Effectiveness of ICP Monitoring in Pediatric Traumatic Brain Injury

ICP 监测在小儿创伤性脑损伤中的有效性

• 批准号: 8847755
• 负责人: Tellen Bennett
• 金额: $ 13.06万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-05 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8847755
• 关键词: Accounting; Acute; Adult; Advisory Committees; American College of Surgeons; Brain Injuries; Caring; Cessation of life; Child; Child Care; Childhood; Clinical; Clinical Sciences; Clinical Trials; Code; Cohort Studies; Critical Care; Data; Data Set; Databases; Development; Discipline of Nursing; Educational workshop; Effectiveness; Ensure; Environment; Epidemiologic Studies; Epidemiology; Equipoise; Evaluation; Expert Opinion; Funding; Gastrostomy; Glasgow Coma Scale; Goals; Health; Health Information System; Healthcare; Heterogeneity; Hospital Mortality; Hospitalization; Hospitals; Image; Impairment; Incidence; Information Technology; Injury; Institution; Intervention; Intracranial Hypertension; Intracranial Pressure; K-Series Research Career Programs; Link; Mentors; Mentorship; Methods; Modeling; Monitor; Morbidity - disease rate; Multicenter Trials; Neurologic; Observational Study; Outcome; Patients; Pediatric Hospitals; Pediatric Research; Pharmaceutical Preparations; Physicians; Prospective Studies; Proxy; Public Health; Research; Research Infrastructure; Research Methodology; Research Personnel; Resources; Risk; Scientist; Scoring Method; Severities; Surgeon; Techniques; Testing; Time; Tracheostomy procedure; Training; Training Programs; Translational Research; Trauma; Traumatic Brain Injury; United States National Institutes of Health; Universities; Update; Utah; Work; administrative database; career; comparative effectiveness; data management; design; disability; effectiveness research; functional outcomes; improved; innovation; insight; intervention effect; mortality; multidisciplinary; neurosurgery; patient oriented; pediatric department; pediatric trauma; pediatric traumatic brain injury; professor; prospective; randomized trial; risk benefit ratio; skills; statistics; success; trauma centers

DESCRIPTION (provided by applicant): This patient-oriented mentored career development award proposal is designed to support the transition of Dr. Tellen D. Bennett into an independent clinician-scientist and national leader in quantitative comparative effectiveness research. Dr. Bennett is an Assistant Professor of Pediatric Critical Care at the University of Utah. He has prior training in epidemiology and comparative effectiveness research methods, and his research is focused on improving outcomes in children with traumatic brain injury (TBI). This proposal will allow Dr. Bennett to develop skills in probabilistic database linkage, prospective cohort studies, propensity methods, multiple imputations, and mixed models. Drs. Mike Dean and Heather Keenan, Dr. Bennett's co- mentors, have extensive expertise in clinical trials, injury research, epidemiology, and large databases. His multidisciplinary advisory committee is made up of national leaders in pediatric trauma and traumatic brain injury, neurosurgery, the Pediatric Health Information System (PHIS) and National Trauma Data Bank (NTDB) databases, probabilistic linkage, and the statistics of comparative effectiveness research methods. Dr. Bennett's over-arching career goal is to improve the outcomes of children with severe TBI and other injuries using comparative effectiveness research methods. His short-term career goal is to become a national expert in pediatric TBI research and quantitative comparative effectiveness methods. Dr. Bennett's long-term career goal is to be an independent clinician-scientist who will: 1) Improve outcomes in children with TBI by analyzing the effect of interventions (intracranial pressure (ICP) monitoring, osmolar therapy, and others) in the linked dataset developed and validated in this proposal, 2) Collaborate with trauma surgeons and others to expand the PHIS-NTDB linkage to perform comparative effectiveness analyses of interventions in children with other injuries, and 3) Participate in multi-center cohort studies an trials conducted through pediatric research networks. The Division of Pediatric Critical Care and the Department of Pediatrics at the University of Utah have a culture of collaborative research that bridges barriers and enables physician scientists to work with local institutions such as Intermountain Healthcare (IHC) and national organizations such as the American College of Surgeons (ACS) and the Children's Hospital Association (CHA, formerly CHCA). The University of Utah and the Department of Pediatrics have outstanding resources for the early development and mentorship of junior investigators, including the NIH-funded Center for Clinical and Translational Science (CCTS) and the NIH- funded training program in Translational and Comparative Effectiveness Research (TCER, Dr. Bennett is a funded Mentored Scholar and currently has 75% protected time). The Division of Pediatric Critical Care maintains a robust computing infrastructure and statistical and information technology staff in order to provide data management, logistical support, and analyses for several large pediatric research networks. All of these resources contribute to the research environment and are available to ensure Dr. Bennett's continued success. Research: TBI causes substantial death and disability in children. The available evidence to support acute interventions in children with severe TBI (Glasgow Coma Scale d 8) is limited. This proposal aims to link and validate two national databases with complementary clinical information, and then conduct a comparative effectiveness analysis of intracranial pressure monitoring in children with severe TBI. Elevated ICP frequently results from severe TBI and worsens patient outcome by causing additional brain injury. ICP monitoring is used to detect elevated ICP and to guide treatment of severe TBI. Treatment of elevated ICP is known to improve outcomes in adults; however, the risk/benefit ratio of ICP monitoring in children is less clear. In spite of this, expert opinion recommends ICP monitoring in children with severe TBI, making a clinical trial of ICP monitoring unlikely. Therefore, observational methods are the best available techniques to assess the effectiveness of ICP monitoring in children. Aim 1 is to use probabilistic linkage techniques to link the PHIS and the NTDB databases and to validate the accuracy of that linkage using retrospective data from one hospital. Aim 2 is to validate the accuracy of database codes in the linked dataset and a proxy poor functional outcome, survival with tracheostomy and gastrostomy, by conducting a three-year prospective cohort study at a single, high volume, pediatric trauma center. Aim 3 is to test the hypothesis that intracranial pressure (ICP) monitoring is associated with a lower likelihood of hospital mortality or poor functional outcome in children with severe TBI. The PIs will validate the result of Aim 3 by repeating the dataset linkage and the comparative effectiveness analysis four years later. Completion of these studies and his training aims will allow Dr. Bennett to generate invaluable information to guide the acute care of children with TBI and to become an independent investigator and national leader in pediatric TBI research and comparative effectiveness research methods.

描述（由申请人提供）：该面向患者的指导职业发展奖提案旨在支持Tellen D. Bennett博士的过渡到定量比较有效性研究的独立临床医生和国家领导者。 Bennett博士是犹他大学的儿科重症监护助理教授。他先前曾接受过流行病学和比较有效性研究方法的培训，他的研究重点是改善创伤性脑损伤儿童（TBI）的结局。该提案将使Bennett博士能够发展概率数据库链接，前瞻性队列研究，倾向方法，多种候选和混合模型的技能。博士。 Bennett博士的合作社Mike Dean和Heather Keenan在临床试验，伤害研究，流行病学和大型数据库方面拥有广泛的专业知识。他的多学科咨询委员会由儿科创伤和创伤性脑损伤，神经外科，儿科健康信息系统（PHIS）和国家创伤数据库（NTDB）数据库，概率联系以及比较有效研究方法的统计数据组成。 Bennett博士的职业生涯过高的目标是使用比较有效性研究方法改善严重TBI和其他伤害儿童的结果。他的短期职业目标是成为小儿TBI研究和定量比较有效性方法的全国专家。贝内特博士的长期职业目标是成为一名独立的临床医生科学家，他将：1）通过分析干预措施（颅内压（ICP）监测，渗透压治疗，其他）在链接的数据集中开发和验证的链接效应，以扩大phiss的链接，改善TBI儿童的预后，并与Trauma Sublics Spearbiention相比，2）对其他伤害儿童的干预措施，以及3）参与多中心队列研究通过小儿研究网络进行的试验。犹他大学的儿科重症监护局和儿科系具有协作研究的文化，使障碍物弥合了障碍，并使医师科学家能够与当地机构合作，例如Intermountain Healthcare（IHC）和国家组织，例如美国外科医生学院（ACS）和儿童医院协会（CHA，CHA，以前的CHCA）。犹他大学和儿科系为初级研究人员的早期开发和指导提供了出色的资源，包括NIH资助的临床和转化科学中心（CCTS）和NIH资助的转化和比较效率研究中的NIH资助的培训计划（TCER，Bennett博士，Bennett博士是一名资助的学者，目前是75％的Prokected Time）。小儿重症监护的部门维护了强大的计算基础架构以及统计和信息技术人员，以便为几个大型儿科研究网络提供数据管理，后勤支持和分析。所有这些资源都为研究环境做出了贡献，可以确保Bennett博士的持续成功。研究：TBI导致儿童的大量死亡和残疾。支持严重TBI儿童（格拉斯哥昏迷量表D 8）急性干预措施的可用证据有限。该建议旨在将两个国家数据库与互补临床信息联系起来，然后对严重TBI儿童的颅内压监测进行比较有效性分析。 ICP升高通常是由于严重的TBI导致的，并通过造成额外的脑损伤来恶化患者的结果。 ICP监测用于检测ICP升高并指导严重TBI的治疗。已知ICP升高的治疗可改善成人的预后；但是，儿童ICP监测的风险/福利比不太清楚。尽管如此，专家意见建议对患有儿童的ICP监测 严重的TBI，进行ICP监测的临床试验。因此，观察方法是评估ICP监测儿童有效性的最佳可用技术。 AIM 1是使用概率链接技术将PHI和NTDB数据库链接起来，并使用一家医院的回顾性数据来验证该联系的准确性。 AIM 2是通过在单个，大容量，大量的儿科创伤中心进行三年的前瞻性队列研究来验证链接数据集中数据库代码的准确性，并具有较差的功能性结果，与气管切开术和胃造口术的生存。目的3是测试以下假设：颅内压（ICP）监测与严重TBI儿童的医院死亡率较低或功能性较差有关。 PI将通过重复数据集链接和四年后的比较有效性分析来验证AIM 3的结果。这些研究的完成及其培训目标将使Bennett博士能够产生宝贵的信息，以指导患有TBI的儿童的急诊护理，并成为小儿TBI研究和比较有效性研究方法的独立研究员和国家领导者。