J C&IE@daniol Vol. 44, No. 6, pp. 579-589, 1991

08954356/91 $3.00 + 0.00 Copyright 0 1991 Perpmon Press plc

Printed in Great Britain. All rights reserved

THE INTERNATIONAL CLINICAL EPIDEMIOLOGY NETWORK (INCLEN): A PROGRESS REPORT SCOTT B. HALSTEAD,*+~ PETER TUGWELL

and KATHRYNBENNETT

Rockefeller Foundation, New York, NY 10036, U.S.A. and McMaster University, Hamilton, Ontario, Canada L8N 325 (Received in revised form 10 July 1990; received for publication 12 December

1990)

Abstract-The International Clinical Epidemiology Network (INCLEN) was established in 1982 to strengthen the research capacity of medical schools in the developing world through the development of Clinical Epidemiology Units (CEUs). The role of these units is to promote a rational approach to clinical and health care decision making, drawing on the methods of clinical epidemiology, biostatistics, health economics and health social science. This paper summarizes the evolution of the INCLEN model and the experience to date. Progress with Phase 1, the designation of sites for CEU development and the provision of advanced research training by developed country training centres has been substantial. The network now consists of 27 units: 26 in developing country medical schools in Asia, Latin America, India and Africa and 1 in France. More than 60% of the target of 270 fellows have completed training and returned to take up faculty positions in their unit. The‘remainder will be trained and on site by 1995. The non-return rate of fellows (2%) is very low. Research productivity is significant given only 60 fellows have been working in their CEUs for more than 3 years following the completion of training. An appropriate balance between hospital and community-based research is evident and changes in clinical and health care policy have been made based on the research conducted. The educational responsibilities of all units include courses and workshops in critical appraisal and clinical .epidemiology for medical trainees and colleagues. Graduate training programs have emerged in 3 units so far. Major challenges lie ahead as we move into Phase 2 of the project-self sustainability and the transfer of training responsibility to the CEUs. The problems encountered during Phase 1 will need to be addressed. These include time protection for research, the limited availability of research funds, the low priority given to research careers and the poor linkage between health researchers and government policy makers. Our experience ethos the recommendations of the recent report of the Commission on Health Research for Development, namely that donors and national governments should give increased priority to the role of health research in less developed countries. We conclude that with continuing support and special attention to the problems encountered, the INCLEN approach can contribute to ensuring that the medical establishment is part of the solution rather than the problem faced by health systems in less developed countries. Clinical epidemiology International health capacity building

Health social science Biostatistics Health economics Health research INCLEN Less developed countries

*Reprint requests should be addressed to: S.B. Halstead, Acting Director, Health Sciences Division, Rockefeller Foundation, 1133 Avenue of the Americas, New York, NY 10036, U.S.A. tOn behalf of the INCLEN Advisory Committee: the authors and C. Bombardier, M. Fanning, R. Fletcher, S. Fletcher, R. Heller, M. Hensley, P. Stolley and B. Strom. 519

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INTRODUCTION

The challenge of establishing effective, efficient and equitable health care systems is enormous. Nowhere is this more greatly felt than among the less developed countries (LDCs) of the world. The slow progress towards “health for all by the year 2000” as proposed in the 1978 Alma Alta Declaration [l] and the increasing recognition of the political, social and economic determinants of health have brought this challenge into focus. The new strategies being suggested to alleviate ill-health require fundamental changes in the allocation of resources for health. Implicit in this redirection is profound behavioral change on the part of the consumers and providers of health care, the planners and implementors of public health policies, and national leaders and legislative bodies. Physicians play a major role in the provision of health care and decisions about the allocation of health care resources. As a result, their activities contribute substantially to the delivery of effective, efficient and equitable health care. One entry point for influencing physician behaviour is through medical education. Another is through creating a demand within the medical and health care community for the disciplined application of research across the spectrum of health care decisions, from the prevention of high risk behaviors to clinical care to health policy decisions. The International Clinical Epidemiology Network (INCLEN) is exploring both of these approaches in collaboration with LDC medical schools. INCLEN was established in 1982 [2] to develop Clinical Epidemiology Units (CEUs) in designated LDC medical schools. The role of the CEU is to promote rational decision-making and the application of quantitative measurement principles (drawn from clinical epidemiology, biostatistics, health economics and health social science) in the development of clinical and health care policy. The approach to CEU development includes two components: (i) the provision of advanced research training by developed country training centres to junior faculty from developing country medical schools committed to establishing a CEU; and (ii) the establishment of a network to support continuing partnership and collaboration between CEUs, training centres and the international health scientific community. This paper is a progress report. As will be evident, the success of a project such as

INCLEN cannot be evaluated in the short-term. At least 10 years following completion of training of all CEU members is needed to determine CEU impact on health research, education and policy. However, we believe that it is useful to share the experience to date. It is our view that the short-term achievement and “lessons learned” will be of interest to colleagues in developed and developing countries interested in health research capacity building and promoting linkages between health researchers and policy-makers. This paper describes the origins of INCLEN and summarizes progress and constraints. The focus is on Phase 1 or CEU establishment and short-term indicators of long-term success. Planning for Phase 2, the transfer of training responsibility to the CEUs has just begun and is not addressed in detail here. In what follows, we inform readers of the evolution of the INCLEN concept and the way that it is now implemented, describe its structure and progress to-date, present the major constraints encountered and outline the major challenges that lie ahead.

THE INCLEN CONCEPT

Origins and goals

The origins of INCLEN lie in a review commissioned by the Rockefeller Foundation in 1978. The objective was to clarify the roles of health science schools in addressing the need for new and more effective means to cope with the broad health issues of the 1980’s. Two major conclusions were drawn [3]: “First, the most pressing problem in the broader field of health in both industrialized and developing countries is more effective management of health services at all levels. Management in this context involves the evaluation of health needs, rational allocation of resources, and successful implementation of programs that depend on a human-services organization. Second, capable as they are in the narrower, technical fields of medicine and public health, those who might provide leadership and management lack the inclination, breadth of perspective, and analytic skills to respond to the challenge.” This report and a subsequent series of conferences [2,4, 12,131 led to the INCLEN concept. Guiding principles

INCLEN was founded on two key principles. First, accurate information about the health

INCLEN: A hogress

needs and priorities of underserved populations and the relative effectiveness and efficiency of health care interventions is needed to guide clinician behaviour as well as health care policy decisions regarding resource allocation. Thus, quantitative measurement skills are needed by physicians and other professionals responsible for the planning, provision and evaluation of health care. Second, an improvement in the quality of evidence upon which health care decisions are made is not sufficient in itself to bring about the needed changes. A broadening of the medical school perspective to include a population based approach to the evaluation of health needs and the provision of care is also required. Such an orientation aims to put a “window in the wall of the medical school” and to open that window. The goal is to encourage a proactive attitude to the improvement of health that is visualized in the context of the population in need rather than only the patients who seek care. The development of INCLEN has also been guided by several principals related to international collaboration and partnership. First and foremost, the relationships established have emphasized long-term partnership and the importance of continuity. The development of the INCLEN model is the result of collaboration with our developing country partners and has capitalized on the expertise already existing in the INCLEN sites; the process has aimed to engender a sense of ownership by all involved and to ensure an understanding of local needs, priorities and perceptions. Second, INCLEN works with institutions and not just individuals to maximize the likelihood of CEU sustainability. As a result, INCLEN trainees return to environments that provide the leadership and resources necessary for the effective application of the new skills learned and the implementation of change. Finally, to ensure appropriate technology transfer, INCLEN aims to transfer skills applicable to the health problems of our partners, not to prescribe solutions. Evaluation and management

Criteria for the success of an INCLEN CEU have been established to guide the development of INCLEN and monitor CEU progress. These criteria (Table 1) consist of behaviourally defined objectives in four areas of CEU responsibility: CEU infrastructure, research, education and clinical and health care policy. They form

Report

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the basis for annual CEU progress reports and site-visits. Policy review and management decisions are made in two ways. An Advisory Committee composed of training centre directors and an officer of the Rockefeller Foundation meets twice yearly; the INCLEN Council, composed of the medical school deans and department heads who act as sponsors for each of the CEUs meets annually to make recommendations to the Advisory Committee. Plans to establish INCLEN as a free standing body are currently underway. INCLEN was incorporated in late 1988 and the resulting “INCLEN Inc.” will take responsibility for leadership and the continuing growth of INCLEN. Finally, the design of a formal evaluation of CEU impact has been completed [5]. This evaluation uses a time-series approach to track impact in each of the four areas of the criteria for CEU success. INCLEN STRUCTURE

AND STRATEGY

The following sections describe the selection of CEU sites, the training programmes offered and the continuing support activities of the network. Clinical Epidemiology Units (CEUs)

INCLEN CEUs are located in 7 medical schools in Asia, 7 in Latin America, 6 in India, 6 in Africa and 1 in France (Fig. 1). These institutions include many of the finest medical training and research institutions in the developing world. One of the objectives of establishing INCLEN Inc. is to provide a mechanism for expanding the number of participating schools. Sites for CEUs were selected by a commission composed of training centre faculty and an officer of the Rockefeller Foundation. The commission visited medical schools expressing a commitment to the INCLEN objectives and held discusions with the dean and clinical department chairpersons to explain the INCLEN concept and the role of the CEU. Each institution designates a senior faculty leader who is the CEU sponsor. The sponsor is expected to nurture the establishment of the CEU by nominating junior faculty with leadership potential for training, establishing an administrative structure and space for the CEU and ensuring the necessary time protection for returned fellows to carry out research and other CEU activities. At present 16 deans, 3 associate

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Table 1. Criteria for the success of an INCLEN CEU Infrastructure

Does the CEU have access to: ??an appropriate mix of trainees (clinical epidemiologists, biostatisticians, health economists and social scientists)? ??adequate space? 0 appropriate management structure? ??institutional support for activities (time protection; facilitation of research and education)? ??computer and data analysis facility? ??adequate library facilities? ??involvement in community and hospital health services? Research

Is the CEU undertaking research into: ??high resource using clinical activities? ??health programs of national or regional priority? ??is there an appropriate balance between: -hospital and community based research, -communicable and non-communicable disease, +stiology, effectiveness, efficiency, and education research, -P.I. research and collaborative research? ??is this research funded adequately? ??is this research being published in both international and local journals? Education Is there evidence that the CEU:

is providing on ongoing analysis of the burden of illness (trends in health status) in the region served by the medical school so that the medical curriculum focusses on the priority problems? ??is helping curriculum planners: -write specific objectives for under- and postgraduate learners regarding critical appraisal of the effectiveness and efficacy of health care for priority problems, -develop eductional modules to teach the relevant knowledge and applications, -develop evaluations of the modules, -CEU members function as role models in provision of effective and efficient clinical/health care, -conduct research and write scientific articles about education and teaching, -teach colleagues (and students where appropriate) health services research methods? ??

Impact on practice and policy

Is there evidence for the following linkages: ??majority of clinical departments, ??community medicine department/school of public health ??local health services, 0 government? Is there dialogue on patterns of health care and health priorities with policy makers in community health services, institutions and government? Is there evidence that the CEU educational activities and research have changed clinical practice and health policy? A final criteria

Members of the CEU should be enjoying the challenges of the CEU objectives, i.e. they should be having fun!

deans, 5 department chairpersons, 2 hospital directors and 1 research director serve in this role. The target faculty complement for each CEU is 6 clinical epidemiologists, 1 biostatistician, 1 physican trained in health economics, 1 health social scientist and 1 senior facilitator. This has evolved since INCLEN was first conceived. Initially, training was offered in clinical epidemiology and biostatistics. This was expanded in 1985 to include health economics and in 1987 to include health social science. Each nominee for training must have a secure faculty position on return and all fellows will have completed specialty or graduate training prior to embarking on INCLEN training (Table 2). The CEU is usually linked to the dean’s office. Sponsors are encouraged to nominate fellows from a range of clinical specialities to facilitate

links between the CEU and the major clinical departments. Training programs

Training is characterized by a problem based approach. The focus is on the application of the methods of clinical epidemiology, biostatistics, health economics and health social science to “real life” problems drawn from the research and education responsibilities trainees will resume when they return home. This training is provided by five developed country clinical epidemiology resource and training centres (CERTCs-see Fig. I). McMaster University, Canada, the Universities of Pennsylvania and North Carolina in the U.S., and the University of Newcastle in Australia provide “longcourse” training leading to a Master of Science degree. The University of Toronto in Canada

INCLEN: A Progress Report

ASIA PACIFIC 1. West China University of Medical Sciences, Chengdu, China 2. Shanghai Medical University (Hua Shan Hospital), China 3. Phillippine General Hospital, University of The Phillippines System, Manila, The Phillippines 4. Chulalongkorn Universir/, Bangkok, Thailand 5. Siriraj Hospital, Mahidol University, Bangkok, Thailand 6. Khon Keen University, Khon Kaen, Thailand 7. Gadjah Mada University, Yogyakarta, Indonesia LATIN AMERICA 8. Escola Paulista de Medicina, Slo Paulo, Brazil 9. Universidad Federal do Rio de Janeiro, Rio de Janeiro, Brazil 10. Universidad de la Frontera, Temuco, Chile 11. University of Chile, Santiago, Chile 12. Pontificia Universidad Javeriana, Bogota, Columbia 13. lnstituto National de la Nutrition, Mexico City, Mexico

A. B. C. D. E.

McMaster University University University University

14.

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Hospital General de Mexico, Universidad National Autonomede Mexico, Mexico City, Mexico

INDIA 15. All India Institute of Medical Sciences, 16. King George Medical College, Lucknow 17. Government Medical College, Nagpur 18. Christian Medical College, Vellore 19. Madras Medical College, Madras 20. College of Medicine, Trivandrum

New Delhi

AFRICA 21. University of Yaounde, Yaounde, Cameroon 22. Addis Ababa University, Addis Ababa, Ethiopia 23. Suez Canal University, Ismailia, Egypt 24. University of Nairobi, Nairobi, Kenya 25. Makerere University, Kampala, Uganda 26. University of Zimbabwe, Harare, Zimbabwe FRANCE 27. Claude Bernard University,

Lyon

TRAINING CENTRES University, Hamilton, Ontario, Canada of Newcastle, Newcastle, Australia of North Carolina at Chapel Hill, USA of Pennsylvania, Philadelphia, USA of Toronto, Toronto, Ontario, Canada

Figure 1. INCLEN CEUs and CERTCs.

provides 3 month fellowships in health care evaluation and management skills to senior CEU medical school personnel. Clinical epidemiology and biostatistics form the core of each fellow’s training. Specially tailored training in biostatistics, health economics and health social science is provided to fellows designated to take a leadership role in the CEU in these areas. This tailoring (as described below) takes into account both the specialized role of the fellow in the CEU and their research area of interest.

Clinical epidemiology. The core clinical epidemiology training includes: (1) advanced courses in epidemiology and research design, as well as an introduction to biostatistics, health economics and health social science; (2) a research prioritization exercise to identify the priority health problems of the trainee’s country and area of specialization; and (3) a research protocol (in a form suitable for submitting to a funding agency) for at least one research project feasible for implementation upon return home. A great deal of care and time is devoted to the

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Table 2. Specialties of INCLEN fellows trained as of December 1989 Internal medicine General Internist Infectious Disease Cardiology Neurology Hematology Rheumatology Gastroenterology Endocrinology Nephrology Respirology Immunology Dermatology Oncology Radiology Opthalmology Pediatrics Obstetrics/gynecology Surgery (including orthopedics) Family medicine/community medicine Psychiatry Anesthesiology Biostatistics Health social science Total

25 17 8 7 4 5 4 3 4 3 1 1 1 2

1 24 15 9 7 2

1 16 4 164

development of the fellow’s research to ensure relevance and feasibility. In addition to the preceptorship provided by CERTC faculty, research projects are formulated in collaboration with the fellow’s CEU sponsor and internationally recognized experts. Core training also assists fellows in the development of skills in teaching, learning and educational evaluation and addresses the role of the CEU in curriculum planning and evaluation. Biostatistics. INCLEN recognizes biostatisticians as key members of the CEU research team who are involved at all stages of a project from design and protocol development, through measurement and data analysis to final report writing. It is expected that biostatistical trainees already possess a masters degree in statistics (or the equivalent). The general objective is to broaden the statisticians’ base of research methods skills and knowledge through a selected program including basic principles of epidemiology and research methods. Trainees may also broaden their statistics knowledge base by taking one or two selected courses with a major emphasis on statistical methods. Following training, biostatistical fellows are expected to function as collaborators in the projects of other CEU members and as independent investigators in their own area of research interest. Health economics. Training in health economics was introduced in 1985 and is defined as the incorporation of the techniques of economic

analysis into research related to diagnosis, treatment and prevention. All INCLEN fellows acquire skills enabling them to collaborate effectively with health economists, to appreciate the economic implications of clinical and health care decisions and to be informed users of the results of economic evaluations. In addition, one fellow (a physican) in each CEU receives intensive training in the techniques of cost-effectiveness, cost-benefit and cost-utility analyses, micro-economics as it relates to clinical medicine, methods of combining epidemiologic and economic research (such as clinical decisionmaking), methods of determining the cost of illness and health care, approaches to investigating the relationship between the economic well-being and the physical or mental health of a population and approaches to teaching this material to other clinicians and clinicians-intraining. Health social science. A health social science training component was implemented in 1988 in recognition of the social, political, cultural and behavioural determinants of health. All fellows are provided with basic health social science training in order to broaden their understanding of: (i) the determinants of health and patient behaviour and strategies to change it; and (ii) to bring social science methods to bear on the development of solutions to the management of disease and disease prevention. In addition, a social scientist who will work collaboratively with the CEU, receives intensive training in clinical epidemiology, biostatistics and health economics as described above. The objective of this training is to foster strong research collaboration across clinical and social science disciplines and to ensure the appropriate integration of health social science concepts into the research being performed within the CEU. Senior faculty training. An intensive 3-month course in health care evaluation and management skills is provided to senior faculty and health policy advisors associated with each CEU medical school. The course is designed to increase the skills of physician administrators in clinical epidemiology, computing and management. Development of these skills is expected to enhance health care decision making and help senior faculty direct and facilitate the growth of a clinical epidemiology unit. Continuing partnership and support An important component of INCLEN is continuing partnership and support through the

INCLEN: A Progress Report

establishment of a network of CEUs, CERTCs and the international scientific community. Ongoing partnership takes the form of annual scientific meetings, continuing collaboration between CEUs and CERTCs, the INCLEN telecommunications and informatics network and financial support. Annual scient@ meetings. Each year all fellows who have completed training are invited to submit abstracts for the INCLEN annual meeting [6]. The main objective of the meeting is to facilitate the career development of individual fellows, particularly during the initial research start-up period following their return from training. In addition to the scientific sessions, the meeting emphasizes one-on-one research consultations between fellows and international experts, continuing education sessions and strategies for CEU development and support. All sponsors are invited to attend as are CERTC faculty representatives, international health research experts and representatives of major research funding agencies. Ongoing collaboration between CElJs and CERTCs. Each fellow is visited by their CERTC faculty preceptor within 6 months of their return. In addition, CEUs are visited each year by faculty from the two CERTCs with designated responsibility for onging support of the CEU. A growing number of international health research experts consult with fellows during training, at annual scientific meetings and onsite, at their home institutions. For example, the Department of International Health of the Johns Hopkins School of Hygiene and Public Health acts in an advisory role in this regard. Collaborative research networks. One of the objectives of INCLEN is to support the development of collaborative research networks at both the local and international level. Seed funds are provided to support multi-centre collaborative research both within and between CEUs. Projects focusing on cardiovascular risk factors, the misuse of antibiotics and acute respiratory infections in children are already underway [7,8]. Telecommunications and informatics. Rapid communication and access to up-to-date scientific literature is an essential component of a global network such as INCLEN. A subcommittee acts as a resource for the establishment of the INCLEN Telecommunications and Informatics Network. This network will link all CERTCs, CEUs and the Rockefeller Foundation using computer-based electronic mail and telefax technologies. CEU access to the

585

medical literature is being enhanced through onsite CD-ROM medline searching and the provision (by telefax) of scientific literature that is unavailable locally. Establishment of INCLEN Inc. INCLEN has now been incorporated to enable its transition from sponsorship by the Rockefeller Foundation to an independent, self-supporting body. A Board of Directors, composed of developed and developing country partners is being appointed; a President will be named to take responsibility for leadership, recruitment of funds and management issues related to the development of INCLEN Inc. as a free-standing initiative. INCLEN PROGRESS

REPORT

This section summarizes the current status of the CEUs and their progress in relation to the criteria for CEU success. CEU establishment and infrastructure INCLEN has been developed in stages by region of the world. CEUs were initiated in Asian medical schools in 1981, in Latin America in 1984, in India in 1985 and in Africa and France in 1987. As of December 1989, 61% (164) of the target of 270 fellows have completed training and returned to work in their CEU (Fig. 2 provides a breakdown of training targets by region of the world). “Time 0” (two fellows trained and on-site in the CEU) has now been achieved by 22 of the 27 designated units. Six of seven Asian CEUs have reached a faculty complement of 8; two of the seven Latin American units achieved this level in 1989. Although this reflects considerable progress in the INCLEN training component, only 8 CEUs have had the opportunity to function for more than 1 year with the minimum faculty complement (3 clinical epidemiologists and 1 biostatistician) necessary to support the CEU objectives. In this short time frame, the primary activity of returned fellows has been the establishment of their personal research programs. This is described in the following section. Research A major indicator of CEU success at this time is the research being carried out, particularly the completed research presented at the annual scientific meetings. Indicators of quality and relevance include the success of fellows in publishing their work both locally and intemationally and in their ability to attract funding from

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ASIA PICIPIC

LATIN AUERICA

% of

INMA

Fellows

AFRICA

FRANCE

TCTAL

Tmlned

NOTE: 1. Non mtum mta la 2% o~nll. 2. The vaflatlon In nto of return rofloctr the vrrldon In 8tW data of INCLEN tralnlng In oath of the feglonr. Slnoa the project began In the AM-P~lflc mglon In 1901, the fate of roturn la greatest them ” of thk writing. gy 1995. tnlnlng will be complete In all lrglona (lo., O(IH g&n the curnnt r&e ot non-return Is m8lntrlned).

Fig. 2. Progress to date in training fellows as a proportion of the 1995 target of 270 fellows.

international peer reviewed agencies such as IDRC, Pricer, BOSTID and WHO. The fact that 72% of eligible fellows submitted acceptable abstracts to the 1989 annual meeting shows their success in carrying out research after training. The scope and relevance to priority health problems of the findings presented also suggests that CEU members are working toward the goals expressed by the “Criteria for CEU Success”. Sixty percent of the research was hospital based (e.g. risk factors for severe life threatening diarrhea in children) and 40% community based (e.g. a randomized trial and economic evaluation of two alternative measles immunization strategies); 47% addressed communicable diseases (e.g. risk factors for severe disease among children with acute respiratory illness) and 53% non-communicable diseases (e.g. the evaluation of invasive diagnostic tests in detecting cancer of the pancreas). Twenty percent of the 1989 research results included an economic component (e.g. costeffectiveness of routine antimicrobial prophylaxis among meconium stained Filipino neonates). The importance of such studies, which provide information on the balance between the benefits of new interventions and their cost is evident given that only 3 CEUs had

fellows returned from intensive training in health economics in 1989. The four abstracts receiving the highest rating for scientific merit and relevance to changes in clinical and health care policy were: (i) The Effect of a Maternal and Child Health Village Health Workers Program on Infant Mortality; (ii) Why are Thai Official Perinatal and Infant Mortality Rates so Low?; (iii) Frequency of Identification of Colonization Factor Antigens of Enterotoxigenic Esherichiu coli and their Role in Acute Diarrhea in a Mexican Urban Community; and (iv) Risk Factors for Ischemic Heart Disease in Shanghai. Collaborative projects with researchers outside the CEUs were also among the research presented, another indicator that CEUs are beginning to move toward the broader CEU goals. A database of CEU publications is being established. Three hundred and twenty-five papers are now logged, with the majority in local and national journals. Visibility locally and nationally is an important indicator of the potential of the CEU to provide leadership in clinical and health care research. It is worth noting that a number of papers have now appeared in international, peer-reviewed, English-language journals such as the New England Journal of Medicine and the Lancet.

INCLEN: A Progress Report

Education The long-term

success of the CEUs will be reflected in their ability to act as independent training centres. Indicators of potential in this regard include: (i) the translation of leading clinical epidemiology texts into Chinese, Thai, Indonesian, Portuguese and Spanish by CEU members; (ii) the organization of more than 12 national workshops on clinical epidemiology in China, the Philippines, Thailand, Indonesia, India, Brazil and Colombia; and (iii) the designation of West China University of Medical Sciences and Shanghai Medical University as National Training Centres in Clinical Epidemiology by the government of China. Three of the first CEUs established have begun to provide graduate training. Chulalongkorn University in Thailand now offers a Master of Science degree, which includes training in clinical epidemiology; Mahidol University in Thailand and Escola Paulista de Medicina in Brazil are planning similar training programs. National clinical epidemiology associations have been formed in Thailand (THAICLEN), China (CHINACLEN) and Indonesia (INDOCLEN). INCLEN fellows are on the editorial boards of 18 national medical journals; at least two new journals focusing on clinical epidemiology and research design are being planned. Influence at the local level is fundamental to the CEU achieving its goals. Clinical epidemiology is being taught by CEU members to medical and post-graduate students during their clinical rotations and journal clubs have been organized for faculty and residents; seven CEUs have input into teaching epidemiology during the basic science years. Three CEUs are contributing to curriculum evaluation and design in their medical school. Clinical and health care policy

The overall effects of CEUs in the long-term will be determined by the extent to which they are able to influence the education of health professionals and clinical and health care policies. Although it is too early to assess success in these areas, some indicators that the behaviour of CEUs is consistent with this longterm goal are available. The development of new education programmes has already been described. Examples of changes in clinical and health care policy that have resulted from the research completed so far include the following. Research studies on the seroepidemiology of

587

hepatitis B and the effectiveness and efficiency of hepatitis B immunization carried out by the INCLEN CEU in Manila in collaboration with the Liver Study Group of the University of the Philippines, resulted in recommendations that were adopted by the Department of Health hepatitis B control program (i.e. mass immunization should focus on newborns; blood and blood products for transfusion should be screened; health education and public information on disease prevention was needed). Research conducted by the Chulalongkorn CEU into the effectiveness of mosquito nets has been adopted in a number of provinces in Thailand. Research by the same group in the Klong Tuey slum area of Bangkok has lead the Bangkok Metropolitan Administration to seek increased health research training for their personnel. A health information system has been developed by members of the Khon Kaen Clinical Epidemiology Unit in north-east Thailand and adopted by the Ministry of Public Health. CEUs are playing a role in policy setting in the areas of research priorities and health planning. In Thailand, leaders of CEUs are members of an advisory board to the Ministry of Public Health (MOPH), viz. the National Epidemiology Board of Thailand. This board was established to review diseases and prioritize them in terms of impact and the feasibility of intervention. Research funds are available through the Rockefeller Foundation to commission the data needed by Board members to frame policy recommendations to the MOPH. CEUs contributed to the deliberations of the Commission on Health Research for Development [9, lo] which was established to assemble views on the strengths and weaknesses of LDC health research capacity. A major goal of the Commission is to act in an advocacy role to increase the interest of governments and the international donor community in epidemiologic research. The “essential national health research” being called for by the Commission requires a national capacity in clinical epidemiology, biostatistics, health economics and health social science. CEUs clearly have a role to play in implementing the recommendations of the Commission and the essential national health research it proposes. CONCLUSION

A number of conclusions can be drawn from the experience to-date. Three are indicators of

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SCOTTB. HALSTEADet al.

progress. First, all 27 sites have established CEUs and demonstrated progress in relation to the criteria for CEU success. Although many factors have contributed to the successful establishment of CEUs, two deserve note. One is the high rate of return of fellows (98%). The other is the support given by the medical school deans and department heads. Their leadership and commitment demonstrates the desire of the 27 participating biomedical communities to increase their research strength. Second, research productivity is evident in spite of the fact that only 60 fellows trained have been working in their CEUs for more than 3 years. Most developed country researchers would view this as the minimum time frame for young investigators to establish themselves. Given the constraints faced by LDC researchers, 3 years is probably an underestimate and research progress appears substantial. Third, the research undertaken by fellows has lead to changes in clinical and health policy decisions. Given that more than half of the results presented at the last annual meeting were decision-oriented, CEUs have the potential to continue to influence clinical and health policy decisions in the long-term. Three further conclusions address constraints to CEU effectiveness and the challenges that lie ahead as we move into Phase 2. The problems encountered are not unique to INCLEN sites and should be relevant to most LDC institutions contemplating health research strengthening initiatives. First, competing priorities and scarce resources force many LDCs to place a low priority on health research and research careers. This is compounded by the relative lack of emphasis by donors on support for research and individual investigators. As a result, many fellows have returned to settings where their skills and motivation are compromised by the lack of funds to protect their time for research and support the costs of carrying it out. In fact, in many INCLEN sites CEU members must forego personal time and income in order to pursue their research. “Twinning” between developing and developed country institutions is one strategy that can increase the pool of funds available to LDC researchers. An example is a program jointly funded by Rockefeller and WHO to support research between 16 developing and developed country partners. Recent initiatives such as the Commission on Health Research for Development may also bring about change in the attitudes of donors and governments towards

health research. The WHO endorsement of the role of epidemiologic research and its potential to contribute to “Health For All” goals should also be helpful [ 111. Second, CEU effectiveness is constrained by the poor links between researchers and policy makers. Although it is encouraging that some of the research completed by fellows has lead to useful policy changes, other important results have not been used. A great deal remains to be learned about how to link research and policy in both developed and developing countries. Approaches are needed that recognize the immediacy of policy decisions but also incorporate strategies to strengthen the evidence base for future decisions. Policy-makers need to increase their understanding of the contribution health researchers can make to an informed decisionmaking process and the setting of priorities. Health researchers need to increase their understanding of the types of information useful to policy-makers. The third constraint relates to the nature of capacity building initiatives such as INCLEN. The impact of INCLEN in the long-term will depend upon the self-sustainability of the CEUs and their ability to make the transition to regional and national training centres. This process will require external support (both technical and financial) much beyond the lifetime of most projects and thus depends on a change in attitudes about project duration and the need for long-term commitment to bring about lasting change. This will be a major challenge in Phase 2 as CEUs work to assume training responsibility. It is too early to assess the impact of INCLEN in changing physican behaviour and health policy decisions in LDCs. Furthermore, INCLEN represents only one of the many approaches needed to increase health care effectiveness, efficiency and equity. The INCLEN model targets physicians as the point of entry and is based on the rationale that the changes it aims to bring about cannot occur without a major re-orientation of the leaders of the medical establishment. Complementary initiatives focusing on interdisciplinary collaboration and research capacity building of other health professions such as nursing and community health workers are needed to achieve the types of health system changes being called for. Ministries of health and primary health care systems are other areas where research collaboration and increased expertise in clinical epidemiology,

INCLEN: A Progress Report

biostatistics, health economics and health social science is needed. It is clear that the identification of cost-effective solutions to health care problems is fundamental to the control of rising costs and improvements in the impact of health care. The methods of clinical epidemiology, biostatistics, health economics and health social science provide powerful tools for increasing our knowledge about effective, affordable health care. Through the establishment of cadres of physicians in influential LDC medical institutions who advocate these approaches to rational decision-making, the medical establishment can work to ensure they are part of the solution and not part of the problem facing LDC health systems. We are optimistic that increasing support will continue to emerge globally for the value of this approach and the enormous contribution research can make to health and development. Acknowledgements-We wish to thank the following for their contributions both past and present to the development of INCLEN: A. Dobson, J. Eisenberg, J. Evans, M. Gent, N. Higginbotham, S. Leeder, V. Neufeld, K. Warren, K. White. We also wish to thank the training centre faculty and the senior members of the developing country medical schools with whom INCLEN is working. INCLEN is supported through grants from the Rockefeller Foundation, United States Agency for International Development, World Health Organization and the International Development Research Centre.

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