Journal of neurotrauma
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Journal of neurotrauma · Sep 2019
Multicenter Study Observational StudyUnbiased Recursive Partitioning to Stratify Patients With Acute Traumatic Spinal Cord Injuries: External Validity in an Observational Cohort Study.
Clinical trials of novel therapies for acute spinal cord injury (SCI) are challenging because variability in spontaneous neurologic recovery can make discerning actual treatment effects difficult. Unbiased Recursive Partitioning regression with Conditional Inference Trees (URP-CTREE) is a novel approach developed through analyses of a large European SCI database (European Multicenter Study about Spinal Cord Injury). URP-CTREE uses early neurologic impairment to predict achieved motor recovery, with potential to optimize clinical trial design by optimizing patient stratification and decreasing sample sizes. ⋯ A previous URP-CTREE model had limited ability to stratify an independent into homogeneous subgroups. Overall accuracy was promising, but may be sensitive to timing of baseline neurological examinations. Further evaluation of external validity in incomplete injuries, influence of timing of baseline examinations, and investigation of additional stratification strategies is warranted.
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Journal of neurotrauma · Sep 2019
Randomized Controlled Trial Multicenter StudyCost-effectiveness of Erythropoietin in Traumatic Brain Injury (EPO-TBI): A multinational trial based economic analysis.
The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia). ⋯ Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64). For a willingness-to-pay threshold of $US50,000 per QALY, 71.8% of replications were considered cost-effective. Therefore, we did not find evidence that EPO was significantly cost-effective in the treatment of moderate or severe TBI at 6-month follow-up.
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Journal of neurotrauma · Sep 2019
Multicenter StudyModelling the influence of age on neurologic outcome and quality of life one year after traumatic brain injury: a prospective multicenter cohort study.
After traumatic brain injury (TBI), the relationship between age and outcome at 1 year, including quality of life, has been poorly explored. The aim of our study was to describe this relationship in a cohort of TBI patients in a regional trauma system. Consecutive TBI patients with severe lesions on initial brain computed tomography (CT) scan were included from July 2014 to July 2016 in two French level-1 trauma centers. ⋯ No difference according to age was found for the quality of life. After TBI, the mortality at 1 year dramatically increased with age after 70 years. For elderly survivors, impairment of quality of life was not different from younger patients.