Applying big data to improve mental health outcomes with restless legs syndrome treatment

项目总结/摘要 不宁腿综合征（RLS）是一种复杂的神经和睡眠障碍，具有高共病率。 精神健康状况的普遍性。RLS的主要特征是夜间症状表现， 会扰乱睡眠和随后的日间功能。精神分裂症新发和加重的风险 由于RLS相关的精神不良反应（AE），健康状况进一步增加 药物治疗.多巴胺激动剂（DA）和加巴喷丁类药物是治疗中度至重度抑郁症的一线药物。 严重的原发性RLS。DA与严重AE相关，包括幻觉、精神病、 躁狂症，最明显的是冲动控制障碍（ICD）。最常见的ICD是赌博障碍，但 还有其他相关的冲动行为较少被描述。这些影响已在 帕金森病用DA治疗，但RLS的风险程度尚不清楚。鉴于这些风险 和其他安全性问题，RLS治疗的偏好已转向加巴喷丁类;然而， 加巴喷丁类化合物具有自杀的危险。虽然这种作用很少见，但尚不清楚 加巴喷丁类化合物是理想的长期用于RLS患者谁是在焦虑，抑郁，失眠， 自杀倾向与RLS治疗无关。因此，这个R36论文奖的目的是 在接受治疗的RLS患者中进行基于人群的心理健康结局评估， 药物流行病学方法。该提案将采用大数据或真实世界数据（RWD），包括 具有全国代表性的医疗保健遭遇和自我报告的健康数据。在目标1中，药物利用 研究方法将用于描述RLS药物治疗的使用和处方， 使用2012年RWD的原发性早发性RLS人群，包括既存精神健康合并症- 2019.在目标2中，将比较DA和加巴喷丁类化合物，以评估每种治疗之间的关系。 关于精神健康状况发作或恶化的风险的课程。急诊和住院数据 将用于检测精神健康合并症的恶化。在目标3中，DA和加巴喷丁类化合物将 比较ICD发作和自杀倾向的风险。冲动控制的创新探索成果 行为将得到发展。总的来说，本研究旨在改善RLS的心理健康负担 人口，增加关于ICD的文献，为自杀预防研究做出贡献，并证明 药物流行病学在精神卫生研究中的应用。本项目作为学员的 博士论文，并提供了宝贵的机会，以促进过渡到一个独立的研究 科学家透过建议的计划，以及在一个强而有力的导师团队的督导下， 实现她追求研究事业的长期目标，运用她对心理健康，药物安全， 和公共卫生。

PROJECT SUMMARY/ABSTRACT Restless legs syndrome (RLS) is a complex neurological and sleep disorder that has a high comorbid prevalence of mental health conditions. The cardinal feature of RLS is symptom manifestation at nighttime that disrupts restful sleep and subsequent daytime functioning. Risks for new onset and exacerbations of mental health conditions are further increased because of psychiatric adverse effects (AEs) associated with RLS pharmacotherapy. Dopamine agonists (DAs) and gabapentinoids are first-line treatments for moderate-to- severe primary RLS. DAs are associated with serious AEs including hallucinations, psychosis, symptoms of mania and most notably, impulse control disorders (ICDs). The most common ICD is gambling disorder, but there are other related impulsive behaviors that are less described. These effects have been well described in Parkinson’s disease treated with DAs, but the magnitude of risk in RLS is not well known. Given these risks and other safety concerns, preference for RLS treatment has shifted to gabapentinoids; however, gabapentinoids carry risks of suicidality. Although this effect is rare, it is not clear if the safety profile of gabapentinoids is ideal for long-term use in RLS patients who are at risk for anxiety, depression, insomnia, and suicidality independent of RLS treatment use. Therefore, the objective of this R36 Dissertation Award is to conduct a population-based assessment of mental health outcomes among treated RLS patients using pharmacoepidemiological methods. This proposal will employ big data, or real-world data (RWD), consisting of nationally representative health care encounters and self-reported health data. In Aim 1, drug utilization research methods will be used to characterize RLS pharmacotherapy utilization and prescribing among the primary early-onset RLS population including pre-existing mental health comorbidities using RWD from 2012- 2019. In Aim 2, DAs and gabapentinoids will be compared to assess the relationship between each treatment class on the risk of onset or worsening of mental health conditions. Emergency department and inpatient data will be used to detect exacerbations of mental health comorbidities. In Aim 3, DAs and gabapentinoids will be compared on the risk of onset of ICDs and suicidality. An innovative exploratory outcome of impulse control behaviors will be developed. Overall, this research aims to improve the mental health burden of the RLS population, to add to the literature on ICDs, to contribute to suicide prevention research, and to demonstrate application of pharmacoepidemiology within mental health research. This project serves as the trainee’s doctoral dissertation and provides an invaluable opportunity to facilitate transition to an independent research scientist. Through the proposed project and supervision under a robust mentorship team, the trainee will achieve her long-term goal of pursuing a research career applying her passion for mental health, drug safety, and public health.