PLASTIC SURGICAL RANDOMIZED CONTROLLED TRIALS: CHALLENGES AND OPPORTUNITIES FOR EVIDENCE-BASED PLASTIC SURGERY, A SYSTEMATIC SCOPING REVIEW

Abstract

<p><em>Background:</em> There is a shifting culture toward evidence-based plastic surgery. The use of high-quality evidence in patient decision-making is essential. To help achieve this goal the best evidence in the field needs to be identified, and the validity of this evidence verified.</p> <p><em>Objective:</em> This systematic review was designed to evaluate the plastic surgery literature by focusing on the prevalence of, and examining key components of quality of, Randomized Controlled Trials (RCTs) comparing surgical interventions.</p> <p><em>Methods: </em>An electronic search of the pertinent plastic surgery literature identified all RCTs published from 2000 to 2013 that compared one surgical intervention to another surgical intervention. Working in teams of two investigators independently, and in duplicate, assessed each manuscript for potential relevance and performed data extraction. Descriptive statistics, theory-driven multinomial regression, and independent samples t-test were used for data analysis.</p> <p><em>Results:</em> Of the 1664 hits obtained, 173 RCTs were included. These RCTs demonstrated the following data: 35% of RCTs performed and reported randomization properly, and 12% of RCTs reported proper allocation concealment methods. Outcome assessors were blinded in 48 (34%) RCTs, and patients blinded in 45 (26%) RCTs. Multinomial regression demonstrated that trials reporting an a <em>priori</em> sample size are significantly more likely to have a low risk of bias. One-third of trials did not state a primary outcome. The mean and median sample sizes were 73 and 43 patients respectively. Funding and conflict of interest reporting improved over time.</p> <p><em>Conclusions:</em> This systematic review establishes a baseline of the quality of evidence that currently guides practice for surgical interventions in plastic and reconstructive surgery. For the readers of plastic surgery literature to have confidence in the literature, risks of bias should be minimized and transparently reported. This will encourage plastic surgeons to apply the results and findings from published RCTs in their practice, providing patients them with the best possible treatments.</p>