The Monte Carlo method used to model the imaging chain is described as noted above. Detailed validation by comparison with measurements and other Monte Carlo calculations is given in Sandborg etal"K Irradiation geometry The geometric model of the X ray examination com prises a rectangular phantom of uniform soft tissue that represents the patient, a grid and an image receptor. Dif ferent conditions are simulated by varying the size and orientation of the phantom, the beam size, the focus film distance and the construction of the grid and the image receptor. The phantom contains a thin contrasting detail that serves as a test object for evaluating image quality.

Grids and image receptors A grid consists of thin lead strips separated by X ray transparent interspaces, surrounded by two covers for protection and rigidity. The grid design parameters are: lead strip width d, grid ratio r, strip density N, and cover thickness t. The strip density is defined by = l/(d + D) and the grid ratio by r = h/D, where D is the interspace width and h the interspace height. Data on commercial grids studied are given in Table 1. The receptors simu lated are 100 and 140 mg.cnr 2 Gd 2 0 2 S.

Image quality descriptors Contrast C in the presence of scattered radiation is calculated as in Dance et al'6'. It includes two factors: the primary contrast Cp and the contrast degradation fac tor CDF, which is the ratio of the contrast with and without scattered photons. When a grid is used, the scat tered photons are selectively absorbed so that CDF increases while Cp is slightly reduced due to the filtering of the primary photons in the interspaces. The total effect is expressed in terms of the contrast improvement factor CIF' 7 '.
211

M. SANDBORG, D . R. DANCE, G. ALM CARLSSON and J. PERSLID EN Radiation risk descriptor The mean absorbed dose D in the phantom is used as the measure of stochastic radiation risk. It is derived as the energy imparted to the phantom divided by its mass. It is normalised to a constant energy imparted per unit area to the image receptor (0.3 mJ.nr 2 ). The increase in absorbed dose when a grid is introduced is quantified by the dose increase factor DIF (Bucky factor), which is the quotient between the mean absorbed dose in the patient with and without the grid. Comparison and optimisation strategies Grids with aluminium or fibre materials for grid covers and interspaces are compared in terms of CIF and DIF for fixed irradiation geometry and tube poten tial. The optimisation strategies used are discussed in a companion paper'5' and are only briefly mentioned here. The grid design parameters (grid ratio, strip width and strip density) are varied and the applied tube potential adjusted so that a predetermined contrast is achieved for visualising the contrasting detail. The combinations of grid design and tube potential which yield the minimum mean absorbed dose in the phantom at the required con trast, are sought. RESULTS Comparison of grids made with aluminium or fibre materials The three curves in Figure 1 show the contrast improvement factor CIF as a function of the dose increase factor DIF when the aluminium covers and interspaces are successively replaced with fibre materials in an adult lumbar spine examination (A P view). For a constant CIF, a lower DIF is found when the aluminium covers are replaced with carbon fibre. When the aluminium in both the covers and interspaces is replaced by fibre materials, the reduction in mean

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Table 1. Parameters of commercial grids. The grids used are specified by strip density N, strip width d, interspace width D, grid ratio r, and cover thickness t. F denotes cotton fibre interspace, CF carbon fibre cover and Al aluminium interspace and cover.
Grid manufacturer Strip density, (strips.cm1) SMIT Rntgen 24 28 36 40 44 60 30 40 70 Mitaya 34 40 60 50 50 46 250 Al 200 A l 120 Al 6. 8, 12, 14 6. 8, 11, 13, 16 8. 12, 16 Strip width, d () 50 50 36 69 36 36 50 40 36 Interspace width, D () 370 300 250 200 200 120 F F F F F F 4, 5. 6. 8. 8, 8. 8, 10, 12 8, 10, 15 10, 12, 14 11, 15 11, 13, 15 10, 13 Grid ratios, r Cover thickness (top + bottom), 2t (mm) 1.0 CF

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RESULTS FROM AN OPTIMISATION OF GRID DESIGN absorbed dose is larger, 10-20% at 100 kV and 20^10% cotton fibre interspaces are located to the left in the figat 50-70 kV, the higher values occurring at the higher ure (in accordance with the results of the previous grid ratios. For constant DIF, CIF is somewhat larger section), having a lower DIF for a given CIF. There is (0-10%) using a fibre grid. This is partly due to less a large spread in grid performance for this examination. filtering of the primary beam in the fibre than in the With a small scattering volume, it is important to use a grid with high primary transmission, i.e. a grid with thin aluminium interspaces. lead strips, low grid height and fibre interspace materials. Aluminium interspaced grids with high strip Survey of commercial grids density perform better than other aluminium interspaced The results from the survey of commercially available grids, particularly at high grid ratios. grids are shown in Figure 2 for the paediatric pelvis examination. Grids with the same strip width and strip Global optimisation of grid design parameters density, but with different grid ratios are plotted on the same curve. A large variation in CIF and DIF is found In Figure 3, the mean absorbed dose D in the phanbetween grids from different manufacturers. The main tom is plotted as a function of the two mutually indereason for the differences is the use of different pendent grid parameters: the grid ratio and the lead strip materials for covers and interspaces, but variations in width in an adult lumbar spine examination. For each grid construction such as strip width and strip density tested strip density, one of the parameters (grid ratio, are also important. Grids with carbon fibre covers and strip width) was varied and the other kept constant. The
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213

M. SANDBORG, D. R. DANCE, G. ALM CARLSSON and J. PERSLIDEN curves show minima defining the optimal value of one parameter for a given fixed value of the other. For grids with 70 strips.cm-1 the mean absorbed dose increases rapidly with increasing lead strip width beyond the minimum. At 25 and 40 strips.cm"1, the minima are shallower and the optimal strip width decreases with increasing strip density. The dependence on grid ratio is large, particularly at ratios smaller than 10 where the mean absorbed dose increases rapidly with decreasing grid ratio. At all data points in Figures 3(a) and (b), the values of the tube potential used are different since the contrast was kept constant. Table 2 summarises the optimal grid designs found
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by using many curves similar to Figure 3 but for other combinations of grid ratio, strip width and tube potential. Grids with widely different strip densities and ratios can have good performance, provided they are used with appropriate strip width and tube potential. Ranges of the grid parameters r and d, and for the tube potential are therefore given. When selecting a grid with a thin strip width, the grid ratio should be taken from the upper part of the interval given. In selecting a grid with a high ratio, the higher tube potentials should be used. Limitations of using high grid ratios Grids require careful alignment in the beam to keep the loss of primary radiation due to lateral decentring and errors in the focus-grid distance of focused grids to a minimum. The loss is generally larger at higher grid ratio. Some minima in Figure 3 are shallow and it is thus possible to find designs with a moderate grid ratio to lessen the grid alignment problems and yet keep the mean absorbed dose in the patient at a low level. The use of high grid ratios should therefore be limited to situations where precise alignment of the grid and X ray beam can be made. CONCLUSIONS The use of fibre materials for grid covers and interspaces will significantly reduce the mean absorbed dose in the patient (10-40%) when all other grid parameters Table 2. Optimal grid ratios and lead strip widths for each strip density. The table gives ranges of the optimal grid design parameters (grid ratio r, and strip width d) and tube potential to use for each strip density in three imaging situations. All grids have fibre cover and interspace material. The optimal grids with aluminium cover and interspace material have lower grid ratios. See text for explanation of optimal combinations of the parameters within the ranges given.
Strip density. (strips.cm-1) Grid ratios. r Strip widths. Tube d potentials, U () (kV)

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Figure 3. The mean absorbed dose D in the phantom (adult lumbar spine examination, AP view) (a) as a function of strip width for girds with ratio 12 and (b) as a function of grid ratio for grids with strip width 30 for three strip densities 25 (x), 40 (o) and 70 (+) strips.cm-1. The contrast level is fixed at 3.0%. The contrasting detail is made of bone.

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RESULTS FROM AN OPTIMISATION OF GRID DESIGN remain unchanged. Superior grid designs were identified the optimal grid ratio increases with increasing strip from the survey of commercial grids. By optimising density. In a paediatric pelvis examination, grids with lead strip design (N, r and d) and tube potential, a thinner strips (1020 ) than used today could be con reduction of mean absorbed dose by 1020% can be sidered. achieved compared to using a standard grid (N = 40 strips.cm 1 , r = 12, d = 50 ) in the adult lumbar spine A CKNOWLEDGEMENTS examination. Grids with different strip densities and The authors are grateful to the CEC Radiation Protec grid ratios can have good performance if they have tion Program (contract numbers Bi70019C(CD) and appropriate strip widths and are used with a suitable FI3PCT920037) and the Swedish Radiation Protection tube potential. The optimal strip width decreases and Institute (SSI) for financial support. REFERENCES 1. Sandborg, M., Dance, D. R., Persliden, J. and A lm Carlsson, G. A Monte Carlo Program for the Calculation of Contrast, Noise and Absorbed D ose in Diagnostic Radiology. Comput. Methods Prog. Biomed. 42(3), 167180 (1994). 2. Sandborg, M., Dance, D. R., A lm Carlsson, G. and Persliden, J. Selection of Antiscatter Grids for D ifferent Imaging Tasks: the Advantage of Low Atomic Number Cover and Interspace Materials. Br. J. Radiol. 66(792), 11511163 (1993). 3. Sandborg, M., Dance, D. R., A lm Carlsson, G. and Persliden, J. Monte Carlo Study of Grid Performance in D iagnostic Radiology: Task Dependent Optimisation for Screenfilm Imaging. Br. J. Radiol. 67(793), 7685 (1994). 4. Chan, H.P. and Doi, K. Investigation of the Performance of Antiscatter Grids: Monte Carlo Simulation Studies. Phys. Med. Biol. 27(6), 785803 (1982). 5. Dance, D. R., Sandborg, M., Alm Carlsson, G. and Persliden, J. Optimisation of the Design of Antiscatter Grids by Computer Modelling. Radit. Prot. Dosim. 57(l^t), 207210, (This issue) (1995). 6. Dance, D. R., Persliden, J. and A lm Carlsson, G. Calculation of D ose and Contrast for Two Mammographie Grids. Phys. Med. Biol. 37(1), 235248 (1992). 7. A lm Carlsson, G., Carlsson, C. ., Nielsen, B. and Persliden, J. Generalised Use of Contrast D egradation and Contrast Improvement Factors in Diagnostic Radiology. Application to Vanishing Contrast. Phys. Med. Biol. 31(7), 737749 (1986).

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Radiation Protection Dosimetry Vol. 57, Nos 1-4, pp. 217-220 (1995) Nuclear Technology Publishing

COMPUTER MODEL FOR RISK-BENEFIT ANALYSIS OF MAMMOGRAPHIC BREAST CANCER SCREENING


J. Th. M. Jansen and J. Zoetelief TNO-ME Radiological Service Centre for Radiological Protection and Dosimetry PO Box 9034, NL-6800 ES Arnhem, The Netherlands Abstract To be able to evaluate and improve breast screening protocols, a Monte Carlo computer model was developed to obtain a belter insight into the influence of various parameters. To test the model, a comparison has been made with results obtained from the Swedish two-county study in terms of prevalence, rate of interval tumours and diameters of screened, interval and spontaneous tumours. Simulation of screening of a stable Swedish female population indicates, e.g. that a starting age for screening of 40 years seems optimal. Screening at ages in excess of 80 years results in detection of a high number of tumours that would not cause mortality due to a limited lifetime expectancy. INTRODUCTION Studies have been initiated to demonstrate a reduction in the mortality rates due to female breast cancer by early detection of lesions employing mammography screening. Most of these studies have yielded positive results of screening after a follow-up period of approximately 10 years and ages in excess of 50 years. As a result, various countries in Europe are performing or planning nationwide breast cancer screening programmes. The protocols being used for the pilot projects differ. For instance, starting ages were used varying from 35 years to 50 years. The intervals between successive screening sessions varied from 12 months to 42 months. To optimise screening, a Monte Carlo computer code has been developed based on random selection from distributions of relevant parameters, e.g. tumour onset, tumour growth rate and detection thresholds. To test the code a comparison was made between the actual results of the Swedish two-county study and the results of the simulation of this study. After validation of the model (that will be described in detail elsewhere), different screening procedures were simulated to study the influence of different parameters, e.g., starting age, screening frequency and detection resolution to enable optimisation of screening protocols. METHOD The simulation code will be described in detail elsewhere. The basic idea is that from a selected onset age the tumour grows exponentially, detection and survival are dependent on the tumour diameter. The screening sessions are age related. The program uses the Monte Carlo technique to simulate an individual history by sampling from distributions of the characteristic parameters, i.e. lifetime expectancy, tumour onset age, tumour doubling time and tumour detection thresholds. By simulating many histories average values are obtained. The following definitions are used to characterise the different types of tumours. A spontaneous tumour is a tumour detected without screening being offered. A screened tumour is a tumour detected due to screening. If this screened tumour could not be detected spontaneously, due to a limited lifetime, it is referred to as an excess tumour. An interval tumour is a tumour that is not detected by screening although the woman is participating in a screening programme. One can subdivide this latter group into: tumours occurring before screening starts; true interval tumours, i.e. observed spontaneously between successive screening sessions and tumours detected after the last planned screening. RESULTS AND DISCUSSION Comparison between the simulation of the Swedish two-county study and the actual results from this project To simulate the Swedish two-county study the following distributions were needed. The distribution of lifetime expectancy was derived from the survival data"1. The tumour onset age (age at which a tumour contains two thousand cells), tumour doubling