OBJECTIVE: Blood pressure (BP) measurement using an auscultatory sphygmomanometer is recommended for diagnosing hypertension in children. As mercury sphygmomanometers (MSs) are banned owing to environmental concerns, it is crucial to determine the accuracy of mercury-free sphygmomanometers to replace them. We analyzed the accuracy of these devices to guide the National Survey selection.
METHODS: BP was measured thrice each with MS, auscultatory device (AD), and oscillometric device (OD) in 104 participants aged 10-18 using the National Survey data. The difference in BP was defined as the difference between MS and other devices. The BP differences, correlations, and influencing factors were analyzed. The frequencies of hypertension were also compared.
RESULTS: Systolic BP (SBP) and diastolic BP (DBP) differences between MS and AD were 0.88±3.36 mmHg and 0.63±3.95 mmHg, and those between MS and OD were 0.43±5.83 mmHg and 4.57±6.89 mmHg, respectively. The absolute error of <10 mmHg for DBP between MS and OD was 76%. The concordance correlation coefficient between MS and AD was 0.94 for SBP and 0.90 for DBP, and 0.81 and 0.67, respectively for MS and OD. Arm circumference negatively correlated with BP differences except for SBP between the MS and OD. The frequency of hypertension was not different between MS and AD but was underestimated by OD.
CONCLUSIONS: AD correlated well with MS, while OD did not, especially for DBP. The superiority of AD over OD suggests AD as a possible alternative for MS in the National Survey.

This study evaluated an oscillometric device (OD), Microlife WatchBP Office AFIB, and a hybrid manual auscultatory device (AD), Greenlight 300TM, to determine a suitable blood pressure (BP) measurement device for the Korea National Health and Nutrition Examination Survey in a mercury-free context. Adhering to the 2018 Universal Standard\'s suggested consensus, the study involved 800 subjects (mean age 51.2 ± 17.5 years; 44.3% male), who underwent triplicate BP measurements following 5 min of rest in a randomized order (OD-first: 398 participants; AD-first: 402 participants). BP difference was calculated as OD value minus AD value, with results stratified by measurement sequence. The overall BP difference and tolerable error probability were -1.1 ± 6.5/-2.6 ± 4.9 mmHg and 89.2%/92.5% for systolic/diastolic BP (SBP/DBP), respectively. Lin\'s concordance correlation coefficient was 0.907/0.844 for SBP/DBP (OD-first/AD-first: 0.925/0.892 for SBP, 0.842/0.845 for DBP). The overall agreement for hypertension (BP ≥ 140 and/or 90 mmHg) was 0.71 (p < 0.0001), and the OD underestimated the overall hypertension prevalence by 5.1%. Analysis of the AD-first data revealed a lower level of agreement compared to the OD-first data; however, the observed blood pressure difference adhered to Criterion 1 of the 2018 Universal Standard. Microlife met the Criterion 1 of 2018 Universal Standard but underestimated the prevalence of hypertension. The BP discrepancy increased with higher BP levels, male sex, and smaller AC. With increasing age, the discrepancy decreased for SBP and increased for DBP.

OBJECTIVE: To report a validation of the Riester Big Ben Square Desk Aneroid Sphygmomanometer according to the international protocol developed by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension 2002 (ESH-IP 2002) in the interest of transparency. This legacy publication is intended to assure users that the device satisfied the requirements in place at that time.
METHODS: Performance of the device was assessed by participants\' age, sex, arm circumference and entry SBP/DBP. Validation was performed in 33 participants. The sphygmomanometer was assessed according to the ESH-IP, which defines zones of accuracy compared to the mercury standard as ≤5, ≤10, ≤15 mmHg or more.
RESULTS: The mean (± SD) age was 50.5 ± 13.0 years, range 29-71 years, entry SBP 142.6 ± 23.7 mmHg, entry DBP 89.0 ± 17.8 mmHg. The device passed all the requirements listed and the validation protocol. The Riester Big Ben Square Desk aneroid sphygmomanometer slightly underestimated the observer-measured SBP, yet slightly overestimated DBP. The observer-device disagreement was -0.8 ± 6.4 mmHg SBP and +0.6 ± 4.0 mmHg DBP.
CONCLUSIONS: These data show that the Riester Big Ben Square Desk aneroid sphygmomanometer fulfilled the ESH-IP 2002 requirements for the validation of BP monitors. It was on this basis that the British and Irish Hypertension Society recommended it for clinical use in the adult population.

OBJECTIVE: There is an increasing number of cuffless blood pressure (BP) measurement (BPM) devices. Despite promising results when comparing single measurements, the ability of these devices to track changes in BP levels over 24 h related to an initial calibration BP (CalibBP) is unknown. Our aim was to analyse this ability in a cuffless device using pulse transit time.
METHODS: We prospectively enrolled 166 participants for simultaneously performed cuffless (Somnotouch-NIBP) and cuff-based (Spacelabs 90217A/IEM Mobil-O-graph) 24 h BPM. As CalibBP for the cuffless device, first cuff-based BP was used. As surrogate for changes in BP levels after the CalibBP, we used the difference between the CalibBP and mean 24 h, awake and asleep BP measured by the two devices. In addition, we analysed the relationship between the difference of the CalibBP and the cuff-based BPM versus the difference between the cuff-based and the cuffless BPM devices.
RESULTS: Mean(SD) difference between the CalibBP and mean 24hBP by the cuff-based or cuffless BP device were 7.4 (13.2) versus 1.8 (8.3) mmHg for systolic ( P  < 0.0001) and 6.6 (6.8) versus 1.6 (5.8) mmHg for diastolic ( P  < 0.0001). A near linear relationship was seen among the difference between the CalibBP and the cuff-based BPM values and the difference between the cuff-based and cuffless BPM device.
CONCLUSIONS: Our data indicate a lower ability of the cuffless BPM device to track changes of BP levels after CalibBP. In addition, cuffless device accuracy was associated with the changes in BP levels after the initial CalibBP - the larger the BP level change, the larger the difference between the devices.
BACKGROUND: https://www.clinicaltrials.gov ; Unique identifier: NCT03054688; NCT03975582.

UNASSIGNED: Mercury sphygmomanometer (MS) has now been less and less used and no new devices have been manufactured (according to Minamata convention 2013). The application of the electronic sphygmomanometer (ES) in clinical practice has become increasingly common. However, reliable evidence for the use of the ES in high-altitude areas remains scarce. The purpose of this study was to validate the applicability of the ES in high altitude areas.
UNASSIGNED: In Luhuo County, Sichuan Province, China, 3,400 m above the sea level, two trained physicians measured the blood pressure (BP) of participants using both the mercury sphygmomanometer and the ES. Pearson correlation analysis and paired T-test, respectively, were used to compare the correlation and the difference between the BP values measured by the two devices. The applicability of the ES in high-altitude areas was evaluated according to the validation standards of the 2018 Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.
UNASSIGNED: In this study, 257 participants were included. There was a strong correlation between BP values measured by the two devices, with correlation coefficients for systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 0.97 and 0.93, respectively. Compared with the MS, the ES tended to measure the subjects\' DBP (76.21 ± 13.29 mmHg vs. 76.53 ± 14.07 mmHg; P = 0.557) accurately, but overestimate the SBP of the subjects (123.32 ± 22.25 mmHg vs. 121.34 ± 22.88 mmHg; P < 0.001) to some extent. The consistency of the two devices in the classification of normal BP, prehypertension, and hypertension was 88.9%, 80.7%, and 89.2%, respectively.
UNASSIGNED: In general, the utilization of ES at 3,400 m altitude successfully met the validation standards of the AAMI/ESH/ISO Collaboration Statement. The use of ES can be recommended at a high altitude, including up to 3,400 m. In addition, because the ES tended to overestimate SBP, we speculate that it may need to be calibrated in high-altitude areas.

To evaluate the accuracy of the DBP-1333b upper-arm blood pressure (BP) measuring device in the adult population according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Subjects were recruited in the adult population. The test device was an arm-type electronic sphygmomanometer (DBP-1333b) and the reference device was a desktop sphygmomanometer (XJ11D). Using the BP data measured by the desktop sphygmomanometer as reference BP, the accuracy of the non-invasive BP module of the test device was evaluated to determine whether it met the requirements. Data from 90 individuals were analysed. According to Criterion 1, the mean difference of SBP between the test and reference device was 0.19 mmHg and the SD was 7.45 mmHg. The mean difference of DBP was -0.59 mmHg and the SD was 6.47 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, SD of SBP was 5.79 mmHg, which was less than 6.95 mmHg and met the requirements. The SD of DBP was 5.58 mmHg, which was less than 6.93 mmHg and met the requirements. It was concluded that the DBP-1333b complies with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020) and can be recommended for use by the adults.

Self-measured blood pressure (SMBP) monitoring is increasingly used for remote hypertension management, but the real-world performance of home blood pressure (BP) devices is unknown. We examined BP measurements from patients\' home devices using the American Medical Association\'s (AMA) SMBP Device Accuracy Test tool.
Patients at a single internal medicine clinic underwent up to five seated, same-arm BP readings using a home device and an automated BP device (Omron HEM-907XL). Following the AMA\'s three-step protocol, we used the patient\'s home device for the first, second, and fourth measurements and the office device for the third and fifth (if needed) measurements. Device agreement failure was defined as an absolute difference in systolic BP >10 mm Hg between the home and office devices in either of two confirmatory steps. Performance was examined by brand (Omron vs. non-Omron). Moreover, we examined patient factors associated with agreement failure via logistic regression models adjusted for demographic characteristics.
We evaluated 152 patients (mean age 60 ± 15 years, 58% women, 31% Black) seen between October 2020 and November 2021. Device agreement failure occurred in 22.4% (95% CI: 16.4%, 29.7%) of devices tested, including 19.1% among Omron devices and 27.6% among non-Omron devices (P = 0.23). No patient characteristics were associated with agreement failure.
Over one-fifth of home devices did not agree based on the AMA SMBP device accuracy protocol. These findings confirm the importance of office-based device comparisons to ensure the accuracy of home BP monitoring.

There is a worldwide need to improve blood pressure (BP) measurement error in order to correctly diagnose hypertension. Cardiovascular diseases cause 17.9 million deaths annually and are a substantial monetary strain on healthcare. The current measurement uncertainty of 3 mmHg should be improved upon. Dynamic pressure measurement standards are lacking or non-existing. In this study we propose a novel method of measuring air pressure inside the sphygmomanometer tubing during BP measurement using a condenser microphone. We designed, built, and tested a system that uses a radiofrequency (RF) modulation method to convert changes in capacitance of a condenser microphone into pressure signals. We tested the RF microphone with a low-frequency (LF) sound source, BP simulator and using a piezoresistive pressure sensor as a reference. Necessary tests were conducted to assess the uncertainty budget of the system. The RF microphone prototype has a working frequency range from 0.5 Hz to 280 Hz in the pressure range from 0 to 300 mmHg. The total expanded uncertainty (k = 2, p = 95.5%) of the RF microphone was 4.32 mmHg. The proposed method could establish traceability of BP measuring devices to acoustic standards described in IEC 61094-2 and could also be used in forming dynamic BP standards.

Accurate blood pressure (BP) measurement is crucial for hypertension detection and management. The Korea National Health and Nutrition Examination Survey (KNHANES) assesses the health of Koreans using representative cross-sectional data. BP measurements were historically done with mercury sphygmomanometers for participants aged ≥10 years. However, KNHANES transitioned to Greenlight 300TM (mercury-free auscultatory device) in 2020 for participants aged ≥6 years and used dual devices (Microlife WatchBP Office AFIB and Greenlight) in 2021-2022. To ensure consistency, KNHANES will adopt Microlife as the unified BP device with Greenlight for device validation from 2023. Under the new protocol, participants aged ≥6 years will have their BP measured three times at 30-second intervals after a 5-minute rest under ambient temperature (20-25℃) and noise ≤65 dB. The average of the 2nd and 3rd readings will be used as the representative BP value. The quality control (QC) program involves four trained examiners passing the \"quality control and assurance of BP measurement program\" three times annually, and undergoing \"video monitoring of weekly calibration process\" once a year. Additionally, the QC team will conduct \"on-site evaluations of BP measurement\" at mobile examination centers three times a year. A Five-Step QC process for BP devices was also developed. This document outlines the standardized BP measurement protocol and rigorous QC program in KNHANES, aiming to ensure accurate and reliable BP data for epidemiological research and public health policymaking in South Korea.

Blood pressure (BP) fluctuations outside of clinic are increasingly recognized for their role in the development of cardiovascular disease, syncope, and premature death and as a promising target for tailored hypertension treatment. However, current cuff-based BP devices, including home and ambulatory devices, are unable to capture the breadth of BP variability across human activities, experiences, and contexts.
Cuffless, wearable BP devices offer the promise of beat-to-beat, continuous, noninvasive measurement of BP during both awake and sleep periods with minimal patient inconvenience. Importantly, cuffless BP devices can characterize BP variability, allowing for the identification of patient-specific triggers of BP surges in the home environment. Unfortunately, the pace of evidence, regulation, and validation testing has lagged behind the pace of innovation and direct consumer marketing. We provide an overview of the available technologies and devices for cuffless BP monitoring, considerations for the calibration and validation of these devices, and the promise and pitfalls of the cuffless BP paradigm.