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Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic

The COVID-19 pandemic has caused tremendous disruptions to non-COVID-19 clinical research. However, there has been little investigation on how patients themselves have responded to clinical trial recruitment during the COVID-19 pandemic. To investigate the effect of the COVID-19 pandemic on rates of...

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Autores principales: Chirinos, Josue D., Turco, Isabella S., Di Fenza, Raffaele, Gianni, Stefano, Larson, Grant M., Swingle, Joseph F., Akeju, Oluwaseun, Berra, Lorenzo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844839/
https://www.ncbi.nlm.nih.gov/pubmed/36649289
http://dx.doi.org/10.1371/journal.pone.0279643
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author Chirinos, Josue D.
Turco, Isabella S.
Di Fenza, Raffaele
Gianni, Stefano
Larson, Grant M.
Swingle, Joseph F.
Akeju, Oluwaseun
Berra, Lorenzo
author_facet Chirinos, Josue D.
Turco, Isabella S.
Di Fenza, Raffaele
Gianni, Stefano
Larson, Grant M.
Swingle, Joseph F.
Akeju, Oluwaseun
Berra, Lorenzo
author_sort Chirinos, Josue D.
collection PubMed
description The COVID-19 pandemic has caused tremendous disruptions to non-COVID-19 clinical research. However, there has been little investigation on how patients themselves have responded to clinical trial recruitment during the COVID-19 pandemic. To investigate the effect of the COVID-19 pandemic on rates of patient consent to enrollment into non-COVID-19 clinical trials, we carried out a cross-sectional study using data from the Nitric Oxide/Acute Kidney Injury (NO/AKI) and Minimizing ICU Neurological Dysfunction with Dexmedetomidine-Induced Sleep (MINDDS) trials. All patients eligible for the NO/AKI or MINDDS trials who came to the hospital for cardiac surgery and were approached to gain consent to enrollment were included in the current study. We defined “Before COVID-19” as the time between the start of the relevant clinical trial and the date when efforts toward that clinical trial were deescalated by the hospital due to COVID-19. We defined “During COVID-19” as the time between trial de-escalation and trial completion. 5,015 patients were screened for eligibility. 3,851 were excluded, and 1,434 were approached to gain consent to enrollment. The rate of consent to enrollment was 64% in the “Before COVID-19” group and 45% in the “During COVID-19” group (n = 1,334, P<0.001) (RR = 0.70, 95% CI 0.62 to 0.80, P<0.001). Thus, we found that rates of consent to enrollment into the NO/AKI and MINDDS trials dropped significantly with the onset of the COVID-19 pandemic. Patient demographic and socioeconomic status data collected from electronic medical records and patient survey data did not shed light on possible explanations for this observed drop, indicating that there were likely other factors at play that were not directly measured in the current study. Increased patient hesitancy to enroll in clinical trials can have detrimental effects on clinical science, patient health, and patient healthcare experience, so understanding and addressing this issue during the COVID-19 pandemic is crucial.
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spelling pubmed-98448392023-01-18 Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic Chirinos, Josue D. Turco, Isabella S. Di Fenza, Raffaele Gianni, Stefano Larson, Grant M. Swingle, Joseph F. Akeju, Oluwaseun Berra, Lorenzo PLoS One Research Article The COVID-19 pandemic has caused tremendous disruptions to non-COVID-19 clinical research. However, there has been little investigation on how patients themselves have responded to clinical trial recruitment during the COVID-19 pandemic. To investigate the effect of the COVID-19 pandemic on rates of patient consent to enrollment into non-COVID-19 clinical trials, we carried out a cross-sectional study using data from the Nitric Oxide/Acute Kidney Injury (NO/AKI) and Minimizing ICU Neurological Dysfunction with Dexmedetomidine-Induced Sleep (MINDDS) trials. All patients eligible for the NO/AKI or MINDDS trials who came to the hospital for cardiac surgery and were approached to gain consent to enrollment were included in the current study. We defined “Before COVID-19” as the time between the start of the relevant clinical trial and the date when efforts toward that clinical trial were deescalated by the hospital due to COVID-19. We defined “During COVID-19” as the time between trial de-escalation and trial completion. 5,015 patients were screened for eligibility. 3,851 were excluded, and 1,434 were approached to gain consent to enrollment. The rate of consent to enrollment was 64% in the “Before COVID-19” group and 45% in the “During COVID-19” group (n = 1,334, P<0.001) (RR = 0.70, 95% CI 0.62 to 0.80, P<0.001). Thus, we found that rates of consent to enrollment into the NO/AKI and MINDDS trials dropped significantly with the onset of the COVID-19 pandemic. Patient demographic and socioeconomic status data collected from electronic medical records and patient survey data did not shed light on possible explanations for this observed drop, indicating that there were likely other factors at play that were not directly measured in the current study. Increased patient hesitancy to enroll in clinical trials can have detrimental effects on clinical science, patient health, and patient healthcare experience, so understanding and addressing this issue during the COVID-19 pandemic is crucial. Public Library of Science 2023-01-17 /pmc/articles/PMC9844839/ /pubmed/36649289 http://dx.doi.org/10.1371/journal.pone.0279643 Text en © 2023 Chirinos et al https://creativecommons.org/licenses/by/4.0/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 use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Chirinos, Josue D.
Turco, Isabella S.
Di Fenza, Raffaele
Gianni, Stefano
Larson, Grant M.
Swingle, Joseph F.
Akeju, Oluwaseun
Berra, Lorenzo
Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic
title Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic
title_full Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic
title_fullStr Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic
title_full_unstemmed Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic
title_short Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic
title_sort patient hesitancy in perioperative clinical trial enrollment during the covid-19 pandemic
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844839/
https://www.ncbi.nlm.nih.gov/pubmed/36649289
http://dx.doi.org/10.1371/journal.pone.0279643
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