Evidence map›Paper›PMID 34775101›Full record

ArticleContemporary clinical trials2021

Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants.

Brian C Coleman, Natalie Purcell, Mary Geda, Stephen L Luther, Peter Peduzzi, Robert D Kerns, Karen H Seal, Diana J Burgess, Marc I Rosen, John Sellinger and 4 more

Open access · greenAbstract read
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.4field-weighted citation impact, top 12% of its field
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

17 citing papers in PubMed, 19 citations in OpenAlex.

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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 at 10 institutions in 1 country.

Brian C ColemanPain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America. Electronic address: Brian.Coleman@yale.edu.
Natalie PurcellSan Francisco VA Health Care System, San Francisco, CA, United States of America; Department of Social and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States of America.
Mary GedaPain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, United States of America.
Stephen L LutherResearch and Development Service, James A. Haley Veterans Hospital, Tampa, FL, United States of America; College of Public Health, University of South Florida, Tampa, FL, United States of America.
Peter PeduzziPain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Biostatistics, Yale School of Public Health, New Haven, CT, United States of America.
Robert D KernsPain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States of America.
Karen H SealSan Francisco VA Health Care System, San Francisco, CA, United States of America; Departments of Medicine and Psychiatry, University of California, San Francisco, San Francisco, CA, United States of America.
Diana J BurgessCenter for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN, United States of America; Department of Medicine, University of Minnesota School of Medicine, Minneapolis, MN, United States of America.
Marc I RosenPain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States of America.
John SellingerDepartment of Psychiatry, Yale School of Medicine, New Haven, CT, United States of America.
Stacie A SalsburyPalmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, United States of America.
Hannah GelmanCenter of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America.
Cynthia A BrandtPain Research, Informatics, Multimorbidities, and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Pain Management Collaboratory Coordinating Center, Yale School of Medicine, New Haven, CT, United States of America; Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, United States of America.
Robert R EdwardsDepartment of Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States of America.
The Coordinating Center · USVA Connecticut Healthcare System · USYale University · USHarvard University · USMinneapolis VA Health Care System · USPalmer College of Chiropractic · USSan Francisco VA Health Care System · USUniversity of California, San Francisco · USUniversity of South Florida · USVA Puget Sound Health Care System · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Pain Management Collaboratory Coordinating Center (PMC3)U24AT009769 · NCCIH · YALE UNIVERSITY · PI WILLIAM C BECKER, Alicia Heapy · 2017 to 2026
$16.4M
Chiropractic Care for Veterans: A Pragmatic Randomized Trial Addressing Dose Effects for cLBPUH3AT009761 · NCCIH · PALMER COLLEGE OF CHIROPRACTIC · PI GOERTZ, CHRISTINE MARIE, LONG, CYNTHIA R · 2019 to 2024
$7.2M
Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Function and Quality of Life in VeteransUH3AT009765 · NCCIH · NORTHERN CALIFORNIA INSTITUTE/RES/EDU · PI BECKER, WILLIAM C, SEAL, KAREN H · 2020 to 2024
$6.9M
Engaging Veterans Seeking Service-Connection Payments in Pain TreatmentUH3AT009758 · NCCIH · YALE UNIVERSITY · PI ROSEN, MARC I · 2019 to 2023
$5.2M
Engaging Veterans Seeking Service-Connection Payments in Pain TreatmentUG3AT009758 · NCCIH · YALE UNIVERSITY · PI MARTINO, STEVE, ROSEN, MARC I · 2017 to 2018
$1.2M
HSRD VA IK6 HX003766HSRD VA IU1 HX002607NCATS NIH HHS UL1 TR001863NCCIH NIH HHS U24 AT009769NCCIH NIH HHS UG3 AT009758NCCIH NIH HHS UH3 AT009758NCCIH NIH HHS UH3 AT009761NCCIH NIH HHS UH3 AT009765
6 · The paper itself

Abstract

Characterizing the impacts of disruption attributable to the COVID-19 pandemic on clinical research is important, especially in pain research where psychological, social, and economic stressors attributable to the COVID-19 pandemic may greatly impact treatment effects. The National Institutes of Health - Department of Defense - Department of Veterans Affairs Pain Management Collaboratory (PMC) is a collective effort supporting 11 pragmatic clinical trials studying nonpharmacological approaches and innovative integrated care models for pain management in veteran and military health systems. The PMC rapidly developed a brief pandemic impacts measure for use across its pragmatic trials studying pain while remaining broadly applicable to other areas of clinical research. Through open discussion and consensus building by the PMC's Phenotypes and Outcomes Work Group, the PMC Coronavirus Pandemic (COVID-19) Measure was iteratively developed. The measure assesses the following domains (one item/domain): access to healthcare, social support, finances, ability to meet basic needs, and mental or emotional health. Two additional items assess infection status (personal and household) and hospitalization. The measure uses structured responses with a three-point scale for COVID-19 infection status and four-point ordinal rank response for all other domains. We recommend individualized adaptation as appropriate by clinical research teams using this measure to survey the effects of the COVID-19 pandemic on study participants. This can also help maintain utility of the measure beyond the COVID-19 pandemic to characterize impacts during future public health emergencies that may require mitigation strategies such as periods of quarantine and isolation.

Indexed as

COVID-19Pragmatic Clinical Trials as TopicHumansPandemicsQuarantineSocial SupportUnited StatesCOVID-19Military personnelPainPhenotypingPragmatic clinical trialsVeterans

Identifiers

PMID34775101
PMCPMC8585559
OpenAlexW3214687605

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.