Evidence map›Paper›PMID 39587730›Full record

ArticleClinical trials (London, England)2025

Ethical considerations for sharing aggregate results from pragmatic clinical trials.

Stephanie R Morain, Abigail Brickler, Joseph Ali, Patricia Pearl O'Rourke, Kayte Spector-Bagdady, Benjamin Wilfond, Vasiliki Rahimzadeh, Caleigh Propes, Kayla Mehl, David Wendler

Abstract read
In one paragraph

Article in Clinical trials (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

10 authors.

Stephanie R MorainJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.ORCID 0000-0001-7278-7517
Abigail BricklerJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.ORCID 0009-0009-7516-218X
Joseph AliJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Patricia Pearl O'RourkeRetired.ORCID 0000-0002-4578-5126
Kayte Spector-BagdadyCenter of Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Benjamin WilfondTreuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital, Seattle, WA, USA.
Vasiliki RahimzadehCenter for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, TX, USA.
Caleigh PropesJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.ORCID 0009-0002-3198-480X
Kayla MehlJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
David WendlerDepartment of Bioethics, NIH Clinical Center, Bethesda, MD, USA.

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
HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics SupplementU24AT010961 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2019 to 2021
$6.4M
NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U24 AT010961
6 · The paper itself

Abstract

A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no prior work has examined these issues in the context of pragmatic clinical trials. Several characteristics of pragmatic clinical trials may complicate both the ethics and the logistics of sharing aggregate results. Among these characteristics include that pragmatic clinical trials may affect the rights, welfare, and interests of not only patient-subjects but also clinicians, meaning that results may be owed to a broader range of groups than typically considered in other research contexts. In addition, some pragmatic clinical trials are conducted under a waiver of informed consent, meaning sharing results may alert participants that they were enrolled without their consent. This article explores the ethical dimensions that can inform decision-making about sharing aggregate results from pragmatic clinical trials, and provides recommendations for that sharing. A central insight is that healthcare institutions-as key partners for the conduct of pragmatic clinical trials-must also be key partners in decision-making about sharing aggregate pragmatic clinical trial results. We conclude with insights for future research.

Indexed as

Clinical Trials as TopicInformation DisseminationPragmatic Clinical Trials as TopicDecision MakingEthics, ResearchHumansInformed Consentaggregate resultsethicsPragmatic clinical trials

Identifiers

PMID39587730
PMCPMC11991889

What Socratic holds

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Registered trials

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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.