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CONCLUSIONS AND RECOMMENDATIONS 101 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. The stringency of these 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. Nevertheless, the committee wishes to emphasize the importance of working toward practice guidelines that exhibit these characteristics. RECOMMENDATIONS: IMPLEMENTATION AND EVALUATION The main work of disseminating and applying guidelines will be in private hands, but as OBRA 89 recognizes, the agency cannot and should not be divorced from implementation. Evaluation will be a major agency concern. The committee's discussions centered on how the processes of implementation and evaluation can reinforce and extend the eight attributes defined above. The Forum should instruct its expert panels and contractors to keep the challenges and difficulties of implementation and evaluation in mind as they develop guidelines. For instance, the tension between extraordinarily detailed, complex, or sophisticated guidelines and those that can be readily translated into medical review criteria, or into documents understandable by the average patient, has to be recognized and dealt with during the
CONCLUSIONS AND RECOMMENDATIONS 102 development process, not after the fact. Keeping implementation and evaluation in mind means, among other things, the following. â¢ The credibility of the development process, the participants, and the scientific grounding of guidelines must be clear to intended users. â¢ A truly multidisciplinary approach to guidelines development will facilitate acceptance and use of guidelines by members of the groups represented and by other, secondary target groups. â¢ Guidelines should be specific, comprehensive, and flexible enough to be useful in the varied settings and circumstances of everyday medical practice and in the evolving programs to assess the appropriateness of care provided in these settings. â¢ Guidelines language, logic, and symbols should be easy to follow and unambiguous, so that movement from guidelines statements to educational tools, review criteria, or other instruments is unimpeded. â¢ The guidelines should specify what information about the clinical problem, the patient's circumstances and preferences, and the delivery setting should be recorded to permit later evaluation of the appropriateness of care (judged against criteria generated from the guidelines). The Forum can underscore its intent to examine critically and improve its processes and products in at least three ways. First, it should ask its expert panels for feedback on the strengths and weaknesses of the procedures followed. Second, the Forum should pretest the guidelines either on a pilot basis in a real delivery setting or on a set of prototypical cases, or using both methods. Third, it should try to evaluate the effectiveness of intermediate steps (for example, formatting, dissemination) that are necessary if guidelines are to have their intended effects on health practices, outcomes, and costs. Each of these steps can be part of a learning process for the Forum and for other interested parties. Attention to implementation and evaluation must start during the process of guidelines development; these aspects of the guidelines effort should not be dealt with sequentially. Moreover, many parties must contribute to these efforts, and the processes recommended and adopted over the years will evolve as sponsors and participants become more experienced. Today there is no "one best way" to develop guidelines, although preferableâand unacceptableâapproaches can be identified. Finally, the effectiveness of any guidelines in reaching desired cost and quality goals cannot be assumed. Useful evaluations of impact will take a real commitment of resources. This report distinguishes between the implementation of the guidelines program called for in OBRA 89 and the implementation of the guidelines themselves. AHCPR and its Forum have the primary responsibility for the former, but the latter will depend largely on private individuals and organizations and will inevitably be harder to coordinate, monitor, and
CONCLUSIONS AND RECOMMENDATIONS 103 evaluate. The committee's discussion of implementation in Chapter 4 focuses primarily on issues involved in guidelines implementation. However, the discussion of definitions and attributes in Chapters 2 and 3 speaks to two aspects of program implementation: the committee's work with expert panels and its assessment of the guidelines they produce. The committee also distinguishes between two kinds of evaluation. One is the evaluation of medical practice. Such evaluations may employ clinical trials and other outcomes-oriented methods, or they may rely on medical review criteria and similar tools that compare actual practice with recommended practice. The other kind of evaluation, considered in Chapter 4, asks about the impact of guidelines on the quality, effectiveness, and cost of care. The implementation of guidelines is a diffuse, difficult-to-track process that will depend on many factors besides the quality and credibility of the guidelines. These factors include the resources devoted to the different steps in implementation, the incentives for use of the guidelines, and the availability of supportive data systems. Different users will have different objectives, and strategies for meeting particular objectives will vary in their cost-effectiveness and manageability for the parties involved. That is, different objectives may call for different choices among (1) formats (physical layout and logic), (2) dissemination media, and (3) administrative supports for users of guidelines in the form of computer-based information systems, periodic feedback, or standard operating procedures. The committee also discussed a few broad policy issues related to the use of medical review criteria and other evaluation tools derived from practice guidelines. First, consistent with the recommendations of the 1989 IOM report on private-sector utilization management and observations of the 1990 IOM Medicare quality assurance report, review criteria should be public with respect to their content and their development process. This does not require that subsequently developed software and other administrative tools be public, although public monies should not be used to generate, in the first instance, proprietary products. Second, when criteria are used to assess quality of care, deny payment for specific services, or take similar steps, an appeals process must be provided. This process must be clearly described to patients and practitioners and be free from unreasonable complexity, delay, or other barriers. The attributes identified by this committeeâparticularly those of clinical applicability and flexibility combinedâ may help reduce the need for appeals. The point is that individual, idiosyncratic cases will surely surface, no matter how complex and comprehensive the guidelines are, and these eventualities can best be met with an appeals process. A third issue relating to implementation of medical review programs is the burden on patients and practitioners. Review organizations should