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Editorial comment 1915

Accuracy of blood pressure measurement:


sphygmomanometer calibration and beyond
Gianfranco Paratia,b, Andrea Fainia and Paolo Castiglionic

Journal of Hypertension 2006, 24:19151918 are summarized in Fig. 2 of their paper [4]. The percent-
a
age of subjects correctly labelled as hypertensives
Department of Clinical Medicine and Prevention, University of Milano-Bicocca,
Milan, bII Cardiology Unit, San Luca Hospital, IRCCS, Istituto Auxologico Italiano, (a measure of the sensitivity of the diagnostic procedure)
Milan and cBioengineering Center, Don C. Gnocchi Foundation, IRCCS, Milan, Italy increased significantly with the increase in the number of
Correspondence and requests for reprints to Gianfranco Parati, Department of doctors visits, when correctly calibrated blood pressure-
Cardiology, San Luca Hospital, Istituto Auxologico Italiano, Via Spagnoletto, 3, measuring devices were employed. This increase reflects
20149 Milan, Italy
Tel: +39 02 619112890; fax: +39 02 619112956;
a reduction in random error obtained by averaging the
e-mail: gianfranco.parati@unimib.it blood pressure values measured over successive visits.
Conversely, when non-calibrated devices were used not
See original paper on page 1931 only the sensitivity of the diagnostic procedure was lower
at the first visit, but also the increment in sensitivity with
repeated visits, observed over subsequent measurements
The importance of accurate blood pressure measurement when using calibrated manometers, was less pronounced.
in the diagnosis of arterial hypertension, and in the This is because the non-calibrated sphygmomanometer
precise titration of antihypertensive treatment, is largely introduces a systematic error in the blood pressure esti-
acknowledged in clinical practice. The relevance of this mate that cannot be reduced by averaging several
issue has recently been further emphasized by hyper- measurements. Because of this, the sensitivity curves
tension management guidelines [13]. Health care givers typical of calibrated and of non-calibrated devices dis-
as well as patients are now aware of the need to follow played a tendency to diverge with the increase in the
carefully standardized procedures when measuring number of visits.
blood pressure, aimed at achieving the highest possible
accuracy of blood pressure estimates. A specific feature of the study by Turner et al. [4], which
deserves some discussion, is represented by the mathe-
Conversely, the possible negative impact that poor main- matical model employed to assess the clinical relevance
tenance of blood pressure-measuring devices may have of sphygmomanometer calibration, a model which may
on the accuracy of patients blood pressure assessment, is not necessarily be familiar to some researchers. The
still largely underestimated or disregarded, even by authors used a simple Monte Carlo simulation to estimate
physicians and nurses. This phenomenon should be the combined effects of systematic sphygmomanometer
considered with concern because a technical problem error and day-to-day random variability of blood pressure
such as sphygmomanometer calibration might impor- measurements on the over- and under-detection of hy-
tantly affect the effectiveness of hypertension manage- pertension in adults aged 18 years and older. Monte Carlo
ment and, surprisingly enough, its influence may be methods are a class of computational algorithms for
greater now than some years ago. This is due to the more simulating the behaviour of various physical and mathe-
and more frequent tendency among hospital staff and matical systems. These techniques are used in situations
general practitioners to shift from use of the classical where the analytic solution of a problem is either hardly
mercury sphygmomanometer to the adoption of other achievable or time consuming. In other words, a Monte
blood pressure-measuring techniques, such as aneroid Carlo algorithm is a method used to find solutions to
sphygmomanometers and electronic devices. mathematical problems (which may be characterized by
many variables) that cannot easily be solved, for example,
In this issue of the journal, Turner et al. [4] provide by integral calculus, or by other numerical methods. Its
further evidence to support the clinical relevance of efficiency when compared with other numerical methods
sphygmomanometer calibration. By means of mathe- increases with the increase in the dimension of the
matical simulations, the authors have extended the problem to be solved. A Monte Carlo technique can be
results of previous studies [5,6], and have estimated differentiated from other simulation methods because of
the combined effects exerted on the detection of arterial its stochastic nature (i.e. because it is characterized by
hypertension by random blood pressure variability non-deterministic algorithms, through use of random
(including intra-individual blood pressure variability as numbers).
well as random measurement errors) and by systematic
errors due to inadequate sphygmomanometer calibration. Monte Carlo techniques have a long history in math-
The main findings of their mathematical simulation ematics, with their earliest application probably being
0263-6352 2006 Lippincott Williams & Wilkins

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1916 Journal of Hypertension 2006, Vol 24 No 10

represented by Buffons Needle in 1733. The name worldwide use, the conventional sphygmomanometric
Monte Carlo was given by Nicholas Metropolis (in measurement of blood pressure through the Riva-Rocci
honour of his uncle Ulam, who was a gambler) during manometer coupled with use of Korotkoff sounds is
the Manhattan Project of World War II, and specifically known to be affected by a number of limitations. A first
refers to the famous casino in Monaco. The use of important problem is the high between-measurement
randomness and the repetitive nature of the analytic variation in office blood pressure readings, which reflects
process characteristic of a Monte Carlo model are both both the physiological variations in blood pressure level
analogous to the gambling activities conducted in a and frequently also errors in the technique of measure-
casino. Perhaps the most famous early use of this model ment, due to conditions of measurement, arm position,
was made by Enrico Fermi in 1930, when he employed a observers attitude. In 1964, Geoffrey Rose [9] classified
random method to calculate the properties of the newly- the observer error into three categories: (i) systematic
discovered neutron. Monte Carlo methods were central errors, which lead to both intraobserver and interobserver
to the simulations required for the Manhattan Project, error; (ii) terminal digit preference, which results in the
although they were strongly limited by the computational observer rounding off the pressure reading to a preferred
tools available at that time. It was only after electronic digit, most often to zero [10]; and (iii) observer prejudice
computers became available (i.e. from 1945 onwards) that or bias, leading the observer simply to adjust the blood
Monte Carlo methods began to be studied in depth. In pressure readings to meet his or her preconceived notion
the 1950s, they were used at Los Alamos for some early of what the blood pressure should be. All these problems
work aimed at the development of the hydrogen bomb, contribute to the between-observer variability in the
and became popular in the fields of physics and oper- accuracy of blood pressure readings, mostly due to differ-
ations research. The Rand Corporation and the US Air ences in skill and training [3]. Other factors, not of a
Force were two of the major organizations responsible for technological nature, can introduce systematic errors in
funding and disseminating information on Monte Carlo sphygmomanometric blood pressure measurements.
methods during this period, which found wide appli- These include errors in arm cuff positioning, as well as
cations in many different fields. The use of Monte Carlo the choice of an inappropriate cuff-size, in relation to
methods requires large amounts of random numbers patients arm circumference. The latter problem has
and, indeed, it was their use that spurred the develop- recently received more attention due to the progressive
ment of pseudorandom number generators, which were increase in the prevalence of obesity and overweight in
far quicker to use than the tables of random numbers developed countries, without a parallel increase in the
previously used for statistical sampling. frequency of large arm-cuff use [11]. A second major
problem affecting the accuracy of sphygmomanometric
Monte Carlo methods have diverse applications, ranging blood pressure readings is the discrepancy between blood
from the simulation of complex physical phenomena, pressure values obtained in the office and those measured
such as radiation transport in the earths atmosphere or outside of a clinic setting (i.e. the so-called white-coat
simulation of the esoteric subnuclear processes in high- effect). This phenomenon shows high inter-individual
energy physics experiments, to daily entertainments, variations, limited reproducibility and its prognostic
such as the simulation of a Bingo game. The analogy importance is still a matter of controversy, but it certainly
of Monte Carlo methods to games of chance is intriguing, interferes with the assessment of subjects true blood
but the game when addressing a scientific problem is a pressure levels [1216].
physical system, and the outcome of the game is not a pot
of money or a stack of chips (unless simulated) but rather Beyond all these factors possibly involved in determining
a satisfactory solution for the problem under assessment. the accuracy of blood pressure measurements, another
critical issue in this context is represented by perform-
Factors involved in the accuracy of blood ance of a regular calibration of the device employed. This
pressure measurements: device calibration is the case for mercury, oscillometric and electronic
and beyond devices, even with important technical differences.
The classic approach to blood pressure measurement is Given the simple structure of the mercury device, its
based on use of the mercury sphygmomanometer, which maintenance is relatively simple [3], and a loss of cali-
has long been regarded as the gold standard for blood bration is observed rarely. The latter is mainly due to
pressure readings in a clinical setting since its first mercury oxidation, a process that occurs in a relatively
description by Scipione Riva-Rocci, published in 1896 slow manner. When such a phenomenon is observed, the
on the Gazzetta Medica di Torino [7,8]. Its use is based instrument can be easily recalibrated by simply replacing
on the theory of the occlusion technique: the pressure of the mercury in the reservoir. This procedure, even if
air within the arm cuff is balanced by the weight of a some attention is needed due to mercury toxicity, can be
mercury column contained in a graded glass tube. easily carried out by the sphygmomanometer users, and
The height of the column therefore measures the air does not require any intervention by the manufacturer.
pressure in the arm cuff in mmHg. In spite of its However, increasing concerns about the toxicity of

Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Calibration of sphygmomanometers Parati et al. 1917

mercury for individuals using or servicing mercury sphyg- automated device will always be necessary. Another
momanometers, and, more importantly, the great concern advantage carried by automated blood pressure-
about the toxic effects of mercury on the environment, measuring devices is their ability to store data for later
have determined a progressive shift towards other kind of analysis and/or to allow for remote teletransmission.
blood pressure-measuring devices [17,18]. The most These favourable properties have promoted the diffusion
commonly employed alternative to mercury manometers of these devices, and a number of large research studies
is represented by aneroid sphygmomanometers. As indi- are already employing automated technology to measure
cated by the name itself (aneroid means without fluid, in blood pressure instead of the traditional mercury gold
the Greek language), these devices do not contain mer- standard.
cury, and are generally of smaller size and easier to handle
than the classic mercury manometers. Typically, they However, most of these devices are based on the oscillo-
consist of a thin brass corrugated bellows that is expanded metric method for blood pressure measurement. This
by the air pressure in the cuff. The expansion moves a pin implies that only mean blood pressure values are
resting on the bellows. The movement is mechanically measured, whereas systolic and diastolic blood pressure
amplified and transmitted to a dial. This bellows and are determined through proprietary and undisclosed
lever system is mechanically more complex than the algorithms, built in each device, and different between
mercury reservoir and column [19]. Moreover, besides different manometers [3]. Moreover, the cuff deflation
being prone to all the problems of the auscultatory rate may be different in different devices, thus introdu-
technique (namely observer bias and terminal digit pre- cing another possible source of error in automated blood
ference), aneroid manometers are easily damaged and can pressure measurements. All these problems may lead to
go out of calibration without detection [3], due to significant differences in the blood pressure values pro-
mechanical shocks and changes in environmental vided by automated oscillometric devices produced by
temperature related to everyday use. They usually lead different manufacturers [3,21,22]. Thus, although auto-
to falsely low readings with the consequent underestima- mated devices may eliminate observer-related systematic
tion of blood pressure. When calibrated against a mercury errors, they may unfortunately introduce other manu-
sphygmomanometer a mean difference of 3 mmHg is facturer-related errors. Moreover, most of the available
considered to be acceptable; however, 58% of aneroid automated devices were designed for self-measurement
sphygmomanometers have been shown to have errors of blood pressure at home, and may not necessarily be
greater than 4 mmHg, with approximately one-third of suitable for clinical application. Evidence is still lacking
these having errors higher than 7 mmHg [3,20]. Aneroid concerning whether they will remain accurate with long-
sphygmomanometers must therefore be checked every term use in a clinic setting, although some of them have
6 months against an accurate mercury sphygmomano- been used successfully in hospital practice and/or in large
meter over the entire pressure range, which can be carried hypertension studies. Furthermore, oscillometric tech-
out by connecting the aneroid sphygmomanometer via a niques cannot measure blood pressure in all situations,
Y-piece to the tubing of the mercury sphygmomanometer particularly in patients with dysrhythmias such as rapid
and inflating the cuff around a metal or wood cylinder. If atrial fibrillation. Finally, many doctors do not trust
inaccuracies or other faults are found, the instrument automated measurements, and prefer manual blood pres-
must be returned to the manufacturer or supplier for sure readings. To improve this situation, and to minimize
repair, given the difficulties which users often have to problems of accuracy related to their use, only automated
face when trying to re-calibrate them [3]. In practice, in devices validated according to internationally accepted
spite of their easier use, this implies that these devices protocols should be considered [2327]. Complying with
are often employed under suboptimal conditions, or this recommendation may help to reduce systematic
even with evident calibration problems and loss of errors, while the known stability of electronic transducers
measurement linearity. means that calibration needs only be performed at rela-
tively long time intervals. The latter advantage applies
The observer-related errors as well as the errors related to also when electronic devices are used manually.
the inaccuracy of aneroid manometers, could in theory be
eliminated by using automated electronic devices, such Notwithstanding the blood pressure-measuring tech-
as those proposed for self blood pressure measurement at nique selected, it should be noted that the parameter
home [3]. Accurate automated sphygmomanometers, under assessment (i.e. blood pressure) is by no means
capable of providing print-outs of systolic, diastolic and constant over time, and is characterized by a pronounced
mean blood pressure together with heart rate and the variability not only between different behavioural con-
time and date of measurement, would eliminate errors of ditions, but also on a beat-by-beat basis at rest [2830].
interpretation and abolish observer bias and terminal This means that, even when making use of a perfect
digit preference. Moreover, the need for observer training blood pressure-measuring tool in ideal environmental
would no longer be necessary, although a period of conditions, the same observer will unavoidably measure
instruction and assessment of proficiency in using the different blood pressure values over successive visits and

Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
1918 Journal of Hypertension 2006, Vol 24 No 10

even at different times within the same visit. This is 14 Mancia G, Parati G, Pomidossi G, Grassi G, Casadei R, Zanchetti A.
Alerting reaction and rise in blood pressure during measurements by
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