Traumatic Brain Injury Anti-Seizure Prophylaxis in the Medicare Program

每年成千上万的医疗保险受益人在创伤性脑损伤（TBI）后常规接受抗癫痫药物（ASM）预防。鉴于癫痫发作后遗症的严重程度，这些药物可能挽救生命，但由于频繁发生严重的不良事件，例如跌倒，这些药物也可能危及生命。患有阿尔茨海默病和相关痴呆（ADRD）的老年人发生脑外伤和脑外伤后并发症的风险更高。他们也更容易受到ASM的负面影响，包括认知减缓。尽管已知的利与弊之间的微妙平衡，但没有试验数据来指导老年人，特别是那些患有ADRD的老年人在脑外伤后的预防决策。由于难以评估相关措施，例如在大数据集中评估TBI严重程度，现有文献的稀疏和冲突受到限制。医疗保险索赔数据提供了潜在的，但缺乏对TBI严重程度或治疗相关不良反应的有效定义。我们将利用多个新颖的关联数据源：与大型区域卫生系统的TBI注册表和电子健康记录（EHR）相关的传统医疗保险索赔，以及与最低数据集（2009-2022年急性后制度化医疗保险/医疗补助受益人的国家注册表）相关的国家医疗保险。首先，我们将改进TBI严重程度的分类算法，以便在公共管理数据库中使用。然后，我们将评估在中度至重度TBI情况下的关键决策，特别是在那些患有ADRD的患者中：在7天内停止预防还是继续预防。我们将运用多种最先进的分析工具来解决混淆和其他挑战。我们有三个目标：1)改进TBI严重程度的分类算法，以便在公共管理数据库中使用；2)探讨脑外伤后患者ASM预防持续时间对6个月事件发生率的影响；3)观察不同ADRD患者治疗效果的差异。这项比较有效性和安全性的研究可以为未来的政策和临床护理提供信息，并通过调整医疗保险质量激励和临床指南来改善TBI和ADRD的护理。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我们如何改善对迅速扩大的ADRD患者群体的护理。

Each year thousands of Medicare beneficiaries routinely receive anti-seizure medication (ASM) for prophylaxis after a traumatic brain injury (TBI). These drugs are potentially life-saving given the severity of seizure sequelae, but also potentially life-threatening because of frequent, serious adverse events, e.g., falls. Older adults with Alzheimer’s Disease and Related Dementias (ADRD) are at higher risk for TBIs and post TBI complications. They are also more vulnerable to ASM adverse effects including cognitive slowing. Despite the known delicate balance between benefit and harm, there are no trial data to guide decisions about prophylaxis after a TBI among older adults, and particularly those with ADRD. The sparse and conflicted existing literature has been limited by the difficulty assessing relevant measures, e.g., TBI severity in large data sets. Medicare claims data offer potential, but lack well-validated definitions for TBI severity or treatment-related adverse effects. We will leverage multiple novel linked data sources: Traditional Medicare claims linked to a TBI registry and Electronic Health Records (EHR) of a large regional health system, and National Medicare linked to the Minimum Dataset (a national registry of post-acute institutionalized Medicare/Medicaid beneficiaries, 2009-2022). First, we will improve classification algorithms for TBI severity for use in common administrative databases. Then, we will assess a critical decision in the setting of moderate to severe TBI, particularly among those with ADRD: stopping prophylaxis within 7 days versus continuing. We will apply multiple state-of-the science analytical tools to address confounding and other challenges. We have three aims: 1) To improve classification algorithms for TBI severity for use in common administrative databases; 2) To examine the impact of the duration of ASM prophylaxis for post-TBI patients on 6-month event rates; and 3) To examine differences in treatment effects with preexisting ADRD status. This comparative effectiveness and safety study could inform future policy and clinical care and improve TBI and 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 the rapidly expanding population of patients with ADRD.