367
NATIONAL
HEALTH
SERVICE
The announcement in April, 1991, of a Research and Development Health Strategy marked thefirst phase in the creation of an R & D programme and infrastructure for the British National Health Service. The Director of Research and Development is Prof Michael Peckham, who outlined the proposed scheme in a Francis Fraser Lecture at the Royal College of Physicians, London, on June 3. This paper is based on the lecture.
Research and
development for the National Health Service
Over four decades the National Health Service (NHS) has responded to a huge range of innovations. Some have been durable, others have been transient; some have been evaluated but many have not. Often new developments have been superimposed on existing practice, creating a kind of medical archaeology where the remnants of earlier practices are discernible among the newer acquisitions. The arrangement has been productive in terms of new methods of care but important areas have been neglected. A research approach has not been brought to bear systematically on issues relating to the effectiveness of clinical practice, the dispersal and use of existing knowledge, the best use of human and other resources, and the contribution of medical interventions to the health status of individuals and the population. Neither has there been a systematic attempt to relate important health issues to the national effort in medical research. Innovation in medical research has been driven largely by the intrinsic interest of disease processes to clinicians and scientists, and medical practice has been shaped by the intellectual challenge of clinical problems. Such an approach has amply demonstrated its value. The challenge now is to introduce a sensible mechanism for handling within the NHS the output of basic and applied research and to apply research methods to examine the content and delivery of health care. Such a mechanism is the only way of resisting the sometimes unreasonable and often unproven resource-consuming demands of lay, professional, and industrial pressure groups. The need for evaluation also applies to many currently used methods of diagnosis and treatment. Every clinician knows that there is indefensible diversity in the use of diagnostic methods and therapies and that there is unacceptable variation in the quality of treatment delivered by different clinical teams. The science of evaluation is an area of neglect between biomedical research and clinical
practice. The support of non-industrial medical research in the UK is complex. The medical schools are funded through the Department of Education and Science and the teaching hospitals through the Department of Health. Research support is derived from multiple sources including the Medical Research Council (MRC), the charities, industry, the NHS, the Universities Funding Council (UFC), and local trusts and other funds. The Economic and Social Research Council and the Science and Engineering Research Council also support research relevant to
medicine. Four charities, the Wellcome Trust, Imperial Cancer Research Fund, Cancer Research Campaign, and the British Heart Foundation, fund about three-quarters of charity-supported research. The level of funding for research from the MRC, UFC, NHS, charities, and industry is broadly comparable.
The NHS and research The NHS
provides the practical outlet for research supported by the funding bodies; the universities and other research establishments provide research expertise and are a source of new developments.
programmes
The support of clinical research within the NHS is obviously central to the interests of the MRC, charities, and industry as is the quality and organisation of the research base to the NHS. In the latter context I have something to say about the organisation of British medical schools. The shortcomings of undergraduate medical education are recognised’ and it has generally been assumed that the pursuit of medical research favours education. Where appropriately constructed the trio of education, research, and clinical practice is an excellent structure. However, there may be a tension between the coverage needed for education and the need to focus to achieve critical mass in research. In some cases disappointingly little effort has been put into medical school strategies for research and education and the relationship between them. Because of a broadening of the science base of medicine it is difficult nowadays for a single school to establish a competitive in-house science programme. This argues for the association of medical schools with university science faculties and other science institutions. The science origins of applied medical research and clinical practice do not necessarily derive from basic medical research. Laser technology, information technology, visual display systems, image analysis, electronics, and materials science are relevant to advances in medicine, yet their basic aspects are likely to be found in non-medical science facilities and in industry. Strengths in social science, including economics, reside largely in faculties outside medicine; the same is true for some basic biological research. Medical schools need to ensure that they function as effective conduits between science and the clinic; their structure and strategy should reflect this aim. Department of Health, Richmond House, 79 Whitehall, London SW1A 2NS, UK (Prof Michael Peckham, FRCP). ADDRESS:
368
The NHS and medical research have been on parallel tracks. The House of Lords Select Committee on Science and Technology, in their report Priorities in Medical Research, identified the problem thus: "The NHS is inextricably involved with medical research, yet the administrative remoteness of medical research from the NHS is a source of weakness to both sides. No research system can function efficiently when their principal customer for research (the NHS) has so small a direct input into the initiation of research programmes. The NHS should be brought into the mainstream of medical research. It should articulate its needs; it should assist in meeting those needs; and it should ensure that the fruits of research are systematically transferred into service."2
The NHS supports clinical research by providing facilities, patients, and expertise. It also provides financial for research. However, there has been no strategic support framework in the NHS within which research resources are managed, and the service has been a largely passive partner to the research funding bodies. One result of this is that the strategies and policies of the NHS do not benefit from all the information available from research and development. This leads to unplanned service pressures arising from researchdriven developments and missed opportunities from increasing efficacy on the basis of knowledge derived from research. In addition the development phase of R & D has been relatively neglected, with the result that research developments that show real promise for improving the NHS are often not introduced in a managed way for greatest benefit. access to
The NHS R &
D programme
Key points To correct the deficiencies identified above a new R & D infrastructure for the NHS will be set in place in the 14 English health regions. The NHS R & D programme is based on several key points. First, research and development is an essential activity-indeed, a prerequisite for achieving a cost-effective health service responsive to changes in needs as well as to innovation. Second, and as a corollary of the first, it is necessary to invest in R & D to achieve sufficient activity to establish a coherent programme. Third, responsibility for R & D should be devolved to the health regions, with mechanisms for ensuring accountability and quality assurance. Fourth, regional planning should take place within a corporately developed national R & D framework to avoid fragmentation, gaps, and unproductive duplication of effort. Fifth, several high priority R & D issues of national importance should be identified and these should be coordinated and funded from the centre. Sixth, the establishment of a countrywide R & D programme developed through the regions requires close collaboration between the universities and the NHS, and this should be reflected in the regional arrangements for R & D. Finally, the NHS R & D programme offers the opportunity of working towards a broadly coherent national programme of research in collaboration with the MRC, the charities, and
industry. The Central Research and Development Committee A new Central Research and Development Committee will be established in the autumn of 1991. The committee, which will be chaired by the Director of Research and Development, will be multidisciplinary with participation from the regions. There will be clinical (hospital and general practice) and non-clinical members including
from nursing and health service management. In addition to the biological sciences and clinical (including dental) research there will be input from epidemiology, health services research, economics, and statistics. The committee will oversee the preparation of a broad R & D framework within which the regions will develop their plans. In particular the committee will identify national R & D priorities and in doing so establish an agenda of issues that it would wish to see addressed in regional
representation
programmes.
Regional research and development A key component of the new programme is the preparation by each region of an R & D plan. Regions will be required to publish and implement the plan and will be held accountable for it. To achieve this each region will identify a director of research and development or equivalent and close collaboration will be needed between the Research and
Development Directorate in the Department of Health, the Central R & D Committee, regional general managers, and regional directors of public health. There will also be a requirement for a regional R & D committee with an appropriate infrastructure. University/NHS collaboration at regional and local level will clearly be of critical importance to ensure high quality peer review. Multidisciplinary input needs to be secured at regional level for the Central R & D Committee. The content of the regional programmes will be in three main categories. The first will relate to R & D relevant to the local needs of the region. A second component will be work identified by the central committee as being of general relevance. The third component will concern national priority R & D issues funded through the central committee. As outlined below, the national priorities will be funded on the basis of bids to the central committee through the regional R & D structure. For the initiative to be successful its activities must pervade the NHS; and to achieve this, regional strategies will need to encompass R & D at local level in the community and primary care settings and in teaching and non-teaching as
hospitals.
Resourcing and accountability The Department of Health/NHS
contributes large research and research-related activities. This includes the research component of the Service Increment for Teaching and Research, which is allocated to regions in recognition of the increased costs of patient care in teaching hospitals. The Department has now introduced a similar scheme for hospitals that conduct a substantial amount of research but do not receive the service increments. Also included are the Locally Organised Research Scheme, the Department of Health centrally managed research budget, other Departmental research funds, the component of the funding of the London postgraduate hospitals related to their research and development functions, and several non-departmental public bodies that perform research (such as the National Radiological Protection Board). In all, this amounts to more than C220 million a year. Although much of the funding is committed, its inclusion within the overall research and development programme means that it will be necessary to ensure that the funds are used to good effect and within an overall framework. In due course each aspect will be separately addressed and reviewed; a start has been made by clarifying the research and development priorities of the Special Health Authorities. It is intended resources to
369
Locally Organised Research Scheme will be the new regional research and development into brought To permit the development of the NHS programme. research and development programme a national expenditure target has been set of 1 -5% of the NHS budget, to be achieved over five years by harnessing R & D resources currently used throughout the service and by seeking new resources through the public expenditure process. The creation in January, 1991, of the NHS Management Executive’s Research and Development Directorate enables D to be a system of accountability for regional R & developed through existing mechanisms. that the
Implementation Project and working groups with participation of NHS clinical and non-clinical staff, health service managers, and university personnel have been set up to advise on the structure and function of the NHS R & D programme. Several advisory groups have been convened to consider issues relating to content, staff requirements, and methodology. These include a health practice and technology assessment group, and a clinical process and outcomes group. Endoscopic surgery, neonatal intensive care, and vaccine development are among the matters being considered by ad hoc groups. An NHS/industry forum is being established and a group is being convened to examine the criteria for setting R & D priorities.
NHS R & D and the bodies funding medical research: research liaison committees The multiple sources of health research funding in Britain argue for collaboration between research funding bodies and, on occasion, for complementary effort. Until now the NHS has not been an active partner even though the facilities of the health service are a common requirement for all bodies supporting clinical research. It is hoped that disease or problem related research liaison committees will be set up, on the lines of the United Kingdom Coordinating Committee for Cancer Research, to bring together in one forum the main funding bodies. A cardiovascular research liaison committee has already been convened.
Content and scope of the NHS R & D programme Research in the NHS programme will take two forms. The first is derivation of new methods of disease prevention, diagnosis, and treatment; it includes approaches to service delivery and concepts relating to staffmg, education, and the provision and design of facilities. The second, conveniently designated as evaluative science, applies research methods to the assessment of new and existing health practice methods and to health care.
From basic research to
operational research
The NHS programme will be oriented towards applied research with emphasis on an integrated approach that fully takes into account advances in basic research and their relation to health priorities. It would be short-sighted to focus exclusively on health service research and operational issues and ignore areas of biomedical research that might have important impact on the NHS. Similarly it would be inappropriate not to present the case for changes in emphasis in biomedical research if the national effort in a particular area was judged to be lacking. In mental illness, for example,
where there is a need for epidemiological and health service research, it would be an error not to be closely in touch with events in biological psychiatry. R & D priorities The setting of R & D priorities will be an early task of the Central R & D Committee. Planning will be much influenced by the Department of Health’s consultation document The Health of the Nation,3taking into account the burdens of disease and targets for health. Cardiovascular disease, cancer, and respiratory disease are three prime causes of life years lost. In terms of premature mortality cardiovascular disease accounts for approximately 50% of deaths. Smoking is a major contributor; hyperlipidaemia and hypertension are also important. Cardiovascular disease, chronic musculoskeletal disease, and mental illness are the main causes of morbidity. In costs to the NHS, mental illness comes first and cardiovascular disease second. Some of the key issues tend to be blurred by the compartmentalisation of health care into community care, general practice, district hospital, teaching hospital, Special Health Authority, and so on. A horizontal view of ill-health and disease prevention is needed to examine issues such as progressive care, from ambulatory community-based treatment to management in high dependency and intensive care units. This "stratum" view will encourage a fresh approach to community-based research including the roles of general practitioners, nurses, and other health workers. We shall need a mechanism for handling the increasing number of new developments being presented to the NHS:
they effective, are they cost-effective, are they being used, and if so are they being used to best effect? The techniques for investigating these matters clearly need refinement. Clinical audit provides the basis for determining whether cost-effective methods are in use and whether they are being used appropriately. Quality of treatment is influenced by severity of illness, professional skills, staffing, and facilities, and to assess it we require reproducible measures of health that can be applied before and after are
Since the lead time between research and practical development is shorter than it used to be, we need to think in advance about the possible impact of new discoveries and techniques upon organisation of care, the workforce, the design of treatment facilities, and so on. The transmission of information between different geographical locations and internally within the hospital environment is another key issue. treatment.
Creating space for new developments R & D will release resources that are not at present being used productively. Methods that are ineffective tend to be abandoned eventually, but usually the tempo is slow. To create space for cost-effective practice and advances in medicine we must identify non-contributory practices that are in use and encourage their abandonment. The most systematic attempt to examine an area of medicine in detail is the work of Chalmers and his colleagues at the National Perinatal Epidemiology Unit in Oxford.4 Some 5000 trials in perinatal medicine were identified by Medline database search, by journal hand search, and by personal approaches to obstetricians and paediatricians. Updated information on published trials was obtained by correspondence and unpublished negative data were sought. This profile of perinatal medicine indicated that in 20% of methods there was convincing evidence of ineffectiveness. In about 30%
370
there was evidence of effectiveness to support their use. The remainder includes methods that were promising but required further evaluation and those in which the effects were unknown. Information of this kind may well be available for other areas of medicine but it remains to be collected and analysed. To achieve this where feasible will be an objective of the NHS R & D programme.
Clinical research The NHS programme will support good clinical research. The content and quality of clinical research being conducted on NHS premises is at present undocumented but experience indicates that, while some is of the highest quality, some contributes little of value to the service, to knowledge, or to the researcher. Support of high quality clinical research needs to be focused (in conjunction with the MRC, charities, and industry) through the NHS R & D
initiative. In the drive for efficiency in the NHS it is important that good clinical research is encouraged and not squeezed. A recent example illustrates the way in which unproven methods can be inadvertently sustained. A trial that sought to establish whether a low dose of drug was as effective as a high dose foundered because the full costs had to be met by the investigator. Paradoxically, the investigator was able to use the high dose of drug in routine practice outside the context of a formal study. Unless clinical research is regarded as part of good clinical practice, a critical, protocol-based aproach to patient care will be discouraged and uncontrolled diversity and unplanned experimentation will persist by default.
Evaluative clinical science A treatment that changes the course of a disease may be so obvious an advance-for example, combination therapy for Hodgkin’s disease or testicular cancer-that comparative assessment is inappropriate. A more common event is for a new treatment to be mistakenly classed as an unequivocal advance. New procedures are sometimes introduced into the NHS on short-term "soft" funding rather than as research projects or as a planned service. Consequently, after the initial support has ceased, they will not have been evaluated and will not be part of a health care strategy. Since they are of unproven value, purchasing authorities may be reluctant to see patients referred. Unless there are convincing arguments to the contrary, approaches new to the NHS should be used in the context of a trial and routine use should be discouraged. At an early stage of planning, the costs and organisational implications for the NHS should be examined in relation to existing methods. Such a system would not inhibit innovation; rather it would stimulate clinicians to examine carefully what they do and to be aware of developments. Purchasers of health care might be encouraged to take into account the evaluation status of health practice methods. The concept of the extended trial protocol should be explored to supplement conventional study design. This would include a complementary study design for economic evaluation and a projection of the outcome if the method became an NHS routine. Extended trial protocols might also include an early assessment of the feasibility of commercial development. Although the randomised clinical trial is regarded as the best way to evaluate competing forms of care, the overall contribution of such trials has been disappointing. Peto and
his colleagues have argued strongly for trials in common diseases that address important but simple questions and that are large in scale with uncomplicated entry protocols.5 Others have argued for non-randomised assessment methods including the use of historical controls, casecontrol studies, and non-randomised current controls with adjustment techniques.6 In view of the number of new and existing methods needing evaluation a stepwise approach to assessment is required, culminating in the use of randomised controlled trials. A randomised trial remains the best way of assessing whether a medical hunch is correct or incorrect. Passamani7 gave an example when reviewing the CAST trial of antiarrhythmic drugs in the treatment of ventricular extrasystoles after acute myocardial infarction.8 Since extrasystoles are associated with an increased risk of death after an infarct, suppression made good clinical sense and might well have been adopted into practice without assessment. However, the trial had to be terminated because of an excess mortality in patients receiving drug therapy. The trial outcome was contrary to expectation, and it is improbable that the adverse effect of the drug therapy would have been detected by non-randomised methods. Another example is chorion villus sampling to detect genetic and cytogenetic disorders of the fetus in the first trimester of pregnancy.9 Initially a randomised trial against amniocentesis in the second trimester was resisted since chorion villus sampling had the advantage of earlier diagnosis. However, the results of the trial show that chorion villus sampling compares unfavourably with amniocentesis in terms of safety, accuracy, and the need for further testing. Obstacles to clinical evaluation include enthusiasm, conviction, public and professional pressure, and the attraction of speedily introducing lower cost methods into routine care. Furthermore, randomised control trials are not part of the ethos of everyday clinical practice although, as Baum10 has pointed out, the ethical difficulties of randomisation and informed consent have to be set against the certainty with which clinicians may offer a treatment of unproven value to patients outside the context of a trial. The randomised trial should also be used where appropriate to evaluate methods of service delivery and health service management. A feature of medicine that will need to be addressed in the R & D strategy is the reluctance to modify practice even when compelling evidence is forthcoming. Another is the widespread use of treatments extrapolated from their evaluation in specific clinical situations. For example, if the clinical use of haemopoietic growth factors tested in patients receiving high dose chemotherapy and marrow transplantation was extended to cancer chemotherapy as a whole, the costs would be prodigious and useful outcomes
improbable. The final steps of R & D Too little attention has been paid to the dissemination of information in such a way as to maximise the chance of securing uptake. We need better methods for promulgating new and existing data, for inducing change, and for auditing uptake; observations derived from audit will feed back into the R & D pathway. Another function of R & D will be to clarify the purpose and use of audit and to explore the relation between audit, algorithms, expert systems, and information technology. An NHS R & D centre will be established to hold information on cost-effective practice methods, the outcomes of evaluation, and the protocols of trials in progress. The data centre will seek input from
371
data centres and from international sources of information. Information technology is obviously a vital component of R & D; there is also scope for R & D in information technology-particularly in relation to its service use.
existing
initiatives in Europe, and it is fitting that the scheme should emerge from the UK, with its strong tradition in medical research, clinical practice, nursing, and primary health care. The R & D programme offers a unique opportunity to develop an overall view of basic and applied research in relation to health care and health priorities.
Manpower and training A national review of existing skills and activities in epidemiology, health service research, health economics, and other disciplines relevant to NHS R & D was started in April, 1991. These disciplines, together with clinical research, are needed for the NHS initiative, and R & D resources will be necessary to ensure their support. Time spent in research has become de rigueur for many doctors in training. This element of training should be encouraged provided that the research is well conceived and well supervised (not always the case). The NHS requires a cadre of clinical scientists who have received a high quality research training and who can pursue a mixture of practice and research (whether biomedical or epidemiological). However, it would also make good sense to offer the possibility of training in evaluative science to provide health care professionals with the skills necessary to contribute to health services research, clinical research, and clinical epidemiology. Some of the existing MSc programmes could fulfil this function; unfortunately UK participants tend to be scarce because the necessary funding is hard to secure.
NHS R & D and industry
industry spends about 800 million perhaps C200 million is spent on research in medical schools and NHS hospitals. Some ;700 million a year is spent by the NHS on medical equipment in the UK. Commercially the British medical equipment industry has been less successful than the pharmaceutical industry. The 1990 report of the working party of the Fellowship of Engineeringll noted that "advances in medical technology have been pioneered in the UK but many of these, including endoscopes, computerised tomography scanning, and magnetic resonance imaging have been developed and manufactured elsewhere". The ACARD report on medical equipment12 commented that a financially healthy industry would depend on strong links with both academic research and clinical practice. The NHS R & D initiative provides a chance to re-examine the relationship between the NHS and industry. The issues include access to the NHS for testing of industrial products, the role of the NHS R & D programme in technology assessment, the pricing of pharmaceutical and other products being developed within the NHS, and the basis on which overhead charges are levied upon industry for trials of their products in the NHS. (For the pharmaceutical industry these are said to range from 20% to 210% of the cost of a trial .13 ) The way in which the clinical research requirements of industry relate to NHS R & D at local level will need to be clarified. Finally, as noted above, the possibilities for commercial exploitation should be envisaged at the planning stage of research and evaluation, so that a plan can be made, delays avoided, and opportunities grasped. The pharmaceutical
a
year on R & D of which
Conclusion The new programme is perhaps the first comprehensive attempt to develop a national R & D infrastructure for health care. The experience gained should be relevant to future
REFERENCES 1. Editorial.
Putting British undergraduate medical education into the twentieth century. Lancet 1991; 337: 1448-49. 2. House of Lords Select Committee on Science and Technology. Priorities in medical research. London: HM Stationery Office, 1988. 3. Department of Health. The health of the nation. London: HM Stationery Office, 1991. 4. Chalmers I, Enkin M, Keirse MJNC. Effective care in pregnancy and childbirth. Oxford: Oxford University Press, 1989. 5. Yusuf S, Collins R, Peto R. Why do we need some large, simple clinical trials? Stat Med 1984; 3: 409-20. 6. Wennberg JE, Roos N, Sola L, et al. Use of claims data system to evaluate care outcomes, mortality and reoperation following prostatectomy. JAMA 1991; 257: 933-36. 7. Passamani E. Clinical trials—are they ethical? N Engl J Med 1991; 324: 1589-92. 8. The Cardiac Arrhythmia Suppression Trial (CAST) investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomised trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989; 321: 406-12. 9. MRC Working Party. Medical Research Council European Trial of Chorion Villus Sampling. Lancet 1991; 337: 1491-99. 10. Baum M. Assessment, ethics and the randomised controlled trial. Int J Technol Assess Health Care 1989; 5: 305-12. 11. Report of the working party on engineering in medicine. The Fellowship of Engineering, 1990. 12. ACARD. Medical equipment. Report of the Advisory Council for Applied Research and Development. London: HM Stationery Office, 1986. 13. Anonymous. Clinical research funding. Lancet 1991; 337: 1472.
BOOKSHELF Geriatric Emergency Medicine G. Bosker, G. R. Schwartz, J. S. Jones, and M. Sequeira. St Louis: Mosby. 1990. Pp 626. 76. ISBN 0-801618088.
Geriatrics is sometimes perceived as a worthy but unspectacular specialty, primarily concerned with the provision of adequate custodial care for frail, dependent old people. In reality, geriatric medicine is exciting, challenging, and highly varied. It involves the comprehensive assessment of the health and social needs of older patients and their carers; the provision of high-quality care to those with medical crises; the restoration of disabled elders to the highest attainable levels of independence and wellbeing; and imaginative, continuing support to the small proportion who require long-term institutional care. Unless acutely ill old people are properly diagnosed and receive timely and appropriate treatment, they may suffer needless distress and become unnecessarily disabled and dependent. We are told that, in the USA, most clinicians are inadequately prepared to deal with ill old people; the editors therefore set out to provide advice to doctors who work in emergency rooms-where old people are more ill, spend more time, have more investigations, and yet are more likely to be misdiagnosed than are their younger counterparts. One in four emergency admissions among elderly Americans arises from an adverse drug reaction, mostly caused by aspirin, digoxin, warfarin, and diuretics: for a given condition, US patients receive four times as much medication
as
do those in Scotland.
NATIONAL
HEALTH
SERVICE
The announcement in April, 1991, of a Research and Development Health Strategy marked thefirst phase in the creation of an R & D programme and infrastructure for the British National Health Service. The Director of Research and Development is Prof Michael Peckham, who outlined the proposed scheme in a Francis Fraser Lecture at the Royal College of Physicians, London, on June 3. This paper is based on the lecture.
Research and
development for the National Health Service
Over four decades the National Health Service (NHS) has responded to a huge range of innovations. Some have been durable, others have been transient; some have been evaluated but many have not. Often new developments have been superimposed on existing practice, creating a kind of medical archaeology where the remnants of earlier practices are discernible among the newer acquisitions. The arrangement has been productive in terms of new methods of care but important areas have been neglected. A research approach has not been brought to bear systematically on issues relating to the effectiveness of clinical practice, the dispersal and use of existing knowledge, the best use of human and other resources, and the contribution of medical interventions to the health status of individuals and the population. Neither has there been a systematic attempt to relate important health issues to the national effort in medical research. Innovation in medical research has been driven largely by the intrinsic interest of disease processes to clinicians and scientists, and medical practice has been shaped by the intellectual challenge of clinical problems. Such an approach has amply demonstrated its value. The challenge now is to introduce a sensible mechanism for handling within the NHS the output of basic and applied research and to apply research methods to examine the content and delivery of health care. Such a mechanism is the only way of resisting the sometimes unreasonable and often unproven resource-consuming demands of lay, professional, and industrial pressure groups. The need for evaluation also applies to many currently used methods of diagnosis and treatment. Every clinician knows that there is indefensible diversity in the use of diagnostic methods and therapies and that there is unacceptable variation in the quality of treatment delivered by different clinical teams. The science of evaluation is an area of neglect between biomedical research and clinical
practice. The support of non-industrial medical research in the UK is complex. The medical schools are funded through the Department of Education and Science and the teaching hospitals through the Department of Health. Research support is derived from multiple sources including the Medical Research Council (MRC), the charities, industry, the NHS, the Universities Funding Council (UFC), and local trusts and other funds. The Economic and Social Research Council and the Science and Engineering Research Council also support research relevant to
medicine. Four charities, the Wellcome Trust, Imperial Cancer Research Fund, Cancer Research Campaign, and the British Heart Foundation, fund about three-quarters of charity-supported research. The level of funding for research from the MRC, UFC, NHS, charities, and industry is broadly comparable.
The NHS and research The NHS
provides the practical outlet for research supported by the funding bodies; the universities and other research establishments provide research expertise and are a source of new developments.
programmes
The support of clinical research within the NHS is obviously central to the interests of the MRC, charities, and industry as is the quality and organisation of the research base to the NHS. In the latter context I have something to say about the organisation of British medical schools. The shortcomings of undergraduate medical education are recognised’ and it has generally been assumed that the pursuit of medical research favours education. Where appropriately constructed the trio of education, research, and clinical practice is an excellent structure. However, there may be a tension between the coverage needed for education and the need to focus to achieve critical mass in research. In some cases disappointingly little effort has been put into medical school strategies for research and education and the relationship between them. Because of a broadening of the science base of medicine it is difficult nowadays for a single school to establish a competitive in-house science programme. This argues for the association of medical schools with university science faculties and other science institutions. The science origins of applied medical research and clinical practice do not necessarily derive from basic medical research. Laser technology, information technology, visual display systems, image analysis, electronics, and materials science are relevant to advances in medicine, yet their basic aspects are likely to be found in non-medical science facilities and in industry. Strengths in social science, including economics, reside largely in faculties outside medicine; the same is true for some basic biological research. Medical schools need to ensure that they function as effective conduits between science and the clinic; their structure and strategy should reflect this aim. Department of Health, Richmond House, 79 Whitehall, London SW1A 2NS, UK (Prof Michael Peckham, FRCP). ADDRESS:
368
The NHS and medical research have been on parallel tracks. The House of Lords Select Committee on Science and Technology, in their report Priorities in Medical Research, identified the problem thus: "The NHS is inextricably involved with medical research, yet the administrative remoteness of medical research from the NHS is a source of weakness to both sides. No research system can function efficiently when their principal customer for research (the NHS) has so small a direct input into the initiation of research programmes. The NHS should be brought into the mainstream of medical research. It should articulate its needs; it should assist in meeting those needs; and it should ensure that the fruits of research are systematically transferred into service."2
The NHS supports clinical research by providing facilities, patients, and expertise. It also provides financial for research. However, there has been no strategic support framework in the NHS within which research resources are managed, and the service has been a largely passive partner to the research funding bodies. One result of this is that the strategies and policies of the NHS do not benefit from all the information available from research and development. This leads to unplanned service pressures arising from researchdriven developments and missed opportunities from increasing efficacy on the basis of knowledge derived from research. In addition the development phase of R & D has been relatively neglected, with the result that research developments that show real promise for improving the NHS are often not introduced in a managed way for greatest benefit. access to
The NHS R &
D programme
Key points To correct the deficiencies identified above a new R & D infrastructure for the NHS will be set in place in the 14 English health regions. The NHS R & D programme is based on several key points. First, research and development is an essential activity-indeed, a prerequisite for achieving a cost-effective health service responsive to changes in needs as well as to innovation. Second, and as a corollary of the first, it is necessary to invest in R & D to achieve sufficient activity to establish a coherent programme. Third, responsibility for R & D should be devolved to the health regions, with mechanisms for ensuring accountability and quality assurance. Fourth, regional planning should take place within a corporately developed national R & D framework to avoid fragmentation, gaps, and unproductive duplication of effort. Fifth, several high priority R & D issues of national importance should be identified and these should be coordinated and funded from the centre. Sixth, the establishment of a countrywide R & D programme developed through the regions requires close collaboration between the universities and the NHS, and this should be reflected in the regional arrangements for R & D. Finally, the NHS R & D programme offers the opportunity of working towards a broadly coherent national programme of research in collaboration with the MRC, the charities, and
industry. The Central Research and Development Committee A new Central Research and Development Committee will be established in the autumn of 1991. The committee, which will be chaired by the Director of Research and Development, will be multidisciplinary with participation from the regions. There will be clinical (hospital and general practice) and non-clinical members including
from nursing and health service management. In addition to the biological sciences and clinical (including dental) research there will be input from epidemiology, health services research, economics, and statistics. The committee will oversee the preparation of a broad R & D framework within which the regions will develop their plans. In particular the committee will identify national R & D priorities and in doing so establish an agenda of issues that it would wish to see addressed in regional
representation
programmes.
Regional research and development A key component of the new programme is the preparation by each region of an R & D plan. Regions will be required to publish and implement the plan and will be held accountable for it. To achieve this each region will identify a director of research and development or equivalent and close collaboration will be needed between the Research and
Development Directorate in the Department of Health, the Central R & D Committee, regional general managers, and regional directors of public health. There will also be a requirement for a regional R & D committee with an appropriate infrastructure. University/NHS collaboration at regional and local level will clearly be of critical importance to ensure high quality peer review. Multidisciplinary input needs to be secured at regional level for the Central R & D Committee. The content of the regional programmes will be in three main categories. The first will relate to R & D relevant to the local needs of the region. A second component will be work identified by the central committee as being of general relevance. The third component will concern national priority R & D issues funded through the central committee. As outlined below, the national priorities will be funded on the basis of bids to the central committee through the regional R & D structure. For the initiative to be successful its activities must pervade the NHS; and to achieve this, regional strategies will need to encompass R & D at local level in the community and primary care settings and in teaching and non-teaching as
hospitals.
Resourcing and accountability The Department of Health/NHS
contributes large research and research-related activities. This includes the research component of the Service Increment for Teaching and Research, which is allocated to regions in recognition of the increased costs of patient care in teaching hospitals. The Department has now introduced a similar scheme for hospitals that conduct a substantial amount of research but do not receive the service increments. Also included are the Locally Organised Research Scheme, the Department of Health centrally managed research budget, other Departmental research funds, the component of the funding of the London postgraduate hospitals related to their research and development functions, and several non-departmental public bodies that perform research (such as the National Radiological Protection Board). In all, this amounts to more than C220 million a year. Although much of the funding is committed, its inclusion within the overall research and development programme means that it will be necessary to ensure that the funds are used to good effect and within an overall framework. In due course each aspect will be separately addressed and reviewed; a start has been made by clarifying the research and development priorities of the Special Health Authorities. It is intended resources to
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Locally Organised Research Scheme will be the new regional research and development into brought To permit the development of the NHS programme. research and development programme a national expenditure target has been set of 1 -5% of the NHS budget, to be achieved over five years by harnessing R & D resources currently used throughout the service and by seeking new resources through the public expenditure process. The creation in January, 1991, of the NHS Management Executive’s Research and Development Directorate enables D to be a system of accountability for regional R & developed through existing mechanisms. that the
Implementation Project and working groups with participation of NHS clinical and non-clinical staff, health service managers, and university personnel have been set up to advise on the structure and function of the NHS R & D programme. Several advisory groups have been convened to consider issues relating to content, staff requirements, and methodology. These include a health practice and technology assessment group, and a clinical process and outcomes group. Endoscopic surgery, neonatal intensive care, and vaccine development are among the matters being considered by ad hoc groups. An NHS/industry forum is being established and a group is being convened to examine the criteria for setting R & D priorities.
NHS R & D and the bodies funding medical research: research liaison committees The multiple sources of health research funding in Britain argue for collaboration between research funding bodies and, on occasion, for complementary effort. Until now the NHS has not been an active partner even though the facilities of the health service are a common requirement for all bodies supporting clinical research. It is hoped that disease or problem related research liaison committees will be set up, on the lines of the United Kingdom Coordinating Committee for Cancer Research, to bring together in one forum the main funding bodies. A cardiovascular research liaison committee has already been convened.
Content and scope of the NHS R & D programme Research in the NHS programme will take two forms. The first is derivation of new methods of disease prevention, diagnosis, and treatment; it includes approaches to service delivery and concepts relating to staffmg, education, and the provision and design of facilities. The second, conveniently designated as evaluative science, applies research methods to the assessment of new and existing health practice methods and to health care.
From basic research to
operational research
The NHS programme will be oriented towards applied research with emphasis on an integrated approach that fully takes into account advances in basic research and their relation to health priorities. It would be short-sighted to focus exclusively on health service research and operational issues and ignore areas of biomedical research that might have important impact on the NHS. Similarly it would be inappropriate not to present the case for changes in emphasis in biomedical research if the national effort in a particular area was judged to be lacking. In mental illness, for example,
where there is a need for epidemiological and health service research, it would be an error not to be closely in touch with events in biological psychiatry. R & D priorities The setting of R & D priorities will be an early task of the Central R & D Committee. Planning will be much influenced by the Department of Health’s consultation document The Health of the Nation,3taking into account the burdens of disease and targets for health. Cardiovascular disease, cancer, and respiratory disease are three prime causes of life years lost. In terms of premature mortality cardiovascular disease accounts for approximately 50% of deaths. Smoking is a major contributor; hyperlipidaemia and hypertension are also important. Cardiovascular disease, chronic musculoskeletal disease, and mental illness are the main causes of morbidity. In costs to the NHS, mental illness comes first and cardiovascular disease second. Some of the key issues tend to be blurred by the compartmentalisation of health care into community care, general practice, district hospital, teaching hospital, Special Health Authority, and so on. A horizontal view of ill-health and disease prevention is needed to examine issues such as progressive care, from ambulatory community-based treatment to management in high dependency and intensive care units. This "stratum" view will encourage a fresh approach to community-based research including the roles of general practitioners, nurses, and other health workers. We shall need a mechanism for handling the increasing number of new developments being presented to the NHS:
they effective, are they cost-effective, are they being used, and if so are they being used to best effect? The techniques for investigating these matters clearly need refinement. Clinical audit provides the basis for determining whether cost-effective methods are in use and whether they are being used appropriately. Quality of treatment is influenced by severity of illness, professional skills, staffing, and facilities, and to assess it we require reproducible measures of health that can be applied before and after are
Since the lead time between research and practical development is shorter than it used to be, we need to think in advance about the possible impact of new discoveries and techniques upon organisation of care, the workforce, the design of treatment facilities, and so on. The transmission of information between different geographical locations and internally within the hospital environment is another key issue. treatment.
Creating space for new developments R & D will release resources that are not at present being used productively. Methods that are ineffective tend to be abandoned eventually, but usually the tempo is slow. To create space for cost-effective practice and advances in medicine we must identify non-contributory practices that are in use and encourage their abandonment. The most systematic attempt to examine an area of medicine in detail is the work of Chalmers and his colleagues at the National Perinatal Epidemiology Unit in Oxford.4 Some 5000 trials in perinatal medicine were identified by Medline database search, by journal hand search, and by personal approaches to obstetricians and paediatricians. Updated information on published trials was obtained by correspondence and unpublished negative data were sought. This profile of perinatal medicine indicated that in 20% of methods there was convincing evidence of ineffectiveness. In about 30%
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there was evidence of effectiveness to support their use. The remainder includes methods that were promising but required further evaluation and those in which the effects were unknown. Information of this kind may well be available for other areas of medicine but it remains to be collected and analysed. To achieve this where feasible will be an objective of the NHS R & D programme.
Clinical research The NHS programme will support good clinical research. The content and quality of clinical research being conducted on NHS premises is at present undocumented but experience indicates that, while some is of the highest quality, some contributes little of value to the service, to knowledge, or to the researcher. Support of high quality clinical research needs to be focused (in conjunction with the MRC, charities, and industry) through the NHS R & D
initiative. In the drive for efficiency in the NHS it is important that good clinical research is encouraged and not squeezed. A recent example illustrates the way in which unproven methods can be inadvertently sustained. A trial that sought to establish whether a low dose of drug was as effective as a high dose foundered because the full costs had to be met by the investigator. Paradoxically, the investigator was able to use the high dose of drug in routine practice outside the context of a formal study. Unless clinical research is regarded as part of good clinical practice, a critical, protocol-based aproach to patient care will be discouraged and uncontrolled diversity and unplanned experimentation will persist by default.
Evaluative clinical science A treatment that changes the course of a disease may be so obvious an advance-for example, combination therapy for Hodgkin’s disease or testicular cancer-that comparative assessment is inappropriate. A more common event is for a new treatment to be mistakenly classed as an unequivocal advance. New procedures are sometimes introduced into the NHS on short-term "soft" funding rather than as research projects or as a planned service. Consequently, after the initial support has ceased, they will not have been evaluated and will not be part of a health care strategy. Since they are of unproven value, purchasing authorities may be reluctant to see patients referred. Unless there are convincing arguments to the contrary, approaches new to the NHS should be used in the context of a trial and routine use should be discouraged. At an early stage of planning, the costs and organisational implications for the NHS should be examined in relation to existing methods. Such a system would not inhibit innovation; rather it would stimulate clinicians to examine carefully what they do and to be aware of developments. Purchasers of health care might be encouraged to take into account the evaluation status of health practice methods. The concept of the extended trial protocol should be explored to supplement conventional study design. This would include a complementary study design for economic evaluation and a projection of the outcome if the method became an NHS routine. Extended trial protocols might also include an early assessment of the feasibility of commercial development. Although the randomised clinical trial is regarded as the best way to evaluate competing forms of care, the overall contribution of such trials has been disappointing. Peto and
his colleagues have argued strongly for trials in common diseases that address important but simple questions and that are large in scale with uncomplicated entry protocols.5 Others have argued for non-randomised assessment methods including the use of historical controls, casecontrol studies, and non-randomised current controls with adjustment techniques.6 In view of the number of new and existing methods needing evaluation a stepwise approach to assessment is required, culminating in the use of randomised controlled trials. A randomised trial remains the best way of assessing whether a medical hunch is correct or incorrect. Passamani7 gave an example when reviewing the CAST trial of antiarrhythmic drugs in the treatment of ventricular extrasystoles after acute myocardial infarction.8 Since extrasystoles are associated with an increased risk of death after an infarct, suppression made good clinical sense and might well have been adopted into practice without assessment. However, the trial had to be terminated because of an excess mortality in patients receiving drug therapy. The trial outcome was contrary to expectation, and it is improbable that the adverse effect of the drug therapy would have been detected by non-randomised methods. Another example is chorion villus sampling to detect genetic and cytogenetic disorders of the fetus in the first trimester of pregnancy.9 Initially a randomised trial against amniocentesis in the second trimester was resisted since chorion villus sampling had the advantage of earlier diagnosis. However, the results of the trial show that chorion villus sampling compares unfavourably with amniocentesis in terms of safety, accuracy, and the need for further testing. Obstacles to clinical evaluation include enthusiasm, conviction, public and professional pressure, and the attraction of speedily introducing lower cost methods into routine care. Furthermore, randomised control trials are not part of the ethos of everyday clinical practice although, as Baum10 has pointed out, the ethical difficulties of randomisation and informed consent have to be set against the certainty with which clinicians may offer a treatment of unproven value to patients outside the context of a trial. The randomised trial should also be used where appropriate to evaluate methods of service delivery and health service management. A feature of medicine that will need to be addressed in the R & D strategy is the reluctance to modify practice even when compelling evidence is forthcoming. Another is the widespread use of treatments extrapolated from their evaluation in specific clinical situations. For example, if the clinical use of haemopoietic growth factors tested in patients receiving high dose chemotherapy and marrow transplantation was extended to cancer chemotherapy as a whole, the costs would be prodigious and useful outcomes
improbable. The final steps of R & D Too little attention has been paid to the dissemination of information in such a way as to maximise the chance of securing uptake. We need better methods for promulgating new and existing data, for inducing change, and for auditing uptake; observations derived from audit will feed back into the R & D pathway. Another function of R & D will be to clarify the purpose and use of audit and to explore the relation between audit, algorithms, expert systems, and information technology. An NHS R & D centre will be established to hold information on cost-effective practice methods, the outcomes of evaluation, and the protocols of trials in progress. The data centre will seek input from
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data centres and from international sources of information. Information technology is obviously a vital component of R & D; there is also scope for R & D in information technology-particularly in relation to its service use.
existing
initiatives in Europe, and it is fitting that the scheme should emerge from the UK, with its strong tradition in medical research, clinical practice, nursing, and primary health care. The R & D programme offers a unique opportunity to develop an overall view of basic and applied research in relation to health care and health priorities.
Manpower and training A national review of existing skills and activities in epidemiology, health service research, health economics, and other disciplines relevant to NHS R & D was started in April, 1991. These disciplines, together with clinical research, are needed for the NHS initiative, and R & D resources will be necessary to ensure their support. Time spent in research has become de rigueur for many doctors in training. This element of training should be encouraged provided that the research is well conceived and well supervised (not always the case). The NHS requires a cadre of clinical scientists who have received a high quality research training and who can pursue a mixture of practice and research (whether biomedical or epidemiological). However, it would also make good sense to offer the possibility of training in evaluative science to provide health care professionals with the skills necessary to contribute to health services research, clinical research, and clinical epidemiology. Some of the existing MSc programmes could fulfil this function; unfortunately UK participants tend to be scarce because the necessary funding is hard to secure.
NHS R & D and industry
industry spends about 800 million perhaps C200 million is spent on research in medical schools and NHS hospitals. Some ;700 million a year is spent by the NHS on medical equipment in the UK. Commercially the British medical equipment industry has been less successful than the pharmaceutical industry. The 1990 report of the working party of the Fellowship of Engineeringll noted that "advances in medical technology have been pioneered in the UK but many of these, including endoscopes, computerised tomography scanning, and magnetic resonance imaging have been developed and manufactured elsewhere". The ACARD report on medical equipment12 commented that a financially healthy industry would depend on strong links with both academic research and clinical practice. The NHS R & D initiative provides a chance to re-examine the relationship between the NHS and industry. The issues include access to the NHS for testing of industrial products, the role of the NHS R & D programme in technology assessment, the pricing of pharmaceutical and other products being developed within the NHS, and the basis on which overhead charges are levied upon industry for trials of their products in the NHS. (For the pharmaceutical industry these are said to range from 20% to 210% of the cost of a trial .13 ) The way in which the clinical research requirements of industry relate to NHS R & D at local level will need to be clarified. Finally, as noted above, the possibilities for commercial exploitation should be envisaged at the planning stage of research and evaluation, so that a plan can be made, delays avoided, and opportunities grasped. The pharmaceutical
a
year on R & D of which
Conclusion The new programme is perhaps the first comprehensive attempt to develop a national R & D infrastructure for health care. The experience gained should be relevant to future
REFERENCES 1. Editorial.
Putting British undergraduate medical education into the twentieth century. Lancet 1991; 337: 1448-49. 2. House of Lords Select Committee on Science and Technology. Priorities in medical research. London: HM Stationery Office, 1988. 3. Department of Health. The health of the nation. London: HM Stationery Office, 1991. 4. Chalmers I, Enkin M, Keirse MJNC. Effective care in pregnancy and childbirth. Oxford: Oxford University Press, 1989. 5. Yusuf S, Collins R, Peto R. Why do we need some large, simple clinical trials? Stat Med 1984; 3: 409-20. 6. Wennberg JE, Roos N, Sola L, et al. Use of claims data system to evaluate care outcomes, mortality and reoperation following prostatectomy. JAMA 1991; 257: 933-36. 7. Passamani E. Clinical trials—are they ethical? N Engl J Med 1991; 324: 1589-92. 8. The Cardiac Arrhythmia Suppression Trial (CAST) investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomised trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989; 321: 406-12. 9. MRC Working Party. Medical Research Council European Trial of Chorion Villus Sampling. Lancet 1991; 337: 1491-99. 10. Baum M. Assessment, ethics and the randomised controlled trial. Int J Technol Assess Health Care 1989; 5: 305-12. 11. Report of the working party on engineering in medicine. The Fellowship of Engineering, 1990. 12. ACARD. Medical equipment. Report of the Advisory Council for Applied Research and Development. London: HM Stationery Office, 1986. 13. Anonymous. Clinical research funding. Lancet 1991; 337: 1472.
BOOKSHELF Geriatric Emergency Medicine G. Bosker, G. R. Schwartz, J. S. Jones, and M. Sequeira. St Louis: Mosby. 1990. Pp 626. 76. ISBN 0-801618088.
Geriatrics is sometimes perceived as a worthy but unspectacular specialty, primarily concerned with the provision of adequate custodial care for frail, dependent old people. In reality, geriatric medicine is exciting, challenging, and highly varied. It involves the comprehensive assessment of the health and social needs of older patients and their carers; the provision of high-quality care to those with medical crises; the restoration of disabled elders to the highest attainable levels of independence and wellbeing; and imaginative, continuing support to the small proportion who require long-term institutional care. Unless acutely ill old people are properly diagnosed and receive timely and appropriate treatment, they may suffer needless distress and become unnecessarily disabled and dependent. We are told that, in the USA, most clinicians are inadequately prepared to deal with ill old people; the editors therefore set out to provide advice to doctors who work in emergency rooms-where old people are more ill, spend more time, have more investigations, and yet are more likely to be misdiagnosed than are their younger counterparts. One in four emergency admissions among elderly Americans arises from an adverse drug reaction, mostly caused by aspirin, digoxin, warfarin, and diuretics: for a given condition, US patients receive four times as much medication
as
do those in Scotland.
