Effect of treatment on outcome after TBI in children and adolescents

描述(由申请人提供)：过去20年的研究描述了儿童和青少年脑损伤的流行病学，概述了康复的自然历史，并确定了损伤后的功能结果。关于急性、短期和长期护理阶段的治疗对脑外伤后的功能、心理社会和残疾结果的影响，重要的问题仍然存在。在这个项目中，哈博维尤医学中心、德克萨斯儿童医院、全国儿童医院和费城儿童医院提出了一项针对7-18岁个体发生的复杂的轻度、中度和重度脑外伤的多中心研究，以解决这些目标：目的1.根据年龄、原因、损伤类型、伴随的体征和症状、内科和外科并存的类型和严重程度、以及急诊护理医院的预先存在的条件、入院和出院时的功能状态，描述复杂的轻度、中度和重度脑外伤的特征；并在伤后6个月、12个月、24个月和36个月检测创伤性脑损伤的具体特征与教育、职业、行为和社会结局之间的关系。目的2.确定颅脑损伤患者在首次住院期间、住院和门诊康复治疗期间接受的治疗，以及治疗与人口学和伤害因素的关系。目的3.确定在急性住院和康复护理阶段接受的治疗与受伤后6个月、12个月、24个月和36个月的教育、职业、行为和社会功能结果的相关性，包括与不同发展阶段的教育和职业里程碑成就的相关性。这项研究将解决许多关于儿科脑外伤的悬而未决的问题。它在许多方面都是创新的。这是一项多中心的研究，汇集了美国在儿科脑损伤方面的领先专业知识。它将使用新开发的通用数据元素来描述受伤情况，并使用新开发的护理质量指标来描述其住院康复护理的特征。这项研究将利用新的PROMIS结果衡量标准，并使用基于网络的技术以纵向方式从照顾者和患者那里收集数据。通过应用新的统计学方法来评估观察设计中的因果效应，它将提供有关脑外伤后CAE不同阶段的治疗对功能结果的影响的关键信息。研究小组代表了一个由非常有经验的研究人员组成的独特的跨学科小组，他们能够进行严格的研究，为未来的研究、护理和政策提供信息。

DESCRIPTION (provided by applicant): Studies over the last two decades have described the epidemiology of TBI in children and adolescents, outlined the natural history of recovery, and determined the functional outcome following injury. Important questions remain about the effect of treatment during the acute, short-term, and longer-term phases of care on the functional, psychosocial, and disability outcomes after TBI. In this project, Harborview Medical Center, Texas Children's Hospital, Nationwide Children's Hospital, and the Children's Hospital of Philadelphia propose a multicenter study of complicated mild, moderate, and severe TBI occurring to individual's ages 7-18 years to address these aims: Aim 1. Characterize complicated mild, moderate and severe TBI with respect to age, cause, type of injury, accompanying signs and symptoms, type and severity of medical and surgical co-morbidities, and pre-existing conditions, functional status at admission and discharge from the acute care hospital; and examine the association between specific characteristics of TBI and educational, vocational, behavioral, and social outcomes 6, 12, 24 and 36 months after injury. Aim 2. Determine the treatment received during the initial hospitalization for TBI, and during inpatient and outpatient rehabilitation and therapy, and the relationship of treatment to demographic and injury factors. Aim 3. Determine the association of treatment received during the acute inpatient and rehabilitation phases of care with the educational, vocational, behavioral, and social functional outcomes 6, 12, 24 and 36 months after injury, including the association with attainment of educational and vocation milestones at different developmental stages. This study will address many of the unanswered questions on pediatric TBI. It is innovative in many ways. It is a multi-centered study bringing together leading expertise in the United States on pediatric TBI. It will employ the newly developed Common Data Elements for characterizing injuries and the newly developed quality of care indicators for characterizing their inpatient rehabilitation care. The study will utilize the new PROMIS outcome measures and collect data in a longitudinal fashion from both caregivers and patients using web- based technology. By applying novel statistical approaches designed to assess causal effects in observational designs, it will provide critical information on the effects of treatment at different stages of cae on functional outcomes after TBI. The study team represents a uniquely interdisciplinary group of very experienced investigators who are capable of carrying out a rigorous study to provide information to inform future research, care and policy.