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Blood Press Monit. 2019 Aug;24(4):163-166. doi: 10.1097/MBP.0000000000000391.

Validation protocols for blood pressure measuring devices: the impact of the European Society of Hypertension International Protocol and the development of a Universal Standard.

Author information

1
The Conway Institute, University College Dublin, Ireland.
2
Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.
3
Department of Medicine. University of Padova, Padua, Italy.
4
Foundation, Medical Research Institutes, Paris, France.
5
Departments of Medicine.
6
Health Research and Policy.
7
Biomedical Data Science, Stanford University School of Medicine.
8
Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, California, USA.
9
Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, London.
10
Nuffield Department of Primary Care Health Sciences and Green Templeton College, University of Oxford, Oxford, UK.
11
Schulich Heart Program, University of Toronto.
12
Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada.
13
Department of Women and Children's Health, School of Life Course Sciences, FoLSM, Kings College, London, UK.
14
Department of Hypertension, Shanghai Institute of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
15
Department of Medicine and Surgery, University of Milano-Bicocca.
16
Cardiology Unit and Department of Cardiovascular, Neural and Metabolic Sciences, Istituto Auxologico Italiano, IRCCS, S.Luca Hospital, Milan, Italy.

Abstract

In the last three decades protocols for the validation of blood pressure measuring devices have been developed by the US Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League, the European Society of Hypertension Working Group on blood pressure Monitoring and the International Organization for Standardization. The European Society of Hypertension International Protocol required much smaller sample size than the other protocols, aiming to reduce the time, resources and cost of validation studies and thereby increase the number of validated devices. Given its specifications, the European Society of Hypertension International Protocol was adequate for 'high- and low-accuracy' devices, yet assessment of 'moderate accuracy' devices had high uncertainty with resultant high rate of device failure. Thus, devices validated using the European Society of Hypertension International Protocol should be considered to be as accurate as those validated with the previous Association for the Advancement of Medical Instrumentation or British Hypertension Society protocols. However, the European Society of Hypertension International Protocol did not allow subgroup evaluation (arm sizes, special populations, etc). The mission of the European Society of Hypertension International Protocol to promote the concept of validation has been well achieved, as almost double studies have been published using it than all the other protocols together. However, the maintenance of different validation protocols is confusing and therefore experts from the Association for the Advancement of Medical Instrumentation, European Society of Hypertension International Protocol and International Organization for Standardization have now developed the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) as the recommended 21st-century procedure for worldwide application. The European Society of Hypertension Working Group has published a practical guide for using the Universal Standard. It is in the interests of all scientific bodies to propagate the Universal Standard and ensure its wide implementation.

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