Cited by 278Blood Pressure and Hypertension StudiesNon-Invasive Vital Sign MonitoringHemodynamic Monitoring and Therapy

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A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement

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Stergiou, George S., Alpert, Bruce, Mieke, Stephan, Asmar, Roland, Atkins, Neil, Eckert, Siegfried, Frick, Gerhard, Friedman, Bruce, Graßl, Thomas, Ichikawa, Tsutomu, Ioannidis, John P., Lacy, Peter, McManus, Richard, Murray, Alan, Myers, Martin, Palatini, Paolo, Parati, Gianfranco, Quinn, David, Sarkis, Josh, Shennan, Andrew, Usuda, Takashi, Wang, Jiguang, Wu, Colin O., O’Brien, Eoin·2018·Journal of Hypertension

DOI 10.1097/hjh.0000000000001634PMC PMC5796427

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Abstract

: 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.

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The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems
Brien, E. O., Petrie, J. C., Littler, W. A., de Swiet, M., Padfield, P. L., O??Malley, K., Jamieson, M., Altman, D. G., Bland, M., & Atkins, N. (1990) · Journal of Hypertension · doi:10.1097/00004872-199007000-00004 · Cited by 764
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Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults
O'Brien, E. T., Pickering, T. G., Asmar, R. G., Myers, M. G., Parati, G., Staessen, J. A., Mengden, T., Imai, Y., Waeber, B., Palatini, P., et al. (2002) · Blood Pressure Monitoring · doi:10.1097/00126097-200202000-00002 · Cited by 735
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European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults
O'Brien, E. T., Atkins, N., Stergiou, G. S., Karpettas, N., Parati, G., Asmar, R. G., Imai, Y., Wang, J., Mengden, T., & Shennan, A. H. (2010) · Blood Pressure Monitoring · doi:10.1097/mbp.0b013e3283360e98 · Cited by 609
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Short report: An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices
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European Society of Hypertension International Protocol for the validation of blood pressure monitors: a critical review of its application and rationale for revision
Stergiou, G. S., Karpettas, N., Atkins, N., & O'Brien, E. T. (2010) · Blood Pressure Monitoring · doi:10.1097/mbp.0b013e3283360eaf · Cited by 63
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Accuracy of ambulatory blood pressure monitors
Hodgkinson, J., Sheppard, J. P., Heneghan, C. J., Martin, U., Mant, J., Roberts, N. W., & McManus, R. J. (2013) · Journal of Hypertension · doi:10.1097/hjh.0b013e32835b8d8b · Cited by 45
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Assessment of the validation of blood pressure monitors: a statistical reappraisal.
Friedman, B. A., Alpert, B., Osborn, D., Prisant, L., Quinn, D. I., & Seller, J. D. (2008) · Blood Pressure Monitoring · doi:10.1097/mbp.0b013e3283071a64 · Cited by 44
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The pursuit of accurate blood pressure measurement: A 35‐year travail
O'Brien, E., & Stergiou, G. S. (2017) · The Journal of Clinical Hypertension · doi:10.1111/jch.13005 · Cited by 39
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The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices
Tholl, U., Lüders, S., Bramlage, P., Dechend, R., Eckert, S., Mengden, T., Nürnberger, J., Sanner, B. M., & Anlauf, M. (2016) · Blood Pressure Monitoring · doi:10.1097/mbp.0000000000000186 · Cited by 33
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Proposals for simplifying the validation protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation
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O’Brien, 1993, The British Hypertension Society protocol for the evaluation of blood pressure measuring devices, J Hypertens, 11, S43

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Authors: Stergiou, G. S., Alpert, B., Mieke, S., Asmar, R., Atkins, N., Eckert, S., Frick, G., Friedman, B., Graßl, T., Ichikawa, T., Ioannidis, J. P., Lacy, P., McManus, R., Murray, A., Myers, M., Palatini, P., Parati, G., Quinn, D., Sarkis, J., Shennan, A., Usuda, T., Wang, J., Wu, C. O., & O’Brien, E.
Affiliations: National and Kapodistrian University of Athens (GR)
University of Tennessee Health Science Center (US)
Physikalisch-Technische Bundesanstalt (DE)
Heart and Diabetes Center North Rhine-Westphalia (DE)
General Electric (United States) (US)
Dräger (Germany) (DE)
Omron (Japan) (JP)
Stanford Medicine (US)
National Institute for Health and Care Research (GB)
University of Oxford (GB)
Newcastle University (GB)
Sunnybrook Health Science Centre (CA)
University of Padua (IT)
IRCCS Istituto Auxologico Italiano (IT)
Welch Allyn (United States) (US)
St Thomas' Hospital (GB)
Nihon Kohden (Japan) (JP)
National Institutes of Health (US)
Corresponding author: Stergiou, George S.
Asmar, Roland
Atkins, Neil
Ioannidis, John P.
Myers, Martin
Palatini, Paolo
Parati, Gianfranco
Shennan, Andrew
ORCID: Stergiou, George S.
Alpert, Bruce
Mieke, Stephan
Asmar, Roland
Atkins, Neil
Eckert, Siegfried
Ioannidis, John P.
Lacy, Peter
McManus, Richard
Murray, Alan
Myers, Martin
Palatini, Paolo
Parati, Gianfranco
Quinn, David
Shennan, Andrew
Wu, Colin O.
Venue: Journal of Hypertension
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2018-03
Volume: 36
Issue: 3
Pages: 472-478
ISSN: 0263-6352 (ISSN-L)
DOI: 10.1097/hjh.0000000000001634
PMC: PMC5796427
OpenAlex: W2787867538
Cited by: 278
References: 19
Citations by year: 2026: 49 · 2025: 42 · 2024: 38 · 2023: 31 · 2022: 39 · 2021: 27 · 2020: 24 · 2019: 17 · 2018: 10
FWCI: 14.75
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Journal of Hypertension (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
UCL Discovery (University College London) (submittedVersion)
BOA (University of Milano-Bicocca) (submittedVersion)
Research Portal (King's College London) (submittedVersion)
Newcastle University ePrints (Newcastle Univesity)
Funders: National Institute for Health and Care Research (NIHR-RP-02-12-015)
National Institutes of Health (Z99 HL999999)
Engineering and Physical Sciences Research Council (EP/N025342/1)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
Health Sciences › Medicine › Surgery › Hemodynamic Monitoring and Therapy
Keywords: blood pressure measuring devices, device validation, validation protocol, measurement accuracy, international standardization, AAMI, European Society of Hypertension, ISO, hypertension monitoring
MeSH terms: Blood Pressure, Blood Pressure Determination, Humans, Hypertension, International Cooperation, Research Design, Reproducibility of Results, Sphygmomanometers, Consensus, Validation Studies as Topic

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A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement

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