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:10.1097/hjh.0000000000001634

Cited by 163 publications

(32 citation statements)

References 18 publications

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“…To establish an agreed single validation protocol that had global acceptance, an international initiative was taken by the AAMI, ESH and ISO experts who agreed to develop a “Universal” validation protocol. This very recently published (January 2018) Universal Standard Protocol, is a better mixture, based on the previous protocols and including parameters and criteria taken from one or other protocol 21,22. For these reasons, our study was performed according to this latest universal validation protocol which differ from the others in terms of BP ranges, arm circumference, and other parameters which are not applied.…”

Section: Discussionmentioning

confidence: 99%

“…According to the literature and to our knowledge, this is the first study assessing the accuracy of the Omron Evolv and the Omron M3 Comfort in pregnancy and pre-eclampsia. Moreover, this is the first validation study performed according to the very recent Universal Standard Protocol for the validation of BP devices jointly developed by the AAMI, ESH, and ISO authorities 21,22…”

Section: Discussionmentioning

confidence: 99%

“…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%

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Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® 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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® 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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“…This international standard requires comparative measurements using the manual blood pressure measurement technique [4,5].…”

Section: Reference Measurementsmentioning

confidence: 99%

Variability in Blood Pressure Measurements from Recorded Auscultation Sounds

Murray¹,

Zheng²,

Liu³

et al. 2019

2019 Computing in Cardiology Conference (CinC)

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Blood pressure measurement is clinically important. The manual auscultation method is retained as the current "gold standard". This study was designed to evaluate the variability of repeat measurements by the same operator, and between operators, when evaluating the same data.Ten young volunteer subjects with no known cardiovascular disease were studied. Korotkoff sounds were recorded from a standard stethoscope head connected to an acoustic microphone, and the audio sounds recorded during blood pressure measurements with cuff deflation, while subjects sat quietly on a chair. All recordings were replayed blindly and independently, to two trained operators. The operators identified systolic and diastolic blood pressure (SBP and DBP) without knowledge of the subject. After all recordings had been analysed once, the analysis was repeated.SBP ranged from 95 to 112 mmHg, and DBP from 58 to 78 mmHg. The difference in repeat listening measurements for each observer mmHg for DBP. The difference between the two operators for each measurement was 0.7 ± 1.6 and 0.9 ± 3.6 mmHg for SBP, and -1.7 ± 2.3 and -1.0 ± 2.0 mmHg for DBP. We have shown similar variability between operators as between repeat measurements on identical recordings.

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“…Как известно, АГ сочетается с рядом метаболических нарушений, неблагоприятно влияющих на прогноз болезни [5,6]. К ним относятся ожирение, гиперлипидемия, гиперинсулинемия и нарушение толерантности к глюкозе.…”

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The effect of three-component antihypertensive treatment on the structural and functional state of the heart and daily blood pressure profile in patients with hypertension grade 3

Azaeva

кызы²

2019

Kazan Med J

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Aim. To study the effect of a fixed combination of perindopril arginine (10 mg) + indapamide (2.5 mg) + amlodipine (5 mg) on the daily profile of blood pressure and the structural and functional state of the heart in patients with hypertension grade 3. Methods. 80 patients with hypertension receiving various variants of treatment [50 patients (experimental group) receiving fixed combination of perindopril arginine (10 mg) + indapamide (2.5 mg) + amlodipine (5 mg) and 30 patients (control group) receiving combination of lisinopril with hydrochlorothiazide (10/12.520/25 mg) and amlodipine (5 mg)] underwent electrocardiography, Doppler echocardiography, daily monitoring of blood pressure at there points: at the beginning, after 2 weeks and 6 months of the treatment. Statistical significance of the indicators was determined by Students t-test. To compare the double changes, 2 was used. Statistical difference between the groups was considered significant if p 0.05. Results. In 86% of patients from the experimental group, a decrease in systolic blood pressure by 20 mm Hg or more and/or diastolic blood pressure by 10 mm Hg was noted, which persisted for 6 months. After 6 months of treatment, according to daily monitoring of arterial pressure, the average daily systolic and diastolic blood pressure significantly decreased by 15.9 and 18.6% (р 0.001), and the values of variability of average systolic and average diastolic pressure at night and daytime by 4 and 4.2%, respectively (р 0.001). A decrease in the morning rise rate of systolic and diastolic blood pressure was also achieved (р 0.001). During treatment, a number of patients with a daily curve of the dipper type increased due to a decrease in non-dippers and night pickers (р 0.001). Conclusion. Positive antihypertensive result after treatment with a combination of perindopril arqinine + indapamide + amlodipin was achieved in the early stages of treatment and was observed as a long-term stable hypotensive effect; a number of patients with normal daily rhythm of blood pressure increased, decrease of the severity of hypertrophy and size of the left ventricle was observed and its diastolic function became normal.

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A universal standard for the validation of blood pressure measuring devices

Cited by 163 publications

References 18 publications

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

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

Variability in Blood Pressure Measurements from Recorded Auscultation Sounds

The effect of three-component antihypertensive treatment on the structural and functional state of the heart and daily blood pressure profile in patients with hypertension grade 3

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A universal standard for the validation of blood pressure measuring devices

Cited by 163 publications

References 18 publications

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

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

Variability in Blood Pressure Measurements from Recorded Auscultation Sounds

The effect of three-component antihypertensive treatment on the structural and functional state of the heart and daily blood pressure profile in patients with hypertension grade 3

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

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