Evidence map›Paper›PMID 25475879›Full record

ArticleClinical trials (London, England)2015

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

Nancy E Kass, Holly A Taylor, Joseph Ali, Kristina Hallez, Lelia Chaisson

Abstract readComparative StudyControlled Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing 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

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

  1. Pooled it
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  12. Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2024
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  20. Navigating ethical challenges of conducting randomized clinical trials on COVID-19.Philosophy, ethics, and humanities in medicine : PEHM · 2022
    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

5 authors.

Nancy E KassJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA nkass@jhu.edu.
Holly A TaylorJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Joseph AliJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Kristina HallezJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Lelia ChaissonDivision of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, CA, USA.

Funding

Testing Modified Approaches to Informed ConsentR21AI074005 · NIAID · JOHNS HOPKINS UNIVERSITY · PI KASS, NANCY E · 2008 to 2010
$582k
NIAID NIH HHS R21 AI074005NIAID NIH HHS R21AI074005
6 · The paper itself

Abstract

backgroundResearch suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding.

methodsParticipants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding.

results144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance.

conclusionsOur study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples.

Indexed as

Informed ConsentFemaleHumansMaleMiddle AgedPatient Education as TopicPilot ProjectsResearch Designbioethicshealth literacyinformed consentResearch ethicsunderstanding

Identifiers

PMID25475879
PMCPMC4344898

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.