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.
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.


CONCLUSIONS
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.
Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France.
Jirar
J
Topouchian
Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France.
Davide
D
Agnoletti
Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France.
Jacques
J
Blacher
Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France.
Ahmed
A
Youssef
Faculty of Medicine of the Lebanese University, Beirut, Lebanon ; Foundation-Medical Research Institutes, Beirut, Lebanon.
Mirna N
MN
Chahine
Foundation-Medical Research Institutes, Beirut, Lebanon.
Isabel
I
Ibanez
Foundation-Medical Research Institutes, Beirut, Lebanon.
Nathalie
N
Assemani
Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France ; Faculty of Medicine of the Lebanese University, Beirut, Lebanon ; Foundation-Medical Research Institutes, Beirut, Lebanon.
Roland
R
Asmar
D000328:Adult; D000368:Aged; D001794:Blood Pressure; D001795:Blood Pressure Determination / Q000295:instrumentation* / Q000592:standards; D004867:Equipment Design; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D006973:Hypertension / Q000175:diagnosis* / Q000503:physiopathology; D007861:Lebanon; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D009991:Oscillometry; D010297:Paris; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D015203:Reproducibility of Results
European Society of Hypertension International Protocol Revision; Omron HEM-7420; Omron M6 Comfort; Polygreen KP-7670; Withings BP-800; self-blood pressure measurement; validation