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Special Communication |

How to Use a Randomized Clinical Trial Addressing a Surgical Procedure Users’ Guide to the Medical Literature

Nathan Evaniew, MD1,2; Alonso Carrasco-Labra, DDS, MSc1,3; P. J. Devereaux, MD, PhD, FRCPC1,4; Kari A. O. Tikkinen, MD, PhD5,6; Yutong Fei, MD, PhD1,7; Mohit Bhandari, MD, PhD, FRCSC1,2; Gordon Guyatt, MD, MSc, FRCPC1,8
[+] Author Affiliations
1Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
2Division of Orthopaedics, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
3Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile
4Population Health Research Institute, Hamilton, Ontario, Canada
5Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
6Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
7Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
8Department of Medicine, McMaster University, Hamilton, Ontario, Canada
JAMA Surg. 2016;151(7):657-662. doi:10.1001/jamasurg.2016.0072.
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Because surgical procedures require clinicians to develop and maintain procedural expertise and because blinding in randomized clinical trials of such therapies is often challenging, their critical appraisal raises unique issues. Risk of bias of trials of surgical procedures increases if investigators fail to rigorously conceal allocation and, where possible, to ensure blinding of those involved in the trial. Variability in surgeons’ expertise can also increase bias and lead to important limitations in applicability. To address these issues, this Users’ Guide to the Medical Literature reviews the use of remote randomization systems, blinding, sham-controlled trials, split-body trials, expertise-based trials, and mechanistic vs practical trials. Consideration of risk of bias and applicability issues will allow clinicians to make optimal use of trials addressing surgical procedures.

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