Is the Guideline Process Replicable and, if Not, What Does This Mean? Allan Sniderman a, ⁎ , Curt D. Furberg b , Peter P. Toth c , George Thanassoulis d a Mike Rosenbloom Laboratory for Cardiovascular Research, McGill University Health Centre, Montreal, Quebec, Canada b Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA c CH Medical Center, Sterling, Illinois and Ciccarone Center for Cardiovascular Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA d Preventive and Genomic Cardiology, Department of Medicine, Royal Victoria Hospital, McGill University Health Centre, Montreal, Quebec, Canada ARTICLE INFO ABSTRACT Increasingly, guidelines determine how medical care will be provided. However there has been limited study of the determinants of the reliability of the guideline process. Guidelines translate evidence into recommendations. If only the evidence determines the recommendations, given the same evidence, different panels of experts should make the same recommendations. That is, the process should be replicable, an essential characteristic of a valid scientific process. The multiple recent cholesterol guidelines, which have considered the same evidence, offer an opportunity to examine guidelines from this perspective. Considerable discordance among the guideline recommendations is evident pointing to an important role for the participants, in addition to the evidence, in the development of guideline recommendations. Guideline recommendations, therefore, appear to be based on both evidence and expert opinion. © 2015 Elsevier Inc. All rights reserved. Keywords: Guidelines LDL-C Cardiovascular prevention Evidence-based medicine Cardiovascular risk Background and objective The practice of medicine is now governed by guidelines. The recommendations of guidelines have become the standard of care and, increasingly, reimbursement is linked to adherence. The knowledge base on which trainees are evaluated is the knowledge base defined by guidelines. The knowledge base on which recertification is based is the knowledge base defined by guidelines. To pretend otherwise is to deny the reality that the practice of medicine is now governed to an increasing degree by the paradigm of evidence-based medi- cine (EBM) and its product-guideline-based care. We accept that values of EBM do not differ from the classical values of medical care of which the principal one is to ensure the best possible outcome for each individual patient. 1 What is different is that EBM has become a method to decide how that should be determined, a method in which best care for an individual patient is based, to the greatest extent possible, on the results of what has occurred in groups of patients studied under the most controlled circumstances possible—the randomized clinical trial (RCT). The strengths and limitations of the RCT as an experimental tool are not the focus of this essay. Rather, our purpose is to examine this process: the translation of evidence by experts into recommendations. PROGRESS IN CARDIOVASCULAR DISEASES 58 (2015) 3 – 9 Statement of Conflict of Interest: see page 8. ⁎ Address reprint requests to Allan D. Sniderman, MD, FRSC, Mike Rosenbloom Laboratory for Cardiovascular Research, Royal Victoria Hospital, McGill University Health Centre, 687 Pine Avenue West, Montreal, Quebec, H3A 1A1 Canada. E-mail address: allansniderman@hotmail.com (A. Sniderman). http://dx.doi.org/10.1016/j.pcad.2015.05.002 0033-0620/© 2015 Elsevier Inc. All rights reserved. Available online at www.sciencedirect.com ScienceDirect www.onlinepcd.com