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ATTRIBUTES OF GOOD PRACTICE GUIDELINES 70 language, such as "severe bleeding," should be avoided in favor of more precise language, such as "a drop in hematocrit of more than 6 percent in less than eight hours." Similarly, guidelines must be specific about what populations and clinical circumstances are covered and what specific elements of care are appropriate, inappropriate, and (if relevant) equivocal, as those terms were defined earlier. For practical reasons, assessments of language and modes of presentation may have to be largely subjective. Depending on the audience, somewhat different standards for assessing clarity may be needed. Materials for consumers might be subject to the "readability" measures that have been variously applied to regulations, consumer warranties, and similar materials. Materials for practitioners may be more technical but should not be burdened by needless jargon, awkward writing, or "unfriendly" software. Software itself may soon allow organizations to apply computer-based "style manuals" or ''templates" to help standardize writing for different purposes (Frankel, 1990). MULTIDISCIPLINARY PROCESS One of the committee's strongest recommendations is that guidelines development include participation by representatives of key affected groups and disciplines.8 The rationale for this position is threefold. First, multidisciplinary participation increases the probability that all relevant scientific evidence will be located and critically evaluated, thereby strengthening the scientific grounding, scope, and flexibility of the guidelines. Second, such participation increases the likelihood that practical problems with using guidelines will be identified and addressed, thus constructing a firmer foundation for successful application of the guidelines in real-world situations. Third, participation helps build a sense of involvement or "ownership" among different audiences for the guidelines, thereby improving the prospect for cooperation in implementing them. Figure 3-2 summarizes these rationales and other key issues in developing or assessing a participation strategy. Among clinicians, multidisciplinary participation may call for the use of clinicians with and without full-time academic ties, for the inclusion of specialists and generalists, and for participation by relevant nonphysician practitioners. Optometrists, for instance, could well have an important role to play on panels to develop guidelines for cataract surgery. Experts in research and analytic methods also need to be represented on guidelines 8 The term multidisciplinary is used broadly here rather than narrowly; it does not refer only to academic and professional disciplines.
ATTRIBUTES OF GOOD PRACTICE GUIDELINES 71 development panels; that is, methodological expertise should not be obtained only on a contractual basis or from specialized technical advisory panels. WHY MULTIDISCIPLINARY PARTICIPATION IS NECESSARY Strengthens scientific base of guidelines Increases real-world utility Creates sense of "ownership" Expands foresight about conceptual and practical problems WHO SHOULD PARTICIPATE Clinicians Academic and nonacademic Specialists and generalists Physicians, nurses, and others as appropriate Methodologists Experts in analyzing science bases Experts in group judgment methods Nonclinician users Patients, potential patients, and families Payers and health plan sponsors Peer review and quality assurance experts Public policymakers HOW PARTICIPATION MIGHT OCCUR Membership on development panel Testimony at public hearings Review of draft guidelines Focus groups Consulting and contracting arrangements WHEN PARTICIPATION MIGHT OCCUR Earlyâsetting the goals, determining the processes Lateâreviewing the results Throughoutâbeginning to end and into implementation and evaluation WHAT PARTICIPANTS MIGHT CONSIDER Scope, quality, and evaluation of scientific evidence Mode of presentation Likely ease of application Identification of user problems and needs FIGURE 3-2 Multidisciplinary participation in guidelines development. User groupsâin addition to cliniciansâinclude health care administrators, members of peer review organizations, payers, and patients or consumers. If guidelines are expected to pertain to groups distinguished
ATTRIBUTES OF GOOD PRACTICE GUIDELINES 72 mainly by sociodemographic characteristics (for example, age or minority ethnic groups), special efforts are warranted to involve representatives of those groups at some early stage of development. Successful involvement of patients or consumers is a challenge that may require multiple strategies, as described below. Documentation for this attribute will need to describe the parties involved, their credentials and potential biases, and the methods used to solicit their views and arrive at group judgments. The committee does not recommend, however, that the Forum develop detailed, rigid definitions of what constitutes a consumer or other participant category. (The often unproductive troubles such definitions created for federally funded health planning agencies were cited during the committee discussion.) A frequent although not necessarily valid criticism of guidelines is that their content can be improperly manipulated by selecting group participants for their known opinions rather than on the basis of their expertise. The position taken here is that all participants in the guideline-setting process are likely to have personal opinions, biases, and preferences about the clinical problem or service at issue, and no amount of effort will expunge those factors. What is critical is that those factors be known and balanced insofar as possible. 9 The committee discussed at some length the question of who should develop guidelines. Some members felt quite strongly that the Forum should not contract with medical specialty societies for guidelines development services. Others felt that establishing such a blanket prohibition was not the right approach. Instead, decisions should be based on a comparative assessment of potential developers' track records and capacities. These capabilities include, for example, related work that the groups or individual participants have already done, existing documentation of participants' credentials and biases, and the methods and evidence with which they have experience. Although the committee did not reach a specific consensus that the Forum should completely exclude specialty societies as potential direct contractors or subcontractors, the agency should be sensitive to the credibility concerns raised by this question. Physician organizations in any case should be extensively consulted by developers of guidelines, involved in reviewing draft guidelines, and used to help disseminate guidelines. Another debate arose during the committee's meetings over the question of who should chair a guidelines development group. Again, some 9 The procedures of the National Academy of Sciences might serve as a model for the panel selection process. These procedures require that members of study committees submit bias statements and that an official of the Academy lead each committee through a member-by-member discussion of possible biases. Major funders of a study cannot be represented on a study committee, and every committee report must be reviewed by a panel of outside experts under the oversight of the National Research Council.