Evaluation of Outcome Measures for Patients Diagnosed with TBI

自2009年10月6日获得CNS IRB Blue批准以来，该项目的工作主要放在获取和测试我们具体的TBI成果指标上。我们最初的重点是提高我们工作人员的能力，因为它们与新的或新的评估有关，并评估针对TBI人群的潜在结果衡量测试工具。该议定书使工作人员能够评估这一广泛评估的适当性和容忍度。到目前为止，已有九(9)名受试者同意并完成了方案。 主要活动包括：获取和测试软件的标准化仪器和测试；开发数据获取工具；招聘；评估受试者容忍度；遵守NIH、CNRM和USUHS的监管规定，包括IRB通信；以及雇用人员支持这些努力。 到目前为止，我们的累计科目应计包括五(5)名女性和五(5)名男性。在登记的十(10)名受试者中，七(7)名是高加索人，三(3)名是非裔美国人或黑人。我们招募了七(7)名健康志愿者或对照组和三(3)名被诊断为脑外伤的受试者。这些参与者使我们的工作人员能够熟悉新的评估和工具，这些评估和工具是针对TBI的。 该议定书已关闭，不适用于受试者登记和调查员数据分析。然而，作为CNRM研究的一部分，这些数据将被准备转移到联邦机构间创伤性脑损伤资料库(FITBIR)。FITBIR是一个信息学系统，旨在共享TBI研究领域的数据，促进合作，以及与其他信息学平台的互联。目的是通过共享数据、方法和相关工具，而不是对这些信息的总结或解释，允许重新分析数据、重新汇总、整合以及与其他数据、工具和方法进行严格比较，从而加快研究进展。

Since receiving CNS IRB Blue approval on October 6, 2009 the efforts of this project have been placed mainly on acquisition and testing of our specific TBI outcome measures. Our initial focus was on improving our staff competencies as they relate to new or novel assessments and evaluating potential outcome measure test instruments for the TBI population. The protocol has allowed for the staff to evaluate both the appropriateness and tolerance of this extensive battery of assessments. To date nine (9) subjects have been consented and completed the protocol. The major activities have included: acquire and test standardized instrumentation and testing of software; developing data acquisition tools; recruitment; evaluation of subject tolerance of assessments; regulatory compliance with both the NIH, CNRM, and USUHS, including IRB correspondence; and hire personnel to support these efforts. To date our cumulative subject accrual consists of five (5) females and five (5) males. Out of the ten (10) subjects enrolled seven (7) are Caucasian and three (3) are African American or Black. We have enrolled seven (7) healthy volunteers or controls and three (3) diagnosed traumatic brain injured subjects. These participants have allowed for our staff members to familiarize themselves with the newer assessments and tools which are TBI specific. The Protocol has been closed to subject enrollment and investigator data analysis. However, as part of a CNRM study, this data will be prepared for transfer into the Federal Interagency Traumatic Brain Injury Repository (FITBIR). FITBIR is an informatics system developed to share data across the TBI research field and facilitate collaboration, as well as interconnectivity with other informatics platforms. With the intent of accelerating research progress by allowing re-analysis of data, re-aggregation, integration, and rigorous comparison with other data, tools, and methods, by means of sharing data, methodologies, and associated tools, rather than summaries or interpretations of this information.