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.
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.
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.
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.

Objective: Accurate and reliable blood pressure (BP) measurement is important for the prevention and treatment of hypertension. The oscillometric-based automatic office blood pressure measurement (AOBPM) is widely used in hospitals and clinics, but measurement errors are common in BP measurements. There is a lack of systematic review of the sources of measurement errors.Approach: A systematic review of all existing research on sources of AOBPM errors. A search strategy was designed in six online databases, and all the literature published before October 2021 was selected. Those studies that used the AOBPM device to measure BP from the upper arm of subjects were included.Main results: A total of 1365 studies were screened, and 224 studies were included in this final review. They investigated 22 common error sources with clinical AOBPM. Regarding the causes of BP errors, this review divided them into the following categories: the activities before measurement, patient\'s factors, measurement environment, measurement procedure, and device settings. 13 sources caused increased systolic and diastolic BP (SBP and DBP), 2 sources caused the decrease in SBP and DBP, only 1 source had no significant effect on BPs, and the other errors had a non-uniform effect (either increase or decrease in BPs). The error ranges for SBP and DBP were -14 to 33 mmHg and -6 to 19 mmHg, respectively.Significance: The measurement accuracy of AOBPM is susceptible to the influence of measurement factors. Interpreting BP readings need to be treated with caution in clinical measurements. This review made comprehensive evidence for the need for standardized BP measurements and provided guidance for clinical practitioners when measuring BP with AOBPM devices.

Many cuffless blood pressure (BP) measuring devices are currently on the market claiming that they provide accurate BP measurements. These technologies have considerable potential to improve the awareness, treatment, and management of hypertension. However, recent guidelines by the European Society of Hypertension do not recommend cuffless devices for the diagnosis and management of hypertension.
This statement by the European Society of Hypertension Working Group on BP Monitoring and Cardiovascular Variability presents the types of cuffless BP technologies, issues in their validation, and recommendations for clinical practice.
Cuffless BP monitors constitute a wide and heterogeneous group of novel technologies and devices with different intended uses. Cuffless BP devices have specific accuracy issues, which render the established validation protocols for cuff BP devices inadequate for their validation. In 2014, the Institute of Electrical and Electronics Engineers published a standard for the validation of cuffless BP devices, and the International Organization for Standardization is currently developing another standard. The validation of cuffless devices should address issues related to the need of individual cuff calibration, the stability of measurements post calibration, the ability to track BP changes, and the implementation of machine learning technology. Clinical field investigations may also be considered and issues regarding the clinical implementation of cuffless BP readings should be investigated.
Cuffless BP devices have considerable potential for changing the diagnosis and management of hypertension. However, fundamental questions regarding their accuracy, performance, and implementation need to be carefully addressed before they can be recommended for clinical use.

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.
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.
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.
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).
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.

This study aims to systematically review the diagnostic accuracy of a digital blood pressure measurement device compared to the gold standard mercury sphygmomanometer in published studies. Searches were conducted in PubMed, Cochrane, EBSCO, EMBASE and Google Scholar host databases using the specific search strategy and filters from 1st January 2000 to 3rd April 2021. We included studies reporting data on the sensitivity or specificity of blood pressure measured by digital devices and mercury sphygmomanometer used as the reference standard. Studies conducted among children, special populations, and specific disease groups were excluded. We considered published manuscripts in the English language only. The risk of bias and applicability concerns were assessed based on the author\'s judgment using the QUADAS2 manual measurement evaluation tool. Based on the screening, four studies were included in the final analysis. Sensitivity, specificity, diagnostic odds ratio (DOR), and 95% confidence interval were estimated. The digital blood pressure monitoring has a moderate level of accuracy and the device can correctly distinguish hypertension with a pooled estimate sensitivity of 65.7% and specificity of 95.9%. After removing one study, which had very low sensitivity and very high specificity, the pooled sensitivity estimate was 79%, and the specificity was 91%. The meta-analysis of DOR suggests that the digital blood pressure monitor had moderate accuracy with a mercury sphygmomanometer. This will provide the clinician and patients with accurate information on blood pressure with which diagnostic and treatment decisions could be made.

OBJECTIVE: A mercury sphygmomanometer has been considered a gold standard for measuring blood pressure. However, by the Minamata Convention on Mercury, the traditional mercury sphygmomanometer is being replaced by an automated oscillometric device. This study aimed to provide scientific evidence to determine whether an automated oscillometric device can replace a mercury sphygmomanometer and if it is applicable in routine practice.
METHODS: MEDLINE, EMBASE, the Cochrane Library, and CINAHL were searched on 4 May 2018. Studies comparing blood pressure measurements between automated oscillometric devices and mercury sphygmomanometers were included. Study characteristics were abstracted using the evidence table, and random-effects meta-analyses were conducted.
RESULTS: Data were compiled from 24 studies comprising 47 759 subjects. The results of meta-analysis showed that automated oscillometric devices measured lower than mercury sphygmomanometers for both systolic blood pressure (mean differences -1.75 mmHg, 95% confidence intervals: -3.05 to -0.45, I = 91.0%) and diastolic blood pressure (mean differences -1.20 mmHg, 95% confidence intervals: -2.16 to -0.24, I = 95.0%). In sub-group analyses by manufacturer, BpTRU measured lower than the mercury sphygmomanometer and OMRON showed no difference compared to the mercury sphygmomanometer for both systolic and diastolic blood pressure, but the results differed depending on the devices.
CONCLUSIONS: As a result of this review, the difference in blood pressure between the mercury sphygmomanometer and the automated oscillometric device was within 5 mmHg, but the heterogeneity between the studies was very high. The automated oscillometric devices showed differences in blood pressure results according to the manufacturer and product type.

Background: This study was conducted to verify if automated oscillometric blood pressure monitors (AOBPMs) have sufficiently high predictive validity to screen patients with atrial fibrillation (AF). Methods: Electronic searches were performed to identify all studies published between 1946 and 14 July 2018, from indexed in Ovid-Medline, Embase, the Cochrane Library, and CINAHL by using the following keywords: \'atrial fibrillation,\' \'atrial flutter,\' \'blood pressure monitor,\' and \'sphygmomanometer.\' Results: Thirteen diagnostic accuracy studies, including a total of 9,380 elderly, were included in our meta-analysis. The meta-analysis showed that the pooled sensitivity was 0.91 (95% CI, 0.89 to 0.93), and the heterogeneity between studies was as high as 88.4% (X2 = 120.55, p < 0.001). The pooled specificity was 0.96 (95% CI, 0.96 to 0.97), and the heterogeneity between studies was 95.3% (X2 = 299.26, p < .001). The area under the curve (AUC) of the summary receiver operating characteristic (sROC) curve was 0.98 (SE = 0.005), and the Q-value was 0.94 (SE = 0.010). Conclusion: The AOBPM is an appropriate screening tool that may be applied to elderly to verify the presence of AF conveniently. The AOBPM has high applicability in practice, since it may prevent potentially fatal complications such as stroke.

Automated office blood pressure (AOBP) measurement involves recording several blood pressure (BP) readings using a fully automated oscillometric sphygmomanometer with the patient resting alone in a quiet place. Although several studies have shown AOBP measurement to be more accurate than routine office BP measurement and not subject to a \"white coat effect,\" the cumulative evidence has not yet been systematically reviewed.
To perform a systematic review and meta-analysis to examine the association between AOBP and office BP readings measured in routine clinical practice and in research studies, and ambulatory BP recorded during awake hours, as the latter is a standard for predicting future cardiovascular events.
The MEDLINE, Embase, and Cochrane Library were searched from 2003 to April 25, 2018.
Studies on systolic and diastolic BP measurement by AOBP in comparison with awake ambulatory BP, routine office BP, and research BP measurements were included if they contained 30 patients or more.
Study characteristics were abstracted independently and random effects meta-analyses and meta-regressions were conducted.
Pooled mean differences (95% CI) of systolic and diastolic BP between types of BP measurement.
Data were compiled from 31 articles comprising 9279 participants (4736 men and 4543 women). In samples with systolic AOBP of 130 mm Hg or more, routine office and research systolic BP readings were substantially higher than AOBP readings, with a pooled mean difference of 14.5 mm Hg (95% CI, 11.8-17.2 mm Hg; n = 9; I2 = 94.3%; P < .001) for routine office systolic BP readings and 7.0 mm Hg (95% CI, 4.9-9.1 mm Hg; n = 9; I2 = 85.7%; P < .001) for research systolic BP readings. Systolic awake ambulatory BP and AOBP readings were similar, with a pooled mean difference of 0.3 mm Hg (95% CI, -1.1 to 1.7 mm Hg; n = 19; I2 = 90%; P < .001).
Automated office blood pressure readings, only when recorded properly with the patient sitting alone in a quiet place, are more accurate than office BP readings in routine clinical practice and are similar to awake ambulatory BP readings, with mean AOBP being devoid of any white coat effect. There has been some reluctance among physicians to adopt this technique because of uncertainty about its advantages compared with more traditional methods of recording BP during an office visit. Based on the evidence, AOBP should now be the preferred method for recording BP in routine clinical practice.

Atrial fibrillation (AF) affects ~3% of the general population and is twice as common with hypertension. Validation protocols for automated sphygmomanometers exclude people with AF, raising concerns over accuracy of hypertension diagnosis or management, using out-of-office blood pressure (BP) monitoring, in the presence of AF. Some devices include algorithms to detect AF; a feature open to misinterpretation as offering accurate BP measurement with AF. We undertook this review to explore accuracy of automated devices, with or without AF detection, for measuring BP. We searched Medline and Embase to October 2018 for studies comparing automated BP measurement devices to a standard mercury sphygmomanometer contemporaneously. Data were extracted by two reviewers. Mean BP differences between devices and mercury were calculated, where not reported and compared; meta-analyses were undertaken where possible. We included 13 studies reporting 14 devices. Mean systolic and diastolic BP differences from mercury ranged from -3.1 to + 6.1/-4.6 to +9.0 mmHg. Considerable heterogeneity existed between devices (I2: 80 to 90%). Devices with AF detection algorithms appeared no more accurate for BP measurement with AF than other devices. A previous review concluded that oscillometric devices are accurate for systolic but not diastolic BP measurement in AF. The present findings do not support that conclusion. Due to heterogeneity between devices, they should be evaluated on individual performance. We found no evidence that devices with AF detection measure BP more accurately in AF than other devices. More home or ambulatory automated BP monitors require validation in populations with AF.

Blood pressure (BP) is a bio-physiological signal that can provide very useful information regarding human\'s general health. High or low blood pressure or its rapid fluctuations can be associated to various diseases or conditions. Nowadays, high blood pressure is considered to be an important health risk factor and major cause of various health problems worldwide. High blood pressure may precede serious heart diseases, stroke and kidney failure. Accurate blood pressure measurement and monitoring plays fundamental role in diagnosis, prevention and treatment of these diseases. Blood pressure is usually measured in the hospitals, as a part of a standard medical routine. However, there is an increasing demand for methodologies, systems as well as accurate and unobtrusive devices that will permit continuous blood pressure measurement and monitoring for a wide variety of patients, allowing them to perform their daily activities without any disturbance. Technological advancements in the last decade have created opportunities for using various devices as a part of ambient assisted living for improving quality of life for people in their natural environment. The main goal of this paper is to provide a comprehensive review of various methodologies for continuous cuff-less blood pressure measurement, as well as to evidence recently developed devices and systems for continuous blood pressure measurement that can be used in ambient assisted living applications.