The accuracy of blood pressure (BP) measuring devices is fundamental to good practice and scientific research. International guidelines on BP measurement are provided for clinicians who diagnose and treat patients with hypertension, clinical researchers who conduct trials on the efficacy of BP lowering drugs and interventional strategies, epidemiologists who conduct population surveys to determine the demographic consequences of hypertension on society, and researchers who perform meta-analyses on published research to further influence the practice of medicine and the provision of resources. Although the outcomes of the endeavors of all these groups are dependent on the accuracy of BP measurements, the equipment is often of doubtful accuracy and the methodology of measurement is often poorly described and frequently not standardized. Thus, the fundamental element of hypertension evaluation has been largely ignored by both clinical practitioners and scientific researchers. Here, the authors briefly review the development of efforts to improve and validate the accuracy of BP measuring devices and highlight the deficiencies that persist. We conclude that, to protect the public from the serious consequences of inaccurate BP measurements, the following steps are required: (1) regulatory requirement for mandatory independent validation of all BP measuring devices using a universal protocol; (2) accreditation of laboratories for the performance of BP device validations; (3) online evaluation of validation studies with detection of protocol violations prior to publication of results; and (4) establishment of an independent scientific forum for the listing of accurate BP measuring devices.

A summary of statements for blood pressure (BP) measurement in the evaluation of hypertension in the 21st century by 25 international experts is provided. The status of office, home and ambulatory BP measurement techniques are discussed. Office BP measurement, whether automated (preferred), or otherwise, should only be used as a screening measurement, and diagnostic decisions for the initiation and titration of drug treatment should be based on out-of-office measurements (ambulatory or home). The hardware and software requirements and the adaptations of BP measuring devices to record other cardiovascular functions, such as arrhythmias, and adaptations for smartphone use and for electronic transmission are discussed. Regulatory bodies are urged to make accuracy and performance assessment mandatory before marketing BP measuring devices. The legal implications of manufacturing inaccurate devices are noted.

Blood pressure (BP) is a vital sign and the essential measurement for the diagnosis of hypertension. Therefore, its accurate measurement is a key element for the evaluation of many medical conditions and for the reliable diagnosis and efficient treatment of hypertension. In the last 3 decades prestigious organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on BP Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. All these initiatives aim to standardize validation procedures and establish minimum accuracy standards for BP monitors. Unfortunately, only a few of the BP measuring devices available on the market have been subjected to independent validation using one of these protocols. Recently, the AAMI, ESH, and ISO experts agreed to develop a single universally acceptable standard (AAMI/ESH/ISO), which will replace all previous protocols. This major international initiative has been undertaken to best serve the needs of patients with hypertension, a public interested in cardiovascular health, practicing physicians, scientific researchers, regulatory bodies, and manufacturers. There is an urgent need to influence regulatory authorities throughout the world to make it mandatory for all BP measuring devices to have undergone independent validation before approval for marketing. Efforts need to be intensified to improve the accuracy of BP measuring devices, further optimize the validation procedure, and ensure that objective and unbiased validation data become available.

In the last 2 decades, several scientific societies have published specific guidelines for blood pressure (BP) measurement, providing detailed recommendations for office, home, and ambulatory BP monitoring. These documents typically provided strong support for using out-of-office BP monitoring (ambulatory and home). More recently, several organizations recommended out-of-office BP evaluation as a primary method for diagnosing hypertension and for treatment titration, with office BP regarded as a screening method. Efforts should now be directed towards making ambulatory and home BP monitoring readily available in primary care and ensuring that such measurements are obtained by following current guidelines. Moreover, it should be mandatory for all published clinical research papers on hypertension to provide details on the methodology of the BP measurement.

Home blood pressure monitoring provides multiple measurements in the usual environment of each individual, allows the detection of intermediate hypertension phenotypes (white-coat and masked hypertension), and appears to have superior prognostic value compared to the conventional office blood pressure measurements. Accumulating evidence suggests that home blood pressure monitoring improves long-term hypertension control rates. Moreover, it is widely available, relatively inexpensive, and well accepted by patients. Thus, current guidelines recommend home blood pressure monitoring as an essential method for the evaluation of almost all untreated and treated patients with suspected or treated hypertension. Validated automated upper-arm cuff devices with automated storage and averaging of readings should be used. The home blood pressure monitoring schedule for 4 to 7 days with exclusion of the first day (12-24 readings) should be averaged to provide values for decision making.

This study assessed the diagnostic accuracy of a novel 24-hour ambulatory blood pressure (ABP) monitor (Microlife WatchBP O3 Afib) with implemented algorithm for automated atrial fibrillation (AF) detection during each ABP measurement. One hundred subjects (mean age 70.6±8.2 [SD] years; men 53%; hypertensives 85%; 17 with permanent AF; 4 paroxysmal AF; and 79 non-AF) had simultaneous 24-hour ABP monitoring and 24-hour Holter monitoring. Among a total of 6410 valid ABP readings, 1091 (17%) were taken in ECG AF rhythm. In reading-to-reading ABP analysis, the sensitivity, specificity, and accuracy of ABP monitoring in detecting AF were 93%, 87%, and 88%, respectively. In non-AF subjects, 12.8% of the 24-hour ABP readings indicated false-positive AF, of whom 27% were taken during supraventricular premature beats. There was a strong association between the proportion of false-positive AF readings and that of supraventricular premature beats (

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

: In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

The European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and Cardiovascular Variability organized a Teaching Course on 'Blood Pressure Monitoring: Theory and Practice' during the 2017 ESH Meeting in Milan, Italy. This course performed by 11 international BP monitoring experts covered key topics of BP monitoring, including office BP measurement, ambulatory BP monitoring, home BP monitoring, ambulatory versus home BP, white-coat and masked hypertension, cuff use, and BP variability. This article presents a summary of the proceedings of the ESH BP Monitoring Teaching Course, including essential information, practical issues, and recommendations on the clinical application of BP monitoring methods, aiming to the optimal management of patients with suspected or diagnosed hypertension.