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Special Communication
July 2016

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

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
Abstract

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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