Reproducibility of the European Society of Hypertension - International Protocol for validation of blood pressure measuring devices in obese patients

Abstract

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.