Knowing What Works in Health Care A Roadmap for the Nation (2008) / Chapter Skim
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5 Developing Trusted Clinical Practice Guidelines
5 Developing Trusted Clinical Practice Guidelines
Pages 121-152
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From page 121... ...
Overall, the quality of clinical practice guidelines is often poor. The committee recommends that the Program establish stan dards for guideline development but also promote voluntary adoption of Program standards by guideline developers.
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From page 122... ...
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)
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From page 123... ...
and tasked it with developing clinical practice guidelines, among its other responsibilities. The Institute of Medicine (IOM)
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From page 124... ...
Guideline Developers As described in Chapter 2, many groups produce clinical practice guidelines and recommendations. The National Guideline Clearinghouse (NGC)
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From page 125... ...
CURRENT LANDSCAPE Quality of Guidelines The IOM Committee on Clinical Practice Guidelines defined highquality guidelines as having a number of attributes, including validity, reliability, reproducibility, clinical applicability and flexibility, clarity, development through a multidisciplinary process, scheduled reviews, and documentation (IOM, 1992)
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From page 126... ...
In addition, it remains true that, aside from the role that AHRQ plays in populating the NGC website, no independent entity exists in the United States to certify guideline quality or to develop national standards regulating the content or methods of guideline developers. The 1990 IOM report Clinical Practice Guidelines: Directions for a New Program sought to encourage more standardization and consistency in guideline development, and although the quality of clinical practice guidelines has generally improved since then, substantial inconsistencies in the methodologies and reporting language used still exist (Guyatt et al., 2006b; Shiffman et al., 2003)
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From page 127... ...
Two examples of such challenges are the approaches to limitations in the evidence base and subjective assessments of the net benefit. Limitations of the evidence base The evidence base that supports clinical practice guidelines is often quite limited and guideline developers must often wrestle with what to do when "the irresistible force of the need to offer clinical advice meets with the immovable object of flawed evidence" (Ricci et al., 2006, p.
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From page 128... ...
Table 5-1 illustrates how the USPSTF addresses net benefit in its strength of recommendation categories. Although some bodies of evidence show a high degree of benefit and few harms, in many cases the benefit and harm seem to be more closely balanced and it is much more difficult to justify a strong recommendation.
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From page 129... ...
have indicated that when value or preference judgments are particularly important to the recommendation, guideline development panels should describe the key values attached to these outcomes, and how they influenced the content or strength of the recommendation. Guideline development panels often do not include patients or consumers as members, and they may not seek patient input when weighing particular health states (Guyatt et al., 2006a)
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From page 130... ...
have argued that guideline development panels with multidisciplinary representation may produce more reliable results because such a structure can balance the biases of the various individuals on the panel. The IOM Committee to Advise the Public Health Service on Clinical Practice Guidelines found that multidisciplinary participation (1)
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. Conflict of interest is a problem for guideline developers as well.
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. Pluralistic Approach to Guideline Development The current approach to developing clinical recommendations in the United States is highly decentralized.
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The NIH Consensus Development Conferences also seek to inform clinical practice, and now contracts with EPCs for systematic reviews of the evidence, although they do not produce practice guidelines. Multiple Conflicting Guidelines One of the challenges inherent in having such a decentralized, pluralistic process is that often multiple groups produce guidelines in the same clinical topic area.
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From page 134... ...
Efforts to Improve Guidelines Consensus Building Recognizing that in some clinical areas multiple organizations may seek to develop guidelines, some groups have developed collaborative activities that promote consensus in clinical practice guidelines. For example, the
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have jointly produced clinical practice guidelines since the 1980s. Because their guidelines are intended for use by a broad range of health providers, the ACC/AHA writing committees often include representatives of other organizations, including other groups specializing in the cardiovascular field, such as the American College of Chest Physicians, and other specialties such as the American Academy of Family Practice and the American College of Physicians.
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. Among the more prominent efforts to standardize and raise the quality of clinical practice guidelines are the Appraisal of Guidelines Research and Evaluation (AGREE)
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. The AGREE instrument for assessing the quality of clinical practice guidelines is a result of an international collaboration that originated in Europe in 1998.
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. Yet physicians often do not agree that the standards being promoted through clinical practice guidelines represent the best course of action for their patients (Cabana et al., 1999)
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From page 139... ...
Common Standards Clinical practice guidelines vary widely in their methodological rigor and protection from bias; however, in the current environment, the organizations and individuals who use guidelines have very limited means to assess their objectivity or accuracy. The committee recommends several steps to ensure that the information communicated through practice guidelines is trustworthy.
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From page 140... ...
Currently, patients and providers often make decisions in the absence of guidance in cases in which evidence reviews and practice guidelines have not been completed. Likewise, health plans and purchasers must make rapid coverage decisions regardless of whether or not guidelines are available.
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From page 141... ...
Common Language The committee believes that a common language that expresses the strength of clinical practice recommendations should be an essential feature of the guideline development and reporting process. The use of a common language for all clinical practice recommendations is an efficient way to communicate the strength of evidence and assist end users with assessing the outputs of the various organizations that produce guidelines.
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From page 142... ...
The committee believes that a common language that describes both the quality of the underlying evidence and the strength of recommendations is an important tool for promoting greater consistency among clinical practice guideline developers. This common language will reduce the requirements placed on end users in sorting through and navigating all the various terms, symbols, and expressions that currently exist.
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From page 143... ...
These biases can occur at the individual, panel, and organizational levels. Groups and organizations that develop clinical practice guidelines should address each of these to ensure that the end users view their guidelines as credible and trustworthy.
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would not be recognized as appropriate sponsors of clinical practice guidelines. Given the extent to which these types of conflicts exist in the current environment, the second "pure" model seems largely impractical.
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strict standards to protect against bias and ensure that clinical practice guideline producers are adhering to these standards. In particular, the committee identified the following measures as a means of improving the quality of the information provided by guideline developers: Recommendation: To minimize bias due to conflicts of interest, panels should include a balance of competing interests and diverse stakehold ers, publish conflict of interest disclosures, and prohibit voting by members with material conflicts.
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From page 146... ...
Moreover, the rigors of their processes are highly variable; and many guideline developers do not have the resources or the ability to meet a set of structure, process, and product standards that are externally imposed. Nevertheless, ensuring the quality and the usability of the information provided in clinical practice guidelines is vital to the performance of the health system and there is a need to promote compliance with these new guideline standards.
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From page 147... ...
Although the documentation that guideline developers provide may not be complete, gaps in that information may serve as a red flag for the end users. In addition, through increased transparency and openness in the guideline development process, the accuracy of the information reported will be more easily verified.
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1999. Why don't physicians follow clinical practice guidelines?
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2000. Practice guidelines developed by specialty societies: The need for critical appraisal.
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2003. Standardized reporting of clinical practice guidelines: A proposal from the Confer ence on Guideline Standardization.
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1994. Internists' attitudes about clinical practice guidelines.
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