limited to representation in the group drafting the guidelines; it can extend to participation in hearings, reviews, pretests, and similar activities. Such an inclusive approach, although potentially requiring more time and funds, can help developers of guidelines better understand the situations in which guidelines may be applied.

The sense of this committee, therefore, is that planning for implementation and later evaluation of guidelines must take place during the development phase. What does or does not happen at the development stage may materially affect the success or failure of a set of guidelines, independent of the quality of the implementing efforts that follow. The examination of guidelines implementation in Chapters 3, 4, 5, and 6 underscores this point and leads to further discussion of guidelines development in Chapter 7.

The succeeding sections of this chapter first describe the major types of organizations involved in guidelines development in both the public and private sectors and then discuss how the enterprise is evolving. The chapter closes with a brief commentary on methods and costs of guideline development. For this overview, the study committee relied heavily on the published literature, its site visits, the public hearing, focus groups, and other study activities, as well as on its own expertise.


Systematic efforts to develop clinical practice guidelines have grown dramatically in recent years. Professional societies, public agencies, health care institutions, and researchers have become appreciably more active and visible in the guidelines arena (Woolf, 1990b; Kosterlitz, 1991); the field also has at least one regular newsletter, Report on Medical Guidelines and Outcomes Research (Robinson, 1991). According to the American Medical Association (AMA), 8 physicians organizations reported active involvement in developing guidelines before 1980; now, more than 50 organizations can report such activity (AMA, 1991a). 1 The creation in 1989 of the Agency for Health Care Policy and Research (AHCPR), and its Forum for Quality and Effectiveness in Health Care, provided new focus and visibility for public-sector activities. Insurers, health maintenance organizations (HMOs), and other private organizations have also become more active.

This pluralism of sponsorship reflects the breadth of interest in guidelines, the special concerns of different sponsors, and the varying outlooks on what topics warrant guideline development and by what methods (Audet


The AMA publishes a Directory of Practice Parameters (AMA, 1991a); as of late 1991, it listed and cross-referenced 1,319 practice parameters developed by 45 U.S. organizations and provided information on how to obtain the actual parameters. The AMA also publishes quarterly updates of this directory, indicating newly completed and withdrawn guidelines.

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