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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Information & Authors

Information

Published In

cover image Journal of Neurotrauma
Journal of Neurotrauma
Volume 40Issue Number 3-4February 2023
Pages: 337 - 348
PubMed: 36097759

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

Affiliations

Yelena G. Bodien
Massachusetts General Hospital, Boston, Massachusetts, USA.
Harvard Medical School, Boston, Massachusetts, USA.
Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, USA.
Jason Barber
University of Washington, Seattle, Washington, USA.
Sabrina R. Taylor
University of California, San Francisco, San Francisco, California, USA.
Kim Boase
University of Washington, Seattle, Washington, USA.
John D. Corrigan
The Ohio State University, Columbus, Ohio, USA.
Sureyya Dikmen
University of Washington, Seattle, Washington, USA.
Raquel C. Gardner
University of California, San Francisco, San Francisco, California, USA.
Joel H. Kramer
University of California, San Francisco, San Francisco, California, USA.
Harvey Levin
Baylor College of Medicine, Houston, Texas, USA.
Joan Machamer
University of Washington, Seattle, Washington, USA.
Thomas McAllister
University of Indiana School of Medicine, Indianapolis, Indiana, USA.
Lindsay D. Nelson
Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Laura B. Ngwenya
University of Cincinnati, Cincinnati, Ohio, USA
Mark Sherer
Baylor College of Medicine, Houston, Texas, USA.
TIRR Memorial Hermann, Houston, Texas, USA.
Murray B. Stein
University of California San Diego, La Jolla, California, USA.
Mary Vassar
University of California, San Francisco, San Francisco, California, USA.
John Whyte
Moss Rehabilitation Research Institute, Elkins Park, Pennsylvania, USA.
John K. Yue
University of California, San Francisco, San Francisco, California, USA.
Amy Markowitz
University of California, San Francisco, San Francisco, California, USA.
Michael A. McCrea
Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Geoffrey T. Manley
University of California, San Francisco, San Francisco, California, USA.
Nancy Temkin
University of Washington, Seattle, Washington, USA.
Joseph T. Giacino* [email protected]
Massachusetts General Hospital, Boston, Massachusetts, USA.
Harvard Medical School, Boston, Massachusetts, USA.
Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, USA.
the TRACK-TBI Investigators**

Notes

**
The TRACK-TBI Investigators may be found at the end of this article.
*
Address correspondence to: Joseph T. Giacino, PhD, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, 300 First Avenue, Charlestown, MA 02114, USA [email protected]

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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