Search

Background: In Cycle 7 (2022), the Canadian Health Measures Survey (CHMS) introduced the OMRON (OM) IntelliSense HEM-907XL blood pressure (BP) monitor after using the BpTRU (BT) BPM-300 BP monitor for six cycles. This study assessed differences between adult BP values measured by both devices and whether equations could be developed to compare BP measurements taken using the two devices., Data and Methods: In Cycle 6 (2018 to 2019) of the CHMS, BP was measured using BT and OM devices. Between-device estimates of systolic BP (SBP), diastolic BP (DBP), and hypertension prevalence were compared for 1,072 adults aged 18 to 79 years. Sex, age, body mass index (BMI), and the use of antihypertensive medication were examined in linear regression models to predict SBP and DBP values measured with OM based on those measured with BT., Results: Average SBP measured with OM was 6 millimetres of mercury (mmHg) higher than average SBP measured with BT, and average DBP measured with OM was 2 mmHg lower than DBP measured with BT. Hypertension prevalence based on OM readings was 35.4%, compared with 34.0% based on BT readings. Between-device BP differences varied in magnitude by sex, age group, and BMI category. Average model-predicted estimates of BP were comparable to measured estimates, but predicted values were lower at higher levels of BP., Interpretation: Switching BP monitors will substantively affect population estimates of adult SBP and DBP but may have less impact on estimates of adult hypertension prevalence. The prediction equations proposed in this study can be applied to adult BP data from cycles 1 to 6 of the CHMS for comparison with BP measurements taken in Cycle 7, with some caveats. The impact of changing to the OM monitor in Cycle 7 should be acknowledged when reporting estimates of adult BP based on the CHMS.

Background: Atrial fibrillation (AF) is often asymptomatic and undiagnosed. As AF and hypertension often coexist, opportunistic AF detection during routine automated blood pressure (BP) measurement appears to be an attractive screening method., Methods: A systematic literature search was conducted to identify studies assessing the diagnostic test accuracy of office, home, or 24-hour ambulatory BP measuring devices with AF detection algorithms versus reference electrocardiography. Analyses were performed per participant (AF status based on several BP readings; most office/home devices) or per reading (AF status based on individual readings; all ambulatory devices). A meta-analysis stratified by device type (office/home/ambulatory) was conducted to calculate pooled measures of diagnostic accuracy. Sensitivity/meta-regression analyses were also performed., Results: Among 3096 records initially retrieved, 23 diagnostic test accuracy studies were included. Data derived from 11 093 individuals (weighted age 69 years, males 56%, hypertensives 79%, diabetics 24%, and AF prevalence 17%) indicated a pooled sensitivity 0.97 (95% CI, 0.92-0.99), specificity 0.93 (95% CI, 0.90-0.95), and accuracy 0.93 (95% CI, 0.89-0.95), with generally consistent results using office, home, or ambulatory BP devices (slightly lower specificity with the latter). The positive and negative predictive values were 0.70 (95% CI, 0.60-0.80) and 0.99 (95% CI, 0.98-1.00), respectively. Sensitivity analyses indicated lower specificity in studies implementing reading versus participant analyses. Most studies presented a low risk of bias and minor applicability concerns., Conclusions: There is considerable and consistent evidence suggesting high diagnostic accuracy of AF detection algorithms implemented in automated BP monitors during routine BP measurements in and out of the office. AF diagnosis requires verification (electrocardiography) before treatment is administered., Competing Interests: Disclosures G.S. Stergiou received lecture fees by A&D and Omron, consulting fees by Microlife, and research funding by Microlife through the University of Athens Special Account for Research Grants. The other authors report no conflicts.

Purpose: This study aimed to determine factors associated with changes in adherence to hypertension management (medication adherence and blood pressure control) in respondents with hypertension before and during the COVID-19 pandemic in Bogor city, Indonesia., Methods: An observational study was conducted using two sources of data (before and during COVID-19 pandemic). Data before the pandemic were derived from the 2019 Cohort Study of non-communicable disease risk factors. Data during the pandemic were derived from an online survey conducted in September and October 2020. Information from 880 participants were analyzed. The dependent variable was the change in adherence to hypertension management before and during the COVID-19 pandemic. Multivariate analysis was performed using logistic polynomial regression., Results: Respondents who adhered to hypertension management decreased from 82.0% in 2019 to 47.8% in 2020. The likelihood of non-adherence (respondents who did not adhere to hypertension management both before and during the pandemic) increased in respondents below 55 years old, who did not own any healthcare insurance, who were not obese, and who had no other comorbidities. In the partial adherence group (respondents who did not adhere to hypertension management either before or during the pandemic), we found that most respondents adhered before the pandemic but no longer adhered during the COVID-19 pandemic. We found an increased partial adherence in young and highly educated respondents., Conclusions: Efforts to improve adherence to hypertension management after the COVID-19 pandemic should target those who were young, highly educated, who did not have any healthcare insurance, and who did not perceive themselves as not having comorbidities., Competing Interests: Conflict of interest The authors have no conflicts of interest associated with the material presented in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Objective: To evaluate the blood pressure (BP) measurement accuracy of the Braun BUA4000 automated oscillometric upper-arm cuff device for self-home use in a 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) and its Amendment 1.2020-01., Methods: Participants were recruited to fulfill the age, sex, BP and limb circumference distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. A single wide-range cuff of the test device was used for arm circumference range 22-42 cm., Results: A total of 98 individuals were recruited and 85 were analyzed [mean age 60.3 ± 16.1 (SD) years, 44 men, arm circumference 31.5 ± 5.1 cm, range 22-41.5 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings ( N  = 255) was 0.9 ± 6.4/-0.3 ± 6.4 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual ( N  = 85) was 5.15/5.81 mmHg (systolic/diastolic; threshold ≤6.88/6.95 mmHg)., Conclusion: The Braun BUA4000 automated oscillometric BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard in a general population and can be recommended for self-monitoring of BP by patients at home., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard., Methods: Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard., Results: For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively., Conclusion: The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the accuracy of the Wellvii VitalDetect automated oscillometric finger blood pressure monitor (single cuff size) for self/home blood pressure measurement according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)., Methods: According to the universal standard, a total of 92 participants were recruited and finally blood pressure of 85 eligible participants was sequentially measured and compared with a standard mercury sphygmomanometer., Results: A total of 255 comparison pairs were obtained and analyzed based on the universal standard. For the validation criterion 1 of the ISO 81060-2:2018 universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.66 ± 7.67 and 1.04 ± 6.45 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was ± 6.49 mmHg (pass ≤ 6.73 mmHg) and ± 5.67 mmHg (pass ≤ 6.86 mmHg) for systolic and diastolic blood pressure, respectively., Conclusion: The Wellvii VitalDetect automated finger blood pressure monitor passed all the requirements for validation by the ISO 81060-2:2018 universal standard and can be recommended for self/home blood pressure measurement in general population., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This study evaluated the accuracy of the automated oscillometric upper-arm cuff device AVITA BPM82 intended for home use in a 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) and its Amendment 1.2020-01., Methods: Participants were recruited to fulfill the age, sex, blood pressure (BP), and limb distribution criteria of the AAMI/ESH/ISO Universal Standard and its Amendment 1.2020-01 in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-33 (medium) and 33-42 cm (large)., Results: One-hundred-one individuals were recruited and 85 were analyzed [mean age 57.3 ± 15.1 (SD) years, 46 men, arm circumference 32 ± 5.1 cm, range 22.3-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was 1.3 ± 6.5/3.6 ± 5.9 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual (N = 85) was 5.70/5.25 mmHg (systolic/diastolic; threshold ≤6.82/5.89 mmHg)., Conclusions: The automated oscillometric home BP monitor AVITA BPM82 comfortably fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 in a general population and can be recommended for clinical use., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

To evaluate associations between home blood pressure monitoring (HBPM) and blood pressure (BP) in vulnerable adults during the COVID-19 pandemic, when access to in-person care was restricted. A retrospective cohort study was conducted in adults with hypertension or elevated BP given a home BP monitor vs. usual care. Change in BP from baseline to follow-up was compared between groups, controlling for potential confounders. Subgroup analyses of BP outcomes were also assessed in patients age >50 years. There was no difference in SBP reduction between n = 82 HBPM patients (-11.7/-2.9 mmHg) and n = 280 usual care patients (-12.5/-5.8 mmHg; P > 0.05). Results were similar in multivariable analysis controlling for potential confounders [coefficient 0.44, 95% confidence interval (CI) -3.98 to 4.87]. However, in the subgroup of patients aged>50 years, there was a significant association between SBP reduction and HBPM in the multivariable analyses (coefficient -7.2, 95% CI -13.8 to -0.62, P = 0.032). HBPM use was not associated with BP reduction in vulnerable adults overall during high telehealth use. An association between SBP reduction and HBPM was observed in those aged>50 years. Targeting limited HBPM resources to those aged >50 years old may have the most impact on BP., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020)., Methods: Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results., Results: A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively., Conclusion: The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Hypertension affects approximately 100 million U.S. adults and is the leading single contributing risk factor to all-cause mortality. Accurate blood pressure (BP) measurement is essential in the treatment of BP, and a number of devices exist for monitoring. Recently, a new watch-type design was released, the Omron HeartGuide (BP8000), with claims to provide clinically accurate BP measurement while also tracking activity and sleep similar to smart watches. The aim of this research was done in two studies: (1) evaluation of the HeartGuide device for measurement of resting BP and heart rate (HR); and (2) assessment of the HeartGuide for BP, HR, step-counting and sleep monitoring during activities of daily living. Study 1 compared the Omron HeartGuide to the previously validated Welch Allyn ProBP 3400 following a modified version of the Universal Standard for validation of BP measuring devices set by the AAMI/ESH/ISO. While resting HR measured by the HeartGuide was similar to Welch Allyn measures, both systolic and diastolic BP were significantly lower ( P ≤0.001), with differences of 10.4 (11.1) and 3.2 (10.0) mmHg, respectively. Study 2 compared HeartGuide measures to Welch Allyn measures for BP, HR, steps and sleep during various body positions (supine, seated, standing), physiological stressors (cold pressor test, lower body submersion, exercise), and free-living. The HeartGuide significantly underestimated BP though provided accurate HR during most conditions. It also significantly underestimated steps, but reported sleep measures similar to those subjectively reported. Based on the significant differences between the HeartGuide and Welch Allyn, our data indicate the HeartGuide is not a suitable replacement for existing BP monitors., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Recently, a ring-type cuffless blood pressure (BP) measuring device has been developed. This study was a prospective, single arm, first-in-human pivotal trial to evaluate accuracy of BP measurement by the new device., Methods: The ring-type smart wearable monitoring device measures photoplethysmography signals from the proximal phalanx and transmits the data wirelessly to a connected smartphone. For the BP comparison, a cuff was worn on the arm to check the reference BP by auscultatory method, while the test device was worn on the finger of the opposite arm to measure BP simultaneously. Measurements were repeated for up to three sets each on the left and right arms. The primary outcome measure was mean difference and standard deviation of BP differences between the test device and the reference readings., Results: We obtained 526 sets of systolic BP (SBP) and 513 sets of diastolic BP (DBP) from 89 subjects, with ranges of 80 to 175 mmHg and 43 to 122 mmHg for SBP and DBP, respectively. In sample-wise comparison, the mean difference between the test device and the reference was 0.16 ± 5.90 mmHg (95% limits of agreement [LOA], -11.41, 11.72) in SBP and -0.07 ± 4.68 (95% LOA, -9.26, 9.10) in DBP. The test device showed a strong correlation with the reference for SBP ( r = 0.94, P < 0.001) and DBP ( r = 0.95, P < 0.001). There were consistent results in subject-wise comparison., Conclusion: The new ring-type BP measuring device showed a good correlation for SBP and DBP with minimal bias compared with an auscultatory method., Competing Interests: The authors have no potential conflicts of interest to disclose., (© 2024 The Korean Academy of Medical Sciences.)

An oscillometric waveform (OMW) envelope-based blood pressure (BP) monitoring device is widely used to monitor blood pressure and prevent hypertension and adverse cardiovascular events. At present, all primary care physicians and clinicians widely recommend oscillometric-based BP devices. The consumer selects the device based on their own decision, without knowing whether the device is validated or not, resulting in over- or under-treatment of hypertension. It is imperative that each device must comply with international protocols. In this study, we have investigated the accuracy of inflation and deflation-based oscillometric BP monitoring devices in the case of sinus rhythm (SR). Since different health conditions of the patient affect the oscillometric waveform, which can affect the device's accuracy, in such cases, many BP monitors are skeptical of succeeding in the norms of international protocols. Therefore, this study also aims to calculate the accuracy of these devices in various health conditions and measure the effect of pulse volume, arrhythmia, and respiratory artifact on it using a non-invasive blood pressure (NIBP) simulator. We found that the oscillometric BP devices failed to measure the correct blood pressure in several clinical conditions., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use., Objective: This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common., Validation Procedures: Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position., Conclusion: The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Home blood pressure (BP) is an important component of digital strategies for hypertension management. However, no studies have used the same device to investigate 24-hour BP control status in relation to different home BP control thresholds., Methods: Participants in the general practitioner-based, multicenter HI-JAMP study (Home-Activity Information and Communication Technology-Based Japan Ambulatory Blood Pressure Monitoring Prospective) underwent office BP measurement, then 24-hour ambulatory BP monitoring, then home BP monitoring for 5 days. A validated all-in-one BP monitoring device was used to measure office, home, and ambulatory BP. Baseline data were used to investigate ambulatory BP control status in individuals with well-controlled home BP based on the different guideline thresholds (125/75 mm Hg, 130/80 mm Hg, and 135/85 mm Hg)., Results: Data from 2269 patients were analyzed. For individuals with well-controlled home BP <135/85 mm Hg (59.5% of the total population), the prevalence of uncontrolled 24-hour (≥130/80 mm Hg), daytime (≥135/85 mm Hg), and nighttime ambulatory BP (≥120/70 mm Hg) was 19.9%, 18.5%, and 33.6%, respectively. Corresponding prevalence rates in the 42.7% of participants with well-controlled home BP <130/80 mm Hg were 13.4%, 12.9%, and 26.0%, and when well-controlled home BP was strictly defined as <125/75 mm Hg (23.9% of the population), prevalence of rates of uncontrolled 24-hour, daytime, and nighttime ambulatory BP were 7.0%, 9.0%, and 15.3%, respectively., Conclusions: Home BP control status defined using different thresholds could predict 24-hour ambulatory BP control status in treated hypertension. One-third of individuals still had uncontrolled nocturnal hypertension when home BP was controlled to <135/85 mm Hg, but ambulatory BP was quite well controlled when home BP was <125/75 mm Hg., Competing Interests: Disclosures K. Kario has received research grants from Omron Healthcare Co., Ltd., A&D Co., Ltd., and Fukuda Denshi Co., Ltd., and M. Nishizawa has received honoraria for lectures from Daiichi-Sankyo Co., Ltd. and Novartis Pharma K.K., T. Kabutoya has received scholarship funding from Abbott Co., Ltd. The other authors report no conflicts.

Background: Smart devices that are able to measure blood pressure (BP) are valuable for hypertension or heart failure management using digital technology. Data regarding their diagnostic accuracy in comparison to standard noninvasive measurement in accordance to Riva-Rocci are sparse. This study compared a wearable watch-type oscillometric BP monitor (Omron HeartGuide), a wearable watch-type infrared BP monitor (Smart Wear), a conventional ambulatory BP monitor, and auscultatory sphygmomanometry., Methods: Therefore, 159 consecutive patients (84 male, 75 female, mean age 64.33 ± 16.14 years) performed observed single measurements with the smart device compared to auscultatory sphygmomanometry (n = 109) or multiple measurements during 24 h compared to a conventional ambulatory BP monitor on the upper arm (n = 50). The two BP monitoring devices were simultaneously worn on the same arm throughout the monitoring period. In a subgroup of 50 patients, single measurements were also performed with an additional infrared smart device., Results: The intraclass correlation coefficient (ICC) between the difference and the mean of the oscillometric Omron HeartGuide and the conventional method for the single measurement was calculated for both systole (0.765) and diastole (0.732). This is exactly how the ICC was calculated for the individual mean values calculated over the 24 h long-term measurement of the individual patients for both systole (0.880) and diastole (0.829). The ICC between the infrared device and the conventional method was "bad" for SBP (0.329) and DBP (0.025). Therefore, no further long-term measurements were performed with the infrared device., Conclusion: The Omron HeartGuide device provided comparable BP values to the standard devices for single and long-term measurements. The infrared smart device failed to acquire valid measurement data.

Background: Home blood pressure (BP) monitoring over a 7-day period is recommended to confirm the diagnosis of hypertension., Methods: We determined upper and lower home BP thresholds with >90% positive predictive value and >90% negative predictive value using 1 to 6 days of monitoring to identify high home BP (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg) based on 7 days of home BP monitoring. The sample included 361 adults from the Improving the Detection of Hypertension Study who were not taking antihypertensive medication. We used two 7-day periods, at least 3 days apart, the first being a sampling period and the second a reference period. For each number of days in the sampling period, we determined the percentage of participants who had a high likelihood of having (>90% positive predictive value) or not having (>90% negative predictive value) high BP and would not need to continue home BP monitoring. Only the participants in an uncertain category (ie, positive predictive value ≤90% and negative predictive value ≤90%) after each day were carried forward to the next day of home BP monitoring., Results: Of the 361 participants (mean [SD] age of 41.3 [13.2] years; 60.4% women), 38.0% had high home BP during the reference period. There were 63.7%, 17.1%, 10.5%, 3.3%, 3.6%, and 1.4% participants who would not need to continue after 1, 2, 3, 4, 5, and 6 days of monitoring., Conclusions: In most people, high home BP can be identified or excluded with a high degree of confidence with 3 days or less of monitoring., Competing Interests: Disclosures None.

Objective: To evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure (BP) monitor in general population (for clinic and home BP measurements in adults) 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) and its Amendment 1. 2020., Methods: Subjects were recruited to fulfill the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22-32 cm (standard) and 22-45 cm (wide range)., Results: Ninety-two subjects were recruited and 85 subjects were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.3 ± 7.2/2.2 ± 5.5 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 6.1/4.8 mmHg (systolic/diastolic)., Conclusion: The YuWell YE660D oscillometric upper-arm electronic BP monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its Amendment 1. 2020 in adults and hence can be recommended for home and clinical use., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

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., Competing Interests: All authors conducted validation studies for various manufacturers; they received honorarium for this validation study from The Foundation-Medical Research Institutes (F-MRI) ® Switzerland. The authors report no other conflicts of interest in this work., (© 2023 Hakobyan et al.)

To validate the JAMR F1701T (arm type) blood pressure (BP) monitor 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). A total of 90 subjects (male 60 and female 30) were recruited to fulfill the criteria of the AAMI/ESH/ISO Universal Standard (the number, gender, age, limber size, and BP distribution), and sequential measurements of BP, including both SBP and DBP were obtained using the test device and the standard mercury sphygmomanometer. A total of 270 sets of comparison data (three sets of each subject) were obtained and analyzed. According to the validation criterion 1 of ISO 81060-2:2018, the mean ± SD of the differences between the JAMR F1701T and mercury sphygmomanometer BP (systolic/diastolic) readings was 2.06 ± 6.83/-4.84 ± 5.23 mmHg. For criterion 2, the SD of the averaged BP (systolic/diastolic) differences between the JAMR F1701 and reference BP (systolic/diastolic) per participant was 5.62/4.39 mmHg (the requirement was ≤6.43/5.01 mmHg by calculation). The JAMR F1701T met all the requirements of the ISO 81060-2:2018, and can be recommended for clinical and self/home use., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: The objective of this study is to evaluate the accuracy of the oscillometric upper-arm device ABPMpro (SOMNOmedics) for ambulatory blood pressure measurement 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) at rest and during dynamic exercise., Methods: Subjects were recruited to fulfill the age, sex, blood pressure (BP) and cuff distribution criteria of the AAMI/ESH/ISO standard using the same arm sequential BP measurement method. Three appropriate cuff sizes (18-24, 24-34 and 34-46 cm) of the tested device were used for the arm-varying circumferences. The inflation and deflation measurement modes of the ABPMpro were investigated., Results: For the general validation study, 100 subjects were recruited and 90 were analyzed. For validation criterion (1), the mean ± SD of the differences between ABPMpro and reference BP was 0.7 ± 7.3/-0.7 ± 5.8 mmHg (systolic/diastolic) for inflation and 1.4 ± 7.7/-0.6 ± 6.1 mmHg for deflation measurements. For criterion (2), the SD of the averaged BP differences per subject was 5.98/5.10 mmHg for inflation and 6.46/5.36 mmHg for deflation measurements, thereby passing the threshold. In the ambulatory validation study ( N  = 36), the mean difference was -1.2 ± 7.9/ 2.4 ± 6.6 mmHg for inflation and -0.7 ± 7.6/3.1 ± 7.0 mmHg for deflation measurements., Conclusion: The ABPMpro device fulfilled the ISO 81060-2:2018 requirements in the general population and in the ambulatory setting and can therefore be recommended for clinical use., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: Atrial fibrillation is the most common arrhythmia of clinical significance and hypertension is one of its major risk factors. This study aimed to evaluate the diagnostic accuracy of an automated oscillometric blood pressure (BP) monitor with the function of atrial fibrillation detection for atrial fibrillation screening., Materials and Methods: Patients attending outpatient cardiology clinics were recruited for atrial fibrillation screening by the BP monitor with triplicate BP measurements for atrial fibrillation detection. Furthermore, a single-lead ECG was recorded simultaneously for comparison as the reference standard. The diagnostic test's evaluation index were analyzed, including sensitivity, specificity, and receiver operator characteristic (ROC) analysis., Results: A total of 295 participants were analyzed including 166 males and 129 females, with an average age of 72.5 ± 5.9 years. The sensitivity and specificity for atrial fibrillation detection by the device were 1.000 and 0.904, respectively, with the area under the ROC curve of 0.952 (95% confidence interval: 0.929-0.975, P  < 0.001). Furthermore, the device had a Kappa-value of 0.781 ( P  < 0.001) with the single-lead ECG in detecting atrial fibrillation., Conclusion: The automated oscillometric BP monitor (G.LAB MD41A0) with atrial fibrillation detection function has high sensitivity and specificity with good accuracy for atrial fibrillation screening, which could be used as a reliable screening tool for the early detection of atrial fibrillation with potential benefits., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Automated cuff blood pressure (BP) devices are widely used for ambulatory, home, and office BP measurement. However, an automated device, which is accurate in the general adult population may be inaccurate in some special populations. A 2018 Collaborative Statement by the US Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization (ISO) considered three special populations requiring separate validation (age <3 years, pregnancy, and atrial fibrillation). An ISO Task Group was appointed to identify evidence for additional special populations., Method: Evidence on potential special populations was identified from the STRIDE BP database, which performs systematic PubMed searches for published validation studies of automated cuff BP monitors. Devices that passed in a general population, but failed in potential special populations were identified., Results: Of 338 publications (549 validations, 348 devices) in the STRIDE BP database, 29 publications (38 validations, 25 devices) involved 4 potential special populations: (i) age 12-18 years: 3 of 7 devices failed but passed in a general population; (ii) age more than 65 years: 1 of 11 devices failed but passed in a general population; (iii) diabetes type-2: 4 devices (all passed); (iv) chronic kidney disease: 2 of 7 devices failed but passed in a general population., Conclusion: Some evidence suggest that the automated cuff BP devices may have different accuracy in adolescents and in patients with chronic kidney disease than in the general population. More research is needed to confirm these findings and investigate other potential special populations., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs., Methods: A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website., Results: We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings., Conclusions: Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation.

Cuffless wearable devices are currently being developed for long-term monitoring of blood pressure (BP) in patients with hypertension and in apparently healthy people. This study evaluated the feasibility and measurement stability of smartwatch-based cuffless BP monitoring in real-world conditions. Users of the first smartwatch-based cuffless BP monitor approved in Korea (Samsung Galaxy Watch) were invited to upload their data from using the device for 4 weeks post calibration. A total of 760 participants (mean age 43.7 ± 11.9, 80.3% men) provided 35,797 BP readings (average monitoring 22 ± 4 days [SD]; average readings 47 ± 42 per participant [median 36]). Each participant obtained 1.5 ± 1.3 readings/day and 19.7% of the participants obtained measurements every day. BP showed considerable variability, mainly depending on the day and time of the measurement. There was a trend towards higher BP levels on Mondays than on other days of the week and on workdays than in weekends. BP readings taken between 00:00 and 04:00 tended to be the lowest, whereas those between 12:00 and 16:00 the highest. The average pre-post calibration error for systolic BP (difference in 7-day BP before and after calibration), was 6.8 ± 5.6 mmHg, and was increased with higher systolic BP levels before calibration. Smartwatch-based cuffless BP monitoring is feasible for out-of-office monitoring in the real-world setting. The stability of BP measurement post calibration and the standardization and optimal time interval for recalibration need further investigation., (© 2023. The Author(s), under exclusive licence to The Japanese Society of Hypertension.)

Objective: In a large-scale population cardiovascular screening programme, peripheral artery disease (PAD) and hypertension would ideally be rapidly assessed using a single device. The ankle-brachial pressure index (ABPI) is calculated by comparing the ankle and brachial blood pressure (BP). However, it is currently unclear whether brachial BP measurements provided by automated PAD screening systems are sufficiently accurate for simultaneous hypertension screening., Methods: Two portable PAD screening devices, the MESI ABPI MD and Huntleigh's Dopplex ABIlity, were evaluated following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010 using a mercury-free sphygmomanometer as a reference device., Results: On average, the MESI slightly underestimated brachial systolic blood pressure (BP) with a bias and standard deviation (SD) of -3.5 (SD: 3.3) mmHg and diastolic BP with a bias of -1.5 (SD: 2.3) mmHg. For systolic BP estimates, the Dopplex was more accurate than the MESI with a lower bias of -0.5 (SD: 4.2) mmHg but less precise. The MESI successfully fulfilled all the requirements of the ESH-IP for hypertension screening. The Dopplex device failed the ESH-IP due to the absence of DBP measurements., Conclusions: The MESI device appears to be suitable for simultaneous PAD and hypertension screening as part of a preventative care programme. Huntleigh's Dopplex ABIlity failed to pass the ESH-IP validation test. Further clinical trials are underway to assess the use of the MESI for simultaneous screening for hypertension and PAD in a population screening setting., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Janus et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: A novel automated auscultatory upper arm-cuff blood pressure (BP) monitor (InBody BPBIO480KV) for office use was developed. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are audible to the user and graphically displayed during cuff deflation. Automated BP measurements are provided, while allowing the user to assess the Korotkoff sounds. The device accuracy was tested using 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) and its Amendment 1.2020-01., Methods: Participants were recruited to fulfil the age, sex, BP, arm circumference and cuff distribution criteria of the Universal Standard in general population using the same arm sequential measurement method. Three cuffs of the test device were used for arm circumference 23-28, 28-35 and 33-42 cm., Results: Data from 85 individuals were analysed [mean age 57.3 ± 15.0 (SD) years, 53 men, arm circumference 23-42 cm]. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings ( N  = 255) was 0.3 ± 5.5/0.6 ± 4.7 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For criterion 2, the SD of the averaged BP differences per individual ( N  = 85) was 3.76/3.61 mmHg (systolic/diastolic; threshold ≤6.95/6.91 mmHg)., Conclusion: The InBody BPBIO480KV device for office use, which provides automated auscultatory measurements while reproducing and displaying the Korotkoff sounds, comfortably fulfilled the AAMI/ESH/ISO Universal Standard requirements in general population and can be recommended for clinical use. The assessment of Korotkoff sounds by healthcare professionals for evaluating the quality of automated measurements requires further evaluation., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Accurate blood pressure (BP) assessment is essential for the optimal diagnosis and management of hypertension. Contemporary clinical practice guidelines strongly endorse use of automated cuff blood pressure measuring devices (BPMD) as the preferred means of measuring and monitoring BP in the office, at home and with ambulatory blood pressure monitoring. To ensure that they are accurate, automated BPMDs should undergo clinical validation testing, performed using an established clinical validation standard. Unfortunately, most BPMDs sold on the global market have not been clinically validated. Furthermore, in the last thirty years, several different clinical validation protocols have been published, with major differences apparent between these standards, causing controversy with respect to which standard is considered acceptable for clinical validation. Complexly worded standards, multiple revisions, and firewalled access also contribute to a lack of understanding and use of clinical validation standards and the number of expert centers performing clinical validations is small. Recently, joint society collaborations have led to creation of the AAMI/ESH/ISO universal standard for the clinical validation of automated cuff BPMDs. Not only is this unified standard a necessary step, but oversight from regulators and influential stakeholders to ensure that only clinically validated BPMDs can be marketed is additionally needed., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

Objective: To evaluate the accuracy of the KANG KC-2850 ambulatory blood pressure monitor (ABPM) for clinical blood pressure (BP) measurement 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: BP was sequentially measured and compared with a standard mercury sphygmomanometer in 85 eligible participants. A standard adult cuff (22-3232 cm) was used for test device measurements. A total of 255 comparison pairs were obtained and analyzed according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO universal standard., Results: The standard requirements were followed precisely. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.12 ± 5.01 and -0.33 ± 4.52 mmHg for SBP and DBP, respectively. For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 3.59 and 3.60 mmHg for SBP and DBP, respectively., Conclusion: The KANG KC-2850 ABPM met all the requirements for validation by the AAMI/ESH/ISO universal standard and can be recommended for clinical use in general population., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the accuracy of the EDAN SA-10 oscillometric upper-arm professional office ambulatory blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension (ESH)/International Organization for Standardization (ISO) Universal Standard (ISO 81060-2:2018)., Methods: Subjects were recruited according to the AAMI/ESH/ISO Universal Standard using the same arm sequential BP measurement method. Four cuffs of the test device were used for arm circumference 16-21.5 cm (extra small), 20.5-28 cm (small), 27-35 cm (medium), and 34-43 cm (large)., Results: A total of 105 subjects were recruited, and 97 subjects were included in the final analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -0.59 ± 4.04/-1.79 ± 4.39 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 3.10/3.80 mmHg (systolic/diastolic)., Conclusion: The EDAN SA-10 upper-arm ambulatory BP monitor has passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Targeted maintenance of blood pressure for hypertensive patients requires accurate monitoring of blood pressure at home. Use of multiparametric vital signs ECG, heart sounds, and thoracic impedance for blood pressure estimation at home has not been reported previously. In an observational multi-site study, 120 subjects (female (N = 61, 52%)) between 18 and 83 years of age were recruited with the following stratification (Normal (20%), prehypertensive (37%), stage 1(26%), and stage 2 (18%). From these subjects, 1686 measurements of blood pressure from a sphygmomanometer were associated with simultaneously acquired signals from the SimpleSense device. An ensemble of tree-based models was trained with inputs as metrics derived from the multiparametric and patient demographics data. A test Mean Absolute Difference (MAD) of ± 6.38 mm of Hg and ± 5.10 mm of Hg were obtained for systolic and diastolic blood pressures (SBP; DBP), respectively. Comparatively, the MAD for wrist-worn blood pressure cuff OMRON BP6350 (GUDID-10073796266353) was ± 8.92 mm of Hg and ± 6.86 mm of Hg, respectively. Machine learning models trained to use multiparametric data can monitor SBP and DBP without the need for calibration, and with accuracy levels comparable to at-home cuff-based blood pressure monitors., (© 2022. The Author(s).)

Hypertension is associated with more end-organ damage, cardiovascular events, and disability-adjusted life years lost in the United States compared with all other modifiable risk factors. Several guidelines and scientific statements now endorse the use of out-of-office blood pressure (BP) monitoring with ambulatory BP monitoring or home BP monitoring to confirm or exclude hypertension status based on office BP measurement. Current ambulatory or home BP monitoring devices have been reliant on the placement of a BP cuff, typically on the upper arm, to measure BP. There are numerous limitations to this approach. Cuff-based BP may not be well-tolerated for repeated measurements as is utilized with ambulatory BP monitoring. Furthermore, improper technique, including incorrect cuff placement or use of the wrong cuff size, may lead to erroneous readings, affecting diagnosis and management of hypertension. Compared with devices that utilize a cuff, cuffless BP devices may overcome challenges related to technique, tolerability, and overall utility in the outpatient setting. However, cuffless devices have several potential limitations that limit its routine use for the diagnosis and management of hypertension. The review discusses the different approaches for determining BP using various cuffless devices including engineering aspects of cuffless device technologies, validation protocols to test accuracy of cuffless devices, potential barriers to widespread implementation, and future areas of research. This review is intended for the clinicians who utilize out-of-office BP monitoring for the diagnosis and management of hypertension., (© The Author(s) 2022. Published by Oxford University Press on behalf of American Journal of Hypertension, Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: In the era of digital health information technology, there has been a proliferation of devices that collect patient-generated health data (PGHD), including consumer blood pressure (BP) monitors. Despite their widespread use, it remains unclear whether such devices can improve health outcomes., Objective: We performed a systematic review of the literature on consumer BP monitors that collect PGHD for managing hypertension to summarize their clinical impact on health and surrogate outcomes. We focused particularly on studies designed to measure the specific effect of using a BP monitor independent of cointerventions. We have also summarized the process and consumer experience outcomes., Methods: An information specialist searched PubMed, MEDLINE, and Embase for controlled studies on consumer BP monitors published up to May 12, 2020. We assessed the risk of bias using an adapted 9-item appraisal tool and performed a narrative synthesis of the results., Results: We identified 41 different types of BP monitors used in 49 studies included for review. Device engineers judged that 38 (92%) of those devices were similar to the currently available consumer BP monitors. The median sample size was 222 (IQR 101-416) participants, and the median length of follow-up was 6 (IQR 3-12) months. Of the included studies, 18 (36%) were designed to isolate the clinical effects of BP monitors; 6 of the 18 (33%) studies evaluated health outcomes (eg, mortality, hospitalizations, and quality of life), and data on those outcomes were unclear. The lack of clarity was due to low event rates, short follow-up duration, and risk of bias. All 18 studies that isolated the effect of BP monitors measured both systolic and diastolic BP and generally demonstrated a decrease of 2 to 4 mm Hg in systolic BP and 1 to 3 mm Hg in diastolic BP compared with non-BP monitor groups. Adherence to using consumer BP monitors ranged from 38% to 89%, and ease of use and satisfaction ratings were generally high. Adverse events were infrequent, but there were a few technical problems with devices (eg, incorrect device alerts)., Conclusions: Overall, BP monitors offer small benefits in terms of BP reduction; however, the health impact of these devices continues to remain unclear. Future studies are needed to examine the effectiveness of BP monitors that transmit data to health care providers. Additional data from implementation studies may help determine which components are critical for sustained BP improvement, which in turn may improve prescription decisions by clinicians and coverage decisions by policy makers., (©Jonathan R Treadwell, Benjamin Rouse, James Reston, Joann Fontanarosa, Neha Patel, Nikhil K Mull. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 02.05.2022.)

Blood pressure monitoring (BPM) devices have to be validated according to strict international validation protocols. Each protocol requests a specific number of participants to be included. All protocols use vast amounts of resources, as three people have to be present for every measurement, making trials costly, especially when the manufacturer has no intention to execute a validation study, reflected in the low share of validated in the commercially available BPM devices. The aim of our study was to develop criteria, which could detect low accuracy devices that could not pass a validation protocol early in the course of the validation process. The 2010 European Society of Hypertension International Protocol (ESH-IP) and the Universal Standard for Validation of BPM devices (AAMI/ESH/ISO) were scrutinized for criteria which can be used for preclusion of passing. Based on this, we developed a fail model. We found that a BPM device cannot pass the ESH-IP protocol, if there are ≥27, 13, or 4 single measurements differing more than 5, 10, or 15 mmHg, respectively, from the reference. For the AAMI/ESH/ISO protocol, we developed a model, which calculates best-case standard deviations (SDs) to detect SDs which would prevent the passing of the protocol before its completion, making a stepwise validation process possible. In conclusion, we found that our model is able to predict failure of low-accuracy BPM devices early during a validation protocol if used in a stepwise-approach. This can be useful to keep costs of validation studies low and to enable investigator-initiated trials., (© 2022 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)

Hypertensive patients account for about 16% to 37% of the global population, and about 9.4 million people die each year from hypertension and its complications. Blood pressure is an important indicator for diagnosing hypertension. Currently, blood pressure measurement methods are mainly based on mercury sphygmomanometers in hospitals or electronic sphygmomanometers at home. However, people's blood pressure changes with time, and using only the blood pressure value at the current moment to judge hypertension may cause misdiagnosis. Continuous blood pressure measurement can monitor sudden increases in blood pressure, and can also provide physicians with long-term continuous blood pressure changes as a diagnostic reference. In this article, we design an artificial intelligence-enhanced blood pressure monitoring wristband. The wristband's sensors are based on piezoelectric nanogenerators, with a high signal-to-noise ratio of 29.7 dB. Through the transformer deep learning model, the wristband can predict blood pressure readings, and the loss value is lower than 4 mmHg. By wearing this blood pressure monitoring wristband, we realized three days of continuous blood pressure monitoring of the subjects. The blood pressure monitoring wristband is lightweight, has profound significance for the prevention and treatment of hypertension, and has wide application prospects in medical, military, aerospace and other fields.

Objective: To evaluate the accuracy of the InBody BPBIO210 manual auscultatory mercury-free hybrid blood pressure (BP) measuring device for professional office use in a 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: Subjects were recruited to fulfil the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large)., Results: A total of 94 subjects were recruited and 86 were analysed (mean age 53.7 ± 18.4 [SD] years, 50 men, arm circumference 32.5 ± 4.8 cm, range 22-42 cm). For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.0 ± 4.1/-0.7 ± 2.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 2.65/1.59 mmHg (systolic/diastolic)., Conclusions: The InBody BPBIO210 manual auscultatory hybrid device for professional office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

In 2020 the ANSI/AAMI/ISO published Amendment 1 to the 81060-2 Standard. The purpose was to try to address issues relating to the distribution of subjects with respect to limb size ranges. It also required a new plot showing the limb circumferences on the x-axis and the device minus reference errors on the y-axis (Alpert plot). The study reported here showed inadequacies of the Amendment if significantly overlapping cuffs were to be tested. The innovative approach led to the testing of 135 subjects. Requirements for blood pressure (BP), arm circumference, and gender were fulfilled. The standard same arm sequential protocol was used. Criterion 1 calculations gave a mean ± standard deviation (SD) device minus manual BP values of 0.22 ± 7.90 mmHg for systolic BP and -0.68 ± 7.36 mmHg for diastolic BP. The maximum allowed mean value for either measurement is 5.0 mmHg. The SD values for Criterion 2 were 6.03 mmHg for systolic BP (maximum allowed 6.95) and 6.47 mmHg for diastolic BP (maximum allowed 6.90). All results passed the Standard requirements. This study demonstrated inadequacies of Amendment 1 and led to the development of an Amendment 2, still in the process of finalization. The new Amendment corrects the issues with significantly overlapping cuffs and "wide-range" cuffs. The A&D UA-651 Plus/UA-651SL Plus BP monitors and the five cuffs not only passed the requirements of 81060-2:2018 and Amendment 1 but also a revised and more rigorous protocol with more subjects involved. These devices and cuffs can be used with confidence., (© 2022 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)

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., Competing Interests: The study was supported by Withings® SA France, The International Society of Vascular Health (ISVH®) France and The Foundation-Medical Research Institutes (F-MRI)® Switzerland. Dr Jirar Topouchian reports personal fees from Foundation-Medical Research Institutes, during the conduct of the study. Prof. Dr. Parounak Zelveian reports personal fees from ISVH, during the conduct of the study. Dr Zoya Hakobyan reports personal fees from ISVH, during the conduct of the study. Dr Heghine Gharibyan reports personal fees from ISVH, during the conduct of the study. Prof. Dr. Roland Asmar reports personal fees from Withings, during the conduct of the study. All authors conducted validation studies for various manufacturers; they received honorarium for this validation study. The study, including its design, conduct, analysis and reporting, was performed completely independently from the manufacturer Withings SA., (© 2022 Topouchian et al.)

Home blood pressure monitor (HBPM) ownership prevalence and the factors that influence it are unclear. This study aimed to investigate factors associated with HBPM ownership among participants in the Treatment in Morning versus Evening (TIME) hypertension study. This study is a sub-analysis of the TIME study, a randomised trial investigating the effect of day-time versus night-time dosing of antihypertensive medication on cardiovascular outcomes in adults with hypertension. As part of the TIME study online registration process, participants were asked to indicate whether they owned an HBPM. A multivariable logistic regression model was constructed to determine factors associated with HBPM ownership. Of 21,104 randomised participants, 11,434 (54.2%) reported owning an HBPM. The mean age of all participants at enrolment was 67.7 ± 9.3 years, 12,134 (57.5%) were male, and 8892 (42.1%) reported a current or previous history of smoking. Factors associated with an increased likelihood of reporting HBPM owned include being male (OR:1.47; 95% CI 1.39-1.56) or residing in a less deprived socioeconomic region (IMD Decile 6-10) (OR:1.31; 95% CI 1.23-1.40). Participants with a history of diabetes mellitus (OR:0.74; 95% CI:0.64-0.86) or current smokers, compared to non-smokers, (OR:0.71; 95% CI:0.62-0.82) were less likely to report owning an HBPM. This study has identified important patient factors influencing HBPM ownership. Further qualitative research would be valuable to identify and explore potential patient-level barriers to engagement with self-monitoring of blood pressure., (© 2021. The Author(s).)

We aimed to assess the difference in the accuracy of readings from automated office blood pressure machines with each other or with manual office blood pressure measurements in Chinese individuals. We collected awake 48-h ambulatory blood pressure monitoring, two automated office blood pressure device (BpTRU and WatchBP) readings, and manual office blood pressure measurements in Chinese patients (n = 135) with hypertension in a randomized sequence. Differences were compared using paired t-tests and Bland-Altman plots. The sensitivity and specificity of the techniques for detecting elevated blood pressure were calculated using awake ambulatory blood pressure monitoring as the reference standard. The WatchBP device's and awake ambulatory blood pressure readings were similar. The BpTRU device provided significantly lower mean systolic (P < 0.001) and diastolic (P < 0.001) blood pressure readings, while manual office BP provided significantly higher mean systolic (P = 0.008) and diastolic (P < 0.001) blood pressure readings than the awake automated office blood pressure readings. Automated and manual office blood pressure measurements showed similar sensitivity, specificity, and 95% limits of agreement as based on Bland-Altman plots. The mean systolic (P < 0.001) and diastolic (P < 0.02) blood pressure readings of WatchBP and BpTRU differed, and their diagnostic performances were not superior than those of manual office blood pressure measurements in Chinese patients. Therefore, automated office blood pressure measurements cannot be routinely recommended for Chinese individuals in clinical practice. More studies are needed to confirm these results., (© 2021. The Author(s), under exclusive licence to The Japanese Society of Hypertension.)

With the progressive elimination of mercury column devices for blood pressure (BP) measurement in children and adolescents, valid alternatives are needed. Oscillometric devices provide a replacement without mercury, are fully automated, and have excellent reliability among evaluators. Here, the goal was to test the accuracy of automatic blood pressure monitor devices compared to the mercury sphygmomanometer for BP measurement in children and adolescents. Electronic databases are EMBASE, MEDLINE (PubMed), SCOPUS, and Web of Science. We selected 8974 potentially eligible articles and two authors independently. We separately reviewed 370 full papers. Potentially eligible articles were selected according to the following criteria: (a) articles published in Portuguese, English, and Spanish; (b) screening of titles; (c) screening of abstracts; and (d) retrieval and screening of the full article to determine whether it met the inclusion criteria. We included 45 articles for analysis, 28 of which were selected for meta-analysis. The systolic BP measured by automatic blood pressure monitors presents 1.17 mmHg on average (95% CI 0.85; 1.48); for diastolic BP, it produced -0.08 mmHg (95% CI -0.69; 0.54) compared with a mercury sphygmomanometer. There is high heterogeneity between studies (> 90%) in the meta-analysis, partly explained by the device model, study environment, and observer training. Only articles that reported BP measurement by both methods were included.Conclusion: Automatic blood pressure monitors have strong measurement validity when compared with the mercury column. Thus, these can be safely used in blood pressure measurements of children and adolescents in clinical and epidemiological studies. What is Known: •The "gold standard" for indirect BP measurement is the mercury sphygmomanometer. •The accuracy of the automatic device is critical to any blood pressure measurement method. What is New: •Oscillometric or automatic devices can be a suitable alternative to auscultation for initial screening, consistent with current pediatric guidelines. •The automatic devices compared to the mercury column have a good validity of measurements, which can be used in blood pressure measurements of children and adolescents in clinical and epidemiological settings, provided that international protocols are followed., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Various home blood pressure monitors (HBPMs) are available to the public for purchase but only some are validated against standardised protocols. This study aimed to assess whether HBPMs owned by participants taking part in a clinical trial were validated models. The TIME study is a decentralised randomised trial investigating the effect of antihypertensive medication dosing time on cardiovascular outcomes in adults with hypertension. No HBPMs were provided to participants in this trial but patients were asked to report if they already owned one. We identified the model of HBPM reported by participants, then cross-referenced this against lists of validated HBPMs produced by dabl Educational Trust and the British and Irish Hypertension Society (BIHS). Of 21,104 participants, 10,464 (49.6%) reported their model of HBPM. 7464 (71.3%) of these participants owned a monitor that could be identified from the participants' entry. Of these, 6066 (81.3%) participants owned a monitor listed as validated by either dabl (n = 5903) or BIHS (n = 5491). Some were listed as validated by both. 1398 (18.7%) participants owned an identifiable HBPM that lacked clear evidence of validation. 6963 (93.3%) participants owned an upper arm HBPM and 501 (6.7%) owned a wrist HBPM. Validated HBPMs had a higher median online retail price of £45.00 compared to £20.00 for HBPMs lacking clear evidence of validation. A significant number of participants own HBPMs lacking evidence of validation., (© 2021. The Author(s).)

Objective: The aim of this study was to assess the accuracy of the OptiBP mobile application based on an optical signal recorded by placing the patient's fingertip on a smartphone's camera to estimate blood pressure (BP). Measurements were carried out in a general population according to existing standards of the Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension (ESH) and the International Organization for Standardization (ISO)., Methods: Participants were recruited during a scheduled appointment at the hypertension clinic of Lausanne University Hospital in Switzerland. Age, gender and BP distribution were collected to fulfill AAMI/ESH/ISO universal standards. Both auscultatory BP references and OptiBP were measured and compared using the opposite arm simultaneous method as described in the 81060-2:2018 ISO norm., Results: A total of 353 paired recordings from 91 subjects were analyzed. For validation criterion 1, the mean ± SD between OptiBP and reference BP recordings was respectively 0.5 ± 7.7 mmHg and 0.4 ± 4.6 mmHg for SBP and DBP. For validation criterion 2, the SD of the averaged BP differences between OptiBP and reference BP per subject was 6.3 mmHg and 3.5 mmHg for SBP and DBP. OptiBP acceptance rate was 85%., Conclusion: The smartphone embedded OptiBP cuffless mobile application fulfills the validation requirements of AAMI/ESH/ISO universal standards in a general population for the measurement of SBP and DBP., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Accurate measurement of blood pressure (BP) is crucial to hypertension control and prevention of future stroke and heart attack. All BP measuring devices must be validated independently in the clinical setting., Objective: To validate the accuracy of three automatic upper arm devices (Omron HEM-7120, Yuwell YE680A and Cofoe KF-65B) for self-measurement of BP in Chinese adults with arm size of 22-32 cm., Methods: The validation was conducted independently for each of the three devices according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010), with the facilitation of a designated smartphone application. Subjects were recruited from those attending Beijing Anzhen Hospital for routine physical examination and clinic visits. For each device, BP was measured sequentially in 33 adults using a mercury sphygmomanometer (two observers) and the test device (one supervisor) with seven measurements alternating between observers and the device, which generated a total of 99 before/after paired values for SBP and DBP separately. The judgments were made based on the distribution of the paired difference among the 99 measurements (Part 1) and among the 33 subjects (Part 2). To pass, a device must achieve all the minimum Pass requirements in Part 1 and Part 2 for both SBP and DBP (Part 3)., Results: Only HEM-7120 achieved the part 1 and part 2 targets for both SBP and DBP. KF-65B achieved the DBP targets of part 1 and part 2 but failed for SBP. YE680A only achieved the DBP targets of part 2 but failed for all others. The findings also indicated that the devices had higher SBP readings (1.3 mmHg, 1.0 mmHg and 4.1 mmHg higher for HEM-7120, YE680A and KF-65B, respectively) and lower DBP readings (2.0 mmHg, 1.1 mmHg and 3.3 mmHg lower, respectively) when compared to the mercury sphygmomanometer., Conclusions: The Omron HEM-7120 passed the requirements of the ESH-IP 2010 revision, while the Yuwell YE680A and Cofoe KF-65B failed (part 3)., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Blood pressure (BP) monitoring is critical to raise awareness of hypertension and hypotension, yet the commonly used techniques require the person staying still along with a cuff around the arm. Some cuff-less approaches have been researched, but all hinder the person from moving around. To address the challenge, we propose using a fusion of accelerometers to achieve motion artifact resilient blood pressure monitoring. Such technique is accomplished with the motion artifact removal process and feature extraction from multi-dimensional seismocardiograms. The efficacy of our BP monitoring models is validated in 19 young healthy adults. Both the diastolic and systolic BP monitoring models fulfill the AAMI standard and British Hypertension Society protocol. For sitting still BP monitoring, the mean and standard deviation of diastolic and systolic difference errors (DE) are 0.09 ± 4.10 and -0.25 ± 5.45 mmHg; moreover, the mean absolute difference errors (MADE) are 3.62 and 4.73 mmHg. In walking motions, the DE are 1.15 ±4.47 mmHg for diastolic BP and -0.38 ± 6.67 for systolic BP; furthermore, the MADE are 3.36 and 5.07 mmHg, respectively. The motion artifact resilient cuff-less BP monitoring reveals the potential of portable BP monitoring in healthcare environments.

The aim of this study was to assess the blood pressure (BP) measurement accuracy of the Kinetik Blood Pressure Monitor-Series 1 (BPM-1) for use in home or clinical settings according to the 2002 European Society of Hypertension International Protocol (ESH-IP). Forty-two participants were recruited to fulfil the required number of systolic and diastolic BP measurements according to the ESH-IP. Nine sequential same-arm BP readings were measured and analysed for each participant using the test device and observer mercury standard readings according to the 2002 ESH-IP. Forty one participants were used to obtain 33 sets of systolic and diastolic BP readings and were included in the analysis. Mean difference between the device measurements and the observer (mercury standard) measurements was 1.1 ± 7.2/1.1 ± 6.8 mmHg (mean ± standard deviation; systolic/diastolic). The number of systolic BP differences between the test and observer measurements that fell within 5, 10 and 15 mmHg was 65, 86 and 92. For diastolic readings, the number of test-observer measurement differences within 5, 10 and 15 mmHg was 77, 91 and 94. The number of participants with at least two out of three differences within 5 mmHg was 28 for systolic and 40 for diastolic BP readings. Three participants had no differences between the test and observer measurements within 5 mmHg in both the systolic and diastolic measurement categories. The Kinetik BPM-1 device fulfilled the requirements of the ESH-IP validation procedure and can be recommended for clinical use and self-measurement within the home., (© 2020. The Author(s), under exclusive licence to Springer Nature Limited.)

Objective: we assessed the accuracy of the QMon-20 oscillometric upper-arm cuff device professional for office blood pressure (BP) in 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: Subjects were recruited according to AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-31 (medium) and 32-42 cm (large)., Results: One-hundred and fourteen subjects were recruited and 106 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.8 ± 5.4/-0.5 ± 4.2 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 4.34/3.48 mmHg (systolic/diastolic)., Conclusion: The QMon-20 oscillometric device for office BPs measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)