Recovery trajectories and long-term outcomes in traumatic brain injury: A secondary analysis of the phase 3 COBRIT clinical trial.

Recovery trajectories and long-term outcomes in traumatic brain injury: A secondary analysis of the phase 3 COBRIT clinical trial.

World Neurosurg. 2019 Feb 11;:

Authors: Puffer RC, Yue JK, Mesley M, Billigen JB, Sharpless J, Fetzick AL, Puccio AM, Diaz-Arrastia R, Okonkwo DO

Abstract
INTRODUCTION: Prospects for recovery after traumatic brain injury (TBI) are often underestimated, potentially leading to withdrawal of care in the comatose TBI patient who may ultimately have a favorable outcome with aggressive care. Outcomes and trajectories of recovery in a large series of TBI patients were evaluated at 30, 90 and 180 days post-injury.
METHODS: A secondary analysis of the Phase 3 COBRIT was performed analyzing recovery trajectories and long-term outcomes at 30, 90 and 180 days post-injury. A GOS-E of 5 or greater was considered favorable. Pearson Chi squared analysis was utilized and a p-value of 0.05 was considered significant. A locally weighted, polynomial regression model was used to model recovery trajectories in a non-linear fashion.
RESULTS: TBI subjects in the COBRIT trial had high rates of favorable outcome (57% of severe TBI, 86% of moderate TBI and 93% of complicated mild TBI) at 6 month follow-up. These favorable outcomes often converted from high rates of unfavorable outcome at initial 1 month follow-up (85% of severe TBI, 57% of moderate TBI and 21% of complicated mild TBI). Recovery trajectories had not plateaued at 6-months, suggesting that further improvement occurs beyond 6-months post-injury.
DISCUSSION: In this secondary analysis of the COBRIT trial, the majority of patients had favorable outcomes by GOS-E at 6-months post-injury in all complicated mild and moderate TBI groups, with over half of severe TBI patients achieving a favorable outcome as well. Of subjects in a vegetative state (GOS-E 2) at 1-month post-injury, 18% improved to a favorable outcome by 6-months post-injury. There was substantial improvement in all groups from 1-month to 6-months, and this improvement may continue beyond 6-months. Clinical trials in TBI should consider recovery curves with repeated measures to assess outcomes, as arbitrary single-moment outcome determination likely underestimates treatment effect in TBI care.

PMID: 30763755 [PubMed - as supplied by publisher]

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