• increased concern about competing and conflicting guidelines, locally adapted guidelines, and transformed versions of guidelines (such as medical review criteria).

More generally, experience with guidelines development is highlighting two rather different (but not mutually exclusive) emphases in or orientations to the process of guidelines development. One approach stresses the significance of the science base for guidelines and the use of quantitative modeling in systematically estimating and comparing outcomes. The other approach stresses professional judgment in areas in which the science base is weak or nonexistent.

This duality need not and should not be seen as an unbridgeable dichotomy. Professional judgment must be applied to the science base, and science must inform professional judgment. When the science base is strong, however, it should not be disregarded in favor of consensus based on customary practice. When consensus is not consistent with the evidence, the case for consensus should be explicitly and persuasively argued.

This chapter begins with a brief discussion of how certain key players in the guidelines arena have evaluated and refined their organizational structures and procedures over the years. Following are several sections that examine persistent issues about methods for developing guidelines, approaches that selected groups have taken in dealing with these issues, and problems that warrant continued attention. A final section discusses the interface of development and implementation as it involves, first, conflicting "national" guidelines; second, local adaptation of existing or emerging "national" guidelines; and, third, formatting and dissemination of guidelines.

The discussion of attributes for review criteria in Chapter 5 and the discussion of cost analysis in Chapter 6 also relate to the theme of this chapter. Although the focus here is on practice guidelines, much of this chapter is also relevant to development of medical review criteria.

GENERAL STRUCTURES AND PROCEDURES

As organizations recognize the demands of developing guidelines in a credible and accountable manner, those entities that plan an ongoing involvement tend to initiate commonly used organizational processes. They create supporting committees, staff positions, procedures, record-keeping systems, budget justification mechanisms, communications links, and eventually, with more difficulty, mechanisms for evaluating performance and results. Certainly, organizational resources constrain what can be established, but if resources are too limited to create and maintain such organizational structures, they may also be too limited to support the development of products consistent with the attributes set forth in Chapter 1.



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