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

J A Helliwell1, B Shelton2, H Mahmood3

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Transparency in surgical randomized controlled trials (RCTs) has improved, with better trial registration and conflict of interest disclosures. However, data-sharing statements remain very low, potentially increasing research waste.

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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.