Blood pressure measurement in special populations and circumstances

Abstract

According to the established validation protocols, a typical validation study of a blood pressure (BP) monitor includes general population adults with normal or elevated BP. It is recognized, however, that the automated (oscillometric) BP monitors may have different accuracy or uses in some special populations compared with adults in the general population. Thus, an automated BP monitor with proven accuracy in a general population of adults may not be accurate in a special population, and therefore separate validation is needed. Recognized special populations deserving separate validation are those for which there is theoretical, and also clinical evidence, that the accuracy of BP monitors in these groups differs from that in the general population. Young children, pregnant women (including those with preeclampsia), individuals with arm circumference >42 cm, and patients with atrial fibrillation are regarded as special populations. Adolescents, individuals older than 80 years, and patients with end-stage renal disease or diabetes mellitus have also been considered as possible special groups, but there is still inadequate evidence of altered accuracy of BP monitors in these subjects. Validation studies should be performed in special populations and evaluated separately after the BP-measuring device has successfully undergone a validation study in a general population (unless the test device is intended only for a special population). This article discusses issues relating to the measurement of BP and the diagnosis of hypertension in selected special populations, as well as in low-resource settings, where a simplified yet efficient evaluation strategy is necessary.

Out of Office Blood Pressure Measurement in Pregnancy and the Postpartum Period

“…Of note, the hemodynamic changes and peripheral edema associated with pregnancy, and preeclampsia in particular, may affect the accuracy of the algorithms used by oscillometric devices to measure BP [23, 33]. As such, guidelines recommend separately validating BP measurement devices for accuracy among pregnant women [34–37].…”

Achieving reliable blood pressure measurements in clinical practice: It's time to meet the challenge

“…The regular provision of lists of validated devices to the vast array of consumers interested in BP measurement is one way in which potential purchasers of BP devices can be alerted to device accuracy. The need for independent validations of BP measuring devices is emphasized many times in this issue, as well as the need for validation in special populations, such as children, pregnancy, patients with atrial fibrillation and people with very large arms …”

Blood Pressure Measurement Methodologies

“…Special populations as defined by the 2018 collaborative statement from the US AAMI, the European Society of Hypertension (ESH), and the International Organization for Standardization for a universal standard for the validation of BP measuring devices are those with theoretical and clinical evidence Table 1: Recommended cuff sizes by AHA [21] Adult patients (arm circumference, cm) Recommended cuff size (cm) 22 of different accuracies of BP measurement on BP monitors. [23,28] A study by Stergiou et al highlighted some of these individuals such as young children, pregnant women (including those with eclampsia), those with high arm circumference (>42 cm) as well as patients with arrhythmias, namely atrial fibrillation (AF). Separate validation studies are recommended for individuals in the special population after the device has gone through a successful validation in the general population.…”

“…Separate validation studies are recommended for individuals in the special population after the device has gone through a successful validation in the general population. [28] As per the ESH-International Protocol, evaluation and validation studies for device suitability in special populations require an additional 35 subjects with the exception of pregnant women which requires 45 subjects after a full validation study of 85 subjects has been done in the general population. [29] If a device is only meant for special population use, a full 85 subject study must be done.…”

“…Elderly individuals with end-stage renal failure or diabetes have also been considered as special populations; however, there is inadequate evidence of significant variation in their BP from the general population. [28] BP Measurement in Children…”