Evidence map›Paper›PMID 35597988›Full record

ArticleTrials2022

The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.

Emily C O'Brien, Jeremy Sugarman, Kevin P Weinfurt, Eric B Larson, Patrick J Heagerty, Adrian F Hernandez, Lesley H Curtis

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

8 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

7 authors at 5 institutions in 1 country.

Emily C O'BrienDepartment of Population Health Sciences, School of Medicine, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA. emily.obrien@duke.edu.
Jeremy SugarmanBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
Kevin P WeinfurtDepartment of Population Health Sciences, School of Medicine, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA.
Eric B LarsonKaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Patrick J HeagertyDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Adrian F HernandezDuke Clinical Research Institute, School of Medicine, Duke University, Durham, NC, USA.
Lesley H CurtisDepartment of Population Health Sciences, School of Medicine, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA.
Clinical Research Institute · USDuke University · USJohns Hopkins University · USKaiser Permanente Washington Health Research Institute · USUniversity of Washington · US

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 AT010961NIH HHS U24AT010961Office of Strategic Coordination U24AT009676
6 · The paper itself

Abstract

backgroundThe COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at high risk of disruption due to the dual impacts on the conduct of both care and research.

methodsWe collected qualitative data using multiple methods to characterize the impact of COVID-19 on the research activities of 14 active pragmatic clinical trials in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. A COVID-19 impact questionnaire was administered electronically to principal investigators in June 2020. Text responses were analyzed thematically, and qualitative summaries were subsequently reviewed by five independent reviewers, who made iterative revisions. Additional COVID-19-related impacts were identified during virtual meetings with trial teams during April-July 2020 and combined with questionnaire responses for analysis.

resultsImpacts of the pandemic were broadly classified into two main types: healthcare operations and social distancing. In some instances, trial delays created statistical challenges, particularly with trials using stepped-wedge designs, and necessitated changing data collection strategies or modifying interventions. The majority of projects used existing stakeholder-driven approaches to adapt interventions. Several benefits of these adaptions were identified, including expanded outreach capabilities and ability to study virtual intervention delivery. All trial teams were able to adapt to pandemic-related modifications.

conclusionIn a group of 14 ongoing pragmatic clinical trials, there was significant impact of COVID-19 on trial activities. Engaging appropriate stakeholders was critical to designing and implementing trial modifications and making continued safe progress toward meeting research objectives.

Indexed as

COVID-19Pragmatic Clinical Trials as TopicDelivery of Health CareHumansNational Institutes of Health (U.S.)PandemicsUnited StatesCOVID-19Pragmatic clinical trialsResearch participation

Identifiers

PMID35597988
PMCPMC9123729
OpenAlexW4281260763

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.