Trial reportPloS one2013
Interactive informed consent: randomized comparison with paper consents.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02332837 (Interactive Tool for Informed Consent), which is not on this map. Cited by 69 papers, 4 of them syntheses that pooled 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.
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.
Interactive Tool for Informed Consent: A Randomized Controlled Trial
Who cites it
69 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.Journal of medical Internet research · 2020Pooled it
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018Pooled it
- Audio-visual presentation of information for informed consent for participation in clinical trials.The Cochrane database of systematic reviews · 2014Pooled it
- Audiovisual Augmentation of Electronic Consent to Improve Consent Rates and Comprehension: A Randomized Clinical Trial.JAMA network open · 2026Trial
- Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.Journal of the American Medical Informatics Association : JAMIA · 2019Trial
- Establishing the Feasibility of a Tablet-Based Consent Process with Older Adults: A Mixed-Methods Study.The Gerontologist · 2019Trial
- Effectiveness of Visual Methods in Information Procedures for Stem Cell Recipients and Donors.Turkish journal of haematology : official journal of Turkish Society of Haematology · 2017Trial
- A qualitative exploration of the informed consent process in hematopoietic cell transplantation clinical research and opportunities for improvement.Bone marrow transplantation · 2017Trial
- Interactive multimedia consent for biobanking: a randomized trial.Genetics in medicine : official journal of the American College of Medical Genetics · 2016Trial
- Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.British journal of clinical pharmacology · 2015Trial
- A randomized controlled trial of an electronic informed consent process.Journal of empirical research on human research ethics : JERHRE · 2014Trial
- iPad-based patient briefing for radiological examinations-a clinical trial.Journal of digital imaging · 2014Trial
- Returning aggregate research results to participants: a scoping review of current practices, preferences and challenges.BMJ open · 2025Article
- An asynchronous electronic consent for improving consent in research among patients with cancer.The oncologist · 2025Article
- Shifting from Traditional to Pragmatic Randomized Controlled Trials: Insights and Lessons Learned from the Toddler Oral Health Intervention.Pragmatic and observational research · 2025Article
- The American Society of Pain and Neuroscience (ASPN) Guidelines for Advanced Practice Providers in Interventional Spine and Pain Management Practice.Journal of pain research · 2025Article
- Fasting Ramadan in Yemeni Patients with Type 1 and Type 2 Diabetes: A Comparative Study on the Ability to Fast in 2 Consecutive years.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025Article
- Article
- Is there an impact of a video-based patient informed consent in elective hand surgery?Archives of orthopaedic and trauma surgery · 2024Article
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session). Among research professionals (n = 14), there was a trend (p = .07) in the direction of iPad subjects testing better on the online test (mean correct = 77%) compared with paper subjects (mean correct = 57%). Among patients (n = 55), iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001). For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz). Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.
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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.