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Emerging Designs in Orthopaedics: Expertise-Based Randomized Controlled Trials
Vanessa A. Scholtes, PhD1; Thomas H. Nijman, MD1; Loes van Beers, Msc1; P.J. Devereaux, MD, PhD2; Rudolf W. Poolman, MD, PhD1
1 Department of Orthopaedic Surgery, Joint Research, Onze Lieve Vrouwe Gasthuis, PO Box 95500, 1090 HM, Amsterdam, The Netherlands. Email address for V.A. Scholtes: v.a.b.scholtes@olvg.nl
2 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, 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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Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jul 18;94(Suppl 1(E)):24-28. doi: 10.2106/JBJS.K.01626
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Abstract

Abstract: 

In this article, we discuss the limitations of conventional randomized controlled trials (RCTs) in the surgical field. Surgeons are often believers in certain surgical techniques and therefore can be reluctant to learn new interventions. In expertise-based trials, the patients are randomized to surgeons with expertise in the intervention under investigation. In conventional RCTs, patients are randomized to an intervention, and surgeons will perform this intervention regardless of whether this is the surgery they typically undertake. Conventional randomization may lead to surgery performed by a less experienced or less motivated surgeon, resulting in differential expertise bias. Expertise-based trials can overcome these limitations if potential pitfalls are taken into account.

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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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