The win ratio in cardiology trials: lessons learnt, new developments, and wise future use

Autores da FMUP

• João Pedro Melo Marques Pinho Ferreira

  Autor

Participantes de fora da FMUP

• Pocock, SJ
• Gregson, J
• Collier, TJ
• Stone, GW

Unidades de investigação

• Cirurgia e Fisiologia

• Laboratório Associado RISE- Rede de Investigação em Saúde

  

  Investigador

  Fernando Carlos De Landér Schmitt

Abstract

Graphical Abstract The graphical abstract figure explains the win ratio method, its advantages over conventional time-to-first event analysis of composite outcomes, and provides recommendations for future use of the win ratio in the design, analysis, and reporting of clinical trials. CI, confidence interval. The win ratio method for analysing a composite clinical hierarchy of outcomes is growing in popularity especially in cardiovascular trials. This article gives a perspective on its use so far and the issues derived from that experience. Specifically, it focuses on the limitations of a conventional composite outcome; how does the win ratio work, what does it mean, and how to display its findings; guidance on choosing an appropriate clinical hierarchy of outcomes including clinical events, quantitative outcomes, and other options; the additional value of the win difference as a measure of absolute benefit: extension to stratified win ratio, subgroup analysis, matched win ratio, and covariate adjustment; determining trial size for a win ratio outcome; specific insights such as adaptive designs, use of repeat events, and use of margins and time averages for quantitative outcomes; a critique of potential misuses; availability of statistical software; and a statistical appendix on the methodological details. Throughout, each principle is illustrated by examples from specific cardiology trials. The article concludes with a set of recommendations for future use of the win ratio.

Keywords

• Clinical trial; Hierarchical composite outcome; Win ratio; Statistical methods; Presentation and interpretation; Systematic review