Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial
Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial
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DOI：
10.1016/j.ahj.2019.06.011
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发表时间：
2019-09-01
影响因子：
4.8
通讯作者：
Lubitz, Steven A.
中科院分区：
文献类型：
--
作者：
Ashburner, Jeffrey M.;Atlas, Steven J.;Lubitz, Steven A.
鉴于与房颤相关的可预防的发病率和死亡率、对未确诊房颤的认识的提高以及移动心电技术的进步，迫切需要评估在临床实践中使用这种技术常规筛查房颤的有效性。VITAL-AF是一项务实的试验，它将测试在初级保健就诊期间对65岁或65岁以上的人使用单导联手持心电进行房颤筛查是否会提高房颤的发现率。这项研究是一项整群随机试验，将8项初级保健实践随机纳入房颤筛查，将8项初级保健实践随机纳入常规护理。我们预计在每一支手臂上研究大约16,000名患者。在为期一年的注册期间，执业医疗助理将使用单导联心电设备筛选同意在办公室就诊期间参与的合格患者。自动筛查结果记录在电子健康记录中，患者可以在预定的访问期间与提供者讨论筛查结果。所有单导联心电信号都会被心脏病专家过度解读。筛查到的房颤由患者的医生自行处理。主要研究终点是筛查期间发生的房颤。关键的次要结果包括新的口服抗凝处方，发生的缺血性中风，以及研究开始后24个月内的大出血。结果是根据电子健康记录文件确定的，并由人工作出裁决。这项务实试验的结果可能有助于确定将房颤筛查作为常规临床实践的一部分广泛采用的模式。
Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice.