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LEEDS INSTITUTE OF HEALTH SCIENCES
Overcoming barriers to the use of patient data for Research and Development between the National Health Service and Higher Education
A Briefing Paper for the UK Faculty of Health Informatics March 2009
Charles Thackrah Building 101 Clarendon Road Leeds, United Kingdom LS2 9LJ Tel. +44 (0) 113 343 4961 www.ychi.leeds.ac.uk firstname.lastname@example.org
Overcoming barriers to the use of patient data for Research and Development between the National Health Service and Higher Education
In this briefing paper and accompanying presentation we discuss the key issues, risks and opportunities associated with the sharing of patient data for Research and Development (R&D) between Higher Education and the National Health Service (NHS), identify lessons that could be learned from countries outside of the UK, present a series of practical ideas and recommendations on how to better facilitate the use of information and data for health research between Universities involved in clinical education and research and the NHS, and discuss throughout how the UK Faculty of Health Informatics could best support the implementation of these recommendations in the future.
In 2005, the UK government committed to develop the research capability of NHS Information Technology (IT) systems in order to facilitate the recruitment of patients to clinical trials and to gather data to support work on the population’s health, and effectiveness of health interventions. This included promoting the Secondary Uses Service (SUS) which is an example of a source of comprehensive data enabling a range of reporting and analysis. In support of this development, the National Institute for Health Research Clinical Research Network Coordinating Centre (NIHR CRN CC) (formerly the UK Clinical Research Collaboration [UKCRC]) and Wellcome Trust carried out paper-based research simulations and made recommendations1 on the technical, regulatory and governance issues surrounding the use of electronic patient records for research and health benefit. The NHS Connecting for Health Research Capability Programme (RCP)2 was established to carry these recommendations forward alongside the Office for Strategic Coordination of Health Research (OSCHR) E-Health Records Research Board3 who act primarily as an external reference group for RCP and in addition “provide strategic oversight of e-health records research in the UK”. E-health
UK Clinical Research Collaboration and Wellcome Trust (2007) “Use of Electronic Patient Records for
Research and Health Benefit” available at: http://www.wellcome.ac.uk/Aboutus/Publications/Reports/Biomedical-science/WTX039411.htm
NHS Connecting for Health Research Capability Programme available at:
OSCHR E-Health Records Research Board available at: http://www.nihr.ac.uk/about/Pages/about_oschr.aspx
records research is being stimulated by the Wellcome Trust, in partnership with the Economic and Social Research Council (ESRC), the Engineering and Physical Sciences Research Council (EPSRC) and the Medical Research Council (MRC) with for instance their current research call4.
2. Organisation of Clinical Research in the UK
The UK has a strong history in clinical research, however, there is a common understanding that the costs of research are high and as a society we are duty-bound to maximise the return on research investment Hence efforts are being made to streamline the research process. These include the emergence of an NHS research strategy5, the pulling together of all government funded applied NHS and social service research under the National Institute for Health Research (NIHR) and the attempted alignment of the academic, NHS and industry agendas. Government-funded basic research is delivered through research councils such as the Medical Research Council (MRC), Economic and Social Research Council (ESRC), the Engineering and Physical Sciences Research Council (EPSRC). In addition charities such as the Wellcome Trust and Nuffield Foundation support both basic and applied health research. The UK Clinical Research Network comprises of a number of Clinical Research Networks (CRNs). Clinical Research Networks in England have been established to support work in the areas of cancer, dementias and neurodegenerative diseases, diabetes, medicines for children, mental health, primary care and stroke. Each CRN consists of a number of Local Research Networks that coordinate and facilitate the conduct of clinical research within a specific geographical area of England. Each Network, with the exception of the Primary Care Research Network, is overseen by a national Coordinating Centre. A major function of each of the CRNs is to increase involvement and recruitment into clinical trials. For example the National Cancer Research Network (NCRN) in England has 33 cancer research networks across England, closely aligned to cancer service networks, which are currently conducting around 400 clinical trails. Alongside these networks there are disease
Wellcome Trust (2007/8) “Electronic patient records and databases in research” available at:
Department of Health (2006) “Best Research for Best Health: a new national health research strategy”
available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4127127
registries which identify all cases of a particular disease in a defined population. A report6 commissioned by the Department of Health Policy Research Programme identified 250 registries in use in England, and with an estimation of around 400 registries in total. Studies based on registers can supplement data available from randomised studies and should be seen as an important adjunct to rather than a replacement for them.
3. Types of Clinical Trials Research
Clinical research studies can take many forms and their design has become something of a science in its own right. All have in common the need to answer a research question and to do so by gathering, analysing and interpreting data. Clinical research mainly falls into two general categories: experimental and observational. Experimental trials can also be sub-divided into two: randomised and non-randomised. Observational studies can be either analytical or descriptive. Whether they are observational, interventional or whether they employ quantitative or qualitative outcomes it is necessary to guard against bias and to provide evidence of sufficient power to avoid false positive or false negative conclusions. Issues of scale, cost, feasibility, ethics and utility have also to be factored into the designs. In some fields, especially cancer, where the number of competing new interventions is large recruiting sufficient subjects is becoming rate limiting and great efforts are being made to invite all possible patients to become participants.
4. Current Uses of Data
In supporting research, patient data can be used in a number of ways. This includes being utilised in clinical trials designed to test the safety and/or effectiveness and/or cost-effectiveness of healthcare interventions, identifying potential participants in specific research trials to seek their consent, providing data from routine care for analysis according to epidemiological principles, to identify trends and unusual patters indicative of more detailed research, and providing specific datasets for defined approved research projects. Indeed, the traditional model of clinical research has been based around the collection of data in support of a specific research objective, which may include developing a specific data collection process or retrospectively seeking to collect data from existing sources. It is against this background that new approaches to harvesting routinely captured clinical data have a potentially significant role. Each of these approaches will present specific issues but one challenge for the Health Informatics (HI) community is to identify the generic questions and to ensure
John Newton & Sarah Garner (2002) “Disease Registers in England” available at:
that developments in this field remain coherent. For example, promoting standards as regards to the way in which data is captured and represented in the databases to ensure interoperability, reusability and greater reliability of the data in a research context. With the growing number, scale and richness of the available clinical data sources the opportunities to exploit these sources have increased. There are many examples of where such approaches have been taken already, for example The General Practice Research Database (GPRD)7 is a clinical dataset which has been running since 1987 and includes 39 million person years of research quality data from over 460 practices. However the degree of sophistication of databases varies with many still disconnected across disparate systems. Many are unstructured and not coded, and require manual data entry between systems. The current question is whether, and how, the potential to support research can be enhanced and exploited.
5. Future Uses of Data
With the development of strategic clinical databases in the NHS there is an opportunity to support real-time collection of clinically relevant outcomes. For example, the SystmOne8 database used by GPs in Yorkshire and the Humber holds information approaching 50% of the population (4.5 million) in a single database instance. This database collects, in real-time, Read/SNOMED-CT coded patient events of the type of interest to clinical researchers. These outcomes could potentially be made available to researchers using either push (XML messages sent to research systems on suitably tagged patients) or pull approaches (authorised database searches) which considerably improve on the current situation. Extending this model to facilitate targeted data capture would provide other generic benefits. For example, a suitably designed architecture could provide messaging interfaces for accessing current patient records and relevant clinical databases which would enable the identification of family members of index cases who are marked as carrying a high risk cancer gene, such as BRCA1. This currently is a difficult and expensive task reliant on family history questionnaires administered manually. A number of models of data use could be envisaged: • Providing access for researchers to clinical systems to conduct work on the data in situ. For example identifying patients who have consented to follow-up and allowing controlled access to their clinical records to collect health activity data.
General Practice Research Database available at: http://www.gprd.com/ TPP SystmOne available at: http://www.tpp-uk.com/
Transferring data sets from NHS systems to research systems in bulk with or without anonymisation. For example exporting large collections of data from specific sub-populations to allow epidemiology analysis of interventions and outcomes, such as trends in epileptic control with different drug regimens.
Harvesting individual data items off clinical systems in support of research, e.g. blood pressure readings or drug prescriptions for a particular research cohort, which could be retrospective.
Providing access to data on patients whose samples have been stored in “bio-banks” against which new diagnostics are being tested. This has the potential to shorten the time to implementation of new tests since the discriminating power can potentially be identified on retrospectively collected clinical data rather than waiting to amass prospective information. This model has worked successfully in many areas such as antenatal screening where outcomes are known at short intervals. It is much more problematic for conditions with longer prodromal lead times.
6. What Are The Issues?
The focus of routine data collection in the NHS is to support clinical care and operational management of patients. Unless specifically engaged, providers do not have time to collect additional data. From a research perspective this can mean that such data collected will be of lower quality than that collected by research staff because of lack of incentives and motivation, lack of time, and interruptions. However, paradoxically, because the data for patient care is likely to be used to provide safe and effective care what is collected maybe more accurate and, from some points of view, of higher quality. Thus if one wished to measure some health impacts across a cohort the clinical database might hold a better validated set than a specifically designed study set collected ‘off-line’. It might also be available at lower cost. Clinical databases however will not answer all questions, particularly prospective ones. Unless data collection procedures can be injected into the clinical pathway to ensure that data is routinely collected on a regular basis it is unlikely that specific questions can be prospectively researched. However, the examples of data collection for Quality Outcomes Framework (QOF) where General Practitioners (GPs) are incentivised to collect items about their patients do show that practise can be influenced at a macro scale. If a sufficiently serious question needed to be addressed one could envisage the injection of a data collection process on a widespread basis to generated large datasets very rapidly. The NIHR CRNCC report of research
simulations 9 highlighted four models of research similar to some of the examples above where it was felt benefit could be identified (See Appendix A). One challenge for the HI community is to study those simulations and to consider the implications they raise and what measures would be needed to bring them into realistic and routine use. Clinical researchers struggle to obtain relevant clinical outcomes for prospective cohort studies, clinical trials and pharmaco-surveillance following the introduction of new therapies and therapeutic strategies. The paradigm adopted is to create independent research databases and for these to be administered in isolation from real-time clinical systems by a pool of research administrators. Longitudinal clinical data is traditionally collected in the setting of a research clinic or postal questionnaire, which is both labour-intensive and expensive. For the single outcome of death it is possible to register research subjects with the Office of National Statistics (ONS) and to receive death notifications automatically, on the same basis as such notifications are now made to NPfIT Patient Administration Systems (PAS). For intermediate outcomes other than death (e.g. heart attack in patients in secondary prevention trials) such notifications are not possible at present even though in many ways such outcomes have high relevance. Similarly, researchers find it difficult to assess baseline health needs against which to design intervention studies especially where multiple agencies are involved in care exemplified by work in assistive technology and disability. Here routine clinical outcome data (e.g. Hospital Episode Statistics [HES]) is too coarse to enable fine-grained analysis or management. ‘Stroke’, a commonly collected major outcome, in itself does not predict disability and may point to a fully recovered episode. Matching electronic assistive technology to ’the independence needs’ of a client requires detailed assessments of their disease progression, as well as current physical, sensory and cognitive impairment. Using intelligent algorithms which integrate information from the patient records has the potential to support a whole-system approach to address posture, mobility, well-being, lifestyle choices and emotional and mental needs of each individual. For record linkage to work effectively robust data identification methods will be needed. One is aware that the use of NHS number is far from universal in NHS systems and most likely used to a minimal degree in research databases. Promoting its use by researchers must be an early step. The predominant coding standard in primary care throughout the NHS is Read, though this is strategically moving to SNOMED-CT. However this is only one relevant code standard and many
UK Clinical Research Collaboration (2007) “UKCRC Advisory Group for Connecting for Health: The Report
of the Research Simulations” available at: http://www.ukcrc.org/publications/reports.aspx
other codes and data recording conventions (e.g. units of measure, drugs, etc) are used within the clinical record. Though some research data is coded in the majority of instances such data will be recorded using idiosyncratic codes. Achieving alignment between the NHS and research representations of data will be a challenge. However, much data in the clinical record is likely to be recorded as free text. In part this is because it provides a richer narrative of a patient’s clinical problem and partly because that systems in current use lack sophistication. Whatever the case, technologies to extract codified information from free text should be of great benefit. Although the benefits seem apparent, and are well documented, the power of modern information technology to gain insights from large databases of population data has yet to be fully realised. In part this is due to public concerns, and media sensationalism, over the confidentiality and security of data. Further analyses are documented in a Wellcome Trust funded report10 on public perspectives on research governance, a working group report11 on secondary uses of patient information, and a consultation on the wider use of patient information12 supported by the Data Sharing Review13. Whilst the public are aware of the principle and potential values of research, many conceded that their awareness of issues surrounding such research was low. Implications for research included researchers needing to pro-actively engage with participants’ desire for more transparency about, and active involvement in, the research process including data access and scope, models of consent and reenforcement of database security and their potential future or other uses. However, we intend to venture from such concerns, as they have already been investigated in great depth, and adopt a more positive approach illustrated with working examples from other countries and the UK of the successful uses of patient data for research and development.
Wellcome Trust (2007) “Public Attitudes to Research Governance: A qualitative study in a deliberative
context” available at: http://www.wellcome.ac.uk/About-us/Publications/Reports/Publicengagement/WTX038446.htm
Connecting for Health (2007) “Report of the Care Record Development Board Working Group on the
Secondary Uses of Patient Information” available at: http://www.connectingforhealth.nhs.uk/crdb/workstreams/
Connecting for Health (2008) “Consultation on the wider use of patient information” available at:
Ministry of Justice (2008) “Data Sharing Review” available at:
7. What Are The Benefits And Opportunities?
Although most healthcare practitioners and institutions in the United States are not yet ready to implement electronic medical record (EMR) systems there are many pioneers and innovators who have overcome enormous obstacles to informing research goals with clinical practice data14. The Mayo Clinic, that conducts more than 4,000 clinical trials per year, is working alongside IBM applying super-computing technology to uncover correlations in clinical data. Kaiser Permanente has automated records for its 8.4 million members and created both a transactional system for patient care and a data warehouse with extracted data for use by researchers. The Indiana Health Service (IHS) and Veterans Health Administration (VA) also provide data repositories for supporting research and population analyses, improving data quality and security, and facilitating patient access to data and health information. European-level collaboration, as well as global partnerships, are helping establish reference frameworks of best practices and mistakes, organisational, ethical, and economic aspects of re-use of electronic patient data. For example the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) has over 200 organisations in 24 EU Member States jointly planning an EU infrastructure to deliver secure access to biological resources required for health-related research and development intended to improve the prevention, diagnosis and treatment of disease and to promote the health of the citizens of Europe15. The year 2007 marked the beginning of the European Commission’s seventh framework programme with a large increase in funding (63%) and the creation of a European Research Council (Mladovsky, Mossialos & McKee, 2008). Despite the allocation of €6bn in the health research budget, little has been done to promote equitable access to the data whose collection it will finance. Ethical and regulatory problems combined with the technical barriers of interoperability of computing systems, make sharing health research data more complex than other types of research data, where individual records should ideally be available to make data meaningful. However, there are examples of countries (including the UK) where great progress has been made. Some believe that Denmark has gathered more data on its citizens than any other country (Frank, 2000) and is one of the most successful applications of data-driven research and development. The
FasterCures (2005) “Think Research: Using Electronic Medical Records to Bridge Patient Care and
Research” available at: http://www.fastercures.org/index.cfm/OurPrograms/ThinkResearch/Electronic_Health_Records
The Biobanking and Biomolecular Resources Research Infrastructure available at: http://www.bbmri.eu/
Danish government manages nearly 200 public databases, some since the 1930s. Denmark’s Civil Registration System (CRS) assigns to all Danish citizens a health insurance card with a unique personal identification number. This number is recorded at all hospital admissions and is also used to register all births, deaths, migrations to and from foreign countries, and domestic address changes (Olesen et al., 2009). The use of this number creates huge opportunities for conducting large-scale cohort studies such as investigations into cellular phone use and cancer (Johansen et al. 2001) and measles, mumps, and rubella vaccination and autism (Madsen et al. 2002). For added confidentiality, all studies must be approved by the Danish Data Protection Agency, which requires adherence to a number of data storage rules to avoid disclosure of personal data (Olesen et al, 2009). In the UK collaborations between the NHS and Higher Education (HE) institutions are already underway in early adopter sites as part of The NHS-HE Connectivity Project16. The project’s objective is to achieve “good interoperability between NHS and HE networks that enable secure anytime, anywhere access by medical, nursing and allied profession students, clinical teachers and researchers”. In England and Scotland collaboration is between NHS Connecting for Health in England, NHS National Services Scotland Information Systems Group and JANET (UK), and in Wales this is run by the Public Sector Broadband Aggregation (PBSA) network. N3 is the broadband network for the NHS in England and Scotland and used to form the N3 JANET Gateway. On a local level there are instances of linkage between NHS systems and research databases, for example, between the St James’s Institute of Oncology and the University of Leeds.
8. Practical Ideas and Recommendations
There is not one solution to these issues. The research field is complex and the emerging technology is still relatively immature. What is apparent is that the awareness of the new pan-sector possibilities of researchers and IT staff whether in academe, the NHS or industry are limited by their previous organisationally bounded experience. A major challenge is to create a common awareness of the potential whilst at the same time increasing insight into the technical, legal and organisational challenges. It is important also to dispel many of the myths surrounding the supposed limitations created by strong information governance and to promote a mature debate about the protection of the rights of the individual and the need to harvest data for the common good.
JANET “The NHS-HE Connectivity Project” available at: http://www.nhs-he.org.uk/
As an early UK investment in the process, the Wellcome Trust has funded a small project to define the training needs of practitioners in the field and to build a core training package17. The project recognises that systems in the two environments, the NHS and in research, have been built with very different objectives, have widely divergent data models, governance frameworks, and utilise different technical standards. This is reflected in the employment backgrounds of many of the staff involved and apart from levels of informatics experience and skills; their knowledge of the different environments is limited. As a first step in defining the training needs the project has surveyed 266 such users and has confirmed the poor understanding of concepts such as SNOMED-CT and HL7 in the research community. Furthermore, it has revealed that a large proportion of people developing and using systems are self-taught and appear to have limited understanding of basic informatics concepts such as normalisation of data tables. The same is true of a large number of key concepts including anonymisation and pseudonymisation and a programme of widespread education will be essential. It is also clear that beyond the HI community much confusion exists about the risks and benefits of allowing access to data for research purposes. The public is rightly concerned about unauthorised access to sensitive data and its potential misuse hence there is a need to develop very robust governance processes for research access to data backed up by an effective public education programme. Whether this is by the establishment of new processes or reinforcement and evolution of current procedures is an obvious target for early research. For some research the necessity for identifiable linkage will be essential and the HI community may have to work hard to increase awareness of the relative benefits of such access and lend credibility to the fact that such access can be achieved without compromise to patients in other ways. What Needs To Be Done? Several strands of intervention need to be initiated across all levels of seniority, and form both local and national priorities. The Faculty could take a major role in all of these, including: 1. Educating and challenging the executive leaders to influence policy and increase representation at senior-level. • Champion cross-representation on Higher Education/NHS bodies – e.g. Trust IT, University IT Boards.
University of Leeds (2008/9) “Training and education for the developers of databases in research and clinical
practice” available at: http://www.ychi.leeds.ac.uk/eprresearch
Ensure Health Informatics involvement in research ethics committees.
2. Educating middle-ranking research leaders and influencing the design of grant forms. • Educate NHS IT managers, Caldicott Guardians, Trust leads for R&D, and Information Governance leads in research needs. • Establish Health Informatics involvement in local Research Design Services.
3. Promoting engagement between suppliers and designers. • Include R&D needs in the procurement cycle, for example adding additional fields to NHS datasets with research use in mind. • • Establish data access requirement for research on all clinical systems. Pressurising for the use of a single identifier within the care environment.
4. Increasing the Health Informatics capacity in the NHS workforce. • Influence recruitment policy to ensure potential staff have the requisite Health Informatics awareness and skills. • Include “Research” in Key Skills Framework for NHS IT staff.
5. Building Health Informatics into teaching and research programmes in Health and Computer Science. • • • Embed Health Informatics in the undergraduate curriculum. Promote intercalated medical degrees in Health Informatics and Computing. Support health related undergraduate projects in Computer Science.
In addition there are a number of practical activities which would cut across these strands to which the Faculty could make a very positive contribution.
Promote guidance resources such as the Information Governance Toolkit18 and Research Capability Programme19, as well as publications by the Wellcome Trust and UK Clinical Research Collaboration, which are not being fully utilised across research environments.
• • •
Support a programme of master classes for senior opinion leaders. Support a funded CPD programme for health, research and industry professionals. Promote Health Informatics within Medical and Computer Science Teaching and Training courses in Higher Education.
The secondary uses of clinical data are already widespread amongst Higher Education institutions and the NHS. Many resources contain personally identifiable or potentially identifiable data amidst, justified or otherwise, concerns of consent, privacy and security. Potential benefits gained through exploitation of such data are recognised amongst local innovation centres but are not reproduced across national boundaries. Apart from consensus on privacy, policy and security, transparent policies and practices, and public awareness of trust (Barrett et al. 2006; Davies & Collins, 2006; Safran et al. 2007) there must also be campaigns to improve the capacity and capability of NHS and research staff on the effective use of clinical data for research.
This paper was written by Mark Hawker, Dr Susan Clamp, and Dr Rick Jones. We are grateful to the many respondents for their contributions. The Yorkshire Centre for Health Informatics is a leading international centre for health informatics expertise, collaboration and research. Our mission is to improve heath care practice through high quality research and evidence based education and training. The centre brings together partners from
Connecting for Health (2009) “Information Governance Toolkit” available at:
Connecting for Health (2009) “Research Capability Programme” available at:
the University, NHS and Industry to help meet the challenges in handling health information. Our objectives are to develop knowledge through multidisciplinary research; develop ‘best practice’ and quality assurance within health informatics processes; disseminate ‘best practice’ through education and training; facilitate knowledge transfer by bridging the gap between health informatics researchers, healthcare providers and health IT industries.
Barrett, G., Cassell, J.A., Peacock, J.L. & Coleman, M.P. (2006) National survey of British public’s views on use of identifiable medical data by the National Cancer Registry, British Medical Journal, 332, 1068-72. Davies, C. & Collins, R. (2006) Balancing potential risks and benefits of using confidential data, British Medical Journal, 333, 349-351. Frank, L. (2000) Epidemiology: When an Entire Country Is a Cohort, Science, 287 (5462), 2398-9. Johansen, C., Boice, J.D., McLaughlin, J.K. & Olsen, J.H. (2001) Cellular Telephones and Cancer – a Nationwide Cohort Study in Denmark, Journal of the National Cancer Institute, 93 (3), 203-7. Madsen, K.M., Hviid, A., Vestergaard, M., Schendel, D., Wohlfahrt, J., Thorsen, P., Olsen, J. & Melbye, M. (2002) A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism, The New England Journal of Medicine, 347, 1477-82. Mladovsky, P., Mossialos, E. & McKee, M. (2008) Improving access to research data in Europe, British Medical Journal, 336, 287-8. Olesen, A.V., Parner, E.T., Mortensen, P.B., Sørensen, H.T. & Olsen, J. (2009) Prenatal Risk Factors for Cutaneous Malignant Melanoma: Follow-up of 2,594,783 Danes Born from 1950 to 2002, Cancer Epidemiology, Biomakers and Prevention, 18 (1), 155-61. Safran, C., Bloomrosen, M., Hammond, E., Labkoff, S., Markel-Fox, S., Tang, P.C. & Detmer, D.E. (2007) Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper, Journal of the American Medical Informatics Association, 14 (1), 1-9.
Appendix A: Report of Research Simulations (Executive Summary)
The UK can significantly enhance its clinical research capability by using, strictly within the bounds of patient confidentiality, the electronic patient data that the UK’s National Programmes for IT in the NHS have the potential to allow. This will have enormous benefits for all types of clinical, public health and health services research and for many aspects of patient care. The UK Clinical Research Collaboration’s (UKCRC) Research & Development Advisory Group to Connecting for Health therefore commissioned a series of simulations in October 2006 to provide the Department of Health Directorate of Research and Development, and NHS Connecting for Health (NHS CfH), with detailed specifications for a range of possible research applications. The objective was to: Inform future development of the NHS Care Records Service (NHS CRS) Highlight technical, regulatory and governance issues Inform plans for any further simulations and full pilots to test the capacity of the infrastructure, using real patient data with appropriate safeguards when this becomes feasible. Four simulations were commissioned, based on a range of clinical research applications. These were: interventional clinical trials; surveillance; prospective tracking of an identified cohort; and observational epidemiological research. Detailed reports and key findings were presented to the Advisory Group in February 2007 and form part of this report. The simulation leads worked as a team over this period and there was strong consensus in relation to both the high level and more detailed messages emerging from their work. They have identified a number of key data, regulatory and governance issues that need to be addressed for future development: Clinical services and research share the same mission of improving patient care and patient safety: research is integral to patient benefit Research makes a very important contribution to assessing the completeness and quality of data used for clinical care and health services Leadership is needed to create the sustainable and governance infrastructure required to exploit the research opportunities afforded by routine patient and other data Solutions should be addressed from a UK-wide perspective and build on the extensive experience with record linkage already in place Much of this research involves information about groups of patients rather than individuals and hence requires anonymised rather than identifiable data. However there will be occasions where data needs to be linkable (possibly by an ‘honest broker’) and comprehensive at the individual patient level in order to have maximum value and to allow quality and completeness to be validated Where data are required at individual patient level, such data access will need to be to pseudonymised data. Where identifiers need to retained, appropriate consent must be gained as part of enabling access to those data Existing UK strengths in the use of routine and other patient data for research will be significantly enhanced by the mandated use of a unique identifier (for example NHS number) in all
UKCRC R&D Advisory Group to Connecting for Health
key NHS records and activities and by ensuring that new and existing data sets are person-based The data made available must cover the whole population, be up-to-date, and be retrospective over a number of years to give a rich historical picture of patients’ health and care. They must also be accurate and based on high-quality input Further work to confirm the detailed requirements for data, which have been spelled out in each of the individual simulation reports, will need to be finalised. Much of the same data required for purposes such as safety monitoring and clinical trial research is of interest for public health and NHS management activity including monitoring service delivery. So there is a high degree of commonality in the data needs The breadth of data needed for the potential research applications explored in the simulations supports the concept of a data switchboard, with potential to link NHS Care Record data widely to other data sources. Thus future strategic developments should be based on this premise, rather than that of a single data warehouse A federated structure of data sources rather than a single data warehouse would also provide an effective infrastructure with optimal governance systems in place. This could be an honest broker with responsibility for removing identifiers, linkage of data and data quality checks Tackling regulatory and governance issues successfully will be key to ensuring appropriate access and use of the data for research purposes. Ensuring patient confidentiality is critical. Data governance must be robust and at the same time capable of facilitating research
Although for some research applications fully anonymised data will suffice, for many research applications pseudonymised data is required to enable linking of data sets or elimination of duplicate records. However, for other research purposes it will be important for patients to be contactable in an appropriate manner. Appropriate approaches to consent will need to be built into access mechanisms for information which might be capable of being linked to a specific patient In order to satisfy regulatory requirements for purposes such as pharmacovigilance and for clinical trials research, there are specific data quality and access requirements that need to be addressed The dual role of the honest broker in ensuring patient data confidentiality and security as well as scientific integrity of data delivered to the research community will be key to engendering trust amongst patient, clinical professional and research communities. The potential benefits for research will be lost unless these issues can be addressed. It is critical that the needs of research be formally prioritised so that both individual healthcare and public health can reap the full benefits of this NHS resource. The recommendations are summarised below.
UKCRC R&D Advisory Group to Connecting for Health
Key recommendations of the UKCRC simulations
Recommendation 1: Mandate a common patient identifier To enable linkage of sources of data at patient level a unique patient identifier will be required: use of the NHS Number should be mandated in all key NHS records and activities, including laboratory records. Recommendation 2: Communicate the relevance of research to healthcare There should be formal recognition that research is a core, not secondary, component of the development of the NHS Care Records Service as it benefits patients directly. Objectives, strategy and resources need to be committed or endorsed at the highest level of NHS Connecting for Health and reflected in its literature including website content.
time capable of facilitating research. Recommendation 6: Engage key stakeholders It is essential to engage professional audiences who are key to implementation, particularly for the enhancement of data quality and improving data access. Patient safety is of importance to all audiences and should be at the forefront when communicating the value of research. A communication strategy regarding the joint benefits of using patient data for research and clinical care needs to be developed. The responsibility for this development and those in recommendation 5 above will be with the Care Record Development Board and may subsequently transfer to the National Information Governance Board upon its formation.
UK-Wide Strategy: Next Steps
In informing plans for next steps, the outcomes of the simulations suggest that more extensive data are required to enable research than those currently available through the Secondary Uses Service. We recommend that an approach that relies on a federated system of databases should be based on a UK-wide strategy. This will require: Initiation of pilots to link datasets, on the basis of existing successful examples within the UK; Definition of methods of access to the different sources housing the data. This should include access to detailed patient-level data from primary care, pathology services, disease registers and key private sector services; Future development which learns from, and build upon, existing skills, knowledge, databases and systems that have been developed in the UK over many years; Adoption of a UK-wide approach: not only are there examples of good practice beyond England that can be built upon, but the future development should ensure compatibility across the UK; An organisation capable of managing the specification and delivery of the required infrastructure and providing the linkage and definition of research support services.
Short Term Deliverables
Recommendation 3: Federate existing databases A federated structure of data sources is required for research. A high-level strategy to support such an infrastructure needs to be developed together with a roadmap for its delivery. This strategy should ensure that the data made available cover the whole population, are up-to-date, person-based and of high quality, and extend back over a number of years to give a rich historical picture of a patients’ health and care. Recommendation 4: Improve data quality Data quality is of paramount importance both in the clinical setting and for research. Data should be accurate (relying on high quality input) and based on a set of standards for recording and processing data. Ongoing processes will need to be developed to improve data completeness and quality which could involve development of incentives. Recommendation 5: Initiate governance discussions Tackling regulatory and governance issues successfully will be key to ensuring appropriate access and use of the data for research purposes. Data governance must be robust and at the same
UKCRC R&D Advisory Group to Connecting for Health
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