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INTRODUCTION AND BACKGROUND 29 practice guidelines, medical review criteria, and standards of quality, and a provisional definition for performance measures. Chapter 3 takes up the attributes of good guidelines. It again describes how the committee approached the topic and what the literature says about desirable properties of guidelines. The themes that underlie this discussion are the importance of credibility and full disclosure of the processes, sources, methods, and participants in guidelines development. The committee has identified eight attributes of guidelines: validity, reliability/reproducibility, clinical applicability, clinical flexibility, clarity, multidisciplinary process, scheduled review, and documentation. The stringency of these attributes, especially taken together, is well recognized, and the committee realizes that a balance needs to be maintained between an ideal process and a feasible one. In a second IOM project on practice guidelines (Appendix C), one task will be to take the conceptual attributes described in Chapter 3 and develop an operationally useful instrument for assessing how specific sets of guidelines conform to these attributes. In Chapter 4, the committee concentrates on implementation and evaluation. This chapter differentiates between the implementation of a government program for guidelines (which includes hiring staff and convening expert panels) and the implementation or application of guidelines after they are developed. It also differentiates between evaluating the impact of clinical practices and evaluating the impact of practice guidelines. Chapter 5 summarizes the committee's recommendations and conclusions. The recommendations, although sensitive to broader congressional expectations for the new agency, reflect the committee's relatively limited charge to advise the Public Health Service on definitions and attributes of guidelines. CONCLUSIONS AND CAUTIONARY NOTES Today, the field of guidelines development is a confusing mix of high expectations, competing organizations, conflicting philosophies, and ill-defined or incompatible objectives. It suffers from imperfect and incomplete scientific knowledge as well as imperfect and uneven means of applying that knowledge. Despite the good intentions of many of the parties involved, the enterprise lacks coherent structures and credible mechanisms for evaluating, improving, and coordinating guidelines development to meet society's needs for good-quality, affordable health care. This situation will not change overnight, even though many promising activities, including those sponsored by AHCPR, are under way. Consequently, expectations for quick results should be somewhat restrained. Otherwise, dashed hopes may lead to calls for premature abandonment of
INTRODUCTION AND BACKGROUND 30 a useful strategy for improving the appropriate use of health care services and to the adoption of more draconian measures to control costs. The committee is also concerned about other unrealistic expectations or assumptionsâfor example, the assumption that guidelines development is a relatively simple or straightforward undertaking. It is not. For many clinical conditions and services, the scientific base is limited. (This is one reason why it is important that the guidelines and knowledge development functions of AHCPR be coordinated.) Methods for analyzing evidence and developing expert opinion vary, but none of the rigorous methods can be properly applied by novices. Where considerable research has been done and good methods have been applied to analyze it, honest clinicians and analysts may come to different conclusions using the same evidence. Agreement on facts may not be accompanied by agreement on what health benefits are desirable at which economic cost with what tolerable accompanying health risks. Such conflicts about the interpretation of evidence and the application of value judgments cannot be ignored. Indeed, the whole process of guidelines development must be undertaken with care at every stage: selecting participants, clarifying biases, adopting procedures and methods, identifying and analyzing evidence, considering alternatives, providing for independent reviews, preparing clear recommendations, and disclosing all important information about the process. This report is intended to reinforce these points. A second assumption of concern to the committee is that there is only one right way to develop guidelines. There is not. Variations in the topics, the clinical disciplines involved, the purposes, and the audiences for guidelines will justify some differences in specific development methods. However, to grant some methodological diversity is not to accept all approaches as equally good. Chapter 3 pursues this point but notes that much remains to be tried and learned about the strengths and weaknesses of different guidelines development methods. One further questionable expectation, which is sometimes explicit but often unstated, is that practice guidelines will help control health care costs.3 They may not. The reasons for caution on this point are several. For instance, variation in practice does not, by itself, demonstrate that the high-use patterns are the inappropriate ones. Moreover, even if high use can be identified as inappropriate, such identification does not automatically change behavior. An array of incentives for behavioral change may be tried, but not all will succeed. Even if behavior changes, expenditures may 3 See, for example, the discussions of expenditure targets, volume performance standards, and guidelines in the Physician Payment Review Commission's 1989 (Chapters 11 and 12) and 1990 (Chapter 2) reports.