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SUMMARY 9 The committee recognizes that the definitions will not resolve all arguments over what these and related terms mean, but it does believe that these four statements will bring a degree of badly needed clarity and uniformity to the field. Moreover, these definitions can be used by the Forum and, indeed, have already been incorporated into its work. One underlying premise highlighted by these definitions is that these four terms are not synonymous. Assisting physicians, nurses, other practitioners, and patients in making decisions (through practice guidelines) is not the same as evaluating practice (using medical review criteria, standards of quality, and performance measures). Therefore, although the definitions may evolve, it is important to underscore that the phrases and concepts are not equivalent and should not be used interchangeably. For various practical or technical reasons, some elements of a set of guidelines may have no corresponding review criteria or other evaluation tools. Not part of the committee's definition of practice guidelines, but central to its view of the field, is the precept that every set of guidelines should be accompanied by a statement of the strength of the scientific evidence and the expert judgment behind them and by projections of the relevant health and cost outcomes. The committee has not tried to distinguish types or levels of practice guidelines (for example, Levels 1 or 2), although this type of discrimination may be useful. RECOMMENDATIONS: ATTRIBUTES OF GOOD GUIDELINES Developing practice guidelines is a challenging task that requires diverse skills ranging from analysis of scientific evidence to management of group decisionmaking to presentation of complex information in understandable forms. To arrange for the development of guidelines by expert panels and contractors, the Forum must be able to state its expectations for the process and then assess the soundness of the resulting products. (OBRA 89 calls this establishing "standards and criteria" for the process. To avoid confusion, this report substitutes the term attributes for the statutory language. As described at the end of this summary, the IOM is preparing in provisional form a practical assessment instrument for the agency.) This report distinguishes between the priorities for selecting particular targets for guidelines and the desirable attributes of guidelines. Priority setting is a crucial but separate task for which OBRA 89 provides guidance. Drawing on its members' experience and expertise and the work of past IOM committees and other relevant organizations, the committee recommends that the agency use the following eight attributes, properties, or characteristics to instruct expert panels or contractors and to assess their products. The attributes focus on practice guidelines and not on medical review criteria and other tools for evaluating practice. The committee
SUMMARY 10 expects this set of attributes to be tested, reassessed, and, if necessary, revised. VALIDITY: Practice guidelines are valid if, when followed, they lead to the health and cost outcomes projected for them, other things being equal. A prospective assessment of validity will consider the projected health outcomes and costs of alternative courses of action, the relationship between the evidence and recommendations, the substance and quality of the scientific and clinical evidence cited, and the means used to evaluate the evidence. RELIABILITY/REPRODUCIBILITY: Practice guidelines are reliable and reproducible (1) ifâgiven the same evidence and methods for guidelines developmentâanother set of experts would produce essentially the same statements and (2) ifâgiven the same circumstancesâthe guidelines are interpreted and applied consistently by practitioners or other appropriate parties. A prospective assessment of reliability may consider the results of independent external reviews and pretests of the guidelines. CLINICAL APPLICABILITY: Practice guidelines should be as inclusive of appropriately defined patient populations as scientific and clinical evidence and expert judgment permit, and they should explicitly state the populations to which statements apply. CLINICAL FLEXIBILITY: Practice guidelines should identify the specifically known or generally expected exceptions to their recommendations. CLARITY: Practice guidelines should use unambiguous language, define terms precisely, and use logical, easy-to-follow modes of presentation. MULTIDISCIPLINARY PROCESS: Practice guidelines should be developed by a process that includes participation by representatives of key affected groups. Participation may include serving on panels that develop guidelines, providing evidence and viewpoints to the panels, and reviewing draft guidelines. SCHEDULED REVIEW: Practice guidelines should include statements about when they should be reviewed to determine whether revisions are warranted, given new clinical evidence or changing professional consensus. DOCUMENTATION: The procedures followed in developing guidelines, the participants involved, the evidence used, the assumptions and rationales accepted, and the analytic methods employed should be meticulously documented and described.
SUMMARY 11 The themes that underly these attributes are credibility and accountability . The link between a set of guidelines and the scientific evidence must be explicit, and scientific and clinical evidence should take precedence over expert judgment. Every set of guidelines should be accompanied by a clear statement of the strength of the relevant scientific evidence and expert judgment. When the empirical evidence has important limitations and experts reach conclusions that are not consistent with the evidence, then the rationale for departing from the evidence, such as it is, should be carefully explained. When expert judgment proceeds in the absence of direct empirical evidence about a particular clinical practice, as is often necessary, the general scientific reasoning and normative principles supporting the judgments should be described. This report does not take a position on whether cost considerations should be explicitly factored into practice recommendations, although some committee members had strong views that they should be. However, documentation of projected health outcomes and costs to the degree possible is important to help developers and users of guidelines better understand the implications of following or not following the guidelines. One of the committee's strongest recommendations is that the process of developing guidelines include participation by representatives of key affected groups and disciplines. Such participation increases the likelihood (1) that all relevant scientific evidence will be located and critically evaluated; (2) that practical problems with using the guidelines will be identified and addressed; and (3) that affected groups will see the guidelines as credible and will cooperate in implementing them. Participation by physicians, nurses, patients, and others can be achieved in several ways including membership on the development panel, testimony at public hearings, participation in focus groups, consultation during site visits, and provision of comments on draft guidelines. The stringency of the attributes, especially taken together, is well recognized. Realistically, neither existing guidelines nor those likely to be developed by the agency in the foreseeable future will "score well" on all eight properties simultaneously. Indeed, near-perfect scores may always lie in the realm of aspiration rather than attainment. Moreover, the process of developing, assessing, using, evaluating, and revising guidelines will be evolutionary. There is today no proven "right way" to conduct this endeavor, even if there clearly are some "better ways." In addition, a balance needs to be maintained between an ideal process and one that is feasible. Guidelines that satisfactorily reflect the eight attributes proposed here may not be products of an ideal process, but in the committee's view they will be defensible.