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Impact of covariate omission and categorization from the Fine–Gray model in randomized-controlled trials

Bakoyannis, G; Chu, FI; Babiker, AGA; Touloumi, G; (2021) Impact of covariate omission and categorization from the Fine–Gray model in randomized-controlled trials. Japanese Journal of Statistics and Data Science , 4 (2) pp. 983-997. 10.1007/s42081-021-00111-5. Green open access

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Abstract

In this paper, we study the statistical issues related to the omission and categorization of important covariates in the context of the Fine–Gray model in randomized-controlled trials with competing risks. We show that the omission of an important covariate from the Fine–Gray model leads to attenuated estimates for treatment effect and loss of proportionality in general. Our simulation studies reveal substantial attenuation in the estimate for treatment effect and the loss of statistical power, while dichotomizing a continuous covariate leads to similar but less pronounced impact. Our results are illustrated using data from a randomized clinical trial of HIV-infected individuals. The relative merits of conducting an adjusted versus an unadjusted analysis of treatment effect in light of both statistical and practical considerations are discussed.

Type: Article
Title: Impact of covariate omission and categorization from the Fine–Gray model in randomized-controlled trials
Open access status: An open access version is available from UCL Discovery
DOI: 10.1007/s42081-021-00111-5
Publisher version: https://doi.org/10.1007/s42081-021-00111-5
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Clinical trial, Covariate omission, Competing risks, Fine–Gray model
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
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
URI: https://discovery.ucl.ac.uk/id/eprint/10147449
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