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The stratified win ratio.

Gaohong Dong1, Junshan Qiu2, Duolao Wang3

  • 1a iStats Inc ., Long Island City , NY , USA.

Journal of Biopharmaceutical Statistics
|November 28, 2017
PubMed
Summary
This summary is machine-generated.

This study introduces a new stratified win ratio method for analyzing composite endpoints in clinical trials. The proposed method performs well, especially with sparse data, and includes a homogeneity test for meta-analyses.

Keywords:
Mantel-Haenszel stratified odds ratiocomposite endpointodds ratioprioritized multiple outcomesprioritized pairwise comparisonstratified win ratiowin ratio

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Area of Science:

  • Biostatistics
  • Clinical Trials Methodology
  • Statistical Analysis

Background:

  • The win ratio, proposed in 2012, analyzes composite endpoints considering component order and timing.
  • Stratified analysis is often required for clinical trials, but existing win ratio methods lack stratification.
  • There is a need for robust statistical methods to handle stratified composite endpoints in clinical research.

Purpose of the Study:

  • To propose a Mantel-Haenszel-type stratified win ratio statistic.
  • To derive a general variance estimator for the stratified win ratio.
  • To assess the statistical performance of the proposed method via simulations and develop a homogeneity test.

Main Methods:

  • Development of a stratified win ratio statistic analogous to the Mantel-Haenszel odds ratio.
  • Derivation of a general variance estimator using plug-in estimators for wins in treatment groups.
  • Simulation studies to evaluate performance, especially in sparse data scenarios.
  • Formulation of a Cochran's approach-based homogeneity test for stratum-specific win ratios.

Main Results:

  • The proposed Mantel-Haenszel-type stratified win ratio demonstrates performance comparable to the Mantel-Haenszel stratified odds ratio in simplified cases.
  • The new stratified win ratio is advantageous over inverse-variance weighted and unweighted win ratios, particularly with sparse data.
  • A homogeneity test was formulated to assess consistency of win ratios across strata.

Conclusions:

  • The proposed stratified win ratio offers a valuable tool for analyzing composite endpoints in stratified clinical trial data.
  • The method shows superior performance in sparse data settings, addressing a key limitation of existing approaches.
  • The developed homogeneity test enhances the utility of the win ratio in meta-analytic contexts.