Lee Wan Ling, Danaee Mahmoud, Abdullah Adina, Wong Li Ping
Department of Nursing Science, Faculty of Medicine, Universiti Malaya, 50603 Kuala Lumpur, Malaysia.
Department of Social and Preventive Medicine, Faculty of Medicine, Universiti Malaya, 50603 Kuala Lumpur, Malaysia.
Cardiol Res. 2023 Dec;14(6):437-445. doi: 10.14740/cr1569. Epub 2023 Dec 9.
The popular wrist-worn wearables recording a variety of health metrics such as blood pressure (BP) in real time could play a potential role to advance precision medicine, but these devices are often insufficiently validated for their performance to enhance confidence in its use across diverse populations. The accuracy of BP-enabled smartwatch is assessed among the multi-ethnic Malaysians, and findings is discussed in comparison with conventional automated upper-arm BP device.
Validation procedures followed the guidelines by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Quota sampling was employed to obtain eligible patients with normal and abnormal BP as per guideline. The measurements of BP were taken at wrist using HUAWEI WATCH D (test BP); and the readings were assessed against reference BP by the mercury sphygmomanometer. Agreement statistics and linear regression analyses were performed.
BP measurements (234 data pairs) from 78 patients that fulfilled AAMI/ESH/ISO protocol were analyzed. The BP readings taken by the HUAWEI WATCH D were comparable to reference BP by sphygmomanometer based on 1) Criterion 1: systolic blood pressure (SBP) = -0.034 (SD 5.24) and diastolic blood pressure (DBP) = -0.65 (SD 4.66) mm Hg; and 2) Criterion 2: SBPs = -0.034 (SD 4.18) and DBPs = -0.65 (SD 3.94) mm Hg. Factors of sociodemographic characteristics, anthropometric measurements, cardiovascular comorbidities, and wrist hair density were not significantly associated with the mean BP differences.
HUAWEI WATCH D fulfilled criteria 1 and 2 of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) guidelines. It can be recommended for clinical use across a wider population. The rich data from real-time BP measurements in concurrent with other health-related parameters recorded by the smartwatch wearable offer opportunities to drive precision medicine in tackling therapeutic inertia by personalizing BP control regimen.
流行的腕戴式可穿戴设备能够实时记录多种健康指标,如血压(BP),这可能对推进精准医学发挥潜在作用,但这些设备的性能往往未得到充分验证,难以增强人们对其在不同人群中使用的信心。在多民族马来西亚人群中评估了具备血压测量功能的智能手表的准确性,并与传统的自动上臂血压测量设备进行比较,讨论了研究结果。
验证程序遵循美国医疗仪器促进协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准(ISO 81060-2:2018)的指南。采用配额抽样方法,按照指南获取血压正常和异常的合格患者。使用华为手表D(测试血压)在手腕处测量血压;并通过汞柱式血压计将读数与参考血压进行评估。进行了一致性统计和线性回归分析。
分析了78例符合AAMI/ESH/ISO方案的患者的血压测量值(234对数据)。基于以下两点,华为手表D测得的血压读数与血压计的参考血压相当:1)标准1:收缩压(SBP)=-0.034(标准差5.24),舒张压(DBP)=-0.65(标准差4.66)毫米汞柱;2)标准2:收缩压(SBP)=-0.034(标准差4.18),舒张压(DBP)=-0.65(标准差3.94)毫米汞柱。社会人口统计学特征、人体测量学指标、心血管合并症和腕部毛发密度等因素与平均血压差异无显著关联。
华为手表D符合AAMI/ESH/ISO通用标准(ISO 81060-2:2018)指南的标准1和标准2。可推荐在更广泛人群中临床使用。智能手表可穿戴设备同时记录的实时血压测量丰富数据,以及其他与健康相关的参数,为通过个性化血压控制方案推动精准医学解决治疗惰性提供了机会。