Editors of several medical research journals have issued a statement calling for rigorous standards and transparency in research that is designed to influence patient care and health policy.
Led by Dr. Harold Sox, co-chair of the 2009 US Institute of Medicine Committee on Comparative Effectiveness Research Prioritization, the statement's author list includes editors of Medical Decision Making, Trials, The Cochrane Library, Journal of Clinical Epidemiology, and PLoS Medicine. Editors of Journal of General Internal Medicine, The American Journal of Managed Care, Clinical and Translational Science, and Croatian Medical Journal have also endorsed the statement.
Comparative effectiveness research (CER) compares the benefits and harms of different medical tests, treatments and procedures, and provides evidence to support clinicians, patients, and policy makers in deciding which approaches to use. Noting that "the challenge will be to realize the full potential of such research to improve health," the editors call on medical journals to "use rigorous approaches... to assess the limitations inherent in such research, such as missing data, incomplete follow-up, unmeasured biases, the potential role of chance, competing interests, and selective reporting of results."
The statement includes a list of 11 standards for the conduct and reporting of CER studies, including involvement of patients in selecting and refining research topics, public registration of research protocols prior to beginning a study, inclusion of representative populations in CER studies, rigorous peer review by independent experts, free availability and public archiving of study publications, and public declaration of all relevant competing interests.
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Public Library of Science