European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.

Autor:	Stergiou GS; Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece., Avolio AP; Macquarie Medical School, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia., Palatini P; Department of Medicine, University of Padova, Padova, Italy., Kyriakoulis KG; Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece., Schutte AE; School of Population Health, University of New South Wales, The George Institute for Global Health, Sydney, New South Wales, Australia., Mieke S; Physikalisch-Technische Bundesanstalt, Berlin, Germany., Kollias A; Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece., Parati G; Department 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., Asmar R; Foundation-Medical Research Institutes, Geneva, Switzerland., Pantazis N; Department of Hygiene, Epidemiology & Medical Statistics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece., Stamoulopoulos A; Department of Hygiene, Epidemiology & Medical Statistics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece., Asayama K; Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan., Castiglioni P; IRCCS Fondazione Don Carlo Gnocchi Onlus, Milan, Italy; Department of Biotechnology and Life Sciences (DBSV), University of Insubria, Varese, Italy., De La Sierra A; Department of Internal Medicine, Hospital Mutua Terrassa, University of Barcelona, Catalonia, Spain., Hahn JO; Department of Mechanical Engineering, University of Maryland, College Park, Maryland, USA., Kario K; Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan., McManus RJ; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Myers M; Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada., Ohkubo T; Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan., Shroff SG; Department of Bioengineering and Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA., Tan I; The George Institute for Global Health, Macquarie Medical School, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia., Wang J; The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai., Zhang Y; Hong Kong Centre for Cerebro-Cardiovascular Health Engineering (COCHE), Hong Kong, China., Kreutz R; Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Department of Clinical Pharmacology & Toxicology, Charité University Medicine, Berlin, Germany., O'Brien E; The Conway Institute, University College Dublin, Dublin, Ireland., Mukkamala R; Department of Bioengineering and Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Jazyk:	angličtina
Zdroj:	Journal of hypertension [J Hypertens] 2023 Dec 01; Vol. 41 (12), pp. 2074-2087. Date of Electronic Publication: 2023 Jun 22.
DOI:	10.1097/HJH.0000000000003483
Abstrakt:	Background: There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use. Objective: This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common. Validation Procedures: Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position. Conclusion: The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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