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On recurrent-event win ratio.

Lu Mao1, KyungMann Kim1, Yi Li1

  • 1Department of Biostatistics and Medical Informatics, 5228University of Wisconsin-Madison, USA.

Statistical Methods in Medical Research
|March 29, 2022
PubMed
Summary
This summary is machine-generated.

The last-event-assisted win ratio enhances analysis of composite endpoints by utilizing recurrent non-fatal events. This improved statistical method offers greater power and clinical interpretability for clinical trials.

Keywords:
Cardiovascular trialsU-statisticscomposite endpointsprioritized outcomesstochastic orderstratified analysis

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Area of Science:

  • Biostatistics
  • Clinical Trial Methodology
  • Statistical Analysis

Background:

  • The standard win ratio method analyzes composite endpoints (e.g., death, hospitalization) but only considers the first non-fatal event.
  • This limitation reduces statistical efficiency and clinical interpretability, especially with recurrent non-fatal events.

Purpose of the Study:

  • To develop and compare novel win ratio variants that incorporate recurrent non-fatal events for improved analysis.
  • To introduce and evaluate the 'last-event-assisted win ratio' for composite endpoint analysis.

Main Methods:

  • Construction and comparison of several win ratio variants utilizing recurrent event data.
  • Focus on the last-event-assisted win ratio, comparing patients by cumulative non-fatal events, with ties broken by the latest event time.
  • Theoretical proof of the last-event-assisted win ratio's properties and performance via simulations and real-world data analysis.

Main Results:

  • The last-event-assisted win ratio utilizes more data than the standard version and reduces to it when events are non-recurrent.
  • Simulations demonstrate higher statistical power for the last-event-assisted win ratio compared to standard win ratio and other methods.
  • Analysis of a cardiovascular trial confirms the practical advantages of the last-event-assisted win ratio.

Conclusions:

  • The last-event-assisted win ratio offers a statistically efficient and clinically relevant approach for analyzing composite endpoints with recurrent events.
  • This method provides enhanced power and better utilization of available data in clinical trial analysis.
  • Future work will focus on developing effect size estimands based on these extended comparison rules.