Clinical Practice Guidelines: Directions for a New Program (1990)

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ATTRIBUTES OF GOOD PRACTICE GUIDELINES 58 guidelines, in terms of their development and implementation, will need to evolve beyond these initial specifications. Table 3-1 lists the eight attributes for assessing guidelines that the committee identified. One theme emphasized here, which ties these guideline attributes together, is credibility—credibility with practitioners, with patients, with payers, with policymakers. This theme encompasses the scientific grounding of the guidelines, the qualifications of those involved in the development process, and the relevance of the guidelines to the actual world in which practitioners and patients make decisions. A second and related theme is the importance of accountability, a key element of which is disclosure. That is, the committee expects that procedures, participants, evidence, assumptions, rationales, and analytic methods will be meticulously documented—preferably in an accompanying background paper. This documentation will help those not participating in any given process of guidelines formulation to assess independently the soundness of the developers' work. Explanations should be provided for any conflict or inconsistency between the guidelines in question and those developed by others. The issue of disagreement or inconsistency among practice guidelines is an important one for patients, practitioners, managers, payers, and policymakers. As discussed in Chapter 5 of this report, merely identifying inconsistencies in guidelines says nothing about the legitimacy of such differences. Careful documentation of the evidence and rationales can help potential users of guidelines judge whether inconsistencies arise from differences in the interpretation of scientific evidence, from differences in the care taken in developing the guidelines, or from other factors. VALIDITY In the committee's view, the validity of practice guidelines ranks as the most critical attribute, even though it may be the hardest to define and measure. Conceptually, a valid practice guideline is one that, if followed, will lead to the health and cost outcomes projected for it, other things being equal. In the research literature, validity is commonly defined by three questions. Do the instruments for measuring some concept (for example, quality of care) really measure that concept? Does the relationship or effect that the researchers assert exists (for example, following a set of guidelines improves quality of care) really exist? Can that relationship be generalized (for example, from clinical trials to everyday medical practice)? Until a guideline is actually applied and the results evaluated, validity must be assessed primarily by reference to the substance and quality of the evidence cited, the means used to evaluate the evidence, and the 

ATTRIBUTES OF GOOD PRACTICE GUIDELINES 59 TABLE 3-1 Eight Attributes of Good Practice Guidelines Attribute Discussion 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) if —given the same evidence and methods for guidelines development—another set of experts would produce essentially the same statements and (2) if—given the same clinical circumstances—the 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.