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. 2023 Aug 21:35:101200.
doi: 10.1016/j.conctc.2023.101200. eCollection 2023 Oct.

Differences in eConsent among diagnosis groups

Deborah Profit  1 , William Carson  1 , Leonard Chuck  2 , Candace Saldarini  1 , Hannah Glenny  1
Affiliations

Differences in eConsent among diagnosis groups

Deborah Profit et al. Contemp Clin Trials Commun. .

Abstract

eConsent is an electronic informed consent experience that contains videos, word flags, and knowledge checks, in addition to an electronic version of the informed consent document to enhance clinical trial participants' understanding of what they are consenting to. There are numerous perceived benefits of eConsent, however despite these benefits, adoption has remained low. eConsent data from 27 clinical trials was analyzed to gain insights and understand differences in the consenting process between diagnosis groups. It was found that those with bipolar disorder spent significantly less time on the instructional video while those with schizophrenia spent significantly more. Participants with autosomal dominant polycystic kidney disease (ADPKD) had the lowest engagement while participants with schizophrenia were the most engaged. Knowledge check scores for participants with attention deficit hyperactivity disorder (ADHD) were significantly lower than the other diagnosis groups. The data available through eConsent provides crucial insights into the consenting differences among participants' diagnoses. Understanding these differences will support tailoring the eConsent process to a more patient centric design and ensure study participants understand what they are consenting to.

Keywords: Clinical trial; Consent; Informed consent; Patient centricity; eConsent.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Deborah Profit, William Carson, Candace Saldarini, and Hannah Glenny are employees of Otsuka Pharmaceutical Development & Commercialization, Inc. Leonard Chuck is an employee of Diablo Clinical Research, Inc. This research was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.

Figures

Fig. 1
Fig. 1
Percent of Video Watched by Diagnosis (Mann-Whitney-Wilcoxon test two-sided, Bipolar v Healthy: P_val = 2.245e-17; Bipolar v ADPKD: P_val = 4.378e-05; Bipolar v ADHD: P_val = 1.861e-30; Bipolar v PTSD: P_val = 7.752e-46; Bipolar v MDD: P_val = 3.140e-12; Bipolar v Schizophrenia: P_val = 8.891e-20). Participants with schizophrenia watched significantly more than those diagnosed with MDD (Mann-Whitney-Wilcoxon test two-sided, P_val = 2.473e-19), ADPKD (Mann-Whitney-Wilcoxon test two-sided, P_val = 2.688e-03), PTSD (Mann-Whitney-Wilcoxon test two-sided, P_val = 2.304e-07), and Bipolar (Mann-Whitney-Wilcoxon test two-sided, P_val = 8.891e-20.
Fig. 2
Fig. 2
Completion rates by diagnosis and clinical trial phase.
Fig. 3
Fig. 3
Completion rates by engagement.
See this image and copyright information in PMC

References

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