Evidence map›Paper›PMID 30803128›Full record

ArticleJournal of clinical hypertension (Greenwich, Conn.)2019

Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-6410T-ZM and HEM-6410T-ZL.

Mitsuo Kuwabara, Kanako Harada, Yukiko Hishiki, Kazuomi Kario

Registry-linked trialAbstract read
In one paragraph

Article in Journal of clinical hypertension (Greenwich, Conn.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03986281 (A Pilot Study to Assess the Accuracy of Blood Pressure Assessment by the Omron HeartGuide Smartwatch), which is not on this map. Cited by 64 papers.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed
–field-weighted citation impact
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.

NCT03986281 nacompletednot on this map

A Pilot Study to Assess the Accuracy of Blood Pressure Assessment by the Omron HeartGuide Smartwatch

TypeinterventionalSponsorThe Cleveland ClinicRan2019 to 2019Enrolled56ConditionsHypertension, Cardiac Disease, SurgeryArmsOmron Wearable Device, Standard Arterial Line
3 · Its place in the literature

Who cites it

64 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
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  5. Article
  6. Review
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  9. Article
  10. Performance of wearable watch-type home blood pressure measurement devices in a real-world clinical sample.Clinical research in cardiology : official journal of the German Cardiac Society · 2024
    Article
  11. Article
  12. Review
  13. Article
  14. Digital hypertension towards to the anticipation medicine.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
    Review
  15. Review
  16. Review
  17. Article
  18. An Update on the Use of Wearable Devices in Men's Health.The world journal of men's health · 2023
    Review
  19. Review
  20. Article

4 more citing papers are in PubMed but not listed here.

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

4 authors.

Mitsuo KuwabaraDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.
Kanako HaradaOmron Healthcare Co., Ltd., Kyoto, Japan.
Yukiko HishikiOmron Healthcare Co., Ltd., Kyoto, Japan.
Kazuomi KarioDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.ORCID 0000-0002-8251-4480

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is growing evidence of the clinical significance of daytime masked hypertension (MHT) and blood pressure (BP) variability (BPV). Recently, watch-type wearable devices for self-BP measurement have become available. Such devices might be promising tools to identify patients with daytime MHT or large BPV in their real-life conditions. The present study aimed to validate the accuracy of the Omron HEM-6410T-ZM and the Omron HEM-6410T-ZL, which are automatic watch-type wearable devices for self-BP measurement, according to the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 guideline. Watches were held with the wrist at heart level. The mean differences between reference BPs and HEM-6410T-ZM readings were -0.9 ± 7.6/-1.1 ± 6.1 mm Hg for systolic BP (SBP)/diastolic BP (DBP) for criterion 1, and -0.9 ± 6.8/-1.1 ± 5.5 mm Hg for SBP/DBP for criterion 2. The mean differences between reference BPs and HEM-6410T-ZL readings were 2.4 ± 7.3/0.7 ± 7.0 mm Hg for SBP/DBP for criterion 1, and 2.4 ± 6.5/0.7 ± 6.5 mm Hg for SBP/DBP for criterion 2. The Omron HEM-6410T-ZM and the Omron HEM-6410T-ZL both fulfilled both validation criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 guidelines.

Indexed as

AgedBiological Variation, PopulationBlood Pressure Monitoring, AmbulatoryBlood Pressure MonitorsCase-Control StudiesEquipment DesignFemaleGuidelines as TopicHumansJapanMaleMasked HypertensionMiddle AgedReproducibility of ResultsWearable Electronic DevicesAAMIANSIblood pressureblood pressure monitorISO81060-2:2013self-measurementvalidationwearable

Identifiers

PMID30803128
PMCPMC8030427

What OpenQuestion holds

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Registered trials

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.