Prospective Harmonization, Common Data Elements, and Sharing Strategies for Multicenter Pre-Clinical Traumatic Brain
Ina-Beate Wanner1, Joseph T McCabe2, J Russell Huie3,4
1Intellectual and Developmental Disability Center (IDDRC), David Geffen School of Medicine, Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, California, USA.
Journal of Neurotrauma
|January 20, 2025
Summary
Harmonizing traumatic brain injury (TBI) research across multiple centers improves data rigor and reproducibility. This approach standardizes data collection and analysis, enabling better validation of TBI assessment tools.
Area of Science:
- Neuroscience
- Translational Research
- Biomedical Informatics
Background:
- Effective team science for traumatic brain injury (TBI) research necessitates procedural harmonization for rigor and reproducibility.
- Multicenter studies across diverse experimental modalities (domains) are crucial for accelerating the translation of findings.
- The Translational Outcomes Project in NeuroTrauma (TOP-NT) consortium aims to establish and validate noninvasive TBI assessment tools through collaborative team science.
Purpose of the Study:
- To present practical approaches for harmonizing TBI research across five centers, establishing a framework for centralized data organization and use.
- To facilitate data sharing for validating data between domains, evaluating inter-site reproducibility, and enabling multimodal analyses.
- To outline strategies for robust pre-clinical research in multicenter trials to improve the translatability of TBI assessments.
Main Methods:
- TOP-NT produced a library of TBI-relevant standard operating procedures (SOPs) and aligned 481 pre-clinical and clinical common data elements (CDEs), generating 272 new pre-clinical TBI CDEs.
- Diverse data types, including magnetic resonance imaging (MRI) protocols and blood biomarkers, were connected to validate assessments across domains and enable multivariable TBI phenotyping.
- Technical quality controls for pre-clinical studies were specified, and data curation steps were developed for storage in a centralized repository (Open Data Commons for TBI).
Main Results:
- Harmonization tools were developed, including SOPs and aligned CDEs, to facilitate reproducibility in team science and distinguish injury spectrum from technical variability.
- Data collected across three rat TBI models at four sites, using 481 TOP-NT pre-clinical CDEs, were organized for unbiased cross-site analysis.
- The approach enabled a higher-level, syndromic understanding of TBI signatures, improving the translatability of TBI assessments.
Conclusions:
- Procedural harmonization and standardized data elements are essential for rigorous, reproducible multicenter TBI research.
- Centralized data organization and sharing through platforms like the Open Data Commons for TBI enhance cross-site validation and analysis.
- The TOP-NT framework provides strategies for robust pre-clinical research, ultimately improving the translatability of TBI assessment tools and understanding.
