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: 8554386
• 负责人: RANDALL M CHESNUT
• 金额: $ 48.44万
• 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/8554386
• 关键词: Area; Brain Diseases; Clinical; Consensus; Country; Decision Making; Development; Environment; Exposure to; Goals; Guidelines; Human Resources; Income; Individual; Injury; Intervention; Intracranial Hypertension; Intracranial Pressure; Judgment; Literature; Measures; Mentors; Methodology; Monitor; Observational Study; Outcome; 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; innovative technologies; knowledge base; mortality; neurobehavioral; prospective; public health relevance; 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) 患者的颅内高压 (ICH) 管理对其生存和最佳康复至关重要《严重创伤性脑损伤管理循证指南》第三版建议使用颅内压 (ICP) 监测仪评估 ICH 并了解何时以及如何进行干预。不幸的是，世界上大多数地区都无法使用 ICP 监测技术。这意味着大多数患有严重 TBI 的人在接受治疗时无需使用 ICP 监测。目前还没有关于如何在不使用 ICP 监测仪的情况下治疗严重 TBI 的指南和文献。该项目的目标是制定治疗严重 TBI 的指南 在没有 ICP 监测的情况下对其进行测试。我们建议通过与在中低收入国家 (LMIC) 严峻环境中实践的临床医生团队合作来制定这些指南，这些临床医生通常根据治疗方案、临床经验或两者共同做出决策。我们将使用新的、系统的、创新的技术和流程来达成临床医生对指南的共识。我们将在资源匮乏的中心实施基于共识的指南 (CBG)，其中一些中心先前接触过不太完善的治疗 TBI 的临时方案，而其他中心则没有接触过。我们将在这两组中心的前后设计中测试 CBG 对严重 TBI 结果的影响。在头两年，患者将根据临时方案或根据个别临床医生的最佳判断进行治疗。然后将制定指南，对所有站点进行使用培训，并将在未来 2 年内用于指导所有站点的治疗。在制定指南之前，我们将通过比较两组中心之间的结果来评估使用临时协议的效果。在每组中心中，我们将通过比较第一阶段和第二阶段的结果，评估使用基于共识的指南协议与无协议或临时协议相比的效果。最后，我们将通过比较两组站点之间第一阶段和第二阶段的差异来评估基于共识的协议比临时协议对结果的影响有多大。在实现研究目标时，我们将创建并测试一个指南用于治疗严重 TBI，可在全球范围内使用以改善这些患者的预后。我们将在中低收入国家验证一种新的、系统的和创新的技术和流程，以达成在高收入国家中达成的共识。最后，我们将对新研究中心的人员进行如何开展高质量科学研究的培训，并将扩大对我们一直合作的人员的培训，巩固以前的能力建设工作，并开展新的工作。