Key result
Withings BPM Core meets Universal protocol accuracy for home BP with ~0.6 mmHg mean SBP difference.
Why the study?
Most scientific societies recommend assessing the accuracy of electronic devices for blood pressure measurements using established validation protocols.
Does the Withings BPM Core device accurately measure blood pressure compared to a mercury sphygmomanometer in the general population?
Observational (n=85)
Does the Withings BPM Core device accurately measure blood pressure compared to a mercury sphygmomanometer in the general population?
The Withings BPM Core device fulfills the accuracy requirements of the Universal Standard for home blood pressure measurement in the general population.
Answers are grounded in this paper and cite their sources.
May support home BP monitoring with Withings BPM Core; leaves open outcome trials in broader populations.
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.
No takes yet. Share an insight, caveat, or question.
Hakobyan et al. (2023) conducted an observational in Blood pressure measurement (n=85). Withings BPM Core device vs. Mercury sphygmomanometer reference measurements was evaluated on Accuracy of BP measurements according to Criterion 1 (mean difference and SD) and Criterion 2 (SD of mean BP differences). The Withings BPM Core device fulfilled the accuracy requirements of the Universal protocol for home blood pressure measurement, with a mean difference versus reference of -0.6 ± 4.8 mmHg for SBP.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: