Common Data Elements for Pediatric Traumatic Brain Injury: Recommendations from the Working Group on Demographics and Clinical Assessment
Common Data Elements for Pediatric Traumatic Brain Injury: Recommendations from the Working Group on Demographics and Clinical Assessment
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DOI：
10.1089/neu.2011.1952
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发表时间：
2012-03-01
影响因子：
4.2
通讯作者：
Wainwright, Mark S.
中科院分区：
文献类型：
--
作者：
Adelson, P. David;Pineda, Jose;Wainwright, Mark S.
公共数据元素(CDE)倡议是美国国立卫生研究院(NIH)为标准化临床研究变量的命名、定义和数据结构而进行的跨机构努力。由于数据编码、定义和样本收集程序的差异，神经疾病临床研究结果的比较一直受到阻碍。CDE项目的目标是能够比较未来主要神经疾病的临床试验结果，包括创伤性脑损伤(TBI)、中风、多发性硬化症和癫痫。作为这项努力的一部分，通过2009年的一项多机构倡议制定了CDE的建议，以供开展全面技术创新的研究。根据人口学和临床评估工作组的初步建议，一个单独的工作组制定了针对18岁以下受试者的儿科脑损伤研究的临床和人口学变量编码建议。本文总结了儿童脑外伤人口学和临床评估工作组选择的措施。变量被分组到模块中，这些模块被分组到类别中。为了与其他CDE工作组保持一致，每个变量都按优先顺序(核心、补充和新兴)进行了分类。制作了模板以总结编码格式，指导数据点的选择，并提供程序建议。这项拟议的标准化与其他儿科脑损伤工作组在成像、生物标记物和结果评估方面的产品一起，将促进多中心研究、跨研究结果的比较以及对单个患者数据的高质量荟萃分析。
The Common Data Elements (CDEs) initiative is a National Institutes of Health (NIH) interagency effort to standardize naming, definitions, and data structure for clinical research variables. Comparisons of the results of clinical studies of neurological disorders have been hampered by variability in data coding, definitions, and procedures for sample collection. The CDE project objective is to enable comparison of future clinical trials results in major neurological disorders, including traumatic brain injury (TBI), stroke, multiple sclerosis, and epilepsy. As part of this effort, recommendations for CDEs for research on TBI were developed through a 2009 multi-agency initiative. Following the initial recommendations of the Working Group on Demographics and Clinical Assessment, a separate workgroup developed recommendations on the coding of clinical and demographic variables specific to pediatric TBI studies for subjects younger than 18 years. This article summarizes the selection of measures by the Pediatric TBI Demographics and Clinical Assessment Working Group. The variables are grouped into modules which are grouped into categories. For consistency with other CDE working groups, each variable was classified by priority (core, supplemental, and emerging). Templates were produced to summarize coding formats, guide selection of data points, and provide procedural recommendations. This proposed standardization, together with the products of the other pediatric TBI working groups in imaging, biomarkers, and outcome assessment, will facilitate multi-center studies, comparison of results across studies, and high-quality meta-analyses of individual patient data.