Transparency in surgical randomized clinical trials: cross-sectional observational study.

Area of Science:

• Medical Research
• Surgical Trials
• Clinical Study Transparency

Background:

• Randomized controlled trials (RCTs) form the bedrock of evidence-based medical treatment decisions.
• Transparent reporting of methods and results in RCTs is crucial for critical appraisal.
• This study investigates transparency in surgical RCTs across key reporting domains.

Purpose of the Study:

• To assess the level of transparency in surgical RCTs.
• To examine trends in trial registration, funding disclosure, conflict of interest declarations, and data-sharing statements.
• To identify areas for improvement in reporting standards for surgical research.

Main Methods:

• A cross-sectional review of published surgical RCTs was conducted.
• Ten high-impact journals were systematically searched for RCTs from 2009, 2012, 2015, and 2018.
• Transparency was evaluated across four domains: trial registration, funding disclosure, investigator conflicts, and data-sharing.

Main Results:

• Of 475 eligible RCTs, 83.6% were registered, with prospective registration increasing significantly over time (26% in 2009 to 72.7% in 2018).
• Funding disclosure rose from 55.0% to 75.4%, and conflict of interest disclosure increased from 49.5% to 98.3% across the study years.
• Data-sharing statements were present in only 3.2% of RCTs, with most appearing in 2018.

Conclusions:

• Surgical RCTs demonstrate marked improvements in trial registration, funding, and conflict of interest disclosures over the past decade.
• The extremely low rate of data-sharing statements in surgical RCTs is a significant concern.
• Improving data-sharing practices is essential to mitigate research waste and advance surgical science.