Evidence map›Paper›PMID 33431386›Full record

Trial reportAnnals of family medicine

An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine.

Elizabeth H Golembiewski, Arch G Mainous, Kiarash P Rahmanian, Babette Brumback, Benjamin J Rooks, Janice L Krieger, Kenneth W Goodman, Ray E Moseley, Christopher A Harle

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of family medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023
    Pooled it
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
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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

9 authors.

Elizabeth H GolembiewskiKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota golembiewski.elizabeth@mayo.edu.
Arch G MainousDepartment of Health Services Research, Management and Policy, University of Florida, Gainesville, Florida.
Kiarash P RahmanianDepartment of Community Health and Family Medicine, University of Florida, Gainesville, Florida.
Babette BrumbackDepartment of Biostatistics, University of Florida, Gainesville, Florida.
Benjamin J RooksDepartment of Community Health and Family Medicine, University of Florida, Gainesville, Florida.
Janice L KriegerDepartment of Advertising, University of Florida, Gainesville, Florida.
Kenneth W GoodmanInstitute for Bioethics and Health Policy, Miller School of Medicine, University of Miami, Miami, Florida.
Ray E MoseleyDepartment of Community Health and Family Medicine, University of Florida, Gainesville, Florida.
Christopher A HarleDepartment of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida.

Funding

An Interactive Patient-Centered Consent for Research Using Medical RecordsR01HD086700 · NICHD · UNIVERSITY OF FLORIDA · PI HARLE, CHRISTOPHER ALBERT, MAINOUS, ARCH G · 2015 to 2017
$1.2M
NICHD NIH HHS R01 HD086700
6 · The paper itself

Abstract

purposePatients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.

methodsA multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.

resultsA majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09;

conclusionsPatients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.

Indexed as

Consumer Health InformaticsInformed ConsentPatient-Centered CareTrustAdultAgedElectronic Health RecordsElectronicsFamily PracticeFemaleHealth CommunicationHumansMaleMiddle AgedTelemedicineconsumer health informaticselectronic health recordshealth communicationinformed consenttrust

Identifiers

PMID33431386
PMCPMC7800739

What OpenQuestion holds

Textmetadata
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.