Traumatic Brain Injury Clinical Trials Network

描述（由申请人提供）：每年有数千人遭受创伤性脑损伤（TBI），导致1999年估计有530万美国人永久残疾。该项目的主要目标是制定战略，以改善创伤性脑损伤的结果。该项目的具体目标是：（1）帮助开发标准术语和数据收集工具，用于开展TBI临床研究;（2）继续开发信息技术系统，以促进TBI的多中心临床研究;（3）确定区分TBI治疗效果的适当结果指标;（4）进行多学科研究，对TBI后治疗干预的安全性和效果进行多中心研究。任何多中心试验的核心目标是准确、完整和适当的数据收集。此外，必须确保可靠的后续行动。目前的建议旨在促进该中心参与TBI临床研究网络，促进两者。它进一步寻求开发改进的工具，以便与其他网络中心以及最终与非网络中心共享。PI提出了一个组织模型进行TBI研究，以确保收集各种数据，包括电子图像和连续监测数据，除了传统收集的数据点。此外，他们提出了一个数据库设计，其中包括从整个连续护理的信息，从可用的发病前信息和现场评估和治疗，通过急性护理阶段到长期随访期间。最后，在所提出的模型中以持续的、前瞻性的方式收集数据，以确保准确性。为了完成必要的详细程度，以收集与TBI结果相关的重要信息，其治疗通常是漫长和复杂的，PI断言，在健康信息管理方面获得认证的个人将是至关重要的。具有医疗信息管理专业知识的个人不仅非常适合收集信息，而且还适合整理数据以供后续解释。了解TBI患者治疗和特殊需求的护士协调员也是研究团队的重要组成部分。提出的模型将促进多学科和中心的合作参与临床TBI研究的进行。

DESCRIPTION (provided by applicant): Thousands of individuals sustain traumatic brain injury (TBI) each year, resulting in permanent disability for an estimated 5.3 million Americans in 1999. The primary objective of this project is to develop strategies to improve outcome from TBI. Specific aims of this project will be to (1) aid in the development of standard terminology and data collection tools for the conduct of clinical research for TBI, (2) continue development of information technology systems to facilitate multicenter clinical research on TBI, (3) determine appropriate outcome measures for distinguishing efficacy of TBI therapies, and (4) conduct multidisciplinary, multicenter research into therapeutic interventions regarding their safety and effects upon outcome after TBI. Central to the goals of any multicenter trial is accurate, complete, and appropriate data collection. In addition, reliable follow-up must be ensured. The present proposal aims to facilitate this center's participation in a TBI clinical research network by promoting both. It further seeks to develop improved tools to be shared with other network centers and ultimately non-network centers. The PIs propose an organizational model for conducting TBI research to insure collection of a wide variety of data, including electronic images and continuous monitoring data, in addition to traditionally collected data points. Furthermore, they propose a database design which includes information from the entire continuum of care, ranging from available pre-morbid information and field assessments and treatments through the acute care phase into the long-term follow-up periods. Finally, the data is collected in an ongoing, prospective manner in the proposed model to insure accuracy. In order to accomplish the level of detail necessary to glean significant information relevant to outcomes from TBI, the treatment of which is often lengthy and complicated, the PIs assert that individuals certified in the management of health information will be crucial. Individuals with expertise in the management of medical information are well suited not only to collect the information, but also to collate data for subsequent interpretation. Nurse coordinators who are knowledgeable about the treatment and special needs of TBI patients are also a vital part of the research team. The model proposed will facilitate the cooperative involvement of multiple disciplines and centers in the conduct of clinical TBI research.