Changes in Patient Demographics and Outcomes in the Inpatient Rehabilitation Facility Traumatic Brain Injury Population from 2002 to 2016: Implications for Patient Care and Clinical Trials

Increasing evidence in animal models and clinical trials for stroke, hypoxic encephalopathy for children, and traumatic brain injury have shown that mild hypothermia may attenuate ischemic damage and improve neurological outcome. However, it is less clear if mild intraoperative hypothermia during vascular neurosurgical procedures results in improved outcomes for patients. This review examines the scientific evidence behind hypothermia as a treatment and discusses factors that may be important for the use of this adjuvant technique, including cooling temperature, duration of hypothermia, and rate of rewarming.

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Assessment of White Matter Injury and Outcome in Severe Brain Trauma

Anesthesiology ◽

10.1097/aln.0b013e3182755558 ◽

2012 ◽

Vol 117 (6) ◽

pp. 1300-1310 ◽

Cited By ~ 90

Author(s):

Damien Galanaud ◽

Vincent Perlbarg ◽

Rajiv Gupta ◽

Robert D. Stevens ◽

Paola Sanchez ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Clinical Trials ◽

Brain Injury ◽

White Matter ◽

Receiver Operating Characteristic Curve ◽

Receiver Operating Characteristic ◽

Operating Characteristic ◽

Characteristic Curve ◽

Unfavorable Outcome ◽

Operating Characteristic Curve

Background Existing methods to predict recovery after severe traumatic brain injury lack accuracy. The aim of this study is to determine the prognostic value of quantitative diffusion tensor imaging (DTI). Methods In a multicenter study, the authors prospectively enrolled 105 patients who remained comatose at least 7 days after traumatic brain injury. Patients underwent brain magnetic resonance imaging, including DTI in 20 preselected white matter tracts. Patients were evaluated at 1 yr with a modified Glasgow Outcome Scale. A composite DTI score was constructed for outcome prognostication on this training database and then validated on an independent database (n=38). DTI score was compared with the International Mission for Prognosis and Analysis of Clinical Trials Score. Results Using the DTI score for prediction of unfavorable outcome on the training database, the area under the receiver operating characteristic curve was 0.84 (95% CI: 0.75-0.91). The DTI score had a sensitivity of 64% and a specificity of 95% for the prediction of unfavorable outcome. On the validation-independent database, the area under the receiver operating characteristic curve was 0.80 (95% CI: 0.54-0.94). On the training database, reclassification methods showed significant improvement of classification accuracy (P < 0.05) compared with the International Mission for Prognosis and Analysis of Clinical Trials score. Similar results were observed on the validation database. Conclusions White matter assessment with quantitative DTI increases the accuracy of long-term outcome prediction compared with the available clinical/radiographic prognostic score.

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The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

Journal of Cerebral Blood Flow & Metabolism ◽

10.1177/0271678x18760109 ◽

2018 ◽

Vol 38 (5) ◽

pp. 749-754 ◽

Cited By ~ 1

Author(s):

Olivia Kiwanuka ◽

Bo-Michael Bellander ◽

Anders Hånell

Keyword(s):

Clinical Trial ◽

Traumatic Brain Injury ◽

Clinical Trials ◽

Brain Injury ◽

Network Analysis ◽

Clinical Studies ◽

Phase Iii ◽

Phase Iii Clinical Trial ◽

Phase Iii Clinical Trials ◽

Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

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