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Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials

  • Original Article
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Clinical Orthopaedics and Related Research

Abstract

Empiric data and theoretical arguments suggest an alternative randomized clinical trial (RCT) design, called expertise-based RCT, has enhanced validity, applicability, and ethical integrity compared with conventional RCT. Little is known, however, about whether physicians will participate in an expertise-based RCT. In a cross-sectional survey of Canadian orthopaedic surgeons, we evaluated preference for and willingness to participate in an expertise-based versus a conventional RCT if given the opportunity to participate in a trial investigating the effectiveness of high tibial osteotomy versus unicompartmental knee arthroplasty. Using an electronic survey (©2005 SurveyMonkey.com), we invited all 767 members of the Canadian Orthopaedic Association (2005) to participate; 276 surgeons completed the questionnaire (37.5% response rate). One hundred two surgeons (53.4%) were willing to participate in an expertise-based RCT compared with 35 surgeons (18.3%) willing to participate in a conventional RCT. Ninety-seven surgeons (52.4%) strongly or moderately preferred the expertise-based design compared with 25 (13.5%) who preferred the conventional design. For the clinical example we presented, the majority of Canadian orthopaedic surgeons were willing to participate in and preferred the expertise-based design. The expertise-based randomized clinical trial design may overcome some of the barriers to conducting clinical trials in orthopaedic surgery and improve the validity of their conclusions.

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Acknowledgments

Expertise-Based Working Group: Elzbieta Bednarska, Mohit Bhandari, Dianne Bryant, Jason Busse, Claudio Cina, Deborah Cook, P.J. Devereaux, Gordon Guyatt, Brian Haynes, Diane Heels-Ansdell, Brad Johnston, Mary Law, Joy MacDermid, Tara Mastracci, Ed Mills, Victor Montori, David Sackett, Holger Schünemann, Stephen Walter, Salim Yusuf, and Qi Zhou.

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Correspondence to Dianne Bryant MSc, PhD.

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Each author certifies that he or she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.

Each author certifies that his or her institution has approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

Appendix 1. Surgeons’ Survey

Appendix 1. Surgeons’ Survey

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Bednarska, E., Bryant, D., Devereaux, P.J. et al. Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials. Clin Orthop Relat Res 466, 1734–1744 (2008). https://doi.org/10.1007/s11999-008-0273-9

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  • DOI: https://doi.org/10.1007/s11999-008-0273-9

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