Working with a cross industry team from AstraZeneca, Oxford PharmaGenesis, and Nottingham Trent University, Signant was pleased to provide scientific contribution to a recent systematic review of published works comparing electronic and pen-and-paper consenting. We explored the effectiveness of electronic informed consent compared to using a paper informed consent form (ICF) in relation to patient comprehension, patient acceptability, study enrollment and retention rates, the time taken by patients to complete the consenting process, and site workload. In this blog, we summarize the findings in relation to patient comprehension, and patient acceptability. More details of these and the other areas can be found in the Journal of Medical Internet Research paper.

eConsent is associated with improved comprehension

Because not understanding the requirements of a study is one of the common reasons for patients withdrawing early from trials, we explored the impact of eConsent on patient comprehension – suggesting that improved comprehension may mitigate this and drive improved retention figures.  A number of the 37 publications we examined, used approaches to measure comprehension and explore the difference between eConsent and paper ICFs. Some approaches leveraged specific instruments developed for this purpose, such as the QuIC (Quality of Informed Consent), DICCQ (Digitized Informed Consent Comprehension Questionnaire) and the BICEP (Brief Informed Consent Evaluation Protocol). Where these approaches incorporated open-ended questions to assess comprehension (e.g., “Tell me what will be done during the study visits”), with a defined scheme to assess the completeness of understanding based upon the verbal responses given, we identified these as more robust methodologies (as opposed to, for example, simply asking the patient if they understood the requirements of the study, and its objectives and risks).

Overall, 6/10 studies using these more comprehensive and specific methods to assess comprehension reported statistically significant superiority of comprehension using eConsent versus  paper-based ICFs, with no statistical tests in favor of superiority of paper.

As we discuss in our published paper, there are psychological frameworks that support the idea of more effective comprehension when using eConsent. Deeper processing, for example, is associated with improved comprehension and recall, and is experienced when using good graphic design (e.g., using images in addition to text). Further, multimedia learning theory suggests that deeper learning can be obtained when using visual and audio information together, which also increases attention.  Interestingly, older adults have been shown to integrate more of the audiovisual information in their environment when performing tasks and so may particularly benefit from multimedia presentation and associated multisensory processing. In fact, a number of the studies we explored included older adults – up to the age of 91 years – and supported the efficacy of eConsent even in older age groups.

eConsent is associated with improved patient acceptability/satisfaction

All studies measuring acceptability and comparing to paper (8 studies, 631 participants) reported either higher or comparable satisfaction or enjoyment with eConsent compared to paper. One study evaluated this using the Computer System Usability Questionnaire and reported statistically significant superior satisfaction scores with eConsent. Interestingly, elsewhere in our paper we found that the time taken to complete consenting was typically a little longer using eConsent vs paper, and this may be a result of the greater engagement with the material meaning participants were less likely to skim content.

Overall, these are helpful findings that put some empirical evidence behind the perceived benefits of using eConsent. Of course, these are in addition to benefits related to eliminating ambiguity and potential inspection findings relating to ICF signatures and completion dates, ensuring the correct ICF version is used at all times, and simplifying the reconsenting process when needed due to transparent protocol amendments.

Learn more about Signant’s leading eConsent solution

Bill Byrom, Ph.D.

VP Product Intelligence and Positioning

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