NHLBI Clinical Guidelines Development
Statement from Barbara Alving, M.D., Acting Director of the National Heart, Lung, and Blood Institute

The National Heart, Lung, and Blood Institute (NHLBI) coordinates the development of clinical practice guidelines under the auspices of several national health education programs. The Institute seeks to ensure the scientific objectivity of these clinical guidelines and updates to guidelines through a variety of mechanisms. Expert panel members are carefully selected, multiple levels of reviewers scrutinize the drafts of the guidelines, and financial disclosure is published by the peer-reviewed journal in the report of the guidelines.

The members of expert panels charged with developing guidelines are selected for their scientific and medical expertise, their stature and track record in the field, and their integrity. Individuals who are most expert in a subject area are the ones most suitable to serve on a guideline panel for assessing the science and developing clinical recommendations. They are also often the very people whose advice is sought by industry. Most if not all guideline panels therefore include experts who interact with industry. However, a careful development and review process ensures objective and scientifically-based guidelines.

The guideline panel conducts a thorough search of the scientific literature and critically evaluates the relevant studies. This examination provides the foundation for developing evidence-based recommendations. Drafts of guideline reports are reviewed by the coordinating committees of the education programs and outside reviewers in an iterative process until the report is ready for approval.

In the case of the recent update to the Adult Treatment Panel III cholesterol guidelines, the members of the working group were selected for their expertise primarily from the members of the expert panel that developed the original ATP III guidelines released in 2001. In addition, the working group included an expert representative of the American College of Cardiology and of the American Heart Association.

The working group critically reviewed the 5 relevant clinical trials and assessed the implications of the trials for the ATP III guidelines. When the update had been drafted, it was subjected to multiple layers of scientific review, first by the Coordinating Committee of the National Cholesterol Education Program, consisting of 35 representatives of leading medical, public health, voluntary, community, and citizen organizations and Federal agencies, and then by the scientific and steering committees of the American Heart Association and the American College of Cardiology. Approximately 90 reviewers were involved in the review of the draft. Their review was the basis for the endorsement of the update by the National Heart, Lung, and Blood Institute, American College of Cardiology, and American Heart Association.

Financial disclosure for the working group members who served on ATP III was made in the Executive Summary of the ATP III report published in JAMA in 2001 (285:2486-2497).

The NHLBI recognizes the desirability of having the financial disclosure information as publicly accessible as possible. We have therefore placed the financial disclosure for all 9 working group members on the NHLBI website where the update appears. (http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm.)

The NHLBI's approach to identifying and managing potential conflict of interest in guideline development includes careful selection of expert panel members, multiple levels of review, and financial disclosure in the peer-reviewed journal report. Because disclosure policies and practices differ among journals, the NHLBI is developing a policy for placement of financial disclosure information on the Institute's Web Site.

The recommendations in the ATP III update, like other guidelines from the NHLBI, are derived from a careful and objective analysis of the evidence. By translating the science into practical recommendations for both health care professionals and the public, these guidelines are a valuable contribution to improving the cardiovascular health of the nation.

A copy of the ATP III update can be found online at http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm. A press release on the ATP III update can be found at http://www.nhlbi.nih.gov/new/press/04-07-12.htm.