IMPACT database of traumatic brain injury: Design and description
IMPACT database of traumatic brain injury: Design and description
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DOI：
10.1089/neu.2006.0036
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发表时间：
2007-02-01
影响因子：
4.2
通讯作者：
Maas, Andrew I. R.
中科院分区：
文献类型：
--
作者：
Marmarou, Anthony;Lu, Juan;Maas, Andrew I. R.
本报告的目的是描述国际预后和临床试验特派团(IMPACT)创伤性脑损伤数据库的设计和内容，该数据库包含过去20年来进行的大多数临床试验和有组织的流行病学研究的完整数据集。这项由美国国立卫生研究院资助的努力，到目前为止已经积累了来自8个随机安慰剂对照试验和3个观察性研究的9205名重度和中度脑损伤患者的数据。与设计和分析实用型III期临床试验相关的数据，包括院前、入院和复苏后评估，急性处理信息，以及短期和长期结果被合并为最优先的数据集(TPDS)。在第一阶段的研究中，主要侧重于从受伤时间到复苏后的信息和6个月的结果，从而为预后分析和旨在优化创伤性脑损伤第三阶段试验设计和分析的研究提供了独特的资源。
The objective of this report is to describe the design and content of the International Mission for Prognosis And Clinical Trial (IMPACT) database of traumatic brain injury which contains the complete dataset from most clinical trials and organized epidemiologic studies conducted over the past 20 years. This effort, funded by the U.S. National Institutes of Health, has led to the accumulation thus far of data from 9205 patients with severe and moderate brain injuries from eight randomized placebo controlled trials and three observational studies. Data relevant to the design and analysis of pragmatic Phase III clinical trials, including pre-hospital, admission, and post-resuscitation assessments, information on the acute management, and short- and long-term outcome were merged into a top priority data set (TPDS). The major emphasis during the first phase of study is on information from time of injury to post-resuscitation and outcome at 6 months thereby providing a unique resource for prognostic analysis and for studies aimed at optimizing the design and analysis of Phase III trials in traumatic brain injury.