Evidence map›Paper›PMID 41264869›Full record

ArticleJMIR formative research2025

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

Eliana Charlotte Goldstein, Zoe Troubh, Krista E Cooksey, Molly Volkmar, Victor Catalan Gallegos, Kimberly A Kaphingst, Clara N Lee, Ashley J Housten, Jessica Mozersky, Mary C Politi

Abstract read
In one paragraph

Article in JMIR formative research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Eliana Charlotte GoldsteinSchool of Public Health, Washington University in St. Louis, 4300 Duncan Ave, Room 2110, St. Louis, MO, 63110, United States, +1 314-935-3802.ORCID 0009-0006-9305-2150
Zoe TroubhWashington University in St. Louis, St. Louis, MO, United States.ORCID 0009-0008-0416-9889
Krista E CookseySchool of Public Health, Washington University in St. Louis, 4300 Duncan Ave, Room 2110, St. Louis, MO, 63110, United States, +1 314-935-3802.ORCID 0000-0001-7236-0089
Molly VolkmarHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, United States.ORCID 0009-0004-9660-3849
Victor Catalan GallegosDepartment of Surgery, Division of Plastic and Reconstructive Surgery, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.ORCID 0009-0003-1006-7567
Kimberly A KaphingstHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, United States.ORCID 0000-0003-2668-9080
Clara N LeeDepartment of Surgery, Division of Plastic and Reconstructive Surgery, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.ORCID 0000-0003-0514-9448
Ashley J HoustenDepartment of Surgery, Division of Public Health Sciences, School of Medicine, Washington University in St. Louis, St. Louis, MO, United States.ORCID 0000-0002-7379-0678
Jessica MozerskyDepartment of Medicine, Division of General Medicine and Geriatrics, School of Medicine, Washington University in St. Louis, St. Louis, MO, United States.ORCID 0000-0002-4942-4571
Mary C PolitiSchool of Public Health, Washington University in St. Louis, 4300 Duncan Ave, Room 2110, St. Louis, MO, 63110, United States, +1 314-935-3802.ORCID 0000-0001-9103-6495

Funding

AHRQ HHS R01 HS029310
6 · The paper itself

Abstract

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.

Indexed as

Informed ConsentAdultFemaleHealth LiteracyHumansMaleMiddle AgedQualitative Researchhealth literacyinformed consentkey informationqualitative mixed-methodsthink-aloud protocolusability testing

Identifiers

PMID41264869
PMCPMC12634007

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.