Healthcare Impact of Consumer-Driven Atrial Fibrillation Detection

消费者驱动的心房颤动检测对医疗保健的影响

• 批准号: 9980996
• 负责人: Rashmee U. Shah
• 金额: $ 7.63万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980996
• 关键词: Adult; Advisory Committees; Affect; Apple; Apple watch; Arrhythmia; Atrial Fibrillation; Benefits and Risks; Cardiovascular system; Caring; Case-Control Studies; Clinic Visits; Clinical; Data; Detection; Devices; Diagnosis; Diagnostic; Electric Countershock; Ensure; Feedback; General Population; Goals; Health; Healthcare; Healthcare Systems; Hemorrhage; Holter Electrocardiography; Infrastructure; Interruption; Intervention; K-Series Research Career Programs; Lead; Marketing; Measures; Medical Device; Monitor; Multicenter Studies; National Heart, Lung, and Blood Institute; Natural Language Processing; Natural Language Processing pipeline; Outcome; Patients; Pattern; Population; Prevalence; Preventive; Quality of life; Reporting; Research; Research Personnel; Risk; Sales; Series; Sinus; Stroke; Technology; Testing; Text; Time; United States Food and Drug Administration; Universities; Utah; Visit; base; care seeking; cohort; cost; cost outcomes; cryptogenic stroke; design; follow-up; handheld mobile device; health care service utilization; heart rhythm; improved; mobile computing; population based; routine screening; self diagnosis; smart watch; uptake

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.

项目摘要/摘要 公司越来越多地将移动技术作为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。最近，苹果公司 发布了Apple Watch Series 4，作为FDA批准的医疗设备。该设备包括一个警报 房颤(房颤)的存在，并允许任何人监测他们的心率，以发现房颤的存在。苹果 拥有庞大的全球受众，以及使用该设备(和其他类似设备)的人数 自我诊断或监测房颤将是实质性的。一方面，该设备可能会允许新的诊断结果 在治疗过程中，生活质量得到改善，房颤相关并发症减少。另一方面，该设备可能导致 在其他健康的人中出现假阳性，导致更多的检测和治疗以及相关的危害。 事实上，美国预防工作组建议不要对房颤进行常规监测 人口，理由是缺乏证据和可能的危害。我们迫切需要一个以人口为基础的 基础设施，以确保作为医疗设备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在以下方面的应用和影响 首次和已知房颤患者的医疗保健利用情况。沙阿博士是一名早期研究员，有一项 NHLBI颁发的K08职业发展奖。作为K08的一部分，她制定了一系列详细的 当代房颤患者，包括临床记录。与一个团队一起，她将按照建议使用真实世界的数据 由FDA，以产生关于消费者驱动的房颤检测的风险和好处的证据。她会用 自然语言处理以利用笔记并识别因医疗原因寻求治疗的房颤患者 设备，并评估下游医疗保健利用率，例如额外的诊所就诊、心脏复律、 额外的远程监控和成本。该项目的目标将通过以下方式实现 具体目标：1)估计房颤患者首次就诊时使用移动设备的比例 以及在FDA批准Apple Watch 4之后，并表征设备的准确性和下游医疗保健 在这一人群中的利用情况；以及2)评估流行的房颤患者的医疗利用模式 使用带有房颤警报的移动设备。 2017年，苹果在一个持续增长的设备市场售出了1770万只智能手表。外推 根据之前的年销售额和保守的假设，用户每年增长5%，几乎达到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，即使在这很短的时间内，吸收也将是巨大的，需要立即进行。 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， 成本增加)消费者驱动的房颤检测。