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

Sharman, James E.; Ordúñez, Pedro; Brady, Tammy M.; Parati, Gianfranco; Stergiou, George S.; Padwal, Raj; Olsen, Michael Hecht; Delles, Christian; Schutte, Aletta E.; Tomaszewski, Maciej; Lackland, Daniel T.; Khan, Nadia; McManus, Richard J; Tsuyuki, Ross T.; Zhang, Xinhua; Murphy, Lisa; Moran, Andrew E.; Schlaich, Markus P.; Campbell, Norman R.C.

doi:10.1038/s41371-022-00747-0

Cited by 15 publications

(13 citation statements)

References 37 publications

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“…The accuracy of cuff BP devices is recognized as playing a pivotal role in the reliability of hypertension diagnosis, but unfortunately the majority of automated cuff BP devices have not undergone rigorous accuracy testing [33–38]. To our knowledge, this current analysis is the first to determine the potential health outcomes and cost implications of cuff SBP by comparison to invasive aortic SBP.…”

Section: Discussionmentioning

confidence: 97%

Cardiovascular and health cost impacts of cuff blood pressure underestimation and overestimation of invasive aortic systolic blood pressure

Fonseca

Palmer

Picone

et al. 2023

Journal of Hypertension

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Objective: Hypertension management is directed by cuff blood pressure (BP), but this may be inaccurate, potentially influencing cardiovascular disease (CVD) events and health costs. This study aimed to determine the impact on CVD events and related costs of the differences between cuff and invasive SBP. Methods: Microsimulations based on Markov modelling over one year were used to determine the differences in the number of CVD events (myocardial infarction or coronary death, stroke, atrial fibrillation or heart failure) predicted by Framingham risk and total CVD health costs based on cuff SBP compared with invasive (aortic) SBP. Modelling was based on international consortium data from 1678 participants undergoing cardiac catheterization and 30 separate studies. Cuff underestimation and overestimation were defined as cuff SBP less than invasive SBP and cuff SBP greater than invasive SBP, respectively. Results: The proportion of people with cuff SBP underestimation versus overestimation progressively increased as SBP increased. This reached a maximum ratio of 16 : 1 in people with hypertension grades II and III. Both the number of CVD events missed (predominantly stroke, coronary death and myocardial infarction) and associated health costs increased stepwise across levels of SBP control, as cuff SBP underestimation increased. The maximum number of CVD events potentially missed (11.8/1000 patients) and highest costs ($241 300 USD/1000 patients) were seen in people with hypertension grades II and III and with at least 15 mmHg of cuff SBP underestimation. Conclusion: Cuff SBP underestimation can result in potentially preventable CVD events being missed and major increases in health costs. These issues could be remedied with improved cuff SBP accuracy.

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Section: Discussionmentioning

confidence: 97%

Cardiovascular and health cost impacts of cuff blood pressure underestimation and overestimation of invasive aortic systolic blood pressure

Fonseca

Palmer

Picone

et al. 2023

Journal of Hypertension

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“…Among the top 100 best-selling BP devices on a popular online site, 79% of upper arm and 83% of wrist cuff devices were nonvalidated. The predominance of nonvalidated devices may have adverse consequences for management of hypertension; therefore, clinicians should ensure they are recommending validated devices to their patients . Study limitations include that sales volume is unknown, the results are specific only to Amazon and the countries assessed, and it is unknown whether the identified devices are used for making clinical decisions.…”

Section: Discussionmentioning

confidence: 99%

“…The predominance of nonvalidated devices may have adverse consequences for management of hypertension; therefore, clinicians should ensure they are recommending validated devices to their patients. 6 Study limitations include that sales volume is unknown, the results are specific only to Amazon and the countries assessed, and it is unknown whether the identified devices are used for making clinical decisions. Consumers purchasing a device from an international online business cannot have confidence that it has been validated.…”

Section: Lettersmentioning

confidence: 99%

“…Discussion | This study found log-linear associations between higher BMI and increased risk of hospitalizations for or death due to severe COVID-19 and URTIs throughout the BMI categories examined, and with LRTIs for BMI greater than 25.This study supports previous findings that 10-unit higher BMI is associated with about double the risk of severe COVID-19. 6 In contrast, the limited previous evidence on the association of BMI with risk of severe LRTIs or URTIs shows substantial variation in the strength of these associations. 3 Several studies have described lower risk for LRTIs with higher BMI, but the current study found no such evidence in the BMI categories examined.…”

mentioning

confidence: 97%

“…This study supports previous findings that 10-unit higher BMI is associated with about double the risk of severe COVID-19. 6 In contrast, the limited previous evidence on the association of BMI with risk of severe LRTIs or URTIs shows substantial variation in the strength of these associations. 3 Several studies have described lower risk for LRTIs with higher BMI, but the current study found no such evidence in the BMI categories examined.…”

mentioning

confidence: 97%

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