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

Background: Key information pages for informed consent require a concise summary of information to improve participant understanding but have not widely incorporated health literacy best practices. Objective: We previously developed a visual key information template to improve informed consent. In this study, we conducted usability testing of this customizable one-page key information template. Methods: We used the Designing for Accelerated Translation framework to plan for actionable, efficient usability testing. Participants (N=15) were asked to spend about 20 minutes using the visual key information template and engaging in a think-aloud protocol. They then responded to qualitative debrief questions about the template and validated measures of acceptability, appropriateness, and feasibility. Interviews were recorded, transcribed, and analyzed with a usability-focused codebook and thematic analysis. Results: The toolkit was positively received. Common usability challenges included interpreting instructions, condensing consent content, replacing and resizing icons, and fitting information into template boxes. Participants had positive experiences with toolkit elements, particularly with the icon library, and generally felt the toolkit was easy to use and encouraged simplification of information. Some participants noted not fully reviewing instructions before the study and discussed specific technical abilities as potential limitations of widespread use. We documented suggestions and made changes to the toolkit in response to feedback received. Conclusions: Overall, participants considered the toolkit to be appropriate, acceptable, and feasible. Additional implementation outcomes are being collected in a multisite stepped-wedge randomized trial. Further research may investigate changes to format and software that balances functionality with ease of use.