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: 8579363
• 负责人: Tellen Bennett
• 金额: $ 13.8万
• 依托单位: UNIVERSITY OF UTAH
• 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/8579363
• 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 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; 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; public health relevance; 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）：这项以患者为导向的指导性职业发展奖提案旨在支持 Tellen D. Bennett 博士转变为独立的临床医生科学家和定量比较有效性研究的国家领导者。 Bennett 博士是犹他大学儿科重症监护助理教授。他之前接受过流行病学和比较有效性研究方法方面的培训，他的研究重点是改善患有创伤性脑损伤 (TBI) 的儿童的治疗结果。该提案将使贝内特博士能够发展概率数据库链接、前瞻性队列研究、倾向方法、多重插补和混合模型方面的技能。博士。 Bennett 博士的导师 Mike Dean 和 Heather Keenan 在临床试验、损伤研究、流行病学和大型数据库方面拥有丰富的专业知识。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、概率关联以及比较有效性研究方法统计方面的国家领导人组成。 Bennett 博士的首要职业目标是利用比较有效性研究方法来改善患有严重 TBI 和其他伤害的儿童的治疗结果。他的短期职业目标是成为儿科 TBI 研究和定量比较有效性方法方面的全国专家。 Bennett 博士的长期职业目标是成为一名独立的临床医生兼科学家，他将：1) 通过分析本提案中开发和验证的关联数据集中的干预措施（颅内压 (ICP) 监测、渗透压治疗等）的效果，改善 TBI 儿童的治疗效果，2) 与创伤外科医生和其他人员合作，扩展 PHIS-NTDB 联系，以执行以下各项的比较有效性分析： 对患有其他伤害的儿童进行干预，以及 3) 参与通过儿科研究网络进行的多中心队列研究和试验。犹他大学儿科重症监护科和儿科拥有合作研究文化，这种文化能够消除障碍，使医师科学家能够与 Intermountain Healthcare (IHC) 等当地机构以及美国外科医生学会 (ACS) 和儿童医院协会 (CHA，以前称为 CHCA) 等国家组织合作。犹他大学和儿科系拥有用于初级研究人员早期发展和指导的优秀资源，包括 NIH 资助的临床和转化科学中心 (CCTS) 以及 NIH 资助的转化和比较有效性研究培训项目（TCER，Bennett 博士是一名资助的导师学者，目前有 75% 的受保护时间）。儿科重症监护科拥有强大的计算基础设施以及统计和信息技术人员，以便为多个大型儿科研究网络提供数据管理、后勤支持和分析。所有这些资源都有助于改善研究环境，并可确保贝内特博士的持续成功。研究：创伤性脑损伤会导致儿童大量死亡和残疾。支持对严重 TBI 儿童（格拉斯哥昏迷量表 d 8）进行急性干预的现有证据有限。该提案旨在链接和验证两个具有互补临床信息的国家数据库，然后对严重 TBI 儿童的颅内压监测进行比较有效性分析。严重的 TBI 经常会导致 ICP 升高，并导致额外的脑损伤，从而使患者的预后恶化。 ICP 监测用于检测升高的 ICP 并指导严重 TBI 的治疗。众所周知，治疗颅内压升高可以改善成人的预后；然而，儿童 ICP 监测的风险/效益比尚不清楚。尽管如此，专家意见还是建议对患有此病的儿童进行ICP监测。 严重的 TBI，使得 ICP 监测的临床试验不太可能。因此，观察方法是评估儿童 ICP 监测有效性的最佳可用技术。目标 1 是使用概率链接技术链接 PHIS 和 NTDB 数据库，并使用一家医院的回顾性数据验证该链接的准确性。目标 2 是通过在单个大容量儿科创伤中心进行为期三年的前瞻性队列研究，验证链接数据集中数据库代码的准确性以及代表不良功能结果（气管造口术和胃造口术生存率）的准确性。目标 3 是检验以下假设：颅内压 (ICP) 监测与严重 TBI 儿童住院死亡率或功能不良的可能性降低相关。 PI 将在四年后通过重复数据集链接和比较有效性分析来验证目标 3 的结果。完成这些研究和他的培训目标将使 Bennett 博士能够产生宝贵的信息来指导 TBI 儿童的急性护理，并成为儿科 TBI 研究和比较有效性研究方法的独立研究者和国家领导者。