Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol
Authors Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine M, Ibanez I, Assemani N, Asmar R
Received 4 September 2013
Accepted for publication 9 November 2013
Published 16 January 2014 Volume 2014:10 Pages 33—44
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 10
Jirar Topouchian,1 Davide Agnoletti,1 Jacques Blacher,1 Ahmed Youssef,1 Mirna N Chahine,2,3 Isabel Ibanez,3 Nathalie Assemani,3 Roland Asmar1–3
1Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France; 2Faculty of Medicine of the Lebanese University, 3Foundation-Medical Research Institutes, Beirut, Lebanon
Background: Four oscillometric devices, including the Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670, designed for self-blood pressure measurement (SBPM) were evaluated according to the European Society of Hypertension (ESH) International Protocol Revision 2010 in four separate studies.
Methods: The four devices measure brachial blood pressure (BP) using the oscillometric method. The Withings BP-800 has to be connected to an Apple® iOS device such as an iPhone®, iPad®, or iPod®. The ESH International Protocol Revision 2010 includes a total number of 33 subjects. The difference between observer and device BP values was calculated for each measure. Ninety-nine pairs of BP differences were classified into three categories (≤5 mmHg, ≤10 mmHg, ≤15 mmHg). The protocol procedures were followed precisely in each of the four studies.
Results: All four tested devices passed the validation process. The mean differences between the device and mercury readings were: −1.8±5.1 mmHg and −0.4±2.8 mmHg for systolic and diastolic BP, respectively, using the Omron M6 Comfort device; 2.5±4.6 mmHg and −1.2±4.3 mmHg for the Omron HEM-7420 device; −0.2±5.0 mmHg and 0.4±4.2 mmHg for the Withings BP-800 device; and 3.0±5.3 mmHg and 0.3±5.2 mmHg for the Polygreen KP-7670 device.
Conclusion: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 readings differing by less than 5 mmHg, 10 mmHg, and 15 mmHg fulfill the ESH International Protocol Revision 2010 requirements, and therefore are suitable for use by patients for SBPM, if used correctly.
Keywords: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, Polygreen KP-7670, self-blood pressure measurement, validation, European Society of Hypertension International Protocol Revision
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