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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 70, NO.

5, 2017

2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 0735-1097/$36.00

PUBLISHED BY ELSEVIER http://dx.doi.org/10.1016/j.jacc.2017.05.064

Accuracy of Cuff-Measured Blood Pressure


Systematic Reviews and Meta-Analyses

Dean S. Picone, BMEDRES(HONS),a Martin G. Schultz, PHD,a Petr Otahal, GDIPSCI,a Svend Aakhus, MD, PHD,b
Ahmed M. Al-Jumaily, PHD,c J. Andrew Black, MBBS(HONS),a,d Willem J. Bos, MD, PHD,e John B. Chambers, MD,f
Chen-Huan Chen, MD,g Hao-Min Cheng, MD, PHD,g Antoine Cremer, MD,h Justin E. Davies, PHD,i
Nathan Dwyer, MBBS, PHD,a,d Brian A. Gould, MD, PHD,j Alun D. Hughes, MBBS, PHD,k Peter S. Lacy, PHD,l
Esben Laugesen, MD, PHD,m Fuyou Liang, PHD,n Roman Melamed, MD,o Sandy Muecke, PHD,p
Nobuyuki Ohte, MD, PHD,q Sho Okada, MD, PHD,r Stefano Omboni, MD,s Christian Ott, MD,t Xiaoqing Peng, MPHARM,a
Telmo Pereira, PHD,u Giacomo Pucci, MD,v Ronak Rajani, MD,f Philip Roberts-Thomson, MBBS,a,d
Niklas B. Rossen, MD, PHD,m Daisuke Sueta, MD, PHD,w Manish D. Sinha, PHD,x Roland E. Schmieder, MD,t
Harold Smulyan, MD,y Velandai K. Srikanth, PHD,a,z,aa Ralph Stewart, MD,bb George A. Stouffer, MD,cc
Kenji Takazawa, MD, PHD,dd Jiguang Wang, MD, PHD,ee Berend E. Westerhof, PHD,ff Franz Weber, MD,gg
Thomas Weber, MD,hh Bryan Williams, MD,l Hirotsugu Yamada, MD, PHD,ii Eiichiro Yamamoto, MD, PHD,w
James E. Sharman, PHDa

ABSTRACT

BACKGROUND Hypertension (HTN) is the single greatest cardiovascular risk factor worldwide. HTN management is
usually guided by brachial cuff blood pressure (BP), but questions have been raised regarding accuracy.

OBJECTIVES This comprehensive analysis determined the accuracy of cuff BP and the consequent effect on BP
classication compared with intra-arterial BP reference standards.

METHODS Three individual participant data meta-analyses were conducted among studies (from the 1950s to 2016)
that measured intra-arterial aortic BP, intra-arterial brachial BP, and cuff BP.

RESULTS A total of 74 studies with 3,073 participants were included. Intra-arterial brachial systolic blood pressure
(SBP) was higher than aortic values (8.0 mm Hg; 95% condence interval [CI]: 5.9 to 10.1 mm Hg; p < 0.0001) and
intra-arterial brachial diastolic BP was lower than aortic values (1.0 mm Hg; 95% CI: 2.0 to 0.1 mm Hg; p 0.038).
Cuff BP underestimated intra-arterial brachial SBP (5.7 mm Hg; 95% CI: 8.0 to 3.5 mm Hg; p < 0.0001) but
overestimated intra-arterial diastolic BP (5.5 mm Hg; 95% CI: 3.5 to 7.5 mm Hg; p < 0.0001). Cuff and intra-arterial
aortic SBP showed a small mean difference (0.3 mm Hg; 95% CI: 1.5 to 2.1 mm Hg; p 0.77) but poor agreement (mean
absolute difference 8.0 mm Hg; 95% CI: 7.1 to 8.9 mm Hg). Concordance between BP classication using the Seventh
Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure cuff
BP (normal, pre-HTN, and HTN stages 1 and 2) compared with intra-arterial brachial BP was 60%, 50%, 53%, and 80%,
and using intra-arterial aortic BP was 79%, 57%, 52%, and 76%, respectively. Using revised intra-arterial thresholds
based on cuff BP percentile rank, concordance between BP classication using cuff BP compared with intra-arterial
brachial BP was 71%, 66%, 52%, and 76%, and using intra-arterial aortic BP was 74%, 61%, 56%, and 65%, respectively.

CONCLUSIONS Cuff BP has variable accuracy for measuring either brachial or aortic intra-arterial BP, and this
adversely inuences correct BP classication. These ndings indicate that stronger accuracy standards for BP devices
may improve cardiovascular risk management. (J Am Coll Cardiol 2017;70:57286) 2017 by the American College of
Cardiology Foundation.

Listen to this manuscripts


audio summary by
JACC Editor-in-Chief
Dr. Valentin Fuster.

From the aMenzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; b
Department of
Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway;
c
Institute of Biomedical Technologies, Auckland University of Technology, Auckland, New Zealand; dRoyal Hobart Hospital,
Hobart, Tasmania, Australia; eDepartment of Internal Medicine, St. Antonius Hospital, Nieuwegein, the Netherlands; fCardiology
Department, Guys and St. Thomas Hospitals, London, United Kingdom; gDepartment of Medicine, National Yang-Ming University,
JACC VOL. 70, NO. 5, 2017 Picone et al. 573
AUGUST 1, 2017:57286 Accuracy of Cuff-Measured BP

C ardiovascular disease is the number 1 cause bias for cuff BP to underestimate intra- ABBREVIATIONS

of mortality worldwide, with elevated blood arterial brachial systolic blood pressure AND ACRONYMS

pressure (BP) as the single largest risk factor (SBP) but overestimate intra-arterial brachial
BP = blood pressure
(13). Noninvasive brachial cuff BP is the principal diastolic blood pressure (DBP), and thereby,
DBP = diastolic blood pressure
method for hypertension (HTN) diagnosis and man- underestimate intra-arterial pulse pressure
HTN = hypertension
agement; thus, accurate BP measurement is among (PP) (911). Second, cuff BP devices being
the most important medical tests performed (4). Rela- tested for accuracy against other noninvasive JNC 7 = Seventh Report of the
Joint National Committee on
tively small errors in cuff BP measurement can have measurements according to international Prevention, Detection,
major public health ramications. An inaccuracy of validation protocols may perform to a pass Evaluation, and Treatment of

5 mm Hg is estimated to result in the misclassication standard even when clinically signicant High Blood Pressure

of BP of 48 million people each year in the United measurement errors occur among many pa- PP = pulse pressure

States alone (21 million underestimated BP, 27 million tients (12). Third, there is large individual SBP = systolic blood pressure

overestimated BP) (5). BP underestimation leads to variability in intra-arterial BP between the aorta and
missed therapeutic potential and unnecessary eleva- brachial artery (9,13,14), and whether oscillometric or
tion of cardiovascular risk (6). BP overestimation cre- auscultatory cuff BP accurately measures either
ates additional cost and exposure to the possible aortic or brachial BP has never been systematically
adverse effects of unnecessary treatment (5). The determined. This question is important to resolve,
recognition of pre-hypertension as a nonbenign clin- given: 1) the possibility that aortic BP is more clini-
ical presentation (7), and the benet to some patient cally relevant than brachial BP (13,1517); and 2) the
populations of achieving low BP targets (8), further burgeoning of commercial devices purporting to
emphasizes the need for accurate cuff BP across the measure aortic BP (18) to (theoretically) better assess
range of BP classications. cardiovascular risk (19). However, this is a contro-
SEE PAGE 587
versial theory (20,21), with some investigators
asserting that there is a lack of evidence to justify
Several lines of evidence question the accuracy of departing from standard cuff BP (20,22). Others sug-
cuff BP. First, many small studies indicate a possible gest that brachial cuff BP may already accurately

Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan; hDepartment of Cardiology/Hypertension,
University Hospital of Bordeaux, Bordeaux, France; iInternational Centre for Circulatory Health, Imperial College London,
London, United Kingdom; jBMI Hospital Blackheath, London, United Kingdom; kInstitute of Cardiovascular Sciences, University
College London, London, United Kingdom; lInstitute of Cardiovascular Sciences University College London (UCL) and National
Institute for Health Research (NIHR) UCL/UCL Hospitals Biomedical Research Centre, London, United Kingdom; mDepartment of
Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark; nSchool of Naval Architecture, Ocean and
Civil Engineering, Shanghai Jiao Tong University, Shanghai, China; oAbbott Northwestern Hospital, Allina Health, Minneapolis,
Minnesota; pDepartment of Critical Care Medicine, Flinders University, Adelaide, South Australia, Australia; qDepartment of
Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan;
r
Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan; sClinical Research Unit,
Italian Institute of Telemedicine, Varese, Italy; tDepartment of Nephrology and Hypertension, University Hospital Erlangen,
Friedrich-Alexander University Erlangen-Nrnberg, Erlangen, Germany; uPolytechnic Institute of Coimbra, Coimbra College of
Health Technology, Department of Cardiopneumology, Lous, Portugal; vUnit of Internal Medicine at Terni University Hospital,
w
Department of Medicine, University of Perugia, Perugia, Italy; Department of Cardiovascular Medicine, Graduate School of
Medical Sciences, Kumamoto University, Kumamoto, Japan; xDepartment of Clinical Pharmacology and Department of Paediatric
Nephrology, Kings College London, Evelina London Childrens Hospital, Guys and St. Thomas NHS Foundation Trust, London,
United Kingdom; yDepartment of Medicine, State University of New York, Upstate Medical University, Cardiology Division,
Syracuse, New York; zCentral Clinical School, Faculty of Medicine, Monash University, Melbourne, Victoria, Australia; aa
Depart-
ment of Medicine, Peninsula Health, Melbourne, Victoria, Australia; bbGreen Lane Cardiovascular Service, Auckland City Hospital,
University of Auckland, Auckland, New Zealand; ccDivision of Cardiology, University of North Carolina at Chapel Hill, Chapel Hill,
dd
North Carolina; Center for Health Surveillance and Preventive Medicine, Tokyo Medical University Hospital, Tokyo, Japan;
ee
Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of
Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;
ff gg
Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, the Netherlands; Department of Nephrology,
hh
Center for Internal Medicine, University Clinic Essen, University Duisburg-Essen, Essen, Germany; Cardiology Department,
Klinikum Wels-Grieskirchen, Wels, Austria; and the iiDepartment of Cardiovascular Medicine, Tokushima University Hospital,
Tokushima, Japan. Microlife Co., Ltd., and National Yang-Ming University have signed a contract for transfer of the noninvasive
central blood pressure technique. The contract of technology transfer includes research funding for conducting the validation
study. Dr. Chen has served as a speaker or a member of a speakers bureau for AstraZeneca, Pzer, Bayer AG, Bristol-Myers Squibb,
Boehringer Ingelheim, Daiichi-Sankyo, Novartis Pharmaceuticals, Servier, Merck & Co., Sano, and Takeda Pharmaceuticals
International. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Manuscript received February 23, 2017; revised manuscript received May 26, 2017, accepted May 30, 2017.
574 Picone et al. JACC VOL. 70, NO. 5, 2017

Accuracy of Cuff-Measured BP AUGUST 1, 2017:57286

measure aortic BP, eliminating the need for specialist micromanometer tip or uid-lled catheters, as well
devices (2325). as indwelling arterial needles and cannulas. For each
These issues create uncertainty as to whether cuff meta-analysis, studies were only included if the BP
BP accurately measures intra-arterial BP, either at the measurements being compared were recorded within
brachial or aortic level. Better understanding of these the immediate period of each other, rather than at
issues is relevant to validation protocol standards for different times (28), due to possible hemodynamic
cuff BP devices, and could lead to improved clinical changes between measurement periods (29). Studies
management of cardiovascular risk through more that measured BP at multiple arterial sites (e.g.,
accurate BP measurement and classication. We brachial and radial) in the same study were included if
completed 3 separate but inter-related systematic authors were able to provide separated data. Studies
reviews and individual participant data meta- that recorded data under nonbasal conditions
analyses to determine the accuracy of cuff BP mea- involving hemodynamic shifts (e.g., exercise or
surement methods. We rst aimed to determine the administration of vasoactive drugs that altered BP
true level of intra-arterial BP agreement between during the recording procedure) were excluded. There
the aorta and brachial artery (meta-analysis 1), and was some minor variability of the inclusion and
then whether cuff BP accurately measured either exclusion criteria that were specic to the goal of each
intra-arterial brachial BP (meta-analysis 2) or intra- meta-analysis. These included cuff BP methods of
arterial aortic BP (meta-analysis 3). Potential clinical auscultation (mercury or aneroid), and oscillometric
consequences of cuff BP measurement error were and automatic Korotkoff sound devices for meta-
determined by the concordance between cuff and analyses 2 and 3. Studies were also excluded if the
intra-arterial BP for classifying HTN according to goal of the work was to determine the effect of
criteria of the Seventh Report of the Joint National different cuff sizes on the relationship between cuff
Committee on Prevention, Detection, Evaluation, and and intra-arterial BP, because of the expectation of
Treatment of High Blood Pressure (JNC 7) (26). cuff BP measurement error (30). For meta-analyses 1
and 3, studies that measured aortic BP distal to
METHODS
the aortic arch were excluded because potential
amplication of SBP along the aorta (31) could
SEARCH TECHNIQUE AND STUDY ELIGIBILITY. The
contribute to discordance of comparisons between
search technique, study eligibility criteria, data
BP measurements.
collection, synthesis, and statistical analysis were
conducted similarly across each meta-analysis, with DATA COLLECTION. For each eligible study, indi-
minor differences reecting the specic needs of each vidual participant-level deidentied BP data were
question. The Preferred Reporting Items for System- requested from authors. PP was calculated as
atic Review and Meta-Analyses of individual partici- SBP DBP. Clinical information, including age, sex,
pant data were adhered to (Online Table 1) (27). Two anthropometry, medications, and disease status, was
reviewers (D.S.P, M.G.S) identied eligible studies by also requested if available. Data were standardized to
title, abstract, or full-text review and performed a be in the international system of units, except for
separate data quality assessment. All of these activ- pressure units. Individual data supplied by authors
ities were undertaken with each reviewer blinded to were checked for consistency with published aggre-
the other reviewers results. Discrepancies were gate data where available. If discrepancies were
resolved via consensus. Results from meta-analysis 1 identied, clarication was sought from authors. If no
are provided in the Online Appendix. response was received to data requests, or authors
Four online databases (PubMed, Scopus, Embase, were not contactable, individual data were extracted
and Web of Knowledge) were systematically searched from within published tables (Online Appendix 2) or
for eligible papers from database inception until May from gure scatterplots using extraction software,
9, 2016, with slight modications for each meta- when possible (32). Data obtained from scatterplots
analysis (Online Table 2). Additional studies were were only included in the meta-analyses when accu-
found by searching the reference lists of identied racy could be veried by comparison with published
studies and personal communication with authors. summary data or correlation coefcients (Online
Unpublished data was accepted if sufcient Table 3). A quality score was applied to each study
methodology was provided (Online Appendix 1). to account for important study design attributes that
Study eligibility was not restricted by subject age, may have affected data quality (Online Appendix 3,
language, or year of publication. We included studies Online Tables 4 to 6). The University of Tasmania
that measured intra-arterial BP by high-delity Health and Medical Human Research Ethics
JACC VOL. 70, NO. 5, 2017 Picone et al. 575
AUGUST 1, 2017:57286 Accuracy of Cuff-Measured BP

Committee approved this study (reference number: This same method was used for sensitivity and
H0015048). specicity analyses for cuff BP delineating HTN based
on the 140/90-mm Hg cut point. Linear mixed
MAGNITUDE OF BP DIFFERENCES. The proportion
modeling (1-stage meta-analysis) was used to account
of cuff BP measurements that were $5, $10,
for clustering of individuals within each study for
or $15 mm Hg different from intra-arterial BP were
mean absolute difference, BP classication analysis,
determined as a measure of accuracy (33).
percentile calculation for the revised intra-arterial BP
BP CLASSIFICATION. To determine accuracy of cuff thresholds, and potential predictors of BP differ-
BP for BP classication, each individuals cuff BP ences. Mean absolute difference was calculated as the
was classied according to JNC 7 criteria (normal absolute value of the BP difference at the individual
BP <120/80 mm Hg; pre-HTN SBP 120 to 139 mm Hg or participant level. In meta-analysis 3, Laugesen et al.
DBP 80 to 89 mm Hg; stage 1 HTN SBP 140 to (35) and Rossen et al. (36) were pooled for analysis,
159 mm Hg or DBP 90 to 99 mm Hg; and stage 2 HTN because participants were from the same population
SBP $160 mm Hg or DBP $100 mm Hg) (26), and and the measurement protocols used were identical,
then compared for concordance with the BP classi- except for the type of cuff BP device.
cation according to the measurement of BP by intra- Sensitivity analyses were among studies that
arterial brachial and aortic BP. For example, for received the maximum study quality score to assess
an individual with cuff BP classied as normal whether results were inuenced by study design
(<120/80 mm Hg), the corresponding intra-arterial factors and to separately assess published data sour-
BP for that individual was classied into the appro- ces compared with unpublished data sources. To
priate category (e.g., normal, pre-HTN, or stage 1 or determine the inuence on results of meta-analyses
2 HTN), and found to be concordant if also falling into 2 and 3, sensitivity analyses were conducted for sin-
the same normal BP classication (<120/80 mm Hg). gle BP measurements compared with the average of
This approach enabled an assessment of the potential multiple cuff BP measures, as well as the type of
effect of cuff BP inaccuracy on clinical practice, but catheter used for intra-arterial BP measurement. A
also involves a level of arbitrariness with BP cut p value < 0.05 was considered statistically signicant.
points because there is a continuous relationship Data were synthesized and analyzed using R version
between BP and cardiovascular risk. Additional ana- 3.1.2 (R Foundation for Statistical Computing, Vienna,
lyses were also undertaken in which the risk cut Austria), primarily using the metafor and lme4 pack-
points for intra-arterial BP (both brachial and aortic) ages, and Stata version 14 (StataCorp, College Station,
were drawn at equal percentile ranks to the tradi- Texas) (2015, metandi module). Additional statistical
tional cuff BP cut points. Sensitivity and specicity methods are in Online Appendix 4.
of cuff BP for delineating HTN at a cut point
of $140/90 mm Hg was also assessed. RESULTS
STATISTICAL ANALYSIS. BP and clinical character-
istics are presented as mean and 95% condence ELIGIBLE STUDIES AND SUBJECT CHARACTERISTICS.
interval (95% CI) unless otherwise specied. BP dif- A total of 75,071 studies were identied from the 3
ferences were calculated as brachial artery BP minus meta-analysis searches. After review based on title
aortic BP (meta-analysis 1) and cuff BP minus intra- and abstract, we performed a full-text review of 371
arterial brachial or aortic BP (meta-analyses 2 and 3). studies, and 152 of these were deemed eligible for
Both 1- and 2-stage meta-analysis was used. The re- inclusion in the meta-analyses. Individual participant
sults generated from each method are considered data were not available from 7, 48, and 23 studies for
equivalent in individual participant data meta- meta-analyses 1, 2, and 3, respectively. This left 13,
analysis (34). Two-stage meta-analyses were used to 22, and 39 studies for SBP analysis, respectively,
analyze mean BP differences, because this method whereas 12, 18, and 36 studies, respectively, were
allowed production of summary forest plots to illus- available for analysis relating to DBP and PP (Online
trate the level of the BP difference across included Tables 7 to 10, Online References). Systematic re-
studies. For this method, data were rst analyzed view ow diagrams and study characteristics for all
study by study, and were then synthesized using meta-analyses are detailed in Online Figures 1 to 6
random effects meta-analysis due to the observa- and Online Tables 7 to 12. Data were extracted from
tional nature of the data. Correlation coefcients published tables in 11 studies (Online Appendix 2),
from individual studies were used to calculate sum- and from published gures in 6 studies (Online
mary correlation coefcients on the relationship Table 3). Data was sourced from 18 countries
between BP measurements in each meta-analysis. (Australia, New Zealand, China, Japan, Singapore,
576 Picone et al. JACC VOL. 70, NO. 5, 2017

Accuracy of Cuff-Measured BP AUGUST 1, 2017:57286

F I G U R E 1 Forest Plot of Brachial Cuff and Intra-Arterial Brachial BP Difference

A
Mean Difference
Author(s) and Year Patients [95% CI]
Berliner et al, 1961 100 4.3 [1.0 , 7.6]
Blank et al, 1988 11 14.3 [21.5 , 7.1]
Bos et al, 1992 57 3.3 [5.0 , 1.6]
Cheng et al, 2010 100 5.4 [7.0 , 3.7]
Cheng et al, unpublished 14 9.4 [16.5 , 2.3]
Ding et al, 2013 33 18.7 [22.7 , 14.7]
Freis et al, 1968 6 0.1 [1.9 , 1.7]
Gelman et al, 1981 5 14.6 [23.7 , 5.5]
Gould et al, 1984 28 4.3 [8.0 , 0.7]
Hayashi et al, 2014 55 1.6 [3.2 , 0.1]
Hunyor et al, 1978 9 9.9 [12.0 , 7.7]
Kobayashi et al, 2013 20 8.2 [12.0 , 4.3]
Lin et al, 2012 78 4.3 [6.8 , 1.8]
Melamed et al, 2012 3 4.3 [13.4 , 4.7]
Muecke et al, 2009 2 5.1 [15.0 , 4.8]
Omboni et al, 1997 12 4.7 [7.8 , 1.7]
Picone et al, unpublished 40 11.5 [14.9 , 8.1]
Pucci et al, unpublished 29 10.5 [15.0 , 6.0]
Raftery and Ward, 1968 50 4.8 [8.3 , 1.3]
Roberts et al, 1953 47 12.3 [16.6 , 7.9]
Sagiv et al, 1999 12 6.9 [3.8 , 10.1]
Vardan et al, 1983 24 2.0 [3.4 , 7.4]
Mean difference model for all studies 5.7 [8.0 , 3.5]
Intra-arterial brachial SBP higher Brachial cuff SBP higher

22.0 10.0 2.0 10.0


Mean Difference Between Brachial Cuff and Intra-Arterial Brachial SBP

B
Mean Difference
Author(s) and Year Patients [95% CI]
Berliner et al, 1961 100 6.6 [4.4 , 8.7]
Bos et al, 1992 57 1.9 [0.3 , 3.5]
Cheng et al, 2010 100 5.8 [4.4 , 7.2]
Cheng et al, unpublished 14 5.4 [0.4 , 10.5]
Ding et al, 2013 33 1.3 [3.8 , 1.2]
Freis et al, 1968 6 8.7 [7. 1 , 10.4]
Gelman et al, 1981 5 1.0 [5.9 , 7.9]
Gould et al, 1984 28 10.4 [6.9 , 13.8]
Hayashi et al, 2014 55 5.0 [2.8 , 7.3]
Hunyor et al, 1978 9 8.0 [4.0 , 12.0]
Lin et al, 2012 78 7.0 [4.7 , 9.2]
Melamed et al, 2012 3 1.3 [11.8 , 14.4]
Muecke et al, 2009 2 9.6 [1.6 , 17.7]
Omboni et al, 1997 12 15.4 [12.9 , 17.8]
Picone et al, unpublished 40 6.9 [5.4 , 8.4]
Pucci et al, unpublished 29 1.1 [1.1 , 3.3]
Raftery and Ward, 1968 50 6.1 [3.4 , 8.9]
Roberts et al, 1953 47 2.8 [5.9 , 0.3]
Mean difference model for all studies 5.5 [3.5 , 7.5]
Intra-arterial brachial DBP higher Brachial cuff DBP higher

12.0 0.0 8.0 16.0


Mean Difference Between Brachial Cuff and Intra-Arterial Brachial DBP

Pooled mean difference and 95% condence interval (CI) for meta-analysis 2, the comparison of brachial cuff and intra-arterial brachial
systolic blood pressure (SBP) (A), diastolic blood pressure (DBP) (B), and pulse pressure (PP) (C). BP blood pressure.

Continued on the next page


JACC VOL. 70, NO. 5, 2017 Picone et al. 577
AUGUST 1, 2017:57286 Accuracy of Cuff-Measured BP

F I G U R E 1 Continued

C
Mean Difference
Author(s) and Year Patients [95% CI]
Berliner et al, 1961 100 2.2 [5.0 , 0.5]
Bos et al, 1992 57 5.2 [7.3 , 3.1]
Cheng et al, 2010 100 11.1 [13.0 , 9.3]
Cheng et al, unpublished 14 14.8 [22.2 , 7.4]
Ding et al, 2013 33 17.4 [20.6 , 14.2]
Freis et al, 1968 6 8.9 [11.1 , 6.7]
Gelman et al, 1981 5 15.6 [29.4 , 1.8]
Gould et al, 1984 28 14.7 [18.1 , 11.3]
Hayashi et al, 2014 55 6.7 [9.4 , 3.9]
Hunyor et al, 1978 9 17.9 [21.3 , 14.5]
Lin et al, 2012 78 11.3 [14.0 , 8.6]
Melamed et al, 2012 3 5.7 [27.1 , 15.8]
Muecke et al, 2009 2 14.7 [32.7 , 3.2]
Omboni et al, 1997 12 20.1 [22.8 , 17.3]
Picone et al, unpublished 40 18.4 [21.4 , 15.4]
Pucci et al, unpublished 29 11.6 [16.5 , 6.7]
Raftery and Ward, 1968 50 10.9 [14.6 , 7.2]
Roberts et al, 1953 47 9.5 [14.5 , 4.4]
Mean difference model for all studies 12.0 [14.7 , 9.3]
Intra-arterial brachial PP higher Brachial cuff PP higher

36.0 24.0 12.0 0.0 8.0


Mean Difference Between Brachial Cuff and Intra-Arterial Brachial PP

United States, Canada, England, Scotland, France, sphygmomanometric cuff methods signicantly
Germany, Italy, Austria, Portugal, the Netherlands, overestimated intra-arterial brachial DBP, and there-
Denmark, Norway, and Israel). Across the 3 meta- fore, also signicantly underestimated intra-arterial
analyses, subjects were generally of middle-to-older brachial PP. Strong correlations were observed be-
age, predominately male, and overweight according tween brachial cuff and intra-arterial brachial SBP
to body mass index (Online Tables 13 to 15). When (r 0.89; 95% CI: 0.86 to 0.93), DBP (r 0.78; 95% CI:
individual participant data were checked as per 0.72 to 0.85), and PP (r 0.82; 95% CI: 0.76 to 0.88),
guidelines (27), no important issues, such as incon- with p < 0.0001 for all (Online Figure 10).
sistency with published aggregate data, arose. There In meta-analysis 3, there was no signicant differ-
were minor differences between the number of sub- ence between brachial cuff and intra-arterial aortic SBP
jects in some published papers and the number of (Figure 2A) (p 0.77); however, this was due to a rela-
subjects used in the meta-analyses (see explanation tive balance in the number of studies reporting either
in Online Appendix 5). signicant overestimation (7 studies) or signicant
META-ANALYSES ON BP DIFFERENCES. See the underestimation (7 studies) of intra-arterial aortic SBP
Online Appendix for all results from meta-analysis 1 by cuff SBP. Indeed, the mean absolute difference was
(Online Appendix 6, Online Figures 7 to 9). 8.0 mm Hg (95% CI: 7.1 to 8.9 mm Hg). Brachial cuff
In meta-analysis 2, brachial cuff BP methods methods signicantly overestimated intra-arterial
signicantly underestimated intra-arterial brachial aortic DBP, and thus signicantly underestimated
SBP and PP, but signicantly overestimated intra- intra-arterial aortic PP (Figures 2B and 2C) (p < 0.0001
arterial brachial DBP (p < 0.0001 for all) (Figures 1A for both). Oscillometric and mercury sphygmomano-
to 1C). The mean absolute difference for SBP was metric cuff methods were not analyzed separately as
7.9 mm Hg (95% CI: 6.5 to 9.5 mm Hg). Intra-arterial per meta-analysis 2, because the mercury method was
brachial SBP was underestimated among studies only used in 2 studies, totaling 21 individuals. There
that used either oscillometric or mercury sphyg- were strong relationships between brachial cuff and
momanometric techniques, although this was only intra-arterial aortic SBP based on the pooled correla-
of borderline signicance for the latter (Online tion coefcients (r 0.88; 95% CI: 0.86 to 0.90), DBP
Table 16). However, both oscillometric and mercury (r 0.75; 95% CI: 0.70 to 0.80), and PP (r 0.81;
578 Picone et al. JACC VOL. 70, NO. 5, 2017

Accuracy of Cuff-Measured BP AUGUST 1, 2017:57286

F I G U R E 2 Forest Plot of Brachial Cuff and Intra-Arterial Aortic BP Difference

A
Mean Difference
Author(s) and Year Patients [95% CI]
Aakhus et al, 1993 28 2.5 [4.9 , 0.0]
Bhatt et al, 2011 98 7.4 [9.9 , 4 .9]
Borow et aI, 1982 30 0.7 [1.1 , 2.5]
Bos et al, 1992 19 0.6 [2.4 , 3.7]
Broyd et al, unpublished 25 12.0 [18.0 , 6.1]
Cheng et al, 2010 100 2.9 [1.0 , 4.8]
Cheng et al, unpublished 17 3.9 [9.5 , 1.7]
Costello et al, 2015 40 0.8 [4.1 , 2.5]
Cremer et al, 2012 144 6.5 [8.9 , 4.1]
Davies et al, 2003 28 3.4 [0.5 , 7.3]
Ding et al, 2013 33 0.8 [4.0 , 2.4]
Kobayashi et al, 2013 20 4.8 [8.8 , 0.8]
Korolkova et al, unpublished 14 9.5 [0.6 , 19.5]
Laugesen/Rossen et al, 2014 37 3.8 [1.0 , 6.6]
Lin AC et al, 2012 35 1.8 [2.6 , 6.1]
Lin MM et al, 2012 78 1.3 [1.4 , 4.0]
Lowe et al, 2009 37 0.7 [5.1 , 3.7]
Milne et al, 2015 9 6.8 [0.5 , 14.1]
Nagle et al, 1966 2 3.4 [8.7 , 1.9]
Nakagomi et al, 2016 139 4.8 [7.3 , 2.4]
Ohte et al, 2007 82 1 .8 [4.3 , 0.8]
Ott et al, 2012 52 10.9 [6.5 , 15.3]
Park et al, 2014 6 0.0 [7.5 , 7.5]
Pereira et al, 2014 15 8.6 [6.4 , 10.8]
Picone et al, unpublished 146 3.1 [1.6 , 4.6]
Pucci et al, 2013 58 1.7 [1.0 , 4.4]
Pucci et al, unpublished 29 2.7 [6.2 , 0.9]
Rajani et al, 2008 14 2.3 [2.4 , 6.9]
Saul et al, 1995 97 1.0 [1.3 , 3.2]
Smulyan et al, 2003 25 18.4 [13.0 , 23.8]
Smulyan et al, 2008 100 0.8 [3.0 , 1.4]
Smulyan et al, 2010 25 0.2 [4.5 , 4.9]
Sueta et al, 2015 85 13.4 [15.5 , 11.4]
Takazawa et al, 2007 18 4.1 [0.8 , 9.0]
Takazawa et al, 2012 52 1.4 [1.7 , 4.5]
Weber et al, 1999 36 1.6 [1.4 , 4.6]
Weber et al, 2011 30 8.8 [12.5 , 5.1]
Williams et al, 2011 20 7.5 [5.2 , 9.8]
Mean difference model for all studies 0.3 [1.5 , 2.1]
Intra-arterial aortic SBP higher Brachial cuff SBP higher

20.0 16.0 12.0 8.0 4.0 0.0 4.0 8.0 12.0 16.0 20.0 24.0
Mean Difference Between Brachial Cuff and Intra-Arterial Aortic SBP

B
Mean Difference
Author(s) and Year Patients [95% CI]
Aakhus et al, 1993 28 7.8 [6.0 , 9.5]
Bhatt et al, 2011 98 5.2 [3.7 , 6.7]
Borow et aI, 1982 30 1.8 [0.7 , 2.9]
Bos et al, 1992 19 5.8 [3.7 , 7.9]
Broyd et al, unpublished 25 4.3 [2.2 , 6.5]
Cheng et al, 2010 100 7.3 [5.6 , 9.0]
Cheng et al, unpublished 17 5.6 [1.1 , 10.1]
Costello et al, 2015 40 10.2 [7.4 , 13.0]
Cremer et al, 2012 142 8.2 [6.5 , 9.9]
Ding et al, 2013 33 1.2 [3.6 , 1.3]
Korolkova et al, unpublished 14 17.8 [14.9 , 20.8]
Laugesen/Rossen et al, 2014 37 13.1 [10.9 , 15.2]
Lin AC et al, 2012 35 4.1 [1.5 , 6.7]
Lin MM et al, 2012 78 6.7 [4.4 , 9.0]
Lowe et al, 2009 37 3.8 [1.5 , 6.2]
Milne et al, 2015 9 10.9 [18.3 , 3.5]
Nagle et al, 1966 2 1.4 [15.9 , 13.1]
Nakagomi et al, 2016 139 12.8 [11.3 , 14.4]
Ohte et al, 2007 82 4.5 [2.5 , 6.5]
Ott et al, 2012 52 0.6 [2.7 , 1.4]
Park et al, 2014 6 7.3 [5.3 , 9.3]
Pereira et al, 2014 15 2.5 [0.1 , 5.2]
Picone et al, unpublished 146 8.5 [7.7 , 9.3]
Pucci et al, 2013 58 4.8 [2.8 , 6.9]
Pucci et al, unpublished 29 2.8 [5.1 , 0.6]
Rajani et al, 2008 14 5.0 [0.2 , 9.7]
Smulyan et al, 2003 25 13.1 [7.5 , 18.8]
Smulyan et al, 2008 100 2.0 [0.6 , 3.5]
Smulyan et al, 2010 25 1.8 [1.6 , 5.2]
Sueta et al, 2015 85 0.4 [1.9 , 1.1]
Takazawa et al, 2007 18 10.8 [7.9 , 13.8]
Takazawa et al, 2012 52 1.3 [1.6 , 4.3]
Weber et al, 1999 36 5.5 [3.9 , 7.1]
Weber et al, 2011 30 6.7 [4.1 , 9.3]
Williams et al, 2011 20 13.5 [11.9 , 15.1]
Mean difference model for all studies 5.5 [4.0 , 7.1]
Intra-arterial aortic DBP higher Brachial cuff DBP higher

20.0 16.0 12.0 8.0 4.0 0.0 4.0 8.0 12.0 16.0 20.0 24.0
Mean Difference Between Brachial Cuff and Intra-Arterial Aortic DBP

Pooled mean difference and 95% CI for meta-analysis 3, the comparison of brachial cuff and intra-arterial aortic SBP (A), DBP (B), and PP (C).
Abbreviations as in Figure 1.

Continued on the next page


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AUGUST 1, 2017:57286 Accuracy of Cuff-Measured BP

F I G U R E 2 Continued

C
Mean Difference
Author(s) and Year Patients [95% CI]
Aakhus et al, 1993 28 10.3 [12.7 , 7.9]
Bhatt et al, 2011 98 12.6 [14.8 , 10.4]
Borow et aI, 1982 30 1.0 [2.9 , 0.9]
Bos et al, 1992 19 5.2 [7.7 , 2.7]
Broyd et al, unpublished 25 16.4 [22.3 , 10.4]
Cheng et al, 2010 100 4.4 [6.4 , 2.3]
Cheng et al, unpublished 17 9.5 [15.5 , 3.4]
Costello et al, 2015 40 11.0 [15.1 , 6.8]
Cremer et al, 2012 142 14.8 [17.5 , 12.0]
Ding et al, 2013 33 0.4 [2.2 , 2.9]
Korolkova et al, unpublished 14 8.4 [16.8 , 0.1]
Laugesen/Rossen et al, 2014 37 9.3 [12.7 , 5.8]
Lin AC et al, 2012 35 2.3 [8.2 , 3.5]
Lin MM et al, 2012 78 5.4 [8.2 , 2.7]
Lowe et al, 2009 37 4.5 [10.2 , 1.1]
Milne et al, 2015 9 17.7 [13.4 , 21 .9]
Nagle et al, 1966 2 2.0 [11.2 , 7.2]
Nakagomi et al, 2016 139 17.7 [20.0 , 15.3 ]
Ohte et al, 2007 82 6.3 [8.8 , 3.7]
Ott et al, 2012 52 11.5 [7.1 , 16.0]
Park et al, 2014 6 7.3 [15.6 , 1.0]
Pereira et al, 2014 15 6.1 [3.4 , 8.7]
Picone et al, unpublished 146 5.4 [6.8 , 3.9]
Pucci et al, 2013 58 3.1 [5.6 , 0.6]
Pucci et al, unpublished 29 0.2 [3.5 , 3.9]
Rajani et al, 2008 14 2.7 [7.7 , 2.3]
Smulyan et al, 2003 25 5.3 [1.4 , 12.0]
Smulyan et al, 2008 100 2.8 [5.0 , 0.6]
Smulyan et al, 2010 25 1.6 [6.0 , 2.8]
Sueta et al, 2015 85 13.0 [15.0 , 1 1.1]
Takazawa et al, 2007 18 6.8 [12.5 , 1.1]
Takazawa et al, 2012 52 0.1 [4.0 , 4.2]
Weber et al, 1999 36 3.9 [7.8 , 0.0]
Weber et al, 2011 30 15.5 [20.3 , 10.6]
Williams et al, 2011 20 6.0 [8.3 , 3.7]
Mean difference model for all studies 4.8 [7.1 , 2.6]
Intra-arterial aortic PP higher Brachial cuff PP higher

22.0 14.0 6.0 2.0 2.0 6.0 10.0 14.0 18.0 22.0
Mean Difference Between Brachial Cuff and Intra-Arterial Aortic PP

95% CI: 0.76 to 0.85), p < 0.0001 for all (Online traditional threshold analysis in some BP categories
Figure 11). In all meta-analyses, there was signicant (for example, in meta-analysis 2, normal and pre-HTN
heterogeneity between studies for the SBP, DBP, and categories changed from 60% to 71% and from 50%
PP analyses (I 2 > 86%; p < 0.0001 for all). to 66%). However, concordance remained similar or
BP CLASSIFICATION BASED ON CUFF BP COMPARED was reduced among other categories (Table 2). The
WITH INTRA-ARTERIAL BP. Among individuals with revised thresholds shifted the systematic underesti-
BP classied as either pre-HTN or stage 1 HTN, only mation of risk using cuff BP compared with intra-
50% to 60% of brachial cuff BP measures were arterial brachial BP among the categories of pre-HTN
concordant with intra-arterial BP measures. Under- and stage 1 HTN to a more even distribution of over-
estimation of BP classication was the predominant estimation and underestimation of the correct BP
issue for brachial cuff comparisons with intra-arterial classication category. For example, in the category
brachial BP, whereas intra-arterial aortic BP classi- of cuff BP pre-HTN, the percentage of intra-arterial
cations were similarly overestimated and under- brachial BP cases that were in the stage 1 HTN cate-
estimated. However, there was reasonable gory was reduced from 36% to 17% (cuff underesti-
concordance between brachial cuff and intra-arterial mation). However, in the category of cuff BP
BP (brachial or aortic) values measured among pre-HTN, the percentage of intra-arterial brachial BP
individuals with stage 2 HTN ($160/100 mm Hg) in the normal category increased from 9% to 13% (cuff
according to intra-arterial BP. There was also overestimation). Similarly, in the category of cuff BP
reasonable concordance between cuff and intra- stage 1 HTN, the percentage of intra-arterial brachial
arterial aortic BP for BP classication in the normal BP cases that were in either stage 2 HTN or pre-HTN
range (<120/80 mm Hg) (Table 1). There were similar categories changed from 32% to 20% (cuff underes-
ndings when BP classication was only based on SBP timation) and from 13% to 26% (cuff overestimation),
thresholds (Online Table 17). When revised percentile respectively. With respect to delineating HTN at the
rank intra-arterial BP thresholds were used, there was traditional cut-off of 140/90 mm Hg, in meta-analysis
an improvement in concordance compared with the 2 the sensitivity was 78.5% (95% CI: 66.8% to 87.0%),
580 Picone et al. JACC VOL. 70, NO. 5, 2017

Accuracy of Cuff-Measured BP AUGUST 1, 2017:57286

T A B L E 1 Number of Subjects and Percentage Concordance Between Brachial Cuff and Intra-Arterial Brachial and Aortic Systolic and Diastolic BP for
Classication of BP Control

Normal Pre-Hypertension Stage 1 Hypertension Stage 2 Hypertension


SBP <120 mm Hg and SBP 120139 mm Hg and/or SBP 140159 mm Hg and/or SBP $160 mm Hg or
Cuff Blood Pressure DBP <80 mm Hg DBP 8089 mm Hg DBP 9099 mm Hg DBP $100 mm Hg

Intra-Arterial Brachial BP (n 668)


Normal 80 (60) 41 (35) 4 (4) 1 (1)
SBP <120 and DBP <80 mm Hg
Pre-hypertension 22 (9) 124 (50) 71 (36) 7 (5)
SBP 120139 and/or DBP 8089 mm Hg
Stage 1 hypertension 1 (2) 20 (13) 79 (53) 43 (32)
SBP 140159 and/or DBP 9099 mm Hg
Stage 2 hypertension 0 (0) 1 (1) 31 (19) 143 (80)
SBP $160 or DBP $100 mm Hg
Pre-hypertension and stage 1 hypertension combined 23 (6) 294 (78) 50 (16)
SBP 120159 and/or DBP 8099 mm Hg
Intra-Arterial Aortic BP (n 1,676)
Normal 322 (79) 78 (19) 4 (1) 2 (1)
SBP <120 and DBP <80 mm Hg
Pre-hypertension 112 (19) 341 (57) 130 (22) 13 (2)
SBP 120139 and/or DBP 8089 mm Hg
Stage 1 hypertension 16 (4) 103 (24) 221 (52) 94 (20)
SBP 140159 and/or DBP 9099
Stage 2 hypertension 0 (0) 7 (3) 48 (21) 185 (76)
SBP $160 or DBP $100 mm Hg
Pre-hypertension and stage 1 hypertension combined 128 (12) 795 (78) 107 (10)
SBP 120159 and/or DBP 8099 mm Hg

Values are n (%), and each row adds to 100%. Linear mixed modeling was used to account for clustering of subjects within studies. Brachial cuff blood pressure (BP) measurements were classied based on
Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines, and compared for concordance by applying the same cut points to the
intra-arterial brachial and aortic systolic blood pressure (SBP) and diastolic blood pressure (DBP). The proportion of intra-arterial brachial or aortic measurements concordant with brachial cuff BP is reported
as a percentage. A value of 100% within the bolded cells is equal to complete concordance of BP classication. Pre-hypertension and stage 1 hypertension were merged as a combined category to explore the
possible clinical implication of cuff BP accuracy at this BP level.

and specicity was 95.2% (95% CI: 86.5% to 98.4%). but age was not signicantly related to the difference
In meta-analysis 3, sensitivity was 81.7% (95% CI: between brachial cuff and intra-arterial brachial
74.9% to 87.0%) and specicity was 88.5% (95% CI: SBP, whereas body mass index was not signicantly
83.4% to 92.2%). related to the difference between brachial cuff and
intra-arterial aortic SBP. There were no consistent
MAGNITUDE OF DIFFERENCE BETWEEN CUFF AND
associations observed for brachial cuff DBP versus
INTRA-ARTERIAL BP. Brachial cuff BP readings
intra-arterial DBP.
were $5, $10 or $15 mm Hg different from intra-
SENSITIVITY ANALYSIS. There were signicantly
arterial brachial SBP in 465 (67%), 275 (41%), and 173
more males in the maximum-rated studies in meta-
(26%) of subjects of meta-analyses 2 (Figure 3A).
analyses 2 and 3. There were no other signicant
Similarly, when compared with intra-arterial aortic BP,
differences between the maximum-rated and non
brachial cuff SBP was $5, $10 or $15 mm Hg different
maximum-rated studies (p > 0.05 all) (Online
in 1,236 (67%), 748 (40%), and 411 (22%) of subjects of
Tables 20 to 22). There were no signicant differ-
meta-analyses 3 (Figure 3B). Results were similar for
ences in BP values for published versus unpublished
DBP differences, although there was better agreement
data (p > 0.05) (Online Tables 23 to 25). In meta-
for DBP differences $15 mm Hg (Online Figure 12).
analyses 2 and 3, there were no signicant differ-
CLINICAL AND DEMOGRAPHIC CORRELATES. Older ences when data was analyzed based on single-cuff
age and higher body mass index were related in uni- BP measures versus the average of multiple-cuff BP
variable analysis to less underestimation of intra- measures. Furthermore, BP classication analysis was
arterial brachial and aortic SBP and PP by brachial consistent irrespective of the number of cuff mea-
cuff SBP and PP (Online Tables 18 and 19). In multi- sures. Correlations between cuff and intra-arterial BP
variable analysis, age and body mass index both were also similar irrespective of the number of cuff BP
remained signicantly related to the difference in PP, measures. Differences between cuff and intra-arterial
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AUGUST 1, 2017:57286 Accuracy of Cuff-Measured BP

T A B L E 2 Number of Subjects and Percentage Concordance Between Brachial Cuff and Intra-Arterial Brachial and Aortic Systolic and Diastolic BP for Classication
of BP Control Based on Revised Intra-Arterial Thresholds

Intra-Arterial Brachial BP (n 668)

Normal Pre-Hypertension Stage 1 Hypertension Stage 2 Hypertension


SBP <124.5 and SBP 124.5 to <150 and/or SBP 150 to <167 and/or SBP $167 or
DBP <74 mm Hg DBP 74 to <85 mm Hg DBP 85 to <91 mm Hg DBP $91 mm Hg
Cuff Blood Pressure Centiles <19th 19th to <54th 54th to <76th $76th

Normal <19th 93 (71) 31 (27) 1 (1) 1 (1)


SBP <120 and DBP <80 mm Hg
Pre-hypertension 19th to <54th 28 (13) 156 (66) 34 (17) 6 (4)
SBP 120 to 139 and/or
DBP 80 to 89 mm Hg
Stage 1 hypertension 54th to <76th 3 (2) 38 (26) 73 (52) 29 (20)
SBP 140 to 159 and/or
DBP 90 to 99 mm Hg
Stage 2 hypertension $76th 0 (0) 6 (3) 31 (21) 138 (76)
SBP $160 or DBP $100 mm Hg
Pre-hypertension and stage 1 19th to <76th 31 (9) 301 (81) 35 (10)
hypertension combined
SBP 120 to 159 and/or
DBP 80 to 99 mm Hg

Intra-Arterial Aortic Blood Pressure (n 1,676)

Normal Pre-Hypertension Stage 1 Hypertension Stage 2 Hypertension


SBP <119.1 and SBP 119.1141.8 and/or SBP 141.8165.1 and/or SBP $165.1 or
DBP <74 mm Hg DBP 7483.5 mm Hg DBP 83.593.1 mm Hg DBP $93.1 mm Hg
Cuff Blood Pressure Centiles <24th 24th to <59th 59th to 86th $86th

Normal <24th 302 (74) 97 (25) 6 (1) 1 (0)


SBP <120 and DBP <80 mm Hg
Pre-hypertension 24th to <59th 89 (15) 364 (61) 133 (22) 10 (2)
SBP 120139 and/or DBP
8089 mm Hg
Stage 1 hypertension 59th to <86th 14 (3) 108 (27) 245 (56) 67 (14)
SBP 140159 and/or
DBP 9099 mm Hg
Stage 2 hypertension $86th 0 (0) 8 (5) 66 (30) 166 (65)
SBP $160 or DBP $100 mm Hg
Pre-hypertension and stage 1 24th to <86th 103 (10) 850 (83) 77 (7)
hypertension combined
SBP 120159 and/or
DBP 8099 mm Hg

Data are presented as n (%), and each row adds to 100%. Linear mixed modeling was used to account for clustering of subjects within studies. Brachial cuff BP measurements were classied based on
Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines, and were compared for concordance with classication of the
corresponding intra-arterial brachial and aortic systolic and diastolic BP. The proportion of intra-arterial brachial or aortic measurements concordant with brachial cuff BP is reported as a percentage. A value
of 100% within the bolded cells is equal to complete concordance of BP classication. Modied intra-arterial thresholds have been calculated from the equivalent percentile rank of cuff BP thresholds.
Pre-hypertension and stage 1 hypertension were merged as a combined category to explore the possible clinical implication of cuff BP accuracy at this BP level.
Abbreviations as in Table 1.

BP were not signicantly inuenced by the type of between the central and peripheral arterial sites.
catheter used for intra-arterial BP measurement (data However, there was extreme individual variability
not shown). in the magnitude of central-to-peripheral differences
for both SBP and DBP. Second, we found that cuff
DISCUSSION BP underestimated intra-arterial brachial SBP (and
PP), but overestimated intra-arterial brachial DBP
With HTN as the single major risk factor for global irrespective of BP technique (e.g., oscillometric or
disease burden (1), the accuracy of clinic BP methods auscultation using mercury methods). This is conr-
is critical. Our study had several key ndings. First, mation of perceived dogma relating to oscillometric
we conrmed the expectation that intra-arterial devices, but as far as we know is the rst compre-
brachial SBP was higher than intra-arterial aortic hensive analysis of all cuff BP methods to be
SBP, and also that there was little difference in DBP reported. Third, when cuff SBP was compared with
582 Picone et al. JACC VOL. 70, NO. 5, 2017

Accuracy of Cuff-Measured BP AUGUST 1, 2017:57286

F I G U R E 3 Individual Brachial Cuff and Intra-Arterial BP Differences

A 70
Mean Difference (Brachial Cuff Minus Intra-Arterial

60
50
40
Brachial Systolic BP), mm Hg

30
20 5 10 15 mm Hg
10
0
10
20 33% 59% 74%
30
40
50
60
70

60 80 100 120 140 160 180 200 220 240 260


Mean of Brachial Cuff and Intra-Arterial Brachial Systolic BP, mm Hg

B 70
Mean Difference (Brachial Cuff Minus Intra-Arterial

60
50
40
Aortic Systolic BP), mm Hg

30
20 5 10 15 mm Hg
10
0
10
20 33% 60% 78%
30
40
50
60
70

60 80 100 120 140 160 180 200 220 240


Mean of Brachial Cuff and Intra-Arterial Aortic Systolic BP, mm Hg

Plots of brachial cuff and intra-arterial brachial (A), as well as brachial cuff and intra-arterial aortic (B) SBP. The mean of the brachial cuff SBP and
intra-arterial SBP is on the x-axis, and the mean difference between brachial cuff SBP and the intra-arterial SBP is on the y-axis. The proportion of brachial
cuff SBP values within 5 mm Hg of the intra-arterial SBP measures is represented by the green dashed line, and is reported under the 5 bar. The
same presentation is provided for cuff SBP values within 10 mm Hg (orange dotted line) and 15 mm Hg (red dot-dashed line). The solid blue
horizontal line represents the mean SBP difference calculated as brachial cuff minus intra-arterial BP. Abbreviations as in Figure 1.

intra-arterial aortic SBP, there was a small mean and indicate the need to improve accuracy stan-
difference but poor agreement between measures at dards of cuff BP devices.
the individual level, whereas cuff DBP overestimated CLINICAL IMPLICATIONS. A key problem in
and cuff PP underestimated intra-arterial aortic addressing the global burden of disease related to
values. Finally, the observed variability in cuff BP high BP is improving the diagnosis and characteriza-
accuracy adversely inuenced correct classication of tion of the hypertensive phenotype (37). A funda-
BP (compared against intra-arterial classication) mental problem with BP accuracy was identied
across all JNC 7 categories, with particular discor- in our study that affects most (but not all) cuff
dance in the range from pre-HTN to stage 1 HTN. BP devices. Despite strong correlations between cuff
These data are summarized in the Central Illustration BP and intra-arterial BP, 16 of 22 examined cuff BP
JACC VOL. 70, NO. 5, 2017 Picone et al. 583
AUGUST 1, 2017:57286 Accuracy of Cuff-Measured BP

C ENTR AL I LL U STRA T I O N Accuracy of Cuff-Measured BP

Hypertension (elevated blood pressure (BP))


is the single largest risk factor for cardiovascular disease mortality

Non-invasive brachial (upper arm) cuff BP is the principal method


for hypertension diagnosis and management
Does the cuff accurately measure BP?

For patients with For patients with For patients with


Normal BP Prehypertension (120/80 to <140/90 mm Hg) Stage 2 hypertension
<120/80 mm Hg or Stage 1 hypertension (140/90 to <160/100 mm Hg) 160/100 mm Hg

Reasonable Cuff overestimates diastolic BP at brachial and aortic level Reasonable


confidence can be Cuff underestimates systolic BP at brachial level confidence can be
placed in cuff BP placed in cuff BP
Cuff variably under- or overestimates SBP at the aorta
readings readings

Improved accuracy is recommended

Picone, D.S. et al. J Am Coll Cardiol. 2017;70(5):57286.

Summary ndings from individual participant data meta-analyses of cuff blood pressure (BP) accuracy. This illustration depicts BP classication based on cuff BP
measurements and corresponding concordance with intra-arterial BP classication. The results are calculated using all available individual participant data from the
1950s to 2016. Reasonable condence can be placed in cuff BP readings <120/80 mm Hg or $160/100 mm Hg to predict intra-arterial brachial or aortic BP. Improved
accuracy is recommended in the BP range from pre-hypertension ($120/80 mm Hg to <140/90 mm Hg) to stage 1 hypertension ($140/90 mm Hg
to <160/100 mm Hg), where concordance with intra-arterial BP was not strong. SBP systolic blood pressure.

devices signicantly underestimated intra-arterial identication of risk related to BP in clinical practice


brachial SBP (Figure 1A) and 15 of 18 signicantly will require future studies.
underestimated PP (Figure 1C). The mean difference It could be argued that our ndings are not a major
in the magnitude of the underestimation often clinical problem, because HTN thresholds have been
exceeded 10 mm Hg. Translating these error margins derived from well conducted clinical trial data using
to the traditional classication of BP based on intra- the same (or similar) cuff BP methods to that analyzed
arterial SBP readings, cuff BP correctly identied in this current work. Thus, whether cuff BP is
pre-HTN and stage 1 HTN in only about one-half of measuring the intra-arterial BP could be largely
the participants, whether based on intra-arterial irrelevant if risk can still be gauged relative to the BP
brachial or aortic SBP (Table 1). Concordance with methods employed in the clinical trials. This
revised intra-arterial brachial BP thresholds (based on contention would be valid if there were consistent
cuff BP percentile rank) was improved from 50% to systematic error(s), but in fact there was wide inter-
66% in the pre-HTN range (Tables 1 and 2). This device variability with respect to SBP, DBP, and PP
analysis also resulted in reduced systematic under- accuracy. To clarify the issue, separate analysis on
estimation of risk using cuff BP among the categories the accuracy of BP devices used in all the seminal
of pre-HTN and stage 1 HTN. Instead, a relatively clinical trials would be required. In any case, a
even distribution was observed toward both over- reasonable degree of condence that cuff BP is
estimation and underestimation of correct classica- representative of intra-arterial brachial or aortic
tion of intra-arterial BP (Table 2). The true SBP is associated with readings <120/80 mm Hg
implications of these ndings with respect to or $160/100 mm Hg (Tables 1 and 2).
584 Picone et al. JACC VOL. 70, NO. 5, 2017

Accuracy of Cuff-Measured BP AUGUST 1, 2017:57286

CUFF BP VALIDATION STANDARDS. Guidance on BP device validation protocols in which cuff BP is


validation protocols for cuff BP devices is provided by compared against intra-arterial BP at the radial (44),
several scientic bodies (33,3842); however, there brachial (10), or aortic (45) level. Improvement of BP
are many procedural differences between guidelines device accuracy standards is desirable (29).
on features such as sample size, acceptable margin STUDY STRENGTHS AND LIMITATIONS. Individual-
of error, and pass criteria (43). When comparing BP level data were acquired from a wide variety of
device performance with the reference standard studies employing high-quality techniques and
(which can be intra-arterial BP or, most often, mer- spanning several decades of investigations, alto-
cury sphygmomanometry), differences of 0 to gether comprising relatively large sample sizes for
5 mm Hg are considered to be very accurate, each meta-analysis. However, this also probably
whereas differences >15 mm Hg are very inaccurate contributed to the observed statistical heterogeneity,
(40). Although there are many ways to determine indicating excess variation among experimental pro-
pass criteria for BP devices, the British Hyperten- tocols and a degree of uncertainty regarding effect
sion Society provide the highest grade pass (A) if estimates. Although intra-arterial BP is the reference
60% of differences fall within 5 mm Hg and only 5% standard measurement of BP (46,47), inaccurate BP
of differences fall outside of 15 mm Hg (33). The is possible due to numerous sources of error: 1) if
analysis we have conducted cannot be directly operators do not follow appropriate techniques
compared with results of validation studies assessing (e.g., catheter handling and dynamic response) (48);
the performance of individual BP devices. However, it 2) variability in BP between the recording of cuff
is of note that only 33% of cuff SBP readings fell and intra-arterial measurements; 3) if measures being
within 0 to 5 mm Hg, and >20% were >15 mm Hg from compared are recorded sequentially rather than
intra-arterial SBP (Figure 3). That would equate to a simultaneously; or 4) if measures are being compared
grade D (fail) device performance. From the available within contralateral rather than ipsilateral arterial
data, weak associations among age, body mass index, sites. Reassuringly, sensitivity analyses showed no
and cuff BP differences were observed in meta- signicant difference between the studies that
analyses 2 and 3, but we were unable to determine received the maximum quality rating for experi-
clear-cut reasons for the disparity between cuff and mental design taking into consideration these sources
intra-arterial BP. of error versus those that did not. Availability of
A novel nding with respect to the use of mercury repeated data would have helped address this issue
sphygmomanometry as a reference standard in BP further, but this was unavailable in most studies.
validation protocols is that this method demonstrated Finally, the study populations were generally typical
sizable imprecision. Compared with intra-arterial of patients presenting with clinical indications for
brachial BP, the mercury method performed better coronary artery catheterization, and therefore, there
than oscillometric BP with respect to the level of SBP was bias toward overweight, middle- to older-age
underestimation, but signicant overestimation of men, and the ndings cannot be widely generalized.
DBP and underestimation of PP was still observed
(Online Table 16). There was insufcient data on CONCLUSIONS
mercury BP to compare this method with oscillo-
metric BP for accuracy compared with intra-arterial Cuff BP is the cornerstone measurement in HTN
aortic BP. Overall, the analyses cast some doubt on management. The most important nding of the
the robustness of mercury sphygmomanometry as the present study was the inaccuracy of cuff BP when
standard against which BP device performance is compared with intra-arterial brachial BP and aortic
gauged (possibly due to inuences of operator error), BP. These deviations substantially inuenced BP
albeit acknowledging that it is the best noninvasive classication according to clinical guideline criteria.
option currently available. Intra-arterial BP measured The inadequacies of cuff BP identied within this
under rigorous criteria has the strongest level of work could be improved with better noninvasive cuff
BP accuracy and may be a better choice as the BP methods to estimate brachial or aortic BP. This
comparator for BP device validation. But, it is less should then lead to enhanced clinical diagnosis and
practical, and it is not ethical to use among some management of HTN.
populations. In any case, our observation of signi-
cant differences (and marked variability) between ADDRESS FOR CORRESPONDENCE: Prof. James E.
intra-arterial aortic and brachial BP clearly shows that Sharman, Menzies Institute for Medical Research,
it is not acceptable to assume peripheral BP is repre- University of Tasmania, Private Bag 23, Hobart, Tasmania
sentative of central BP. This nding is applicable to 7000, Australia. E-mail: James.Sharman@utas.edu.au.
JACC VOL. 70, NO. 5, 2017 Picone et al. 585
AUGUST 1, 2017:57286 Accuracy of Cuff-Measured BP

PERSPECTIVES

COMPETENCY IN MEDICAL KNOWLEDGE: TRANSLATIONAL OUTLOOK: New methods of


Measurement of BP with pneumatic cuff devices is subject noninvasive BP measurement should undergo robust
to considerable variability that affects correlations validation to ensure accuracy before they are employed in
with direct intra-arterial brachial and aortic pressure patient care or population health studies.
measurements. When compared with intra-arterial
pressures, brachial cuff sphygmomanometry generally
underestimates systolic and overestimates diastolic BP.

REFERENCES

1. Forouzanfar MH, Alexander L, Anderson HR, 11. Cheng HM, Wang KL, Chen YH, et al. Estima- 23. Narayan O, Casan J, Szarski M, Dart AM,
et al. Global, regional, and national comparative tion of central systolic blood pressure using an Meredith IT, Cameron JD. Estimation of central
risk assessment of 79 behavioural, environmental oscillometric blood pressure monitor. Hypertens aortic blood pressure: a systematic meta-analysis
and occupational, and metabolic risks or clusters Res 2010;33:5929. of available techniques. J Hypertens 2014;32:
of risks in 188 countries, 19902013: a systematic 172740.
12. Gerin W, Schwartz AR, Schwartz JE, et al.
analysis for the Global Burden of Disease Study
Limitations of current validation protocols for 24. Davies JI, Band MM, Pringle S, Ogston S,
2013. Lancet 2015;386:2287323.
home blood pressure monitors for individual pa- Struthers AD. Peripheral blood pressure measure-
2. Lewington S, Clarke R, Qizilbash N, Peto R, tients. Blood Press Monit 2002;7:3138. ment is as good as applanation tonometry at
Collins R. Age-specic relevance of usual blood predicting ascending aortic blood pressure.
13. Kelly RP, Gibbs HH, ORourke MF, et al.
pressure to vascular mortality: a meta-analysis of J Hypertens 2003;21:5716.
Nitroglycerin has more favorable effects on left-
individual data for one million adults in 61 pro-
ventricular afterload than apparent from mea- 25. Cheng HM, Lang D, Tufanaru C, Pearson A.
spective studies. Lancet 2002;360:190313.
surement of pressure in a peripheral artery. Eur Measurement accuracy of non-invasively obtained
3. Kannel WB. Role of blood pressure in cardio- Heart J 1990;11:13844. central blood pressure by applanation tonometry:
vascular disease: the Framingham Study. Angiol- a systematic review and meta-analysis. Int J
14. Kavanagh-Gray D. Comparison of central aortic
ogy 1975;26:114. Cardiol 2013;167:186776.
and peripheral artery pressure curves. Can Med
4. Pickering TG, Hall JE, Appel LJ, et al. Recom- Assoc J 1964;90:146871. 26. Chobanian AV, Bakris GL, Black HR, et al. The
mendations for blood pressure measurement in
15. Kollias A, Lagou S, Zeniodi ME, seventh report of the Joint National Committee on
humans and experimental animals: part 1: blood Prevention, Detection, Evaluation, and Treatment
Boubouchairopoulou N, Stergiou GS. Association
pressure measurement in humans: a statement for of High Blood Pressure: the JNC 7 report. JAMA
of central versus brachial blood pressure with
professionals from the Subcommittee of Profes-
target-organ damage: systematic review and 2003;289:256072.
sional and Public Education of the American Heart
meta-analysis. Hypertension 2016;67:18390.
Association Council on High Blood Pressure 27. Stewart LA, Clarke M, Rovers M, et al.
Research. Hypertension 2005;45:14261. 16. Vlachopoulos C, Aznaouridis K, ORourke MF, Preferred reporting items for systematic review
Safar ME, Baou K, Stefanadis C. Prediction of and meta-analyses of individual participant data:
5. Jones DW, Appel LJ, Sheps SG, Roccella EJ,
cardiovascular events and all-cause mortality with the PRISMA-IPD statement. JAMA 2015;313:
Lenfant C. Measuring blood pressure accurately:
central haemodynamics: a systematic review and 165765.
new and persistent challenges. JAMA 2003;289:
meta-analysis. Eur Heart J 2010;31:186571.
102730. 28. Laugesen E, Knudsen ST, Hansen KW, et al.
17. Cheng HM, Chuang SY, Sung SH, et al. Deri- Invasively measured aortic systolic blood pressure
6. Psaty BM, Smith NL, Siscovick DS, et al. Health
vation and validation of diagnostic thresholds for and ofce systolic blood pressure in cardiovascular
outcomes associated with antihypertensive ther-
central blood pressure measurements based on risk assessment: a prospective cohort study. Hy-
apies used as rst-line agents. A systematic review
long-term cardiovascular risks. J Am Coll Cardiol pertension 2016;68:76874.
and meta-analysis. JAMA 1997;277:73945.
2013;62:17807.
29. Sharman JE, Avolio AP, Baulmann J, et al.
7. Liszka HA, Mainous AG 3rd, King DE, Everett CJ,
18. Millasseau S, Agnoletti D. Non-invasive esti- Validation of non-invasive central blood pressure
Egan BM. Prehypertension and cardiovascular
mation of aortic blood pressures: a close look at devices: Artery Society task force consensus
morbidity. Ann Fam Med 2005;3:2949.
current devices and methods. Curr Pharm Des statement on protocol standardization. Eur Heart J
8. Wright JT Jr., Williamson JD, Whelton PK, et al. 2015;21:70918. 2017 Jan 30 [E-pub ahead of print].
A randomized trial of intensive versus standard
19. Sharman JE, Laurent S. Central blood pressure 30. Sprafka JM, Strickland D, Gomez-Marin O,
blood-pressure control. N Engl J Med 2015;373:
in the management of hypertension: soon reach- Prineas RJ. The effect of cuff size on blood pres-
210316.
ing the goal? J Hum Hypertens 2013;27:40511. sure measurement in adults. Epidemiology 1991;2:
9. Kobayashi H, Kinou M, Takazawa K. Correlation
20. Mitchell GF. Central pressure should not be 2147.
between the brachial blood pressure values ob-
used in clinical practice. Artery Res 2015;9:813. 31. Temmar M, Jankowski P, Peltier M, et al.
tained using the cuff method and the central
blood pressure values obtained invasively. Intern 21. Sharman JE. Central pressure should be used in Intraaortic pulse pressure amplication in subjects
Med 2013;52:167580. clinical practice. Artery Res 2015;9:17. at high coronary risk. Hypertension 2010;55:
32732.
10. Hunyor SN, Flynn JM, Cochineas C. Compari- 22. Cameron JD. Comparison of noninvasive
son of performance of various sphygmomanome- devices for assessing central blood pressure 32. Tummers B. DataThief III manual v. 1.1. 2005.
ters with intra-arterial blood-pressure readings. Br parameters: what to compare, when and why. Available at: http://datathief.org/DatathiefManual.
Med J 1978;2:15962. J Hypertens 2013;31:2731. pdf. Accessed March 31, 2016.
586 Picone et al. JACC VOL. 70, NO. 5, 2017

Accuracy of Cuff-Measured BP AUGUST 1, 2017:57286

33. OBrien E, Petrie J, Littler W, et al. The British 39. OBrien E, Atkins N, Stergiou G, et al. European measurement in the elderly. Br Med J (Clin Res Ed)
Hypertension Society protocol for the evaluation Society of Hypertension International Protocol 1983;286:15456.
of blood pressure measuring devices. J Hypertens revision 2010 for the validation of blood pressure
45. Ohte N, Saeki T, Miyabe H, et al. Relationship
1993;11:S4362. measuring devices in adults. Blood Press Monit
between blood pressure obtained from the upper
2010;15:2338.
34. Riley RD, Lambert PC, Staessen JA, et al. arm with a cuff-type sphygmomanometer and
Meta-analysis of continuous outcomes combining 40. OBrien E, Pickering T, Asmar R, et al. Working central blood pressure measured with a catheter-
individual patient data and aggregate data. Stat Group on Blood Pressure Monitoring of the Euro- tipped micromanometer. Heart Vessels 2007;22:
Med 2008;27:187093. pean Society of Hypertension International Pro- 4105.
tocol for validation of blood pressure measuring 46. Avolio AP, Van Bortel LM, Boutouyrie P, et al.
35. Laugesen E, Rossen NB, Peters CD, et al.
devices in adults. Blood Press Monit 2002;7:317. Role of pulse pressure amplication in arterial
Assessment of central blood pressure in patients
with type 2 diabetes: a comparison between 41. Tholl U, Anlauf M. [Conscientious evaluation hypertension: experts opinion and review of the
SphygmoCor and invasively measured values. Am of measuring accuracy. Hypertension League pro- data. Hypertension 2009;54:37583.
J Hypertens 2014;27:16976. vides approval seals for automatic blood pressure 47. Perloff D, Grim C, Flack J, et al. Human blood
units]. MMW Fortschr Med 1999;141:45. pressure determination by sphygmomanometry.
36. Rossen NB, Laugesen E, Peters CD, et al.
Circulation 1993;88:246070.
Invasive validation of arteriograph estimates of 42. White WB, Berson AS, Robbins C, et al. Na-
central blood pressure in patients with type 2 tional standard for measurement of resting and 48. Gardner RM. Direct blood pressure measure-
diabetes. Am J Hypertens 2014;27:6749. ambulatory blood pressures with automated mentdynamic response requirements. Anesthe-
sphygmomanometers. Hypertension 1993;21: siology 1981;54:22736.
37. Olsen MH, Angell SY, Asma S, et al. A call to
5049.
action and a lifecourse strategy to address the
global burden of raised blood pressure on current 43. Beime B, Deutsch C, Gomez T, Zwingers T,
KEY WORDS blood pressure determination,
and future generations: the Lancet Commission on Mengden T, Bramlage P. Validation protocols for
hemodynamics, sphygmomanometers
Hypertension. Lancet 2016;388:2665712. blood pressure-measuring devices: status quo and
development needs. Blood Press Monit 2016;21:
38. American National Standard Non-Invasive
18.
SphygmomanometersPart 2: Clinical Validation A PPE NDI X For an expanded Methods section,
of Automated Measurement Type. ANSI/AAMI/ISO 44. OCallaghan WG, Fitzgerald DJ, OMalley K, as well as supplemental gures and tables,
81060-2:2009. Arlington, Virginia: AAMI, 2009. OBrien E. Accuracy of indirect blood pressure please see the online version of this article.

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