In a comparison of two electronic methods of securing consumer informed consent for medical procedures, participants preferred an enhanced approach with interactive digital elements over a text-only approach. The enhanced approach included videos, periodic knowledge checks, a graphic on the treatment journey, and collapsible visit summaries. In addition to participant preference, the researchers also assessed participant comprehension after completing the electronic informed consent (eIC).
The context was a mock Phase III clinical trial with 24 participants with hypertension. Half reviewed the text-only eIC first and then reviewed the enhanced eIC, and the other half reviewed the enhanced eIC first followed by the text-only eIC. The enhanced eIC included videos about placebos, randomization, and electrocardiograms; four knowledge checks via drop-down panels; and a map showing the treatment path and visit summaries.
About three-fourths of the group were very satisfied with both approaches. The enhanced eIC took longer to complete than the text-only eIC. However, 71% of the participants said they preferred the enhanced eIC. They indicated that the digital elements made them feel more informed, engaged, comfortable, and ready to participate. They said the various components forced them to slow down to consider the consent information. There were no differences in participant comprehension and satisfaction between the two eIC approaches.
These findings were reported in “Participant Comprehension And Acceptability Of Enhanced Versus Text-Only Electronic Informed Consent: An Innovative Qualitative Pilot Study” by Amy Corneli, Summer Starling, Yujung Choi, and colleagues. The researchers concluded that enhancing the eIC process with digital elements could improve participant comprehension and satisfaction, especially when enrolling participants across multiple geographic areas.
For more information, contact: Amy L. Corneli, Ph.D., MPH, Professor, Department of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Durham, North Carolina 27701; Email: amy.corneli@duke.edu; Website: https://medicine.duke.edu/profile/amy-lynn-corneli