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The Journal of Clinical Hypertension logoLink to The Journal of Clinical Hypertension
. 2018 Jul 13;20(7):1122–1127. doi: 10.1111/jch.13296

Blood pressure measurement in special populations and circumstances

George S Stergiou 1,✉, Eamon Dolan 2, Anastasios Kollias 1, Neil R Poulter 3, Andrew Shennan 4, Jan A Staessen 5,6, Zhen‐Yu Zhang 5, Michael A Weber 7
PMCID: PMC8030798  PMID: 30003705

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.

Keywords: accuracy, atrial fibrillation, blood pressure measurement, children, pregnancy

1. INTRODUCTION

There is evidence that automated (oscillometric) blood pressure (BP) monitors may have different accuracy or uses in special populations compared with a general population of individuals with normotension or hypertension.1, 2, 3, 4 Thus, an automated BP monitor with proven accuracy in a general population may not be accurate in a special population, such as children or pregnant women, and separate validation is needed.

All established validation protocols provide recommendations for separate validation of automated BP monitors in special populations.1, 2, 3, 4 The 2018 collaborative statement by the US Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization for a universal standard for the validation of BP‐measuring devices4 defined special populations as those for which there is theoretical and also clinical evidence of different accuracy of BP monitors.

Young children, pregnant women (including those with preeclampsia), individuals with a large arm circumference (>42 cm), and patients with atrial fibrillation (AF) are regarded as special populations.1, 2, 3, 4 Adolescents, individuals older than 80 years, and those with end‐stage renal disease or diabetes mellitus have also been considered as possible special groups, but there is still uncertainty on the adequacy of existing data, suggesting altered accuracy of BP monitors.4

Validation study data for special populations are evaluated separately from general population data. The number of subjects for a special population validation study is 35 (45 for pregnancy), which should be undertaken only after a full 85‐subject study in the general population has been successfully completed.4 If the test device is intended only for a special population, then a full 85‐subject study is required. Children aged 3 to 12 years can be investigated in a 35‐subject study or included together with 50 older subjects in an 85‐subject general population study.

This article discusses issues regarding 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.

2. BP MEASUREMENT IN CHILDREN

G.S. Stergiou and A. Kollias

The prevalence of pediatric hypertension is rising, mainly as a result of the pediatric epidemic of obesity, and the measurement of BP has become part of the routine medical evaluation of children.5, 6 There is general consensus that children aged 3 years and older should have their BP measured once every year.5, 6

BP measurement in children presents several obstacles, caused by anatomical and physiological characteristics, including small arm dimensions, small and elastic arteries, small waveforms, large differences between brachial and aortic BP values, low amplitude and often difficult‐to‐detect Korotkoff sounds, and occasional absence of Korotkoff sound K5 in young children.

Current guidelines recommend that the diagnosis of office hypertension in children should be based on classic auscultatory BP measurements.5, 6 When Korotkoff sounds are audible at complete deflation or at unphysiologically low levels, Korotkoff sound K4 should be used for defining diastolic BP.5, 6 It is recommended that elevated BP detected using automated (oscillometric) devices needs confirmation with auscultatory measurement.5, 6

As in the adults, white‐coat and masked hypertension are common in children and out‐of‐office BP monitoring is necessary to confirm the diagnosis of hypertension and decide on drug treatment.5, 6 Ambulatory BP monitoring (ABPM), which allows the identification of white‐coat, masked, and nocturnal hypertension, is recommended as the ultimate method to diagnose hypertension in children.5, 6, 7 The research evidence for home BP monitoring in children is much less than that for ABPM, and therefore home BP is not recommended for diagnosing hypertension in this population.5, 6 Preliminary evidence on home BP monitoring in children shows that, as in adults, its reproducibility and association with preclinical target organ damage is superior to that of office BP and similar to that of ABPM.8, 9, 10, 11, 12 It should be noted, however, that in children and adolescents, daytime ABPM is higher than home BP, whereas there is no such difference in adults,9, 10 and is probably attributable to the high level of physical activity of young individuals during the day. Although the evidence for using ABPM is stronger than for home BP monitoring in children, at the present time the latter is more easily accessible in primary care and more practical for long‐term monitoring of children treated for hypertension.11

An electronic (oscillometric) BP monitor that has been successfully validated in adults might be inaccurate in children.5, 13 Thus, children are regarded as a special population for BP monitor validation requiring separate investigation.13 The evidence on the accuracy of oscillometric BP monitors in children is limited. A systematic review identified 31 published validation studies in children, of whom 16 evaluated devices for office use (five failed), nine evaluated ABPM monitors (three failed), and six evaluated home monitors (one failed).13 Most of these studies also included older subjects and did not report validation results separately for children.13

For defining hypertension in children, normalcy tables, which have been developed using distributional criteria and centiles from cross‐sectional population studies, provide BP thresholds according to sex, age, and body size, and are different for office,5, 6 ambulatory,5, 7, 14 and home BP measurements.6, 15 With all BP measurement methods, cuff size should have an inflatable bladder with length of about 80% to 90% of the individual's arm circumference and width of 40% to 50%.5, 6

3. BP MEASUREMENT IN PREGNANCY

A. Shennan

The hypertensive disorders of pregnancy affect up to 10% of women. They include chronic hypertension, which is a risk factor for subsequent complications, and pregnancy‐induced problems, which can be a sign of severe and/or acute disease that needs urgent action.16 Worldwide hypertension remains a major cause of maternal mortality, affecting >60 000 women a year.17 BP measurement is key in identifying women at risk, and simple cost‐effective interventions can save lives. These include instigating delivery of the baby while treating severe hypertension and giving anticonvulsant medication such as magnesium sulphate. Aspirin is an effective prophylactic agent given to women at risk, including those with chronic hypertension.18

Korotokoff sound K5 is more reproducible and reliable in pregnancy19 and should be used with the auscultatory technique. Preeclampsia is a serious multisystem disorder and is associated with reduced intravascular volume and peripheral edema and increased peripheral vascular resistance, all which can affect oscillometric signals—the technique commonly used by automated devices. 20 Oscillometric devices tend to under‐record the BP in preeclampsia, a condition that occurs in around 5% of pregnant women and is characterized by hypertension and proteinuria. Only devices validated in pregnancy should be used, and most validation protocols provide criteria to do this (Association for the Advancement of Medical Instrumentation criteria, the British Hypertension Society, and International protocols [Table]). Validation procedures require at least 15 women with a clinical diagnosis in each of the categories of preeclampsia, hypertension, and normotension.

Table 1.

Automated oscillometric blood pressure monitors successfully validated in pregnancy

Omron MIT Elite
Omron MIT
Omron HEM‐705CP
Omron M7
Microlife WatchBP Home
Microlife BP 3BTO‐A
Microlife BP 3AS1‐2/Cradle VSA
Welch Allyn Spot Vital Signs
Dinamap ProCare 400
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BP is gestation specific, but fixed thresholds for diagnosis are used to ease interpretation. A BP of ≥140/90 mm Hg at any gestation signifies disease and systolic BP ≥150 mm Hg should be treated as a medical emergency in pregnancy to avoid the risk of stroke.18 The value of treating moderate BP is uncertain, as it does not alter preeclampsia progression and may even be detrimental to placental blood flow and fetal well‐being. However, more tight control does prevent episodes of severe hypertension, and a target diastolic of 85 mm Hg has been recommended following trials.21

As 99% of maternal deaths occur in low‐ and middle‐income countries, simple, cost‐effective but robust and accurate monitoring would be desirable in pregnancy throughout the world. Recently, a BP device, the CRADLE VSA (Vital Sign Alert) has been developed for use in pregnancy in low‐ and middle‐income countries. It has low power requirements and micro–USB‐charging capabilities (as mobile phone charging is ubiquitous in the world). It also has a validated early warning traffic light system for both hypertension and shock index (pulse/systolic BP)22 to manage bleeding and sepsis23 (other common causes of maternal mortality) and has been uniquely validated in hypotension. The cost is under $25 (info@apec.org.uk). The CRADLE VSA is also suitable for home monitoring, including in nonpregnant individuals (in whom it has been validated). Since hypertensive pregnancy complications are associated with future cardiovascular risk (relative risk of early‐onset preeclampsia is more than doubled), the device can be used after pregnancy for screening.24

4. BP MEASUREMENT IN THE ELDERLY

E. Dolan, Z.Y. Zhang, and J.A. Staessen

Most Western societies now face the challenge of providing health care to an ageing population. The effective management of common conditions such as hypertension will become increasingly important in order to reduce the burden of conditions such as dementia and stroke.25 The control of BP in older adults, however, can be challenging as a result of comorbidities, high prevalence, polypharmacy, and existing target organ damage.26 Against this, treatment initiation targets in the very elderly, based on office BP, are higher than those recommended for their younger counterparts. The increased use of “out‐of‐office” BP monitoring (home and ambulatory) has assisted greatly in the management of hypertension in older adults. As with any other age group, an accurate assessment of BP is essential before contemplating therapy. Accordingly, BP measurement in the elderly can be more difficult because of orthostatic hypotension, white‐coat hypertension, and advanced atherosclerotic disease with stiff arteries. For clinical use, office measurement, home BP monitoring, and ABPM all play a complementary role in patient management. Office BP must be recorded on a number of visits and orthostatic hypotension excluded. While office BP is useful for screening purposes, the use of home BP monitoring and ABPM can identify those with white‐coat and masked hypertension. ABPM identifies abnormal circadian BP profiles, which are also more common in older adults.27 All of this is crucially underpinned by the use of appropriately validated devices.

Outcome studies in the elderly have shown ABPM, particularly ambulatory pulse pressure, to be more closely associated with both fatal and nonfatal cardiovascular events and total mortality than BP taken in the office setting. The Syst‐Eur study showed that ABPM is a better predictor of risk than office BP measurement in older patients with isolated systolic hypertension.28 After adjustment for office BP measurements, ambulatory daytime, nighttime, and 24‐hour systolic BP all independently predicted cardiovascular mortality.28 A recent international collaboration of data from several outcome studies suggested that home BP monitoring remains a significant predictor of cardiovascular mortality and cardiovascular events after adjusting for office BP and allows more accurate risk stratification than office BP, particularly in cases with masked hypertension.29

Abnormal circadian BP patterns with higher nocturnal than daytime BP values are more frequently found in the elderly. These BP profiles are more closely associated with target organ damage and cardiovascular events.30 In addition, nondipping and nocturnal hypertension in the elderly are associated with cognitive dysfunction and stroke.30 Concomitant conditions, such as prostatic hypertrophy, sleep apnea, and sleep fragmentation, can increase nighttime BP through reduced sleep quality, and, in such cases, nocturnal BP loses some of its prognostic significance. Whether extreme dipping with marked nocturnal BP fall is associated with increased cardiovascular risk is uncertain, but excessive BP lowering should be avoided in older adults. The risk of extreme dipping in the elderly may be partially explained by its association with a steeper morning surge in BP, which frequently accompanies an excessive nocturnal fall in BP.31 An increase in the physiological morning BP surge is determined by advancing age and higher 24‐hour BP level. The exaggerated morning BP surge can only be identified by ABPM and is associated with increased risk of subclinical target organ damage, cardiovascular events, and cardiovascular mortality, independently of age and average 24‐hour BP.32 The disrupted circadian BP variation in the elderly is also associated with orthostatic hypotension. BP variability significantly increases with age, predominantly caused by baroreflex failure and increased arterial stiffness, and may advance target organ damage and trigger cardiovascular events in elderly patients.33

The elderly population is increasing and hypertension management can be difficult because of changes in their physiology and arterial structure brought about by the aging process. Isolated systolic hypertension, white‐coat hypertension, orthostatic hypotension, pseudohypertension, and resistant hypertension are common in older adults.34 Furthermore, there has been recent focus on lower BP targets across age groups, highlighting the need for accurate BP measurement at the outset through greater use of home BP monitoring and ABPM.

5. BP MEASUREMENT IN ATRIAL FIBRILLATION

G. S. Stergiou and A. Kollias

Cuff‐based measurement of BP in the presence of AF is regarded as difficult and uncertain as a result of variations in ventricular filling time, stroke volume, and contractility, all of which increase beat‐to‐beat BP variability. Thus, for the evaluation of office BP in patients with AF, triplicate measurements are recommended using the auscultatory method and the automated oscillometric method is regarded as questionable.35 Because of the above, patients with AF have been systematically excluded from hypertension trials, from validation trials of BP monitors and from using 24‐hour ABPM. Thus, the evidence regarding key issues of BP evaluation and hypertension management in patients with AF and the usefulness of automated home BP measurement and ABPM is scarce.

The established validation protocols for BP monitors refer to patients with AF as a special population requiring separate validation. However, there are no agreed guidelines for determining BP in AF, and the accuracy of the auscultatory method (reference for validating BP monitors) is unknown.3 Inter‐observer and intraobserver variation is higher in AF than in sinus rhythm, and triplicate BP measurement provides a more reliable assessment.3, 36, 37

A meta‐analysis of validation studies of automated BP monitors (mostly oscillometric for office, ambulatory, or home use) in AF showed reasonable accuracy in measuring systolic BP.38 However, there was a small yet consistent overestimation of diastolic BP,38 which is less important in elderly patients with AF.35 ABPM is feasible in AF, with similar proportion of errors as in sinus rhythm.39

Preliminary evidence suggests that both auscultatory and oscillometric BP measurements in AF are clinically relevant, as they show similar associations with intra‐arterial measurements37, 40 and indices of organ damage as in sinus rhythm.41, 42 Most importantly, in long‐term outcome studies in patients with AF, usual office BP measurement predicted major cardiovascular events, such as thromboembolic stroke and systemic embolism.43

An oscillometric BP monitor equipped with an algorithm specific for the detection of AF during automated BP measurement has been shown to have good diagnostic accuracy for AF detection during routine BP measurement.44 The UK's National Institute for Health and Care Excellence (NICE) recommended the use of this technology for opportunistic AF screening during routine office BP measurement in primary care in the elderly.45 Recently, an ABPM device has been developed with high sensitivity and moderate specificity for AF screening during routine evaluation of elderly hypertension with automated detection of AF during each BP reading.46

6. BP MEASUREMENT IN LOW‐RESOURCE SETTINGS

M.A. Weber, A. Shennan, and N. R. Poulter

Since hypertension is so common across almost all populations worldwide, the majority of patients with this condition is found in countries and communities characterized as low‐resource settings.47 Their care requires strategies that are inexpensive but still clinically relevant. Measuring BP accurately is critical to this process and, with adequate infrastructure planning and education, can be made widely accessible. This requires the following steps, all of which should be attainable in low‐resource settings.

Health policy should incorporate routine BP measurement: (1) in adults older than 30 years, (2) in individuals taking oral contraceptives, and (3) during pregnancy.

Non‐professional staff should be trained to measure BP accurately.

Patients should be seated, with their feet on the ground, with the cuff placed on an arm supported at heart level. There should be no recent smoking or talking during measurement.

Preferably there should be a 5‐minute rest before the measurement, but in crowded circumstances a shorter interval of 1 to 3 minutes can be used.

For initial diagnosis of hypertension in adults, guidelines recommend using the average of two readings on at least two separate clinic visits, but realistically in low‐resource settings we suggest the following: Perform two separate measurements at least 1 minute apart. If systolic BP is ≥140 mm Hg on both measurements, or if diastolic BP is ≥90 mm Hg on both measurements, then hypertension therapy should be considered. If only one of the two measurements of systolic BP or diastolic BP meets these thresholds, delay the treatment decision and repeat the measurement procedure after 6 months. If neither of the two readings reaches the thresholds, repeat the measurements after 12 months.

Using this simple approach there is a risk of overdiagnosis—termed white‐coat hypertension—but given the tolerability, safety, and inexpensiveness of modern drugs, we believe it is more prudent to overdiagnose rather than underdiagnose hypertension. Some guidelines recommend ABPM to confirm the diagnosis of hypertension,26, 48 but the costs of providing skilled professional support and of acquiring, repairing, and replacing the necessary equipment generally cannot be justified in low‐resource settings.

For greatest accuracy and greatest consistency between clinic visits, we recommend automated electronic devices (ideally validated) rather than the traditional sphygmomanometer, which highly depends on operator technique and experience. Automated devices do incur a cost, and the batteries needed to power them also incur a cost, but their ease of use and accuracy justifies the expense, even in low‐resource settings. New nonbattery‐powered devices may soon resolve this problem.Recording the data is critical both for continuing individual patient care as well as to support public health policy making. Paper records are acceptable but, if available, electronic records are more accessible and allow the remote intervention of specialists who can view clinical information and recommend appropriate further testing and therapies.49 Even low‐income communities can be supported by smart phones, which also can be used to record and transmit data.50

Therapeutic intervention is largely beyond the scope of these comments, but in the simplest model of hypertension care, BP measurements should lead directly to treatment decisions. Non‐BP factors such as calculated cardiovascular risk may not be available in low‐resource settings where routine tests such as blood chemistries and electrocardiograms are not always available. Algorithms for the selection and use of appropriate therapies are currently being addressed by new major global initiatives.51

CONFLICT OF INTEREST

G.S. conducted validation studies for various manufacturers and advised manufacturers on device development. A.S. conducted validation studies for various manufacturers and developed the CRADLE VSA. M.A.W. has been an advisor to projects supported by Omron. A.K., E.D., N.P., J.A.S., and Z.Y.Z. have nothing to declare.

Stergiou GS, Dolan E, Kollias A, et al. Blood pressure measurement in special populations and circumstances. J Clin Hypertens. 2018;20:1122–1127. 10.1111/jch.13296

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