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Electronic Informed Consent in the Multi-Arm Optimization of Stroke Thrombolysis Trial
S Iris Davis1, Abbey Staugaitis2, Ian Rines3
1Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (S.I.D., A.D.R., P.K., J.P.B.).
Stroke
|April 16, 2025
Summary
Electronic consent (eConsent) adoption in acute ischemic stroke trials increased site enrollment and remote consent rates. This method improved consent documentation adherence compared to traditional paper methods, showing potential for future stroke research.
Area of Science:
- Neurology
- Clinical Trials
- Health Informatics
Background:
- Timely informed consent is a significant challenge in recruiting patients for acute ischemic stroke clinical trials.
- Electronic consent (eConsent) offers a potential solution by streamlining the delivery and documentation of the informed consent process.
- The adoption and impact of eConsent in acute ischemic stroke trials remain understudied.
Purpose of the Study:
- To analyze the adoption trends of electronic consent (eConsent) in the Multi-Arm Optimization of Stroke Thrombolysis Trial (MOST).
- To evaluate the impact of eConsent on clinical trial recruitment and participant enrollment.
- To compare the adherence and efficiency of eConsent versus traditional paper-based consent methods.
Main Methods:
- A post hoc analysis of the MOST phase III clinical trial data (October 2019 - July 2023) involving 514 participants across 57 sites.
- Categorization of consent modalities: paper-in person, paper-remote, eConsent-in person, and eConsent-remote.
- Statistical analysis (chi-squared, Kruskal-Wallis tests) to compare enrollment, remote consent rates, time metrics, data clarifications, and adverse events between consent groups.
Main Results:
- eConsent was used for 33.7% of participants, with 56.1% of sites utilizing it at least once.
- Sites using eConsent showed significantly higher median enrollment compared to non-eConsent sites (7.5 vs. 3 participants).
- eConsent facilitated remote consent more frequently (46.2% vs. 1.2%) and demonstrated superior consent documentation adherence with fewer data clarifications and adverse events.
Conclusions:
- eConsent adoption in the MOST trial correlated with increased site enrollment and higher rates of remote consent.
- The study highlights improved consent documentation adherence with eConsent compared to paper methods.
- eConsent presents significant advantages for future acute ischemic stroke clinical trials and stroke research networks.
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