The urgency to regulate validation of automated blood pressure measuring devices: a policy statement and call to action from the world hypertension league

James E. Sharman; Pedro Ordunez; Tammy Brady; Gianfranco Parati; George Stergiou; Paul K. Whelton; Raj Padwal; Michael Hecht Olsen; Christian Delles; Aletta E. Schutte; Maciej Tomaszewski; Daniel T. Lackland; Nadia Khan; Richard J. McManus; Ross T. Tsuyuki; Xin Hua Zhang; Lisa D. Murphy; Andrew E. Moran; Markus P. Schlaich; Norm R.C. Campbell

doi:10.1038/s41371-022-00747-0

The urgency to regulate validation of automated blood pressure measuring devices: a policy statement and call to action from the world hypertension league

James E. Sharman^*, Pedro Ordunez, Tammy Brady, Gianfranco Parati, George Stergiou, Paul K. Whelton, Raj Padwal, Michael Hecht Olsen, Christian Delles, Aletta E. Schutte, Maciej Tomaszewski, Daniel T. Lackland, Nadia Khan, Richard J. McManus, Ross T. Tsuyuki, Xin Hua Zhang, Lisa D. Murphy, Andrew E. Moran, Markus P. Schlaich, Norm R.C. Campbell

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Originalsprog	Engelsk
Tidsskrift	Journal of Human Hypertension
Vol/bind	37
Udgave nummer	2
Sider (fra-til)	155-159
ISSN	0950-9240
DOI	https://doi.org/10.1038/s41371-022-00747-0
Status	Udgivet - feb. 2023

Bibliografisk note

Funding Information:
TMB is co-chair of the Association for the Advancement of Medical Instrumentation Sphygmomanometer committee. TMB is co-chair of the American Medical Association’s Validated Device Listing Independent Review Committee. TMB has also received funding research or salary support from Resolve to Save Lives. Resolve to Save Lives is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy. RJMs employer (University of Oxford) receives licensing and consulting fees from Omron and Sensyne for telemonitoring solutions developed from his research. NRCC reports personal fees from Resolve to Save Lives, the Pan American Health Organization, the World Bank and Switch Health Inc. outside the submitted work; and is an unpaid member of World Action on Salt, Sugar, and Health and an unpaid consultant on dietary sodium and hypertension control to numerous governmental and non-governmental organizations. RP is CEO of mmHg, provider of digital health and software services, including remote patient monitoring software. AES is on the Executive Management Board of STRIDE BP and is co-author of the World Health Organization’s technical specifications of blood pressure devices. JES is a consultant of HEARTS in the Americas, an initiative of the Pan American Health Organization. JES is principal investigator of a National Health and Medical Research Council partnership grant (S0026615) that includes a medical technology company that manufactures a central blood pressure monitor. MPS has received research support from Medtronic, Abbott, Metavention, Recor, and Boehringer Ingelheim and personal fees/travel support from Medtronic and Abbott. GSS is chairing the STRIDE BP organization for blood pressure measurement methods and devices, conducted validation studies of blood pressure monitors, and advised manufacturers on device and software development. MT has received unrestricted gift in kind from Omron for the purpose of a clinical study. None of the other authors have disclosures.

Dokumenter og links

10.1038/s41371-022-00747-0Licens: CC BY

Open Access VersionForlagets udgivne version, 720 KBLicens: CC BY

Citationsformater

Sharman, J. E., Ordunez, P., Brady, T., Parati, G., Stergiou, G., Whelton, P. K., Padwal, R., Olsen, M. H., Delles, C., Schutte, A. E., Tomaszewski, M., Lackland, D. T., Khan, N., McManus, R. J., Tsuyuki, R. T., Zhang, X. H., Murphy, L. D., Moran, A. E., Schlaich, M. P., & Campbell, N. R. C. (2023). The urgency to regulate validation of automated blood pressure measuring devices: a policy statement and call to action from the world hypertension league. Journal of Human Hypertension, 37(2), 155-159. https://doi.org/10.1038/s41371-022-00747-0

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title = "The urgency to regulate validation of automated blood pressure measuring devices: a policy statement and call to action from the world hypertension league",

author = "Sharman, {James E.} and Pedro Ordunez and Tammy Brady and Gianfranco Parati and George Stergiou and Whelton, {Paul K.} and Raj Padwal and Olsen, {Michael Hecht} and Christian Delles and Schutte, {Aletta E.} and Maciej Tomaszewski and Lackland, {Daniel T.} and Nadia Khan and McManus, {Richard J.} and Tsuyuki, {Ross T.} and Zhang, {Xin Hua} and Murphy, {Lisa D.} and Moran, {Andrew E.} and Schlaich, {Markus P.} and Campbell, {Norm R.C.}",

note = "Funding Information: TMB is co-chair of the Association for the Advancement of Medical Instrumentation Sphygmomanometer committee. TMB is co-chair of the American Medical Association{\textquoteright}s Validated Device Listing Independent Review Committee. TMB has also received funding research or salary support from Resolve to Save Lives. Resolve to Save Lives is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy. RJMs employer (University of Oxford) receives licensing and consulting fees from Omron and Sensyne for telemonitoring solutions developed from his research. NRCC reports personal fees from Resolve to Save Lives, the Pan American Health Organization, the World Bank and Switch Health Inc. outside the submitted work; and is an unpaid member of World Action on Salt, Sugar, and Health and an unpaid consultant on dietary sodium and hypertension control to numerous governmental and non-governmental organizations. RP is CEO of mmHg, provider of digital health and software services, including remote patient monitoring software. AES is on the Executive Management Board of STRIDE BP and is co-author of the World Health Organization{\textquoteright}s technical specifications of blood pressure devices. JES is a consultant of HEARTS in the Americas, an initiative of the Pan American Health Organization. JES is principal investigator of a National Health and Medical Research Council partnership grant (S0026615) that includes a medical technology company that manufactures a central blood pressure monitor. MPS has received research support from Medtronic, Abbott, Metavention, Recor, and Boehringer Ingelheim and personal fees/travel support from Medtronic and Abbott. GSS is chairing the STRIDE BP organization for blood pressure measurement methods and devices, conducted validation studies of blood pressure monitors, and advised manufacturers on device and software development. MT has received unrestricted gift in kind from Omron for the purpose of a clinical study. None of the other authors have disclosures. ",

year = "2023",

month = feb,

doi = "10.1038/s41371-022-00747-0",

language = "English",

volume = "37",

pages = "155--159",

journal = "Journal of Human Hypertension",

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Sharman, JE, Ordunez, P, Brady, T, Parati, G, Stergiou, G, Whelton, PK, Padwal, R, Olsen, MH, Delles, C, Schutte, AE, Tomaszewski, M, Lackland, DT, Khan, N, McManus, RJ, Tsuyuki, RT, Zhang, XH, Murphy, LD, Moran, AE, Schlaich, MP & Campbell, NRC 2023, 'The urgency to regulate validation of automated blood pressure measuring devices: a policy statement and call to action from the world hypertension league', Journal of Human Hypertension, bind 37, nr. 2, s. 155-159. https://doi.org/10.1038/s41371-022-00747-0

TY - JOUR

T1 - The urgency to regulate validation of automated blood pressure measuring devices

T2 - a policy statement and call to action from the world hypertension league

AU - Sharman, James E.

AU - Ordunez, Pedro

AU - Brady, Tammy

AU - Parati, Gianfranco

AU - Stergiou, George

AU - Whelton, Paul K.

AU - Padwal, Raj

AU - Olsen, Michael Hecht

AU - Delles, Christian

AU - Schutte, Aletta E.

AU - Tomaszewski, Maciej

AU - Lackland, Daniel T.

AU - Khan, Nadia

AU - McManus, Richard J.

AU - Tsuyuki, Ross T.

AU - Zhang, Xin Hua

AU - Murphy, Lisa D.

AU - Moran, Andrew E.

AU - Schlaich, Markus P.

AU - Campbell, Norm R.C.

N1 - Funding Information: TMB is co-chair of the Association for the Advancement of Medical Instrumentation Sphygmomanometer committee. TMB is co-chair of the American Medical Association’s Validated Device Listing Independent Review Committee. TMB has also received funding research or salary support from Resolve to Save Lives. Resolve to Save Lives is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy. RJMs employer (University of Oxford) receives licensing and consulting fees from Omron and Sensyne for telemonitoring solutions developed from his research. NRCC reports personal fees from Resolve to Save Lives, the Pan American Health Organization, the World Bank and Switch Health Inc. outside the submitted work; and is an unpaid member of World Action on Salt, Sugar, and Health and an unpaid consultant on dietary sodium and hypertension control to numerous governmental and non-governmental organizations. RP is CEO of mmHg, provider of digital health and software services, including remote patient monitoring software. AES is on the Executive Management Board of STRIDE BP and is co-author of the World Health Organization’s technical specifications of blood pressure devices. JES is a consultant of HEARTS in the Americas, an initiative of the Pan American Health Organization. JES is principal investigator of a National Health and Medical Research Council partnership grant (S0026615) that includes a medical technology company that manufactures a central blood pressure monitor. MPS has received research support from Medtronic, Abbott, Metavention, Recor, and Boehringer Ingelheim and personal fees/travel support from Medtronic and Abbott. GSS is chairing the STRIDE BP organization for blood pressure measurement methods and devices, conducted validation studies of blood pressure monitors, and advised manufacturers on device and software development. MT has received unrestricted gift in kind from Omron for the purpose of a clinical study. None of the other authors have disclosures.

PY - 2023/2

Y1 - 2023/2

U2 - 10.1038/s41371-022-00747-0

DO - 10.1038/s41371-022-00747-0

M3 - Comment/debate

C2 - 36476777

AN - SCOPUS:85131052089

VL - 37

SP - 155

EP - 159

JO - Journal of Human Hypertension

JF - Journal of Human Hypertension

SN - 0950-9240

IS - 2

ER -