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SUMMARY 15 conditions, the developers of guidelines may choose not to recommend a single course of action but to lay out alternative courses of treatment that may be appropriate depending on, for example, the preferences of a patient or the characteristics of a delivery setting or community. In sum, merely identifying inconsistencies in guidelines says nothing about the legitimacy of those inconsistencies. Some inconsistencies may arise from biased or inept development processes. Some may result from reasonable differences in the interpretation of scientific evidence or in the application of patient, practitioner, or social values. Other inconsistencies may essentially disappear when the rationales for specific recommendations are closely examined. The challenge is to determine which explanation applies. Meticulous documentation of the evidence and rationales for guidelines will make this determination easier. EXPECTATIONS FOR PRACTICE GUIDELINES 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 involved parties, the enterprise lacks clearly articulated goals, coherent structures, and credible mechanisms for evaluating, improving, and coordinating guidelines development to meet social 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. Thus, expectations of quick results should be restrained. Otherwise, dashed hopes may lead to calls for premature abandonment of a useful strategy for improving the appropriate use of health services and to the adoption of more draconian measures to control costs.1 The committee is also concerned about other expectations or assumptions that may be unrealistic. One such assumption is that guidelines development is a relatively simple or straightforward undertaking. It is not. For many clinical conditions and services, the science base is limited. Methods for analyzing evidence and developing expert opinions vary, but none of the rigorous methods can be properly applied by novices. Even in cases where considerable research has been done and sound methods 1 In this vein, see the 1973 book by political scientists Jeffrey L. Pressman and Aaron B. Wildavsky, Implementation: How Great Expectations in Washington Are Dashed in Oakland; Or, Why It's Amazing that Federal Programs Work at All, This Being a Saga of the Economic Development Administration as Told by Two Sympathetic Observers Who Seek to Build Morals on a Foundation of Ruined Hopes (Berkeley, Calif.: University of California Press).
SUMMARY 16 applied to analyze it, honest clinicians and analysts may still come to different conclusions from the same evidence. Agreement on facts may not be matched 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 application of value judgments cannot be ignored. Indeed, the whole process of guidelines development has to be undertaken with great 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. Most of this report reinforces these points. A second assumption of concern to the committee is that there is 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 the specific methods for developing guidelines. However, to grant some methodological diversity is not to accept all approaches as equally good. Much remains to be tried and learned about the strengths and weaknesses of different methods. A further questionable expectation, which is sometimes explicit but often unstated, is that practice guidelines will help control health care costs. They may not. The reasons for caution on this point are several. For instance, variation in practice does not, by itself, demonstrate that high-use patterns are necessarily 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 behavior change may be tried, but not all will succeed. Even if behavior changes, expenditures may not. Some guidelines undoubtedly will save money by reducing the use of inappropriate services; some will increase costs by encouraging more use of underutilized services; and some will shift costs from one service or place or payer to another. The net impact on costs cannot be predicted with confidence, even if the priorities for guidelines development focus on clinical conditions for which overuse of expensive services is suspected. Nevertheless, if guidelines do succeed in improving the appropriateness and hence the value of this country's expenditures for medical care, then the endeavor will be a success. This committee believes that AHCPR's practice guidelines effort has real potential to advance the state of the art in this field. The conditions for such success are demanding but not out of reach. In particular, expectations for the agencyâand for practice guidelines per seâmust be realistic regarding timetables and results. All parties concerned must act in good faith and keep the credibility and accountability of their actions in mind. Strict regard for the scientific rigor of the process is critical as is avoidance of premature closure on a single method of guidelines development.
