Evidence map›Paper›PMID 23747986›Full record

Trial reportContemporary clinical trials2013

Development and pilot testing of a video-assisted informed consent process.

Susan C Sonne, Jeannette O Andrews, Stephanie M Gentilin, Stephanie Oppenheimer, Jihad Obeid, Kathleen Brady, Sharon Wolf, Randal Davis, Kathryn Magruder

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
–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

34 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023
    Pooled it
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  9. Article
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  12. U.S. Vietnamese Parents' Perceptions of Different Approaches for Confirming Adolescent HPV Vaccination Records in Research Studies.Health expectations : an international journal of public participation in health care and health policy · 2025
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  13. Article
  14. Article
  15. Article
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  18. Review
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  20. Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020
    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

9 authors.

Susan C SonneMedical University of South Carolina, Charleston, SC 29425, USA. sonnesc@musc.edu
Jeannette O Andrews
Stephanie M Gentilin
Stephanie Oppenheimer
Jihad Obeid
Kathleen Brady
Sharon Wolf
Randal Davis
Kathryn Magruder

Funding

SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
An Open Source Research Permissions Framework for South CarolinaRC2LM010796 · NLM · UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA · PI MOSKOWITZ, JAY · 2009 to 2010
$4.8M
NCATS NIH HHS UL1 TR000062NCRR NIH HHS UL1 RR029882NLM NIH HHS RC2 LM010796
6 · The paper itself

Abstract

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock-informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n = 61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, the comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted.

Indexed as

Informed ConsentPatient PreferenceResearch SubjectsVideotape RecordingAdultComprehensionFemaleHealth Knowledge, Attitudes, PracticeHealth LiteracyHumansMaleMiddle AgedPilot ProjectsResearch DesignElectronic formsInformed consent processTablet computingVideos

Identifiers

PMID23747986
PMCPMC3769445

What OpenQuestion holds

Textmetadata
LicenceTDM
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.