Managing severe TBI without ICP monitoring - guidelines development and testing

在没有 ICP 监测的情况下管理严重的 TBI - 指南的制定和测试

• 批准号: 9115726
• 负责人: RANDALL M CHESNUT
• 金额: $ 49.24万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9115726
• 关键词: Area; Brain Diseases; Clinical; Consensus; Country; Decision Making; Development; Environment; Exposure to; Goals; Guidelines; Health; Human Resources; Income; Individual; Injury; Intervention; Intracranial Hypertension; Intracranial Pressure; Judgment; Literature; Measures; Mentors; Methodology; Monitor; Observational Study; Outcome; Patient-Focused Outcomes; Patients; Phase; Phase I Clinical Trials; Physicians; Process; Protocols documentation; Recovery; Research; Resources; Site; Technology; Testing; Training; Traumatic Brain Injury; Treatment Protocols; Work; base; design; evidence based guidelines; experience; improved outcome; innovative technologies; knowledge base; mortality; neurobehavioral; prospective; randomized trial; teacher

DESCRIPTION (provided by applicant): Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury (TBI) is crucial to their survival and optimal recovery The evidence-based Guidelines for the Management of Severe Traumatic Brain Injury, 3rd Edition, recommends the use of intracranial pressure (ICP) monitors to assess ICH and to know when and how to intervene. Unfortunately, in most areas of the world there is no access to ICP monitor technology. This means that most people with severe TBI are treated without use of ICP monitoring. There are no guidelines and no literature on how to treat severe TBI without use of ICP monitors. The objective of this project is to create guidelines for the treatment of severe TBI in the absence of ICP monitoring and to test them. We propose to derive these guidelines by working with a team of clinicians that practice in austere environments in low-to-middle income countries (LMICs) and who routinely make decisions based either on a treatment protocol, their clinical experience, or both. We will use a new, systematic and innovative technology and process to accomplish consensus for the guidelines among the clinicians. We will implement the Consensus-Based Guidelines (CBG) in resource-poor centers, some of which have prior exposure to less well developed ad hoc protocols for treatment of TBI, and others that do not have prior exposure. We will test the influence of the CBG on outcomes of severe TBI in a before/after design in these two sets of centers. In the first two years, patients will be treated according to the ad hoc protocol or according to individual clinician best judgment. Then the Guidelines will be developed, all sites will be trained in their use, and they will be used to guid treatment in all sites for the next 2 years. We will evaluate the effect of using an ad hoc protoco by comparing outcomes between the two sets of centers before the Guidelines are developed. In each set of centers we will evaluate the effect of using the consensus-based guideline protocol compared to either no protocol or the ad hoc protocol by comparing the outcomes in the first and second periods. Finally, we will evaluate how much more the consensus-based protocol effects outcome than the ad hoc protocol by comparing the difference from the first to the second period between the two sets of sites In accomplishing the study objectives, we will create and test a guideline for the treatment of severe TBI that could be used globally to improve outcomes for these patients. We will validate in LMICs a new, systematic and innovative technology and process to accomplish consensus that was derived in an HIC. Finally, we will train personnel in centers new to research in how to conduct high-quality scientific studies, and will extend the training for the personnel with whom we have been working, solidifying previous capacity-building efforts, and initiating new efforts.

描述（由申请人提供）：严重创伤性脑损伤（TBI）患者的颅内高血压（ICH）的管理对于他们的生存和最佳恢复至关重要的，并且最佳恢复了基于证据的脑损伤的基于证据的指南，第三版的严重创伤性脑损伤指南，建议使用颅内压（ICP）monitors（ICP）Monitors（ICP）Monitors来评估ICH和何时及其间隔。不幸的是，在世界上大多数地区，无法访问ICP Monitor技术。这意味着大多数患有严重TBI的人在不使用ICP监测的情况下接受治疗。没有指南，也没有关于如何在不使用ICP监视器的情况下处理严重TBI的文献。该项目的目的是为治疗严重的TBI创建准则 在没有ICP监控并测试的情况下。我们建议通过与一个在低到中收入国家（LMIC）的严峻环境中实践的临床医生团队合作来得出这些准则，并根据治疗方案，其临床经验或两者兼而有之。我们将使用一种新的，系统的和创新的技术和过程来达成临床医生指南的共识。我们将在资源贫乏的中心实施基于共识的准则（CBG），其中一些事先接触了不太发达的临时协议，用于治疗TBI，而另一些则没有事先接触。我们将在这两组中心中测试CBG在设计前/之后的严重TBI结果的影响。在最初的两年中，将根据临时方案或单个临床医生的最佳判断对患者进行治疗。然后，将制定准则，所有站点都将在其使用中进行培训，并将在未来两年内用于在所有地点进行GUD治疗。我们将通过在制定指南之前比较两组中心之间的结果来评估使用临时原始的效果。在每个中心中，我们将通过比较第一个和第二个时期的结果来评估使用基于共识的指南协议的效果。最后，我们将通过比较两组站点之间的第一个到第二阶段的差异，在实现研究目标时，我们将评估基于共识的协议效应结果的结果，我们将创建和测试一个可以在全球范围内使用的严重TBI的指南，以改善这些患者的兴趣。我们将在LMIC中验证一种新的，系统的和创新的技术和过程，以实现在HIC中得出的共识。最后，我们将培训在如何进行高质量科学研究的研究中心的人员中培训人员，并将扩大我们一直在工作的人员的培训，巩固以前的能力建设工作以及开始新的努力。