230
and return 335-42.
to
ovulation in
Bangkok. Int J Gynecol Obstet 1989;
30:
15. Shaaban MM, Kennedy KI, Sayed GH, Ghaneimah SA, Abdel-aleem AM. The recovery of fertility during breast-feeding in Assiut, Egypt. J Biosoc Sci 1990; 22: 19-32. 16. Khan T, Kennedy KI, Kazi A, Steiner M. A study of breastfeeding and the return of menses and pregnancy in Karachi, Pakistan. Contraception 1989; 40: 365-76. 17. Savina G, Kennedy K. The effect of a breastfeeding education program on lactational amenorrhoea in the Philippines. Stud Fam Plann 1989;
20: 203-14. 18. Benitez I, De la Cruz J,
Suplido A, Oblepias V, Kennedy K, Visness C. Extending lactational amenorrhoea in Manila: a successful breastfeeding education program. J Biosoc Sci (in press). 19. Goldzieher JW, Nakamura Y. A clinical method for the determination of urinary pregnanediol and pregnanetriol. Acta Endocrinol 1962; 41: 371.
LF, Cos RI, Holmes J, Smith MA. Chemical and homogeneous enzyme immunoassay methods for the measurement of oestrogens and pregnanediol and their glucuronides in urine. Prog Biol
20. Brown JB, Blackwell
Chem Res 1988; 285: 119-38. 21. Howie PW, McNeilly AS, Houston MJ, Cook A, Boyle H. Fertility after childbirth: adequacy of postpartum luteal phases. Clin Endocrinol 1982; 17: 609-15. 22. SAS Institute, Inc. SAS user’s guide: statistics, version 5 edition. Cary, NC: SAS Institute, Inc: 1985. 23. Family Health International: LIFETAB: A program for lifetable analysis of clinical trials. Durham, NC: Family Health International, 1989. 24. Wood JW. Fecundity and natural fertility in humans. Rev Reprod Biol 1989; 11: 61-109. 25. Trussell J, Hatcher RA, Cates W, Stewart FH, Kost K. Contraceptive failure in the United States: an update. Stud Fam Plann 1990; 21: 51-54.
VIEWPOINT Funding research and development in the NHS
Introduction In the new strategy for National Health Service (NHS) research’2 the emphasis will be on research relating to the effectiveness of clinical practice, the dispersal and use of existing knowledge, and the contribution of medical interventions to the health status of individuals and the population. NHS regions will play an important part in implementing the plan and will be held accountable for it. Regional health authorities will be required to prepare, publish, finance, and implement their own research and development plans.2 To permit the development of the NHS research and development (R & D) programme, a national expenditure target has been set. This target, of 1-5% of the NHS budget, will be achieved over 5 years by harnessing R & D resources now in use throughout the service and by seeking new funds through the public
expenditure process. The new R & D plan is to be welcomed, but it also has to be recognised that the NHS is in the midst of the most wide-ranging reform since its inception. In particular, the separation of the roles of purchaser and provider and the establishment of contracts for services in an "internal market" are likely to have a profound effect on all NHS activities, including R & D. Concerns have already been raised, by those charities sponsoring clinical research, that the reforms may make NHS authorities wary about covering the costs of care for patients enrolled in research studies.3-5 This has the implication that funds originally allocated for research could be diverted to providing treatment. Furthermore, regions faced with an expenditure target for research could redefine activities so as to ensure that the target is met--eg, activities such as medical audit and quality assurance that should be part of routine NHS practice might be redefined as an R & D activity.
Defining
R &
acquisition of new knowledge of broad relevance beyond the setting in which the research took place. Development activities, on the other hand, are usually to do with the application of existing knowledge and sometimes have specific relevance to the setting in which they are
with the
D
In the context of the changes in NHS funding, it is important to make a distinction between "research" and "development". Research activities are usually associated
undertaken.
The
distinction
between
research and
development is important since, under the new contracting arrangements, one can see a stronger case for a purchaser to pay for development than for research.
Impact of NHS reforms on
R &
D
The
major impact of the reforms will arise from the specification of contracts. Purchasers will question whether the higher costs of some providers implicitly include an R & D component. In turn, providers will take a harder look at all their staff contracts, including joint appointments, since manpower represents the largest component of NHS expenditure. Also, the closer examination ofNHS treatment technologies, by both purchasers and providers, is likely to identify practices that contribute to research knowledge rather than patient outcome. All these changes will be assisted by improvements in NHS financial information systems, which are necessary for operating the internal market. One of the most difficult issues will be that of selecting the criteria that determine whether or not the purchaser pays for the clinical care of patients enrolled in research protocols. Peckham1 pointed to the anomaly whereby a health authority refused to pay for care when a clinician wanted to allocate patients to either normal-dose or low-dose regimens of a given drug in a randomised clinical trial. Paradoxically, ADDRESSES Centre for Health Economics, University of York, Heslington, York YO1 5DD, UK (Prof M. F. Drummond, DPhil);Department of Public Health, South Birmingham Health Authority, Birmingham (B. J. Crump, MFPHM); and Health Services Management Centre, University of Birmingham, Birmingham, UK (V A Little, MSocSc) Correspondence to Prof M F Drummond
231
the authority was quite happy to pay for the normal-dose regimen for all patients prescribed as part of the clinician’s regular practice. On the other hand, should a purchaser pay for an extra-contractual referral to a specialist clinical centre when the general practitioner believes that a patient should be enrolled in a clinical trial? Resolution of this issue will not be easy. However, from the purchaser’s viewpoint the argument for payment for the clinical care of patients enrolled in a trial would be strengthened if the treatment concerned was one that the purchaser would normally place contracts for, if the research was being conducted according to a well-designed protocol, if the other costs of the research were properly identified, and if the aims of the study (in terms of improved patient care or more cost-effective use of resources in the future) were
justified.
With longer-term research there is the risk of the "free-rider" problem, whereby people wait for someone else to bear the costs of an investment that will benefit all. This "public good" characteristic of research means that a sizeable part of the funds should come from central and regional authorities. In addition, the size of the resources required for some types of research, or the economies of scale in its execution, suggest that a measure of central or regional direction is required. It is therefore particularly important that these responsibilities be clearly specified and protected in the context of the NHS reforms. Another potentially undesirable consequence of the reforms may be the commercialisation of NHS R & D. Providers who undertake R & D may then be reluctant to share the results with others since a market advantage can be obtained by developing a novel treatment. Of course, researchers themselves may resist this trend, because publication of results is considered important in career development. Nevertheless, they may be reluctant to explain in detail to colleagues in competing centres how the development took place. Over a longer timescale a "market" in research itself may develop within the NHS. A provider wishing to develop a new service may be willing to pay for help and advice from elsewhere.
Policies for funding NHS R &
D
First, consideration needs to be given to how health regions can strengthen their locally organised research schemes.6 These will probably be greatly expanded in scope since the recent initiatives from the Department of Health require that regions take note of national priorities for research when making their own funding allocations. However, health authorities should also seize the opportunity that local schemes provide for the pursuit of regional priorities, by commissioning research that is likely to maximise the potential for local health gain. This move implies the selection of areas where diseases impose the greatest burden and where the development of effective and cost-effective treatments has the greatest potential. Thus membership of local research committees should be broadened to include specialists in public health, health services research, and NHS purchasing, because research proposals will need to be assessed for their relevance as well their scientific merit. Secondly, further consideration should be given to the methods of allocating the research component of the special increment for teaching and research (SIFTR), which has been variously estimated to be between 25 and 40% of the totalIn the NHS internal market, SIFTR will be used to
as
subsidise the prices charged by the major teaching and research centres, and help them to maintain a research infrastructure. There is scope for applying a procedure similar to that now operated by the University Funding Council for university academic departments. Essentially, this system rewards those institutions with the largest research output. Although there are difficulties in making assessments of the quality and relevance of research, the mere fact that SIFTR is to be allocated on the basis of research performance, rather than distributed as before, may increase research output. It would also open the door to those provider units that do good research but that are not receiving SIFTR. Thirdly, further consideration needs to be given to moderating the effects of the internal market on the conduct of research and development. There are several ways in which this could be done. In some regions the health authority will continue to purchase regional specialty services and therefore a component for R & D can be explicitly incorporated into the price paid. In addition, guidance on R & D could be given to purchasers-it should include advice on when they should pay for the cost of the clinical care of patients enrolled in research studies and how R & D should be written into contracts for clinical services. A more far-reaching proposal would be for regions to encourage R & D by operating a "development bank", whereby providers could borrow funds to develop new services and subsequently repay the loan out of the income received from the additional contracts won as a result of the new developments. The region could also go into partnership with particular provider units if R & D is likely to have a broad relevance; this could involve a regional subsidy for the development concerned, on condition that the findings would be widely disseminated throughout the
region. Finally, more attention needs to be given to training and staff development for research. This could include the provision of appropriate courses and the granting of research fellowships to particularly promising researchers. Much clinical research is currently undertaken by junior doctors as part of their career development and it is possible that some of the funds used for this work would be better used for organised research programmes based in health
regions. In conclusion, it can be seen that, in view of the changes in the funding of the NHS, several actions are required at local level to ensure that the new national strategy for R & D succeeds. In particular, it will be important to ensure that competition for contracts does not squeeze out research, that there is no unnecessary short-termism in research, that standards are maintined or improved, and that research is closely targeted towards maximising health gain. REFERENCES 1. Peckham M. Research and development for the National Health Service. Lancet 1991; 338: 367-71. 2. Department of Health. Research for health: a research, and development strategy for the NHS. London: HM Stationery Office, 1991. 3. Anonymous. NHS reforms will sap money from medical research. New Scientist 1989; June 3: 25. 4. Kingman S. NHS reforms ’could divert money money from research’. New Scientist 1990; Jan 27: 25. 5. Coghlan A. Government under fire over NHS research. New Scientist 1990; May 5: 21. 6. Selby P. Regional research in the National Health Service. Yorkshire Med 1991; Autumn: 18-19. 7. Sheldon TA. The NHS review and the funding of teaching hospitals. J Management Med 1991; 5: 6-17.
and return 335-42.
to
ovulation in
Bangkok. Int J Gynecol Obstet 1989;
30:
15. Shaaban MM, Kennedy KI, Sayed GH, Ghaneimah SA, Abdel-aleem AM. The recovery of fertility during breast-feeding in Assiut, Egypt. J Biosoc Sci 1990; 22: 19-32. 16. Khan T, Kennedy KI, Kazi A, Steiner M. A study of breastfeeding and the return of menses and pregnancy in Karachi, Pakistan. Contraception 1989; 40: 365-76. 17. Savina G, Kennedy K. The effect of a breastfeeding education program on lactational amenorrhoea in the Philippines. Stud Fam Plann 1989;
20: 203-14. 18. Benitez I, De la Cruz J,
Suplido A, Oblepias V, Kennedy K, Visness C. Extending lactational amenorrhoea in Manila: a successful breastfeeding education program. J Biosoc Sci (in press). 19. Goldzieher JW, Nakamura Y. A clinical method for the determination of urinary pregnanediol and pregnanetriol. Acta Endocrinol 1962; 41: 371.
LF, Cos RI, Holmes J, Smith MA. Chemical and homogeneous enzyme immunoassay methods for the measurement of oestrogens and pregnanediol and their glucuronides in urine. Prog Biol
20. Brown JB, Blackwell
Chem Res 1988; 285: 119-38. 21. Howie PW, McNeilly AS, Houston MJ, Cook A, Boyle H. Fertility after childbirth: adequacy of postpartum luteal phases. Clin Endocrinol 1982; 17: 609-15. 22. SAS Institute, Inc. SAS user’s guide: statistics, version 5 edition. Cary, NC: SAS Institute, Inc: 1985. 23. Family Health International: LIFETAB: A program for lifetable analysis of clinical trials. Durham, NC: Family Health International, 1989. 24. Wood JW. Fecundity and natural fertility in humans. Rev Reprod Biol 1989; 11: 61-109. 25. Trussell J, Hatcher RA, Cates W, Stewart FH, Kost K. Contraceptive failure in the United States: an update. Stud Fam Plann 1990; 21: 51-54.
VIEWPOINT Funding research and development in the NHS
Introduction In the new strategy for National Health Service (NHS) research’2 the emphasis will be on research relating to the effectiveness of clinical practice, the dispersal and use of existing knowledge, and the contribution of medical interventions to the health status of individuals and the population. NHS regions will play an important part in implementing the plan and will be held accountable for it. Regional health authorities will be required to prepare, publish, finance, and implement their own research and development plans.2 To permit the development of the NHS research and development (R & D) programme, a national expenditure target has been set. This target, of 1-5% of the NHS budget, will be achieved over 5 years by harnessing R & D resources now in use throughout the service and by seeking new funds through the public
expenditure process. The new R & D plan is to be welcomed, but it also has to be recognised that the NHS is in the midst of the most wide-ranging reform since its inception. In particular, the separation of the roles of purchaser and provider and the establishment of contracts for services in an "internal market" are likely to have a profound effect on all NHS activities, including R & D. Concerns have already been raised, by those charities sponsoring clinical research, that the reforms may make NHS authorities wary about covering the costs of care for patients enrolled in research studies.3-5 This has the implication that funds originally allocated for research could be diverted to providing treatment. Furthermore, regions faced with an expenditure target for research could redefine activities so as to ensure that the target is met--eg, activities such as medical audit and quality assurance that should be part of routine NHS practice might be redefined as an R & D activity.
Defining
R &
acquisition of new knowledge of broad relevance beyond the setting in which the research took place. Development activities, on the other hand, are usually to do with the application of existing knowledge and sometimes have specific relevance to the setting in which they are
with the
D
In the context of the changes in NHS funding, it is important to make a distinction between "research" and "development". Research activities are usually associated
undertaken.
The
distinction
between
research and
development is important since, under the new contracting arrangements, one can see a stronger case for a purchaser to pay for development than for research.
Impact of NHS reforms on
R &
D
The
major impact of the reforms will arise from the specification of contracts. Purchasers will question whether the higher costs of some providers implicitly include an R & D component. In turn, providers will take a harder look at all their staff contracts, including joint appointments, since manpower represents the largest component of NHS expenditure. Also, the closer examination ofNHS treatment technologies, by both purchasers and providers, is likely to identify practices that contribute to research knowledge rather than patient outcome. All these changes will be assisted by improvements in NHS financial information systems, which are necessary for operating the internal market. One of the most difficult issues will be that of selecting the criteria that determine whether or not the purchaser pays for the clinical care of patients enrolled in research protocols. Peckham1 pointed to the anomaly whereby a health authority refused to pay for care when a clinician wanted to allocate patients to either normal-dose or low-dose regimens of a given drug in a randomised clinical trial. Paradoxically, ADDRESSES Centre for Health Economics, University of York, Heslington, York YO1 5DD, UK (Prof M. F. Drummond, DPhil);Department of Public Health, South Birmingham Health Authority, Birmingham (B. J. Crump, MFPHM); and Health Services Management Centre, University of Birmingham, Birmingham, UK (V A Little, MSocSc) Correspondence to Prof M F Drummond
231
the authority was quite happy to pay for the normal-dose regimen for all patients prescribed as part of the clinician’s regular practice. On the other hand, should a purchaser pay for an extra-contractual referral to a specialist clinical centre when the general practitioner believes that a patient should be enrolled in a clinical trial? Resolution of this issue will not be easy. However, from the purchaser’s viewpoint the argument for payment for the clinical care of patients enrolled in a trial would be strengthened if the treatment concerned was one that the purchaser would normally place contracts for, if the research was being conducted according to a well-designed protocol, if the other costs of the research were properly identified, and if the aims of the study (in terms of improved patient care or more cost-effective use of resources in the future) were
justified.
With longer-term research there is the risk of the "free-rider" problem, whereby people wait for someone else to bear the costs of an investment that will benefit all. This "public good" characteristic of research means that a sizeable part of the funds should come from central and regional authorities. In addition, the size of the resources required for some types of research, or the economies of scale in its execution, suggest that a measure of central or regional direction is required. It is therefore particularly important that these responsibilities be clearly specified and protected in the context of the NHS reforms. Another potentially undesirable consequence of the reforms may be the commercialisation of NHS R & D. Providers who undertake R & D may then be reluctant to share the results with others since a market advantage can be obtained by developing a novel treatment. Of course, researchers themselves may resist this trend, because publication of results is considered important in career development. Nevertheless, they may be reluctant to explain in detail to colleagues in competing centres how the development took place. Over a longer timescale a "market" in research itself may develop within the NHS. A provider wishing to develop a new service may be willing to pay for help and advice from elsewhere.
Policies for funding NHS R &
D
First, consideration needs to be given to how health regions can strengthen their locally organised research schemes.6 These will probably be greatly expanded in scope since the recent initiatives from the Department of Health require that regions take note of national priorities for research when making their own funding allocations. However, health authorities should also seize the opportunity that local schemes provide for the pursuit of regional priorities, by commissioning research that is likely to maximise the potential for local health gain. This move implies the selection of areas where diseases impose the greatest burden and where the development of effective and cost-effective treatments has the greatest potential. Thus membership of local research committees should be broadened to include specialists in public health, health services research, and NHS purchasing, because research proposals will need to be assessed for their relevance as well their scientific merit. Secondly, further consideration should be given to the methods of allocating the research component of the special increment for teaching and research (SIFTR), which has been variously estimated to be between 25 and 40% of the totalIn the NHS internal market, SIFTR will be used to
as
subsidise the prices charged by the major teaching and research centres, and help them to maintain a research infrastructure. There is scope for applying a procedure similar to that now operated by the University Funding Council for university academic departments. Essentially, this system rewards those institutions with the largest research output. Although there are difficulties in making assessments of the quality and relevance of research, the mere fact that SIFTR is to be allocated on the basis of research performance, rather than distributed as before, may increase research output. It would also open the door to those provider units that do good research but that are not receiving SIFTR. Thirdly, further consideration needs to be given to moderating the effects of the internal market on the conduct of research and development. There are several ways in which this could be done. In some regions the health authority will continue to purchase regional specialty services and therefore a component for R & D can be explicitly incorporated into the price paid. In addition, guidance on R & D could be given to purchasers-it should include advice on when they should pay for the cost of the clinical care of patients enrolled in research studies and how R & D should be written into contracts for clinical services. A more far-reaching proposal would be for regions to encourage R & D by operating a "development bank", whereby providers could borrow funds to develop new services and subsequently repay the loan out of the income received from the additional contracts won as a result of the new developments. The region could also go into partnership with particular provider units if R & D is likely to have a broad relevance; this could involve a regional subsidy for the development concerned, on condition that the findings would be widely disseminated throughout the
region. Finally, more attention needs to be given to training and staff development for research. This could include the provision of appropriate courses and the granting of research fellowships to particularly promising researchers. Much clinical research is currently undertaken by junior doctors as part of their career development and it is possible that some of the funds used for this work would be better used for organised research programmes based in health
regions. In conclusion, it can be seen that, in view of the changes in the funding of the NHS, several actions are required at local level to ensure that the new national strategy for R & D succeeds. In particular, it will be important to ensure that competition for contracts does not squeeze out research, that there is no unnecessary short-termism in research, that standards are maintined or improved, and that research is closely targeted towards maximising health gain. REFERENCES 1. Peckham M. Research and development for the National Health Service. Lancet 1991; 338: 367-71. 2. Department of Health. Research for health: a research, and development strategy for the NHS. London: HM Stationery Office, 1991. 3. Anonymous. NHS reforms will sap money from medical research. New Scientist 1989; June 3: 25. 4. Kingman S. NHS reforms ’could divert money money from research’. New Scientist 1990; Jan 27: 25. 5. Coghlan A. Government under fire over NHS research. New Scientist 1990; May 5: 21. 6. Selby P. Regional research in the National Health Service. Yorkshire Med 1991; Autumn: 18-19. 7. Sheldon TA. The NHS review and the funding of teaching hospitals. J Management Med 1991; 5: 6-17.
