Evidence map›Paper›PMID 25747685›Full record

Trial reportJournal of empirical research on human research ethics : JERHRE2014

A randomized controlled trial of an electronic informed consent process.

Erin Rothwell, Bob Wong, Nancy C Rose, Rebecca Anderson, Beth Fedor, Louisa A Stark, Jeffrey R Botkin

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of empirical research on human research ethics : JERHRE, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 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

33 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023
    Pooled it
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  13. JAMIA open · 2022
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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

7 authors.

Erin RothwellUniversity of Utah, Salt Lake City, USA erin.rothwell@nurs.utah.edu.
Bob WongUniversity of Utah, Salt Lake City, USA.
Nancy C RoseUniversity of Utah, Salt Lake City, USA Intermountain Healthcare, Salt Lake City, UT, USA.
Rebecca AndersonUniversity of Utah, Salt Lake City, USA.
Beth FedorIntermountain Healthcare, Salt Lake City, UT, USA.
Louisa A StarkUniversity of Utah, Salt Lake City, USA.
Jeffrey R BotkinUniversity of Utah, Salt Lake City, USA.

Funding

Parent Education about Newborn Screening and Bloodspot RetentionR01HG006266 · NHGRI · UNIVERSITY OF UTAH · PI BOTKIN, JEFFREY R. · 2011 to 2014
$2.1M
NHGRI NIH HHS 1R01HG006266-02NHGRI NIH HHS R01 HG006266
6 · The paper itself

Abstract

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study.

Indexed as

Audiovisual AidsComprehensionInformed ConsentResearchConsent FormsElectronicsHumansPaperResearch SubjectsSurveys and Questionnaireselectronicinformed consentrandomized controlled trials

Identifiers

PMID25747685
PMCPMC5847281

What OpenQuestion holds

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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.