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On reporting results from randomized controlled trials with recurrent events
Lisa Kuramoto1, Boris G Sobolev, Meghan G Donaldson
1Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, Canada. lisa.kuramoto@vch.ca
BMC Medical Research Methodology
|June 3, 2008
Summary
Reporting guidelines for recurrent event outcomes in randomized controlled trials (RCTs) are crucial. This study provides recommendations to ensure appropriate statistical methods are used for analyzing recurrent events in clinical research.
Area of Science:
- Clinical Trials
- Biostatistics
- Epidemiology
Background:
- Standardized reporting in randomized controlled trials (RCTs) is vital for assessing evidence quality.
- Statistical methods for analyzing recurrent events in clinical research are not well-understood.
- Guidelines are needed for reporting results from RCTs with recurrent event outcomes.
Purpose of the Study:
- To outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event.
- To improve the understanding and reporting of recurrent event analyses in clinical research.
Main Methods:
- A simulation study was used to analyze recurrent event data.
- Compared statistical methods including gamma-Poisson, independent-increment, conditional, and marginal Cox models.
- Reviewed the utility of regression models for recurrent event rates by examining study questions, risk sets, and coefficient interpretation.
Main Results:
- Different statistical models for recurrent events have distinct study questions, assumptions, risk sets, and rate ratio interpretations.
- Inferences from recurrent event analyses depend on the appropriateness of the chosen statistical model for the specific RCT.
- Simulation results highlighted the variability in outcomes based on the statistical method employed.
Conclusions:
- The choice of statistical methods for recurrent event outcomes in RCTs should be guided by the study question and trial objectives.
- Guidelines facilitate the selection of appropriate measures for understanding intervention effects on recurrent events.
- Improved reporting will enhance the clarity and reliability of findings from clinical trials with recurrent outcomes.
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