Evidence map›Paper›PMID 35386428›Full record

ArticleVascular health and risk management2022

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

Jirar Topouchian, Parounak Zelveian, Zoya Hakobyan, Heghine Gharibyan, Roland Asmar

Open access · goldAbstract read
In one paragraph

Article in Vascular health and risk management, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

8 citing papers in PubMed, 14 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 2 institutions in 2 countries.

Jirar TopouchianDiagnosis and Therapeutic Center, Hôtel Dieu Hospital, Paris, France.
Parounak ZelveianPreventive Cardiology Dept, Institute of Cardiology Named After Levon Hovhannisyan, Yerevan, Armenia.ORCID 0000-0002-6513-6772
Zoya HakobyanPreventive Cardiology Dept, Institute of Cardiology Named After Levon Hovhannisyan, Yerevan, Armenia.ORCID 0000-0002-9587-2252
Heghine GharibyanPreventive Cardiology Dept, Institute of Cardiology Named 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 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: As recommended by various authorities and scientific societies, electronic devices for blood pressure (BP) measurements must undergo independent clinical validations for accuracy assessment. Objective: To assess the accuracy of the Withings BPM Connect device in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization "AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)". Methods: The Withings BPM Connect device measures BP at the brachial level using the oscillometric method. According to this protocol using the same-arm sequential BP measurement method, subjects (n ≥ 85) fulfilling the age, gender, BP and cuff distribution criteria must be included. Two criteria are used for the analysis: Criterion 1: differences between observers' mercury sphygmomanometer reference measurements and test device BP values (test versus reference) and their standard deviation (SD) must be ≤5 ± 8 mmHg for both systolic (SBP) and diastolic BP (DBP). Criterion 2: the SD of the mean BP differences between the test device and reference BP per subject must be ≤6.91/6.62 mmHg for SBP/DBP. Results: Ninety-two subjects were selected, 85 of whom were included. For validation criterion 1, the mean difference ± SD between the reference and device BP values was 0.6 ± 5.3 mmHg for SBP and 2.1 ± 4.3 mmHg for DBP. For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 4.2/3.6 mmHg (SBP/DBP). These results fulfilled the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) protocol requirements. Conclusion: The Withings BPM Connect oscillometric device for home BP measurement fulfilled all of the accuracy requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and consequently can be recommended for home BP measurements.

Indexed as

Blood Pressure DeterminationHypertensionBlood PressureBlood Pressure MonitorsHumansReference StandardsSphygmomanometersaccuracyblood pressure measurementshome blood pressureoscillometricvalidationWithings

Identifiers

PMID35386428
PMCPMC8979570
OpenAlexW4220865941

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LicenceCC BY-NC
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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.