Auralife Instant Blood Pressure App in Measuring Resting Heart Rate: Validation Study

T. Plante, Anna C. O'Kelly, Bruno Urrea, Zane T. Macfarlane, L. Appel, Edgar R Miller III, R. Blumenthal, S. Martin
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引用次数: 1

Abstract

Background: mHealth apps that measure heart rate using pulse photoplethysmography (PPG) are classified as class II (moderate-risk) Food and Drug Administration devices; therefore, these devices need clinical validation prior to public release. The Auralife Instant Blood Pressure app (AuraLife IBP app) is an mHealth app that measures blood pressure inaccurately based on a previous validation study. Its ability to measure heart rate has not been previously reported. Objective: The objective of our study was to assess the accuracy and precision of the AuraLife IBP app in measuring heart rate. Methods: We enrolled 85 adults from ambulatory clinics. Two measurements were obtained using the AuraLife IBP app, and 2 other measurements were achieved with a oscillometric device. The order of devices was randomized. Accuracy was assessed by calculating the relative and absolute mean differences between heart rate measurements obtained using each AuraLife IBP app and an average of both standard heart rate measurements. Precision was assessed by calculating the relative and absolute mean differences between individual measurements in the pair for each device. Results: The relative and absolute mean (SD) differences between the devices were 1.1 (3.5) and 2.8 (2.4) beats per minute (BPM), respectively. Meanwhile, the within-device relative and absolute mean differences, respectively, were <0.1 (2.2) and 1.7 (1.4) BPM for the standard device and −0.1 (3.2) and 2.2 (2.3) BPM for the AuraLife IBP app. Conclusions: The AuraLife IBP app had a high degree of accuracy and precision in the measurement of heart rate. This supports the use of PPG technology in smartphones for monitoring resting heart rate. (JMIR Biomed Eng 2018;3(1):e11057) doi: 10.2196/11057
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测量静息心率的Auralife即时血压应用程序:验证研究
背景:使用脉冲光电体积描记术(PPG)测量心率的mHealth应用程序被归类为II类(中等风险)食品和药物管理局设备;因此,这些设备在公开发布之前需要进行临床验证。Auralife即时血压应用程序(Auralife IBP应用程序)是一款mHealth应用程序,它根据之前的验证研究不准确地测量血压。它测量心率的能力以前没有报道过。目的:我们研究的目的是评估AuraLife IBP应用程序在测量心率方面的准确性和精密度。方法:我们从门诊诊所招募了85名成年人。使用AuraLife IBP应用程序进行了两次测量,另外两次测量使用示波设备进行。器械的顺序是随机的。通过计算使用每个AuraLife IBP应用程序获得的心率测量值与两个标准心率测量值的平均值之间的相对和绝对平均差来评估准确性。通过计算每种设备的成对个体测量之间的相对和绝对平均差来评估精度。结果:两种设备之间的相对平均值和绝对平均值差异分别为1.1(3.5)和2.8(2.4)次/分(BPM)。同时,标准设备的设备内相对平均差和绝对平均差分别<0.1(2.2)和1.7(1.4)BPM,AuraLife IBP应用程序的设备内平均差分别为-0.1(3.2)和2.2(2.3)BPM。结论:AuraLife IBP应用程序在心率测量方面具有较高的准确性和精密度。这支持在智能手机中使用PPG技术来监测静息心率。(JMIR Biomed Eng 2018;3(1):e11057)doi:10.196/11057
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