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Recommendations for Program Structure PURPOSE AND SCOPE OF THE PROGRAM Scope of Topics as Defined by Program Purpose The stated purpose of the NIH COP should be expanded to in- clude issues related to the management of clinical conditions in addition to the evaluation of specific biomedical technologies. According to the OMAR pamphlet "Guidelines for the Selection and Management of Consensus Development Conferences,', the NIH consensus development conferences are organized to "produce Con- sensus Statements on important and controversial topics in medi- cine.t' However, He current OMAR guidelines proceed to describe a more restrictive purpose for the NTH CDP: The purpose of a Consensus Development Conference is to evaluate the avail- able scientific information on a biomedical technology and to produce a Con- sensus Statement that advances understanding of the technology or issue in question .... In practice, NTH consensus development conferences have addressed the management of clinical conditions, as well as biomedical tech- nologies. Examples of clinical conditions that have been addressed by NTH consensus development conferences include osteoporosis 9

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10 CONSENSUS DEVELOPMENT AT THE NIH (1984), neurofibromatosis (1987), and urinary incontinence (1988~.~ Accordingly, it would be appropriate to include reference to man- agement of clinical conditions in the program's statement of pur- pose. Scope of Inquiry as Defined by Program Purpose The scope of inquiry of the NIH CDP should be expanded. The program should seek to ensure that relevant economic, social, and ethical aspects of assessing biomedical technologies and manage- ment of clinical problems are appropriately addressed as part of the consensus process. OMAR should commit the necessary resources to identify and, where appropriate, evaluate these aspects. Specifi- cally, OMAR should do one or more of the following for each con- ference topic: expand or modify the structure of consensus develop- ment conferences (i.e., planning committee and conference pane] membership, questions, speakers, and consensus statement) to ad- dress these aspects of assessment; convene a second pane! to ad- d~ress the relevant economic, social, and' ethical issues and prepare a statement to be issued in conjunction with the consensus statement on the biomedical aspects of a topic; anal request another appropri- ate organization to prepare a statement that addresses these aspects and to issue that statement in conjunction with the NIH CDP con- sensus statement. The scope of inquiry of the NIH CDP should reflect its role in technology assessments and the intent that the program should have an impact on health care practice. As a prominent program of health technology assessment, the NTH CDP has the potential to influence decisions about clinical practice, health technology acquisition and use, insurance coverage and reimbursement, product development, MA complete list of conference topics is provided in Appendix B. The committee's definition of technology assessment is consistent with the defi- nition outlined by IOM; that is, medical technology assessment is "any process of examining and reporting properties of a medical technology used in health care, such as safety, efficacy, feasibility, and indications for use, cost, and cost-effective- ness, as well as social, economic, and ethical consequences, whether intended or unintended" (IOM, 1985~.

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RECOMMENDATIONS FOR PROGRAM SIRUCI URE 11 and public health policies. As noted in the recent RAND Corpora- tion study of the program's impact on medical practice, The COP is more than an assessment program. It is also a communication program to the professional community and the public. It aims to disseminate the results to health care professionals (as well as researchers) throughout the county in order to improve the state of professional practice. The expecta- tion is that once physicians and other relevant health care professional person- nel know the expert consensus about a particular medical procedure, device, or condition, they will change their practice to conform to the consensually validated recommendation. Increasing public knowledge about the technol- ogy under review will help to encourage this change (Kanouse et al., 1989) (emphasis added). This recommendation regarding the scope of inquiry of the NIH CDP recognizes the overarching mission of NIH. Through the conduct, support and promotion of biomedical research, NIH seeks to improve the health of the American people by: increasing the under- standing of the processes underlying human heals, disability, and disease; advancing knowledge concerning the health effects of interactions between man and the environment; developing methods of preventing, detecting, diag- nosing, and Beating disease; and disseminating research results for critical review and ultimately for medical application (NIH, 1989~. Assessment of technology and related health practices has the poten- tial to affect people's health by influencing their health habits, health care providers' actions, and resource allocation within the health care system. But, evaluation of safety and efficacy provides only part of the information needed by health care professionals, patients, third-party payers, and other decision makers. To be effective in improving health care practice, health technology assessments must also address relevant economic, social, and ethical consequences, such as cost, access, and quality of life. By limiting its explicit attention to matters pertaining to evalu- ation of safety and efficacy, the NIH CDP does not adequately meet the needs of health care professionals, patients, policymakers, third- party payers, industry, and members of the general public who look to NTH consensus statements for authoritative guidance. If NTH is to undertake consensus development, it must seek to ensure that applicable economic, social, and ethical issues are addressed in or- der to provide useful information about a technology to interested parties and decision makers, even if such analyses extend beyond the core mission of NTH.

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12 CONSENSUS DEVELOPME~JI AT THE NIT Expanding the structure of the NTH consensus development con- ferences to address relevant economic, social, and ethical aspects has the advantage of providing explicit attention to these aspects. It is important that such matters as cost, accessibility, equity, societal norms, and legal implications be considered in a shared context with technologic performance, safety, efficacy, and other strictly biomedi- cal issues in order to deal explicitly with me trade-offs among these that are raised in research settings as wed as clinical practice. However, within the current time constraints allotted for confer- ences, expansion of scope may become too burdensome to produce useful results. Therefore, it may be necessary for OMAR to con- vene a second pane} to produce a statement, or to have a statement prepared by an outside organization, in order to address these as- pects adequately. Such a supplemental effort could be performed concurrent with or subsequent to the consensus development confer- ence on issues of safety and efficacy. In some instances, certain salient economic, social, and ethical issues may not become evident until consensus on the strictly biomedical issues has been achieved. In those cases, OMAR could provide for a second pane} to address such issues. Convening a second panel or contracting with another organization would require additional coordination by OMAR, and, if conducted in a sequential rather than parallel manner, would add time to the consensus development process. In particular, it may be appropriate for NTH to coordinate a two- stage or other complementary process with the Agency for Health Care Policy and Research (AHCPR). As provided in Section 904 of P.~. 101-239 (U.S. Congress, 1989), AHCPR `'shall conduct alla support specific assessments of health care technologies" and in so doing "shall consider the safety, efficacy, and effectiveness, and, as appropriate, the cost-effectiveness, legal, social and ethical implica- tions, and appropriate uses of such technologies, including consid- eration of geographic factors." Alternatively, other organizations in government or the private sector could be requested to provide assis- tance to NTH in addressing relevant economic, social, arid ethical issues. Program Purpose OMAR should expand the purpose of the NIH COP to acknowI- edge explicitly that the ultimate goal of the program is to change behavior toward appropriate use of health practices and technology.

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RECOMMENDATIONS FOR PROGRAM S7RUCIURE 13 A clear and accurate statement of purpose is essential to me suc- cess of the COP. A clearly stated purpose provides guidance to conference planners and participants and assists users of conference findings by delineating what is to be addressed by a conference, the intended target of the resulting information, and the reason for gen- erating this information. Such a statement of purpose should define the program scope by identifying the appropriate range of topics and extent of inquiry to be addressed. The current purpose of the NIH CDP as described in OMAR's guidelines is to evaluate the available scientific inflation on a biomedical technology and to produce 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) rsic] (OMAR, NIH, 1988~. The statement of purpose should be expanded to encompass be- haviorally oriented program objectives. This will assist NTH in de- veloping, conducting, disseminating, and evaluating the CDP. Clearly stating that the purpose of the NTH CDP is to influence behavior regarding the appropriate use of medical interventions will establish a focused program goal or standard toward which the program can be managed and against which its impact can be measured. Specif~- cally, the statement of purpose should explicitly note the program objectives to promote me timely incorporation of beneficial medical innovations into clinical practice, encourage the abandonment of obsolete technologies in favor of ones that are more efficacious or safe, discourage the adoption of technologies that have little value, and inform public policy choices that encourage or discourage the use of certain medical technologies (Kanouse et al., 1989~. Each of these objectives seeks to influence behavior in order to improve health care practices, but is not given due weight in the current NTH CDP statement of purpose. Objectives of Individual Consensus Development Conferences The objectives of each consensus development conference should be clearly stated as part of the planning process (including topic selection), the conference itself, and the consensus statement. To aid in delineating objectives for a particular conference, OMAR should consider developing a topology that identifies various poten- tial conference objectives and the audiences that the conference might serve.

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14 CONSENSUS DEVELOPMENT AT THE NIH In fulfilling the mission of the NIH CDP, an individual consensus development conference can meet one or more objectives for one or more audiences. The objectives of an individual conference might include education, policy-making, resolution of controversial issues, or examination of specific clinical practices. The audience for the resulting consensus statement might include researchers, clinicians, third-party payers, health care administrators, professional organiza- tion representatives, consumers (patients), or the general public. Such variation in objectives and audiences among consensus development conferences is necessary and appropriate given the diversity of top- ics to be addressed. Explicit acknowledgment of objectives and intended audiences will assist in conference planning, conduct, and dissemination efforts. ORGANIZATIONAL ISSUES OMAR is part of the Office of the Director of NIH, where it reports to the Associate Director for Disease Prevention. OMAR is the focal point in NIH for technology assessment and transfer. The aim of OMAR's activities is to facilitate the transfer of NTH-sup- ported biomedical research results into clinical applications and to evaluate these research findings for safety and efficacy. In addition to the CDP, OMAR coordinates NIH medical and scientific review of Medicare coverage issues,3 conducts research and evaluation stud- ies of NTH technology assessment and transfer efforts, and serves as liaison between NIH and health professionals and the general public (IOM, 19X51. As a result, OMAR has a varied constituency that includes the BIDs of NTH, biomedical researchers, health care pro- viders, professional societies, voluntary organizations, private in- dustry, state and local governments, other federal agencies, con- sumer groups, and the general public (OMAR, NIH, undated). Location of OMAR within NIH Organizational support for the NIH CDP should be strengthened at the highest levels of NIH. Specifically, OMAR's reporting rela- 31~ese issues are referred to NIH and other Public Health Service agencies (e.g., the Food and Drug Administration) from the Health Care Financing Administration primarily via the Office of Health Technology Assessment (OHTA). OHTA was formerly part of National Center for Health Services Research and is retained in the Agency for Health Care Policy and Research.

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RECOMMENDATIONS FOR PROGRAM STRUCTURE 15 tionship to the director of NIH should be reevaluated with respect to the CDP. Further, OMAR should be an equal partner with the BIDs in setting the agenda of the CDP. Given NIH's traditional focus on biomedical research, some ob- servers may regard technology assessment and transfer as subordi- nate or marginal concerns of NTH. Nevertheless, the functions of technology assessment and transfer are essential to the mission of NIH. In order to have an impact on the health of the public, the knowledge gained through the efforts of NTH and other scientific programs must be transmitted to health care providers and others in the health care system. Successful accomplishment of technology assessment and transfer requires that the needs of the intended audi- ences of these activities are represented and understood. Thus, the scope of the CDPespecially as reflected in the selection of con- sensus development topics and the drafting of conference questions must be responsive to health care providers and others in the health care system. These needs should be reflected in the CDP, but may not, in all instances, be consonant with the particular priorities of the respective BIDs of NTH. Furthermore, OMAR's role in technol- ogy assessment and transfer, in particular, as coordinator of the CDP, offers opportunities for NIH to gain the insights of representatives of the broader health care system that may be useful to the agency in formulating its research agenda and related policies. To ensure that the functions of technology assessment and trans- fer remain integral aspects of NTH activity and that OMAR is able to adequately represent the concerns of those outside of NTH in the CDP, OMAR's organizational role should be strengthened. There appears to be no particular advantage to the current placement of OMAR in the Office of Disease Prevention; indeed, this may have the potential, or give the appearance, of skewing the emphasis of the program. Stronger organizational support would be best achieved through a closer, perhaps direct, reporting relationship between the directors of NTH and OMAR. Further, OMAR should be an equal partner with the BIDs in setting the agenda of the CDP. OMAR Advisory Council 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 development conference topic se-

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16 CONSENSUS DEV~U)PME~ AT THE NIT lection. The council should be broadly constituted so that the views of health care professionals, provider organizations, industry, re- searchers, thirdl-party payers, and the general public can be heard(. In order to be effective in technology assessment and transfer, OMAR must have an understanding of the perspectives and priori- ties of the broader health care system. Currendy, there is no stand- ing means for providing OMAR with the views of its constituencies outside NIH. Formalizing OMAR's link to the venous segments of the health care system would benefit the CDP and may prove useful for OMAR's other technology assessment and transfer activities as well. PROGRAM EVALUATION OMAR should develop an explicit ongoing research effort to de- termine ways to improve the NIH CDP and to monitor the impact of the program. This report constitutes just one step in a continuing process of improvement of the NTH CDP in particular and of the methodology of consensus development in general. OMAR should experiment with new techniques (see the recommendations in the section Devel- opment of Consensus and Group Dynamics in Chapter 3 of this report) to improve its program and to provide guidance to other consensus development efforts. As noted in Chapter ~ of this report, dissemination of CDP findings is as essential an element in the proc- ess as the other program components addressed here are, given the intent to use consensus statements to influence health care practice. Thus, OMAR should build on its efforts to improve dissemination by engaging in further analysis of this area. In addition, evaluation by OMAR and outside organizations of the impact of the NIH CDP should receive high priority and should be performed on an ongoing basis. FINANCIAL SUPPORT OMAR should revise its budget expectations for consensus dlevel- opment conferences in light of the recommendations of this report, which likely would require additional resources. If N H is unable to

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RECOMMENDATIONS FOR PROGRAM SIRUCrURE 17 increase the funding available to OMAR for the consensus develop- ment conferences accordingly, then OMAR should reduce the num- ber of conferences it sponsors to have adequate funding for each conference held. A number of the committee's recommendations will result in an increase in the amount of money spent per conference and in admin- istrative costs for OMAR (e.g., pertaining to the broader scope of the program, use of a professional facilitator, establishment of an OMAR advisory council, meta-analysis, decision modeling, and ongoing evaluation). Given the importance of the NTH CDP and the au~or~ty attributed to it, OMAR should focus on the quality, rather than the quantity, of its consensus development conferences. It is more important to conduct fewer conferences that address the full range of issues required by decision makers than to conduct a greater number of conferences that do not provide decision makers with adequate information to change behavior.