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Topic and Scope of Consensus Development Conferences: Criteria and Approach for Selection of Topics and Properties for Assessment Tore Schersten During the past 10 to 15 years, unparalleled advances in biomedi- cal and technical research have revolutionized the practice of medi- cine. Powerful new health care technologies for prevention, diagno- sis, and treatment have emerged, for example, vaccines, computed tomography (CT) scanners, magnetic resonance imaging, and organ and cell transplantation procedures. New biotechnologies such as the technique of recombinant DNA, gene cloning and protein pro- duction, monoclonal antibody fonnation, and microchemical instru- mentation all open up novel, almost unlimited, opportunities for medicine. These advances, however, have created serious problems for the public and its representatives, for the patient, and for the medical community. The problems are not only scientific and medi- cal but also of ethical, economic, social, and legal concern. There- fore, not surprisingly, the need and demand for comprehensive as- sessments of health care technologies have grown in the developed world. A technological assessment should provide decision makers with useful information and guidelines on policy questions that con- cern the application of medical technology. The recommendations should be based on the validation of safety and efficacy, of cost- effectiveness, and of social and ethical implications of the use of the technologyin short, the assessment should answer the question of whether the benefits from the use of a particular technology out- weigh the costs in human and monetary terms. 18

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TOPIC AND SCOPE SCOPE OF THE CONFERENCE 19 The consensus development conference, a rapid data synthesis method, has the potential to be a powerful instrument for the provi- sion of balanced advice about a technology and for the definition of the need for further information and research. By and large, these are the main reasons for He great interest and rapid adoption of this synthesis method in the Western world. The consensus development conference process does not generate new scientific data and therefore cannot solve or contribute to the solution of a true scientific conflict. The conference can disclose and define what is known and what is not known about a technology and can also contribute to new interpretations and evaluations of the available scientific data. Thus, the participants may formulate the best current judgment of a given technology in relation to the health care service requirements, the patients' desires, and the demands of the society. The aims and the expectations of a consensus develop- ment conference differ between countries because of variations in the cultural settings and in the health care systems. In the United States, where the consensus development confer- ence originated, the National Institutes of Health (NIH) initially proposed the process in 1977 as a means to facilitate the transfer of biomedical research results into clinical practice. NIH considered the consensus development conference to be a natural extension of the biomedical research community's obligation to assume more responsibility for the practical implications of research results. The primary goal of the conference process was to validate the safety and efficacy of a particular technology. The original intent of the scope of the program was to emphasize emerging technologies. However, with time the scope of the program has widened, and most of the technologies assessed through the consensus exercises are already in use (Perry, 1987, 19881. The NIH emphasis on safety and efficacy was natural in view of the activities of the National Center for Health Care Technology (NCHCr). NCHCT was involved in assessment activities related to the delivery of health services, hospital management, and biding systems in the time period of 1977 to 1981. The NCHCI assess- ments focused on the economic and social implications of medical technologies (P.L`. 95-623; U.S. Congress, 19781. Seven European countries, including Denmark, Finland, The Neth-

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20 CONSENSUS DEVELOPMENT eriands, Norway, Sweden, Switzerland, and the United Kingdom, have started consensus development conference programs. These countries have modified the conference according to the cultural settings and health care systems of their societies. In general, the scope of the European consensus exercises is broader than that of the NIH conferences. European conferences usually include an eco- nomic evaluation of the technology and an attempt to address the ethical implications of technological use. In the Nordic countries, the conferences also examine the availability of a technology to ensure equal access for all patients in need of the technology. In these countries, the conferences create a base for societal debate and evaluation of the medical technology. The consensus development conference has also been used in policy-making and in the allocation of resources. The target groups of the conferences in these countries include doctors, politicians, administrators, and the public (Andreasen, 1988; Klazinga et al., 1987~. Questions about technologies may address the effects on patients, the patients' relatives, and organizations, including the potential additional personnel and equipment requirements (for example, the need for physicians, assistants, or technicians). The effects on hu- man resources in terms of education and training of new specialists and the employment of persons in isolated areas, as well as the overall opportunity costs to society of technological use have also been examined. There are several examples in European countries where a conference has influenced the allocation of resources. In Sweden, for example, the resources for total hipjoint replacement were increased and reallocated after a consensus development con- ference. The diffusion of CI scanners was also enhanced after the conference on the management of stroke. Only one direct comparison between the NIH conference and the European model has been performed (Rogers et al., 1982~. NIH arranged a conference on hipjoint replacement, and a similar con- ference was held on the same topic in Sweden. The conferences provided the opportunity to compare consensus development in two cultures with different health care systems. The Swedish conference was convened to discuss the costs and the availability of the technol- ogy in Sweden as well as safety and efficacy. The conference in the United States focused on safety and efficacy but did not include considerations of costs or availability. Despite differences in the cultures and the focus of the conferences, the consensus statements

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TOPIC AND SCOPE 21 were remarkably similar in the evaluation of efficacy and safety. This comparison supports the possibility of the transfer of informa- tion on biomedical technologies between countries and the use of evaluations done in different countries independent of the original health care systems. In addition, the process may be used effec- tively in different cultural settings. SELECTION OF TOPIC In the United States as well as in other countries with consensus development conference programs, all types of medical technologies (i.e., for prevention, diagnosis, treatment, and rehabilitation) have been examined. The initial intent of the NIH program was to emphasize new and emerging technologies, although most of the conferences in the United States and other countries have addressed established technologies already in widespread use. This selection seems natural in view of the fact that the majority of technologies in use have never been comprehensively evaluated for safety, efficacy, and social conse- quences. The following criteria for the selection of topics are similar in all countries. The topic under consideration should be important from a quan- titative and/or qualitative point of view; i.e., it should be of medical importance, affect a significant number of people, and/or be very costly. There must be an available base of scientific information about the technology. There must be a scientific debate about the use of the technol- ogy and a discrepancy between the available knowledge and its prac- tical application in medicine. In the Nordic countries the availability of the technology for the people (i.e., equity) has also been an important criterion for selec- tion. International experience with consensus development conferences has shown that the method is important for the evaluation of the quality of clinical practice and/or for the provision of information and guidelines to administrative and political decision makers. Data concerning the efficacy and safety of a medical technology are of

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22 CONSENSUS DEVELOPMENT universal value and therefore can be transferred between health care systems. On the other hand, evaluation of factors of importance for education, health care system organization, and economics will have limited transferability between countries. Hence, there are good reasons for a country to develop a national consensus conference program. REFERENCES Andreasen, P.B. 1988. Consensus conferences in different countries, aims and per- spectives. International Journal of Technology Assessment in Health Care 4:305- 308. Klazinga, N.S., A.F. Casparie, and J.J.E. van Everdingen. 1987. Contribution of medical decision-making to consensus development conferences. Health Policy 8:339-346. Perry, S. 1987. The NIH consensus development program a decade later. New England Journal of Medicine 317:485488. Perry, S. 1988. Consensus development: An historical note. International Journal of Technology Assessment in Health Care 4:481-485. Rogers, E.M., J.K. Larsen, and C.U. Lowe. 1982. The consensus development process of medical technologies: A cross-cultural comparison of Sweden and the United States. Joumal of the American Medical Association 248:1880-1882. U.S. Congress. 1978. P.L. 95-623. Health Services Research, Health Statistics and Health Care Technology Act of 1978.