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Appendix A: Background Paper for the Committee to Improve the National Institutes of Health Consensus Development Program
Pages 39-64

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From page 39...
... Appendixes
From page 41...
... The following synthesis of available literature about the program is intended to provide a common base of understanding for the examination of the NTH CDP. Following a brief history of the NIH CDP, a general overview of the planning and implementation of consensus development conferences is provided.
From page 42...
... THE CONSENSUS DEVELOPMENT PROGRAM The CDP provides a forum for concerned individuals to evaluate medical technologies. Observers have noted that the three-day consensus development conference borrows processes from the scientific meeting, the judicial process, and the town meeting (Jacoby and Rose, 1986; Mulian and Jacoby, 1985~.
From page 43...
... The topics of consensus development conferences have varied substantially since the inception of the program. Conferences tend to focus on a technology, e.g., electroconvuIsive therapy (1985)
From page 44...
... The chairperson of the consensus development conference is chosen at an early stage in conference planning so that he or she can participate as a member of the planning committee and thus bridge the gap between conference planning and implementation (Elliott, 19891. The planning committee is composed of NTH staff' including OMAR and BID staff, and outside experts from the research community who are not federal employees (OMAR, NTH, 1988~.
From page 45...
... The agenda of a [consensus development conference] is structured around key questions posed to me pane} that serve to determine the scope and substance of the conference.
From page 46...
... At least one month in advance of the actual conference date, panelists receive abstracts of the speakers' presentations to prepare them for the consensus development conference. Speakers are also asked to bring photocopies of their slides to the consensus development conference for panelists.
From page 47...
... At that time, the OMAR and BID coordinators are present to act as resources for the panel (e.g., to check statistics) and to ensure that the panel adheres to OMAR guidelines regarding the general content of the consensus statement (e.g., to ensure that direct recommendations for specific individuals
From page 48...
... To prepare for the first pane} meeting, panelists receive materials from an extensive literature search done by HEM. The first meeting is held 12 to 18 months prior to the consensus development conference so that the pane} has time to develop a draft report on the chosen topic, including a list of important issues that need to be discussed during the meeting.
From page 49...
... REVIEW OF THE MAJOR COMPONENTS OF THE CONSENSUS DEVELOPMENT PROGRAM The structure of OMAR's CDP comprises the following steps: · topic selection · formation of the planning committee and selection of the chairperson · selection of specific conference questions, the consensus panel, and conference speakers · presentation and synthesis of conference data · development of consensus · preparation of initial and final consensus statements · dissemination of consensus information Many participants and observers have examined, commented upon, and made suggestions regarding improvement of the program. The substance of such reviews is summarized here, and is arranged by the components identified above.
From page 50...
... According to Markle and Chubin, the emotional aspect of a costly liver transplantation, especially when conducted for children, prompted extensive media coverage and congressional pressure to hold a consensus development conference. Markle and Chubin held that the staff of the National Institute of Arthritis, Diabetes, and Digestive and Kidney Diseases and OMAR contended that the procedure was still experimental, given the absence of clinical data to substantiate stable positive outcomes after treatment.
From page 51...
... The program planning committee is responsible for the definition of conference questions, formulation of a conference agenda, and nomination of the speakers and panelists. The consensus development conference chairperson is appointed prior to the first meeting of the planning committee.
From page 52...
... (1988) noted that the association between Reye's syndrome and aspirin was not a question posed for the consensus development conference for Reye's syndrome: A decision to eliminate a question that did not have a scientific answer at that time was acceptable to the institute planners involved, but could not be kept entirely out of the conference and on the basis of audience reactions and the concern of some panelists, a brief section had to be added to die consensus statement regarding the issue.
From page 53...
... inferred that the NIH CDP "assumes that a strict separation of factual and value issues is possible, and further, that objective evidence compels experts to converge on the 'correct' decision." In contrast to concerns regarding the circumscribed scope of the program, some observers and participants have voiced frustration with the broad agenda of certain consensus development conferences. Four to six questions are usually addressed, and one of these normally pertains to suggestions regarding further research (Jacoby, 1985~.
From page 54...
... Consumer representatives, lawyers, economists, and ethicists are not always represented at consensus development conferences. In general, the planning committee considers the relevance of these types of experts for a particular conference, given the limited speaking time available.
From page 55...
... held that this division of responsibilities among members of the panel, speakers, and the planning committee, throughout the consensus development conference program, would help ensure an "impartiality of thought and equality of influence." At present, members of the planning committee may participate in the consensus development conference as expert speakers but not as panelists, although this is discouraged by OMAR (Elliott, 1989~. Presentation and Synthesis of Conference Data Asch and Lowe (1984)
From page 56...
... Panelists may extrapolate from the evidence presented at the conference when they write the consensus statement. The 1984 consensus development conference on lowering blood cholesterol to prevent heart disease produced a contested consensus statement.
From page 57...
... questioned the panel's use of data on reduction of blood cholesterol in high-nsk males, in whom little or no great health improvement was obtained, to support the consensus statement's broad recommendation for all Americans over age two to adhere to a diet "generally consistent with the most recent recommendations of the American Heart Association and the Atherosclerosis Study Group of the Inter-Society Commission on Heart Disease Resources" (NIH, 19851. In addition, Ahrens noted the absence of details on alternative diets for those who do attempt to lower blood cholesterol levels.
From page 58...
... Several consensus development conferences have experimented with decision models to help the panel explore the implications of the data presented by speakers (lacoby and Pauker, 19861. McNeil and Pauker (1984)
From page 59...
... . Six consensus development conferences have made some use of this approach: diagnostic ultrasound in pregnancy (19841; postmenopausal estrogens in the prevention of osteoporosis (1984~; limb-sparing treatment of adult soft-tissue and osteogenic sarcoma (19X4~; registries for bone marrow transplantation (19XS)
From page 60...
... Preparation of Initial and Final Consensus Statements Early in the program, critics were concerned that consensus statements would be "bland generalities that represent the lowest common denominator of a debate" (Rennie, 1981~. Kahan et al.
From page 61...
... There have been two attempts to involve a science writer in the composition of the consensus statement. In one instance, the science writer was brought in by the program planning committee; in the other, the chairperson selected the science writer to join the panel in executive session.
From page 62...
... 1985. Assessing Medical Technologies.
From page 63...
... 1988. The consensus statements on adjuvant chemotherapy in breast cancer: Fact or artifact.
From page 64...
... 1981. Consensus statements.


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