Evidence map›Paper›PMID 27625314›Full record

Trial reportClinical trials (London, England)2017

A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.

Stephanie A Kraft, Melissa Constantine, David Magnus, Kathryn M Porter, Sandra Soo-Jin Lee, Michael Green, Nancy E Kass, Benjamin S Wilfond, Mildred K Cho

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical trials (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. An Evaluation of Clinical Trial Multimedia to Support Hispanic Cancer Patients' Informational and Decision-Making Needs.Journal of cancer education : the official journal of the American Association for Cancer Education · 2021
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  16. Tailored Messages About Research Participation: Using an Interactive Information Aid to Improve Study Recruitment.Journal of cancer education : the official journal of the American Association for Cancer Education · 2022
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  20. The Ethics of Consent in a Shifting Genomic Ecosystem.Annual review of biomedical data science · 2021
    Review
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.

Stephanie A Kraft1 Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA.
Melissa Constantine2 Division of Health Policy and Management, University of Minnesota, Minneapolis, MN, USA.
David Magnus3 Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA, USA.
Kathryn M Porter1 Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA.
Sandra Soo-Jin Lee3 Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA, USA.
Michael Green4 Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.
Nancy E Kass5 Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Benjamin S Wilfond1 Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA.
Mildred K Cho3 Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA, USA.

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
Institute of Translational Health SciencesUL1TR000423 · NCATS · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2012 to 2016
$49.4M
Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1 TR001085NCATS NIH HHS UL1 TR002319
6 · The paper itself

Abstract

BACKGROUND/

aimsParticipant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices.

methodsWe administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms.

resultsThere were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without.

conclusionOur results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.

Indexed as

Biomedical ResearchHealth Knowledge, Attitudes, PracticeInformed ConsentMultimediaAdultComparative Effectiveness ResearchFemaleHumansMaleMiddle AgedPatient Education as TopicPragmatic Clinical Trials as TopicSurveys and QuestionnairesVideo Recordingcomparative effectiveness researchinformed consentmultimediapragmatic clinical trialsresearch ethicsResearch on medical practicesvideo

Identifiers

PMID27625314
PMCPMC5300898

What OpenQuestion holds

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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.