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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
PubMed
Summary

Electronic consent (eConsent) improves patient understanding, engagement, and satisfaction in clinical trials compared to paper methods. This systematic review highlights eConsent

Keywords:
acceptabilityclinical trialcomprehensiondigital consenteConsenteffectivenesselectronic consentinformed consent formpatient engagementusability

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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.