Andrew Maas

..The complexity of problems occurring in clinical trial design and analysis in TBI is such that a strong and sustained multidisciplinary input and effort is required from all experts involved in the field of neurotrauma...

..We conclude that both the CT classification and individual CT characteristics are important predictors of outcome in TBI. For clinical trials, a central review process is advocated to minimize observer variability in CT assessment...

..This classification is increasingly used as a predictor of outcome. We aimed to examine the predictive value of the Marshall CT classification in comparison with alternative CT models...

..Traumatic brain injury is a major cause of death and disability. We sought to assess the safety and efficacy of dexanabinol, a synthetic cannabinoid analogue devoid of psychotropic activity, in severe traumatic brain injury...

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..Many of our approaches are based on simple graphical displays of the data, but, where appropriate, we have also used methods that although established in the statistical literature are relatively novel in their application to TBI...

..We conclude that outcome following TBI is dependent on age, race, to a lesser extent on education, but not on gender...

..0001). Pupil reactivity was more robust between these time points. It is recommended that the study hospital enrollment GCS and pupil reactivity be used for prognostic analysis...

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..Falls were found to be associated with an older age and with a higher incidence of mass lesions. Following adjustment for age in the analysis, the relationship between cause of injury and outcome was lost...

..The occurrence of secondary insults prior to or on admission to hospital in TBI patients is strongly related to poorer outcome and should therefore be a priority for emergency department personnel...

..Our finding of a smooth relationship with improving outcome as SBP increases up to 135 mm Hg, while not supporting a strong causal inference, does suggest that current guidelines need to be reconsidered...

..Recommendations were made for enhancing the utility of available or emerging tools in order to facilitate implementation of a pathoanatomic classification approach for clinical trials...

..An awareness of this procedural error and methods to reduce misclassification should be incorporated in TBI clinical trials...

..The time frame during which hemorrhagic expansion occurs provides an opportunity for early intervention to limit a process with adverse prognostic implications...

..To describe the modeling techniques used for early prediction of outcome in traumatic brain injury (TBI) and to identify aspects for potential improvements...

..To analyze factors determining the time between injury and study drug administration (SDA) in a randomized controlled trial (RCT) of acute severe traumatic brain injury (TBI) and to discuss the ethical implications...

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..60-0.78). Higher glucose values were associated with increasing age, but on adjusted analysis, the strength of the association with outcome remained. Whether treatment of abnormal values may improve outcome needs further rigorous study...

..The satisfactory discrimination indicates that logistic regression models, developed on large samples, can be used for classifying TBI patients according to prognostic risk...

..The high incidence of both outcomes in patients primarily referred support direct admission of more and particularly older patients with severe or moderate brain trauma to level I trauma centers...

..The authors studied the shape and strength of the relationship between age and outcome, that is, the 6-month mortality rate and unfavorable outcome based on the Glasgow Outcome Scale...

..The high discriminative ability indicates the potential of this model for classifying patients according to prognostic risk...

..Pathophysiologic evidence warrants targeting therapy for patients with traumatic brain injury and subarachnoid hemorrhage toward improvement of cerebral oxygenation guided by continuous monitoring of brain tissue oxygen tension...

..We critically reviewed the use of two types of secondary analyses, covariate adjustment and subgroup analysis, which are common in TBI trials...

..The goal of this study was to examine what regional differences in patient characteristics, case management, and outcomes exist between continents and among countries within a patient population included in a randomized clinical trial...

..A major reduction in sample size can be obtained with covariate adjustment in TBI trials. Covariate adjustment for strong predictors should be incorporated in the analysis of future TBI trials...

..The approach raises issues of clinical, statistical, and regulatory importance, and we initiate what we believe needs to become a widespread debate amongst the community involved in clinical research in head injury and stroke...

..This first prospective, randomized, placebo-controlled, dose-escalation study evaluated the safety and preliminary effectiveness of rFVIIa to limit tICH progression...

..3 to 25.1 mm3). The current data therefore suggest that the delayed secondary expansion of a cortical contusion following traumatic brain injury may not be caused by a reduction of CBF alone...

..We aimed to explore observer variation in the assessment of outcome in a recently completed trial of dexanabinol in head injury and to consider steps to reduce such variation...

..We present technical data including strengths and weaknesses of these systems, information from clinical studies and formulate a vision for the future...

..Further refinements in future research are likely to improve results from transplantation-based treatments for TBI...

..This review has specific reference to traumatic brain injury, and is based on an extensive evaluation of the literature and on expert opinion...

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..The relative benefits of early versus delayed surgery in patients with intraparenchymal lesions and on the indications, technique and benefits of decompressive craniectomy could be topics for future head injury research...

..CONCLUSIONS: The number of actual and potential organ donors is declining, but a considerable number of potential CNHB donors exists. Refusal by relatives is the most important reason for failure to procure organs...

..Suggestions are provided for the way forward, with an emphasis on epidemiological monitoring, trauma organisation, and approaches to management...

..The global aim is to optimize chances for demonstrating benefit of an effective new therapy or therapeutic agent in the field of TBI. ..

..IMPACT: International Mission on Prognosis and Analysis of Clinical Trials in TBI. ..

..IMPACT: International Mission on Prognosis and Analysis of Clinical Trials in TBI. ..