Neil J. Stone, Jennifer Robinson, Alice H. Lichtenstein, C. Noel Bairey Merz, Conrad B. Blum, Robert H. Eckel, Anne C. Goldberg, David Gordon, Daniel Levy, Donald M. Lloyd-Jones, Patrick

McBride, J. Sanford Schwartz, Susan T. Shero, Sidney C. Smith, Jr, Karol Watson and Peter W.F. Wilson

Association Goals: “ The goals of the American College of Cardiology (ACC) and the American Heart Association (AHA) are to prevent cardiovascular (CV) diseases, improve the management of people who have these diseases through professional education and research, and develop guidelines, standards and policies that promote optimal patient care and cardiovascular health.”

Association Collaboration: “ACC and AHA have collaborated with the National Heart, Lung, and Blood Institute (NHLBI) and stakeholder and professional organizations…”

Process:

I. 2008: In 2008, the NHLBI initiated these guidelines by sponsoring rigorous systematic evidence reviews for each topic by expert panels convened to develop critical questions (CQs), interpret the evidence and craft recommendations.”

II. 2011: “In response to the 2011 report of the Institute of Medicine on the development of trustworthy clinical guidelines (1), the NHLBI Advisory Council (NHLBAC) recommended that the NHLBI focus specifically on reviewing the highest quality evidence and partner with other organizations to develop recommendations (2,3).”

III. 2013: “ in June 2013 the NHLBI initiated collaboration with the ACC and AHA to work with other organizations to complete and publish the 4 guidelines noted above and make them available to the widest possible constituency.”

IV. The joint ACC/AHA Task Force on Practice Guidelines (Task Force) appointed a subcommittee to shepherd this transition.

V. The ACC/AHA and partner organizations recruited a limited number of expert reviewer.

VI. Expert Panel Selection: “Systematic evidence reports and accompanying summary tables were developed by the expert panels and NHLBI. The guideline was reviewed by the ACC/AHA Task Force and approved by the ACC Board of Trustees, the AHA Science Advisory and Coordinating Committee, and the governing bodies of partnering organizations. In addition, ACC/AHA sought endorsement by other stakeholders, including professional organizations. It is the hope of the writing panels, stakeholders, professional organizations, NHLBI, and the Task Force that the guidelines will garner the widest possible readership for the benefit of patients, providers and the public health.”

VII. Expert Panel Charge: “The Expert Panel was charged with updating the clinical practice recommendations for the treatment of blood cholesterol levels to reduce atherosclerotic cardiovascular disease (ASCVD) risk using data from randomized controlled trials (RCTs) and systematic reviews and meta-analyses of RCTs. For this guideline, ASCVD includes coronary heart disease (CHD), stroke, and peripheral arterial disease, all of presumed atherosclerotic origin. These recommendations are intended to provide a strong evidence-based foundation for the treatment of cholesterol for the primary and secondary prevention of ASCVD in women and men.”

VII. Transparency: “ In consultation with NHLBI, the policies adopted by the writing panels to manage relationships of authors with industry and other entities (RWI) are outlined in the methods section of each panel report. These policies were in effect when this effort began in 2008 and throughout the writing process and voting on recommendations, until the process was transferred to ACC/AHA in 2013. In the interest of transparency, the ACC/AHA requested that panel authors resubmit RWI disclosures as of July 2013.”

VIII. Buy-In: “Systematic evidence reports and accompanying summary tables were developed by the expert panels and NHLBI. The guideline was reviewed by the ACC/AHA Task Force and approved by the ACC Board of Trustees, the AHA Science Advisory and Coordinating Committee, and the governing bodies of partnering organizations. In addition, ACC/AHA sought endorsement by other stakeholders, including professional organizations. It is the hope of the writing panels, stakeholders, professional organizations, NHLBI, and the Task Force that the guidelines will garner the widest possible readership for the benefit of patients, providers and the public health.”

IX. Peer Review: “A formal peer review process was initially completed under the auspices of the NHLBI which included 23 expert reviewers and representatives of Federal agencies. This document was also reviewed by 4 expert reviewers nominated by the ACCF and the AHA when the management of the guideline transitioned to the ACC/AHA…This document was approved for publication by the governing bodies of the ACC and AHA and endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Pharmacists Association, American Society for Preventive Cardiology, Association of Black Cardiologists, Preventive Cardiovascular Nurses Association, and WomenHeart: The National Coalition for Women with Heart Disease.”