Reporting Adverse Events in Plastic Surgery: A Systematic Review of Randomized Controlled Trials

Abstract

Background: Accurate knowledge of adverse events is critical for evaluation of the safety of interventions. Historically, adverse events in surgical trials have been poorly reported. The objective of this study was to systematically evaluate the reporting of adverse events in randomized controlled trials in the plastic surgery literature.

Methods: Two independent reviewers conducted a systematic search using MEDLINE, Embase, and Scopus of the top seven plastic surgery journals with the highest impact factors. Randomized controlled trials describing a potentially invasive treatment, published between January of 2012 and December of 2016, were included.

Results: One hundred forty-five randomized controlled trials involving 10,266 patients were included, of which 30 percent were registered. Anticipated adverse events were clearly defined in 15 percent of trials, and in 70 percent it was not clear who would be documenting adverse events. Furthermore, 72 percent of randomized controlled trials reported the occurrence of adverse events, of which 61 percent failed to report events occurring in the intrainterventional period. Binary logistic regression revealed that funded randomized controlled trials were 4.04 times more likely to report adverse events compared with nonfunded randomized controlled trials (95 percent CI, 1.41 to 10.83; p = 0.009).

Conclusions: The authors' findings suggest the need for reporting standards for adverse events in the plastic surgery literature, as such reporting remains heterogeneous and is lacking rigor. Improved quality and transparency are needed to strengthen evidence-based practice and permit a balanced intervention assessment. This study provides a set of recommendations aimed at improving adverse event reporting.