Institute of Cardiology After Levon Hovhannisyan, Yerevan, Armenia.
Diagnosis and Therapeutic Center, Hôtel Dieu Hospital, Paris, France.
Vasc Health Risk Manag. 2023 Jul 3;19:391-398. doi: 10.2147/VHRM.S413195. eCollection 2023.
Most of the scientific societies recommend assessing the accuracy of electronic devices for blood pressure (BP) measurements using established validation protocol.
To determine the accuracy of the BP measurements using the Withings BPM Core device in the general population according to the "Universal Standard (ISO 81060-2:2018/AMD 1:2020)".
The Withings BPM Core is an oscillometric device measuring BP at the brachial level. The study was performed according to the "Universal Standard (ISO 81060-2:2018/AMD 1:2020) protocol" using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were included. Analysis was performed as required by the Universal protocol using Criterion 1 - differences between observers' mercury sphygmomanometer reference measurements and test device BP values (test versus reference) and their standard deviation (SD); and Criterion 2 - The SD of the mean BP differences between the test device and reference BP per subject.
Eighty-six subjects were selected, 85 of whom were included. The mean BP differences between the simultaneous two observers' measurements were -0.2 ± 2.1 mmHg for systolic BP (SBP) and 0.3 ± 2.1 mmHg for diastolic BP (DBP). For validation criterion 1, the mean difference ± SD between the reference and device BP values was -0.6 ± 4.8 mmHg for SBP and 0.1 ± 3.7 mmHg for DBP (≤5 ± 8 mmHg for both SBP and DBP). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 3.2/2.6 mmHg for SBP and DBP (≤6.91/6.95 mmHg).
The results of this study showed that the Withings BPM Core oscillometric device for home BP measurement fulfilled the accuracy requirements of the (ISO 81060-2:2018/AMD 1:2020) Universal protocol in the general population.
大多数科学协会建议使用既定的验证方案来评估电子血压（BP）测量设备的准确性。
根据“通用标准（ISO 81060-2:2018/AMD 1:2020）”，确定 Withings BPM Core 设备在普通人群中的血压测量准确性。
Withings BPM Core 是一种测量肱动脉水平血压的示波法设备。该研究根据“通用标准（ISO 81060-2:2018/AMD 1:2020 协议）”进行，使用相同手臂顺序血压测量方法。符合协议中年龄、性别、血压和袖带分布标准的受试者（n≥85）被纳入研究。使用通用协议要求的标准进行分析，包括标准 1-观察者汞柱血压计参考测量值和测试设备血压值（测试与参考）之间的差值及其标准差（SD）；和标准 2-每个受试者测试设备与参考血压之间平均血压差值的 SD。
选择了 86 名受试者，其中 85 名被纳入。两名观察者同时测量的血压差值平均值为收缩压（SBP）-0.2±2.1mmHg，舒张压（DBP）0.3±2.1mmHg。对于验证标准 1，参考值和设备值之间的平均差值±SD 为 SBP-0.6±4.8mmHg，DBP0.1±3.7mmHg（SBP 和 DBP 均为≤5±8mmHg）。对于标准 2，每个受试者测试设备与参考血压之间平均血压差值的 SD 为 SBP 和 DBP 的 3.2/2.6mmHg（SBP 和 DBP 均为≤6.91/6.95mmHg）。
本研究结果表明，Withings BPM Core 家庭血压测量示波法设备在普通人群中符合（ISO 81060-2:2018/AMD 1:2020）通用标准的准确性要求。
