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

Josue D Chirinos, Isabella S Turco, Raffaele Di Fenza, Stefano Gianni, Grant M Larson, Joseph F Swingle, Oluwaseun Akeju and Lorenzo Berra

PLOS ONE, 2023, vol. 18, issue 1, 1-16

Abstract: 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

Date: 2023
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0279643

DOI: 10.1371/journal.pone.0279643

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