Guidelines for Reporting Results from Trials with Recurrent Events
Author Information
Author(s): Lisa Kuramoto, Boris G Sobolev, Meghan G Donaldson
Primary Institution: Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute
Hypothesis
How can we improve the reporting of results from randomized controlled trials (RCTs) that involve recurrent events?
Conclusion
The study provides guidelines for reporting results from RCTs involving recurrent events, emphasizing the importance of aligning statistical methods with study objectives.
Supporting Evidence
- The intervention group had significantly fewer falls compared to the control group.
- Statistical methods for recurrent events were evaluated through simulation.
- The guidelines aim to improve the quality of reporting in clinical trials.
Takeaway
This study helps researchers know how to report results when patients have the same event happen to them multiple times, like falling down.
Methodology
The study used simulation to compare various statistical models for analyzing recurrent events in RCTs.
Potential Biases
Potential biases may arise from the assumptions made in the statistical models used.
Limitations
The study primarily focuses on simulation data, which may not fully represent real-world scenarios.
Participant Demographics
The study involved 500 subjects, with 250 in the control group and 250 in the intervention group.
Statistical Information
P-Value
0.55
Confidence Interval
95% CI 0.48–0.63
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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