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Profile of the Consensus Development Program in Norway: The Norwegian Institute for Hospital Research and The National Research Council Bj0rn Backe NATIONAL CONTEXT The Norwegian Institute for Hospital Research (NIHR) initiated the first consensus conference, Use of Ultrasound Screening in Preg- nancy, in 1986. This nonprofit, health services research institute mainly conducts health planning and contract research for health authorities and hospital owners. The NTHR arranged the first con- sensus development conference in cooperation with the Health Ser- vices Research Unit of the National Institute of Public Health. The NTHR sponsored the conference in conjunction with the Royal Nor- wegian Ministry of Health and Social Affairs. In 1987, the Ministry of Health and Social Affairs asked the Nor- wegian National Research Council (NRC) to develop a program for consensus development conferences in Norway. The NRC recom- mended a three-year program with two consensus development con- ferences per year. At present, the Norwegian Institute for Hospital Research and the NRC work together to organize and finance the consensus development program. The first conference in this pro- gram, on mammography screening, occurred in February 1989. The second conference, on reduction of the population's cholesterol level, occurred in October 1989. The purpose of the program is to improve the policy and practice for areas of concern in the health services by providing objective ~8

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NORWEGIAN IN=I~E FOR GOSPEL INCH 119 information on controversial medical matters for political and ad- ministrative decision makers, medical professionals, patients, and general consumers. The pane! from the first conference on ultrasound in pregnancy recommended that one routine examination should be offered to all pregnant women (Norwegian Institute for Hospital Research, 1987~. The Directorate of Health immediately endorsed the statement as the national guidelines for obstetrical use of ultrasound. Recent re- search indicates that the consensus development conference state- ment has had a measurable influence on the practice of ultrasound (Nafstad and Backe, 1989~. Two national cross-sectional surveys of ultrasound practice have been made: a short time before and two years after He consensus conference. In this time period, there was a reduction in the total number of examinations perfor-~ed and an increase in the proportion of pregnant women being examined (98 percent). There are roughly 52,000 deliveries per year in Norway. At present approximately 12,000 fewer examinations are performed per year in Norway compared with the 1986 rate for the procedure. The second consensus pane} noted Hat mammography screening should not yet be routinely offered, pending the results of ongoing research that is expected to provide further evidence toward resolu- tion of the controversy. The Minister for Health and Social Affairs referred to the statement in a parliamentary debate shortly after pub- lication. She agreed with the consensus statement and stated that the national guidelines (i.e., the treatment program for the use of mammography) would be published in the near future, based on the consensus development conference statement. The national health authorities, the county hospital owners, and the health professionals have used the statements from the Norwe- gian consensus development conferences as a reliable form of ad- vice. The two past conferences have been funded jointly by the Royal Norwegian Department for Health and Social Affairs and the NIHR. The total cost per conference is about NKr 382,580 (U.S. $55,X51~. This includes direct costs for He planning group, confer- ence report, informational material, and staffing, including overhead costs. The panelists and the expert presenters do not receive compensa- tion for their participation. Funds for the conference are used to employ the leader of the conference planning group. The planning group leader may be one of the researchers at the NIHR who works

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120 CONSENSUS DEVELOPMENT part time with consensus development conferences or, in some in- stances, may be employed on a short-term contract. The planning group leader is responsible for the financial aspects of the consensus development conference program. For the most part, the planning group leaders have been involved in research projects that addressed issues concerning the particular topic for the consensus development conference. SCOPE OF THE PROGRAM A medical technology must meet the following criteria before assessment by the consensus conference method. The technology must be of broad general interest. The ethical, social, and/or other consequences must be large. The number of patients must be large, or the costs great. The topic is within the medical-scientific framework (i.e., there must be enough scientific evidence for the questions to be answered on a scientific basis). There must be disagreement as to the utility of the technology (i.e., there must be a real dispute within the medical profession on how to interpret the available scientific results. and how to aDDIv the technology in practice). . . ~ The statement should have the ability to influence He diffusion of the technology and to alter current clinical practice. The term medical technology broadly defines those instruments, practices' and procedures based upon medicaVbiological knowledge. The Norwegian program does not have explicit limitations as to the appropriate stage in the life cycle of a technology for assessment by a consensus development conference. The program will probably focus upon new and established technologies. At present, NRC and NTHR are collecting suggestions for future conference topics. NRC established a subcommittee on technology assessment: the TA committee. Two health services research insti- tutes, the Royal Norwegian Ministry for Health and Social Affairs and the Directorate of Health, are represented on the TA committee. The committee chair is a representative of the Medical Research Council. The TA committee selects conference topics, drafts the questions, and appoints a planning group for each conference. As a rule, both

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NORWEGIAN INS17TlrTE FOR HOSPITAL RESEARCH 121 the chair of the consensus panel (appointed by the TA committee) and one or more of the topic experts in the field participate in the planning group. The planning group refines the questions for the panel, selects panelist and experts, and prepares the practical ar- rangements for the conference. The work of the planning group is subject to the approval of the TA committee. The aspects of a technology addressed at a consensus develop- ment conference include effectiveness and efficacy (or practical, achievable health benefits); health risk; monetary cost; and organ- izational, ethical, social, and psychological consequences of increased or decreased use of a technology. Equal access to the technology (equity) is a particularly important consideration. The questions are formulated so that the statements can be used as a basis for treat- ment programs that serve as guidelines for the treatment of certain conditions or patient groups. The consensus development confer- ence statement itself is insufficient for use as a treatment program, as treatment programs provide far more detail on patient care. FORMAT AND CONDUCT OF THE PROCESS The necessary preparation time for a consensus development con- ference, from the selection of a topic to the composition of the consensus statement, is approximately one year. The conference it- self lasts two and a half days; the pane} completes the statement during the second night of the conference. The pane} members are offered assistance from NTHR in the as- sembly of relevant literature. Panelists received reports of pertinent randomized controlled trials (RCTs) and other relevant literature before the two recent conferences. No formal protocol exists for the distribution of information to the panel before each conference. The chair of the panel and the planning group decide upon a procedure for materials procurement and dissemination for the individual con- ference. The Norwegian program does not have a formal procedure for selection of the panelists. Approximately half of the panel is to come from the medical profession, including experts in epidemiol- ogy and statistics, community medicine, and general practice, as well as experts in other medical fields who are familiar with the technology in question but who are not experts on the subject. The nonmedical members of the panel are experts in health economics, ..

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122 CONSENSUS DEVELOPMENT ethics, law, health journalism, health administration at various lev- els, and health politics. As a rule, the panelist should not have expressed strong opinions on the consensus topic. They are invited as individuals, rather than as members or representatives of groups or organizations. They are experts in their fields, although they are not necessarily experts on the topic of the conference. They receive both written and oral information on the concept of consensus development. In general, the panel of representative, well-informed individuals seeks to achieve consensus through discussion and debate. The conferences are public meetings with short scientific presen- tations by experts (15 minutes each) that are followed by discus- sions.- During the general discussion period, the panel members question the experts. Questions and comments may also come from the audience. Approximately 200 people attended the first two con- ferences, most of whom were physicians. On the morning of the third day, the pane} presents the consensus statement. The panel prepares the final version of the statement without the assistance of any other individuals. The pane} meets privately a number of times during the conference. The first closed session occurs the evening before the start of the public presenta- tions. DOCUMENTATION AND USE OF EVIDENCE IN CONSENSUS DEVELOPMENT The first two Norwegian conferences focused upon technologies for health screening. In both cases, the question of utility rested heavily upon a small number of RCTs (four and three studies, re- spectively). If the RCTs were performed in Nordic countries, the principal author presented the material. In other cases, the confer- ence planners commissioned an expert to present the material. The experts must submit a written abstract of their oral presenta- tion. Panelists receive the abstracts a minimum of four weeks be- fore the conference. The working language throughout the confer- ence is Norwegian. As a rule, only published evidence has been considered. Docu- mentation of both the state of knowledge and the state of practice are important elements of the consensus development conference process. Often studies must be performed before each conference to

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NORWEGIAN IN517TUTE FOR HOSPITAL RESEARCH 123 estimate the actual diffusion, use, costs, and health effects of He relevant technology. Appropriate institutions and experts are com- missioned to prepare reports in these cases. Panelists do not adhere to any formal guidelines for weighting the presentations. The pane! reaches consensus through discussion. The process is not rigidly structured. References are not available in the consensus statement, as they are not considered to be necessary. The panels do, however, provide conclusions and detail the reason- ing behind the consensus statement. DISSEMINATION AND IMPACT OF THE CONSENSUS STATEMENT After each conference, the proceedings are published in a report, together with the consensus statement and a short review of the main reasons for holding He conference. The mechanisms for dis- semination of the consensus findings include: press conference newsletter to the media distribution of the statement to administrative authorities publication of the statement in the Journal of the Norwegian Medical Association and distribution of the statement to over ap- propriate journals, and to radio, television, and over news media. An evaluation of the impact of the first conference (which was held in 1986) is in progress as a part of a thesis on the diffusion of medical technologies. The previously mentioned study of the prac- tice of ultrasound before and two years after the consensus develop- ment conference was presented at the June 1989 meeting of the International Society of Technology Assessment in Heals Care (Backe and Nafstad, 1989~. The sponsoring organizations are currency considering the feasibility of an evaluation of the ongoing three-year program. REFERENCES Backe, B., and P. Nafstad. 1989. Development in practice of diagnostic ultrasound in Norway after the consensus conference recommending routine screening (ab- stract). Presented at the annual meeting of the International Society of Technol- ogy Assessment in Health Care, London.

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124 CONSENSUS DEKELOPMENT Nafstad, P., and B. Backe. 1989. Prevalence and practice of obstetrical ultrasound in Norway (in Norwegian). Tidsskr Nor Laegeforen 109:2975-2978. Norwegian Institute for Hospital Research. 1987. Ultrasound in pregnancy: Con- sensus statement, 1986. International Journal of Technology Assessment in Health Care 3(3):463-470.