Journal article
Challenges in Use of Practice-based Research Networks for a Medical Device Trial to Detect SARS-CoV-2
Journal of primary care & community health, Vol.14, 21501319231164540
04/02/2023
DOI: 10.1177/21501319231164540
PMCID: PMC10070755
PMID: 37005790
Abstract
Primary 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.
Semi-structured interviews were conducted with lead personnel from participating PBRNs and UMass.
Four 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.
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.
Primary 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.
Details
- Title: Subtitle
- Challenges in Use of Practice-based Research Networks for a Medical Device Trial to Detect SARS-CoV-2
- Creators
- Jeanette M Daly - Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, USALaurel O'Connor - Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USAMegan E Schmidt - Department of Community and Behavioral Health, College of Public Health, University of Iowa, Iowa City, IA, USALaura K Ferrara - Oregon Health & Science UniversityKim Parang - University of California, San FranciscoBarcey T Levy - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Journal of primary care & community health, Vol.14, 21501319231164540
- DOI
- 10.1177/21501319231164540
- PMID
- 37005790
- PMCID
- PMC10070755
- NLM abbreviation
- J Prim Care Community Health
- ISSN
- 2150-1319
- eISSN
- 2150-1327
- Grant note
- name: University of Iowa, Department of Family Medicine; DOI: 10.13039/100006108, name: National Center for Advancing Translational Sciences, award: KL2TR001454; DOI: 10.13039/100006108, name: National Center for Advancing Translational Sciences, award: UL1TR002537; name: Subaward to the University of Iowa from the University of Massachusetts at Worcester, award: OSP/WPM33765-IOWA
- Language
- English
- Date published
- 04/02/2023
- Academic Unit
- Epidemiology; Family and Community Medicine; Community and Behavioral Health
- Record Identifier
- 9984385049502771
Metrics
34 Record Views