Healthcare Impact of Consumer-Driven Atrial Fibrillation Detection

项目总结/摘要 越来越多的公司将移动的技术作为FDA批准的医疗设备进行营销，但我们没有 了解这些设备对医疗保健利用率、成本和结果的影响。近日苹果 Apple Watch Series 4作为FDA批准的医疗设备发布。该设备包括针对 心房颤动（AF）的存在，并允许任何人监测他们的心律AF的存在。Apple 拥有庞大的全球受众，并且将使用此（和其他类似设备）的人数 自我诊断或监测AF将是实质性的。一方面，该设备可以允许新的诊断， 在治疗方面，提高了生活质量，减少了AF相关并发症。另一方面，该装置可能导致 在其他健康人群中出现假阳性，导致更多的测试和治疗，并产生相关危害。 事实上，美国预防性工作组建议在一般情况下不要对房颤进行常规监测。 人口，理由是缺乏证据和可能的伤害。我们迫切需要一个基于人口的 基础设施，以确保作为医疗器械进入市场的技术是有益和安全的。 该项目的总体目标是衡量Apple Watch 4发布的吸收和影响， 首次和已知AF患者的医疗保健利用率。Shah博士是一名早期研究人员， 获得NHLBI颁发的K08职业发展奖。作为K08的一部分，她开发了一个详细的队列， 当代AF患者，包括临床记录。沿着一个小组，她将使用真实的世界数据，正如提议的那样 由FDA进行，以生成关于消费者驱动的AF检测的风险和益处的证据。她会用 自然语言处理，以利用笔记并识别因医疗原因而寻求护理的AF患者 设备，并评估下游医疗保健利用率，如额外的诊所访视，心脏复律， 额外的远程监控和成本。本项目的目标将通过以下方式实现： 具体目的：1）估计在首次房颤患者访视之前，可归因于移动终端的比例 在Apple Watch 4获得FDA批准后，并表征设备准确性和下游医疗保健 该人群的医疗保健利用率;以及2）评价以下患者的普遍AF患者的医疗保健利用模式： 使用带有AF警报的移动的设备。 2017年，苹果在一个持续增长的设备市场上售出了1770万只智能手表。外推 从以前的年销售额来看，保守地假设用户每年增长5%，近6000万 到2020年底，人们将拥有Apple Watch（不包括具有类似功能的非Apple设备）。 功能）。因此，即使在这一短时间内，吸收也将是巨大的，需要立即采取行动 反馈该项目的结果将为长期多中心研究提供初步数据， 评估益处（改善生活质量，减少中风）和危害（增加治疗并发症， 增加成本）的消费者驱动的AF检测。

PROJECT SUMMARY/ABSTRACT Companies are increasingly marketing mobile technologies as FDA-cleared medical devices, yet we do not know the consequences of these devices on healthcare utilization, cost, and outcomes. Recently, Apple released the Apple Watch Series 4 as an FDA-cleared medical device. The device includes an alert for the presence of atrial fibrillation (AF) and allows anyone to monitor their heart rhythm for the presence of AF. Apple has an enormous global audience, and the number of people who will use this (and other similar devices) to self-diagnose or monitor AF will be substantial. On one hand, the device may allow new diagnoses that result in treatment, improved quality of life, fewer AF related complications. On the other hand, the device may result in false positives in otherwise healthy people, resulting in more testing and treatments with associated harms. In fact, the U.S. Preventative Task Force recommends against routine surveillance for AF in the general population, citing lack of evidence and possible harm. We have an urgent need for a population-based infrastructure to ensure that technologies entering the market as medical devices are beneficial and safe. The overall goal of this project is to measure the uptake and effect of the Apple Watch 4 release on healthcare utilization among first-time and known AF patients. Dr. Shah is an early stage investigator with a K08 Career Development Award from the NHLBI. As part of the K08, she has developed a detailed cohort of contemporary AF patients, including clinical notes. Along with a team, she will use real world data, as proposed by the FDA, to generate evidence about risks and benefits of consumer-driven AF detection. She will use natural language processing to leverage the notes and identify AF patients who seek care due to the medical device, and evaluate downstream healthcare utilization, such as additional clinic visits, cardioversions, additional remote monitoring, and cost. The goals of this project will be accomplished through the following Specific Aims: 1) Estimate the proportion of first-time AF patient visits attributable to a mobile device before and after FDA clearance of the Apple Watch 4, and characterize device accuracy and downstream healthcare utilization in this population; and 2) Evaluate healthcare utilization patterns among prevalent AF patients who use mobile devices with AF alerts. In 2017, Apple sold 17.7 million smart watches, in a device market that continues to grow. Extrapolating from prior annual sales and conservatively assuming a 5% increase in users each year, almost 60 million people will have an Apple Watch by the end of 2020 (not accounting for non-Apple devices with similar functionality). Thus, even in this short period of time, uptake will be substantial and warrant immediate feedback. The results of this project will provide preliminary data for a long-term, multicenter study that evaluates the benefits (improved quality of life, fewer strokes) and harms (increased treatment complications, increased cost) of consumer-driven AF detection.