Evidence map›Paper›PMID 30938751›Full record

Trial reportJournal of the American Medical Informatics Association : JAMIA2019

Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.

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

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Medical Informatics Association : JAMIA, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03063268 (An Interactive Patient-Centered Consent for Research Using Medical Records), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 7% of its field
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.

NCT03063268 nacompletednot on this map

An Interactive Patient-Centered Consent for Research Using Medical Records

TypeinterventionalSponsorUniversity of FloridaRan2017 to 2019Enrolled734ConditionsAttitude to Computers, Attitude of Health Personnel, Researcher-Subject Relations, TrustArmsTrust-Enhanced Messaging on E-Consent, Interactive features on E-Consent, Standard E-Consent
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023
    Pooled it
  3. Pooled it
  4. Trial
  5. Embedding research study recruitment within the patient portal preCheck-in.Journal of the American Medical Informatics Association : JAMIA · 2023
    Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. The importance of consumer- and patient-oriented perspectives in biomedical and health informatics.Journal of the American Medical Informatics Association : JAMIA · 2019
    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

8 authors at 5 institutions in 1 country.

Christopher A HarleDepartment of Health Policy and Management, Indiana University, Indianapolis, Indiana, USA.
Elizabeth H GolembiewskiDepartment of Health Policy and Management, Indiana University, Indianapolis, Indiana, USA.
Kiarash P RahmanianDepartment of Community Health and Family Medicine, University of Florida, Gainesville, Florida, USA.
Babette BrumbackDepartment of Biostatistics, University of Florida, Gainesville, Florida, USA.
Janice L KriegerDepartment of Advertising, University of Florida, Gainesville, Florida, USA.
Kenneth W GoodmanInstitute for Bioethics and Health Policy, Miller School of Medicine, University of Miami, Miami, Florida, USA.
Arch G MainousDepartment of Community Health and Family Medicine, University of Florida, Gainesville, Florida, USA.
Ray E MoseleyDepartment of Community Health and Family Medicine, University of Florida, Gainesville, Florida, USA.
University of Florida Health · USUniversity of Florida · USIndiana University – Purdue University Indianapolis · USRegenstrief Institute · USUniversity of Miami · US

Funding

Reporting Nutrition Risk Factors via Virtual Humans for Colorectal Cancer Prevention.R01CA207689 · NCI · UNIVERSITY OF FLORIDA · PI LOK, BENJAMIN, RAUP-KRIEGER, JANICE LEE · 2017 to 2021
$3.7M
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
NCI NIH HHS R01 CA207689NICHD NIH HHS R01 HD086700
6 · The paper itself

Abstract

objectiveIn the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement). MATERIALS AND

methodsA randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up.

resultsAcross all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting.

conclusionsA large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268).

Indexed as

Biomedical ResearchConfidentialityElectronic Health RecordsInformed ConsentAdolescentAdultAgedAged, 80 and overDisclosureEducational StatusHumansMiddle AgedMinority GroupsMultivariate AnalysisTrustYoung Adultbroad consentCommon Rulee-consentelectronic health recordinformation systems designresearch informatics

Identifiers

PMID30938751
PMCPMC6562160
OpenAlexW2934266997

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.