Validation of the Withings BPM Core Device for Self-Blood Pressure Measurements in General Population According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard

Abstract

Background

Most of the scientific societies recommend assessing the accuracy of electronic devices for blood pressure (BP) measurements using established validation protocol.

Objective

To determine the accuracy of the BP measurements using the Withings BPM Core device in the general population according to the “Universal Standard (ISO 81060-2:2018/AMD 1:2020)”.

Methods

The Withings BPM Core is an oscillometric device measuring BP at the brachial level. The study was performed according to the “Universal Standard (ISO 81060-2:2018/AMD 1:2020) protocol” using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were included. Analysis was performed as required by the Universal protocol using Criterion 1 – differences between observers’ mercury sphygmomanometer reference measurements and test device BP values (test versus reference) and their standard deviation (SD); and Criterion 2 – The SD of the mean BP differences between the test device and reference BP per subject.

Results

Eighty-six subjects were selected, 85 of whom were included. The mean BP differences between the simultaneous two observers’ measurements were −0.2 ± 2.1 mmHg for systolic BP (SBP) and 0.3 ± 2.1 mmHg for diastolic BP (DBP). For validation criterion 1, the mean difference ± SD between the reference and device BP values was −0.6 ± 4.8 mmHg for SBP and 0.1 ± 3.7 mmHg for DBP (≤5 ± 8 mmHg for both SBP and DBP). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 3.2/2.6 mmHg for SBP and DBP (≤6.91/6.95 mmHg).

Conclusion

The results of this study showed that the Withings BPM Core oscillometric device for home BP measurement fulfilled the accuracy requirements of the (ISO 81060-2:2018/AMD 1:2020) Universal protocol in the general population.

Keywords:

• blood pressure measurements
• accuracy
• validation
• home blood pressure
• oscillometric
• Withings

Acknowledgments

Our heartfelt thanks to all of the patients who took part in the study. Our grateful thanks to the Foundation-Medical Research Institutes^® (F-MRI) and the International Society of Vascular Health for their support.

Disclosure

All authors conducted validation studies for various manufacturers; they received honorarium for this validation study from The Foundation-Medical Research Institutes (F-MRI) ^® Switzerland. The authors report no other conflicts of interest in this work.

Additional information

Funding

The study was supported by Withings^® SA France, the International Society of Vascular Health (ISVH^®) France and the Foundation-Medical Research Institutes (F-MRI) ^® Switzerland. The study, including its design, conduct, analysis, and reporting, was performed completely independently from the manufacturer Withings SA.