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.
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