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Comparative Effectiveness of eConsent: Systematic Review
Edwin Cohen1, Bill Byrom2, Anja Becher3
1AstraZeneca BV, The Hague, Netherlands.
Journal of Medical Internet Research
|September 1, 2023
Summary
Electronic consent (eConsent) improves patient understanding, engagement, and satisfaction in clinical trials compared to paper methods. This systematic review highlights eConsent
Area of Science:
- Clinical Trials
- Informed Consent
- Digital Health
Background:
- Informed consent is crucial for clinical trial participation, but traditional paper-based processes often have flaws like missing signatures and dates.
- Electronic consent (eConsent) utilizes digital technology to enhance participant understanding and engagement with study information, aiming to improve data quality.
Approach:
- A systematic literature review was conducted following PRISMA guidelines.
- Searched Embase and MEDLINE for comparative studies on eConsent versus paper consent.
- Assessed study validity using established instruments, categorizing methodologies as 'high' validity for comprehensive assessments.
Key Points:
- 35 studies (13,281 participants) were included in the review.
- eConsent demonstrated significantly better results in patient comprehension, acceptability, and usability compared to paper consent, particularly in high-validity studies.
- While eConsent increased patient engagement time (cycle time), it showed potential for reduced site workload and administrative burden.
Conclusions:
- eConsent significantly enhances patient understanding, engagement, acceptability, and usability of clinical trial information compared to paper-based methods.
- eConsent solutions offer a promising approach to address data quality concerns and improve the overall informed consent process.
- The findings support the adoption of eConsent to improve the efficiency and effectiveness of clinical trial consenting.
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