Evidence map›Paper›PMID 34998990›Full record

ArticleContemporary clinical trials2022

Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem.

Joseph Ali, Stephanie R Morain, P Pearl O'Rourke, Benjamin Wilfond, Emily C O'Brien, Christina K Zigler, Karen L Staman, Kevin P Weinfurt, Jeremy Sugarman

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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.

Joseph AliJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: jali@jhu.edu.
Stephanie R MorainJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
P Pearl O'RourkeHarvard Medical School, Boston, MA, USA.
Benjamin WilfondTreuman Katz Center for Pediatric Bioethics, Seattle, WA, USA; Seattle Children's Research Institute, Seattle, WA, USA; University of Washington School of Medicine, Seattle, WA, USA.
Emily C O'BrienDuke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Durham, NC, USA.
Christina K ZiglerDuke University School of Medicine, Durham, NC, USA.
Karen L StamanDuke University School of Medicine, Durham, NC, USA.
Kevin P WeinfurtDuke University School of Medicine, Durham, NC, USA.
Jeremy SugarmanJohns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins School of Medicine, 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
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

backgroundEthical responsibilities for monitoring and responding to signals of behavioral and mental health risk (such as suicidal ideation, opioid use disorder, or depression) in general clinical research have been described; however, pragmatic clinical trials (PCTs) raise new contextual challenges.

methodsWe use our experience with the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) program, which is a component of the Helping End Addiction Long-Term (HEAL) Initiative, to provide examples of research studying nonpharmacologic interventions for pain that collect sensitive data. Members of the PRISM Ethics and Regulatory Core and Patient-Centered Outcome Core Working Group discussed and refined considerations and recommendations.

resultsPCT researchers can help identify the extent of their ethical obligations to monitor and respond to signals of potential behavioral and mental health risks by understanding and aligning stakeholder expectations; considering characteristics of the trial and study population; defining triggers, thresholds, and responsibilities for action; identifying appropriate response mechanisms and capabilities; integrating responses with health systems; and addressing privacy. Based on such an assessment, researchers should proactively identify if, when, and how a response will be triggered. Doing so necessitates that stakeholders understand their roles in managing such risks. Finally, consent forms and other study disclosures should clearly state what if any responses might be taken.

conclusionEarly and ongoing bi-directional communication with relevant stakeholders is critical to identifying and meeting the ethical challenges for PCTs when managing and responding to behavioral and mental health data that potentially signal elevated risk to individuals.

Indexed as

Analgesics, OpioidEcosystemHumansPractice Patterns, Physicians'Pragmatic Clinical Trials as TopicResearch DesignResearch PersonnelAnalgesics, OpioidBehavioral healthCommon data elementsEthicsMental healthPainPragmatic clinical trials

Identifiers

PMID34998990
PMCPMC8844235

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.