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Scientific Articles   |    
Randomized Trials in Surgery: How Far Have We Come?
S. Samuel Bederman, MD, PhD, FRCSC1; James G. Wright, MD, MPH, FRCSC2
1 Department of Orthopaedic Surgery, University of California at Irvine, 101 The City Drive South, Pavilion III, Orange, CA 92868. E-mail address: sbederma@uci.edu
2 Department of Orthopaedic Surgery, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at the Department of Orthopaedic Surgery, University of California at Irvine, Orange, California


Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jul 18;94(Suppl 1(E)):2-6. doi: 10.2106/JBJS.K.01627
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Abstract

Abstract: Randomized controlled trials continue to be at the pinnacle of the evidence hierarchy. With this unique vantage point, they inform medical practice, clinical guidelines, health policy, and reimbursement. Prior to an emphasis on randomized controlled trials, traditional clinical research consisted primarily of uncontrolled case series and expert opinions. Randomized controlled trials are a true experiment in clinical practice and provide the most valid answers to clinical questions by reducing bias originating from patients, providers, and investigators. Riding on the coattails of other medical subspecialties, orthopaedic surgeons have recognized the importance of evidence-based medicine. From 1975 to 2005, the number of Level-I studies increased over fivefold and comprised >20% of studies published in The Journal of Bone and Joint Surgery (American Volume) (JBJS). With the emergence of comparative effectiveness research, the definition and methods of best evidence may continue to evolve. In conclusion, substantial improvements in both the quantity and the quality of randomized controlled trials in orthopaedic surgery have occurred, although unique considerations still limit their widespread use.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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