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

Area of Science:

• Plastic Surgery Research
• Evidence-Based Medicine
• Clinical Trial Methodology

Background:

• Assessing randomized controlled trial (RCT) quality is key for evidence-based plastic surgery.
• Prior reviews highlighted issues in RCT reporting and methodology.
• This study evaluates RCTs in Plastic and Reconstructive Surgery (PRS) from 2013-2022.

Purpose of the Study:

• To assess the methodologic and reporting quality of RCTs published in PRS.
• To identify predictors of methodologic quality and temporal trends.
• To provide recommendations for improving future RCTs.

Main Methods:

• A comprehensive review of 146 RCTs published in PRS between 2013 and 2022.
• Methodologic quality assessed using the Jadad score and a modified Cochrane risk-of-bias tool.
• Reporting quality evaluated through data extraction on key reporting elements.

Main Results:

• Mean Jadad score was 2.96, and average risk-of-bias score was 5.65, indicating moderate methodologic quality.
• Trials on surgical techniques/devices had lower quality than drug interventions; breast trial quality declined over time.
• Nearly half of trials lacked explicit primary outcomes or analysis sets, indicating suboptimal reporting.

Conclusions:

• RCTs in PRS demonstrate moderate methodologic quality but suboptimal reporting.
• Enhancing transparent reporting and methodologic rigor is crucial for advancing evidence-based plastic surgery.
• Adherence to standards can improve the reliability and impact of plastic surgery research.