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Summary At the request of the National Institutes of Health (NIH), the Institute of Medicine established the Committee on Improving the National Institutes of Health Consensus Development Program (CDP). The committee's report provides specific recommendations to the Office of Medical Applications of Research (OMAR) for strengthen- ing the Consensus Development Program. Four main themes arise from the committee's recommendations that address the structure and function of the NTH CDP. First, as the intent of the NTH CDP, as well as other technology assessment pro- grams, is to change the behavior of clinicians and others in the health care system, the purpose, scope of inquiry, and planning of the program should reflect greater emphasis on understanding and representing the concerns of the users of the consensus statements. The scope of inquiry of the NIH CDP should be broadened lo in- clude relevant economic, social, and ethical aspects of assessing biomedical technologies. OMAR should expand the programs pur- pose to acknowledge explicitly that the ultimate goal of the program is to change behavior toward appropriate use of health practices and technologies. The program planning process should seek to identify the concerns of the broader health care system (i.e., beyond NTH) Trough solicitation of suggestions for conference topics, questions, panelists, and speakers. Second, adding greater structure to certain elements of the NIH CDP will enhance the program's ability to generate useful findings.

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SUMMARY The topic selection process should be formalized and should include consideration of evidence on the state of clinical practice. The plan- ning committee should include members who understand the clini- cal, methodologic, and societal issues related to the conference topic and should reflect representation of the health care system's con- cerns about the topic. Conference questions should be reviewed by persons not involved in the process of drafting to ensure that the questions are clearly stated. Conference speakers should submit more thorough information in advance of the conference. When available data make it feasible, meta-analysis should be performed prior to convening the conference to obtain more rigorous interpre- tation of multiple sources of evidence. Evidence should be pre- sented to the pane] in a standardized format and be graded for its quality. A working definition of consensus should be made avail- able to, and agreed upon by, the panel prior to initiating delibera- tions; the definition of consensus used by the panel should be in- cluded in the consensus statement. The consensus statement should include well-reasoned minority opinions when they exist, note when minority opinions do not exist, identify items that lack adequate evidence for a judgment to be made. and identify specific areas for further research. , ~ . Third, as is the case with group judgment programs in general, the NTH- CDP can benefit from continued experimentation and evalu- ation. OMAR should develop an explicit ongoing research effort to determine ways to improve the CDP and to monitor the impact of the program. OMAR should experiment with quantitative decision modeling and other resources and means to aid the efforts of panels to achieve well-founded consensus. Fourth, adequate financial support and a strong organizational commitment at the highest levels of NIH are required to enable OMAR to perform its challenging role in technology assessment and transfer on behalf of NIH. OMAR's reporting relationship to the director of NTH should be reevaluated with respect to the CDP. OMAR should be an equal partner with the bureaus, institutes, and divisions- in setting the agenda of the CDP. An external advisory council should be established to assist OMAR in setting its agenda, including provision of oversight to the NIH CDP and guidance in consensus conference topic selection. OMAR should revise its budget expectations for consensus development conferences in light of the recommendations of this report, which likely would require addi- tional resources.