Cardiovascular Research Center, Dedinje Cardiovascular Institute, Belgrade, Serbia.
Diagnosis & Therapeutic Center, Hôtel Dieu Hospital, Paris, France.
J Hypertens. 2019 Sep;37(9):1832-1837. doi: 10.1097/HJH.0000000000002106.
Electronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and special populations. Reproducibility of such validation protocols is unknown.
The aim of this study was to assess the inter-centre reproducibility of the European Society of Hypertension-International protocol (ESH-IP) in patients with large arm circumference at least 32 cm or obesity.
Two independent validation studies were performed in parallel according to the ESH-IP protocol in two centres (Serbia and Armenia). The two studies were performed blindly and independently. The ESH-IP criteria were applied for the analysis. The OMRON RS7 wrist oscillometric devices were used in both studies.
The distribution of the mean differences values of 5 or less, 10 or less and 15 mmHg or less between the observers and the device were for the Serbia team: 74, 95 and 98 for SBP and 78, 95 and 99 for DBP; and for the Armenia team: 86, 95 and 99 for SBP and 90, 99 and 99 for DBP. The mean differences (SD) of BP values between the observers and the device were for the Serbia team of 1.7 ± 4.8 mmHg for SBP and 1.2 ± 4.6 mmHg for DBP and for the Armenia team of -1.1 ± 4.2 mmHg for SBP and -0.3 ± 3.5 mmHg for DBP.
This study showed that the ESH-IP validation protocol presents a good inter-centre reproducibility. The OMRON RS7 device showed similar results, fulfilling the validation criteria in two independent studies in patients with arm circumference at least 32 cm.
电子血压计（BP）需要按照不同机构的建议进行独立的临床验证，包括一般人群和特殊人群。目前尚不清楚此类验证方案的重复性。
本研究旨在评估欧洲高血压学会-国际方案（ESH-IP）在臂围至少 32cm 或肥胖患者中的中心间可重复性。
根据 ESH-IP 方案，在两个中心（塞尔维亚和亚美尼亚）同时进行了两项独立的验证研究。这两项研究均为盲法、独立进行。采用 ESH-IP 标准进行分析。两项研究均使用 OMRON RS7 腕式振荡血压计。
观察者与设备之间差值为 5mmHg 或以下、10mmHg 或以下和 15mmHg 或以下的平均值差异分布为：塞尔维亚组的收缩压分别为 74、95 和 98，舒张压分别为 78、95 和 99；亚美尼亚组的收缩压分别为 86、95 和 99，舒张压分别为 90、99 和 99。观察者与设备之间血压值的平均差值（SD）为：塞尔维亚组的收缩压为 1.7±4.8mmHg，舒张压为 1.2±4.6mmHg；亚美尼亚组的收缩压为-1.1±4.2mmHg，舒张压为-0.3±3.5mmHg。
本研究表明，ESH-IP 验证方案具有良好的中心间可重复性。OMRON RS7 设备在至少 32cm 臂围的患者中进行的两项独立研究中均满足验证标准，结果相似。
