Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): A Prospective Longitudinal Observational Study
Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): A Prospective Longitudinal Observational Study
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DOI：
10.1227/neu.0000000000000575
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发表时间：
2015-01-01
期刊：
影响因子：
4.8
通讯作者：
Sorgner, Annina
中科院分区：
文献类型：
--
作者：
Maas, Andrew I. R.;Menon, David K.;Sorgner, Annina
背景：目前对创伤性脑损伤(TBI)的分类还不够理想，治疗方法缺乏证据，很少尝试个体化治疗。需要结合新兴技术的新的精确医学和分层管理方法。目的：利用比较有效性研究方法，改善脑外伤的特征和分类，并确定最佳临床护理。方法：这项在欧洲和以色列22个国家进行的多中心、纵向、前瞻性、观察性研究将收集5400名同意的患者的详细数据，这些患者在受伤后24小时内提出临床诊断和计算机断层扫描的指征。在大约20000名患者中进行更广泛的登记级数据收集将评估普适性。将在6个月时进行横断面综合结果评估，包括生活质量和神经心理测试。在患者亚群中，纵向评估将持续到脑外伤后24个月。先进的神经成像以及基因组和生物标记物数据将用于改善表征，分析将包括神经信息学方法，以解决过程和临床护理中的差异。在知识转让过程中，将把成果与现场系统评价结合起来。研究开始于2014年10月至12月，招募时间为18至24个月。执行结果：在脑外伤领域的欧洲神经创伤有效性合作研究应该为脑损伤的表征和分类提供新的多维方法，支持治疗建议的证据，以及护理质量的基准。数据和样本库将确保传统研究的机会。讨论：比较有效性研究通过利用生物学、护理和结果方面的差异来支持最优的个性化患者管理，为受限患者人群中的简约式临床试验提供了一种替代方案。
BACKGROUND: Current classification of traumatic brain injury (TBI) is suboptimal, and management is based on weak evidence, with little attempt to personalize treatment. A need exists for new precision medicine and stratified management approaches that incorporate emerging technologies.OBJECTIVE: To improve characterization and classification of TBI and to identify best clinical care, using comparative effectiveness research approaches.METHODS: This multicenter, longitudinal, prospective, observational study in 22 countries across Europe and Israel will collect detailed data from 5400 consenting patients, presenting within 24 hours of injury, with a clinical diagnosis of TBI and an indication for computed tomography. Broader registry-level data collection in approximately 20 000 patients will assess generalizability. Cross sectional comprehensive outcome assessments, including quality of life and neuropsychological testing, will be performed at 6 months. Longitudinal assessments will continue up to 24 months post TBI in patient subsets. Advanced neuroimaging and genomic and biomarker data will be used to improve characterization, and analyses will include neuroinformatics approaches to address variations in process and clinical care. Results will be integrated with living systematic reviews in a process of knowledge transfer. The study initiation was from October to December 2014, and the recruitment period was for 18 to 24 months.EXPECTED OUTCOMES: Collaborative European NeuroTrauma Effectiveness Research in TBI should provide novel multidimensional approaches to TBI characterization and classification, evidence to support treatment recommendations, and benchmarks for quality of care. Data and sample repositories will ensure opportunities for legacy research.DISCUSSION: Comparative effectiveness research provides an alternative to reductionistic clinical trials in restricted patient populations by exploiting differences in biology, care, and outcome to support optimal personalized patient management.