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. 2017 Nov 15;34(22):3158-3172.
doi: 10.1089/neu.2017.5139. Epub 2017 Aug 17.

Validating Multi-Dimensional Outcome Assessment Using the Traumatic Brain Injury Common Data Elements: An Analysis of the TRACK-TBI Pilot Study Sample

Lindsay D Nelson  1 , Jana Ranson  2 , Adam R Ferguson  3 , Joseph Giacino  4 , David O Okonkwo  5 , Alex B Valadka  6 , Geoffrey T Manley  7 , Michael A McCrea  1
Affiliations

Validating Multi-Dimensional Outcome Assessment Using the Traumatic Brain Injury Common Data Elements: An Analysis of the TRACK-TBI Pilot Study Sample

Lindsay D Nelson et al. J Neurotrauma. .

Abstract

The Glasgow Outcome Scale-Extended (GOSE) is often the primary outcome measure in clinical trials for traumatic brain injury (TBI). Although the GOSE's capture of global functional outcome has several strengths, concerns have been raised about its limited ability to identify mild disability and failure to capture the full scope of problems patients exhibit after TBI. This analysis examined the convergence of disability ratings across a multi-dimensional set of outcome domains in the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot Study. The study collected measures recommended by the TBI Common Data Elements (CDE) Workgroup. Patients presenting to three emergency departments with a TBI of any severity enrolled in TRACK-TBI prospectively after injury; outcome measures were collected at 3 and 6 months post-injury. Analyses examined frequency of impairment and overlap between impairment status across the CDE outcome domains of Global Level of Functioning (GOSE), Neuropsychological (cognitive) Impairment, Psychological Status, TBI Symptoms, and Quality of Life. GOSE score correlated in the expected direction with other outcomes (mean [M] Spearman's rho = 0.21 and 0.49 with neurocognitive and self-report outcomes, respectively). The subsample in the Upper Good Recovery (GOSE 8) category appeared quite healthy across most other outcomes, although 19.0% had impaired executive functioning (Trail Making Test Part B). A significant minority of participants in the Lower Good Recovery subgroup (GOSE 7) met criteria for impairment across numerous other outcome measures. The findings highlight the multi-dimensional nature of TBI recovery and the limitations of applying only a single outcome measure.

Trial registration: ClinicalTrials.gov NCT01565551.

Keywords: Glasgow Outcome Scale; common data elements; neuropsychological; outcome assessment; traumatic brain injury.

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Conflict of interest statement

Dr. Nelson reports grants from NIH and the Medical College of Wisconsin's Center for Patient Care and Outcomes Research, Clinical and Translational Science Institute, and Advancing a Healthier Wisconsin Endowment during the conduct of the study. Dr. Ranson has nothing to disclose. Dr. Ferguson reports grants from the NIH (R01NS067092, R01NS088475), the VA (1I01RX002245), the Craig H. Neilsen Foundation, and Wings for Life during the conduct of this study. Dr. Giacino reports grants from the Department of Defense, NIH, NIDILRR, James S. McDonnell Foundation and other support from the Barbara Epstein Foundation during the conduct of the study. Dr. Okonkwo reports grants from NIH and the Department of Defense during the conduct of the study. Dr. Valadka has nothing to disclose. Dr. Manley reports grants from the Department of Defense, NIH, and other support from One Mind, Palantir, and Johnson & Johnson Family of Companies/DePuySynthes/Codman Neuro during the conduct of the study. Dr. McCrea reports grants from the Department of Defense, National Collegiate Athletic Association, and National Football League during the conduct of the study.

Figures

<b>FIG. 1.</b>
FIG. 1.
Multi-dimensional assessment of traumatic brain injury (TBI) outcome with the TBI Common Data Elements (CDE).
<b>FIG. 2.</b>
FIG. 2.
Distribution of valid cases per the Glasgow Outcome Scale-Extended (GOSE) categories 3–8 at 3 and 6 months. N with GOSE outcome data was 456 at 3 months and 415 at 6 months (of 586 subjects enrolled).
<b>FIG. 3.</b>
FIG. 3.
Distribution of select 6-month outcome measures stratified by Glasgow Outcome Scale-Extended (GOSE) score. Top left: California Verbal Learning Test-Second Edition (CVLT-II) Trials 1–5 T score. Top right: Brief Symptom Inventory-18 (BSI-18) Global Severity Index T score. Bottom left: 3-item Rivermead Post-Concussion Symptom Questionnaire (RPQ) total score. Bottom right: Satisfaction with Life Scale (SWLS) total score.
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