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J Hypertens. 2019 Mar;37(3):459-466. doi: 10.1097/HJH.0000000000002039.

Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO).

Author information

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

Abstract

: In the past 30 years, several organizations have developed protocols for clinical validation of blood pressure measuring devices. An international initiative was recently launched by the US Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension Working Group on Blood Pressure Monitoring (ESH) and the International Organization for Standardization (ISO), aiming to reach consensus on a universal AAMI/ESH/ISO validation standard. The purpose of this statement by the ESH Working Group on Blood Pressure Monitoring is to provide practical guidance for investigators performing validation studies according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), to ensure that its stipulations are meticulously implemented and data are fully reported. Thus, this statement provides: a list of key recommendations for validation studies of intermittent non-invasive automated blood pressure measuring devices according to the AAMI/ESH/ISO Universal Standard; practical stepwise guidance for researchers performing these validation studies; a checklist for authors and reviewers of such studies; an example of a complete validation study report.

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