A Universal Standard for the Validation of Blood Pressure Measuring Devices

Stergiou, George S.; Alpert, Bruce S.; Mieke, Stephan; Asmar, Roland; Atkins, Neil; Eckert, Siegfried; Frick, G; Friedman, Bruce A.; Graßl, Thomas; Ichikawa, Tsutomu; Ioannidis, John P. A.; Lacy, Peter; McManus, Richard J; Murray, Alan; Myers, Martin G.; Palatini, Paolo; Parati, Gianfranco; Quinn, David; Sarkis, Josh; Shennan, Andrew; Usuda, Takashi; Wang, Ji‐Guang; Wu, Colin O.; O’Brien, Eoin

doi:10.1161/hypertensionaha.117.10237

Cited by 291 publications

(115 citation statements)

References 18 publications

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“…2,3 If these devices are used in special populations (eg, children, pregnancy, atrial fibrillation), separate validations must be performed for each. 2,3 The use of auscultatory OBPM should be limited to special situations where electronic devices may not be accurate. With the increasing use of electronic devices, training in the auscultatory technique is likely to disappear.…”

Section: Office Bp Measurementmentioning

confidence: 99%

Section: Hypertensionmentioning

confidence: 99%

“…2 For arm circumference 23 to 28, 28 to 35, and 33 to 42 cm, a cuff with bladder length 23, 28, and 33 cm should be used, respectively. 2 Smaller cuffs are needed for thinner arms and larger cuffs for arm circumference >42 cm, which should have conical shape to fit the arm shape. 4 For electronic (oscillometric) devices for office, home, or ambulatory use, the recommendations of the manufacturer for cuff selection according to arm size should be followed, which should be supported by appropriate validation studies.…”

Section: Hypertensionmentioning

confidence: 99%

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Blood Pressure Measurement and Hypertension Diagnosis in the 2017 US Guidelines

Stergiou

Palatini

Asmar³

et al. 2018

Hypertension

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T he 2017 US guidelines for hypertension have given a lot of attention to the accurate evaluation of blood pressure (BP) and the importance of out-of-office measurements for confirming diagnosis.1 This emphasis is to be welcomed, and at the time of writing, these guidelines provide the most comprehensive recommendations for both out-of-office and office BP measurement (OBPM). As such, the guidelines have provided to doctors clear BP measurement recommendations for managing the white-coat and masked hypertension phenomena in both untreated and treated subjects.Inadequate evaluation of BP often leads to overdiagnosis, resulting in unnecessary investigation and long-term treatment, or to underdiagnosis with consequent undertreatment and increased risk of cardiovascular disease. Because the 2017 guidelines recommend a more aggressive strategy for treatment initiation and hypertension control, it is imperative that (1) OBPM becomes more standardized, yet feasible for clinical practice; and (2) BP levels are confirmed with out-ofoffice measurements.We have critically reviewed the methodological issues of BP measurement and hypertension diagnosis in the 2017 US guidelines, which are the first and essential steps before further evaluation and intervention can be decided. Other important aspects, such as the new definition of hypertension and the treatment BP targets, are not discussed in this article. Office BP MeasurementThe 2017 US guidelines provide detailed instructions for OBPM, including the auscultatory method.1 However, it is now accepted that although in a research laboratory the auscultatory technique remains the reference for testing the accuracy of novel BP measuring devices, in clinical practice it has too many sources of error and therefore electronic (oscillometric) devices are preferable.1 Moreover, the use of electronic devices is currently evidence based, given that all the hypertension outcome trials in the past two decades have used such devices for OBPM. Only, validated upper-arm-cuff devices should be used.2,3 If these devices are used in special populations (eg, children, pregnancy, atrial fibrillation), separate validations must be performed for each.2,3 The use of auscultatory OBPM should be limited to special situations where electronic devices may not be accurate. With the increasing use of electronic devices, training in the auscultatory technique is likely to disappear. Meanwhile, appropriate training for auscultatory OBPM will remain an unresolved concern.Besides problems specific to the auscultatory method, OBPM is inherently inaccurate because it induces the whitecoat effect, it fails to detect masked hypertension, and has poor reproducibility. 4 Thus, OBPM alone is not appropriate for the diagnosis of hypertension in untreated subjects, or titration of therapy in treated patients. However, OBPM, albeit imperfect, does have a role in screening for hypertension. Individuals with borderline or elevated office BP should be referred for confirmatory out-of-office BP measurement. Indeed, this ...

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Section: Office Bp Measurementmentioning

confidence: 99%

Section: Hypertensionmentioning

confidence: 99%

Section: Hypertensionmentioning

confidence: 99%

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Blood Pressure Measurement and Hypertension Diagnosis in the 2017 US Guidelines

Stergiou

Palatini

Asmar³

et al. 2018

Hypertension

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“…Therefore, an international initiative was taken by the AAMI, ESH, and the International Organization for Standardization (ISO) experts to develop a universal standard for device validation. This Universal Standard Protocol for the validation of BP devices has been recently published 21,22…”

Section: Introductionmentioning

confidence: 99%

“…The objective of this study was to assess the accuracy of the automatic oscillometric BP measurements, the Omron Evolv ® (HEM-7600T-E) and the Omron M3 Comfort ® (HEM −7134-E) devices in pregnant women including pre-eclampsia according to the Universal Standard Protocol.”21,22…”

Section: Introductionmentioning

confidence: 99%

Clinical accuracy of the Omron M3 Comfort<sup>®</sup> and the Omron Evolv<sup>®</sup> for self-blood pressure measurements in pregnancy and pre-eclampsia – validation according to the Universal Standard Protocol

Topouchian¹,

Hakobyan²,

Asmar³

et al. 2018

VHRM

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BackgroundElectronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and in special populations such as pregnancy.ObjectiveTo evaluate the accuracy of the Omron Evolv® (HEM-7600T-E) and the Omron M3 Comfort® (HEM-7134-E) devices in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol.MethodsBoth devices, the Evolv and the M3 Comfort, measure BP at the brachial level using the oscillometric method. The study was performed according to the recently published protocol, the so-called “modified Advancement of Medical Instrumentation (AAMI)/British Hypertension Society (BHS)/European Society of Hypertension (ESH) protocol” or the “Universal Standard Protocol.” Validation of each device included 45 pregnant women in the second and third gestational trimester of whom 15 had pre-eclampsia, 15 had gestational hypertension and 15 were normotensives. BP differences between the observer and the device BP values were classified into three categories (≤5, ≤10, and ≤15 mmHg) and the mean BP differences (test vs reference) and its SD were calculated.ResultsBoth devices, the Evolv and the M3 Comfort, achieved a grade A/A in both pregnancy and pre-eclampsia. The mean difference (SD) between the mercury standard and the device BP values in pregnancy were: 1) for the Evolv of −0.7±2.3 mmHg for systolic blood pressure (SBP) and −0.1±1.8 mmHg for diastolic blood pressure (DBP); 2) for the M3 Comfort of −1.6±2.8 mmHg for SBP and −0.1±2.3 mmHg for DBP.ConclusionBoth devices, the Evolv and the M3 Comfort, achieved a grade A/A for both SBP and DBP and fulfill the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, these two devices can be recommended for home BP measurements in this specific population.

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Smart Skins Based on Assembled Piezoresistive Networks of Sustainable Graphene Microcapsules for High Precision Health Diagnostics

Aljarid,

Dong,

et al. 2023

Adv Funct Materials

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The environmental impact of plastic waste has had a profound effect on our livelihoods and there is a need for future plastic‐based epidermal electronics to trend toward more sustainable approaches. Infusing graphene into the culinary process of seaweed spherification produces core‐shell, food‐based nanocomposites with properties exhibiting a remarkably high degree of tunability. Unusually, mechanical, electrical, and electromechanical metrics all became decoupled from one another, allowing for each to be individually tuned. This leads to the formation of a general electromechanical model which presents a universal electronic blueprint for enhanced performances. Through this model, performance optimization and system miniaturization are enabled, with gauge factors (G) >108 for capsule diameters (D) ≈290 µm and produced at a record rate of >100 samples per second. When coalesced into quasi‐2D planar networks, microcapsules form the basis of discrete, recyclable electronic smart skins with areal independent sensitives for muscular, breathing, pulse, and blood pressure measurements in real‐time.

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A Universal Standard for the Validation of Blood Pressure Measuring Devices

Cited by 291 publications

References 18 publications

Blood Pressure Measurement and Hypertension Diagnosis in the 2017 US Guidelines

Blood Pressure Measurement and Hypertension Diagnosis in the 2017 US Guidelines

Clinical accuracy of the Omron M3 Comfort<sup>®</sup> and the Omron Evolv<sup>®</sup> for self-blood pressure measurements in pregnancy and pre-eclampsia – validation according to the Universal Standard Protocol

Smart Skins Based on Assembled Piezoresistive Networks of Sustainable Graphene Microcapsules for High Precision Health Diagnostics

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A Universal Standard for the Validation of Blood Pressure Measuring Devices

Cited by 291 publications

References 18 publications

Blood Pressure Measurement and Hypertension Diagnosis in the 2017 US Guidelines

Blood Pressure Measurement and Hypertension Diagnosis in the 2017 US Guidelines

Clinical accuracy of the Omron M3 Comfort<sup>&reg;</sup> and the Omron Evolv<sup>&reg;</sup> for self-blood pressure measurements in pregnancy and pre-eclampsia &ndash; validation according to the Universal Standard Protocol

Smart Skins Based on Assembled Piezoresistive Networks of Sustainable Graphene Microcapsules for High Precision Health Diagnostics

Contact Info

Product

Resources

About

Clinical accuracy of the Omron M3 Comfort<sup>®</sup> and the Omron Evolv<sup>®</sup> for self-blood pressure measurements in pregnancy and pre-eclampsia – validation according to the Universal Standard Protocol