Evidence map›Paper›PMID 32815061›Full record

ArticleJournal of general internal medicine2020

Patients' Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study.

Juli M Bollinger, Gail Geller, Kevin Weinfurt, Elizabeth May, Stephanie R Morain, Debra J H Mathews, Jeremy Sugarman

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of general internal medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. A Framework of Institutional Obligations for Pragmatic Clinical Trials.The American journal of bioethics : AJOB · 2026
    Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Juli M BollingerBerman Institute of Bioethics, Johns Hopkins University, , Baltimore, MD, USA. jmurph46@jhu.edu.ORCID http://orcid.org/0000-0001-6850-8562
Gail GellerBerman Institute of Bioethics, Johns Hopkins University, , Baltimore, MD, USA.
Kevin WeinfurtDepartment of Population Health Sciences, Duke University School of Medicine, , Durham, NC, USA.
Elizabeth MayBerman Institute of Bioethics, Johns Hopkins University, , Baltimore, MD, USA.
Stephanie R MorainCenter for Medical Ethics and Health Policy, Baylor College of Medicine, , Houston, TX, USA.
Debra J H MathewsBerman Institute of Bioethics, Johns Hopkins University, , Baltimore, MD, USA.
Jeremy SugarmanBerman Institute of Bioethics, Johns Hopkins University, , Baltimore, 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
NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U24AT009676
6 · The paper itself

Abstract

backgroundPragmatic clinical trials (PCTs) are increasingly being conducted to efficiently generate evidence to inform healthcare decision-making. Despite their growing acceptance, PCTs may involve a variety of ethical issues, including the management of pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in PCTs that is unrelated to the primary research questions but may have implications for patients, clinicians, and health systems.

objectiveWe sought to understand patients' views about PCT-CF disclosure, including how, by whom, and the nature and extent of information provided.

designProspective, qualitative focus group study.

participantsFocus groups were conducted in Baltimore, MD; Houston, TX; and Seattle, WA (overall N = 66), during July and August 2019. APPROACH: All groups discussed a hypothetical scenario involving the detection of a PCT-CF of contraindicated medications. Participants were asked about their reactions to the PCT-CF and issues related to its disclosure. KEY

resultsReactions to learning about the PCT-CF were mixed, ranging from fear of a significant health problem, anger that the contraindicated medications had gone unnoticed and/or for being included in research without their permission, to gratitude for the information. Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. Many wanted their treating clinician to be informed of the PCT-CF so that they would be prepared to answer patients' questions and to discuss treatment options.

conclusionsThe detection of PCT-CFs is likely to increase with further expansion of PCTs. As such, clinicians will undoubtedly become involved in the management of PCT-CFs. Our data illustrate some of the challenges clinicians may face when their patients are informed of a PCT-CF and the need to develop guidance for disclosing PCT-CFs in ways that align with patients' preferences and values.

Indexed as

DisclosureFocus GroupsHumansProspective StudiesQualitative Researchcollateral findingpatient perspectivepragmatic clinical trial

Identifiers

PMID32815061
PMCPMC7728860

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.