Evidence map›Paper›PMID 41046994›Full record

Trial reportAmerican heart journal2026

Effect of opt-in versus opt-out framing on trial recruitment: a study within a trial of the GAMEPAD randomized trial.

Tayyab Shah, Samantha Coratti, David Farraday, Laurie Norton, Charles Rareshide, Jingsan Zhu, Michael G Levin, Sae-Hwan Park, Scott M Damrauer, Jay S Giri and 4 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in American heart journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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

2 citing papers in PubMed.

  1. Article
  2. 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

14 authors.

Tayyab ShahDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Samantha CorattiPenn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
David FarradayPenn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
Laurie NortonPenn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA.
Charles RareshidePenn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
Jingsan ZhuDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA.
Michael G LevinDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA.
Sae-Hwan ParkDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA.
Scott M DamrauerCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, PA; Penn Cardiovascular Institute, University of Pennsylvania, Philadelphia, PA; Division of Vascular Surgery, University of Pennsylvania, Philadelphia, PA.
Jay S GiriDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA.
Neel P ChokshiDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA; Penn Center for Digital Cardiology, University of Pennsylvania, Philadelphia, PA.
Benjamin M JacksonDivision of Vascular Surgery, Lehigh Valley Heart and Vascular Institute, Allentown, PA.
Mitesh S PatelAscension Health, St. Louis, MO.
Alexander C FanaroffDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA; Penn Center for Digital Cardiology, University of Pennsylvania, Philadelphia, PA. Electronic address: alexander.fanaroff@pennmedicine.upenn.edu.

Funding

Phenotypic Diversity in COVID-19UL1TR001878 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2016 to 2025
$102.4M
NCATS NIH HHS UL1 TR001878
6 · The paper itself

Abstract

Directly contacting eligible participants with an offer to join a randomized clinical trial (RCT) is an efficient recruitment method, but the effect of different outreach strategies on enrollment fraction and completion of the trial protocol is uncertain. In a study within a trial (SWAT) of an RCT testing a physical activity intervention in patients with peripheral artery disease, eligible patients were randomized to receive an email with an invitation to join the study and a link to the trial's online platform ("opt-in") or to receive an email framing participation as part of the standard of care followed by telephone outreach from a study coordinator ("opt-out"). Among 5176 participants contacted by unsolicited email (3909 opt-in, 1267 opt-out), enrollment fraction was 1.0% in the opt-in arm (n = 39) versus 3.6% in the opt-out arm (n = 45) (OR 3.65, 95% CI 2.37-5.64); there were no significant differences between opt-in and opt-out participants in the rate of completion of trial protocol steps. This SWAT of recruitment strategies demonstrates the potential for opt-out framing and active outreach to increase enrollment fraction without compromising protocol completion in direct-to-participant RCTs.

Indexed as

Electronic MailPatient SelectionPeripheral Arterial DiseaseRandomized Controlled Trials as TopicAgedFemaleHumansMaleMiddle Aged

Identifiers

PMID41046994
PMCPMC13088173

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.