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Methodology reporting improved over time in 176,469 randomized controlled trials.

Halil Kilicoglu1, Lan Jiang1, Linh Hoang1

  • 1School of Information Sciences, University of Illinois Urbana-Champaign, Champaign, IL, USA.

Journal of Clinical Epidemiology
|August 10, 2023
PubMed
Summary
This summary is machine-generated.

Randomized controlled trial (RCT) reporting has improved over time, with increased documentation of key methods. However, areas like allocation concealment require further enhancement for better trial transparency and reproducibility.

Keywords:
CONSORTMachine learningMeta-researchRandomized controlled trialsReporting guidelinesText mining

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Area of Science:

  • Clinical Trials Methodology
  • Research Integrity
  • Evidence-Based Medicine

Background:

  • The quality of reporting in randomized controlled trials (RCTs) is crucial for assessing study validity and reproducibility.
  • The Consolidated Standards of Reporting Trials (CONSORT) statement provides essential guidelines for minimum RCT reporting requirements.
  • Understanding historical trends in RCT reporting can identify areas needing improvement.

Purpose of the Study:

  • To quantitatively describe the evolution of RCT methodology reporting over time.
  • To assess the impact of journal impact factor and medical discipline on reporting trends.
  • To identify specific CONSORT items with persistent reporting deficiencies.

Main Methods:

  • A deep learning-based sentence classification model was developed using the CONSORT statement.
  • 176,469 RCT reports published between 1966 and 2018 were analyzed.
  • Reporting trends were examined across 5-year periods, with analysis stratified by journal impact factor and medical discipline.

Main Results:

  • Reporting of Population, Intervention, Comparator, Outcome (PICO) items and interventions generally increased over time.
  • Significant improvements were observed in reporting of sequence generation (10.8% to 41.8%), but allocation concealment remains infrequent (5.1% to 19.3%).
  • The number of reported items showed a weak correlation with journal impact factor, and differences between medical disciplines were minimal.

Conclusions:

  • Large-scale quantitative data support the hypothesis that RCT methodology reporting has improved.
  • Extending automated reporting checks based on CONSORT items can aid manuscript authoring and peer review.
  • These findings support the use of such models for facilitating compliance and advancing metaresearch.