Abstract
Accurate blood pressure (BP) assessment is essential for the optimal diagnosis and management of hypertension. Contemporary clinical practice guidelines strongly endorse use of automated cuff blood pressure measuring devices (BPMD) as the preferred means of measuring and monitoring BP in the office, at home and with ambulatory blood pressure monitoring. To ensure that they are accurate, automated BPMDs should undergo clinical validation testing, performed using an established clinical validation standard. Unfortunately, most BPMDs sold on the global market have not been clinically validated. Furthermore, in the last thirty years, several different clinical validation protocols have been published, with major differences apparent between these standards, causing controversy with respect to which standard is considered acceptable for clinical validation. Complexly worded standards, multiple revisions, and firewalled access also contribute to a lack of understanding and use of clinical validation standards and the number of expert centers performing clinical validations is small. Recently, joint society collaborations have led to creation of the AAMI/ESH/ISO universal standard for the clinical validation of automated cuff BPMDs. Not only is this unified standard a necessary step, but oversight from regulators and influential stakeholders to ensure that only clinically validated BPMDs can be marketed is additionally needed.
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References
Global Burden of Disease Risk Factor Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1923–94.
Joffres MR, Campbell NRC, Manns B, Tu K. Estimate of the benefits of a population-based reduction in dietary sodium additives on hypertension and its related health care costs in Canada. Can J Cardiol. 2007;23:437–43.
Kaplan NM, Commentary on the sixth report of the Joint National Committee (JNC-6). Am J Hypertens. 1998;11:134–6.
Instrumentation AFTAOM. American national standards for electronic or automated sphygmomanometers. ANSI/AAMI SP 10-1987, Arlington VA, USA: Association for the Advancement of Medical Instrumentation; 1987.
International Organization for Standardization. ISO 81060-2:2018. Non-invasive sphygmomanometers - Part 2: clinical investigation of intermittent automated measurement type. 2018. https://www.iso.org/standard/73339.html.
Booth J. A short history of blood pressure measurement. Proc R Soc Med. 1977;70:793–9.
Kallioinen N, Hill A, Horswill MS, Ward HE, Watson MO. Sources of inaccuracy in the measurement of adult patients’ resting blood pressure in clinical settings. J Hypertens. 2017;35:421–41.
Rabi DM, McBrien KA, Sapir-Pichhadze R, Nakhla M, Ahmed SB, Dumanski SM, et al. Hypertension Canada’s 2020 comprehensive guidelines for the prevention, diagnosis, risk assessment, and treatment of hypertension in adults and children. Can J Cardiol. 2020;36:596–624.
Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, et al. Measurement of blood pressure in humans: a scientific statement from the American Heart Association. Hypertension. 2019;73:e35–e66.
Whelton PK, Carey RM, Aronow WS, Casey DEJ, Collins KJ, Dennison Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13–e115.
Stergiou GS, Palatini P, Parati G, O’Brien E, Januszewicz A, Lurbe E, et al. 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement. J Hypertens. 2021;39:1293–302.
Forouzanfar M, Dajani HR, Groza VZ, Bolic M, Rajan S, Batkin I. Oscillometric blood pressure estimation: past, present, and future. IEEE Rev Biomed Eng. 2016;8:44–63.
Izzo JJ, Mitchell GF. Pitfalls of pulse wave analysis and oscillometic blood pressure derivatives. Hypertension. 2021;78:372–375.
O’Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O’Malley K, et al. The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens. 1990;8:607–19.
Tholl U, Anlauf M. Conscientious evaluation of measuring accuracy. Hypertension League provides approval seals for automatic blood pressure units. MMW Fortschr Med. 1999;141:45.
O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, et al. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Press Monit. 2002;7:3–17.
Standardization IOF ISO 81060-2:2018/Amd.1:2020(E). Non-invasive sphgmomanometers - Part 2: Clinical validation of automated measurement type. Amendment 1. www.iso.org.
Stergiou GS, Asmar R, Myers M, Palatini P, Parati G, Shennan A, et al. Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-IP) for the validation of blood pressure measuring devices and future perspectives. J Hypertens. 2018;36:479–87.
Padwal R, Wood PW, McLean D, Ringrose JS. Impact of choosing the closest rather than the mean auscultatory blood pressure value on the European Society of Hypertension International Protocol device validation results. Blood Pressure Monitoring. 2020;25:224–226.
Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, et al. A universal standard for the validation of blood pressure measuring devices. J Hypertens. 2018;36:472–8.
Ng K-G. Clinical validation protocols for noninvasive blood pressure monitors and their recognition by regulatory authorities and professional organizations: rationale and considerations for a single unified protocol or standard. Blood Press Monit. 2013;18:282–9.
Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, et al. 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). J Hypertens. 2019;37:459–66.
Ringrose JS, McLean D, Ao P, Yousefi F, Sankaralingam S, Millay J, et al. Effect of cuff design on auscultatory and oscillometric blood pressure measurements. Am J Hypertens. 2016;29:1063–9.
Sprague E, Padwal RS. Adequacy of validation of wide-range cuffs used with home blood pressure monitors: a systematic review. Blood Press Monit. 2018;23:219–24.
Ringrose J, Millay J, Babwick SA, Neil M, Langkaas LA, Padwal R. Effect of overcuffing on the accuracy of oscillometric blood pressure measurements. J Am Soc Hypertens. 2015;9:563–8.
Ringrose JS, Polley G, McLean D, Thompson A, Morales F, Padwal R. An assessment of the accuracy of home blood pressure monitors when used in device owners. Am J Hypertens. 2017;30:683–9.
Padwal RS, McLean D, Ringrose J. Should patients with higher blood pressure variability be excluded from validation studies? An assessment of the ‘12/8’ rule. Blood Press Monit. 2017;22:112–4.
International Organization for Standardization. ISO 81060-1:2007. Non-invasive sphgmomanometers - Part 1: Requirements and test methods for non-automated measurement type. http://www.iso.org/iso/catalogue_detail.htm?csnumber=42914.
Barnett AG, Sans S, Salomaa V, Kuulasmaa K, Dobson AJ, Project WHOM. The effect of temperature on systolic blood pressure. Blood Press Monit. 2007;12:195–203.
Picone DS, Deshpande RA, Schultz MG, Fonseca R, Campbell NRC, Delles C, et al. Nonvalidated home blood pressure devices dominate the online marketplace in Australia: major implications for cardiovascular risk management. Hypertension. 2020;75:1593–9.
Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, et al. 2020 International Society of Hypertension global hypertension practice guidelines. Hypertension. 2020;75:1334–57.
World Health Organization. WHO technical specifications for automated non-invasive blood pressure measuring devices with cuff. Geneva: World Health Organization; 2020.
Sharman JE, O’Brien E, Alpert B, Schutte AE, Delles C, Hecht Olsen M, et al. Lancet Commission on Hypertension Group position statement on the global improvement of accuracy standards for devices that measure blood pressure. J Hypertens. 2020;38:21–9.
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JR and RP are cofounders and shareholders of mmHg Inc., a digital health developer of medical software, including remote patient monitoring software solutions.
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Ringrose, J.S., Padwal, R. Automated blood pressure measuring devices: how are they clinically validated for accuracy?. J Hum Hypertens 37, 101–107 (2023). https://doi.org/10.1038/s41371-022-00761-2
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DOI: https://doi.org/10.1038/s41371-022-00761-2
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