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Lancet commission on hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure

Sharman, James E.a; O’Brien, Eoinb; Alpert, Brucec,*; Schutte, Aletta E.d; Delles, Christiane; Hecht Olsen, Michaelf,g; Asmar, Rolandh; Atkins, Neili; Barbosa, Eduardoj; Calhoun, Davidk; Campbell, Norm R.C.l; Chalmers, Johnm; Benjamin, Ivorn; Jennings, Garryo; Laurent, Stéphanep; Boutouyrie, Pierrep; Lopez-Jaramillo, Patricioq; McManus, Richard J.r; Mihailidou, Anastasia S.s; Ordunez, Pedrot; Padwal, Raju; Palatini, Paolov; Parati, Gianfrancow,x; Poulter, Neily; Rakotz, Michael K.z; Rosendorff, Cliveaa,bb; Saladini, Francescacc; Scuteri, Angelodd; Sebba Barroso, Weimaree; Cho, Myeong-Chanff; Sung, Ki-Chulgg; Townsend, Raymond R.hh; Wang, Ji-Guangii; Willum Hansen, Tinejj; Wozniak, Gregoryz; Stergiou, Georgekk on behalf of the Lancet Commission on Hypertension Group

doi: 10.1097/HJH.0000000000002246
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The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organisation for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.

aMenzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia

bThe Conway Institute, University College Dublin, Dublin, Ireland

cUniversity of Tennessee Health Science Center, Memphis, Tennessee, USA

dHypertension in Africa Research Team, Medical Research Council Unit for Hypertension and Cardiovascular Disease, North-West University, Potchefstroom, South Africa

eInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK

fDepartment of Internal Medicine, Holbaek Hospital, Holbaek

gCentre for Individualized Medicine in Arterial Diseases (CIMA), Odense University Hospital, University of Southern Denmark, Odense, Denmark

hFoundation-Medical Research Institutes, Geneva, Switzerland

iMedaval Ltd., Dublin, Ireland

jHypertension League of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

kVascular Biology and Hypertension Group, University of Alabama at Birmingham, Birmingham, Alabama, USA

lDepartment of Medicine, Physiology and Pharmacology and Community Health Sciences, O’Brien Institute for Public Health and Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada

mThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia

nAmerican Heart Association, Dallas, Texas, USA

oSydney Medical School, University of Sydney and Baker Heart & Diabetes Institute, Melbourne, Victoria, Australia

pDepartment of Pharmacology, European Georges Pompidou Hospital, Assistance Publique Hôpitaux de Paris, Inserm UMR 970 and University Paris Descartes, Paris, France

qFOSCAL, Instituto Masira, Facultad de Ciencias de la Salud, UDES, Bucaramanga, Colombia

rNuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK

sCardiovascular & Hormonal Research Laboratory, Department of Cardiology & Kolling Institute, Royal North Shore Hospital and Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia

tDepartment of Non Communicable and Mental Health, Pan American Health Organization, Washington, District of Columbia

uDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada

vStudium Patavinum, University of Padova, Padua

wDepartment of Cardiovascular, Neural and Metabolic Sciences, Istituto Auxologico Italiano, IRCCS, San Luca Hospital

xDepartment of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy

yImperial Clinical Trials Unit, Imperial College London, London, UK

zAmerican Medical Association, Improving Health Outcomes, Chicago, Illinois

aaDepartment of Medicine (Cardiology), Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York

bbThe James J. Peters VA Medical Center, Bronx, New York, USA

ccCardiology Unit, Department of Medicine, University of Padova, Town Hospital of Cittadella, Padova

ddDepartment of Medical, Surgical, and Experimental Sciences, University of Sassari, Sassari, Italy

eeHypertension League, Department of Cardiology, Federal University of Goiás, Goiânia, Brazil

ffDepartment of Internal Medicine, Chungbuk National University College of Medicine, Cheongju

ggDivision of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

hhPerelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA

iiThe Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

jjSteno Diabetes Center Copenhagen, Gentofte, Denmark

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

*Retired.

Correspondence to James E. Sharman, Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia. Tel: +61 0 3 6226 4709; e-mail: james.sharman@utas.edu.au

Received 7 June, 2019

Revised 5 August, 2019

Accepted 14 August, 2019

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