Effect of treatment on outcome after TBI in children and adolescents

描述（由申请人提供）：过去二十年的研究描述了儿童和青少年TBI的流行病学，概述了恢复的自然史，并确定了损伤后的功能结局。重要的问题仍然是在急性，短期和长期护理阶段的功能，心理和残疾的结果TBI后的治疗效果。在该项目中，Harborview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岁个体发生的复杂轻度、中度和重度TBI的多中心研究，以解决这些目标：目标1。描述复杂的轻度、中度和重度TBI的年龄、原因、损伤类型、伴随体征和症状、内科和外科合并症的类型和严重程度、预先存在的疾病、入院和出院时的功能状态;并检查创伤性脑损伤的具体特征与受伤后6、12、24和36个月的教育、职业、行为和社会结果之间的关联。目标2.确定TBI初次住院期间、住院患者和门诊患者康复和治疗期间接受的治疗，以及治疗与人口统计学和损伤因素的关系。目标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、12、24和36个月的教育、职业、行为和社会功能结果之间的关联，包括与不同发育阶段教育和职业里程碑的实现之间的关联。这项研究将解决许多关于儿童TBI的未回答的问题。它在许多方面都是创新的。这是一项多中心研究，汇集了美国儿科TBI的领先专业知识。它将采用新开发的通用数据元素来描述伤害，并采用新开发的护理质量指标来描述住院康复护理。该研究将利用新的PROMIS结局指标，并使用基于网络的技术从护理人员和患者中纵向收集数据。通过应用新的统计方法，旨在评估因果关系的观察设计，它将提供关键信息的影响，在不同阶段的脑外伤后功能结果的治疗。该研究小组代表了一个独特的跨学科小组，由经验丰富的研究人员组成，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.