规范卒中临床和流行病学研究数据结构：美国国立神经病学与卒中研究院（NINDS）卒中通用数据元素（CDE）项目。
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.
机构信息
UCLA Stroke Center, 710 Westwood Plaza, Los Angeles, CA 90095, USA.
出版信息
Stroke. 2012 Apr;43(4):967-73. doi: 10.1161/STROKEAHA.111.634352. Epub 2012 Feb 2.
BACKGROUND AND PURPOSE
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.
METHODS
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 on the basis of comments from leading national and international neurovascular research organizations and the public.
RESULTS
The first iteration of the National Institute of Neurological Disorders and Stroke (NINDS) stroke-specific CDEs comprises 980 data elements spanning 9 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 end points; (8) stroke presentation; and (9) stroke types and subtypes. A CDE website provides uniform names and structures for each element, a data dictionary, and template case report forms, using the CDEs.
CONCLUSIONS
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.
背景与目的
作为一个旨在为所有神经科学领域的资助临床研究制定数据标准的项目的一部分，美国国立神经病学与卒中研究院启动了针对特定于卒中的通用数据元素（CDE）的开发。在脑血管疾病的转化、临床和人群研究中，使数据元素标准化可以减少研究启动时间，促进数据共享，并为临床实践指南提供信息支持。
方法
一个由脑血管临床试验、流行病学和生物统计学领域的多元化专家组成的工作组定期开会，开发了一套卒中 CDE，从国家登记处和资助的试验和研究中现有的、经过现场测试的数据元素中进行选择、改进和添加。候选元素根据来自领先的国家和国际神经血管研究组织以及公众的意见进行修订。
结果
美国国立神经病学与卒中研究院（NINDS）首批卒中特定 CDE 共有 980 个数据元素，涵盖 9 个内容领域：（1）生物样本和生物标志物；（2）医院病程和急性治疗；（3）影像学；（4）实验室检查和生命体征；（5）长期治疗；（6）既往病史和健康状况；（7）结局和终点；（8）卒中表现；（9）卒中类型和亚型。CDE 网站为每个元素提供了统一的名称和结构、数据字典和模板病例报告表，使用 CDE。
结论
现在可以使用标准化、经过科学验证的、可变结构的特定于卒中的 CDE，方便脑血管患者为导向的研究中的数据收集和数据共享。CDE 是一个不断发展的资源，将根据研究人员的使用情况、新技术以及新出现的概念和研究发现进行迭代改进。
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