Journal
JOURNAL OF NEUROTRAUMA
Volume 38, Issue 23, Pages 3288-3294Publisher
MARY ANN LIEBERT, INC
DOI: 10.1089/neu.2021.0152
Keywords
adult brain injury; assessment tools; clinical trial; human studies; outcome measures
Funding
- National Institutes of Neurological Disorders and Stroke (NINDS) [R01 NS110856]
- NINDS [R01 NS19643]
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The study found that the Functional Status Examination (FSE) is more precise in characterizing individual differences in functional limitations after traumatic brain injury compared to the more commonly used Glasgow Outcome Scale-Extended (GOSE). Additionally, the FSE showed consistent test performance regardless of the type of interviewee, indicating its applicability for both TBI patients and significant others. These findings support the FSE as a viable substitute for the GOSE in clinical trials and studies of TBI.
A limited evidence base supports the Functional Status Examination (FSE) as superior to the more commonly used Glasgow Outcome Scale-Extended (GOSE) for precisely characterizing injury-related functional limitations. The aim of this study was to use modern psychometric tools to test the hypothesis that the FSE is more precise than the GOSE in characterizing individual differences in functional limitations after moderate-to-severe traumatic brain injury (TBI). Secondarily, we sought to confirm that the type of interviewee (patient, significant other) does not affect the test performance of the FSE. Using data from 357 individuals with TBI who participated in the Magnesium Sulfate clinical trial and had six-month outcome data, we performed item response theory (IRT) analyses comparing the FSE and GOSE at six months post-injury. Results showed that the FSE yielded higher measurement precision (IRT test information) than the GOSE across most of the disability severity spectrum. The GOSE yielded more information than the FSE at a very high level of disability, because of the GOSE's assignment of a unique score for individuals who are in a vegetative state. Finally, the FSE showed no evidence of differential item functioning by interviewee, indicating it is appropriate to interview either persons with TBI or significant others and combine data across respondents as is typically done. The findings support the FSE as a viable and oftentimes advantageous substitute for the GOSE in clinical trials and translational studies of TBI.
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