ArticleBMJ open2025
Accelerating implementation of visual key information to improve informed consent in research: a single-institution feasibility study and implementation testing.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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.
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.
Who cites it
5 citing papers in PubMed.
- Evaluating Whether Icons and Visual Elements Help or Hinder Understanding of Key Information for Research Studies: Results From a Randomized Trial.Health literacy research and practice · 2026Trial
- Patients' Perspectives and Experiences of Participating in Anesthesia Research: A Qualitative Study.Anesthesia and analgesia · 2026Article
- Implementing and evaluating visual key information pages compared to text-based key information: protocol for a stepped-wedge cluster randomized trial.BMC medical ethics · 2025Article
- Assessing the Usability of a Novel Toolkit for Creating Visual Key Information Pages for Informed Consent for Research: Mixed Methods Usability Study.JMIR formative research · 2025Article
- Engaging migrants and immigrants in genetics research.Nature genetics · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectiveCurrent consent processes often fail to communicate study information effectively and may lead to disparities in study participation. The 2018 Common Rule introduced a mandatory key information (KI) section as a means of improving consents; however, it frequently remains lengthy and prohibitively complex. We conducted a feasibility study of an accessible visual KI template for use in routine studies.
designParallel feasibility study and implementation testing.
settingSingle Midwestern US academic centre, between July 2023 and July 2024.
participantsTo develop and implement the visual KI template, we used rapid implementation science methods and recruited decision-making and clinical experts, patients and community partners to iteratively adapt the KI template. To assess its efficacy, we surveyed patient participants eligible to enrol in one of four clinical trials that used the visual KI template as part of informed consent. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was participant knowledge about clinical trial details. Secondary outcomes included decisional conflict about joining the trial (validated SURE measure), KI template acceptability (validated Acceptability of Intervention Measure) and perceived self-efficacy communicating about trial details with researchers/clinicians (items adapted from the Perceived Efficacy in Patient/Physician Interaction measure). Feasibility was evaluated based on reach, number of modifications needed to tailor the intervention to each pilot trial, and time required for ethics reviews.
resultsOf 85 study participants across the four clinical trials using the visual KI page, the weighted mean knowledge score about trial details was 87.4% correct (range 77.8%-88.9%). Few (n=9; 10.6%) reported decisional conflict about whether to participate. Almost all (n=82; 96.5%) participants stated they approve using the visual KI template. 79 (92.9%) participants reported feeling confident asking clinicians or researchers questions about the trial.
conclusionsVisual KI templates can improve potential participant comprehension and in doing so, may reduce barriers to participation in research. Parallel feasibility studies and implementation science methods can facilitate the rapid development and evaluation of evidence-based interventions, such as improved informed consent templates.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.