Evidence map›Paper›PMID 37426327›Full record

ArticleVascular health and risk management2023

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.

Zoya Hakobyan, Parounak Zelveian, Jirar Topouchian, Lusine Hazarapetyan, Roland Asmar

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Article in Vascular health and risk management, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 3 countries.

Zoya HakobyanInstitute of Cardiology After Levon Hovhannisyan, Yerevan, Armenia.ORCID 0000-0002-9587-2252
Parounak ZelveianInstitute of Cardiology After Levon Hovhannisyan, Yerevan, Armenia.ORCID 0000-0002-6513-6772
Jirar TopouchianDiagnosis and Therapeutic Center, Hôtel Dieu Hospital, Paris, France.
Lusine HazarapetyanInstitute of Cardiology After Levon Hovhannisyan, Yerevan, Armenia.
Roland AsmarFoundation-Medical Research Institutes (F-MRI), Geneva, Switzerland.ORCID 0000-0002-5676-3491
Foundation for laboratory medicine · CHHôtel-Dieu de Paris · FRYerevan State Medical University · AM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

HypertensionBlood PressureBlood Pressure DeterminationBlood Pressure MonitorsHumansReference StandardsSphygmomanometersaccuracyblood pressure measurementshome blood pressureoscillometricvalidationWithings

Identifiers

PMID37426327
PMCPMC10328101
OpenAlexW4382986122

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.