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A major challenge associated with converting paper-based consent to electronic versions is to assure that the level of comprehension offered by the electronic consenting systems is not reduced. A randomized between-subject trial comparing patient comprehension with four different electronic consenting formats of the same consent information presented on an Apple iPad was conducted using a non-clinical sample of 32 participants. The formats were Text-Based, text-based with Text Being Read out, Video-Based and Video-Based with Subtitles. The participants were asked to read and complete a consent form in one of the formats. The participants were subsequently asked to complete a semantic comprehension quiz, the NASA Task Load Index and the computer system usability questionnaire (CSUQ). Upon completing the questionnaires, the participants took part in a retrospective think-aloud session to understand any difficulties they had using the consent forms. Statistically significant differences among the formats were found for task completion time, the mental demand and frustration sub-components of the NASA-TLX, and the comprehension quiz. Video with subtitles to convey consent information appears to be the best format among the formats tested for electronic consent presentation.
Madathil et al. (2012) studied this question.