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Profile of the Consensus Development Program in Sweden: The Swedish Medical Research Council and The Swedish Planning and Rationalization Institute for the Health and Social Services Ste fan Hikansson and Ingemar EckerIund NATIONAL CONTEXT Sweden was the first country outside of the United States to adopt the consensus development conference as a method for technology assessment (Calitorp and Smedby, 1989~. The format of the Swed- ish conferences follows the U.S. National Institutes of Health model quite closely. Since 1982, 11 consensus development conferences have been arranged jointly by the Swedish Medical Research Coun- cil (MFR) and the Swedish Planning and Rationalization Institute of the Health and Social Services (Spri). The goal of each conference is to reach consensus among special- ists from different disciplines concerning the safety, benefit, and appropriate use of a particular medical technology. Practicing phy- sicians, representatives of the lay public, health care administrators, and politicians often participate. Swedish consensus development conferences have three major purposes: I. to review and assess the scientific base for a medical technol- ogy 2. to contribute to He dissemination of knowledge concerning the technology 3. to provide information concerning the appropriate use of the technology. 125

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126 CONSENSUS DEVELOPME:NT The cost of a Swedish consensus conference is about Skr 500,000 (about U.S. $75,000) in 1989 prices. This includes costs for plan- ning, staffing, and report dissemination and overhead costs associ- ated with consensus development activities. The costs are equally divided between the MFR and Spr'. SCOPE OF THE PROGRAM Since 1982, the following consensus development conferences have been held: Total Hip Joint Replacement (1982) Treatment of Myocardial Infarction (1983) Treatment of Depressive Disorders (19X4) Sight Improving Surgery (1984) Diagnostic Imaging of Liver Tumor (1985) Cerebral Hemorrhage and Stroke Diagnosis and Treatment (1986) Urinary Incontinence in Adults Diagnosis and Treatment (1986) Chronic Leg Ulcers Diagnosis and Treatment (1988) Postoperative Wound InfectionsHygienic Routines in Hospi- tal (1988) Preoperative Routines (1989) Venous Thrombosis Diagnosis, Prevention and Treatment Indications (1989~. The types of technologies that have been addressed are primarily medical and surgical procedures. Table ~ details the types of tech- nological interventions and the stages in the life cycle of technolo- gies that have been assessed by way of consensus development. Safety, efficacy, effectiveness, cost, and economic implications are technological properties or concerns that are usually addressed during the consensus development conferences. Ethical, legal, or social implications have hitherto played a relatively minor role. The criteria for selection of a topic in the consensus development program include the following. The topic should be medically important and have the potential to eventually produce changes in medical practice (i.e., there is a gap between current knowledge and current medical practice). The topic should be clearly defined, and a corresponding scien- tific knowledge base must exist.

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128 CONSENSUS DEVELOPMENT It must be possible to answer the questions on technical scien- tific grounds, and the result must not be biased by the subjective values of the panel. FORMAT AND CONDUCT OF THE PROCESS The planning and implementation of the consensus development conference process lasts from one to one and a half years. The conference itself lasts for two and a half days. The MFR's initiative group on the assessment of medical technol- ogy considers topics for consensus development conferences. The proposals from this group go to a steering committee, having repre- sentation from the sponsoring organizations (MFR and Spri), which in turn selects topics, develops conference questions, and appoints participants to the panels and expert groups. Since 1985, both the Federation of the County Councils of Sweden and the Swedish Soci- ety of Medicine have been asked to suggest conference topics. The conferences are planned in detail by special working groups ap- pointed for each conference. These working groups usually consist of the panel chair, the expert group, two representatives from each of MFR and Spri, one representative from the Swedish Society of Medicine, and one representative from the National Board of Health and Welfare. The panels normally consist of approximately 16-18 members. About half of the panelists are medical experts, while the others usually represent health economics, epidemiology, health policy, administration, and concerned patient groups. Although the format of the Swedish conferences follows the U.S. model quite closely, the scope is somewhat broader. In addition to the evaluation of the safety and efficacy of a technology, the Swed- ish conferences address health care organization, cost effectiveness, and social and ethical questions. One and a half days are dedicated to expert presentations, includ- ing questions and discussion. The speakers present not only their own data but also general overviews of available data in order to present the actual state of the art. The panel begins to write the statement on the afternoon of the second day. On the third day the panel presents the statement to the experts and the audience (ap- proximately 200 individuals) for discussion. The panel meets again

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SWEDISH MAR AND Spri 129 after this general session to decide on possible modifications. The conference ends with a press conference. DOCUMENTATION AND USE OF EVIDENCE IN CONSENSUS DEVELOPMENT The expert group assembles information for each consensus de- velopment conference. The presentations by the experts are based on various kinds of information. For example, reports of clinical trials, epidemiologic studies, and literature reviews have been used as evi- dence. Panelists and participants receive paper abstracts about one month before the conference begins. The consensus statement's validity rests solely upon the scientific evidence presented to the pane} for decision making. Information that has not been presented at the conference is not to be considered by the panel. Only presentations by the experts, distributed materials, and answers to the questions of the panelists are to be taken into account in the panel's statement. There are no explicit rules for the development of consensus and the use of evidence during the executive sessions of the panel. The panels for each conference decide upon the definition of consensus. The chairperson leads the discussion and consideration of evidence in the format chosen by the panelists. The Anal product of the consensus development process is the consensus statement. In general, consensus statements do not cite articles used as evidence. Each consensus statement contains a list of the members of the program committee, the expert speakers, and the panelists. DISSEMINATION AND IMPACT Spri publishes the consensus statements and distributes them free of charge to politicians, health care administrators, chief medical officers, and concerned health care personnel. The statements are also published in their entirety in the Journal of the Swedish Medi- cal Association. The Swedish consensus statements~regularly re- ceive considerable publicity through the radio and television media. The press actively disseminates the key points of the statements.

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130 CONSENSUS DEKELOPME~T A committee worked for two years to evaluate Swedish consensus development conferences and to trace the impact of consensus state- ments on the principal actors in me health care arena (Berfenstam et al., 1986; CalItorp, 1988; lohnsson, 19XX). The studies were di- rected toward the evaluation of the impact of the conference on specialists in the actual specialties concerned and on the top admin- istrators and politicians in the county councils. Details of the evaluations were presented by Calitorp (1988) and Johnsson (1988~. The main conclusions are as follows. The statements are very well known among all major groups concemed. The politicians and administrators tend to report a higher practical utility of the statements. The statements are regarded as good educational material, as they provide useful background reading for planning and decision making. The conferences and the statements could be influential in the priority setting process within county councils. REFERENCES Berfenstam, R., G. Carlsson, and L. Werko. 1986. Konsensuskonferensers Roll och Effekter. (The Role and Effects of Consensus Development Conferences.) Stock- holm: Medicinska Forskningsradet, Spri. Calltorp, J. 1988. Consensus development conferences in Sweden: Effects on health policy and administration. International Journal of Technology Assessment in Health Care 4:75-88. Calltorp, J., and B. Smedby. 1989. Technology assessment activities in Sweden. International Journal of Technology Assessment in Health Care 5:263-268. Johnsson, M. 1988. Evaluation of the consensus conference program in Sweden: Its impact on physicians. International Journal of Technology Assessment in Health Care 4:89-94.