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Reporting of analyses from randomized controlled trials with multiple arms: a systematic review
Gabriel Baron1, Elodie Perrodeau, Isabelle Boutron
1INSERM, U738 Paris, France. gabriel.baron@htd.aphp.fr
BMC Medicine
|March 28, 2013
Summary
Reporting of analyses in multiple-arm randomized trials often deviates from the original plan. This systematic review found significant discrepancies in how these complex trials report their statistical analyses.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Scientific Reporting
Background:
- Multiple-arm randomized trials present unique challenges in design, analysis, and reporting compared to two-arm trials.
- Assessing the reporting quality of analyses in multiple-arm randomized controlled trials (RCTs) is crucial for scientific integrity.
Purpose of the Study:
- To systematically review and assess the reporting of statistical analyses in published reports of multiple-arm randomized controlled trials (RCTs).
Main Methods:
- A systematic literature search was conducted on the MEDLINE database for reports of multiple-arm RCTs published in 2009 in core clinical journals.
- Data extraction was performed by two independent reviewers using a standardized form.
Main Results:
- Of 298 identified reports, 15.1% and 16.1% omitted baseline characteristics and outcomes per group, respectively.
- While 57.4% reported planned global tests, 39.2% lacked analysis details, and 10.3% of those reporting global tests did not follow the plan.
- Planned pairwise comparisons were reported in 60% of publications, but 11.1% omitted them, and 21.6% of reported pairwise comparisons were not pre-specified.
Conclusions:
- Significant discrepancies exist between the planned and reported statistical analyses in multiple-arm randomized trials.
- This highlights a need for improved adherence to planned analyses and clearer reporting standards in complex trial publications.
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