Evidence map›Paper›PMID 36966921›Full record

ArticleAmerican heart journal2023

Secondary analysis of electronic opt-out consent in pragmatic research: A study design method to diversify clinical trials?

Prerna Gupta, Lisa C Sandy, Thomas J Glorioso, Amber Khanna, Prateeti Khazanie, Larry A Allen, Pamela N Peterson, Sheana Bull, Pei Jai Michael Ho

Open access · greenAbstract readLetter
In one paragraph

Article in American heart journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

9 authors at 4 institutions in 1 country.

Prerna GuptaAnschutz Medical Center, Division of Cardiology, University of Colorado, Aurora, CO. Electronic address: prerna.gupta@cuanschutz.edu.
Lisa C SandyAnschutz Medical Center, Division of General Internal Medicine, University of Colorado, Aurora, CO.
Thomas J GloriosoRocky Mountain Regional Veteran Affairs Medical Center, Cardiology Section, Aurora, CO.
Amber KhannaAnschutz Medical Center, Division of Cardiology, University of Colorado, Aurora, CO.
Prateeti KhazanieAnschutz Medical Center, Division of Cardiology, University of Colorado, Aurora, CO.
Larry A AllenAnschutz Medical Center, Division of Cardiology, University of Colorado, Aurora, CO.
Pamela N PetersonAnschutz Medical Center, Division of Cardiology, University of Colorado, Aurora, CO; Department of Cardiology, Denver Health, Denver, CO.
Sheana BullColorado School of Public Health, Aurora, CO.
Pei Jai Michael HoAnschutz Medical Center, Division of Cardiology, University of Colorado, Aurora, CO; Rocky Mountain Regional Veteran Affairs Medical Center, Cardiology Section, Aurora, CO.
University of Colorado Anschutz Medical Campus · USColorado School of Public Health · USDenver Health Medical Center · USThe Medical Center of Aurora · US

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
POSTGRADUATE TRAINING IN CARDIOVASCULAR RESEARCHT32HL007822 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI BUTTRICK, PETER N., LEINWAND, LESLIE ANNE · 1996 to 2023
$6.2M
Personalized Patient data and behavioral nudges to improve adherence to chronic cardiovascular medicationsUH3HL144163 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI ALLEN, LARRY ALEXANDER, BULL, SHEANA S · 2019 to 2022
$5.7M
Enhancing cardiac and pulmonary rehabilitation adherence through home-based rehabilitation and behavioral nudges: ERA NudgeR33HL143324 · NHLBI · DENVER HEALTH AND HOSPITAL AUTHORITY · PI PETERSON, PAMELA N · 2019 to 2022
$2.9M
Variations in Use of Heart Replacement Therapies Among Patients with Advanced Heart FailureK23HL145122 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI KHAZANIE, PRATEETI · 2019 to 2023
$961k
NCCIH NIH HHS U24 AT009676NHLBI NIH HHS K23 HL145122NHLBI NIH HHS R33 HL143324NHLBI NIH HHS T32 HL007822NHLBI NIH HHS UH3 HL144163
6 · The paper itself

Abstract

We conducted a multi-center pragmatic trial of a low-risk intervention focused on medication adherence using an opt-out consent approach, where patients could opt out by letter and then electronically. We focus on the cohort after opt-out by mail. Here, we describe that 8% of patients opted out electronically, resulting in a 92% participation rate. Patients who self-identify as Black or Hispanic were less likely to opt out in the study, and half the study cohort was female. This demographic data is useful for planning future trials employing this approach.

Indexed as

Informed ConsentResearch DesignFemaleHumans

Identifiers

PMID36966921
PMCPMC10286777
OpenAlexW4360838250

What OpenQuestion holds

Textmetadata
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.