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Standards for Developing Trustworthy Clinical Practice Guidelines

Completed

The committee will conduct a study to recommend standards for developing clinical practice guidelines and recommendations. The standards should ensure that clinical practice guidelines are unbiased, scientifically valid, and trustworthy and also incorporate separate grading systems for characterizing quality of available evidence and strength of clinical recommendations.

Description

An ad hoc committee will conduct a study to recommend standards for developing clinical practice guidelines and recommendations. The standards should ensure that clinical practice guidelines are unbiased, scientifically valid, and trustworthy and also incorporate separate grading systems for characterizing quality of available evidence and strength of clinical recommendations. In this context, the committee should:(1) Assess whether, if widely adopted, any existing set of standards would assure the development of unbiased, scientifically valid, and trustworthy clinical practice guidelines.(2) Endorse an existing set of standards for developing clinical practice guidelines. If the committee judges current standards to be inadequate, it will develop a new set of standards.(3) Determine best practices for promoting voluntary adoption of the standards.The project is sponsored by the U.S. Department of Health and Human ServicesThe approximate start date for the project was July 13, 2009.A report will be issued at the end of the project in approximately 21 months.Note: Please see the companion study on “Standards for Systematic Reviews of Comparative Effectiveness Research” that is also posted in the Current Projects System.

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Conflict of Interest Disclosure

Disclosure of Conflict of Interest: Raymond Gibbons

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, at least one person who has been involved in a leadership capacity in all aspects of the development of high quality clinical practice guidelines.

To meet the need for this expertise and experience, Dr. Raymond Gibbons is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he has played a leadership role in, and is strongly identified with, the development of a number of practice guidelines for the American Heart Association and the American College of Cardiology. The committee’s study of standards for developing clinical practice guidelines will involve, at least indirectly, consideration of the appropriateness of the standards followed in developing the guidelines with which Dr. Gibbons is associated.

As his biographical summary makes clear, Dr. Gibbons is a nationally recognized expert in clinical practice guidelines development. His familiarity with all aspects of the complex process of clinical practice guidelines development is critical for the committee in meeting its task. We believe that Dr. Gibbons can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

After an extensive search, we have been unable to find another individual with experience and expertise equivalent to Dr. Gibbons who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Sponsors

Agency for Healthcare Research and Quality

Staff

Robin Graham

Lead

Major units and sub-units

Health and Medicine Division

Lead

Institute of Medicine

Lead

Board on Health Care Services

Lead

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