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Table of Contents
Introduction The
Topic The Staff The Initial Planning The Panel Chairperson The Planning Committee The Planning Meeting Conference
Evaluation Conference Publicity Continuing Medical Education Credit The Consensus Development
Conference Conference Results Logistical Support Reference
Information The Consensus Development Conference (CDC) Program is an influential and innovative activity in health technology assessment and transfer conducted by the National Institutes of Health (NIH). Under this program, which has operated since 1977, NIH organizes major conferences that produce consensus statements on important and controversial topics in medicine. Each conference is jointly sponsored and administered by one or more Institutes, Centers, or Divisions (ICD's) of NIH and by the Office of Medical Applications of Research (OMAR) in the Office of the Director of NIH. Depending on the topic, other Federal agencies with biomedical components may join in the sponsorship of a CDC.
The CDC Program complements other NIH activities in technology assessment and transfer. These include scientific publications, lectureships, symposia, workshops, conferences, colloquia, task force and committee reports, staff studies, and brochures developed for a variety of audiences including research scientists, health policymakers and providers, health educators, and the public.
The purpose of a CDC is to evaluate the available scientific information on a biomedical technology and to develop a consensus statement that advances understanding of the technology or issue in question (assessment) and that will be useful to health professionals and the public at large (transfer). A broad-based panel listens to the scientific data presented by experts, weighs the information, and then composes a consensus statement that addresses a set of questions previously posed to the panel. This statement is an independent report of the panel and is not a policy statement of NIH or the Federal Government. The panel is not an advisory body to NIH, although NIH or any other Government or non-Government organization may adopt all or part of the panel's recommendations.
CDC's examine either emerging or established technologies. Although many aspects of a technology under review may be discussed--economic, sociologic, legal, and ethical--the primary purpose of a CDC is to provide scientific evaluation. To this end, the statements in general and the recommendations issued in particular should focus on medical safety and efficacy, although they may refer to other issues in passing. CDC's are particularly useful for providing guidance when a controversy exists in differing therapeutic or diagnostic options and when the issue is of public as well as professional interest. The timing of the conference should neither be so early in the developmental course of a new technology that data are insufficient nor be so late that the conference merely reiterates a consensus already reached by the profession.
A consensus statement is based on publicly available data and information. It is not intended as a legal document or as a primary source of detailed technical information such as one might find in a review article or task force report. Rather, the statement reflects the unified view of a panel of thoughtful people who understand the issues before them and have carefully examined and discussed the scientific data available on these issues. The creative work of the panel is to synthesize this information, along with sometimes conflicting interpretations of the data, into clear and accurate answers to the questions posed to the panel. When consensus cannot be achieved, the statement should reflect this by noting uncertainties, options, or minority viewpoints. Following the conference, the consensus statement receives wide circulation through both the lay and the medical media. The conference proceedings may be published and telecast, and a summary videotape may be produced.
The basic principles governing the conduct of a CDC follow:
Topics for CDC's may be suggested by the ICD's, OMAR, other government health agencies, Congress, and the public. Final selection of a topic is made when agreement is reached between a sponsoring ICD and OMAR. Sponsorship by additional ICD's or non-NIH organizations will be considered subsequently.
A topic must meet the following selection criteria:
OMAR and ICD staff are responsible for planning and conducting the conference logistics, publicity, evaluation, continuing medical education accreditation, and any other tasks required to make the conference a success.
The sponsoring ICD nominates the ICD coordinator, who usually chairs the planning committee and serves as the representative of the ICD in managing the conference. The ICD coordinator should be knowledgeable in the area of science under consideration.
OMAR assigns a senior staff member to serve as the OMAR coordinator. This individual works with the ICD coordinator and other ICD representatives in organizing the conference and also serves on the planning committee.
The sponsoring ICD's information office assigns a staff person to assist the OMAR Director of Communications in planning conference publicity and media coverage as well as dissemination of the consensus statement following the conference. Both of these individuals serve on the planning committee.
The ICD coordinator, the OMAR coordinator, and other appropriate ICD and OMAR staff review the conference topic, review the general scientific base supporting the topic, and agree on whether the topic meets the criteria for a CDC. After acceptance of the topic, they outline the general conference objectives and establish a timetable for conference planning. The coordinators identify other interested organizations within and outside NIH and consider appropriate roles for them, which may include cosponsorship of the conference. Representatives from other ICD's and organizations may be asked to join the planning process at this stage.
An informal organizational meeting is held between the OMAR coordinator, the ICD coordinator, and representatives from the other interested organizations. Here the scope, title, and approximate date of the conference are tentatively determined, and a panel chairperson is chosen (see The Panel Chairperson). The panel chairperson takes part in all major conference planning activities. Additionally, two or three persons from the general research community, who are not Federal employees and are knowledgeable about the conference issues, are selected to become members of the planning committee.
At the organizational meeting, the participants might want to consider development of background review papers, meta-analyses, or use of a decision model to assist the panelists in dealing with the data presented during the consensus conference. Planning for evaluating conference impact is encouraged. The potential impact of the conference should be defined in terms that are amenable to quantitative measurement and evaluation.
The coordinators develop the travel and conference budget. The OMAR coordinator arranges logistical support for the CDC through a non-Government logistical support contractor (see Logistical Support).
The panel chairperson should be a knowledgeable and prestigious figure in the field of medical science under consideration but should not be identified with strong advocacy of the conference topic or with research that might be presented to answer any of the conference questions.
The individual selected will be responsible for chairing the plenary session of the CDC, the deliberations of the panel, and the press conference, and thus should be both a strong public moderator and a skillful leader of small group discussions.
The panel chairperson must be a citizen of the United States and must not be a Federal employee.
The planning committee has four major functions: to draft the conference questions, to draft the conference program, to recommend conference speakers, and to recommend panel members.
The planning committee is ordinarily composed of the panel chairperson and representatives from the sponsoring ICD, OMAR, and other interested Federal agencies within and outside the NIH. The planning committee also includes several recognized experts who are not Federal employees.
The planning committee is usually chaired by the ICD coordinator, although the ICD director or another representative may serve in this role.
To prevent the appearance of bias, no planning committee members, except for the panel chairperson, may serve on the panel. Planning committee members may serve as speakers at the CDC. Disclosure of scientific bias and commercial conflicts of interest is requested of planning committee members for the record.
The planning committee convenes a meeting for the purpose of performing its four major functions.
Drafting the Conference
Questions
The agenda of a CDC is structured around key questions posed to the panel. Ordinarily, four to six questions are posed, including questions on efficacy, risks, clinical applications, and a final one soliciting the panel's opinion on directions for future research. These questions determine the scope and substance of the conference. They should be framed so that answers can be derived from scientific information presented by the speakers. The phrasing of the questions should not allow for responses based solely on subjective judgments or opinions of the panel. Questions should be straightforward and concise so that it will be evident whether consensus has been achieved.
The planning committee should plan the entire program, including evening and luncheon executive sessions and alternate activities for the second afternoon. An appropriate balance should be provided among the times allotted for speakers, discussion, breaks for scientific exchange, and drafting the consensus statement.
The conference program should be broad enough to encompass the body of scientific information essential to answering the conference questions and should include divergent scientific and medical views. Presentation topics should be selected so that speakers can use style and format appropriate to scientific meetings; that is, the presentations should be based on analysis of data with methodology fully explained and citations to the relevant scientific literature provided. The intent is that speakers present information to the panel and the audience as scientific experts, not as advocates for particular answers to specific questions.
In some instances, the usual 2-l/2 day CDC format may be insufficient for the creation of a thoughtful consensus statement or else unnecessarily long. Alternative formats include
Speakers are selected for their scientific/technical expertise and may include clinical investigators, basic scientists, and general authorities in the field. Where differences of scientific opinion exist, care should be exercised to include the presentation of opposing data and interpretations. Speakers are asked to confine their presentations to the scientific topic that they have agreed to address and to be certain to present all relevant data and information. Speakers are expected to provide abstracts of their presentations to the ICD coordinator at least 2 months before the conference.
A range of expertise on the panel is important to the panel's ability to deliberate on the varied scientific material presented. This diversity enhances the credibility of the consensus statement. The panel should represent various sectors of professional and community life, including each of the following four general categories:
Panel members should not be professionally identified with advocacy or promotional positions with respect to the issues to be resolved by the conference or with research that might be presented to answer any of the conference questions. Also, panelists should not have financial interest in the issues to be resolved.
Panel members must be thoughtful, able to weigh evidence, and capable of collaborative work.
The size of the panels has varied from 9 to 16 members, with 12 or 13 found to be a reasonable working group.
Because the CDC is an exercise in peer review, in which the panel reviews information presented by the experts, panelists should not be speakers.
Full-time Federal employees may not serve on panels so as to avoid the appearance of undue Federal involvement. Panelists must be citizens of the United States.
The OMAR and ICD evaluation offices plan evaluation protocols and collect data both before the conference and at intervals following the conference. Every effort is made to collect input from planning committee members regarding techniques for evaluating the impact of the conference.
Planning of conference publicity is coordinated with the OMAR Director of Communications and the information office representative from the sponsoring ICD.
Planning includes development of an information dissemination plan that:
The NIH Office of Education is accredited to sponsor continuing medical education (CME) for physicians in Category I of the Physician's Recognition Award of the American Medical Association. Most CDC's average between 13 and 15 CME credits.
Occasionally, the potential audience for a CDC includes groups other than physicians (e.g., psychologists, dentists, nurses). Thus other types of continuing education may be appropriate for a conference. Often, the application process for other types of continuing education is handled directly with the sponsoring professional society (e.g., Academy of General Dentistry, American Psychological Association).
On the day before the conference, the Director of OMAR briefs the panel on the consensus development process and procedures. Panelists may then discuss the areas in which they wish to probe individual speakers and outline their approaches to the conference questions.
The conference plenary sessions are moderated by the panel chairperson. The chairperson ensures that speakers adhere to time limits, allows ample opportunity for scheduled discussion, and invites comments from panelists and the audience, taking questions from panelists first.
The entire panel, working in subgroups, begins to draft the consensus statement during the evening executive session on the first night. When the noon executive session begins on the second day, the chairperson directs the panel to finish its statement within the allotted time. (Experience has shown that several drafts of the statement are necessary.) The panel should start this session with at least a first draft to work on.
The panel should attempt to reach consensus on each question based on the scientific evidence presented. To produce a firm statement, the panel is encouraged to draw conclusions and form recommendations whenever feasible. If consensus cannot be achieved, minority or alternative views should be included. A straightforward expression of diversity is preferable to a contrived or ambiguous consensus.
The conference convenes again in plenary session on the morning of the final day, and the proposed consensus statement is read by the chairperson. At this time, the statement is subject to review and comment by the conference attendees. The panel adjourns following this session for a final, brief executive session (approximately 2 hours long), where it may revise the draft statement to reflect comments from the floor. The first 10 to 15 minutes of this final executive session are spent on reviewing the draft press release, which highlights the conclusions of the panel as set forth in the consensus statement. The press release is written by the OMAR Director of Communications and the ICD information office representative and is distributed at the press conference and disseminated nationwide after the press conference.
After the final executive session, a press conference is held, with the panel chairperson serving as spokesperson for the panel. Panel members are expected to remain for the press conference, which usually lasts about an hour. The panel chairperson opens the press conference with a brief summary (about 5 minutes long) of the panel's findings in lay language. Subsequently, the floor is opened to questions from the media. The panel members and chairperson should participate in responding to press questions. The panel chairperson, in particular, as well as the other panel members should be available for a brief time after the press conference for possible questions and interviews by newspaper, radio, or television reporters.
Following the conference, the consensus statement is promptly edited for style, syntax, and clarity by the OMAR and ICD coordinators and sent to the panelists for their final review. The edited statement is then sent to the chairperson for final approval. Following this process the statement is considered final.
As soon as possible following the conference, the OMAR Director convenes a debriefing (followup) meeting for OMAR and ICD staff to review the strengths, weaknesses, and outcome of the conference.
CDC's usually receive considerable attention from the media. The nation's major print and broadcast media often report the results of a CDC, which serves to focus attention on the topic and the statement of the panel.
The OMAR Director of Communications and the ICD information office representative develop an information dissemination plan covering the publicity for the conference, the media coverage of the conference results, and the strategy for distributing the consensus statement.
The consensus statement is printed by OMAR and distributed routinely to a variety of Federal health agencies, health care organizations, directors of continuing medical education at American Hospital Association member hospitals, deans of medical schools, directors of State and county medical societies, and directors of HMO's and PPO's. Additionally, the consensus statement is sent to targeted individuals and organizations specified in the information dissemination plan.
The Journal of the American Medical Association publishes many of the consensus statements, as do specialty journals in the area of the topic. In addition, OMAR places notices in numerous professional journals announcing the availability of the consensus statement and inviting inquiry. On several occasions, the consensus statement along with selected papers from a CDC have been published either as a supplement to a specialty journal or as a monograph.
Summary videotapes and audiotapes of the conference may be prepared and distributed to specialty groups.
A summary of the statement is also prepared and sent to appropriate specialty journals, popular medical and health magazines and newsletters, and health and science sections of major newspapers.
OMAR maintains a logistical support contract to provide travel and management assistance throughout the planning and conduct of a CDC. The contractor assigns an individual to work with the ICD and OMAR coordinators from the beginning of the planning process through completion of the conference to the final distribution of the consensus statement.
Expenses for planning committee members, panel members, and conference speakers are paid by OMAR through the contractor.
The CDC budget developed by the ICD and OMAR coordinators governs the expenditure of funds from the logistical support contract.
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