Institute of Medicine Makes Recommendations on Producing Trustworthy Guidelines

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Mar 28, 2011, 06:43 ET

Organizations also acknowledge Archives of Internal Medicine Article

DALLAS, March 28, 2011 /PRNewswire-USNewswire/ -- Few issues are more important to the American College of Cardiology and the American Heart Association than translating scientific evidence into guidelines and performance measures for healthcare providers, a process we have been engaged in for several decades. The use of these evidence-based guidelines has been proven to improve the quality of care and actual outcomes for patients. We applaud the IOM for its new report and share its position that it is critical that no commercial or any other bias can be allowed to influence the development of clinical practice guidelines.

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The new Institutes of Medicine report, "Clinical Practice Guidelines We Can Trust," published March 23, 2011, cites the American College of Cardiology and American Heart Association's standards for guideline development as being almost perfectly aligned with their recommendations.

Both the AHA and ACC also appreciate the focus on the issue in the Archives of Internal Medicine article by Mendelson et al, which analyzes the disclosure of relationships with industry in joint guidelines developed by the American College of Cardiology and American Heart Association between 2004 and 2008.

Both the American College of Cardiology and the American Heart Association have long had strict policies for preventing any undue influence of industry. In 2004-2008, these policies relating to practice guidelines included the requirements that:

All writing panel members must verbally disclose all relevant relationships with industry at every meeting and conference call.
Individual panelists with a relationship with industry were held responsible to recuse themselves from any matter relevant to their relationship.
All disclosures would be published as an appendix to each guideline.
Multiple tiers of reviewers assured the lack of bias of each guideline document.

As the Archives article states, the American College of Cardiology and the American Heart Association refined their policies in 2010 to require even more stringent management of relationships with industry, to align with the Council of Medical Specialty Societies (CMSS). Thus the data within and the conclusions drawn by the article do not reflect the reality of the guidelines development process today.

Updated practices include these additions:

The Chair of the guidelines writing panel may not have any relevant relationships with industry.
In addition to the Chair, a majority (at least 50 percent) of guidelines writing committee members must not have any relevant relationships with industry.
A writing committee member may not draft a recommendation nor any text nor vote on any recommendation that is relevant to any of their industry relationships.
Members of the final approving bodies of both ACC and AHA, Science Advisory Coordinating Committee and the Board of Trust respectively, also must recuse themselves from voting if they have a relevant relationship with industry.

For determining eligibility to serve on a writing committee, a person is considered to have a relevant relationship IF:

The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or
The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or
The person or a member of the person's household has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.

The American College of Cardiology and the American Heart Association remain fully committed to transparency in the development of all our guidelines. We will continue to look closely at our policies regarding relationships with industry and welcome public dialogue that may help us continue to enhance our practices in the future.

The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding.

The ACC adheres to strict guidelines regarding its relationships with industry and the funding it receives to carry out its mission to advocate for improved quality cardiovascular care and to promote science, workforce development, diversity, medical education and lifelong learning. As such, the College is transparent in disclosing its funding sources. The ACC annually reports sources of industry support and displays this information on its website, www.cardiosource.org.

The American College of Cardiology is transforming cardiovascular care and improving heart health through continuous quality improvement, patient-centered care, payment innovation and professionalism. The College is a 39,000-member nonprofit medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at http://www.cardiosource.org/ACC.

The American Heart Association is the nation's oldest and largest voluntary health organization dedicated to fighting heart disease and stroke. Our mission is to build healthier lives by preventing, treating and defeating these diseases. We fund cutting-edge research, conduct lifesaving public and professional educational programs, and advocate to protect public health. To learn more or join us in helping all Americans, call 1-800-AHA-USA1 or visit www.heart.org.

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