A Critical Analysis of Randomized Controlled Trial Quality in Plastic and Reconstructive Surgery.

[BACKGROUND] Assessing the methodologic and reporting quality of randomized controlled trials (RCTs) in plastic surgery is crucial in maintaining the standards of evidence-based practice. Previous evaluations underscored deficiencies in reporting and methodology, prompting a call for improvement. This review scrutinizes the methodologic and reporting standards of RCTs published in Plastic and Reconstructive Surgery (PRS) from 2013 to 2022.

[METHODS] The authors conducted a review of RCTs published in PRS from 2013 to 2022. Methodologic quality of RCTs was assessed using the Jadad score and a modified Cochrane risk-of-bias tool. Additional relevant data were gathered to assess reporting quality, ascertain predictors of methodologic quality, and identify temporal trends.

[RESULTS] A total of 146 RCTs were reviewed. The mean Jadad score was 2.96 ± 1.21, and the average risk-of-bias score was 5.65 ± 2.14, indicating moderate methodologic quality. Trials assessing surgical techniques or medical devices were associated with poorer methodologic quality compared with drug interventions. Breast trials showed one of the highest methodologic scores, but this declined over time. Overall reporting standards were suboptimal, with nearly half of the trials failing to explicitly state primary outcomes or analysis sets. No significant temporal trends were observed.

[CONCLUSIONS] RCTs published in PRS between 2013 and 2022 exhibited moderate methodologic quality. The authors' findings underscore the importance of transparent reporting and methodologic rigor in advancing evidence-based practices in plastic surgery. By adhering to established methodologic standards and reporting guidelines, researchers can enhance the reliability and impact of their studies.