Pediatric anxiety: Pharmacotherapy and psychotherapy utilization and serious adverse outcomes

 描述（由申请人提供）：焦虑症是儿童中最常见的精神疾病之一，并与导致损害和功能障碍的症状有关。有效的早期治疗焦虑可以减少其负面影响，并减少其持续到年轻的成年。根据随机对照试验证据，抗抑郁类选择性5-羟色胺再摄取抑制剂（SSRIs）被推荐为功能损害性焦虑症儿童的一线药物治疗。目前尚不清楚焦虑儿童是否按照指南开始处方药物治疗。焦虑儿童的严重不良后果负担也是未知的。考虑到认知行为疗法和SSRIs的组合已被证明在治疗患有中度至重度焦虑的儿童方面比单独使用SSRIs和单独使用心理疗法具有优势，因此假设接受组合疗法的儿童与接受单一疗法的儿童相比可能会减少严重不良后果。与医疗保健提供者（即接受联合治疗的儿童）的接触增加也可能导致药物依从性改善。 这项拟议的研究将描述2004-2013年期间焦虑症的处方药使用情况，药物服用时间，以及2004-2013年诊断为非强迫症焦虑症的儿童（3-17岁）开始药物治疗时使用心理治疗的频率（目标1）。焦虑儿童中严重不良结局的发生率以及严重不良结局是否因治疗类型而异：联合治疗（SSRI +心理治疗）vs. SSRI单药治疗和心理治疗单药治疗，以及将估计结果是否因共病抑郁状态而异（目标2）。评价的严重不良结局将包括治疗的自伤事件、精神健康相关住院和急诊室就诊。最后，拟议的研究将评估焦虑儿童的SSRI依从性，以及联合治疗与SSRI单一治疗的儿童之间的依从性是否存在差异（目标3）。拟定的观察性研究将使用管理索赔表，提供真实的世界人群、足够的样本量和纵向数据，以有效和高效地解决研究问题。这项研究的结果将为进一步的工作提供信息，并将帮助提供者，患者和护理人员优化治疗，以最大限度地减少严重不良后果的风险。

 DESCRIPTION (provided by applicant): Anxiety disorders are one of the most common mental illnesses in children and are associated with symptoms causing impairment and poor functioning. Effective early treatment of anxiety may reduce its negative impact and reduce its persistence into young adulthood. The antidepressant class selective serotonin reuptake inhibitors (SSRIs) are recommended as the first line medication treatment for children with functional impairing anxiety disorders, based on randomized controlled trial evidence. It is unknown whether children with anxiety initiate prescription medication concordant with guidelines. The burden of serious adverse outcomes in children with anxiety is also unknown. Given that the combination of cognitive behavioral therapy and SSRIs has been shown to offer an advantage over SSRIs alone and psychotherapy alone in treating children with moderate to severe anxiety, it is hypothesized that children receiving combination therapy may experience reduced serious adverse outcomes compared to children on mono-therapy. Increased contact with a healthcare provider (i.e. children on combination therapy) may also result in improved medication adherence. The proposed study will describe prescription medication utilization for anxiety, how long the medications are taken, and the frequency in which psychotherapy is used surrounding medication initiation in children (3-17 years) with a non-OCD anxiety diagnosis from 2004-2013 (Aim 1). The rate of serious adverse outcomes in children with anxiety and whether serious adverse outcomes vary by treatment type: combination therapy (SSRI + psychotherapy) vs. SSRI mono-therapy and psychotherapy mono-therapy, and whether results differ by co-morbid depression status will be estimated (Aim 2). The serious adverse outcomes evaluated will include treated self-harm events, mental health related hospitalizations, and emergency room visits. Lastly the proposed study will estimate SSRI adherence in children with anxiety and whether adherence varies between children on combination therapy vs. SSRI mono-therapy (Aim 3). The proposed observational study will utilize an administrative claims datasource providing a real world population, adequate sample size, and longitudinal data to effectively and efficiently address the study questions. Results from this study will inform further work and will assist providers, patients, and caregivers in optimizing treatment to minimize the risk of serious adverse outcomes.