Standardizing, harmonizing, and protecting data collection to broaden the impact of COVID-19 research: the rapid acceleration of diagnostics-underserved populations (RADx-UP) initiative.

Journal Article (Journal Article;Review)

OBJECTIVE: The Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program is a consortium of community-engaged research projects with the goal of increasing access to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tests in underserved populations. To accelerate clinical research, common data elements (CDEs) were selected and refined to standardize data collection and enhance cross-consortium analysis. MATERIALS AND METHODS: The RADx-UP consortium began with more than 700 CDEs from the National Institutes of Health (NIH) CDE Repository, Disaster Research Response (DR2) guidelines, and the PHENotypes and eXposures (PhenX) Toolkit. Following a review of initial CDEs, we made selections and further refinements through an iterative process that included live forums, consultations, and surveys completed by the first 69 RADx-UP projects. RESULTS: Following a multistep CDE development process, we decreased the number of CDEs, modified the question types, and changed the CDE wording. Most research projects were willing to collect and share demographic NIH Tier 1 CDEs, with the top exception reason being a lack of CDE applicability to the project. The NIH RADx-UP Tier 1 CDE with the lowest frequency of collection and sharing was sexual orientation. DISCUSSION: We engaged a wide range of projects and solicited bidirectional input to create CDEs. These RADx-UP CDEs could serve as the foundation for a patient-centered informatics architecture allowing the integration of disease-specific databases to support hypothesis-driven clinical research in underserved populations. CONCLUSION: A community-engaged approach using bidirectional feedback can lead to the better development and implementation of CDEs in underserved populations during public health emergencies.

Full Text

Duke Authors

Cited Authors

  • Carrillo, GA; Cohen-Wolkowiez, M; D'Agostino, EM; Marsolo, K; Wruck, LM; Johnson, L; Topping, J; Richmond, A; Corbie, G; Kibbe, WA

Published Date

  • August 16, 2022

Published In

Volume / Issue

  • 29 / 9

Start / End Page

  • 1480 - 1488

PubMed ID

  • 35678579

Pubmed Central ID

  • PMC9382379

Electronic International Standard Serial Number (EISSN)

  • 1527-974X

Digital Object Identifier (DOI)

  • 10.1093/jamia/ocac097

Language

  • eng

Conference Location

  • England