title: An alternative approach to confidence interval estimation for the win ratio statistic.
abstract: Pocock et al. (2012, European Heart Journal 33, 176-182) proposed a win ratio approach to analyzing composite endpoints comprised of outcomes with different clinical priorities. In this article, we establish a statistical framework for this approach. We derive the null hypothesis and propose a closed-form variance estimator for the win ratio statistic in all pairwise matching situation. Our simulation study shows that the proposed variance estimator performs well regardless of the magnitude of treatment effect size and the type of the joint distribution of the outcomes.
authors.affiliation: Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York 10029, U.S.A.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Luo
authors.affiliation: Janssen Research and Development, Raritan, New Jersey 08869, U.S.A.
authors.forename: Hong
authors.initials: H
authors.lastname: Tian
authors.affiliation: Janssen Research and Development, Raritan, New Jersey 08869, U.S.A.
authors.forename: Surya
authors.initials: S
authors.lastname: Mohanty
authors.affiliation: Department of Biostatistics, Columbia University, New York, New York 10032, U.S.A.
authors.forename: Wei Yann
authors.initials: WY
authors.lastname: Tsai
mesh_terms: D000465:Algorithms; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D065427:Factor Xa Inhibitors / Q000627:therapeutic use; D006801:Humans; D016017:Odds Ratio; D017063:Outcome Assessment, Health Care / Q000379:methods*; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods; D000069552:Rivaroxaban / Q000627:therapeutic use*; D012680:Sensitivity and Specificity; D016008:Statistical Distributions; D020521:Stroke / Q000401:mortality* / Q000517:prevention & control*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban
keywords: Clinical trials; Composite endpoints; Hypothesis testing; Variance estimation; Win ratio