Research Reports - Distinct 6-Month functional outcome trajectories and predictors after traumatic brain injury

Raquel Gardner, Jing Cheng, Adam Ferguson, John Boscardin, Ross Zafonte, Geoffrey Manley

Neurology Apr 2018, 90 (15 Supplement) P6.302

Objective: Our aim was to use data-driven analytics to identify distinct 6-month functional outcome trajectories after traumatic brain injury (TBI) to inform design of clinical trials.

Background: Cross-sectional approaches to outcome assessment may not adequately capture heterogeneity in recovery after TBI. The Citicoline Brain Injury Treatment (COBRIT) trial was a negative trial of Citicoline vs. placebo in patients with mild-complicated to severe TBI (age 18–71y). While the primary endpoint was a 3-month binary outcome derived from the Glasgow Outcome Scale Extended (GOSE; the most widely used TBI functional outcome assessment) and a cognitive battery, the study also collected data on 1 and 6-month GOSE, thus facilitating functional trajectory analysis.

Design/Methods: In this secondary analysis of COBRIT trial data, we used latent class growth analysis (LCGA) to identify distinct 6-month functional recovery trajectories among 1,045 TBI survivors. LCGA is a data-driven analytic that identifies groups of patients with similar trajectories allowing for visualization of multiple distinct recovery patterns. Next, we used multinomial logistic mixed effect models and backward elimination to identify independent baseline clinical predictors of these trajectories.

Results: 4 distinct functional recovery trajectories were identified: 1. “Slight-decliners” (n=149) who started with good recovery followed by stability or slight post-recovery decline, 2. “rapid-improvers” (n=103) who experienced rapid total recovery despite starting with a range of disabilities, 3. “gradual-improvers” (n=699) who experienced steady gradual improvement, and 4. “non-improvers” (n=94) who started with severe disability and did improve. Trajectory group membership was not predicted by Citicoline treatment (p=0.997). Age, race, pre-injury employment, TBI mechanism, Glasgow Coma Scale, post-traumatic amnesia, midline shift, and subarachnoid hemorrhage (SAH) on head CT were identified as independent predictors of 6-month functional trajectory.

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