Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP)

Mirna N Chahine; Jirar Topouchian; Parounak Zelveian; Zoya Hakobyan; Arevik Melkonyan; Alaa Azaki; Reem Diab; Aya Harb; Roland Asmar

doi:10.2147/MDER.S142126

Validation of BP devices QardioArm^® in the general population and Omron M6 Comfort^® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP)

Med Devices (Auckl). 2017 Dec 27:11:11-20. doi: 10.2147/MDER.S142126. eCollection 2018.

Authors

Mirna N Chahine^{1

2}, Jirar Topouchian^{3

4}, Parounak Zelveian³, Zoya Hakobyan³, Arevik Melkonyan³, Alaa Azaki¹, Reem Diab¹, Aya Harb¹, Roland Asmar^{1

2}

Affiliations

¹ Faculty of Medical Sciences, Lebanese University, Hadath, Lebanon.
² Foundation-Medical Research Institutes (F-MRI), Beirut, Lebanon.
³ Preventive Cardiology Center, Yerevan, Armenia.
⁴ Diagnostic Center, Hotel-Dieu Hospital, Paris, France.

Abstract

Background: Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm^® and Omron M6 Comfort IT^® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement.

Methods: Both devices, QardioArm^® and Omron M6 Comfort^®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated. In all, 99 pairs of BP differences are classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely.

Results: QardioArm^® and Omron M6 Comfort^® fulfilled the requirements of the ESH-IP and passed the validation process successfully. For QardioArm^®, a total of 69 out of 99 comparisons for systolic blood pressure (SBP) showed an absolute difference within 5 mmHg and 82 out of 99 for diastolic blood pressure (DBP). As for Omron M6 Comfort^®, a total of 83 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 77 out of 99 for DBP. The mean differences between the device and mercury readings were 0.7±5.9 mmHg for SBP and 0.3±4.1 mmHg for DBP for QardioArm^® and -1.4±4.7 mmHg for SBP and -2.1±4.3 mmHg for DBP for Omron M6 Comfort^®. With regard to part 2 of ESH-IP 2010, 27 out of 33 subjects had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 subjects for DBP for the QardioArm^®, and 29 out of 33 patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 26 out of 33 patients for DBP for Omron M6 Comfort^®.

Conclusion: QardioArm^® and Omron M6 Comfort^® readings differing from the mercury standard by <5, 10, and 15 mmHg fulfill the ESH-IP Revision 2010 requirements. Consequently, these two devices are suitable for use in the general population and non-insulin-dependent type II diabetic patients, respectively.

Keywords: International Protocol; Omron M6 Comfort®; QardioArm®; blood pressure measurement; type II diabetes; validation.