A detailed analysis of level I evidence (randomized controlled trials and meta-analyses) in five plastic surgery journals to date: 1978 to 2009.

BACKGROUND: Evidence-based medicine is the synthesis of clinical expertise, best available clinical evidence, and patient values to provide optimal health outcomes. A scant number of randomized controlled trials exist in the plastic surgery literature. The authors sought to analyze the level I studies (randomized controlled trials and meta-analyses) in five leading plastic surgery journals to date to understand the distribution of primary categories of study, primary outcomes, age breakdown, degree of quality, and the trend in publication rates.

METHODS: PubMed/MEDLINE was searched by leaving entry field empty and applying the following limitations: randomized controlled trials and meta-analysis, English, all ages, all dates, humans and animals, Plastic and Reconstructive Surgery, Annals of Plastic Surgery, British Journal of Plastic Surgery, Aesthetic Plastic Surgery, and Journal of Plastic, Reconstructive & Aesthetic Surgery.

RESULTS: Three hundred nine publications were included in the analysis. There was a steady increase in the number of level I studies from 1978 to 2009. Thirty-eight percent were double-blinded, 31 percent were single-blinded, 20 percent were not blinded, and 8 percent were meta-analyses. Cosmetic was the most common category. Cost and efficiency were primary outcomes in only 2.6 and 4.2 percent, respectively. Power analysis was performed 15.5 percent of the time, and randomization technique was reported in only 39 percent of the studies.

CONCLUSIONS: Level I studies in plastic surgery continue to increase in number; however, most are not randomized or blinded, do not have power analyses, and do not consider cost. Future studies should be designed to produce high-quality evidence and should address cost and comparative effectiveness.