Data for: Assessing the Usability of a Novel Toolkit for Creating Visual Key Information Pages for Informed Consent for Research

<h3>Project Overview</h3>
Federally required key information pages for research informed consent require a condensed summary of information to improve participant understanding, but these pages have not widely incorporated health literacy best practices. We previously developed a visual key information template based on these best practices to improve informed consent documents using qualitative methods and pilot testing (qualitative article doi: 10.1017/cts.2024.662; qualitative data doi: 10.5064/F6DDBH8U; pilot testing article doi: 10.1136/bmjopen-2024-092185). This related study conducted usability testing of this customizable one-page key information template through a think-aloud protocol. Common usability challenges included: interpreting instructions, condensing consent content, replacing/resizing icons, and fitting information into template boxes. Participants generally felt the toolkit was easy to use, encouraged simplification of information, and specifically liked the icon library. Some participants noted not fully reviewing instructions before the study and discussed specific technical ability or knowledge as potential limitations of widespread use. We documented suggestions and made changes to the toolkit in response to feedback received. The toolkit was rated appropriate, acceptable, and feasible by participants. Further research should investigate changes to format and software that balances functionality with ease of use.