Agreement Between Community Pharmacy and Ambulatory and Home Blood Pressure Measurement Methods to Assess the Effectiveness of Antihypertensive ...
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ORIGINAL PAPER
Agreement Between Community Pharmacy and Ambulatory and Home
Blood Pressure Measurement Methods to Assess the Effectiveness of
Antihypertensive Treatment: The MEPAFAR Study
Daniel Sabater-Hernández, PharmD;1 Alejandro De La Sierra, MD, PhD;2 Pablo Sánchez-Villegas, MSc;3
Fidelina M. Santana-Pérez, MSc;4 Luisa Merino-Barber, MSc;4 Marı́a J. Faus, PharmD;1
on behalf of the MEPAFAR Study Workgroup*
From the Pharmaceutical Care Research Group, University of Granada, Granada, Spain;1 the Department of Internal Medicine, Hospital Mutua
Terrassa, University of Barcelona, Barcelona, Spain;2 the Andalusian School of Public Health, Granada, Spain;3 and Community Pharmacy, Gran
Canaria, Spain4
The usefulness of the community pharmacy blood pres- coefficient. The agreement was acceptable between HBP
sure (CPBP) method in the diagnosis or treatment of and CPBP (CCC=0.80 for systolic BP [SBP] and 0.80 for
hypertension has not been adequately addressed in con- diastolic BP [DBP]; j=0.62) and moderate between awake
trolled studies. The authors’ aim was to assess the agree- ABP and CPBP (CCC=0.74 ⁄ 0.67, respectively; j=0.56).
ment between awake ambulatory blood pressure (ABP), The Bland-Altman plots also showed lowest mean differ-
home blood pressure (HBP), and CPBP in treated hyper- ences (0.5 ⁄ 0.3 for SBP and DBP, respectively) for the
tensive patients. This was a cross-sectional study carried comparison between CPBP and HBP. The CPBP has a
out in 169 patients in which blood pressure (BP) was mea- better agreement with HBP than with awake ABP. Thus,
sured at the pharmacy (4 visits), at home (4 days), and by the CPBP measurement method could be a good alterna-
24-hour ABP monitoring. Lin correlation-concordance coef- tive to HBP monitoring, whereas it cannot be used as a
ficient (CCC) and Bland-Altman plots were used to evalu- screening test to assess the degree of BP control by
ate quantitative agreement. The qualitative agreement to awake ABP. J Clin Hypertens (Greenwich). 2012;14:236–
establish the degree of BP control was evaluated using j 244. 2012 Wiley Periodicals, Inc.
An optimal approach to blood pressure (BP) measure- measurements obtained by the reference methods in
ment in the hypertensive patient requires the use of the management of hypertension (ABPM or HBPM)
devices and methods with the lowest possible error. should be analyzed through agreement studies.12–14
Ambulatory BP (ABP) monitoring (ABPM) is the cur- Recently, we reported that the white-coat effect in the
rent reference method, whereas home BP (HBP) moni- community pharmacy was negligible and significantly
toring (HBPM) represents an acceptable alternative.1,2 lower than that observed at the physician office.15,16
Compared with office BP measurements, both ABPM Thus, it is possible that the absence of a white-coat
and HBPM lack significant white-coat effect and show effect in the community pharmacy favors the agree-
a better correlation with target organ damage and car- ment with BP measurement methods outside the
diovascular risk.3–6 clinical setting.
In addition to the methods mentioned above, the The aim of the present work was to assess the
community pharmacy BP (CPBP) measurement method agreement between CPBP, awake ABP, and HBP in
is an interesting alternative when HBPM and ⁄ or treated hypertensive patients. The prevalence of com-
ABPM are not available or are not indicated. This munity pharmacy–isolated hypertension and masked
method is widely demanded by patients,7 readily hypertension were also determined.
accessible, and recommended by several scientific
hypertension societies, including some Spanish and METHODS
Canadian societies.8–10 However, the usefulness of this The investigation of the clinical usefulness of the CPBP
method in the diagnosis or treatment of hypertension (the MEPAFAR study) was a cross-sectional study in
has not been adequately addressed in previous stud- treated hypertensive patients older than 18 years from
ies.11 In order to better assess its usefulness, both sys- 8 community pharmacies in Gran Canaria, Spain,
tematic and random errors with respect to other BP between June 2008 and June 2009. Patients were
excluded if any of the following criteria were met:
*MEPAFAR study workgroup members are listed in the Appendix. systolic BP (SBP) 200 mm Hg and ⁄ or diastolic BP
Address for correspondence: Daniel Sabater-Hernández, PharmD, (DBP) 110 mm Hg on the initial visit to the phar-
Grupo de Investigación en Atención Farmacéutica, Universidad de Gra- macy, arm circumference >42 cm, atrial fibrillation,
nada, Campus Universitario de Cartuja s ⁄ n. C.P. 18071, Granada, Spain
E-mail: dsabater@gmail.com
physical or mental impairment, inability to perform
HBPM, changes in the antihypertensive treatment
Manuscript received: December 6, 2011; Revised: December 27,
2011; Accepted: January 7, 2012 schedule during the previous 4 weeks, history of
DOI: 10.1111/j.1751-7176.2012.00598.x cardiovascular diseaseAgreement Between BP Measurement Methods | Sabater-Hernández et al. Selection and Size of the Sample each evening. HBP control was defined as SBP The sample size was based on the agreement between
Agreement Between BP Measurement Methods | Sabater-Hernández et al.
measurements. Fleiss29 proposed CCC limits that were
TABLE I. General Characteristics of the Sample
used for agreement interpretation: very good
(N=169)
(CCC>0.9), acceptable (0.71CCC0.9), moderate
(0.51CCC0.7), poor (0.31CCC0.5), or no Age, y 56.4 (10.6)
agreement (CCCAgreement Between BP Measurement Methods | Sabater-Hernández et al.
TABLE II. Lin Correlation-Concordance Coefficients and Summary of the Bland-Altman Method to Test the
Agreement Between the 3 Blood Pressure Measurements Used in the Study
Percentage of
Concordance Differences
Measurement Methods MDM (SD) Limits (MDM 2 SD) AmplitudeaAgreement Between BP Measurement Methods | Sabater-Hernández et al. FIGURE 1. Bland-Altman plots to assess the agreement between blood pressure (BP) measurements. HBP indicates home blood pressure; ABP, ambulatory blood pressure; SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation. 240 The Journal of Clinical Hypertension Vol 14 | No 4 | April 2012 Official Journal of the American Society of Hypertension, Inc.
Agreement Between BP Measurement Methods | Sabater-Hernández et al.
FIGURE 2. Classification of blood pressure (BP) control defined by the different BP measurement methods used in the study. HBP indicates home
blood pressure; ABP, ambulatory blood pressure.
TABLE III. Sensitivity, Specificity, Positive and Negative Predictive Values of CPBP and HBP
Sensitivity, % 95% CI Specificity, % 95% CI PPV 95% CI NPV 95% CI PLR IC95% NLR IC95%
a
CPBP 61.0 47.7–74.3 91.8 86.2–97.4 80.0 67.2–92.8 81.4 74.2–88.7 7.4 3.8–14.4 0.4 0.3–0.6
CPBPb 60.5 48.5–72.6 98.0 94.6–100 95.5 88.4–100 77.4 69.6–85.2 29.7 7.4–118.5 0.4 0.3–0.5
HBPa 74.6 62.6–86.5 75.4 67.0–83.9 62.0 50.0–74.0 84.7 77.0–92.3 3.0 2.1–4.3 0.3 0.2–0.5
Abbreviations: CI, confidence interval; CPBP, community pharmacy blood pressure; HBP, home blood pressure; NLR, negative likelihood ratio; NPV,
negative predictive value; PLR, positive likelihood ratio; PPV, positive predictive value. aAwake ambulatory blood pressure as the reference. bHBP as
the reference.
the CPBP measurement method as a screening test to high awake ABP and ⁄ or HBP figures) despite normal
determine the degree of BP control by awake ABP BP values at the community pharmacy.32
cannot be recommended from the present results. It should be noted that the upper limit for normal
We found a very low prevalence of community HBP and awake ABP used in this study are still under
pharmacy–isolated hypertension (1.2% using HBP as discussion, as there is no evidence showing which HBP
the reference or 5.3% using awake ABP as the refer- or awake ABP should be considered as the optimal tar-
ence), which can be explained by the high specificity get for drug treatment.22,33,34 Furthermore, there is no
and positive predictive values of the CPBP (high reli- recommendation that indicates which normal BP values
ability to confirm the presence of lack of BP control). should be used for the CPBP. We have assumed the
This may support the usefulness of the CPBP measure- thresholds used in the clinical setting as reasonable
ment method to detect patients who need to be points of reference. Therefore, this matter should be
referred to the physician and ⁄ or require up-titration of studied in depth, as it is possible that the normal CPBP
their antihypertensive treatment. On the other hand, values may be different from those defined in the clini-
sensitivity and negative predictive values of CPBP were cal setting; even similar to those established for HBP or
lower (low ability to confirm the presence of BP awake ABP. In order to go in depth into the agreement
control) and, therefore, the prevalence of masked between CPBP and both awake ABP and HBP, we also
hypertension was high (16.6% using HBP as the refer- performed an analysis using 135 ⁄ 85 mm Hg as the
ence or 13.6% using awake ABP as the reference). cut-off for the CPBP (Table S1). Overall, the results of
This limits its usefulness in controlled patients, as this analysis also reinforced the usefulness of the CPBP
some may require treatment intensification (based on measurement method as an alternative to HBPM.
Official Journal of the American Society of Hypertension, Inc. The Journal of Clinical Hypertension Vol 14 | No 4 | April 2012 241Agreement Between BP Measurement Methods | Sabater-Hernández et al. FIGURE 3. Receiver operating characteristic curves for systolic and diastolic blood pressure in the community pharmacy. *Optimal cut-off points for CPBP using awake or home BPs as the references were community pharmacy BP (CPBP) values with greater overall sensitivity and specificity (sensitivity and specificity >80.0%). AUC indicates area under the curve; CI, confidence interval; Se, sensitivity; Sp, specificity. From a clinical viewpoint, the MEPAFAR study pro- LIMITATIONS AND STRENGTHS vides the first evidence to establish recommendations It is important to note that the present investigation for community pharmacists and physicians when was a short-term study and its results were limited to interpreting CPBP measurements in treated hyperten- a specific sample of treated hypertensive patients. sive patients. These recommendations are of particular Therefore, further research to assess the long-term interest due to the involvement of the community phar- agreement between methods is needed. Also, the macist in the follow-up of treated hypertensive patients impact of changing the schedule of CPBP measure- and the need to achieve a better shared management ments (ie, twice a day) is still unknown. Caution of these patients (physician ⁄ pharmacist collaborative should be exercised in interpreting these results more management).35–37 On the other hand, it is possible broadly, as the CPBP measurements were measured by that in some circumstances, HBPM and ABPM may the same pharmacist in each community pharmacy. not be available or cannot be properly used. Then, the This is distinct to a patient measuring his ⁄ her BP in CPBP measurement method can be a valuable alterna- the community pharmacy without pharmacist super- tive to assess the effectiveness of treatment. vision, ie, using self-attended BP monitors.38,39 Also 242 The Journal of Clinical Hypertension Vol 14 | No 4 | April 2012 Official Journal of the American Society of Hypertension, Inc.
Agreement Between BP Measurement Methods | Sabater-Hernández et al.
different pharmacists or pharmacy technicians who office blood pressure: the Finn-Home study. Hypertension. 2010;55:
1346–1351.
take CPBP measurements in the same pharmacy may 6. Stergiou GS, Giovas PP, Kollias A, et al. Relationship of home blood
impact the results. Finally, our results could be pressure with target-organ damage in children and adolescents.
affected by specific characteristics of the MEPAFAR Hypertens Res. 2011;34:640–644.
7. Viera AJ, Cohen LW, Mitchell CM, Sloane PD. Hypertensive
study, such as using trained pharmacists and trained patients’ use of blood pressure monitors stationed in pharmacies and
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8. De la Sierra A, Gorostidi M, Marin R, et al. Evaluation and man-
ogy will lead to the same results. We are aware that, agement of hypertension in Spain. A consensus guide. Med Clin
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9. Tsuyuki R, Campbell N. 2007 CHEP-CPhA guidelines for the man-
business model, staff training, reimbursement for phar- agement of hypertension by pharmacists. Can Pharm J. 2007;140:
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not used in all Spanish-community pharmacies nor in 10. Sabater-Hernández D, de la Sierra A, Bellver-Monzó O, et al.
Action guide for community pharmacist in patients with hyper-
others from abroad (eg, United States). However, we tension and cardiovascular risk. Consensus document (condensed
believe that our methods are relatively simple and version). Hipertens Riesgo Vasc. 2011;28:169–181 (Spanish).
could be exported to any pharmacy in the world. 11. Sabater-Hernández D, Azpilicueta I, Sanchez-Villegas P, et al.
Clinical value of blood pressure measurement in the community
Moreover, this approach meets the quality require- pharmacy. Pharm World Sci. 2010;32:552–558.
ments that pharmaceutical care services should pro- 12. Zaninelli A, Parati G, Cricelli C, et al. Office and 24-h ambulatory
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14. Lurbe E, Parati G. Out-of-office blood pressure measurement in
CONCLUSIONS children and adolescents. J Hypertens. 2008;26:1536–1539.
15. Sabater-Hernández D, de la Sierra A, Sánchez-Villegas P, et al. Mag-
CPBP showed an acceptable agreement with HBP and nitude of the white-coat effect in the community pharmacy setting.
a moderate agreement with awake ABP. As a conse- The MEPAFAR study. Am J Hypertens. 2011;24:887–892.
16. Sendra-Lillo J, Sabater-Hernández D, Sendra-Ortola A, Martinez-
quence, the CPBP measurement method could be a Martinez F. Comparison of the white-coat effect in community
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is a relatively common condition, whereas community according to the International Protocol of the European Society of
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Acknowledgments and disclosures: We thank Eleonora Feletto for device according to the International Protocol in adults and obese
assistance in editing the text. This work has been partially supported by a adults. Blood Press Monit. 2007;12:219–225.
grant from LACER Laboratories (Spain). The authors do not have potential 20. Altunkan S, Iliman N, Altunkan E. Validation of the Omron M6
conflict of interest. (HEM-7001-E) upper arm blood pressure measuring device accord-
ing to the International Protocol in elderly patients. Blood Press
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nanda García Morales, Nayra Díaz Merino, María Esther Artiles Ruano, Ana 22. Mancia G, Laurent S, Agabiti-Rosei E, et al. Reappraisal of Euro-
María Contardi Lista, Ana Rosa García Rodríguez. pean guidelines on hypertension management: a European Society of
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2158.
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