utilization of services that are effective but underused, and target services to those populations most likely to benefit (Grimshaw and Russell, 1993).

Underlying the effort to produce evidence-based guidelines is a pressing need for trusted information on clinical effectiveness. As described earlier, in recent years there has been a substantial increase in the number of treatment alternatives available to providers and patients, as well as in the volume of studies describing the effectiveness (or ineffectiveness) of those options. This body of evidence has become complex and difficult to manage for most providers. As a result, guidelines have become a key tool for summarizing the available literature and placing it in a format accessible to physicians (Druss and Marcus, 2005).

This chapter has three principal objectives: (1) to review the current landscape of clinical practice guideline development in the United States, (2) to present the committee’s recommendations for creating trusted clinical practice guidelines, and (3) to highlight key challenges in promoting the development and adoption of high-quality guidelines under the aegis of a proposed national clinical effectiveness assessment program (“the Program”).


Clinical practice guidelines attempt to define practices that meet the needs of most patients under most circumstances. They do not attempt to supplant the independent judgment of clinicians in responding to particular clinical situations. Ideally, the specific clinical recommendations that are contained within practice guidelines have been systematically developed by panels of experts who have access to the available evidence, an understanding of the clinical problem and the relevant research methods, and sufficient time to absorb the information and make considered judgments (GRADE Working Group, 2004). These panels are expected to be objective and to produce recommendations that are unbiased, up-to-date, and free from conflict of interest.

Groups that measure provider performance frequently use adherence to clinical practice guidelines as a basis upon which to evaluate the quality of care, and many payers are now moving toward the use of pay-for-performance strategies that establish differential payments on the basis of adherence to quality measures. In addition to performance-based payment, with the increased use of health information technology and direct decision support at the point of care, guidelines are likely to become increasingly influential in clinical practice (O’Malley et al., 2007).

Perhaps the earliest guidelines produced in the United States were the American Academy of Pediatrics’ Redbook of Infectious Diseases, pub-

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