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Comparative Safety of Seizure Prophylaxis within the Medicare Program

医疗保险计划中癫痫预防的比较安全性

基本信息

批准号：
10495203
负责人：
Lidia Maria Veras Rocha de Moura
金额：
$ 82.52万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2027-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10495203
关键词：
Academy Acute Address Adverse effects Adverse event Advisory Committees Alzheimer&apos s Disease Alzheimer&apos s disease related dementia American American Heart Association Anticonvulsants Case Series Centers for Disease Control and Prevention (U.S.)Clinical Clinical Management Clinical Trials Communities Complex Complication Cox Proportional Hazards Models Data Data Set Detection Diagnosis Drug Labeling Drug usage Elderly Electroencephalography Electronic Health Record Emergency department visit Enrollment Epilepsy Etiology Event Family Fee-for-Service Plans Foundations Future Guidelines Hospitalization Incentives Individual Ischemic Stroke Life Link Literature Measures Medicare Medicare Part A Medicare claim Methods Modeling Names National Committee for Quality Assurance Neurology Observational Study Outcome Outpatients Patient Care Patients Pattern Pharmaceutical Preparations Physicians Policies Policy Maker Positioning Attribute Predisposition Prophylactic treatment Provider Registries Relative Risks Risk Safety Sampling Savings Scoring Method Seizures Serious Adverse Event Severities Stroke Symptoms Therapeutic Time Validation acute stroke adjudicate adverse event risk aged analytical tool base beneficiary clinical care comorbidity comparative safety cost dementia care electronic data experience fall injury falls follow-up high risk improved individualized medicine machine learning method multidisciplinary novel population based post stroke predictive modeling prevent programs randomized trial recruit safety study stroke event stroke risk stroke survivor treatment duration trial comparing

项目摘要

PI Name(s): Moura, Lidia Maria Veras Rocha de Project Title: Comparative Safety of Seizure Prophylaxis within the Medicare Program 1R01AG073410-01 Each year thousands of Medicare beneficiaries with Alzheimer’s disease and/or Alzheimer’s-related dementias (AD/ADRD) receive anticonvulsant drugs for seizure prophylaxis. These drugs are life-saving given the severity of seizure sequalae, but also life-threatening because of serious adverse events. Patients with AD/ADRD are particularly vulnerable given their high susceptibility to both stroke and adverse events. The decision to start and stop anticonvulsants also might change when the patient have AD/ADRD, in part because anticonvulsant therapy management becomes more complex when patients have difficulty with therapy having a narrow therapeutic range or difficulty recognizing early complication symptoms. There are no trial data to guide decisions about prophylaxis after an ischemic stroke among patients with or without AD/ADRD. The sparse and conflicted existing literature has been limited by the difficulty assessing relevant measures, e.g., stroke severity or AD/ADRD status, in claims. Medicare claims offer potential, but lack well-validated definitions for stroke severity, AD/ADRD status, seizures, or adverse effects. We will address these issues using a novel dataset with individual-level linked longitudinal information from registries, electronic health records, and Medicare claims, and will develop prediction models for key baseline and outcome variables. Then, using a random 20% sample of national traditional, fee-for-service Medicare claims over 18 years (2006-23), we will emulate clinical trials assessing two critical decisions in the setting of first mild to moderate ischemic stroke among patients with or without AD/ADRD: a) initiating outpatient prophylaxis versus not; and b) stopping prophylaxis at six months versus continuing. We will apply multiple analytical tools to address confounding and other challenges. We will stratify our population based on AD/ADRD status because the patterns of strokes, post-stroke seizures, and treatment complications differ among patients with compared to those without AD/ADRD, as could the clinical management patterns. We have three aims: 1) To validate claims-based prediction models for our study variables; 2) To emulate a clinical trial comparing outpatient prophylaxis initiation versus not; and 3) To emulate a clinical trial comparing stopping outpatient prophylaxis at six months versus continuing. This comparative safety study could inform future policy and clinical care and improve stroke and AD/ADRD care, e.g., through adjustments in Medicare quality incentives and clinical guidelines. Moreover, these data could help inform patients, families, clinicians, and policy makers about how we can improve care for patients who could require seizure prophylaxis.

PI 姓名：Moura、Lidia Maria Veras Rocha de 项目名称：医疗保险计划内癫痫预防的比较安全性 1R01AG073410-01 每年，数以千计患有阿尔茨海默病和/或阿尔茨海默病相关痴呆症 (AD/ADRD) 的医疗保险受益人接受抗惊厥药物来预防癫痫发作。考虑到癫痫后遗症的严重程度，这些药物可以挽救生命，但由于严重的不良事件也可能危及生命。 AD/ADRD 患者特别容易受到中风和不良事件的影响。当患者患有AD/ADRD时，开始和停止抗惊厥药物的决定也可能会改变，部分原因是当患者难以接受治疗范围狭窄的治疗或难以识别早期并发症症状时，抗惊厥治疗管理变得更加复杂。目前尚无试验数据可指导患有或不患有 AD/ADRD 的患者在缺血性中风后进行预防决策。现有文献稀疏且相互矛盾，因为难以评估索赔中的相关措施，例如中风严重程度或 AD/ADRD 状态，因此受到限制。医疗保险索赔提供了潜力，但缺乏对中风严重程度、AD/ADRD 状态、癫痫发作或不良反应的充分验证的定义。我们将使用一个新颖的数据集来解决这些问题，该数据集包含来自登记处、电子健康记录和医疗保险索赔的个人层面的关联纵向信息，并将开发关键基线和结果变量的预测模型。然后，使用 18 年（2006-23 年）全国传统按服务付费医疗保险索赔的随机 20% 样本，我们将模拟临床试验，评估患有或不患有 AD/ADRD 的患者首次发生轻度至中度缺血性卒中时的两个关键决策：a) 是否开始门诊预防； b) 在六个月时停止预防与继续预防。我们将应用多种分析工具来解决混淆和其他挑战。我们将根据 AD/ADRD 状态对人群进行分层，因为与无 AD/ADRD 的患者相比，中风、中风后癫痫发作和治疗并发症的模式不同，临床管理模式也不同。我们有三个目标：1）验证我们研究变量的基于声明的预测模型； 2) 模拟一项临床试验，比较是否开始门诊预防； 3) 模拟一项临床试验，比较六个月后停止门诊预防与继续进行的情况。这项比较安全性研究可以为未来的政策和临床护理提供信息，并改善中风和 AD/ADRD 护理，例如通过调整医疗保险质量激励措施和临床指南。此外，这些数据可以帮助患者、家属、临床医生和政策制定者了解如何改善对可能需要癫痫预防的患者的护理。