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Composite endpoints are widely used in cardiovascular clinical trials to improve statistical efficiency while preserving clinical relevance. The Win Ratio (WR) measure and more general frameworks of Win Statistics have emerged as…

Methodology · Statistics 2025-11-24 Yunhan Mou , Fan Li , Denise Esserman , Yuan Huang

The win ratio offers a flexible approach to incorporate the hierarchy of clinical outcomes into the analysis of a composite endpoint, enabling simultaneous consideration of multiple outcome types, unlike traditional time-to-first-event…

Methodology · Statistics 2025-07-22 David Kronthaler , Matthias Schwenkglenks , Felix Beuschlein , Ulrike Held

Composite endpoints that combine recurrent non-fatal events with a terminal event are increasingly used in randomized clinical trials, yet conventional time-to-first event analyses may obscure clinically relevant information. We compared…

Methodology · Statistics 2025-12-16 Adrien Orué , Derek Dinart , Laurent Billot , Carine Bellera , Virginie Rondeau

Conventional methods for analyzing composite endpoints in clinical trials often only focus on the time to the first occurrence of all events in the composite. Therefore, they have inherent limitations because the individual patients' first…

Methodology · Statistics 2022-11-29 Jialu Wang , Yeh-Fong Chen , Thomas Gwise

Composite endpoints, which combine two or more distinct outcomes, are frequently used in clinical trials to enhance the event rate and improve the statistical power. In the recent literature, the while-alive cumulative frequency measure…

Methodology · Statistics 2025-11-14 Xi Fang , Hajime Uno , Fan Li

Cardiovascular outcome trials commonly face competing risks when non-CV death prevents observation of major adverse cardiovascular events (MACE). While Cox proportional hazards models treat competing events as independent censoring,…

Methodology · Statistics 2026-02-19 Tuo Wang , Yu Du

Composite endpoints are widely used in cardiovascular clinical trials. In recent years, hierarchical composite endpoints-particularly the win ratio approach and its predecessor, the Finkelstein-Schoenfeld (FS) test, also known as the…

Methodology · Statistics 2025-08-22 Yunhan Mou , Haitao Pan , Yu Jiang , Yuan Huang

The Win Ratio has gained significant traction in cardiovascular trials as a novel method for analyzing composite endpoints (Pocock and others, 2012). Compared with conventional approaches based on time to the first event, the Win Ratio…

Methodology · Statistics 2024-10-10 Baoshan Zhang , Yuan Wu

In many biomedical research, recurrent events such as myocardial infraction, stroke, and heart failure often result in a terminal outcome such as death. Understanding the relationship among the multi-type recurrent events and terminal event…

Methodology · Statistics 2025-12-10 Mithun Kumar Acharjee , AKM Fazlur Rahman

Composite endpoints are frequently used as primary or secondary analyses in cardiovascular clinical trials to increase clinical relevance and statistical efficiency. Alternatively, the Win Ratio (WR) and other Win Statistics (WS) analyses…

Methodology · Statistics 2025-12-23 Yunhan Mou , Scott Hummel , Yuan Huang

Under a composite estimand strategy, the occurrence of the intercurrent event is incorporated into the endpoint definition, for instance by assigning a poor outcome value to patients who experience the event. Composite strategies are…

Methodology · Statistics 2025-07-01 Brennan C Kahan , Tra My Pham , Conor Tweed , Tim P Morris

Mixed-effects models are fundamental tools for analyzing clustered and repeated-measures data, but existing high-dimensional methods largely focus on penalized estimation with vector-valued covariates. Bayesian alternatives in this regime…

Methodology · Statistics 2026-02-24 Sreya Sarkar , Kshitij Khare , Sanvesh Srivastava

Time-to-event endpoints are frequently used as outcomes in oncology and other disease areas where the outcome of interest may not be observed within a predetermined period. Although many analytical methods address the challenges of…

Methodology · Statistics 2026-04-14 Chen-Yen Lin , Susan Halabi , Taehwa Choi

Mixed outcome endpoints that combine multiple continuous and discrete components to form co-primary, multiple primary or composite endpoints are often employed as primary outcome measures in clinical trials. There are many advantages to…

Methodology · Statistics 2019-12-12 Martina McMenamin , Jessica K. Barrett , Anna Berglind , James M. S. Wason

Summary points: - This article considers the combination of two binary or two time-to-event endpoints to form the primary composite endpoint for leading a trial. - It discusses the relative efficiency of choosing a composite endpoint over…

Applications · Statistics 2020-01-13 Marta Bofill Roig , Jordi Cortés Martínez , Guadalupe Gómez Melis

Cardiopulmonary exercise testing (CPET) provides a comprehensive assessment of functional capacity by measuring key physiological variables including oxygen consumption ($VO_2$), carbon dioxide production ($VCO_2$), and pulmonary…

Machine Learning · Computer Science 2025-03-19 Muhammet Alkan , Gruschen Veldtman , Fani Deligianni

We propose Cooperative Component Analysis (CoCA), a new method for unsupervised multi-view analysis: it identifies the component that simultaneously captures significant within-view variance and exhibits strong cross-view correlation. The…

Methodology · Statistics 2024-07-25 Daisy Yi Ding , Alden Green , Min Woo Sun , Robert Tibshirani

This paper is motivated by evaluating the benefits of patients receiving mechanical circulatory support (MCS) devices in end-stage heart failure management inference, in which hypothesis testing for a treatment effect on the risk of…

Applications · Statistics 2026-01-06 Yiyuan Huang , Ling Zhou , Min Zhang , Peter X. K. Song

Causal inference across multiple data sources offers a promising avenue to enhance the generalizability and replicability of scientific findings. However, data integration methods for time-to-event outcomes, common in biomedical research,…

Methodology · Statistics 2025-05-16 Yi Liu , Alexander W. Levis , Ke Zhu , Shu Yang , Peter B. Gilbert , Larry Han

In biomedical settings, multitype recurrent events such as stroke and heart failure occur frequently, often concluding with a terminal event such as death. Understanding the links between these recurring and terminal events is fundamental…

Methodology · Statistics 2025-09-15 Mithun Kumar Acharjee , AKM Fazlur Rahman
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