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

• 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
• 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' s Disease; Alzheimer' 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

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.

主要研究者姓名：莫拉，Lidia Maria Veras罗查德 项目名称：Medicare计划中癫痫预防的比较安全性 1R01AG073410-01 每年有数千名患有阿尔茨海默病和/或阿尔茨海默病相关痴呆（AD/ADRD）的医疗保险受益人接受抗惊厥药物以预防癫痫发作。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，也会危及生命。AD/ADRD患者特别容易受到卒中和不良事件的影响。当患者患有AD/ADRD时，开始和停止抗惊厥药的决定也可能改变，部分原因是当患者难以接受治疗范围狭窄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。没有试验数据来指导有或没有AD/ADRD的患者在缺血性卒中后的预防决策。现有文献稀少且相互矛盾，但由于难以评估相关措施，卒中严重程度或AD/ADRD状态。医疗保险索赔提供了潜在的，但缺乏充分验证的定义中风的严重程度，AD/ADRD状态，癫痫发作，或不良反应。我们将使用一个新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水平相关纵向信息，并将为关键基线和结果变量开发预测模型。然后，使用18年（2006-23年）全国传统的按服务收费的医疗保险索赔的随机20%样本，我们将模拟临床试验，评估在有或没有AD/ADRD的患者中首次发生轻度至中度缺血性卒中时的两个关键决定：a）开始门诊预防与不开始预防;和B）在6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状态对我们的人群进行分层，因为与无AD/ADRD的患者相比，患者的卒中、卒中后癫痫发作和治疗并发症模式不同，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索赔的预测模型; 2）模拟一项临床试验，比较门诊预防开始与否; 3）模拟一项临床试验，比较在6个月时停止门诊预防与继续门诊预防。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，并改善卒中和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，家庭，临床医生和政策制定者了解我们如何改善对可能需要癫痫预防的患者的护理。