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

Eliana Charlotte Goldstein¹, Zoe Troubh², Krista E Cooksey¹

¹School of Public Health, Washington University in St. Louis, 4300 Duncan Ave, Room 2110, St. Louis, MO, 63110, United States, +1 314-935-3802.

JMIR Formative Research

|November 20, 2025

Summary

A visual key information template improves informed consent by enhancing participant understanding. Usability testing revealed challenges but confirmed the toolkit

Keywords:

health literacy informed consent key information qualitative mixed-methods think-aloud protocol usability testing

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Area of Science:

Health Literacy
Informed Consent Process
Clinical Trial Recruitment

Background:

Key information pages in informed consent need concise summaries to boost participant understanding.
Health literacy best practices are not widely integrated into informed consent documents.
Improving participant comprehension is crucial for ethical research conduct.

Purpose of the Study:

To conduct usability testing of a previously developed visual key information template designed to enhance informed consent.
To assess the acceptability, appropriateness, and feasibility of a customizable one-page key information template.

Main Methods:

Usability testing utilized the Designing for Accelerated Translation framework.
Fifteen participants engaged in a think-aloud protocol for approximately 20 minutes using the template.
Qualitative debriefing and validated measures assessed user experience, with interviews analyzed thematically.

Main Results:

The visual key information toolkit was positively received, with participants finding it easy to use and encouraging information simplification.
Common challenges included interpreting instructions, condensing content, and managing icons within the template.
Participants particularly valued the icon library, though some noted potential limitations related to technical abilities and instruction review.

Conclusions:

The visual key information toolkit was deemed appropriate, acceptable, and feasible for improving informed consent.
Ongoing research in a multisite trial will collect further implementation outcomes.
Future work may explore format and software adjustments to balance functionality and user-friendliness.