Key result
A Users' Guide to the Medical Literature reviews methodological issues in surgical trials, including randomization, blinding, and sham controls, to help clinicians appraise surgical evidence.
This guide provides clinicians with methodological considerations for critically appraising randomized clinical trials of surgical procedures.
May improve appraisal of surgical RCTs by clinicians; leaves open optimal designs for blinding and sham controls.
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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Evaniew et al. (2016) conducted a review in Surgical procedures. A Users' Guide to the Medical Literature reviews methodological issues in surgical trials, including randomization, blinding, and sham controls, to help clinicians appraise surgical evidence.
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