Amendment 5.7 Cover letter — 10/10/2006 Substantial amendment form — 11/10/2008 Acknowledgement letter — 19/10/2006 REC opinion letter — 06/11/2006PACE Trial Coordinating Centre, 3 Floor Dominion House, St Bartholomew's Hospital, London, EC1A 7BE Telephone: 0207801 8160, Facsimile: 020 7601 8176 Email: pace@qmul.ac.uk Nicola Murphy Committee Coordinator, West Miclands Mult-centre Research Ethics Committee 27 Highfield Road, Edgbaston, RECEIVED Birmingham, 815 30P 6 OCT 206 10 October 2006 Dear Ms Murphy, Full title of study: The PACE trial — A randomised controlled trial of adaptive pacing, ‘cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for pationts with the chronic fatigue syndrome / myalgic encephalomyelitis or encephalopathy MREC reference number 02/7/89 Re: Substantial Amendment 5.7 — Sub-study analysing experience of PACE trial therapists Please find attached @ Substantial Amendment for the first PACE trial participant newsletter Please find atiached the following documentation for consideration by the committee: « Substantial Amendment 5.7, 10 October 2006 = Sub-study protocol version 1, 08 September 2008 * Sub-study information sheet for participants (therapists), version 1, 08 September 2006 © Sub-study consent form, version 4, 08 September 2008 -~ Please do not hesitate to contact me should you require any further information relating to this or any other PACE tnal matter. ‘Yours sincerely, uw \c (et Professbr Peter D White If of Professors Michael Sharpe and Trudie Chalder (Principal investigators and the PACE Trial Management Group [vc] anaigee DWP Siatzaitin MREC* 10 October 2006 vent isrcTustzesossims Central Office for Research Ethics Committees (COREQ) NOTICE OF SUBSTANTIAL AMENDMENT For use in the case of all research other than clinical trials of investigational medicinal products (CTIMPs). For substantial amendments fo CTIMPs, please use the EU-epproved notice of Gmendment ferm (Annex 2 to ENTR/CT}) st hito:/eudract emea eu int/document.htmitquidance. To be completed in typescript by the Chief Investigator in languege comprehensible to a lay person ‘and submitted to the Research Ethics Committee that gave a favourable opinion of the research ("the main REC’) In the case of multi-sto studies, there is no need fo send copies to other RECs unless speciticaly required by the main REC. Further guidance is available at http://w corec.org.uk/applicants/epply/amendments.him. Details of Chief Investigator: Name: Prof Peter Denton White Adaress. clo Julia DeCesare PACE Trial Manager Barts and the London ‘Queen Mary's School of Medicine and Dentistry Department of Psychiatry Institute of Community Health Sciences Room 3.112 3rd Floor, Dominion House St Bartholomew's Hospital London EC1A7BE Telephone: PACE trial centre number: 020 7601 8160 E-mail: p.d.white@qmul.ac.uk Fax: 020 7601 8176 Notce of amendment (non-CTIMP), version 3.1, November 2065| Short title of frial- Pacing, graded Actwity, and Cognitive behaviour therapy, a randomised Evaluation Full title of study: Long title of trial: A randomised controlled trial of adaptive Pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for Patients with the chronic fatigue syndrome / myalgic encephalomyeltis or encephalopathy West Midlands MREC Name of main REC: MREC/02/7/89 REC reference number: First approval 317 March 2003 Date study commenced: Final approval 11" February 2005 Further verbal approval 25" February 2005 (verbal by phone to confirm submitted minor amendments were indeed minor). First participant randomised 18" March 2005 ISRCTN number: ISRCTN54285094 Protocol reference (if applicable), | MRC code number: 60200434 current version and date; Final protocol | Protocol version number §.3 Protocol date: 06 April 2006 Amendment number and date: Substantial Amendment 5.7, 10 October 2006 Type of amendment (indicate all that apply in bold) (a) Amendment to information previously given on the REC application form Yes No 'f'yes. please refer to relevant soctions of the REC application in the “summary of changos” below, (b) Amendment to the protocol Yes No yes, please submit either the revised protocol with a new version number and dale, highlighting changes in bold, er a document isting the changes and giving both the previous and revised text. (6) Amenciment io the information sheet(s) and consent form(s) for participants, or io any other supporting documentation for the study Yes No NNetice of emenciment (non-CTIMP), version 3.1, November 2005yes, please submi all revised documents with new version numbers and dates, highlighting new tex: in boid. Is this a modified version of an amendment proviously notified to the REC and given an unfavourable opinion? yes No ‘Summary of changes Background & Rationale ‘The PACE Trial is an inter-professional multi-centre therapy based randomised controlled trial. The aim of supervision within the tial is to maintain specificity, sustain retention, menage quelity control and assurance, monitor competence in delivering therapy and enhance professional development. The rationele for the proposed ancillary study is that the gpproach to supervision within the PACE trial appears to be different from the previous experience of supervision for many of the therapists within the tial A review of the literature on supervision and reflective practice has highlighted that there are many models, methods, approaches and factors that influence the effectiveness of supervision (Edwards et al 2008, van Ooijen 2000). ‘Aim of the proposed study The aim of the proposed study is to explore the expenence of supervision within the PACE trial. To consider whether the experience of supervision differs between the therapies and whether previous experionce of supervision is similar or cifferent to that within the PACE ‘rial Potential Questions: «How is supervision perceived within PACE by therapists? How are models/ methods of supervision perceived by therapists? What are the perceived advaniages and disadvantages of the different methods? Ave there any perceived barriers to use of reflection within the supervision process? How does supervision with PACE relate to the therapists on-site service! management supervision? «Is supervision perceived differently within therapies and/ or professional groups? Implications of the Study “The aim of the study ie to identify the perceived experience of supervision within the PACE tral and whether this differs from previous practice and experience. This proposed ancillary study could offer insights into the model (S) of supervision favoured by therapists and use of training and supervision within research studios. =. Itmay identify the need for additional training in the use and application of supervision for therapy leads and/ or therapists. + Itmay offer guidance for researchers carrying similiar inter-professicnal multi-centre studies in the future «It may offer insight into preferred methods of supervision in relation to level of experience and/ or expertise in a specific field Research Design & Methodology ‘A number of research designs and frameworks were considered for this small exoloratory ‘tudy fo gain an insight into the experience of supervision within the PACE Trial (Fossey et ‘ai 2002, Reynolds 2003, Bowling & Ebrahim 2005). Qualitative research aims to gain Understanding from the subjects point of view. to give meaning to actions and experiences Notice of amendment (non-CTIMP), version 3.1, Novernber 2005(Denzin & Lincoln 2008a). Qualilative data is commonly collected through in-depth interviews, Observation, group interviews or focus groups (Fossey et al 2006), itis common in Qualiialive research for the researcher to work closely with the participants, and have we understanding of their role in the process i.e. reflecting on own values. beliefs and personal Saberience that may affect the research (reflexivity) (Bowing 2002, Denzin & Lincoln 20032, 2003b). The researcher 1s therefore studying. In order to reduce this possi potential barriers in gaining information from therapists in the PACE trial a self report questionnaire uliizing survey methodology was chosen rather than qualitative semi structured interviews and ‘eove groups, as the method of data collection (Bowiing & Ebrahim 2005), The devised Questionnaire will collect both qualitative (open) and quantitative (closed) data. To further reduce ary bias in collecting and analysing the data and to maintain conficentially the Gpestionnaire wil be distributes, collated and analysed by a research assistant independent of the PACE Trial Potential Sample: 19 therapists (6 to 7 therapists per therapy approach) withn the PACE trial Analysis Descriptive, content and thematic analysis will be conducted (Fossey et al 2005, Bowling & Ebrahim 2006). Where appropriate frequencies and percentage of response would be ecoidee. More detziled statistical analysis would be inappropriate due to the mainly Qualitative nature of the data and size of the study. Ethical considerations Wintten informed consent would be required from therapists to take part in the study. Each person would be required to complete an anonymous questionnaire. The professionel group and type of therapy the therapist 's delivering would be recorded, The intention is for ths fret author (DLC) to be study manager. The 1* author is aware of the implications of reflexivity and would be aware of the potential bias of being both researcher and therapy lead withiy PACE (Denzin & Lincoln 2002a). Each participant wil be assured of the confidentiality of the data thoy provide within the questionnaire. As this type of request has not been previously considered futher approval from MREC will be required. Each therapist would have the right not to participate in the study. Feasibility The study would need the suppor of all therapists involved in PACE to give a fair reflection of the use and experience of supervision within PACE, However, each therapist would have the right not to paricipate in the study. No additonal funding is being requested for completion of the study. References > Bowling, A (2002) Resoarch methods in health: investigating health and health services. 2" edition, Buckingham: Open University Press » Bowling A, Ebrahim S (2005) Handbook of Health Research Methods: Investigation, Moasurement end Analysis Buckingham: Open University Press ® Denzin NK, Lincoln YS (2003a) Strategies of Qualitative Inquiry 2° Ed, London: SAGE. ® Denzin NK, Lincoln YS (2003b) Collecting and Interpreting Qualitative Matenals Londen: SAGE. » Edwards D. Cooper L, Burnard P, Hanningan B, Adams J, Fothergill A, Coyle D (2005) Factors influencing the effectiveness of clinical supervision. Journal of Psychiatrie and Mental Health Nursing 12: 405-414 > Fossey E, Harvey C, McDermott F, Davidson L (2002) Understanding and evaluating qualitative research. Ausiralian and New Zealand Journal of Paychiairy 30: 711-732 > Reynolds F (2003) Exploring the meanings of artistic occupation for women living with chronic illness: a comparison of template and interpretative phenomenological approaches to analysis. British Journal of Occupational Therapy 66; 12: 551-558 ® Van Ooijen E (2000) Clinical Supervision: A practical Approach. Edinburgh: Churchill Livingstone ‘Notice of amendment (non-CTIMP), version 3.1, November 2005[Any other relevant information ‘As the potential participants of the study are therapists working within the PACE trial, every ‘attempt has been made to reduce bias and maintain confidentiality end anonymity. All uestionnaires will be anonymous. A research assistant independent of the tial will cistripute, collate and analyse the findings prior to the information being received by the principal investigators (Dr, Diane Cox, Prof Peter White, and Prof Michael Sharpe) List of enclosed documents ‘Document oa ies [Project proposal 4 8" September 2006 Information Sheet 4 8" September 2006 Consent Form 4 ‘8 September 2006 Questionnaire: 4 8" September 2006 Declaration «Iconfirm that the information in this form is accurate to the best of my knowlede and | take full responsibilty fort = [consider that it would be reasonable for the proposed amendment to be implemented. Signature of Chief Investigator: a pare Rae, Senta EE (wre) Date of submission: href Sh. Notice of amendment (nen-CTIMP), version 3.1, Noverber 2005IE West Midlands Multi-centre Research Ethics Committee 19 October 2008 27 Highfield Road Edgbaston Dr Peter D White Birmingham clo Julia DeCesare BI530P Barts and the London ‘Queen Mary's Schoo! of Medicine & Dentistry Depariment of Psychiairy Institute of Community Health Sciences Room 3. 112 3 Floor, Dominion House St Bartholomew's Hospital London, EC1A 7BE Tel: 0121 245 2544 Fax: 0121 245 2519 Dear Dr White Stuay title: A randomised, controlled trial of adding cognitive behaviour therapy, graded exercise, or adaptive pacing to usual medical care, compared to usual medical care alone for the chronic fatigue syndrome [ME] PACE TRIAL REC reference: 02/7/1089 Amendment ref: AMO03 Amendment date: 10 October 2006 Thank you for submitling the above amendment, which was received on 16 October 2006. | can confirm that this 1s a valid notice of @ substantial amendment and will be reviewed by tha Sub Committee at its next meeting, Documents received are as follows: Document [Wersion [Date Protocol 7 (08 September 2006 Parlicipant Information Shee! (herapist) i (08 September 2006 Parlicipant Consent Form 1 08 September 2006 Nolice of Substantial Amendment (non-GTIMPs) 70 October 2006, Notification of the Committee’s decision The Committee will issue an ethical opinion on the amendment within a maximum of 35 days from the date of receipt. Research governance approval All investigators and research collaborators in the NHS should notify the R&D Deparment for the relevant NHS care organisation of this amendment and check whether it affects research governance approval for the research Tho Contral Office for Research thes Committers iz responsible for the ‘operational management of Multrcentie Reseerch Ethics Conmittees(oarroas: Please quote this number on al correspondence Yours sincerely Q wee Miss Nikki Murphy Assistant Committee Co-ordinatorNHS} West Midlands Multi-centre Research Ethics Committee 08 Novernber 2008 27 Highfield Road Edgbaston Birmingham Professor Peter D White B15 3DP clo Julia DeCesare Barts and the London Tet: 0121 245 2544 Quoen Mary's School of Medicine & Dentistry Fax 0121 245 2519 Department of Psychiatry Institute of Community Health Sciences Room 3. 112, 3" Floor, Dominion House ‘St Bartholomew's Hospital London, EC1A TBE Dear Professor White Study title: A randomised, controlled trial of adding cognitive behaviour therapy, graded oxorcise, or adaptive pacing to usual medical care, compared to usual medical care alone for the chronic fatigue syndrome [ME] PACE TRIAL REC reference: 02/7/089 Amendment number: ‘Amendment date: 40 October 2006 ‘The above amendment was reviewed at the meeting of the Sub-Committee of the REC held on 01 November 2006, Ethical opinion ‘The members of the Committee present gave 2 favourable ethical opinion of the amendment on the basis described in the notice of amendment form and supporting documentation, Approved documents The documents reviewed and approved at the meeting were: Document Version Date Protocol 1 08 September 2008 Participant Information Sheet (therapist) 06 September 2000. | Parlicipant Consent Form 1 08 September 2008 Notice of Substantial Amendment (non-CTIMPS) 10 Octoer 2096 Membership of the Committe ‘The members oF the Ethics Committee who were present a! the meeting are listed below: + Dr Robert Hawker, Retired Clinical Scientist, Chair * Dr Ronald Jubb, Consultant Rheumatologist, Altemate Vice Chair The Central Office for Research Ethics Committees ic responsible for the ‘eperational management of Multi centre Research Ethie CommitteesResearch governance approval All investigators and research collaborators in the NHS should notify the R&D Depertmment for the relevar NHS care organisation of this amendment and check whether it affecis research governance approval ot the research Statement of compliance ‘The Commitice is constituted in accordance with the Governance Arrangements for Research Ethics Commitiges (July 2001) and complies fully with the Standard Operating Procedures for Research Ethics Committees in the UK. o2r7i089: Please quote this number on all correspondence Yours sincaraly Quam meCrt Mrs Anne McCullough E-mail: enne.mecullough@westmidlands.nhs.uk Copy to: Clinical Trials Uni, MHRA Research end Development Dept St Bartnolomew’s Hospital London ECIA 7BE