This study validated a hybrid mercury-free device as a replacement of the mercury sphygmomanometer for professional use, and also as a standard for future validations. A validation study was performed according to the European Society of Hypertension International Protocol 2010 (ESH-IP) in 33 subjects using simultaneous blood pressure (BP) measurements. A total of six BP measurements were taken per participant simultaneously by a supervisor (S; hybrid auscultatory device Nissei DM3000) and two observers (A and B; mercury sphygmomanometers). ESH-IP analysis (99 BP readings): mean device–observer systolic/diastolic BP difference 0.2±2.0/0.1±2.0 mm Hg; systolic BP differences ⩽5/10/15 mm Hg in 97/99/99 readings, respectively (diastolic 98/99/99). All 33 subjects had 2 of 3 BP differences ⩽5 mm Hg and none without a difference ⩽5 mm Hg. Further analysis (198 BP readings): mean differences S–A 0.1±2.4/0.2±2.4 mm Hg (systolic/diastolic), S–B 0.3±2.1/0.2±2.2, A–B 0.2±2.4/0.0±2.3; differences ⩽2 mm Hg S–A in 88/84% (systolic/diastolic), S–B 87/85%, A–B 87/86% and ⩽4 mm Hg S–A 95/96%, S–B 95/96%, A–B 95/98%. In conclusion, a hybrid mercury-free auscultatory BP monitor comfortably passed the ESH-IP 2010 requirements and has the same level of accuracy as the mercury sphygmomanometer. This device appears to be a reliable alternative to the mercury sphygmomanometer for professional use and also as a standard for future validations.
The accurate diagnosis of hypertension and the decision to administer long-term antihypertensive drug treatment is based on the correct measurement of blood pressure (BP). Virtually, all the evidence on the risks associated with elevated BP and the benefits of treatment-induced BP decline has been obtained using measurements of BP taken in the office or clinic by observers using mercury sphygmomanometers and the auscultatory technique.1, 2 Therefore, this method has been regarded as the cornerstone of hypertension diagnosis and management.
Another important application of the mercury sphygmomanometer is as reference method and standard against which any new device and technology for BP measurement is being compared. All the established protocols for clinical validation of BP monitors, such as the European Society of Hypertension International Protocol (ESH-IP),3, 4 the British Hypertension Society (BHS) protocol5 and the American Association for the Advancement of Medical Instrumentation (AAMI) protocol,6 essentially use the same procedure, which involves the comparison of the device against observers’ taking BP measurements using standard mercury sphygmomanometers and the auscultatory method.
It is recognized that mercury is highly toxic for humans, ecosystems and wildlife, and a European Community strategy has been adopted aiming to ban the use of mercury for medical or other purposes.7 In 2009, the European Commission Scientific Committee on Emerging and Newly Identified Health Risks recommended that mercury sphygmomanometers should remain available for clinical validation studies as reference standard for alternative mercury-free BP measurement devices, until an alternative standard is developed and recognized.8 As the mercury sphygmomanometer is being progressively banned in several countries, there is an urgent need of a replacement for professional use in clinical practice, as well as for the validation of new devices and technologies for BP measurement.9, 10, 11, 12
The objective of this study is to assess the accuracy of a mercury-free BP monitor as a replacement of the standard mercury sphygmomanometer for professional clinical use and also as a standard for the validation of other devices and technologies for BP measurement.
This study validated the accuracy of a hybrid mercury-free auscultatory BP monitor on the basis of (i) the revised ESH-IP 2010 validation criteria and (ii) stricter validation criteria required for the replacement of the mercury sphygmomanometer as a standard.
The Nissei DM3000 (Nissei Japan Precision Instruments, Gunma, Japan) is a professional hybrid BP measuring device designed for office/clinic use that allows both automated oscillometric and manual auscultatory BP measurement at the upper arm. The user can choose which method to use and only one operates each time. For the automated oscillometric BP measurement, the device has a liquid crystal display where the measurement results appear (systolic and diastolic BP and pulse rate). For the manual auscultatory BP measurement there is a back-lit graphic liquid crystal display column displaying 0–300 mm Hg in a graduation scale of 2 mm Hg steps, which very much like a mercury column, displays the pressure in the cuff during deflation for the observer to identify systolic and diastolic BP by hearing the Korotkov sounds with a stethoscope. In the automated oscillometric mode the inflation and deflation is fully automated, whereas in the manual auscultatory mode these can be manually controlled by the observer (using a bulb) or partially controlled with automatic inflation and deflation and selection of the maximum inflation pressure (100–280 mm Hg) and the deflation rate (2.5, 4.5 or 6.5 mm Hg per second). The device can operate either on AC power or through a 4.8-V rechargeable battery. Two cuffs were available for use with the device: standard cuff with inflatable bladder size 12 × 22 cm and large cuff with 15 × 32 cm.
The present study assessed the accuracy of only the auscultatory BP measurement mode of the Nissei DM3000. One device was provided by the local distributor of the Nissei company with a written declaration by the manufacturer that this was a standard production model. The manufacturer and the local distributor were not aware neither involved in any way in the design and execution of this study, the data analysis and the preparation of the manuscript. All the observers who participated in this study used the test device in the auscultatory mode for several days to take BP measurements and be familiar with its functions and performance. The protocol has been approved by the Sotiria Hospital Scientific Committee and registered at the ClinGov NIH website NCT01120990. All the study participants signed informed consent for study inclusion.
Validation requirements of the ESH-IP 2010 protocol
The revised ESH-IP 2010(ref.4) requires five BP measurements to be obtained by two observers (blinded to each other's measurements) using two Y-tube connected mercury sphygmomanometers, alternating with four measurements taken by the supervisor using the test device. The supervisor is not blinded to the observers’ measurements, but on the contrary checks the BP differences between them after each measurement. If they differ by more than 4 mm Hg, the measurement is repeated. The first BP measurements by the observers and the test device are not included in the analysis. The average of the observers’ first measurements is used to classify the subjects into a low, medium or high BP range to ensure homogeneous BP distribution of the study sample (each range must have 10–12 subjects). The second measurement, which is the first by the test device, is regarded as a familiarization measurement. The differences between the remaining four measurement averages taken by the observers using mercury sphygmomanometers and the three test device measurements are calculated and used in the analysis. At first, the absolute difference of each test device's measurement from the preceding and the following sphygmomanometer measurement is assessed and the smaller one is used. These absolute differences are categorized into 3 categories (within 5, 10 and 15 mm Hg) and the results are compared with the requirements of the protocol.4 Part 1 deals with the accuracy of the individual BP measurements (BP differences within 5, 10 and 15 mm Hg among 99 comparisons) and part 2 with the accuracy per subject (subjects with two of their three and none of their three BP comparisons having a difference within 5 mm Hg). If the achieved results meet the requirements in both part 1 and 2 for systolic and diastolic BP, the study result is a ‘Pass’.
Modification of the ESH-IP 2010 protocol
The present validation study followed the revised ESH-IP 2010 requirements in terms of recruitment, methodology and analysis.4 However, as the study objective was not simply to perform a formal validation study of the device, but also to investigate whether the test device has the same level of accuracy as the mercury sphygmomanometer, the following modifications of the ESH-IP 2010 validation procedure were made:
Simultaneous instead of sequential BP measurements. The two observers using mercury sphygmomanometers and the supervisor using the test device listened to the same Korotkov sounds during manual deflation by the supervisor (all three devices connected by two Y-tubes, triple-headed stethoscope, observers and supervisor blinded to each other's measurements). This approach avoids the effect of BP fluctuation and was feasible in this study, because the deflation rate of the test device was manually controlled by the supervisor using a connected bulb at a rate of about 2 mm Hg per second or per pulse beat.
A randomized rotation of the observers/supervisor was done to prevent obtaining all auscultatory measurements using the test device by a single observer and to expose all observers equally in the use of the test device within the study.
Check of BP differences between the observers’ taken mercury device measurements in the end of each validation (participant) session (instead of after each observers’ measurement), in order to prevent observer prejudice and bias by the supervisor using the test auscultatory device. When testing an automated device the modifications two and three are not needed, because the supervisor is only recording the measurement result and not measuring BP.
Increase of the number of paired comparisons between mercury and test device BP measurements from three per participant (according to the ESH-IP) to six to ensure that at least four observers’ BPs without measurement disagreement will remain in the end of each session (for the formal ESH-IP study the first one used as entry BP and the next three for validation analysis).
Application of more stringent validation criteria
More stringent validation criteria were applied in order to evaluate whether the test device has the same level of accuracy as the mercury sphygmomanometer being thereby a perfect substitute even for the validation of new devices and technologies for BP measurement. For this purpose, evaluation of the accuracy limits (sensitivity) of the validation procedure is required.
Differences between the observers’ measurements >4 mm Hg were not omitted. This approach allows a fair evaluation of the accuracy of the test device against the mercury sphygmomanometer, given that with both devices the observers might have random disagreement of >4 mm Hg. Indeed, observer errors in auscultatory measurement can also occur while using the test device, but cannot be differentiated from the true test device errors. This deficiency of the validation procedure can be quantified—and be corrected—by assessing the mercury vs mercury device measurements. By analyzing the unedited measurements obtained by the observers, the same proportion of errors is expected to occur when comparing the two mercury device measurements as when comparing the mercury vs the test auscultatory device, ensuring thereby a fair evaluation of the performance of the test device.
The thresholds for quantifying the test device accuracy in terms of the BP differences against the mercury sphygmomanometer were tightened (evaluation of within 2 and 4 mm Hg BP differences rather than within 5, 10 and 15 mm Hg differences required in the ESH-IP validation).
In order to increase the power of this analysis all six paired simultaneous measurements obtained were included in the analysis (198 paired BP comparisons instead of 99 with the ESH-IP). This approach is justified by our intention to (a) detect small BP differences (0–2 mm Hg, which is the limit of inter-observer agreement) and (b) to provide information on a ‘perfect’ substitute of the mercury sphygmomanometer.
The concept behind this analysis is that if the test device is a perfect substitute of the mercury sphygmomanometer, then it should differ from the mercury sphygmomanometer, as much as the two mercury sphygmomanometers differ between each other.
Analysis according to the ESH-IP 2010 protocol
This analysis is based on the first four simultaneous BP measurements obtained per participant. The first one was used as recruitment BP and other three for the validation analysis.4 A total of 51 subjects were recruited from an outpatients blood pressure clinic and among ambulatory patients and staff of a University Department of Medicine. In all, 18 subjects were excluded for reasons shown in Table 1. A total of 33 subjects were included in the analysis, all contributing with both systolic and diastolic BP. Table 1 presents the recruitment BP range and treatment status of the study participants and Table 2 the participants’ characteristics, the cuff sizes used and the recruitment BP levels.
The mean difference between the observers—(n=99) was 0.2±2.0 mm Hg (range −4:+4) for systolic and 0.1±2.0 mm Hg (range −4:+4) for diastolic BP. In 10 measurements there was >4 mm Hg BP difference between the two observers and the next measurement was used (maximum difference 8 mm Hg for systolic and 10 mm Hg for diastolic BP). Among the 99 observer-taken BP measurements included in the analysis, 35, 36 and 28 fall into the low-, medium- and high-recruitment BP range, respectively, for systolic (range 100:207 mm Hg) and 29, 39 and 31, respectively, for diastolic (range 41:137 mm Hg).
The results of the validation study according to the ESH-IP 2010(ref.4) are shown in Table 3. Almost all systolic (97 of 99) and diastolic (98 of 99) device–observer BP differences fall within 5 mm Hg. Therefore, the test device comfortably passed all the validation criteria of part 1 and 2 (Table 3).
Application of more stringent validation criteria
The results of the additional analysis using more stringent criteria for the evaluation of the device accuracy are presented in Table 4. The mean and s.d. of the device–observer BP differences were almost identical as the differences between observers, both in terms of mean and of absolute BP differences. Scatterplots of the BP differences between the two observers, and between the test device and observer A and B are shown in Figure 1. Furthermore, the number of BP measurements with absolute device–observer BP differences within 2 and 4 mm Hg were similar to those of the between observers’ differences (Table 4).
This study validated the accuracy of a hybrid mercury-free auscultatory BP monitor on the basis of (a) the revised ESH-IP 2010 criteria4 required to recommend the clinical use of the device and (b) stricter criteria, which are required for using this device as an alternative to the mercury sphygmomanometer in the validation of new BP monitors and technologies. The main findings of this study are that the test device (i) comfortably pass all the validation requirements of the recently revised ESH-IP 2010(ref.4) that has more stringent criteria than the initial 2002 version,3, 13 and (ii) has high accuracy, which is not inferior to that of the mercury sphygmomanometer, at least as far as the sensitivity of the ESH-IP validation procedure is capable to assess.
Validation according to the ESH-IP 2010 protocol
The present study provides the first application of the revised ESH-IP 2010, which has more stringent criteria than the initial 2002 version, both in terms of recruitment and requirements to pass.3, 4 A retrospective analysis of 113 validation studies performed using the 2002 version of the ESH-IP estimated that the revised version 2010 more than doubles the failure rate of devices for BP monitoring.13 However, this study showed that the test device easily passes all the 2010 ESH-IP criteria, with 100% success in two of the three Part 1 criteria and in both the Part 2 criteria. Indeed, only 2 of 99 systolic and 1 of the respective diastolic readings differed by >5 mm Hg from the reference method (mercury).
It might be argued that the use of simultaneous instead of sequential BP measurements in this study might have favored the successful validation. However, in the ESH-IP analysis the impact of the BP variation on sequential measurements is compensated—at least in part—by allowing to choose for comparison of the preceding or the following observer-taken BP measurement that has the smallest absolute BP difference from the test device measurement. Thus, the use of simultaneous measurements cannot explain the high performance of the test device in this study.
Interestingly, in the 2010 ISO/AAMI validation protocol it is allowed to use either sequential or simultaneous measurements (the latter when the deflation rate is continuous linear and at 2–3 mm Hg/s or the test device controls the deflation as a function of the pulse rate and the deflation rate is 2–3 mm Hg/pulse) and propose the use of the same validation criteria for both methods.6 This decision is justified by the results of two recent validation studies of electronic auscultatory devices14 that used the ESH-IP, but with simultaneous measurements and reported similar findings as in validation studies of the same devices using the ESH-IP with sequential measurements.15, 16
The accuracy of at least four mercury-free electronic auscultatory devices has been tested using the ESH-IP protocol, using sequential15, 16, 17, 18 or simultaneous measurements.14 The Accoson Greenlight device (Accoson Works, Harlow Business Park, Harlow, Essex, UK), which has a LED scale display similar to an aneroid device, was shown to have 84 of the systolic and 74 of the diastolic BP measurements (out of 99) within 5 mm Hg from those obtained by a mercury sphygmomanometer using sequential measurements,15 and 81 and 87, respectively, using simultaneous measurements.14 The A&D UM101 hybrid device (A&D Company, Ltd., Toshima Ku, Tokyo, Japan), which has a liquid crystal display column very similar to that of the device tested in this study, had 87/91 of 99 systolic/diastolic measurements within 5 mm Hg from the mercury device using sequential measurements,16 and 86/94, respectively, using simultaneous measurements.14 Another hybrid device of similar design (Pic Indolor Professional, Artsana Co., Milan, Italy) gave excellent results with 98 of 99 systolic BP measurements and all 99 diastolic measurements differing ⩽5 mm Hg from the mercury sphygmomanometer.17 Finally, a recent validation of the device tested in this study (Nissei DM-3000) showed 86 systolic and 89 diastolic BP measurements (total of 99) taken using the auscultatory mode differing up to 5 mm Hg from the mercury sphygmomanometer.18 However, these results were achieved using controlled automatic deflation (2.5 mm Hg per second), whereas in the present study the deflation rate of the test device was manually controlled by the supervisor using a connected bulb at a rate of about 2 mm Hg per second or per pulse beat. This was necessary to ensure that the reference mercury device measurements, which were obtained simultaneously, were optimal.
Simultaneous instead of sequential BP measurements
These studies, together with findings of the present study (97/98 of the 99 systolic/diastolic measurements within 5 mm Hg; Table 3) suggest that the hybrid mercury-free auscultatory devices have a high level of accuracy, which is superior to that of the automated oscillometric devices19 and, therefore, should be the preferred alternative to the mercury sphygmomanometer for routine measurement of BP by those trained in accurate auscultatory measurement.
The exceptional validation results of the present analysis (Table 3) suggest that the conventional clinical validation criteria based on differences within 5, 10 and 15 mm Hg, such as those of the ESH-IP,3, 4 are too loose to quantify the accuracy of the test device that has unusually high accuracy compared with other devices previously assessed using the ESH-IP.19, 20 Thus, a novel approach with more stringent validation criteria was deemed necessary to evaluate the level of accuracy of this device.
More stringent validation for replacing the mercury sphygmomanometer as a standard
The methodology for clinical validation of BP monitors has been extensively studied.3, 4, 5, 6, 19, 20 It should be mentioned that the established validation protocols (ESH-IP,3, 4 BHS5 and AAMI6) have been designed mainly for the assessment of the accuracy of electronic (oscillometric) BP monitors, and therefore allow a considerable level of inaccuracy. For example, for a device that passes the revised ESH-IP 2010 it is accepted to have up to 19% of the BP measurements differing by >10 mm Hg from the reference mercury sphygmomanometer or up to 35% by >5 mm Hg and 27% of subjects are allowed to have a BP difference >5 mm Hg in two of their three comparisons, while 9% are allowed to have a BP difference >5 mm Hg in all three of their comparisons.4 On clinical grounds this allowance might be regarded as unacceptable for a professional BP monitor to be used in the office or clinic for treatment decisions. On the other hand, for the validation of a BP monitor to replace the mercury sphygmomanometer as a standard (for future validation studies), more stringent requirements than those of the currently used validation protocols should be applied to ensure the same level of accuracy as the mercury sphygmomanometer.
The auscultatory mode of the device tested in this study has been successfully validated in a previous study using the ESH-IP.18 However, the design of the present validation protocol and the data analysis have several features that significantly increased the study power and allowed more detailed assessment of the accuracy of the test device compared with that obtained by the ESH-IP. First, a more powerful analysis based on 198 BP comparisons was performed (99 with the ESH-IP), which allowed the evaluation of smaller BP differences (within 2 and 4 mm Hg). Second, simultaneous instead of the sequentially BP measurements required in the ESH-IP procedure were used. This modification prevented the effect of random BP fluctuations and the bias of selecting the closest (preceding or following) measurement as proposed by the ESH-IP. This use of simultaneous measurements was possible, because the deflation rate of the test device was manually controlled by the supervisor as required for accurate auscultatory BP measurement.6 Third, in contrast to all the established validation protocols that set arbitrary criteria to pass,3, 4, 5, 6 in this study the accuracy of the reference method was quantified (observer A vs observer B, both using mercury sphygmomanometers) and was used as the standard against which the accuracy of the test device was evaluated (Table 4; Figure 1). In other words, the test device BP measurements were compared with those taken by each of the two observers using mercury sphygmomanometers, and these differences were compared with the differences between the two observers (the later giving the sensitivity of the validation procedure). This was necessary because the clinical validation procedure involves observers and therefore is imperfect in terms of sensitivity to quantify the performance of a device.
Indeed the analysis using the above approach showed that the differences between BP measurements taken by the test device and the mercury sphygmomanometer were similar to those between two mercury sphygmomanometers (Table 4; Figure 1). The mean BP difference and its s.d., as well as the within 2 and 4 mm Hg BP differences were similar when the mercury sphygmomanometer was compared with the test device or with another mercury sphygmomanometer (Table 4). These data suggest that the test device has the same level of accuracy as the mercury sphygmomanometer—as far as the clinical validation procedure is capable to evaluate—and therefore might replace the mercury sphygmomanometer as a reference method in future validation studies. It is important to mention that these excellent results were obtained using the test device in the auscultatory mode and with manually deflation, and therefore apply for these conditions only.
In conclusion, these data suggest that a hybrid mercury-free auscultatory BP monitor fulfills the current validation requirements for clinical use and has the same level of accuracy as the standard mercury sphygmomanometer. Therefore, this device appears to be a reliable alternative to the mercury sphygmomanometer for professional use in the office and also as a standard for future validation studies of new BP monitors.
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The study was funded by the Hypertension Center, Third University Department of Medicine, Athens, Greece. The test device was provided by the local distributor of the Nissei company with a written declaration by the manufacturer that this was a standard production model. The manufacturer and the local distributor were not aware neither involved in any way in the design and execution of this study, the data analysis and the preparation of the manuscript.
The authors declare no conflict of interest.
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Cite this article
Stergiou, G., Karpettas, N., Kollias, A. et al. A perfect replacement for the mercury sphygmomanometer: the case of the hybrid blood pressure monitor. J Hum Hypertens 26, 220–227 (2012). https://doi.org/10.1038/jhh.2011.77
- mercury sphygmomanometer
- office blood pressure measurement
- hybrid blood pressure monitor
- international protocol
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