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

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.