An investigation of format modifications on the comprehension of information in consent form when presented on mobile devices

Abstract

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.