RFA-CE-23-008, Development and Validation of a Clinical Tool to Predict Mental Health Sequelae After Mild TBI in Adolescents

项目摘要/摘要 先前的研究表明，25%-50%患有轻度创伤性脑损伤(MTBI)的青少年 他们在康复过程中会有严重的心理健康后遗症。此外，31%-78%的患有脑损伤的儿童 新的或日益恶化的心理健康问题没有得到适当的心理健康护理，种族，民族， 以及TBI后管理和成果中存在的经济不平等。虽然有相当数量的 在mTBI后的头三个月里，儿童会经历持续或恶化的心理健康问题。 没有经过验证的预后工具来评估这些患者持续或恶化的心理健康问题的风险 病人。我们的目标是开发和验证一种预测精神健康后遗症的临床工具 脑外伤后的青少年。我们将在六个PECARN进行一项多中心的前瞻性观察研究 (儿科急救应用研究网络)急诊科。我们将招收一个 四个站点的派生队列(n=1512)和两个站点的验证队列(n=1080)。患者将被招募 并在指数ED访问后1-2周、1个月和3个月进行随访评估。这个 主要结果是对新的或恶化的精神健康后遗症的综合自我报告测量(基于 临床上最小的差异)mTBI后1-3个月，用广泛性焦虑来衡量 精神障碍-7和患者健康问卷-8。我们还将衡量未得到满足的精神卫生保健需求， 定义为对患有新的或恶化的焦虑或焦虑的患者没有接受任何心理或行为保健 抑郁症。我们选择了患有mTBI的儿童数量较多的地点，以及来自 不同的背景。我们的研究有可能影响受伤儿童的健康和福祉 全世界。结果将立即产生重大影响，影响临床实践、指南和政策。 这项研究将在PECARN地点进行，PECARN数据协调中心和一个集中的 心理健康结果核心，利用现有资源和调查人员与多中心、儿科 急诊临床预测工具开发经验。

PROJECT SUMMARY/ABSTRACT Prior studies demonstrate that 25-50% of adolescents with mild traumatic brain injuries (mTBIs) have substantial mental health sequelae during their recoveries. Moreover, 31-78% of children with TBI who have new or worsening mental health concerns are not receiving appropriate mental health care, with racial, ethnic, and economic inequities existing in post-TBI management and outcomes. While a substantial number of children experience ongoing or worsening mental health concerns in the first three months after mTBI, there are no validated prognostic tools to assess risk of ongoing or worsening mental health concerns in these patients. Our objective is to develop and validate a clinical tool to predict mental health sequelae in adolescents after mTBI. We will conduct a multicenter, prospective observational study in six PECARN (Pediatric Emergency Care Applied Research Network) emergency departments (EDs). We will enroll a derivation cohort (n=1512) at four sites and a validation cohort (n=1080) at two sites. Patients will be enrolled in EDs and have follow-up evaluations at 1 to 2 weeks, 1 month, and 3 months after the index ED visit. The primary outcome is a composite self-report measure of new or worsening mental health sequelae (based on minimal clinically important difference) 1 to 3 months after mTBI as measured by the Generalized Anxiety Disorder-7 and the Patient Health Questionnaire-8. We will also measure unmet mental health care needs, defined as not receiving any mental or behavioral health care in patients with new or worsening anxiety or depression. We selected sites with large numbers of children with mTBI and a high proportion of children from diverse backgrounds. Our study has the potential to impact the health and wellbeing of injured children worldwide. The results will be immediately significant, affecting both clinical practice, guidelines, and policy. The study will be conducted at PECARN sites, with the PECARN data coordinating center, and a centralized mental health outcome core, leveraging existing resources and investigators with multicenter, pediatric emergency care clinical prediction tool development experience.