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CONSORT 2010 statement: extension checklist for reporting within person randomised trials.

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Reporting quality for within-person randomized controlled trials (RCTs) needs improvement. The new CONSORT extension provides guidelines to enhance transparency and reliability in reporting these efficient trial designs.

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Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Evidence-Based Medicine

Background:

  • Reporting quality of randomized controlled trials (RCTs) is suboptimal, hindering assessment of findings and leading to research waste.
  • Within-person trials, common in ophthalmology, dentistry, and dermatology, offer efficiency but suffer from variable and incomplete reporting.
  • Existing reporting guidelines do not adequately address the specific needs of within-person trial designs.

Purpose of the Study:

  • To present the Consolidated Standards of Reporting Trials (CONSORT) extension specifically for within-person trials.
  • To improve the transparency and completeness of reporting for within-person RCTs.
  • To facilitate better interpretation and utilization of within-person trial data by clinicians and researchers.

Main Methods:

  • Extension of 16 items from the CONSORT 2010 checklist.
  • Introduction of a modified flowchart tailored for within-person trial designs.
  • Development of a revised baseline table to capture key participant characteristics and outcomes.

Main Results:

  • The CONSORT extension provides specific guidance for reporting within-person trials.
  • Enhanced transparency in reporting facilitates critical appraisal of trial validity and reliability.
  • The proposed modifications aim to reduce research waste and improve the utility of trial findings.

Conclusions:

  • The CONSORT extension for within-person trials addresses critical gaps in current reporting standards.
  • Adoption of these guidelines will lead to more reliable and interpretable research.
  • Improved reporting supports evidence-based decision-making and efficient knowledge synthesis.