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Description
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Project Overview 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.
Data and Data Collection Overview From June 2024-November 2024, we conducted usability testing of the toolkit with 15 participants whose professional roles might include creating informed consent documents for studies (principal investigators, research team members, research support team members). Potential participants were recruited through previously compiled lists, along with snowball sampling and word-of-mouth referrals. Participants were asked to spend 20 minutes using the visual key information template, engaging in a think-aloud process. They based their visual key information page on either their own study protocol or a sample protocol from a randomized trial of an educational intervention about breast reconstruction. They then responded to debrief questions about the template. Interviews were recorded, transcribed, and coded with a usability-focused codebook and thematic analysis.
Selection and Organization of Shared Data This data deposit comprises 14 de-identified transcripts of interviews with 15 participants (two of the participants requested to complete a simultaneous interview). Participants were affiliated with one of three large U.S. research institutions (one in the Midwest, one in the West, one in the South). All instructions and stimuli that the participants reviewed and responded to are shared in a folder labeled “Study Materials”. The documentation files shared are the exempt project info sheet and debrief questionnaire, as well as this Data Narrative and an administrative README file.
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