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

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 function 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 multidimensional 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 3 emergency departments with a TBI of any severity enrolled in TRACK-TBI prospectively after injury; outcome measures were collected at 3 and six months postinjury. 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 (M Spearman's rho = .21 and .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 multidimensional nature of TBI recovery and the limitations of applying only a single outcome measure.

Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research

“…436 These considerations suggest the need for detailed assessments that are sensitive to smaller transitions in outcome and that take account of a range of aspects of outcome. [437][438][439][440] Nevertheless, summary or integrated measures of outcome could still provide a useful basis for allocating patients to broad care pathways, and such applications are worth developing.…”

Sub-classifying patients with mild traumatic brain injury: A clustering approach based on baseline clinical characteristics and 90-day and 180-day outcomes

“…A recent publication provides evidence that patients within each of these two categories might have substantially different multidimensional outcomes. [ 32 ] Future analyses will consider patients with GOSE score of 7 and GOSE score of 8 separately. 4) Patient outcomes beyond 180 days post-TBI were not evaluated.…”

Outcome assessment after traumatic brain injury – Authors' reply

“…The option of selecting from a range of validated tools 2 to answer questions specific to the clinical or research focus, in addition to assessing a global outcome, should not be overlooked. New approaches being investigated include formative measures composed of indicators that together determine the construct of outcome after head injury 3 .…”

“…There have been increasing calls for more detailed descriptions of outcome than can be provided by the GOSE alone. 3 Initiatives such as the Common Data Elements and the recommendations from Honan and colleagues 4 provide useful advice on assessments. As McMillan and colleagues make clear, challenges exist in incorporating such outcomes in clinical studies.…”

“…1 Sample analyses revealed that this synthetic heroin consisted of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP), 2 a potent neurotoxin targeting neurons within the substantia nigra. 3 The discovery of MPTP-induced parkinsonism was the basis of a paradigm shift in Parkinson's disease research, which started with careful clinical observation of the seven index cases. As an historical tribute, we present unique video footage of five of these patients (appendix).…”