Evaluation of Outcome Measures for Patients Diagnosed with TBI
诊断为 TBI 的患者的结果评估
基本信息
- 批准号:9154121
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:
- 资助国家:美国
- 起止时间:至
- 项目状态:未结题
- 来源:
- 关键词:African AmericanBrainCaucasiansCollaborationsComputer softwareConsentDataData AnalysesDiagnosisEnrollmentEvaluationFemaleHuman ResourcesInformaticsInstitutional Review BoardsMethodologyMethodsOutcome MeasureParticipantPatientsPopulationProtocols documentationResearchResearch PersonnelSystemTBI PatientsTestingTimeTraumatic Brain InjuryUnited States National Institutes of Healthdata acquisitiondata sharinghealthy volunteerimprovedinjuredinstrumentinstrumentationmalemembernovelpatient populationrepositorytool
项目摘要
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.
自 2009 年 10 月 6 日获得 CNS IRB Blue 批准以来,该项目的工作主要集中在获取和测试我们特定的 TBI 结果指标。我们最初的重点是提高员工与新的或新颖的评估相关的能力,并评估 TBI 人群的潜在结果测量测试工具。该协议允许工作人员评估这一系列广泛评估的适当性和容忍度。迄今为止,九 (9) 名受试者已同意并完成了方案。
主要活动包括:获取并测试标准化仪器和软件测试;开发数据采集工具;招聘;评估受试者对评估的耐受性;遵守 NIH、CNRM 和 USUHS 的监管要求,包括 IRB 通信;并雇用人员来支持这些努力。
迄今为止,我们的累计受试者人数包括五 (5) 名女性和五 (5) 名男性。在登记的十 (10) 名受试者中,七 (7) 名是白人,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者以及三 (3) 名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 TBI 特定的新评估和工具。
该协议已关闭受试者招募和研究者数据分析。然而,作为 CNRM 研究的一部分,这些数据将准备好转移到联邦机构间创伤性脑损伤存储库 (FITBIR)。 FITBIR 是一个信息学系统,旨在共享 TBI 研究领域的数据并促进协作以及与其他信息学平台的互连。目的是通过允许对数据进行重新分析、重新聚合、整合以及与其他数据、工具和方法的严格比较,通过共享数据、方法和相关工具来加速研究进展,而不是对这些信息进行总结或解释。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Leighton Chan其他文献
Leighton Chan的其他文献
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