Background: Outside of a clinical setting, oscillometric devices make remote monitoring of blood pressure and virtual care more convenient and feasible. HeartBeat Technologies Ltd developed a novel approach to measuring blood pressure remotely after an initial blood pressure reading by a nurse using the conventional measurement method. Using a finger pulse oximeter, a photoplethysmogram wave is transmitted by Bluetooth to a smartphone or tablet. A smartphone app (MediBeat) transmits the photoplethysmogram to a server for analysis by a proprietary algorithm—the person’s current blood pressure is sent back to the smartphone and to the individual’s health care provider. Objective: This study sought to determine whether the HeartBeat algorithm calculates blood pressure as accurately as required by the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) for validation of blood pressure measuring devices. Methods: ESH-IP2 requirements, modified to conform to a more recent international consensus statement, were followed. The ESH-IP2 establishes strict guidelines for the conduct and reporting of any validation of any device to measure blood pressure, including using the standard manual blood pressure instrument as a comparator and specific required accuracy levels for low, medium, and high ranges of blood pressure readings. The consensus statement requires a greater number of study participants for each of the blood pressure ranges. The validation of the accuracy of the algorithm was conducted with a Contec CMS50EW pulse oximeter and a Samsung Galaxy XCover 4 smartphone. Results: The differences between the HeartBeat-calculated and the manually measured blood pressures of 62 study participants did not meet the ESH-IP2 standards for accuracy for either systolic or diastolic blood pressure measurements. There was no discernible pattern in the inaccuracies of the HeartBeat-calculated measurements. Conclusions: The October 4, 2019 version of the HeartBeat algorithm, implemented in combination with the MediBeat app, a pulse oximeter, and an Android smartphone, was not sufficiently accurate for use in a general adult population. Trial Registration: ClinicalTrials.gov NCT04082819; http://clinicaltrials.gov/ct2/show/NCT04082819

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中文翻译：

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基于 Web 的智能手机算法，用于在一般成人人群中通过光电体积描记术远程计算血压：验证研究

背景：在临床环境之外，示波设备使远程监测血压和虚拟护理更加方便和可行。HeartBeat Technologies Ltd 开发了一种新方法，可在护士使用传统测量方法读取初始血压后远程测量血压。使用手指脉搏血氧仪，光电容积脉搏波通过蓝牙传输到智能手机或平板电脑。智能手机应用程序 (MediBeat) 将光电容积脉搏波传输到服务器，以通过专有算法进行分析——人的当前血压被发送回智能手机和个人的医疗保健提供者。客观的：本研究旨在确定 HeartBeat 算法计算血压的准确性是否符合欧洲高血压学会国际协议 2010 版 (ESH-IP2) 对血压测量设备验证的要求。方法：遵循 ESH-IP2 要求，修改以符合最近的国际共识声明。ESH-IP2 为测量血压的任何设备的任何验证的实施和报告制定了严格的指导方针，包括使用标准手动血压仪器作为比较器以及低、中和高血压范围的特定要求的准确度水平读数。共识声明要求每个血压范围有更多的研究参与者。使用 Contec CMS50EW 脉搏血氧仪和三星 Galaxy XCover 4 智能手机验证算法的准确性。结果：62 名研究参与者的 HeartBeat 计算血压和手动测量血压之间的差异不符合 ESH-IP2 收缩压或舒张压测量准确性的标准。在 HeartBeat 计算的测量值的不准确性中没有明显的模式。结论：2019 年 10 月 4 日版本的 HeartBeat 算法与 MediBeat 应用程序、脉搏血氧计和 Android 智能手机结合实施，对于一般成年人群的使用不够准确。试验注册：ClinicalTrials.gov NCT04082819；http://clinicaltrials.gov/ct2/show/NCT04082819 62 名研究参与者的 HeartBeat 计算血压和手动测量血压之间的差异不符合 ESH-IP2 收缩压或舒张压测量准确性的标准。在 HeartBeat 计算的测量值的不准确性中没有明显的模式。结论：2019 年 10 月 4 日版本的 HeartBeat 算法与 MediBeat 应用程序、脉搏血氧计和 Android 智能手机结合实施，对于一般成年人群的使用不够准确。试验注册：ClinicalTrials.gov NCT04082819；http://clinicaltrials.gov/ct2/show/NCT04082819 62 名研究参与者的 HeartBeat 计算血压和手动测量血压之间的差异不符合 ESH-IP2 收缩压或舒张压测量准确性的标准。在 HeartBeat 计算的测量值的不准确性中没有明显的模式。结论：2019 年 10 月 4 日版本的 HeartBeat 算法与 MediBeat 应用程序、脉搏血氧计和 Android 智能手机结合实施，对于一般成年人群的使用不够准确。试验注册：ClinicalTrials.gov NCT04082819；http://clinicaltrials.gov/ct2/show/NCT04082819 在 HeartBeat 计算的测量值的不准确性中没有明显的模式。结论：2019 年 10 月 4 日版本的 HeartBeat 算法与 MediBeat 应用程序、脉搏血氧计和 Android 智能手机结合实施，对于一般成年人群的使用不够准确。试验注册：ClinicalTrials.gov NCT04082819；http://clinicaltrials.gov/ct2/show/NCT04082819 在 HeartBeat 计算的测量值的不准确性中没有明显的模式。结论：2019 年 10 月 4 日版本的 HeartBeat 算法与 MediBeat 应用程序、脉搏血氧计和 Android 智能手机结合实施，对于一般成年人群的使用不够准确。试验注册：ClinicalTrials.gov NCT04082819；http://clinicaltrials.gov/ct2/show/NCT04082819

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