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  • 1
    Language: English
    In: Journal of neurotrauma, 15 August 2016, Vol.33(16), pp.1461-78
    Description: Moderate-to-severe traumatic brain injury (TBI) remains a major global challenge, with rising incidence, unchanging mortality and lifelong impairments. State-of-the-science reviews are important for research planning and clinical decision support. This review aimed to identify randomized controlled trials (RCTs) evaluating interventions for acute management of moderate/severe TBI, synthesize key RCT characteristics and findings, and determine their implications on clinical practice and future research. RCTs were identified through comprehensive database and other searches. Key characteristics, outcomes, risk of bias, and analysis approach were extracted. Data were narratively synthesized, with a focus on robust (multi-center, low risk of bias, n 〉 100) RCTs, and three-dimensional graphical figures also were used to explore relationships between RCT characteristics and findings. A total of 207 RCTs were identified. The 191 completed RCTs enrolled 35,340 participants (median, 66). Most (72%) were single center and enrolled less than 100 participants (69%). There were 26 robust RCTs across 18 different interventions. For 74% of 392 comparisons across all included RCTs, there was no significant difference between groups. Positive findings were broadly distributed with respect to RCT characteristics. Less than one-third of RCTs demonstrated low risk of bias for random sequence generation or allocation concealment, less than one-quarter used covariate adjustment, and only 7% employed an ordinal analysis approach. Considerable investment of resources in producing 191 completed RCTs for acute TBI management has resulted in very little translatable evidence. This may result from broad distribution of research effort, small samples, preponderance of single-center RCTs, and methodological shortcomings. More sophisticated RCT design, large multi-center RCTs in priority areas, increased focus on pre-clinical research, and alternatives to RCTs, such as comparative effectiveness research and precision medicine, are needed to fully realize the potential of acute TBI research to benefit patients.
    Keywords: Clinical Trial ; Review ; Traumatic Brain Injury ; Randomized Controlled Trials As Topic ; Brain Injuries, Traumatic -- Therapy
    ISSN: 08977151
    E-ISSN: 1557-9042
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  • 2
    Language: English
    In: Journal of neurotrauma, 25 August 2016
    Description: Living systematic reviews (LSRs) are online summaries of health care research that are updated as new research becomes available. This new development in evidence synthesis is being trialled as part of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) project. We will develop and sustain an international TBI knowledge community that maintains up-to-date, high quality LSRs of the current state of knowledge in the most important questions in TBI. Automatic search updates will be run three-monthly, and newly identified studies incorporated into the review. Review teams will seek to publish journal updates at regular intervals, with abridged updates available more frequently online. Future project stages include the integration of LSR and other study findings into "living" clinical practice guidance. It is hoped these efforts will go some way to bridging current temporal disconnects between evidence, guidelines, and practice in TBI.
    Keywords: Knowledge Translation ; Living Systematic Reviews ; Traumatic Brain Injury
    ISSN: 08977151
    E-ISSN: 1557-9042
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  • 3
    Language: English
    In: Journal of neurotrauma, October 2009, Vol.26(10), pp.1623-33
    Description: Recent calls have been made for the inclusion of health-related quality of life (HRQoL) in traumatic brain injury studies. This study reports the impact of TBI on traditional measures (general health, depression, social isolation, labor force participation), self-assessed health function status using the SF-36 version 2 (SF-36V2), and self-assessed health preference using two generic utility instruments, the assessment of quality of life (AQoL) and the SF6D. A random sample of TBI cases (n = 66) was drawn from a trauma registry and matched (gender, age, education, and relationship status) with non-trauma-exposed cases from a population health survey. All participants were interviewed and the two cohorts compared. When compared with matched comparators, TBI cases experienced worse general health, elevated probabilities of depression, social isolation, and worse labor force participation rates. The TBI-cohort reported worse health status on the SF-36V2. The most affected areas were social function, role emotion, and mental health (effect sizes -0.70 to -0.86). The reported utility values indicative of a HRQoL between 13 and 24% worse than their non-TBI contemporaries (effect sizes -0.80 to -0.81). The findings suggest that TBI has long-term consequences across all aspects of peoples' lives, and that these consequences can be self-assessed using generic instruments. The challenge is to provide and evaluate long-term services targeted at the life areas that those with TBI find particularly difficult.
    Keywords: Health Status ; Brain Injuries -- Epidemiology ; Depressive Disorder -- Epidemiology ; Quality of Life -- Psychology
    ISSN: 08977151
    E-ISSN: 1557-9042
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  • 4
    Language: English
    In: Journal of Neurotrauma, 04/2019, Vol.36(7), pp.1080-1092
    Description: Observer variability in local radiological reading is a major concern in large-scale multi-center traumatic brain injury (TBI) studies. A central review process has been advocated to minimize this variability. The aim of this study is to compare central with local reading of TBI imaging datasets and to investigate the added value of central review. A total of 2050 admission computed tomography (CT) scans from subjects enrolled in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study were analyzed for seven main CT characteristics. Kappa statistics were used to calculate agreement between central and local evaluations and a center-specific analysis was performed. The McNemar test was used to detect whether discordances were significant. Central interobserver and intra-observer agreement was calculated in a subset of patients. Good agreement was found between central and local assessment for the presence or absence of structural pathology (CT+, CT−, κ = 0.73) and most CT characteristics (κ = 0.62 to 0.71), except for traumatic axonal injury lesions (κ = 0.37). Despite good kappa values, discordances were significant in four of seven CT characteristics (i.e., midline shift, contusion, traumatic subarachnoid hemorrhage, and cisternal compression; p  = 0.0005). Central reviewers showed substantial to excellent interobserver and intra-observer agreement (κ = 0.73 to κ = 0.96), contrasted by considerable variability in local radiological reading. Compared with local evaluation, a central review process offers a more consistent radiological reading of acute CT characteristics in TBI. It generates reliable, reproducible data and should be recommended for use in multi-center TBI studies.
    Keywords: Original Articles ; Agreement ; Central Radiology Review ; Traumatic Brain Injury;
    ISSN: 0897-7151
    E-ISSN: 1557-9042
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