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)

Abstract

BackgroundFollowing 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.MethodsBoth 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.

The QardioArm Blood Pressure App for Self-Measurement in an Obese Population: Validation Study Using the European Society of Hypertension International Protocol Revision 2010

“…To the best of our knowledge, this was the first study providing information regarding the accuracy of the QardioArm app for measuring BP and HR in an obese population. This device had previously been validated in the general population by our team [ 45 ] and by others [ 46 ].…”

“…Nevertheless, it presents some limitations. First, the ESH-IP2 did not specify the number of validation studies that are needed to validate the instrument despite some findings reporting that a device should be validated in no fewer than 2 different centers separately [ 41 , 45 , 46 , 48 ]. Therefore, it is important to check the validity of BP measuring devices in specific populations as an add-on step to the validation process before widespread application in clinics or homes.…”

“…A few studies [ 42 - 44 ] demonstrated the accuracy of automatic BP monitors in specific populations such as obese patients, and none validated a mobile app that measures BP following the ESH protocol in this population. In 2017, QardioArm was validated in the general [ 45 , 46 ] and diabetic populations [ 46 ].…”

Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation

“…Regarding the validation protocols, the presence of several protocols for this function [ 16 - 19 ] is problematic for several reasons. Manufacturers cannot perform the 3 protocols and experts focus on their own protocols (eg, the AAMI is followed more in the United States and the ESH is followed in Europe), and it is impossible to compare several validation studies that are governed by different principles [ 23 ].…”

<p>Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)</p>

“…2 Many population-based survey protocols use automatic digital devices for measuring BP since they require no strict training and have no observer error. [3][4][5][6] Medical device agencies, challenged with recommending suitable BP monitors as a replacement for mercury sphygmomanometers, are progressively relying on results of technology assessments in the form of clinical validations against published US, European or British protocols. [7][8][9] Validation compared to these protocols provides evidence of the degree of agreement between clinical readings from the mercury sphygmomanometer that extensively used as the gold standard for blood pressure measurement and those on the automated devices.…”