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Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis

BACKGROUND: Clinical trials for coronavirus disease 2019 (COVID-19) have struggled to achieve diverse patient enrollment, despite underrepresented groups bearing the largest burden of the disease and, presumably, being most in need of the treatments under investigation. METHODS: To assess the willin...

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Autores principales: Kaczynski, Matthew, Benitez, Gregorio, Mylona, Evangelia K, Tran, Quynh-Lam, Atalla, Eleftheria, Tsikala-Vafea, Maria, Kalagara, Saisanjana, Shehadeh, Fadi, Mylonakis, Eleftherios
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10173548/
https://www.ncbi.nlm.nih.gov/pubmed/37180601
http://dx.doi.org/10.1093/ofid/ofad197
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author Kaczynski, Matthew
Benitez, Gregorio
Mylona, Evangelia K
Tran, Quynh-Lam
Atalla, Eleftheria
Tsikala-Vafea, Maria
Kalagara, Saisanjana
Shehadeh, Fadi
Mylonakis, Eleftherios
author_facet Kaczynski, Matthew
Benitez, Gregorio
Mylona, Evangelia K
Tran, Quynh-Lam
Atalla, Eleftheria
Tsikala-Vafea, Maria
Kalagara, Saisanjana
Shehadeh, Fadi
Mylonakis, Eleftherios
author_sort Kaczynski, Matthew
collection PubMed
description BACKGROUND: Clinical trials for coronavirus disease 2019 (COVID-19) have struggled to achieve diverse patient enrollment, despite underrepresented groups bearing the largest burden of the disease and, presumably, being most in need of the treatments under investigation. METHODS: To assess the willingness of patients to enroll into inpatient COVID-19 clinical trials when invited, we conducted a cross-sectional analysis of adults hospitalized with COVID-19 who were approached regarding enrollment. Associations between patient and temporal factors and enrollment were assessed by multivariable logistic regression analysis. RESULTS: A total of 926 patients were included in this analysis. Overall, Hispanic/Latinx ethnicity was associated with a nearly half-fold decrease in the likelihood to enroll (adjusted odds ratio [aOR], 0.60 [95% confidence interval {CI}, .41–.88]). Greater baseline disease severity (aOR, 1.09 [95% CI, 1.02–1.17]), age 40–64 years (aOR, 1.83 [95% CI, 1.03–3.25]), and age ≥65 years (aOR, 1.92 [95% CI, 1.08–3.42]) were each independently associated with higher likelihood to enroll. Over the course of the pandemic, patients were less likely to enroll during the summer 2021 wave in COVID-19–related hospitalizations (aOR, 0.14 [95% CI, .10–.19]) compared with patients from the first wave in winter 2020. CONCLUSIONS: The decision to enroll into clinical trials is multifactorial. Amid a pandemic disproportionately affecting vulnerable groups, Hispanic/Latinx patients were less likely to participate when invited, whereas older adults were more likely. Future recruitment strategies must consider the nuanced perceptions and needs of diverse patient populations to ensure equitable trial participation that advances the quality of healthcare for all.
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spelling pubmed-101735482023-05-12 Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis Kaczynski, Matthew Benitez, Gregorio Mylona, Evangelia K Tran, Quynh-Lam Atalla, Eleftheria Tsikala-Vafea, Maria Kalagara, Saisanjana Shehadeh, Fadi Mylonakis, Eleftherios Open Forum Infect Dis Major Article BACKGROUND: Clinical trials for coronavirus disease 2019 (COVID-19) have struggled to achieve diverse patient enrollment, despite underrepresented groups bearing the largest burden of the disease and, presumably, being most in need of the treatments under investigation. METHODS: To assess the willingness of patients to enroll into inpatient COVID-19 clinical trials when invited, we conducted a cross-sectional analysis of adults hospitalized with COVID-19 who were approached regarding enrollment. Associations between patient and temporal factors and enrollment were assessed by multivariable logistic regression analysis. RESULTS: A total of 926 patients were included in this analysis. Overall, Hispanic/Latinx ethnicity was associated with a nearly half-fold decrease in the likelihood to enroll (adjusted odds ratio [aOR], 0.60 [95% confidence interval {CI}, .41–.88]). Greater baseline disease severity (aOR, 1.09 [95% CI, 1.02–1.17]), age 40–64 years (aOR, 1.83 [95% CI, 1.03–3.25]), and age ≥65 years (aOR, 1.92 [95% CI, 1.08–3.42]) were each independently associated with higher likelihood to enroll. Over the course of the pandemic, patients were less likely to enroll during the summer 2021 wave in COVID-19–related hospitalizations (aOR, 0.14 [95% CI, .10–.19]) compared with patients from the first wave in winter 2020. CONCLUSIONS: The decision to enroll into clinical trials is multifactorial. Amid a pandemic disproportionately affecting vulnerable groups, Hispanic/Latinx patients were less likely to participate when invited, whereas older adults were more likely. Future recruitment strategies must consider the nuanced perceptions and needs of diverse patient populations to ensure equitable trial participation that advances the quality of healthcare for all. Oxford University Press 2023-04-12 /pmc/articles/PMC10173548/ /pubmed/37180601 http://dx.doi.org/10.1093/ofid/ofad197 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Major Article
Kaczynski, Matthew
Benitez, Gregorio
Mylona, Evangelia K
Tran, Quynh-Lam
Atalla, Eleftheria
Tsikala-Vafea, Maria
Kalagara, Saisanjana
Shehadeh, Fadi
Mylonakis, Eleftherios
Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis
title Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis
title_full Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis
title_fullStr Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis
title_full_unstemmed Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis
title_short Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis
title_sort factors associated with enrollment into inpatient coronavirus disease 2019 randomized controlled trials: a cross-sectional analysis
topic Major Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10173548/
https://www.ncbi.nlm.nih.gov/pubmed/37180601
http://dx.doi.org/10.1093/ofid/ofad197
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