Validity of a wrist digital monitor for blood pressure measurement in comparison to a mercury sphygmomanometer

Abstracts

FUNDAMENTO: Medidas válidas da pressão arterial, em situações clínicas e na comunidade, são essenciais para a monitoração dessa variável em nível populacional. OBJETIVO: Avaliar a validade de um monitor digital de pulso para mensuração da pressão arterial em adolescentes, em comparação com um esfigmomanômetro de mercúrio. MÉTODOS: Um estudo de validação foi realizado na cidade de Pelotas, região sul do Brasil. A pressão arterial foi medida duas vezes, utilizando-se dois esfigmomanômetros diferentes: um aparelho digital de pulso OMRON e um aparelho de mesa BD de mercúrio. Metade da amostra foi medida primeiro através do manômetro digital e depois pelo de mercúrio, enquanto a outra metade foi avaliada na ordem inversa. A concordância entre as duas medidas foi avaliada através do método de Bland & Altman. RESULTADOS: 120 adolescentes com idade entre 14 e 15 anos foram incluídos no estudo (50% de cada sexo). A pressão sistólica média entre os meninos foi de 113,7 mmHg (DP 14,2) usando o manômetro de mercúrio e 115,5 mmHg (DP 15,2) usando o aparelho digital. Os valores equivalentes para a pressão diastólica foram 61,5 mmHg (DP 9,9) e 69,6 mmHg (10,2), respectivamente. Entre as meninas, a pressão sistólica média foi de 104,7 mmHg (DP 10,1) usando o manômetro de mercúrio e 102,4 mmHg (DP 11.9) usando o aparelho digital. Os valores equivalentes para a pressão diastólica foram 60,0 mmHg (DP 10,4) e 65,7 mmHg (DP 7,7), respectivamente. CONCLUSÕES: O manômetro digital apresentou alta concordância com o manômetro de mercúrio para medir a pressão arterial sistólica. A concordância foi menor para a pressão arterial diastólica. O uso de equações de correção pode ser uma alternativa para estudos utilizando esse monitor digital de pulso em adolescentes.

Monitores de pressão arterial; determinação da pressão arterial; esfigmomanômetros; estudos de validação; adolescente

ORIGINAL ARTICLE

Programa de Pós-Graduação em Epidemiologia da Universidade Federal de Pelotas, Porto Alegre, RS - Brazil

Corespondência

ABSTRACT

BACKGROUND: Valid measurements of blood pressure, both at clinical and community settings, are essential for monitoring this variable at the population level.

OBJECTIVE: To evaluate the validity of a wrist digital monitor for measuring blood pressure among adolescents in comparison to a mercury sphygmomanometer.

METHODS: A validation study was carried out in the city of Pelotas, Southern Brazil. Blood pressure was measured twice using two different sphygmomanometers; an OMRON wrist digital and a desktop BD mercury one. Half of the sample was measured first with the digital manometer and subsequently with the mercury one, whereas the remaining half was evaluated in the opposite order. Agreement between both measures was evaluated using the Bland and Altman method.

RESULTS: 120 adolescents aged 14 to 15 years were included (50% of each sex). Mean systolic blood pressure among boys was 113.7 mmHg (SD 14.2) when using the mercury manometer and 115.5 mmHg (SD 15.2) when using the digital one. Equivalent values for diastolic blood pressure were 61.5 mmHg (SD 9.9) and 69.6 mmHg (10.2), respectively. Among girls, the mean systolic blood pressure was 104.7 mmHg (SD 10.1) when using the mercury manometer and 102.4 mmHg (SD 11.9) when using the digital device. Values for diastolic blood pressure were 60.0 mmHg (SD 10.4) and 65.7 mmHg (SD 7.7), respectively.

CONCLUSIONS: The digital device showed a high level of agreement with the mercury manometer when measuring systolic blood pressure. The level of agreement was lower for diastolic blood pressure. The use of correction equations may be an alternative for studies using this wrist digital monitor in adolescent patients.

Key words: Blood pressure monitors; blood pressure determination; sphygmomanometers; validation studies; adolescent.

Introduction

An accurate assessment of blood pressure is very important for the diagnosis and treatment of hypertension. The importance of attaining the diagnosis of high blood pressure and its continuous monitoring are well known. Therefore, several equipments have been available for the measurement of blood pressure, not only to be used by specialized individuals, but also by the population itself. In this sense, wrist digital monitors have been increasingly used, instead of mercury and aneroid devices, which require a trained professional to operate them^1,2.

Although digital monitors are much easier to use when compared to the mercury sphygmomanometers, it is essential to establish their reliability and validity. There is some evidence in the literature that wrist digital monitors are reliable and accurate when compared with other devices, such as the aneroid or mercury devices^3,4. It seems that this type of equipment can replace the others in some contexts, such as at home or in epidemiological studies within the community⁵. However, most studies so far included only adults, and therefore, the validity of these methods among adolescents in unclear.

The aim of the present study was to test the validity of a wrist digital monitor against that of a mercury sphygmomanometer - the gold standard - in a convenience sample of adolescents living in Pelotas, southern Brazil.

Methods

A sample of 120 adolescents aged 14 to 15 years from five public schools of the city had their blood pressure measured with two different sphygmomanometers - a desktop BD mercury and a wrist digital (OMRON HEM 629, Beijing, China) - by two trained technicians. A Tycos stethoscope was used with the mercury sphygmomanometer. The students were allowed to rest for 10 minutes prior to the measurements. Their height was measured twice using a stadiometer accurate to 0.1 cm (Seca, Birminghan). All adolescents were sitting on a chair with support for their backs and arms, with the legs uncrossed, and the right arm and wrist were used for the measurements. Each adolescent had his/her blood pressure measured twice with one minute of difference between each measurement; thus, venous congestion was prevented and the variability of BP was kept to a minimum⁶.

For half of the sample, the mercury sphygmomanometer was used first; for the remaining half, the opposite order was used. This selection was carried out randomly. The technicians used both sphygmomanometers (mercury and digital) alternatively, which prevented the first and second observer from seeing each other's measurements. The digital monitor was used following the manufacturer's instructions contained in the user's manual and special attention was paid to the position of the monitor, which should be at the level of the heart⁷; the mercury sphygmomanometer was used according to the technique recommended by the American Heart Association⁸. The average of the measurements by each technician was calculated and this value was considered for the analyses; the same was done for height.

The statistical analyses included a description of blood pressure variables using percentiles, means and standard deviations. Spearman's correlation coefficients were calculated for systolic and diastolic blood pressure, by comparing the digital and mercury manometers. Agreement was measured using the Bland and Altman⁹ method. Mean differences and standard deviations were calculated. We also performed sensitivity, specificity, predictive values and kappa analyses for the categorical outcome 'pre-hypertension', defined in accordance with The Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents¹⁰. All analyses were performed for boys and girls separately, except for the categorical analyses, because results were very similar for both sexes.

The Ethical Committee of the Federal University of Pelotas Medical School approved the study protocol, and informed consents were obtained.

Results

Of the 120 adolescents included in the study, 60 were boys. Mean age was 14.7 years (SD 0.46), ranging from 14.0 to 15.9 years. Mean height was 1.64 m (SD 0.8) in the whole sample, 1.67 m (SD 0.8) among boys and 1.61 m (SD 0.6) among girls. Table 1 presents descriptive data on blood pressure. Mean systolic blood pressure for boys was 113.7 mmHg (SD 14.2) when using the mercury manometer and 115.5 mmHg (SD 15.2) when using the digital one. Equivalent values for diastolic blood pressure were 61.5 mmHg (SD 9.9) and 69.6 mmHg (10.2), respectively. For girls, the mean systolic blood pressure was 104.7 mmHg (SD 10.1) when using the mercury manometer and 102.4 mmHg (SD 11.9) when using the digital device. Values for diastolic blood pressure were 60.0 mmHg (SD 10.4) and 65.7 mmHg (SD 7.7), respectively. Median values (50^th percentile) were very similar for systolic blood pressure, but substantially different for diastolic blood pressure.

Figure 1 shows the agreement between the two devices for measuring systolic blood pressure in the overall sample. Spearman's correlation coefficient was 0.74. The mean difference (digital - mercury) was -0.3 mmHg (SD 9.2) and it was not statistically different from zero (P=0.75). Figures 2 and 3 present these data for boys and girls separately. The mean difference was positive for boys (1.8 mmHg; P=0.15) and negative for girls (-2.3 mmHg; P=0.03).

Figure 4 presents the agreement between the two manometers when measuring diastolic blood pressure in the whole sample. Spearman's correlation coefficient was 0.47. The mean difference was 6.9 mmHg (SD 9.8) and it was highly statistically significant (P<0.001). When results are stratified by sex (Figures 5 and 6), results are consistent with those observed in the whole sample; the mean difference was 8.0 mmHg (SD 10.4) in boys and 5.8 mmHg (SD 9.2) in girls.

Of the 120 adolescents measured, 21 were classified as pre-hypertensive, according to the mercury manometer. Out of these, 17 (81.0%) were correctly classified according to the digital device (sensitivity). Of the 99 adolescents who were below the pre-hypertension cut-off, 88 (88.9%) were correctly identified by the digital device (specificity). Positive and negative predictive values were 60.7% and 95.7%, respectively. The overall percent of agreement was 87.5% and the kappa value was 0.62. Because only five adolescents were classified as hypertensive by the mercury manometer, we chose not to present analyses for this variable.

Based on the validity results presented in this study, the following correction equations were created to be applied when the digital monitor is used in adolescents aged 14-15 years.

We tested the applicability of these equations in a database of the 1993 Pelotas (Brazil) birth cohort, in which over 4,000 adolescents aged 14-15 years were interviewed in 2008 and had their blood pressure measured using the digital device. We regressed systolic and diastolic blood pressure measured by the digital device on body mass index (BMI). Afterwards, we regressed the corrected values of blood pressure using the equations proposed. The magnitude of the association between blood pressure and BMI was consistently attenuated when the correction was applied. For instance, in the whole sample, the regression coefficient for systolic blood pressure was 1.08, whereas it was 0.76 when the correction was applied. The equivalent values were 0.73 and 0.45 for diastolic blood pressure.

Discussion

Blood pressure monitoring is essential, both at the clinical and at the population level. If blood pressure values are under control, there is a decreased risk of morbidity and mortality due to cardiovascular disease¹¹. However, blood pressure monitoring has been challenging, because aneroid and mercury manometers are expensive and require a trained health professional to use them¹². As an alternative, digital devices have received growing attention, and well-known health associations are recommending their use^13-15. Regardless of the recommendations, the validity of digital monitors needs to be confirmed prior to their widespread utilization.

Most validation studies of digital monitors carried out so far were restricted to adults^6,7,12,14,16. However, hypertension in adolescence, one of the possible consequences of the obesity epidemics, is a growing public health concern. In a sample of adolescents living in Southern Brazil, we aimed to help filling this literature gap. In summary, our data shows that the digital monitor provides accurate data on systolic blood pressure, but overestimates diastolic pressure. This is different from most of the studies in adults, in which systolic blood pressure tends to be more overestimated using the digital device in comparison to diastolic pressure.

In order to correct the values obtained by the digital device, we propose four separate equations (systolic and diastolic blood pressure, boys and girls). This is essential because the magnitude of the overestimation in diastolic blood pressure was considered relevant in the context of public health. There is no agreement on which is the limit to be considered acceptable for digital devices. Some authors have proposed that average errors below 5 mmHg, with standard deviation below 8 mmHg, are acceptable among adults. In our sample, the mean error was only 0.3 mmHg for systolic pressure, but 6.9 mmHg for diastolic blood pressure. For this reason, we believe that the use of correction equations is necessary in studies among adolescents within the age range used in the present study. One should note, however, that correction factors are population-specific, and therefore, authors should test the applicability of our equations for other age groups and populations.

When categorical variables are used, in order to define hypertension or pre-hypertension, the agreement between the instruments should be checked again. In our sample, because hypertension was very rare, we were not able to explore this issue further. However, for pre-hypertension, we show that the digital device has a specificity close to 90%, and sensitivity close to 80%. These values are acceptable for research purposes. Obviously, in clinical settings, these values are not acceptable, and therefore, the use of aneroid monitors is recommended.

The growing use of digital manometers for measuring blood pressure is positive in terms of public health. It can likely make blood pressure monitoring more accessible to the population. It can also be an excellent tool for epidemiological studies, particularly in low and middle-income settings, where most research is carried out at the household level.

Authors' contributions

Ana M. B. Menezes had the original idea and was in charge of the writing of the manuscript. Samuel C. Dumith carried out most of the analyses, with the supervision of Pedro C. Hallal. Ricardo B. Noal was responsible for training the technicians on the blood pressure measurement and was responsible for planning the study design. Ana Paula Nunes, Fernanda Mendonça, Marta A. Duval and Paulo E. Caruso performed the fieldwork and data entry. Cora L. Araujo, Ana M. B. Menezes and Pedro C. Hallal are coordinating the 1993 Pelotas (Brazil) Birth Cohort Study. All authors contributed to the early drafts of this manuscript and approved its final version.

Potential Conflict of Interest

No potential conflict of interest relevant to this article was reported.

Sources of Funding

There were no external funding sources for this study.

Study Association

This study is not associated with any post-graduation program.

References

• 1. O'Brien E, Waeber B, Parati G, Staessen J, Myers MG. Blood pressure measuring devices: recommendations of the European Society of Hypertension. BMJ. 2001; 322: 531-6.
• 2. Park MK, Menard SW, Yuan C. Comparison of auscultatory and oscillometric blood pressures. Arch Pediatr Adolesc Med. 2001; 155 (1): 50-3.
• 3. Dolan E, Stanton A, Thijs L, Hinedi K, Atkins N, McClory S, et al. Superiority of ambulatory over clinic blood pressure measurement in predicting mortality: the Dublin outcome study. Hypertension. 2005; 46 (1): 156-61.
• 4. Jones DW, Appel LJ, Sheps SG, Roccella EJ, Lenfant C. Measuring blood pressure accurately: new and persistent challenges. JAMA. 2003; 289 (8): 1027-30.
• 5. Altunkan S, Iliman N, Altunkan E. Validation of the nissei 250 ambulatory blood pressure monitoring device according to the International Protocol. J Hypertens. 2003; 21 (Suppl 4): S22.
• 6. Altunkan S, Genc Y, Altunkan E. A comparative study of an ambulatory blood pressure measuring device and a wrist blood pressure monitor with a position sensor versus a mercury sphygmomanometer. Eur J Intern Med. 2007; 18 (2): 118-23.
• 7. Nelson D, Kennedy B, Regnerus C, Schweinle A. Accuracy of automated blood pressure monitors. J Dent Hyg. 2008; 82 (4): 35.
• ⁸
  American Heart Association, Pennsylvania Affiliate. Standardized blood pressure measurement manual. Philadelphia: Departement of Health, Commonwealth of Pennsylvania; 1990.
• 9. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999; 8 (2): 135-60.
• ¹⁰
  US Department of Health and Human Services. The Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents: US Department of Health and Human Services; 2005.
• 11. Johnson KA, Partsch DJ, Rippole LL, McVey DM. Reliability of self-reported blood pressure measurements. Arch Intern Med. 1999; 159 (22): 2689-93.
• 12. Stergiou GS, Lin CW, Lin CM, Chang SL, Protogerou AD, Tzamouranis D, et al. Automated device that complies with current guidelines for office blood pressure measurement: design and pilot application study of the Microlife WatchBP Office device. Blood Press Monit. 2008; 13 (4): 231-5.
• 13. Macdonald E, Froggatt P, Lawrence G, Blair S. Are automated blood pressure monitors accurate enough to calculate the ankle brachial pressure index? J Clin Monit Comput. 2008; 22 (5): 381-4.
• 14. White WB, Anwar YA. Evaluation of the overall efficacy of the Omron office digital blood pressure HEM-907 monitor in adults. Blood Press Monit. 2001; 6 (2): 107-10.
• 15. Stryker T, Wilson M, Wilson TW. Accuracy of home blood pressure readings: monitors and operators. Blood Press Monit. 2004; 9 (3): 143-7.
• 16. Johnson KA, Partsch DJ, Gleason P, Makay K. Comparison of two home blood pressure monitors with a mercury sphygmomanometer in an ambulatory population. Pharmacotherapy. 1999; 19 (3): 333-9.

Validity of a wrist digital monitor for blood pressure measurement in comparison to a mercury sphygmomanometer

Ana M. B. Menezes; Samuel C. Dumith; Ricardo B. Noal; Ana Paula Nunes; Fernanda I. Mendonça; Cora L. P. Araújo; Marta A. Duval; Paulo E. Caruso; Pedro C. Hallal

Publication Dates

• Publication in this collection
  28 Apr 2010
• Date of issue
  Mar 2010

History

• Accepted
  24 July 2009
• Reviewed
  30 Mar 2009
• Received
  11 Mar 2009