Feasibility and Utility of a Flexible Outcome Assessment Battery for Longitudinal Traumatic Brain Injury Research: A TRACK-TBI Study
Abstract
The effects of traumatic brain injury (TBI) are difficult to measure in longitudinal cohort studies, because disparate pre-injury characteristics and injury mechanisms produce variable impairment profiles and recovery trajectories. In preparation for the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, which followed patients with injuries ranging from uncomplicated mild TBI to coma, we designed a multi-dimensional Flexible outcome Assessment Battery (FAB). The FAB relies on a decision-making algorithm that assigns participants to a Comprehensive (CAB) or Abbreviated Assessment Battery (AAB) and guides test selection across all phases of recovery. To assess feasibility of the FAB, we calculated the proportion of participants followed at 2 weeks (2w) and at 3, 6, and 12 months (3m, 6m, 12m) post-injury who completed the FAB and received valid scores. We evaluated utility of the FAB by examining differences in 6m and 12m Glasgow Outcome Scale-Extended (GOSE) scores between participant subgroups derived from the FAB-enabled versus traditional approach to outcome assessment applied at 2w. Among participants followed at 2w (n = 2094), 3m (n = 1871), 6m (n = 1736), and 12m (n = 1607) post-injury, 95–99% received valid completion scores on the FAB, in full or in part, either in person or by telephone. Level of function assessed by the FAB-enabled approach at 2w was associated with 6m and 12m GOSE scores (proportional odds p < 0.001). These findings suggest that the participant classification methodology afforded by the FAB may enable more effective data collection to improve detection of natural history changes and TBI treatment effects.
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TRACK-TBI Investigators
Ramon Diaz-Arrastia, University of Pennsylvania; Adam R. Ferguson, University of California, San Francisco; Ramesh Grandhi, University of Utah; Ruchira Jha, Barrow Neurological Institute; C. Dirk Keene, University of Washington; Frederick K. Korley, University of Michigan; Christopher Madden, UT Southwestern; Randall Merchant, Virginia Commonwealth University; Pratik Mukherjee, University of California, San Francisco, David Okonkwo, University of Pittsburgh; Claudia Robertson, Baylor College of Medicine; David Schnyer, UT Austin; Ross Zafonte, Harvard Medical School
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Copyright 2023, Mary Ann Liebert, Inc., publishers.
History
Published in print: February 2023
Published online: 31 January 2023
Published ahead of print: 14 October 2022
Published ahead of production: 13 September 2022
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Authors
Authors' Contributions
Yelena G. Bodien: Conceptualization, Methodology, Validation, Formal Analysis, Investigation, Data Curation, Writing–Original Draft, Review and Editing, Visualization, Supervision, Project Administration; Jason Barber: Methodology, Validation, Formal Analysis, Data Curation, Writing–Original Draft, Review and Editing; Sabrina R Taylor: Conceptualization, Validation, Investigation, Data Curation, Writing–Review and Editing, Project Administration; Kim Boase: Conceptualization, Methodology, Validation, Data Curation, Writing–Review and Editing, Supervision; John D. Corrigan: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Sureyya Dikmen: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Raquel C. Gardner: Conceptualization, Writing–Review and Editing; Joel H Kramer: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Harvey Levin: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Joan Machamer: Conceptualization, Methodology, Validation, Data Curation, Writing–Review and Editing; Thomas McAllister: Conceptualization, Methodology, Investigation, Writing – Review and Editing; Lindsay D. Nelson, PhD: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Laura B. Ngwenya: Methodology, Investigation, Writing–Review and Editing; Mark Sherer: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Murray B. Stein: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Mary Vassar: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Project Administration; John Whyte: Conceptualization, Methodology, Investigation, Writing–Review and Editing; John K. Yue: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Amy Markowitz: Investigation, Writing–Review and Editing, Project Administration, Funding Acquisition; Michael A. McCrea: Conceptualization, Methodology, Investigation, Writing–Review and Editing; Geoffrey T. Manley, Nancy Temkin: Conceptualization, Methodology, Investigation, Validation, Formal Analysis, Writing–Original Draft, Review and Editing, Funding Acquisition; Joseph T. Giacino: Conceptualization, Methodology, Validation, Formal Analysis, Investigation, Data Curation, Writing–Original Draft, Review, and Editing, Visualization, Supervision, Project Administration, Funding Acquisition; TRACK-TBI Investigators: Investigation, Writing–Review and Editing
Author Disclosure Statement
No competing financial interests exist.
Funding Information
The contents of this publication were developed under grants from: NIH/NINDS (Grant UO1-NS086090) and DoD (Grant W81XWH-14-2-0176).
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