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Is the relationship among outcome variables shown in randomized trials?
David L Schriger1, Richelle J Cooper2, Ana Lopez-O'Sullivan3
1Department of Emergency Medicine, University of California, 924 Westwood Blvd, Suite 300, Los Angeles, CA, 90024, USA. schriger@ucla.edu.
Reports of randomized controlled trials (RCTs) rarely show how different outcomes relate at the patient level. This limits understanding of outcome associations and redundancy in clinical research.
Area of Science:
- Medical Research Methodology
- Clinical Trial Reporting
- Data Analysis in Healthcare
Background:
- Randomized controlled trials (RCTs) frequently assess multiple outcomes, including primary, secondary, and harm endpoints.
- Understanding the relationships between these outcomes is crucial for interpreting trial results and identifying associations, such as between intermediate and clinical outcomes.
Purpose of the Study:
- To evaluate the frequency with which reports of RCTs depict the relationships among outcomes at the individual patient level.
- To assess how often composite outcomes in RCTs include depictions of the relationships between their component elements.
Main Methods:
- A systematic review of RCTs published in 2011-2012 from 20 high-impact medical journals.
- Random selection of 10 RCTs per journal, totaling 200 articles.
- Data extraction on the number of outcomes, composite outcomes, and the portrayal of relationships between outcomes or composite elements.
Main Results:
- Out of 200 RCTs, 92% had multiple outcomes, but only 1% (2 studies) reported the relationships between them.
- 17% of studies reported composite outcomes, with 97% detailing component data.
- No studies presented cross-tabulations of composite outcome components.
Conclusions:
- There is a significant deficit in reporting the relationships between outcomes in RCTs.
- Mandatory data sharing or detailed appendices could enable readers to analyze outcome associations, identify redundancy, and understand outcome responsiveness.
- Current reporting practices seldom provide insights into the interrelations of outcomes within clinical trials.
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