New Assessment Battery Enables Longitudinal Evaluation of Patients With Severe TBI
Yelena Bodien, PhD, Joseph Giacino, PhD, and colleagues helped create the Flexible Outcome Assessment Battery (FAB) for patients with traumatic brain injury, which proved feasible across the entire spectrum of severity and discerned different levels of function among traditionally "untestable" patients.
At 18 level I trauma centers, the Translating Research and Clinical Practice in Traumatic Brain Injury (TRACK-TBI) prospective, longitudinal study follows adult and pediatric patients with TBI across a wide range of severity and causes.
The Flexible Outcome Assessment Battery (FAB), specially created for the study, is designed to assess all patients, including those with confusion or disorders of consciousness who would ordinarily be excluded from clinical trials.
Feasibility testing of the FAB in 2,209 adults indicated valid completion rates were high overall, although rates were lower for performance-based measures that required in-person assessment.
A utility analysis demonstrated that among subgroups of participants traditionally considered ''untestable'' because of severe cognitive impairment, the FAB can reveal distinct outcomes six and 12 months post-injury.
The FAB appears capable of reducing the challenges to outcomes assessment that are inherent to TBI heterogeneity and may prevent underestimation of improvement in clinical trials.
Patients with traumatic brain injury (TBI) vary widely in pre-injury status, injury mechanisms, impairment profiles, and recovery rates. This makes standardized outcomes assessment challenging, and clinical trials usually exclude severely cognitively impaired patients or use a measure so broad it can't detect subtle group distinctions.
For TRACK-TBI, a longitudinal study being conducted at 18 level I trauma centers, a Flexible Outcome Assessment Battery (FAB) was created to accommodate participants across the full spectrum of injury severity.
Yelena G. Bodien, PhD, a research scientist in the Department of Physical Medicine and Rehabilitation at Spaulding Rehabilitation Hospital, Joseph T. Giacino, PhD, director of the Spaulding Rehabilitation Neuropsychology Laboratory and TRACK-TBI co-PI, and a team of TRACK-TBI investigators describe the FAB in the Journal of Neurotrauma. They found it feasible to use in all participants and separated traditionally "untestable" participants into four subgroups with discernibly different levels of function.
TRACK-TBI enrolled 2,697 adult and pediatric patients. In the first study phase, the FAB was used to follow them for one year.
The current analysis included 2,209 adults (69% male, mean age 41). Two weeks after injury, 82% were classified as having mild injury, 5% moderate, and 13% severe.
The FAB is divided into the Abbreviated Assessment Battery (AAB), which was administered to 316 participants with confusion or disorders of consciousness, and the Comprehensive Assessment Battery (CAB), used for all others.
Among participants followed, valid scores were obtained by telephone for at least 95% of participants at all time points (two weeks and three, six, and 12 months post-injury).
For outcomes that could be measured only in person, completion rates ranged from 64%–85% for the CAB and 34%–72% for the AAB.
Overall, they had a high valid completion rates across all measures.
The researchers categorized the participants based on their Glasgow Outcome Scale-Extended (GOSE) score at two weeks and further classified the most severely-injured participants into four distinct subgroups (coma/vegetative state, minimally conscious state without language function, minimally conscious state with language function, post-traumatic confusional state) using the AAB.
At both six and 12 months, GOSE scores differed significantly among participants who were sub-categorized into the four subgroups. In some cases, the median GOSE score for individual participants was as much as two categories higher when the FAB-enabled approach was compared with the traditional approach of collapsing all "untestable" patients into a single group.
These findings suggest the FAB may unmask meaningful differences in outcome that would otherwise be overlooked.
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