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Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials
Competing risks data are commonly encountered in randomized clinical trials or observational studies. Ignoring competing risks in survival analysis leads to biased risk estimates and improper conclusions. Often, one of the competing events is of primary interest and the rest competing events are han...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10315219/ https://www.ncbi.nlm.nih.gov/pubmed/37035880 http://dx.doi.org/10.1002/sim.9728 |
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author | Wen, Jiyang Wang, Mei-Cheng Hu, Chen |
author_facet | Wen, Jiyang Wang, Mei-Cheng Hu, Chen |
author_sort | Wen, Jiyang |
collection | PubMed |
description | Competing risks data are commonly encountered in randomized clinical trials or observational studies. Ignoring competing risks in survival analysis leads to biased risk estimates and improper conclusions. Often, one of the competing events is of primary interest and the rest competing events are handled as nuisances. These approaches can be inadequate when multiple competing events have important clinical interpretations and thus of equal interest. For example, in COVID-19 in-patient treatment trials, the outcomes of COVID-19 related hospitalization are either death or discharge from hospital, which have completely different clinical implications and are of equal interest, especially during the pandemic. In this paper we develop nonparametric estimation and simultaneous inferential methods for multiple cumulative incidence functions (CIFs) and corresponding restricted mean times. Based on Monte Carlo simulations and a data analysis of COVID-19 in-patient treatment clinical trial, we demonstrate that the proposed method provides global insights of the treatment effects across multiple endpoints. |
format | Online Article Text |
id | pubmed-10315219 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
record_format | MEDLINE/PubMed |
spelling | pubmed-103152192023-07-02 Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials Wen, Jiyang Wang, Mei-Cheng Hu, Chen Stat Med Article Competing risks data are commonly encountered in randomized clinical trials or observational studies. Ignoring competing risks in survival analysis leads to biased risk estimates and improper conclusions. Often, one of the competing events is of primary interest and the rest competing events are handled as nuisances. These approaches can be inadequate when multiple competing events have important clinical interpretations and thus of equal interest. For example, in COVID-19 in-patient treatment trials, the outcomes of COVID-19 related hospitalization are either death or discharge from hospital, which have completely different clinical implications and are of equal interest, especially during the pandemic. In this paper we develop nonparametric estimation and simultaneous inferential methods for multiple cumulative incidence functions (CIFs) and corresponding restricted mean times. Based on Monte Carlo simulations and a data analysis of COVID-19 in-patient treatment clinical trial, we demonstrate that the proposed method provides global insights of the treatment effects across multiple endpoints. 2023-06-30 2023-04-10 /pmc/articles/PMC10315219/ /pubmed/37035880 http://dx.doi.org/10.1002/sim.9728 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
spellingShingle | Article Wen, Jiyang Wang, Mei-Cheng Hu, Chen Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials |
title | Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials |
title_full | Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials |
title_fullStr | Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials |
title_full_unstemmed | Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials |
title_short | Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials |
title_sort | simultaneous hypothesis testing for multiple competing risks in comparative clinical trials |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10315219/ https://www.ncbi.nlm.nih.gov/pubmed/37035880 http://dx.doi.org/10.1002/sim.9728 |
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