Progression of Pilot Trials to Completed Randomized Controlled Trials in Plastic Surgery: A Systematic Review.

Abstract

Well-designed pilot trials are essential in determining feasibility prior to initiating definitive randomized controlled trials (RCTs) and their implementation into clinical practice. The primary outcome of this study was to identify the number of pilot or feasibility studies in Plastic Surgery that progressed to a definitive RCT. Secondary outcomes included a) number of pilot studies expressing feasibility statements and outcomes and b) reporting quality. MEDLINE, Embase, Web of Science, and clinicaltrials.gov were searched for all pilot RCTs and definitive RCTs in plastic surgery between 2012-2023. Pilot trials were matched to definitive RCTs by keyword, author, and citation report. Feasibility outcomes were presented using descriptive statistics. Reporting quality was evaluated using the Consolidated Standards of Reporting Trials 2010 randomized pilot and feasibility trials extension. Among 11,540 and 6035 citations screened in 2 separate literature searches, 171 pilot studies and 779 definitive RCTS were included, respectively. Ten (5.8%) pilot studies were associated with a completed RCT, 4 (2.3%) were in progress, and 2 (1.2%) were stopped. For studies that did not progress to a definitive RCT, "inadequate funding" (n = 11, 41.4%) was the most cited reason followed by "insufficient efficacy to justify study progression" (n = 5, 17.3%). The average reporting adherence to the Consolidated Standards of Reporting Trials items was 65.6% (SD 16). Fifty (29.2%) pilot RCTs reported a feasibility statement and 30 (17.5%) reported feasibility outcomes. Few pilot trials in plastic surgery progressed to a definitive RCT, and most did not present feasibility statements or outcomes. Pilot studies should precede RCTs and include clear feasibility statements and outcomes.