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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)

Stergiou, George S.a; Palatini, Paolob; Asmar, Rolandc; Ioannidis, John P.d; Kollias, Anastasiosa; Lacy, Petere; McManus, Richard J.f; Myers, Martin G.g; Parati, Gianfrancoh; Shennan, Andrewi; Wang, Jiguangj; O’Brien, Eoink on behalf of the European Society of Hypertension Working Group on Blood Pressure Monitoring

doi: 10.1097/HJH.0000000000002039
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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.

aHypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece

bDepartment of Medicine. University of Padova, Italy

cFoundation, Medical Research Institutes, Paris, France

dDepartments 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

eInstitute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, UK

fGreen Templeton College, and Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK

gUniversity of Toronto, Schulich Heart Program. Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada

hDepartment of Medicine and Surgery, University of Milano-Bicocca; Istituto Auxologico Italiano, IRCCS, Cardiology Unit and Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Milan, Italy

iDepartment of Women and Children's Health, School of Life Course Sciences, FoLSM, Kings College, London, UK

jShanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

kThe Conway Institute, University College Dublin, Ireland

Correspondence to Professor George S. Stergiou, MD, FRCP, Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital. 152 Mesogion Avenue, Athens 11527, Greece. Tel: +30 2107763117; fax: +30 2107719981; e-mail: gstergi@med.uoa.gr

Abbreviations: AAMI, US Association for the Advancement of Medical Instrumentation; BP, blood pressure; ESH, European Society of Hypertension; ISO, International Organization for Standardization; SD, standard deviation

Received 13 October, 2018

Revised 9 December, 2018

Accepted 10 December, 2018

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