ArticleJMIR formative research2021
Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial.
Article in JMIR formative research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02537886 (Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023Pooled it
- A feasibility randomised controlled trial of patient education videos assessing multimedia design effects on engagement and learning in adolescents with scoliosis.BMC medical education · 2026Trial
- Digital informed consent for urological surgery - randomized controlled study comparing multimedia-supported vs. traditional paper-based informed consent concerning satisfaction, anxiety, information gain and time efficiency.Prostate cancer and prostatic diseases · 2024Trial
- Short-Form Video Informed Consent Compared With Written Consent for Adolescents and Young Adults: Randomized Experiment.JMIR formative research · 2024Trial
- Development of a multimedia informed consent tool for fixed prosthodontic treatment: A cognitive theory-based approach to enhance patient understanding.PEC innovation · 2026Article
- eConsent vs traditional consent among prospective biobank participants: a randomized study within a study trial.npj digital public health · 2026Article
- eConsent vs. Traditional Consent Among Prospective Biobank Participants: A Randomized Trial.medRxiv : the preprint server for health sciences · 2025Article
- Enhancing randomized clinical trials with digital twins.NPJ systems biology and applications · 2025Review
- An asynchronous electronic consent for improving consent in research among patients with cancer.The oncologist · 2025Article
- Using dataflow diagrams to support research informed consent data management communications: participant perspectives.Journal of the American Medical Informatics Association : JAMIA · 2025Article
- Medical researchersZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2025Article
- Development of a Framework for the Enrollment of Children and Families in Emergency Department Research.Journal of the American College of Emergency Physicians open · 2025Article
- Development of a novel multimedia tool for obtaining informed consent from survivors of sexual offenses and its comparison with the conventional method.Medical journal, Armed Forces India · 2024Article
- An Evaluation of the Design of Multimedia Patient Education Materials in Musculoskeletal Health Care: Systematic Review.JMIR rehabilitation and assistive technologies · 2024Review
- Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital.BMC health services research · 2024Article
- Digital consent in gynecology: an evaluation of patient experience.Archives of gynecology and obstetrics · 2024Article
- A Review of the Design of Multimedia Patient Educational Materials in Low Back Pain Research.Physical therapy research · 2024Review
- Narrative review of telemedicine applications in decentralized research.Journal of clinical and translational science · 2024Review
- Article
- Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.Journal of medical Internet research · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
Abstract
backgroundThe traditional informed consent (IC) process rarely emphasizes research participants' comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies.
objectiveThis paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC.
methodsUsing digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer's cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires.
resultsA total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process.
conclusionsThe use of dynamic, interactive audiovisual elements in VIC may improve participants' satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC's potential to improve research participants' comprehension and the overall process of IC.
trial registrationClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.
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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.