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. 2018 Dec 25;21(2):148–155. doi: 10.1111/jch.13462

Unattended versus attended automated office blood pressure: Systematic review and meta‐analysis of studies using the same methodology for both methods

Anastasios Kollias 1, Emelina Stambolliu 1, Konstantinos G Kyriakoulis 1, Areti Gravvani 1, George S Stergiou 1,✉
PMCID: PMC8030301  PMID: 30585383

Abstract

There is increasing interest in unattended automated office blood pressure (OBP) measurement, which gives lower blood pressure values than the conventional auscultatory OBP. Whether unattended automated OBP differs from standardized attended automated OBP performed using the same device and measurement protocol remains uncertain. A systematic review and meta‐analysis of studies (aggregate data) comparing unattended vs attended automated OBP using the same device and measurement protocol (conditions, number of measurements, visits) was performed. Ten eligible studies (n = 1004, weighted age 60.8 ± 4.2 [SD] years, 55% males) were analyzed. Unattended OBP (pooled systolic/diastolic 133.9 [95% CI: 129.7, 138]/80.6 [95% CI: 77, 84.2] mm Hg) did not differ from attended OBP (135.3 [95% CI: 130.9, 139.6]/81 [95% CI: 77.6, 84.3] mm Hg); pooled systolic OBP difference −1.3, 95% CI: −4.3, 1.7 mm Hg and diastolic −0.4, 95% CI: −1.2, 0.3 mm Hg. Nine of ten studies achieved high quality score and no publication bias was identified. Meta‐regression analysis did not reveal any effect of age, gender, or attended systolic OBP on the unattended‐attended systolic OBP difference (P = NS for all). However, there was a trend toward higher attended than unattended OBP at higher OBP levels. These data suggest that, when the same device and measurement protocol are used, attended automated OBP provides similar blood pressure values as unattended automated OBP. Although unattended automated OBP is theoretically advantageous as it ensures that standardized conditions and measurement protocol are used, attended automated OBP, if carefully performed, appears to be a reasonable and practical alternative.

Keywords: clinic blood pressure, electronic, methodology, observer, unobserved

1. INTRODUCTION

For almost a century, office blood pressure (OBP) measurement has been regarded as the cornerstone for treatment decisions in hypertension.1, 2 This is because the vast majority of the evidence regarding the cardiovascular risk associated with elevated blood pressure (BP) and the benefits of the treatment‐induced BP lowering have been based on OBP measurements.3 However, it is recognized that OBP is a “weak” cornerstone, mainly due to the white‐coat and the masked hypertension phenomena, observer‐related issues, such as observer error and bias, and unstandardized conditions and protocol of measurements.1, 2

To eliminate the observer factor in OBP measurement, validated automated BP monitors are being increasingly used in clinical research and practice. Several years ago, Myers et al introduced the concept of “unattended automated OBP” measurement with multiple automated OBP measurements taken while the patient is resting alone in the examination room (no presence of physician or nurse).4, 5 Studies have shown that unattended OBP appears to be lower than conventional auscultatory OBP and similar to awake ambulatory BP and reduces the prevalence of white‐coat hypertension.4, 5

In the Systolic BP Intervention Trial (SPRINT), both unattended and attended automated OBP measurements were performed using the same device and measurement protocol but in different patients, and no difference between the two methods was found in average follow‐up OBP as well as in cardiovascular risk decline in the intensively treated group.6 In a recent editorial which accompanied the SPRINT OBP measurement analysis report,6 we presented a review of previous studies comparing unattended vs attended OBP using automated devices and showed no difference between them.1 However, this review was not systematic and meta‐analysis of the data was not performed.1

This article presents a systematic review and meta‐analysis of the published evidence on the difference between unattended and attended OBP from studies that applied the two methods in the same patients using the same device, conditions, and measurement protocol.

2. METHODS

2.1. Search strategy

A systematic literature search was performed independently by three investigators (ES, KGK, and AG) at PubMed and EMBASE databases using the following search keywords: (("blood pressure") AND (office OR clinic)) AND (unattended OR unobserved OR automated OR electronic). For the EMBASE search, guided mapping of keywords to abstract/title/Emtree indexing terms was applied. Articles were also selected from references of relevant articles. Disagreements were resolved by consensus with a senior author (AK).

2.2. Selection criteria, data extraction, and statistical analysis

A systematic review was performed in line with the PRISMA recommendations ( www.prisma-statement.org). Eligible studies were full‐text articles written in English with comparative data on unattended vs attended OBP measurements that (1) were performed in the same subjects, (2) used the same device and methodology (conditions, protocol and number of measurements and visits), and (3) reported the OBP difference between the two methods.

2.3. Assessment of methodologic quality

The quality of the studies was assessed in terms of selection bias, detection bias, accuracy of measurement, analysis, and confounding using a combination of questions from the QUADAS‐2 and CASP checklists for assessing cohort studies.7, 8 Studies fulfilling ≥4 of the quality domains were deemed as high quality. Because of the strict methodological criteria for study inclusion in the meta‐analysis, mainly high‐quality studies were expected to be included.

2.4. Statistical analysis

Meta‐analysis was performed based on aggregate data from selected studies for pooling the outcome of interest, which was the mean OBP difference with 95% confidence interval (CI) between unattended and attended measurements. Random rather than fixed effects models were performed as more appropriate for balancing weights across large and small studies and to allow for variation in study effects due to the expected dispersion in the effect size across studies (attributed to factors such as age, ethnicity, and methodology).9 Sensitivity and stratified analyses based on several criteria such as the quality of the included studies, exclusion of outlier studies, age, gender, average level of attended systolic OBP, type of the device used, rest period, number of readings, and protocol used were also performed. Meta‐analysis regression was performed using the Stata/SE 11.2, Texas, USA software. Heterogeneity was tested using I 2 statistics. Publication bias was evaluated using Begg's funnel plots and Begg's and Egger's statistical tests.10, 11 When average OBP difference was reported without its SD, the latter was calculated using the following formula:12

SD of difference = SD12+SD22-2rSD1SD2

SD1, SD of attended OBP; SD2, SD of unattended OBP; r, correlation coefficient between attended and unattended OBP.

In 2 studies in which this was not feasible, the average SD of the comparison groups was used. Summary descriptive statistics are presented as mean ± SD weighted by sample size, unless stated otherwise. Two‐sided P values <0.05 were considered significant.

3. RESULTS

The initial literature search identified 3783 potentially relevant articles. The flow diagram for articles’ selection procedure is presented in Figure 1. Twenty‐three studies were relevant for the review reporting unattended vs attended OBP data.6, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 In one study, data were modified after communication with the corresponding author.30 Thirteen of these studies were excluded because in comparing unattended with attended OBP they assessed different subjects with each method,6 obtained different number of readings,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 had different number of visits,17, 18, 22 used a different BP monitor,13, 22 or used different methodology (rest time, intervals between measurements, position).13, 24 Ten studies fulfilled all the inclusion requirements for the meta‐analysis (n = 1004, weighted age 60.8 ± 4.2 [SD] years, 55% males) (Table 1).25, 26, 27, 28, 29, 30, 31, 32, 33, 34

Figure 1.

Figure 1

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Flow chart for study selection

Table 1.

Studies comparing unattended vs attended automated office blood pressure measurements taken using the same devices and measurement protocol

Study N Age (y) Males (%) Rest before readings; N of BP readings/visit; interval Device type Visits; Order of BP measurements Attended BP Unattended‐attended BP difference (95% CI)
Vinyoles et al25 106 65.7 44 NR; 3; 2‐min Omron HEM‐705CP Same single visit; Random

S: 137 ± 17.9

D: 80 ± 10

S: 2 (0.1, 3.9)

D: 0 (−1.1, 1.1)
Stergiou et al26 30 48.9 NR 5‐min; 3; 1‐min; Omron HEM‐705CP 2 different separate visits per method; Randomized

S: 139.3 ± 16.2

D: 89.2 ± 8.0

S: −1.9 (−4.1, 0.3)

D: −1.6 (−3.3, 0.1)
Greiver et al27 50 NR NR NR; 6; 1‐min BpTRU Same single visit; Random

S: 121.1 ± 17.9

D: 73.9 ± 10.2

S: −1.8 (−3.6, 0.1)

D: −0.8 (−2.5, 0.8)
Al‐Karkhi et al28 162 62.6 49 5‐min; 3; 1‐min Omron i‐C10 (semiautomatic) Same single visit; Random

S: 139.1 ± 18

D: 84.8 ± 11

S: −1.1 (−2.6, 0.4)

D: 1.1 (−0.1, 2.3)
Wang et al29 54 52.9 48 10‐min; 3; 1‐min Omron HEM 7080‐IC Same single visit; Randomized

S: 146.6 ± 13.5

D: 91.3 ± 10.3

S: 0.2 (−3.7, 4.1)

D: −0.3 (−3.0, 2.4)
Rinfret et al30 65 66.3 68 0‐min; 6; 1‐min BpTRU Same single visit; Attended first

S: 127.4 ± 15.9

D: 72.6 ± 11.3

S: 1.2 (−0.4, 2.8)

D: −0.5 (−1.4, 0.4)
Bauer et al31 51 65 59 5‐min; 3; 1‐min Omron HEM‐907 Same single visit; Random

S: 135.7 ± 21.5

D: 80.6 ± 12.0

S: −1.5 (−3.5, 0.5)

D: 0.0 (−1.4, 1.4)
Andreadis et al32 146 56 53 5‐min; 3; 1‐min Omron HEM‐907 Same single visit; Alternating sequence

S: 129 ± 15

D: 78 ± 13

S: 0.6 (−0.3, 1.6)

D: 0.2 (−0.5, 0.8)
Paini et al33 329 61 59 5‐min; 3; 1‐min Omron HEM‐9000Ai Same single visit; Random

S: 138.4 ± 16.7

D: 79.3 ± 11.9

S: −8.6 (−9.4, −7.8)

D: −2 (−2.6, −1.4)
Papademetriou et al34 11 NR NR 5‐min; 3; 1‐min Omron HEM‐907 Same single visit; Alternating sequence

S: 143.6 ± 28.3

D: 79.4 ± NR

S:‐2.9 (−20, 14.2)

D:‐1.4 (−10.7, 7.9)
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BP, blood pressure; CI, confidence intervals; D, diastolic BP (mean ± SD); NR, not reported; S, systolic BP.

Analysis of these studies revealed that the difference between unattended OBP (pooled value 133.9 [95% CI: 129.7, 138]/80.6 [95% CI: 77, 84.2] mm Hg, systolic/diastolic) and attended OBP (135.3 [95% CI: 130.9, 139.6]/81 [95% CI: 77.6, 84.3] mm Hg) was not statistically significant for systolic (pooled difference −1.3, 95% CI: −4.3, 1.7 mm Hg) or diastolic BP (−0.4, 95% CI: −1.2, 0.3 mm Hg) (Figure 2).

Figure 2.

Figure 2

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Forest plot of pooled difference between unattended and attended systolic (A) and diastolic (B) office blood pressure [Colour figure can be viewed at wileyonlinelibrary.com]

All studies except one achieved high quality rating (Table 2) and no publication bias was identified in Begg's funnel plots (Supplementary Figure S1) and Egger's testing (P = NS for both systolic/diastolic OBP differences). However, in trim‐and‐fill analysis, the addition of three estimated unpublished studies rendered the summary estimate of the random effect model for systolic OBP difference significant to −2.6 (95% −4.9, −0.2) mm Hg, whereas no additional studies were identified for diastolic OBP difference (−0.4, 95% −1.2, 0.3 mm Hg) (Supplementary Figure S2).

Table 2.

Methodological quality of the included studies

Study Patient selection Outcome measurement Analysis Confounding Overall quality rating
Was patients’ selection appropriate? Did the study avoid inappropriate exclusions? Was the sample representative of the intended population? Is the outcome variable measured appropriately? Was the unattended vs. attended BP difference as primary endpoint? Were important confounding factors identified in design or analysis (ie order effect)?
Vinyoles et al25 Yes Unclear Unclear Yes Yes Yes High
Stergiou et al26 Yes Unclear Unclear Yes Yes Yes High
Greiver et al27 Yes Yes Yes Yes Yes Yes High
Al‐Karkhi et al28 Yes Unclear Unclear Yes Yes Yes High
Wang et al29 Yes Unclear Unclear Unclear Yes Yes Moderate
Rinfret et al30 Yes Yes Unclear Yes Yes No High
Bauer et al31 Yes Unclear Unclear Yes Yes Yes High
Andreadis et al32 Yes Unclear Unclear Yes Yes Yes High
Paini et al33 Yes Unclear Unclear Yes Yes Yes High
Papademetriou et al34 Yes Unclear Unclear Yes Yes Yes High
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BP, blood pressure.

Sensitivity and stratified analyses based on several criteria are shown in Table 3. In all of these analyses, there were no significant systolic and/or diastolic OBP differences (Table 3). However, there was a trend for larger differences (lower unattended than attended OBP) for higher vs lower attended systolic OBP levels (Table 3).

Table 3.

Sensitivity and stratified analyses

Type of analysis Criterion Studies included in the analysis N of studies Systolic BP difference Diastolic BP difference
Sensitivity analyses Quality of studies High‐quality studies 9 −1.4 (−4.6, 1.7) −0.5 (−1.3, 0.4)
Outlier studies Exclusion of Paini et al 9 −0.2 (−1.2, 0.7) −0.1 (−0.5, 0.4)
Exclusion of Vinyoles et al 9 −1.7 (−4.9, 1.5) −0.5 (−1.4, 0.4)
Stratified analyses Age >60 years 5 −1.6 (−6.4, 3.1) −0.3 (−1.5, 0.8)
≤60 years 3 −0.2 (−2.0, 1.5) −0.4 (−1.6, 0.8)
Gender Males >50% 4 −2.1 (−7.6, 3.4) −0.6 (−1.8, 0.6)
Males ≤50% 3 0.3 (−1.9, 2.6) 0.4 (−0.4, 1.2)
Attended systolic BP >137 mm Hg 5 −3.0 (−7.7, 1.8) −0.8 (−2.5, 0.9)
≤137 mm Hg 5 0.2 (−1.1, 1.4) −0.1 (−0.5, 0.4)
Device Omron 8 −1.6 (−5.2, 2.1) −0.4 (−1.4, 0.6)
BpTRU 2 −0.3 (−3.2, 2.7) −0.6 (−1.4, 0.2)
Rest period Studies with reported rest period before measurements 7 −2.1 (−6.1, 1.8) −0.5 (−1.6, 0.7)
Studies without or with no reported rest period before measurements 3 0.5 (−1.7, 2.7) −0.4 (−1.0, 0.3)
Number of readings 3 readings 8 −1.6 (−5.2, 2.1) −0.4 (−1.4, 0.6)
6 readings 2 −0.3 (−3.2, 2.7) −0.6 (−1.4, 0.2)
Protocol SPRINT protocol (5‐min rest; 3 automated readings; 1‐min intervals) 4 −3.2 (−9.5, 3.2) −0.7 (−2.3, 0.9)
Other protocol 6 −0.3 (−1.6, 1.1) −0.3 (−1.0, 0.5)
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BP, blood pressure.

Meta‐regression analysis did not reveal any effect of age, gender, or attended systolic OBP on the unattended‐attended systolic OBP difference (P = NS for all). However, there was again a trend toward a larger BP difference (lower unattended than attended OBP) at higher attended systolic OBP levels (Figure 3).

Figure 3.

Figure 3

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Meta‐regression analysis of the effect of attended systolic office blood pressure on the unattended minus attended systolic office blood pressure difference

4. DISCUSSION

The main finding of this meta‐analysis of 10 studies is that unattended OBP and standardized attended automated OBP performed in the same subjects and using the same methodology (device, number of readings, time intervals) provide similar BP values. The pooled unattended‐attended OBP difference was −1.3/−0.4 mm Hg (systolic/diastolic) and 95% CI excluded a systolic OBP difference larger than 4.3 mm Hg and diastolic larger than 1.2 mm Hg. Thus, these data suggest that the difference between unattended and attended OBP is not clinically important as it is less than 5 mm Hg. These findings are in line with the SPRINT study results,6 yet different subjects were assessed with the two methods in that study.

If unattended automated OBP is compared with auscultatory OBP, then a significant BP difference is expected with the latter being higher due to its well‐known observer‐related issues.5 Moreover, if unattended automated OBP is compared with attended automated OBP but different number of BP readings is obtained with each method, again a BP difference is expected with lower BP levels when more OBP readings are obtained.15, 20 To demonstrate the net effect of “unattended” automated OBP, this should be compared with attended automated OBP but using the same device and in identical conditions and using identical protocol of measurements with the two methods, which is the specific methodology followed for selecting studies to be included in the present analysis.

The studies in this meta‐analysis suggest that when automated OBP measurements are taken under standardized conditions (resting period, at least triplicate measurements, no talking), the “presence” of the observer itself has minimal or no effect on measured OBP. It should be noted, however, that if attended OBP measurements are not standardized (eg, no resting period, single BP measurement, talking during measurements), which is not uncommon in routine clinical practice, then attended OBP will probably be higher than unattended OBP.

An interesting observation is that at higher OBP levels, attended automated OBP may be higher than unattended OBP (Figure 3), which is in line with the larger BP differences between office and ambulatory or home BP in subjects with higher OBP levels.35 However, these differences are more likely to alter therapeutic decisions in subjects with OBP levels close to the diagnostic thresholds for treatment decisions and less so in those with higher BP levels.

These findings should be interpreted in light of some limitations, the most important of which is the heterogeneity across the studies included. In order to compensate for the heterogeneity, random effects models, as well as sensitivity and stratified analyses were used. Moreover, it should be mentioned that all studies apart from one were of high quality. Last, these results are based on published summary statistics rather than raw data.

In conclusion, these data suggest that standardized attended automated OBP gives similar BP values as unattended automated OBP provided that the same standardized methodology is followed. OBP measurement remains the most evidence‐based method for hypertension evaluation and diagnosis, and despite the increasing use of out‐of‐office BP monitoring and its endorsement by hypertension societies, at present and for some time to come it is likely that in many people, the diagnosis and management of hypertension will be based on OBP measurement alone.1, 2 However, the methodological details of OBP measurement are crucial for extracting reliable conclusions.1, 2 Unattended automated OBP measurement has the advantage to ensure the avoidance of several sources of error (talking, no resting, single measurement, etc), yet it requires additional resources within a routine office visit (office space and additional time) and therefore cannot be implemented in all primary care settings. On the other hand, to obtain triplicate automated attended OBP measurement after few minutes rest is feasible for wide application in primary care. It is important to note that the latter is an evidence‐based method as in the last 20 years the vast majority of outcome studies in hypertension have used attended automated OBP measurements.36 National practice protocols should be developed for widespread implementation of standardized automated OBP measurement across primary care settings.

CONFLICT OF INTEREST

GSS has conducted validation studies of automated blood pressure measuring devices for various manufacturers and advised manufacturers on device development. The other authors have nothing to declare.

Supporting information

 

Click here for additional data file. (69.4KB, pdf)

Kollias A, Stambolliu E, Kyriakoulis KG, Gravvani A, Stergiou GS. Unattended versus attended automated office blood pressure: Systematic review and meta‐analysis of studies using the same methodology for both methods. J Clin Hypertens. 2019;21:148–155. 10.1111/jch.13462

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