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

项目摘要/摘要 创伤性脑损伤是导致儿童死亡和后天残疾的主要原因。数据共享- ING对于最大限度地从研究数据中产生可操作的知识是很重要的。共享TBI数据 是美国国立卫生研究院的目标之一。为了实现这一目标，美国国立卫生研究院和美国国防部开发了 联邦跨部门TBI研究(FITBIR)信息学系统将作为中央存储库 用于TBI数据。然而，FITBIR目前包含的关于需要危重儿童的信息很少 脑外伤后的护理。这项提议将标志着fi可以极大地扩展FITBIR中的可用数据-- 创伤性脑外伤患儿。NICHD支持的TBI(PEDALFAST)变量的儿科验证 前瞻性队列研究纳入了395名连续入院的急性颅脑损伤患儿 美国两个大型一级儿科创伤中心的重症监护室PEDALFAST是fi的第一项研究 报告一种重要的新结果测量工具--功能状态量表(FSS)在婴幼儿中的使用情况。 患有脑外伤的儿童。PEDALFAST收集有关患者、损伤和成像特征的信息，并 从院前、急诊科、ICU和康复护理阶段的事件。目标 1是使PEDALFAST数据与由NIH开发的TBI公共数据元素(CDE)相协调， 开发完整的元数据，并将详细的fi数据和元数据存储在FITBIR中。目标2是去- 开发和分发一个免费的、开源的R数据包，其中包含Deidentifi版、CDE协调版 PEDALFAST数据和元数据。此目标将利用结构、元数据和文档 内置于R统计编程环境中的“包”中，以提供易于使用和良好的 CDE协调的PEDALFAST数据的文件来源。这项提议是有意义的，因为它fi 将大幅增加有关患有脑外伤的危重儿童的数据量-秒- 二次使用。这些数据将与目前儿科脑外伤的黄金标准CDE相协调，并将 伴随着完整的元数据。这项提议是创新的，因为PEDALFAST数据将 可在美国最大的TBI数据库(FITBIR)中获得，也可免费下载 R数据包。这种开源包格式的创新使用将立即使数据 可供分析团队重复使用。预计可以随时重用PEDALFAST数据，因为它 将以两种不同的记录良好的格式提供。

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.