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TBI的结果。该项目的具体目标是：(1)为开展脑损伤的临床研究协助开发标准术语和数据收集工具；(2)继续开发信息技术系统，以促进脑损伤的多中心临床研究；(3)为区分脑损伤疗法的疗效确定适当的结果指标；(4)对脑损伤后的治疗干预措施进行多学科、多中心的研究。准确、完整和适当的数据收集是任何多中心试验目标的核心。此外，还必须确保可靠的后续行动。目前的提案旨在通过促进两者的结合来促进该中心参与TBI临床研究网络。它还寻求开发改进的工具，以便与其他网络中心共享，并最终与非网络中心共享。PIS提出了一个组织模式，用于进行TBI研究，以确保除了传统收集的数据点外，还收集各种数据，包括电子图像和连续监测数据。此外，他们提出了一个数据库设计，其中包括整个护理连续体系的信息，从现有的疾病前信息和现场评估和治疗，到急性护理阶段到长期随访期。最后，在建议的模型中，以持续的、前瞻性的方式收集数据以确保准确性。为了完成收集与脑损伤结果相关的重要信息所需的详细程度，治疗通常是漫长和复杂的，私人投资者断言，获得健康信息管理认证的个人将是至关重要的。在医学信息管理方面具有专业知识的个人不仅非常适合收集信息，而且还适合为随后的解释整理数据。熟悉脑外伤患者治疗和特殊需求的护士协调员也是研究团队中至关重要的一部分。提出的模型将促进多个学科和中心在临床脑损伤研究中的合作参与。

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.