Islam Sheikh Mohammed Shariful, Chow Clara K, Daryabeygikhotbehsara Reza, Subedi Narayan, Rawstorn Jonathan, Tegegne Teketo, Karmakar Chandan, Siddiqui Muhammad U, Lambert Gavin, Maddison Ralph
Institute for Physical Activity and Nutrition, Deakin University, Melbourne, Australia.
Westmead Applied Research Centre, University of Sydney, Sydney, Australia.
Eur Heart J Digit Health. 2022 May 2;3(2):323-337. doi: 10.1093/ehjdh/ztac021. eCollection 2022 Jun.
High blood pressure (BP) is the commonest modifiable cardiovascular risk factor, yet its monitoring remains problematic. Wearable cuffless BP devices offer potential solutions; however, little is known about their validity and utility. We aimed to systematically review the validity, features and clinical use of wearable cuffless BP devices.
We searched MEDLINE, Embase, IEEE Xplore and the Cochrane Database till December 2019 for studies that reported validating cuffless BP devices. We extracted information about study characteristics, device features, validation processes, and clinical applications. Devices were classified according to their functions and features. We defined devices with a mean systolic BP (SBP) and diastolic BP (DBP) biases of <5 mmHg as valid as a consensus. Our definition of validity did not include assessment of device measurement precision, which is assessed by standard deviation of the mean difference-a critical component of ISO protocol validation criteria. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 tool. A random-effects model meta-analysis was performed to summarise the mean biases for SBP and DBP across studies. Of the 430 studies identified, 16 studies (15 devices, 974 participants) were selected. The majority of devices (81.3%) used photoplethysmography to estimate BP against a reference device; other technologies included tonometry, auscultation and electrocardiogram. In addition to BP and heart rate, some devices also measured night-time BP ( = 5), sleep monitoring ( = 3), oxygen saturation ( = 3), temperature ( = 2) and electrocardiogram ( = 3). Eight devices showed mean biases of <5 mmHg for SBP and DBP compared with a reference device and three devices were commercially available. The meta-analysis showed no statistically significant differences between the wearable and reference devices for SBP (pooled mean difference = 3.42 mmHg, 95% CI: -2.17, 9.01, I 95.4%) and DBP (pooled mean = 1.16 mmHg, 95% CI: -1.26, 3.58, I 87.1%).
Several cuffless BP devices are currently available using different technologies, offering the potential for continuous BP monitoring. The variation in standards and validation protocols limited the comparability of findings across studies and the identification of the most accurate device. Challenges such as validation using standard protocols and in real-life settings must be overcome before they can be recommended for uptake into clinical practice.
高血压是最常见的可改变的心血管危险因素，但其监测仍存在问题。可穿戴式无袖血压设备提供了潜在的解决方案；然而，人们对其有效性和实用性知之甚少。我们旨在系统评价可穿戴式无袖血压设备的有效性、特点及临床应用。
我们检索了MEDLINE、Embase、IEEE Xplore和Cochrane数据库至2019年12月，以查找报告验证无袖血压设备的研究。我们提取了有关研究特征、设备特点、验证过程及临床应用的信息。根据设备的功能和特点进行分类。我们将平均收缩压（SBP）和舒张压（DBP）偏差<5 mmHg的设备定义为具有一致性的有效设备。我们对有效性的定义不包括设备测量精度的评估，测量精度由平均差值的标准差评估——这是ISO协议验证标准的关键组成部分。使用诊断准确性研究质量评估第2版工具评估研究质量。进行随机效应模型荟萃分析以总结各研究中SBP和DBP的平均偏差。在检索到的430项研究中，选择了16项研究（15种设备，974名参与者）。大多数设备（81.3%）使用光电容积脉搏波描记法对照参考设备估计血压；其他技术包括眼压测量法、听诊法和心电图。除血压和心率外，一些设备还测量夜间血压（n = 5）、睡眠监测（n = 3）、血氧饱和度（n = 3）、体温（n = 2）和心电图（n = 3）。与参考设备相比，8种设备的SBP和DBP平均偏差<5 mmHg，3种设备已上市。荟萃分析显示，可穿戴设备和参考设备在SBP（合并平均差值 = 3.42 mmHg，95% CI：-2.17，9.01，I² = 95.4%）和DBP（合并平均值 = 1.16 mmHg，95% CI：-1.26，3.58，I² = 87.1%）方面无统计学显著差异。
目前有几种采用不同技术的无袖血压设备，具有连续血压监测的潜力。标准和验证方案的差异限制了各研究结果的可比性以及最准确设备的识别。在推荐其应用于临床实践之前，必须克服诸如使用标准方案和在现实生活环境中进行验证等挑战。
