Evidence map›Paper›PMID 34600345›Full record

ArticleHealthcare (Amsterdam, Netherlands)2021

Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research.

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

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Healthcare (Amsterdam, Netherlands), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Observational
  2. Article
  3. Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials.Circulation. Cardiovascular quality and outcomes · 2024
    Article
  4. 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.

Stephanie R MorainCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 310D, Houston, TX, 77030, USA; Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA. Electronic address: smorain1@jhu.edu.
Debra J H MathewsBerman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA; Department of Genetic Medicine, Johns Hopkins University School of Medicine, 1800 Orleans Street, Baltimore, MD, 21287, USA.
Gail GellerBerman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA; Department of Medicine, Johns Hopkins University School of Medicine, 1800 Orleans Street, Baltimore, MD, 21287, USA.
Juli BollingerBerman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA.
Kevin WeinfurtDepartment of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Durham, NC, 27701, USA.
Jeffrey G JarvikDepartments of Radiology and Neurological Surgery and the Clinical Learning, Evidence and Research Center for Musculoskeletal Disorders, University of Washington School of Medicine, Box 359728, 325 Ninth Ave, Seattle, WA, 98104, USA.
Elizabeth MayBerman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA.
Jeremy SugarmanBerman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA; Department of Medicine, Johns Hopkins University School of Medicine, 1800 Orleans Street, Baltimore, MD, 21287, USA.

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · DUKE UNIVERSITY · 2025 to 2025
$2.7M
UW Core Center for Clinical Research of Musculoskeletal ConditionsP30AR072572 · UNIVERSITY OF WASHINGTON · 2025 to 2025
$703k
NCCIH NIH HHS U24 AT009676NIAMS NIH HHS P30 AR072572
6 · The paper itself

Abstract

While the embedded nature of pragmatic clinical trials (PCTs) can improve the efficiency and relevance of research for multiple stakeholders, embedding research into ongoing clinical care can also involve ethical and regulatory challenges. An emergent challenge is the management of pragmatic clinical trial collateral findings (PCT-CFs). While PCT-CFs share some features with incidental or secondary findings that are encountered in conventional clinical trials and clinical care, the PCT context differs in ethically relevant ways that complicate PCT-CF identification and management. We report on the results of a two-year multi-method investigation of PCT-CFs. Overall, five core themes emerged: 1) the liminal nature of PCTs and the implications of this for PCT-CFs; 2) the context-specific nature of PCT-CF management; 3) the centrality of institutions; 4) the importance of prospective planning; and 5) patient expectations. Among the central lessons of this work are that prior ethics guidance from other settings cannot easily be adapted to address PCT-CFs, nor can a single approach readily accommodate all PCT-CFs. Moving forward, stakeholders, including researchers, institutions, ethics oversight bodies, and funders, should anticipate and plan for PCT-CFs in the design, conduct, and analysis of PCTs. Future scholarship is needed to examine experiences with PCT-CFs, and the practical and conceptual issues they raise for the future conduct of PCTs.

Indexed as

Pragmatic Clinical Trials as TopicResearch DesignHumansProspective StudiesResearch PersonnelEmbedded researchEthicsHealth care systemsPragmatic clinical trialsRegulation

Identifiers

PMID34600345
PMCPMC8664991

What Socratic 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 Socratic graph.