Commentary Population screening in the NHS: a systematic pathway from evidence to policy formulation

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Journal of Public Health Medicine Vol. 20, No. 1, pp. 58-62 Printed in Great Britain Commentary Population screening in the NHS: a systematic pathway from evidence to policy formulation Robert Sherriff, Lesley Best and Paul Roderick Summary In 1994 the Chief Medical Officer of England set out a framework for the evaluation and implementation of national screening programmes in the National Health Service (NHS). The framework highlighted the importance of the link between research evidence and the formulation of national policy. It also stressed the necessity for monitoring, evaluation and quality control as integral components for all new screening programmes. There is now an established link between the Health Technology Assessment programme of the NHS Research and Development Directorate and the NHS's new policy advisory group, the National Screening Committee. The objective of this systematic approach is to ensure that screening programmes are not introduced into the NHS unless there is robust evidence that benefit outweighs harm. The Population Screening Panel, an advisory panel of the NHS Health Technology Assessment programme, has the responsibility for determining priorities in research on proposed or existing population screening programmes. The National Screening Committee has a remit to consider this research evidence and to advise government ministers and the NHS on the appropriateness of the implementation, development and modification of national screening programmes. The example of prostatic cancer screening is presented as an illustration of how the NHS is developing a systematic approach to the implementation of screening policy based upon the strategic commissioning of research evidence. Keywords: screening, Health Technology National Health Service, policy Introduction Assessment, In 1994 the Chief Medical Officer of England, Sir Kenneth Caiman, set out a framework for the evaluation and implementation of national screening programmes in the National Health Service (NHS). 1 The framework recognized that screening is a complex intervention which incorporates not only the scientific issues of effectiveness, but also ethical dimensions and the issues of organizational and quality assurance infrastructure. In particular, it highlighted the importance of the link between research evidence and the formulation of national screening policy. The framework also stressed the necessity to ensure that monitoring, evaluation and quality control were integral components of the implementation plan for all new screening programmes. The objective of this systematic approach is threefold: (1) to ensure that screening programmes are not introduced into the NHS unless there is robust evidence that benefit outweighs harm; (2) to ensure that new programmes meet the recognized criteria for population screening programmes; 2 (3) to ensure that programmes are implemented with built-in management plans, quality assurance and explicit quality standards. It is hoped that this third point will prevent any future screening programmes from being introduced in an ad hoc fashion with the resulting variation in local practice, standards and organization. The intervening years have seen the implementation of this framework to the extent that there is now an established link between the Health Technology Assessment programme of the NHS Research and Development programme and the new policy advisory group, the National Screening Committee. This paper will describe the collaborative process and will use the example of prostatic cancer screening as an illustration of how the NHS is developing a systematic approach to the implementation of screening policy based upon the strategic commissioning of research evidence. Population screening and the Health Technology Assessment programme The Health Technology Assessment (HTA) programme, established in 1993, is the largest single programme of work within the NHS Research and Development strategy. The National Screening Committee Secretariat, NHS Executive Anglia and Oxford, 6-12 Capital Drive, Linford Wood, Milton Keynes MK14 6QP. Robert SherrilT, Specialist Registrar in Public Health Medicine National Coordinating Centre for Health Technology Assessment, Wessex Institute for Health Research and Development, University of Southampton, Biomedical Sciences Building, Bassett Crescent East, Southampton SO 16 7PX. Ledey Best, Research Fellow Paul Roderick, Senior Lecturer in Public Health Medicine Address correspondence to Lesley Best Oxford University Press 1998

POPULATION SCREENING IN THE NHS 59 Central Research & Development Committee (CRDC) Standing Group on Health Technology (SGHT) Commissioning Group on Health Technology (CGHT) Advisory Panels Population Screening Acute Sector Primary & Community Care programme is a systematic, needs-led approach which aims to commission research in those areas of greatest importance to the NHS. Questions on the effectiveness and cost-effectiveness of health technologies are the primary focus of this programme, which commissions both primary and secondary research. 3 The structure of the HTA programme is illustrated in Fig. 1. The Standing Group on Health Technology Assessment advises on national priorities for research and is aided by six expert advisory panels. The Population Screening Panel has the responsibility for determining priorities of research on proposed or existing population screening services, the minority of which are currently organized as formal 'programmes'. The panel has a wide remit which includes both screening of the general population and high-risk sub-groups. Recommendations from the six advisory panels are forwarded to the Standing Group, which selects approximately 50 research areas per year for funding. Table 1 Sources in 1997 identification process Diagnostics Pharmaceuticals Methodologies & Imaging Scientific Secretariat Support Figure 1 Structures of the HTA programme. 3 A 'bottom-up' approach is adopted for the identification of potential HTA research questions eliciting the concerns of purchasers, providers and users of health care services, as well as the academic community and professional bodies (Table 1 lists the consultation sources for the 1997 identification round). Research questions may relate to specific screening programmes (thereby considering the performance of screening tests, effectiveness of early interventions, acceptability to participants, compliance, facilities for implementation, and quality assurance mechanisms) or to generic issues affecting all screening activities (e.g. factors affecting uptake, impact of false-negative results). Research is considered on both new (e.g. fragile X) and existing screening programmes (e.g. child health surveillance). The Population Screening Panel has an important role in that it is required to judge the merits of each topic in terms of the importance to the NHS. Explicit criteria are laid out to aid this Widespread mailing including Royal Colleges, academic departments, hospitals, chanties, and guideline groups Survey of Regional Research and Development Directors, and Research and Development Support Units National Screening Committee, Department of Health expert advisory groups Faculty of Public Health Medicine Screening Committee Standing Medical Advisory Committee Focus groups of general practitioners and purchasers Scanning the research recommendations from completed HTA pnmary research and systematic reviews; scanning of recent Cochrane reviews Regular scanning of relevant journals by panel researchers, e.g. Journal of Medical Screening Advertisement in Bandolier and Health Service Journalfor suggested research topics

60 JOURNAL OF PUBLIC HEALTH MEDICINE 1. (NCCHTA) Identifying the problemsforthenhs National Screening Committee 6. (NHS) Using research results and evaluating change Population Screening Panel 2. (NCCHTA) Translating problems into research questions 5. Research results decision-making, including consideration of the burden of disease, current levels of uncertainty, importance of early assessment, pace of diffusion, and the value for money of the research. The panel is also guided by the Wilson and Jungner criteria for the assessment of screening programmes. 2 The Population Screening panel has 12 expert members representing a wide range of screening expertise including antenatal and neonatal screening, child health surveillance, cancer and cardiovascular disease, women's health, the psychosocial and economic impact of health care interventions, and genetic screening. Current research given priority by the Population Screening panel (and commissioned by the HTA programme) includes both new and existing programmes and is largely in the form of systematic reviews, e.g. screening for cystic fibrosis, screening for stroke through detection and management of hypertension, screening for fragile X, preschool vision screening, and screening for Down's syndrome. Some major randomized controlled trials given priority are being taken forward by the Medical Research Council, namely screening for colorectal cancer by flexible sigmoidoscopy and screening for abdominal aortic aneurysm in men aged 65-74 years. The entire HTA programme is supported by the National Coordinating Centre for HTA (NCCHTA), based at the Wessex Institute for Health Research and Development, University of Southampton, in collaboration with partners at the Centre for Health Economics and Department of Health Sciences and Clinical Evaluation, at the University of York. The NCCHTA supports the six HTA panels and the Standing Group by co-ordinating consultation, compiling key information to aid priority setting, managing the commissioning process, monitoring current research and publishing completed work. The cyclical nature of the research process within the HTA programme is illustrated in Fig. 2. Once topics are given priority by the Standing Group, the majority are advertised 4. Funding projects within priority areas Figure 2 Stages of the HTA research cycle. 3.(PSP,SGHT) Prioritising research topics nationally for interested parties to work up proposals. Institutional curriculum vitaes and outline proposals are shortlisted by the Commissioning Group, whoseremitis to advise on the quality and value of work, and relevance to the HTA priority. Proposals are refereed by external experts before selection and commissioning. Current research is monitored through site visits and the submission of progress reports, to ensure the quality and timeliness of work. Completed research is publicly available, after peer review and revision as necessary. Within the HTA programme, the area of population screening is unique in that the knowledge outputs of the programme are automatically considered for implementation, following the establishment of the National Screening Committee. This important link between high-quality research and controlled implementation will be pivotal in promoting evidence-based population screening policies. The National Screening Committee The National Screening Committee, which first met in July 1996, has a remit to advise Department of Health ministers, the Government's Chief Medical Officer (CMO) and the NHS Executive on the timeliness and appropriateness of the implementation, development, review and modification of national screening programmes. The basis for this advice is evidence on clinical and cost-effectiveness, population need, medical ethics and clinical outcomes. Potential screening programmes exist in every specialty and sub-specialty of clinical practice, and for this reason it would not have been possible to have every group represented on the National Screening Committee. Members were therefore selected to form a body which would be able to consider screening programmes in their broadest perspective. The Committee, chaired by the Chief Medical Officer (CMO) of England, has a membership including the CMOs of Northern

POPULATION SCREENING IN THE NHS 61 Ireland, Scotland and Wales, Directors of Public Health, the chairman of the Population Screening Panel, a general practitioner, a journalist, a consumer representative and the NHS Finance Director. The National Screening Committee will consider evidence on both new and existing screening programmes. This evidence, usually in the form of randomized controlled trials or systematic reviews, may originate from the Health Technology Assessment programme or elsewhere. If the National Screening Committee decides that further information is required, this task will be co-ordinated by specialist subgroups which will have the authority to co-opt expert members from outside of the main committee. Currently, specialist subgroups exist for antenatal screening and the ethics of screening. A key task of these sub-groups will be to consider how monitoring, evaluation and quality assurance would be managed for each screening programme. The National Screening Committee will expect this information to be included as an integral part of the implementation plan for any new screening programme. The scientific secretariat for the National Screening Committee is located at the NHS Executive Anglia and Oxford Regional Office in Milton Keynes. All enquiries regarding screening programmes and the future work programme of the National Screening Committee may be addressed to this office (National Screening Committee Secretariat, NHS Executive Anglia and Oxford, 6-12 Capital Drive, Linford Wood, Milton Keynes MK14 6QP). The National Screening Committee secretariat is developing an inventory of current and potential screening programmes, which is being used to help determine priorities in the future work programme of the Committee. It is anticipated that during the next three years the National Screening Committee will consider the majority of potential screening programmes which have been proposed for national implementation. This work will eventually lead to the development of three categories of screening programmes: (1) screening programmes which should be offered to the public; (2) screening programmes which should not be offered to the public; (3) screening programmes which should only be offered to the public as part of a formal research trial. An example of the work so far: screening for prostate cancer The diagnosis and management of early prostate cancer arose from both the Population Screening and Diagnostics and Imaging HTA panels in 1993. An important part of this topic was the cost-effectiveness of screening for prostate cancer (including the use of the prostatic-specific-antigen (PSA) test). There is currently no organized national screening programme for prostate cancer. An urgent assessment was required as ad hoc PSA testing was known to be taking place. Table 2 Key findings from systematic reviews on prostate cancer screening 6 Routine testing of men to detect prostate cancer should be discouraged, irrespective of family history Purchasers should not fund screening services for prostate cancer Evidence from randomized controlled trials of prostate cancer screening using PSA (or similar tests) and treatment are needed before consideration is given to funding prostate cancer screening Patients enquiring about prostate screening should be clearly informed about the current state of evidence on the benefits and harms of screening and treatment In early 1994, the HTA Commissioning Group invited full proposals from a number ofresearchcentres, of which two were selected to undertake systematic reviews. This selection followed extensive discussions on the scientific merit of each proposal, relevance to the priority area, and peer review by external experts. The systematic reviews were undertaken by research teams at the Department of Social Medicine, University of Bristol, 4 and the Cancer Screening Evaluation Unit, Institute of Cancer Research. 5 After completion, each report was peer-reviewed by three referees, and final reports were issued in July 1996 and November 1996, respectively. Key findings from systematic reviews of prostate cancer screening are summarized in Table 2. Further research on prostatic cancer has been commissioned in the 1996 round of HTA priorities, the key question being the effectiveness of treatments in early (screen-detected) prostatic cancer. A press launch organized by the NHS Centre for Reviews and Dissemination, University of York, was held in February 1997, to publicize these systematic reviews (available from National Coordinating Centre for HTA, The Wessex Institute for Health Research and Development, University of Southampton, Biomedical Sciences Building, Bassett Crescent East, Southampton SO 16 7PX; http://www.soton.ac.uk/~wi/hta), and toreleasesummary reports aimed at patients, clinicians and purchasers. 6 ' 7 Subsequently, the reports received coverage in The Lancet, 6 where issues were raised about the importance of patient views and the merits of consensus conferences in the formulation of health policy. The HTA reports (and programme) received both praise and criticism in the letters that followed. 9 ' 10 The two systematic reviews were considered by the National Screening Committee in early 1997. In particular, the Committee focused on the criterion that there must be evidence that benefit from screening outweighs harm. In light of the lack of evidence to support this, the National Screening Committee concluded that population screening for prostatic cancer should not be offered to the public. This advice, having been accepted by ministers and the NHS Executive, was subsequently disseminated to the wider NHS in the form of an Executive Letter."

62 JOURNAL OF PUBLIC HEALTH MEDICINE Conclusion This paper has described a systematic and strategic approach to the commissioning of research and the formulation of an evidence-based national screening policy. It is anticipated that this process will continue to form a useful and robust mechanism for developing NHS screening policy into the twenty-first century. Acknowledgements We are grateful to Dr Ruairidh Milne and Dr Muir Gray for their helpful comments. References 1 Caiman K. Developing screening in the NHS. J Med Screen 1994; 1: 101-105. 2 Wilson JMG, Jungner G. Principles and practice of screening for disease. Geneva: WHO, 1968. 3 NHS Executive. Report of the NHS Health Technology Assessment programme. London: Department of Health, 1996. 4 Selley S, Donovan J, Faulker A, Coast J, Gillat D. Diagnosis, management and screening of early localised prostate cancer: a systematic review. Health Technol Assessment 1997; 1(2). 5 Chamberlain J, Melia J, Moss S, Brown J. The diagnosis, management, treatment and costs of prostate cancer in England and Wales. Health Technol Assessment 1997; 1(3). 6 NHS Centre for Reviews and Dissemination. Screening for prostate cancer. Effectiveness matters. York: University of York, 1997. 7 NHS Centre for Reviews and Disseminatioa Information for men considering or asking for PSA tests. Effectiveness matters. York: University of York, 1997. 8 Anonymous. The prostate question, unanswered still (Editorial). Lancet 1997; 349: 443. 9 Swales J, Winyard G. Screening for prostate cancer (letters). Lancet 1997; 349: 1098. 10 Woolf S. Screening for prostate cancer (letters). Lancet 1997; 349: 1098. 11 NHS Executive. Population screening for prostate cancer. EL (97)12. Leeds: Department of Health, 1997. Accepted on 16 September 1997