OBJECTIVE: Informed consent forms for research are often lengthy and complex. One way to improve consent forms is to clarify the key information page required for federally funded research in the United States. We developed a visual key information page using color, plain language, bulleted text, and icons. In formative studies, the visual key information page was positively received, but some asked whether icons improve outcomes or distract from information. This study tested whether icons affect knowledge, satisfaction, or engagement with study information. METHODS: We recruited English-speaking, U.S.-based adults through Prime Panels. Participants were randomized to view one of three versions of a key information page about a hypothetical biobank study: Version A used bulleted, plain language text organized in boxes, incorporating icons and visual elements; Version B was identical but with no icons or other visual elements; Version C displayed identical plain language text only. We measured participants' intention to join the study, decisional conflict about choice intention, knowledge of study details, satisfaction with the information, and engagement with the information. Finally, they viewed all versions and reported their preference among the three and their attitudes about icons in Version A. KEY RESULTS: values > .05), including when stratifying by health literacy. After viewing all versions, most (69.4%) preferred Version A over other versions. In addition, most liked the icons (78.2%), found them helpful (74.2%) and did not find them distracting (77%). CONCLUSIONS: Although participants preferred icons and visual elements over text alone, icons and visual elements did not affect knowledge, satisfaction, or engagement with study information. Future research will investigate whether and how visual key information enhances text-based consent forms in a multisite randomized trial with ongoing studies.
Politi et al. (Wed,) studied this question.