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Composite end points and competing risks analysis

Dayan, Victor; Grant, Stuart W; Brophy, James M; Barili, Fabio; Freemantle, Nick; (2024) Composite end points and competing risks analysis. Interdisciplinary CardioVascular and Thoracic Surgery , 39 (1) , Article ivae126. 10.1093/icvts/ivae126. Green open access

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Abstract

Composite end points are common primary outcomes in clinical trials. Their main benefit of utilizing a composite outcome is increasing the number of primary outcome events, meaning fewer participants are required to deliver an adequately powered trial. By combining multiple important end points in the primary outcome rather than having to select only 1, composite end points potentially make clinically meaningful benefits easier to detect and avoid ranking outcomes hierarchically. However, there are a number of important considerations when designing and interpreting clinical trials that utilize composite end points. In this Statistical Primer, issues with composite end points such as competing events, halo effect, risk of bias, time-to-event limitations and the win ratio are discussed in the context of real world clinical trials.

Type: Article
Title: Composite end points and competing risks analysis
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/icvts/ivae126
Publisher version: http://dx.doi.org/10.1093/icvts/ivae126
Language: English
Additional information: Copyright © The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Composite outcomes, Competing risks, Statistics
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > Comprehensive CTU at UCL
URI: https://discovery-pp.ucl.ac.uk/id/eprint/10195657
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