Clinical Practice Guidelines We Can Trust (2011) / Chapter Skim
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7 Development, Identification, and Evaluation of Trustworthy Clinical Practice Guidelines
7 Development, Identification, and Evaluation of Trustworthy Clinical Practice Guidelines
Pages 187-204
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From page 187... ...
Finally, the committee urges that AHRQ continue to provide a clearinghouse function, through the NGC, but require higher standards for guideline inclusion and efficient identification of guidelines from certified organizations. AHRQ also should be involved in evaluation of the proposed standards, their effect on the quality of guidelines, and ultimately on patient care.
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From page 188... ...
Finally, the committee makes recommendations regarding the identification and certification of trustworthy CPGs, research on harmonization of inconsistent CPGs, and evaluation of the proposed standards and the impact of trustworthy clinical practice guidelines on healthcare and patient outcomes.
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From page 189... ...
(The committee addresses this problem of identifying trustworthy CPGs below.) Current CPG development generally is financed by each organization creating a guideline.
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From page 190... ...
SHOULD THERE BE A PROCESS TO IDENTIFY CPGS THAT MEET THE PROPOSED TRUSTWORTHY STANDARDS? With nearly 2,700 guidelines in the National Guideline Clearinghouse, numerous additional commercial guidelines, and an unknown number of others in existence, many addressing identi cal topics, users often face challenges in identification of guidelines based on high-quality development methods.
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From page 191... ...
Linking such identification to regulatory procedures, insurance coverage, payment systems, or quality measures is not within the committee's scope, but an official identification or certification of trustworthy CPGs is a goal. No organization or process in the United States currently distinguishes trustworthy CPGs.
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From page 192... ...
Certification of Organizations with Trustworthy CPG Development Procedures Alternatively, one could review organizations developing CPGs and their production procedures, certifying adherence to quality development standards. In that case, guidelines issued over a specified time period by certified organizations might be considered trustworthy.
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From page 193... ...
Compared to the CPG environment in the United States, which has a few hundred independent developers (the NGC includes more than 280 separate organizations developing CPGs) , NICE contracts with a relatively small number of organiza tions to produce various guidance forms, including clinical practice guidelines (NHS, 2009)
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From page 194... ...
At the same time, creation of the public–private certifying body would alert CPG developers of the new standards, encourage them to adopt the standards, and build on existing capacities. Because the certification process will entail significant costs, the committee believes the Secretary of HHS should develop a way to fund this certification mechanism by drawing on the resources of interested stakeholders without biasing its decision making or the public's perception that such a bias exists.
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From page 195... ...
Because PCORI funding originates from Medicare Trust Funds, rather than industry, risk of COI is limited and funds are more protected and steady than those requiring annual appropriations or private fundraising.1 1The Patient Protection and Affordable Care Act, Public Law 111-148, § 6301, 111th Cong. (March 23, 2010)
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From page 196... ...
The National Guideline Clearinghouse has served as a public, accessible repository of CPGs for a number of years and has an established role in the promulgation of new and updated guide lines. NGC reviews each CPG submitted to assure compliance with the clearinghouse's minimal standards, and requests additional information if needed.
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From page 197... ...
These syntheses high light the importance of coordination among various organi zations developing CPGs on similar topics, may highlight potential areas for harmonization, and offer assistance to CPG users. • The proposed standards will require additional NGC effort as current NGC abstraction does not require review of de velopment process data adequate to meet the requirements of the proposed standards.
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From page 198... ...
The standards are likely to reduce current and future levels of guideline duplication for several reasons: • The total number of CPGs produced may be smaller because some organizations will be unable to meet the standards. Those organizations either will choose not to produce infe rior guidelines or choose to use existing trustworthy CPGs if the topic is closely related to what they need.
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From page 199... ...
• If the NGC adopts higher standards for clearinghouse ad mission, fewer CPGs will be accessible and probably some what fewer will require harmonization now and in the fu ture because some CPGs that do not meet NGC standards will not be widely circulated. Whether or not commercial guideline developers choose to follow the proposed standards, to the extent they rely on existing CPGs from reputable developers, and to the extent there would be fewer CPGs in need of harmonization, commercial guidelines would contribute to the convergence toward existing, higher quality CPGs, rather than to a proliferation of poorer quality CPGs.
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From page 200... ...
The evidence base for a measure posted in the NQMC can be minimal -- at least "one or more research studies published in a National Library of Medicine indexed, peerreviewed journal, a[n] SR of the clinical literature, a CPG or other peer-reviewed synthesis of the clinical evidence, or a formal con sensus procedure involving expert clinicians and clinical researchers," and evidence from patients for measures of patient experience, as well as documentation concerning use of the measure (NQMC, 2010)
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From page 201... ...
Without evaluation of the recommended guideline development process and interventions to promote CPG implementation, it will not be known whether the standards give rise to development of unbiased, scientifically valid, and trustworthy CPGs, or whether implementation of IOM standards-based CPGs gives rise to improved health outcomes. The committee believes answering questions related is important, such as, • What are strengths and weaknesses in the current execution of standards and how might the standards be revised before broad distribution (e.g., what is the optimal model of GDG SR relationship, what is the optimal method of involving consumers, etc.)
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From page 202... ...
The recommendations below should help to improve the quality of CPGs available for their use. RECOMMENDATION: DEVELOPMENT, IDENTIFICATION, AND EVALUATION OF TRUSTWORTHY CPGS • The Secretary of HHS should establish a public–private mechanism to examine, at the request of developer orga nizations, the procedures they use to produce their clinical practice guidelines and to certify whether these organiza tions' CPG development procedures comply with stan dards for trustworthy CPGs.
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From page 203... ...
Presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. McClure, J
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