Transforming Traumatic Brain Injury Research and Clinical Care

改变创伤性脑损伤研究和临床护理

• 批准号: 7941731
• 负责人: GEOFFREY T MANLEY
• 金额: $ 211.86万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7941731
• 关键词: Adoption; Age; Applications Grants; Basic Science; Biological Markers; Cause of Death; Classification; Clinical Trials; Code; Collaborations; Common Data Element; Consensus; Data; Data Collection; Data Element; Databases; Development; Discipline; Economics; Educational workshop; Effectiveness; Emerging Technologies; Failure; Future; Genomics; Goals; Health; Health Care Quality Assessment; Image; Individual; Injury; Intervention; Magnetic Resonance Imaging; Medical; Medicine; Mental Health; Meta-Analysis; Military Personnel; Mission; National Institute of Neurological Disorders and Stroke; Observational Study; Online Systems; Outcome; Outcome Assessment; Outcome Measure; Patients; Performance; Public Health; Recommendation; Rehabilitation Centers; Relative (related person); Research; Research Infrastructure; Research Personnel; Serum; Severities; Societies; Standardization; Testing; Time; Translating; Translations; Traumatic Brain Injury; United States; United States National Institutes of Health; age group; clinical care; clinical practice; cost; demographics; disability; effectiveness research; experience; health care quality; improved; infancy; multidisciplinary; neuroimaging; novel; novel strategies; public health relevance; tool

DESCRIPTION (provided by applicant): Traumatic Brain Injury (TBI) remains one of the greatest unmet needs in medicine and public health. Advances in basic science research in the past 20 years have created new opportunities for targeted therapies for TBI. However, these advances have failed to translate into a successful clinical trial or a new treatment for TBI. Two recent workshops sponsored by NINDS, NIDRR, DVBIC, and DCOE identified important reasons for the failure in translation that include lack of standardisation in data collection, outdated approaches to TBI classification and outcome. There was consensus that the selection of variables in TBI studies should be standardized across studies and a strong recommendation was made to develop novel and improved approaches to TBI classification. The application of emerging technologies was also recommended. With broad-agency support, a multidisciplinary group of thought leaders was brought together to draft a proposal for standardisation of data collection across TBI studies with an emphasis on demographics, neuroimaging, outcome measures, biomarkers, and psychological health, referred to as the TBI Common Data Elements (TBI-CDE). This now provides a potential framework for all future TBI research, but it was acknowledged that a web-based data entry format and further refinement and testing of the beta-version in clinical practice would be required for implementation and widespread adoption of the TBI-CDE. The global aim of this proposal is to test and refine standards for data collection in TBI studies, suitable for use across the broad spectrum of TBI (Aim 1), and to explore novel approaches for TBI classification (Aim 2) and outcome after TBI (Aim 3), making use of emerging technology. In addition, we aim to develop a pilot set of performance indicators for assessment of the health care quality and effectiveness in TBI (Aim 4). Testing and validating the TBI-CDE will be performed in a multicenter observational study with 3 TBI Centers (UCSF, UPMC, UT Houston) and a TBI Rehabilitation Center (Mount Sinai). These Centers have multicenter TBI research experience and existing infrastructure to rapidly and successfully complete the study. We will create, or expand existing, data repositories for patient demographics, neuroimaging, serum biomarkers and genomics thereby providing researchers and clinicians with the infrastructure to develop the TBI field in a concerted multidisciplinary effort. The project is aimed at developing infrastructure, collaborations, and tools. It will build bridges across disciplines, break down artificial constructs and barriers that have slowed progress and facilitate comparison and meta-analyses of individual patient data across studies. It represents one of the most integrative TBI efforts to date. A unique feature is that it will span the entire spectrum of TBI from mild to severe, from early to late presentation and from infancy to the age of seniors. For the first time, the development of TBI specific performance indicators will be explored. Taken in combination, the deliverables of this project have the potential to transform TBI research and clinical care. PUBLIC HEALTH RELEVANCE: Traumatic Brain Injury (TBI) remains one of the greatest unmet needs in medicine and public health. The overall goal of this proposal is to test and refine standards for data collection in TBI studies in order to improve classification, outcome assessment, and healthcare quality and effectiveness research Together, the deliverables of this project have the potential to transform TBI research and clinical care.

描述（由申请人提供）：创伤性脑损伤（TBI）仍然是医学和公共卫生领域最大的未满足需求之一。过去20年基础科学研究的进步为TBI靶向治疗创造了新的机遇。然而，这些进展未能转化为成功的临床试验或 TBI 的新治疗方法。最近由 NINDS、NIDRR、DVBIC 和 DCOE 主办的两次研讨会确定了翻译失败的重要原因，包括数据收集缺乏标准化、TBI 分类和结果方法过时。人们一致认为，TBI 研究中变量的选择应该在各个研究中标准化，并强烈建议开发新颖和改进的 TBI 分类方法。还建议新兴技术的应用。在广泛机构的支持下，一个由思想领袖组成的多学科小组聚集在一起，起草了一份关于 TBI 研究数据收集标准化的提案，重点是人口统计、神经影像、结果测量、生物标志物和心理健康，称为 TBI 通用数据元素 (TBI-CDE)。现在，这为所有未来的 TBI 研究提供了一个潜在的框架，但人们承认，为了实施和广泛采用 TBI-CDE，需要基于网络的数据输入格式以及在临床实践中进一步完善和测试 beta 版本。该提案的全球目标是测试和完善 TBI 研究中的数据收集标准，适用于广泛的 TBI（目标 1），并利用新兴技术探索 TBI 分类（目标 2）和 TBI 后结果（目标 3）的新方法。此外，我们的目标是开发一套试点绩效指标，用于评估 TBI 的医疗保健质量和有效性（目标 4）。 TBI-CDE 的测试和验证将在一项多中心观察性研究中进行，该研究涉及 3 个 TBI 中心（UCSF、UPMC、UT Houston）和一个 TBI 康复中心（西奈山）。这些中心拥有多中心 TBI 研究经验和现有基础设施，可以快速、成功地完成研究。我们将为患者人口统计、神经影像、血清生物标志物和基因组学创建或扩展现有的数据存储库，从而为研究人员和临床医生提供基础设施，以便通过多学科的协调努力开发 TBI 领域。该项目旨在开发基础设施、协作和工具。它将建立跨学科的桥梁，打破减缓进展的人为结构和障碍，并促进跨研究的个体患者数据的比较和荟萃分析。它代表了迄今为止最具综合性的 TBI 工作之一。其独特之处在于，它涵盖了从轻度到重度、从早期表现到晚期表现、从婴儿期到老年期的整个 TBI 范围。将首次探索TBI具体绩效指标的制定。综合来看，该项目的成果有可能改变 TBI 研究和临床护理。 公共卫生相关性：创伤性脑损伤 (TBI) 仍然是医学和公共卫生领域最大的未满足需求之一。该提案的总体目标是测试和完善 TBI 研究中的数据收集标准，以改进分类、结果评估以及医疗保健质量和有效性研究。该项目的交付成果有可能改变 TBI 研究和临床护理。