National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations
National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations
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DOI：
10.1089/neu.2018.5643
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发表时间：
2018-07-23
影响因子：
4.2
通讯作者：
Joseph, Kristen
中科院分区：
文献类型：
--
作者：
Broglio, Steven P.;Kontos, Anthony P.;Joseph, Kristen
通过与国家神经疾病和中风研究所（NINDS），美国国立卫生研究院和国防部的合作，开始开发运动相关脑震荡（SRC）通用数据元素（CDE）。此次合作的目的是提高临床研究和临床治疗结果的效率和有效性，提高数据质量，促进研究之间的数据共享，减少研究启动时间，更有效地将信息汇总到元数据结果中，并教育新的临床研究者。SRC CDE工作组由来自不同相关专业领域的32名全球脑震荡专家组成，分为三个亚组：急性（脑震荡后3个月）。为了制定CDE，各分组审查了各个领域，然后从现有CDE、病例报告表和来自国家登记处和资助研究的实地测试数据元素中选择、完善和添加。建议于2017年2月至2017年4月发布到NINDS CDE网站供公众审查。经过内部工作组对建议的审查，沿着对公众审查期间收到的意见的考虑，NINDS SRC CDE的第一次迭代（版本1.0）于2017年6月完成。这些建议包括认知数据元素和症状检查表的核心和补充高度推荐CDE，以及其他结果和终点（例如，前庭、眼神经、平衡、焦虑、抑郁），以及样本病例报告表（例如，损伤报告、人口统计学、脑震荡史）。NINDS SRC CDE和支持性文件可在NINDS CDE网站www.commondataelements. ninds.nih.gov上公开获取。研究人员和临床医生广泛使用CDE将促进SRC临床研究和试验设计、数据共享和元数据回顾性分析的一致性。
Through a partnership with the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, and Department of Defense, the development of Sport-Related Concussion (SRC) Common Data Elements (CDEs) was initiated. The aim of this collaboration was to increase the efficiency and effectiveness of clinical research studies and clinical treatment outcomes, increase data quality, facilitate data sharing across studies, reduce study start-up time, more effectively aggregate information into metadata results, and educate new clinical investigators. The SRC CDE Working Group consisted of 32 worldwide experts in concussion from varied fields of related expertise divided into three Subgroups: Acute (3 months post-concussion). To develop CDEs, the Subgroups reviewed various domains, then selected from, refined, and added to existing CDEs, case report forms and field-tested data elements from national registries and funded research studies. Recommendations were posted to the NINDS CDE Website for Public Review from February 2017 to April 2017. Following an internal Working Group review of recommendations, along with consideration of comments received from the Public Review period, the first iteration (Version 1.0) of the NINDS SRC CDEs was completed in June 2017. The recommendations include Core and Supplemental-Highly Recommended CDEs for cognitive data elements and symptom checklists, as well as other outcomes and end-points (e.g., vestibular, oculomotor, balance, anxiety, depression), and sample case report forms (e.g., injury reporting, demographics, concussion history) for domains typically included in clinical research studies. The NINDS SRC CDEs and supporting documents are publicly available on the NINDS CDE website www.commondataelements.ninds.nih.gov. Widespread use of CDEs by researchers and clinicians will facilitate consistent SRC clinical research and trial design, data sharing, and metadata retrospective analysis.