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CONCLUSIONS AND RECOMMENDATIONS 104 make their review activities as manageable and nonintrusive as possible for all those affected by the guidelines. Such organizations are one contributor to the perceived and real "hassle factor" in medical care, which grows out of burgeoning demands by payers and others for more information and justification for services delivered or proposed. The Forum needs to be sensitive to this issue during the guidelines development phase; it also needs to work with HCFA and other organizations to minimize negative effects from poor translation of otherwise good guidelines into review criteria, from unduly stringent application of such criteria, or both. As noted previously, early involvement of provider groups and respected representatives of review organizations, such as the Medicare PROs, is desirable as one means of enhancing the later manageability of guidelines. Fourth, review organizations should, insofar as possible, provide constructive information and feedback to physicians and other clinicians. This material, and its mode of presentation, should aim to improve practice rather than punish missteps, a view consistent with the overall strategy proposed by the IOM in its Medicare quality assurance study (1990). Regardless of their form, guidelines will not be successful if they are perceived (correctly or not) as vehicles solely for the external control of an obdurate professional community, and the Forum needs to be sensitive to this point. With respect to evaluation, the study committee believes that the OBRA 89 timetable is unrealistic. The Secretary of Health and Human Services is due to report on the impact of the first three guidelines by January 1, 1993. It is unlikely that these guidelines would have measurable effects on health care or costs that quickly, and even if they did, it is unlikely that appropriate data on patient outcomes and program costs would be available and analyzed. Instead of a full-fledged evaluation, the agency can more reasonably be expected to provide a report on its evaluation plan, the steps being taken to implement the plan, and any preliminary evidence of impact. DIVERSITY IN CLINICAL PRACTICES AND GUIDELINES In its discussions, the committee repeatedly returned to questions of diversity in clinical practice and inconsistency among guidelines. Diversity in clinical practice can be acceptable or unacceptable. It may be reasonable when the scientific evidence to support different courses of care is uncertain. In addition, some degree of diversity may be warranted by differences in individual patient characteristics and preferences and variations in delivery system capacities related to locale, resources, and patient populations. However, even though practice variation based on scientific uncertainty or differences in values may be acceptable, both science and values are
CONCLUSIONS AND RECOMMENDATIONS 105 open to change. Thus, what is perceived as acceptable diversity in clinical practice may change over time. Diversity in practice is unacceptable when it stems from poor practitioner skills, poor management of delivery systems, ignorance, or deliberate disregard of well-documented preferable practices. It should not be tolerated when it is a self- serving disguise for bad practices that harm people or waste scarce resources. Guidelines can clarify what is acceptable and unacceptable variation in clinical practice, but that clarification itself has limits that may lead different groups to different and even inconsistent guidelines. Weak evidence is still weak evidence, although the processes described in Chapter 3 should allow the best use of whatever evidence is available. For example, the more formal methods of analyzing and characterizing evidence can reduce the opportunity for inconsistency arising from poor analysis of evidence. Nonetheless, these methods can still leave room for differences of expert opinion about such issues as whether a flaw in research design "matters" or whether differences in results between two treatment alternatives are "clinically important" or only "statistically significant." Inconsistency among guidelines can also arise from variations in values and tolerance of risk. People may simply differ in how they perceive different health outcomes and how they judge when benefits enough outweigh harms to make a service worth providing. One way to approach this kind of variation is for guidelines developers to try to establish practitioner and patient attitudes toward different benefits and harms and then identify what is known about the probabilities of those different outcomes. In some cases, the developers of guidelines take the further step of applying their own values, but others considering the guidelines later might look at the same information and perhaps come to different conclusions. Also, for some services and clinical conditions, the developers of guidelines may choose not to recommend one 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.