Standardizing the structure of stroke clinical and epidemiologic research data: the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element (CDE) project.
Standardizing the structure of stroke clinical and epidemiologic research data: the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element (CDE) project.
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DOI：
10.1161/strokeaha.111.634352
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发表时间：
2012-04
期刊：
影响因子：
8.3
通讯作者：
National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element Working Group
中科院分区：
文献类型：
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作者：
Saver JL;Warach S;Janis S;Odenkirchen J;Becker K;Benavente O;Broderick J;Dromerick AW;Duncan P;Elkind MS;Johnston K;Kidwell CS;Meschia JF;Schwamm L;National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element Working Group
美国国家神经疾病和中风研究所启动了针对中风的公共数据元素（CDEs）的开发，这是一个项目的一部分，该项目旨在为所有神经科学领域的资助临床研究制定数据标准。规范脑血管疾病转化、临床和人群研究中的数据要素，可以缩短研究启动时间，促进数据共享，并促进知情的临床实践指南。一个由脑血管临床试验、流行病学和生物统计学方面的不同专家组成的工作组定期召开会议，制定一套卒中cde，从国家登记处和资助的试验和研究中选择、改进和增加现有的现场测试数据元素。候选元素根据国内和国际领先的神经血管研究组织和公众的意见进行修订。NINDS卒中特异性CDEs的第一次迭代包括980个数据元素，涵盖9个内容领域：1)生物标本和生物标志物；2)病程和急性治疗；3)成像;4)实验室检查和生命体征；5)长期治疗；6)病史及既往健康状况；7)结局和终点；8)笔画呈现；9)笔画类型和子类型。CDE网站为使用CDE的每个元素提供统一的名称和结构、数据字典和模板案例报表（crf）。脑卒中特异性CDEs现已作为标准化的、经过科学审查的可变结构提供，以促进面向脑血管患者的研究中的数据收集和数据共享。CDEs是一种不断发展的资源，将根据研究者的使用、新技术、新兴概念和研究成果进行迭代改进。
The National Institute of Neurological Disorders and Stroke initiated development of stroke-specific Common Data Elements (CDEs) as part of a project to develop data standards for funded clinical research in all fields of neuroscience. Standardizing data elements in translational, clinical and population research in cerebrovascular disease could decrease study start-up time, facilitate data sharing, and promote well-informed clinical practice guidelines. A Working Group of diverse experts in cerebrovascular clinical trials, epidemiology, and biostatistics met regularly to develop a set of Stroke CDEs, selecting among, refining, and adding to existing, field-tested data elements from national registries and funded trials and studies. Candidate elements were revised based on comments from leading national and international neurovascular research organizations and the public. The first iteration of the NINDS stroke-specific CDEs comprises 980 data elements spanning nine content areas: 1) Biospecimens and Biomarkers; 2) Hospital Course and Acute Therapies; 3) Imaging; 4) Laboratory Tests and Vital Signs; 5) Long Term Therapies; 6) Medical History and Prior Health Status; 7) Outcomes and Endpoints; 8) Stroke Presentation; 9) Stroke Types and Subtypes. A CDE website provides uniform names and structures for each element, a data dictionary, and template case report forms (CRFs) using the CDEs. Stroke-specific CDEs are now available as standardized, scientifically-vetted variable structures to facilitate data collection and data sharing in cerebrovascular patient-oriented research. The CDEs are an evolving resource that will be iteratively improved based on investigator use, new technologies, and emerging concepts and research findings.