Thomas Majda, PharmD, MS, 2104 Connor Way, Lake Saint Louis, MO 63367, P: 314-917-5791, E:
J Prev Alzheimers Dis. 2024;11(5):1251-1259. doi: 10.14283/jpad.2024.115.
Linking data from clinical trials and real-world claims may improve the robustness of trial data and provide information on the health, economic, and societal impacts of a disease.
To report on the feasibility of linking trial data to Medicare claims data in early symptomatic Alzheimer's disease (AD) in the US.
Alzheimer's Disease Linkage to Real-World Evidence (AD-LINE) was a noninterventional cohort study that included participants recruited from the GRADUATE program whose trial data were linked to their Medicare claims.
AD-LINE participants were 66 years and older with early symptomatic AD (ie, mild cognitive impairment [MCI] due to AD or mild AD dementia) and were enrolled in the GRADUATE program and a Medicare fee-for-service or Medicare Advantage plan.
The Centers for Medicare and Medicaid Services linked participants' clinical trial identifiers to their Medicare beneficiary identifiers using a deterministic, exact matching process. Demographics and clinical characteristics of the AD-LINE cohort at baseline were collected. Outcomes measured in this study included healthcare resource utilization derived from Medicare claims data.
In total, 147 participants across 21 US sites were invited to participate and 111 provided informed consent. Of those, 61 patients had linkable data (ie, Medicare beneficiary identifier), Medicare Parts A/B enrollment, and no health maintenance organization (HMO) enrollment in the year before trial entry. Of the 61 participants whose data were analyzed in this study, 30 had MCI due to AD and 31 had mild AD dementia. Participants in the MCI due to AD group had more healthcare resource utilization on average in the baseline period than those in the mild AD dementia group (29.9 [SD, 20.9] vs 24.5 claims [SD, 12.3]). In an ad hoc analysis, a relatively high concordance (85.3%) was seen between the rates of clinically confirmed AD diagnosis and evidence of AD diagnosis in claims data.
This linkage process may serve as a proof of concept for researchers interested in linking clinical trial and real-world claims data. The lessons learned from AD-LINE and innovation of data linkage approaches may encourage key stakeholders to link data in the future.
将临床试验数据与真实世界的理赔数据进行关联，可能会提高试验数据的稳健性，并提供有关疾病健康、经济和社会影响的信息。
报告在美国早期症状性阿尔茨海默病（AD）中将试验数据与医疗保险理赔数据进行关联的可行性。
AD 与真实世界证据的关联（AD-LINE）是一项非干预性队列研究，其中包含了从 GRADUATE 项目招募的参与者，他们的试验数据与他们的医疗保险理赔数据相关联。
AD-LINE 参与者年龄在 66 岁及以上，患有早期症状性 AD（即 AD 引起的轻度认知障碍[MCI]或轻度 AD 痴呆），并参加了 GRADUATE 项目和医疗保险按服务付费或医疗保险优势计划。
医疗保险和医疗补助服务中心使用确定性、精确匹配过程，将参与者的临床试验标识符与他们的医疗保险受益人标识符进行关联。收集了 AD-LINE 队列在基线时的人口统计学和临床特征。本研究中测量的结果包括来自医疗保险理赔数据的医疗资源利用情况。
共有 21 个美国站点的 147 名参与者受邀参加，111 名参与者表示同意。其中，61 名患者具有可关联的数据（即医疗保险受益人标识符）、医疗保险 A/B 部分的参保情况，并且在进入试验前一年没有健康维护组织（HMO）的参保情况。在这项研究中，对 61 名参与者的数据进行了分析，其中 30 名患有 AD 引起的 MCI，31 名患有轻度 AD 痴呆。在基线期，患有 AD 引起的 MCI 的参与者的医疗资源利用率平均高于患有轻度 AD 痴呆的参与者（29.9[SD，20.9]与 24.5 项理赔[SD，12.3]）。在一项特别分析中，在理赔数据中，临床上确诊的 AD 诊断率和 AD 诊断证据之间的一致性相对较高（85.3%）。
该关联过程可能为有兴趣将临床试验和真实世界理赔数据进行关联的研究人员提供概念验证。AD-LINE 中吸取的经验教训和数据关联方法的创新可能会鼓励关键利益相关者在未来进行数据关联。
