Managing severe TBI without ICP monitoring - guidelines development and testing

描述(由申请人提供)：重型创伤性脑损伤(TBI)患者的颅内高压(ICH)的处理对他们的生存和最佳康复至关重要。第三版重型创伤性脑损伤的循证指南建议使用颅内压(ICP)监测仪来评估ICH，并了解何时和如何干预。不幸的是，在世界上大多数地区，无法获得国际比较方案监测技术。这意味着大多数重型颅脑损伤患者在没有使用颅内压监测的情况下得到治疗。没有指南和文献说明如何在不使用颅内压监测仪的情况下治疗重型颅脑损伤。该项目的目标是为重型脑外伤的治疗制定指南 在没有比较方案监测的情况下，并对其进行测试。我们建议通过与在中低收入国家(LMIC)艰苦环境中执业的临床医生团队合作来得出这些指南，这些医生通常根据治疗方案、他们的临床经验或两者都做出决定。我们将使用新的、系统的和创新的技术和流程，以实现临床医生对指南的共识。我们将在资源匮乏的中心实施以共识为基础的指导方针(CBG)，其中一些中心以前曾接触过不太完善的治疗脑损伤的特别方案，另一些以前没有暴露过。我们将在这两组中心的前/后设计中测试CBG对重型颅脑损伤预后的影响。在头两年，患者将按照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，并在接下来的两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特别方案的效果。在每一组中心中，我们将通过比较第一和第二阶段的结果来评估使用基于共识的指南协议与无协议或特别协议的效果。最后，我们将评估基于共识的方案比特别方案对结果的影响有多大，通过比较两组站点在完成研究目标的第一阶段和第二阶段的差异，我们将创建并测试可在全球范围内用于改善这些患者预后的重型颅脑损伤治疗指南。我们将在LMIC中验证一种新的、系统的和创新的技术和流程，以实现在HIC中达成的共识。最后，我们将在新的研究中心培训如何进行高质量科学研究的人员，并将培训延伸到与我们合作的人员，巩固以往的能力建设成果，开创新的努力。 公共卫生相关性：这一设计将允许对使用和不使用方案来管理严重脑外伤的中心的结果进行比较。它还将允许在执行最先进的、基于共识的议定书时，以及从方便的议定书改为使用严格的、基于共识的方法制定的议定书时，对结果进行中心内比较。该项目的主要目标是开发和评估这一基于共识的议定书。

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. PUBLIC HEALTH RELEVANCE: This design will allow a comparison of outcomes between centers that do and do not use a protocol to manage severe TBI. It will also allow within-center comparisons of outcomes when a state-of-the-art, consensus-based protocol is implemented and when changing from a protocol of convenience to one developed using rigorous, consensus-based methodology. The main goal of this project is to develop and evaluate this consensus-based protocol.