Evidence map›Paper›PMID 37005790›Full record

ArticleJournal of primary care & community health

Challenges in Use of Practice-based Research Networks for a Medical Device Trial to Detect SARS-CoV-2.

Jeanette M Daly, Laurel O'Connor, Megan E Schmidt, Laura K Ferrara, Kim Parang, Barcey T Levy

Open access · goldAbstract read
In one paragraph

Article in Journal of primary care & community health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 35% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
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

6 authors at 4 institutions in 1 country.

Jeanette M DalyDepartment of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.ORCID 0000-0001-7130-4552
Laurel O'ConnorDepartment of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Megan E SchmidtDepartment of Community and Behavioral Health, College of Public Health, University of Iowa, Iowa City, IA, USA.ORCID 0000-0002-9122-1241
Laura K FerraraOregon Health & Science University, Portland, OR, USA.
Kim ParangUniversity of California, San Francisco, San Francisco, CA, USA.ORCID 0000-0002-9248-1168
Barcey T LevyDepartment of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.
University of Iowa · USOregon Health & Science University · USUniversity of California, San Francisco · USUniversity of Massachusetts Chan Medical School · US

Funding

The Center for Advancing Point of Care in Heart, Lung, Blood and Sleep DiseasesU54HL143541 · NHLBI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI Nathaniel Scott Hafer · 2018 to 2026
$141.0M
University of Massachusetts Center for Clinical Science and Translational SupplementUL1TR001453 · NCATS · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI LUZURIAGA, KATHERINE F · 2015 to 2024
$39.0M
The University of Iowa Clinical and Translational Science AwardUL1TR002537 · NCATS · UNIVERSITY OF IOWA · PI HANSEN, MARLAN R, WINOKUR, PATRICIA · 2018 to 2022
$20.0M
University of Massachusetts Center for Clinical and Translational ScienceTL1TR001454 · NCATS · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI LEWIS, BRIAN C · 2015 to 2024
$3.6M
NCATS NIH HHS TL1 TR001454NCATS NIH HHS UL1 TR001453NCATS NIH HHS UL1 TR002537NHLBI NIH HHS U54 HL143541
6 · The paper itself

Abstract

INTRODUCTION/

objectivesPrimary care practice-based research networks (PBRNs) participated in a point of care (POC) device study funded by by the National Institutes of Health and led by the University of Massachusetts Chan Medical School (UMass) to speed the development, validation, and commercialization of POC tests to detect SARS-CoV-2. The purposes of this study were to describe the characteristics of participating PBRNs and their respective collaborators in this device trial and describe complications challenging its execution.

methodsSemi-structured interviews were conducted with lead personnel from participating PBRNs and UMass.

resultsFour PBRNs and UMass were invited to participate and 3 PBRNs and UMass participated. This device trial recruited 321 subjects in 6 months; 65 subjects from PBRNs. Each PBRN and the academic medical center site enrolled and recruited subjects differently. Main challenges identified were having adequate clinic personnel to enroll and aid in consent and questionnaire completion, frequently changing inclusion/exclusion criteria, use of the digital electronic data collection platform, and having access to a -80°C freezer to store supplies. DISCUSSION: This trial involved numerous researchers, primary care clinic leaders and staff, and academic center sponsored program staff and attorneys resulting in a resource-intensive endeavor to enroll 65 subjects in the real-world clinical setting of primary care PBRNs with the academic medical center enrolling the rest. Multiple obstacles to standing up the study were encountered by the PBRNS.

conclusionsPrimary care PBRNs rely largely on the goodwill established between academic health centers and participating practices. For future investigations involving device studies, collaborating PBRN leaders should assess whether recruitment criteria may change, obtain detailed lists of equipment needed, and/or know if the study is likely to be halted suddenly to appropriately prepare their member practices.

Indexed as

COVID-19SARS-CoV-2Academic Medical CentersHumansSchools, MedicalSurveys and QuestionnairesCOVID-19device trialpractice-based research networkprimary careSARs-CoV-2

Identifiers

PMID37005790
PMCPMC10070755
OpenAlexW4362502981

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.