Archiving Common Data Element-Harmonized Pediatric Traumatic Brain Injury Data and Metadata

项目概要/摘要 创伤性脑损伤（TBI）是儿童死亡和获得性残疾的主要原因。数据共享- 对于最大限度地利用从研究数据中产生的可操作知识来说，信息化是很重要的。共享TBI数据 这是NIH的目标。为了实现这一目标，NIH和美国国防部开发了 联邦跨部门TBI研究（FITBIR）信息系统作为中央存储库 TBI数据。然而，FITBIR目前包含的关于需要关键治疗的儿童的信息很少。 TBI后的护理这一提议将大大扩展FITBIR中关于以下关键问题的可用数据- 儿童TBI受伤NICHD支持的TBI中变量的儿科评估（PEDALFAST） 前瞻性队列研究纳入了395名连续的急性TBI儿童， PEDALFAST是美国两个大型1级儿科创伤中心的第一项研究， 报告使用一个重要的新的结果测量，功能状态量表（FSS），在儿童- 与TBI的关系PEDALFAST收集了有关患者、损伤和成像特征的信息， 来自院前、急诊科（艾德）、ICU和康复护理阶段的事件。目的 1是将PEDALFAST数据与NIH开发的TBI公共数据元素（CDE）协调， 开发完整的元数据，并将已去识别的艾德数据和元数据存款FITBIR。第二个目标是： 开发并分发一个免费的开源R数据包，其中包含去身份化的艾德、CDE协调的 PEDALFAST数据和元数据。这一目标将利用结构、元数据和文档 内置到R统计编程环境中的“包”中，以提供一个易于使用和良好的 CDE协调的PEDALFAST数据的记录来源。这一建议意义重大，因为它 将大大增加有关严重受伤的TBI儿童的数据量， 一次性使用。数据将与儿科TBI的当前金标准CDE协调，并将 并附带完整的元数据。该提案具有创新性，因为PEDALFAST数据将 在美国最大的TBI数据库（FITBIR）中提供，也可以作为免费和可下载的 R数据包。这种创新性地使用了一种开源包格式， 可供分析团队重用。PEDALFAST数据的可重用性是预期的，因为它 将以两种不同的有据可查的格式提供。

PROJECT SUMMARY/ABSTRACT Traumatic brain injury (TBI) is the leading cause of death and acquired disability in children. Data shar- ing is important to maximize the actionable knowledge generated from research data. Sharing TBI data is a goal of the NIH. To achieve that goal, NIH and the U.S. Department of Defense have developed the Federal Interagency TBI Research (FITBIR) Informatics System to serve as a central repository for TBI data. However, FITBIR currently contains little information about children who require critical care after TBI. This proposal will significantly expand the data available in FITBIR about critically in- jured children with TBI. The NICHD-supported PEDiatric vAlidation oF vAriableS in TBI (PEDALFAST) prospective cohort study enrolled 395 consecutive children with acute TBI admitted to the intensive care unit (ICU) at two large level 1 pediatric trauma centers in the U.S. PEDALFAST was the first study to report the use of an important new outcome measure, the Functional Status Scale (FSS), in chil- dren with TBI. PEDALFAST collected information about patient, injury, and imaging characteristics and events from the pre-hospital, Emergency Department (ED), ICU, and rehabilitation phases of care. Aim 1 is to harmonize the PEDALFAST data to the TBI common data elements (CDEs) developed by NIH, develop complete metadata, and deposit the de-identified data and metadata in FITBIR. Aim 2 is to de- velop and distribute a free, open source R data package containing the de-identified, CDE-harmonized PEDALFAST data and metadata. This aim will leverage the structure, metadata, and documentation built into “packages” in the R statistical programming environment to provide an easy-to-use and well- documented source for the CDE-harmonized PEDALFAST data. This proposal is significant because it will substantially increase the amount of data about critically injured children with TBI available for sec- ondary use. The data will be harmonized to the current gold standard CDEs for pediatric TBI and will be accompanied by complete metadata. This proposal is innovative because the PEDALFAST data will be made available in the largest U.S. TBI data repository (FITBIR) and also as a free and downloadable R data package. This innovative use of an open-source package format will make the data immediately available for reuse by analytic teams. Ready reuse of the PEDALFAST data is anticipated because it will be available in two different well-documented formats.