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Research ArticleOriginal ResearchA

Pragmatic Method Using Blood Pressure Diaries to Assess Blood Pressure Control

James E. Sharman, Leigh Blizzard, Wojciech Kosmala and Mark R. Nelson
The Annals of Family Medicine January 2016, 14 (1) 63-69; DOI: https://doi.org/10.1370/afm.1883
James E. Sharman
1Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia
BHMS (Hons), PhD
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  • For correspondence: James.Sharman@menzies.utas.edu.au
Leigh Blizzard
1Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia
PhD
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Wojciech Kosmala
1Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia
2Wroclaw Medical University, Wroclaw, Poland
MD,PhD
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Mark R. Nelson
1Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia
MBBS(Hons), MFM, FRACGP, FAFPHM, PhD
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  • Author Response to the Journal Club questions
    James E Sharman
    Published on: 07 March 2016
  • Journal Club discussion, "Pragmatic Method Using Blood Pressure Diaries to Assess Blood Pressure Control"
    Jordan Sharlin
    Published on: 01 March 2016
  • Published on: (7 March 2016)
    Page navigation anchor for Author Response to the Journal Club questions
    Author Response to the Journal Club questions
    • James E Sharman, Senior research fellow
    • Other Contributors:

    We appreciate the thoughtful discussion and questions raised on our work from Jordan Sharlin and other members of the University of Illinois Journal Club.

    We agree that variations in clinical practice between the US and other countries may explain the unfamiliarity with the methods of 7-day home BP and 24-hour ambulatory BP. Having said this, both methods are addressed (albeit briefly) in the US JNC7 High Blood...

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    We appreciate the thoughtful discussion and questions raised on our work from Jordan Sharlin and other members of the University of Illinois Journal Club.

    We agree that variations in clinical practice between the US and other countries may explain the unfamiliarity with the methods of 7-day home BP and 24-hour ambulatory BP. Having said this, both methods are addressed (albeit briefly) in the US JNC7 High Blood Pressure Guidelines (Chobanian A et al Hypertension 2003;42:1206-52), but are notably absent from the JNC8 report in 2014 (James P et al JAMA 2014;311:507-20). We contend that the evidence base underpinning the rationale for using these out of clinic BP methods to refine and improve clinical decisions is substantive enough to warrant inclusion in the medical training curriculum of all doctors, including those in the US. Home BP guidelines have been produced by several international societies and the method is widely used across Australia, Europe and Asia, with online resources (endorsed by professional societies) available to help doctors and patients http://www.racgp.org.au/afp/2016/januaryfebruary/how-to-measure-home-blood-pressure-recommendations-for-healthcare-professionals-and-patients/ We would wholeheartedly welcome the new generation of US doctors taking this information to their daily practice.

    The Journal Club raised excellent points around issues regarding our methods used to target general practice clinics, participant flow, sample size, inclusion criteria and failure to specifically address HFpEF or undertake stress echocardiography. It is important to remember that the data were derived from the baseline examination of patients with hypertension who were participating in a clinical trial relating to a separate hypothesis (Sharman J et al, BP GUIDE study. Hypertension 2013;62:1138-45). Thus, the study design relating to home BP was not perfect and the findings may not be widely generalizable to people with different clinical characteristics, as correctly asserted by the Journal Club. This restriction of study design also relates to the question around our selection of cardiovascular markers of end organ disease; we simply capitalized on existing data used in the BPGUIDE clinical trial, but also remembering that these are recognized markers of asymptomatic organ damage (Mancia G et al European Hypertension Guidelines [section 3.7] J Hypertens 2013;31:1281-357).

    The study participants were relatively healthy, with no exercise intolerance and normal LV mass and ejection fraction. However, the prespecified inclusion criteria allowed recruitment of patients with LV diastolic dysfunction and/or thickened LV walls. Thus, the clinical profile of the investigated population included both stage A (predominantly) and stage B heart failure. The pathophysiology of HFpEF is much more complex than diastolic deficit with LV filling pressure elevation and includes abnormalities of multiple cardiovascular domains such as systolic performance, atrial mechanics, vascular stiffness, endothelial function, ventriculo-arterial interaction, skeletal muscle oxygen extraction, and autonomic nervous system regulation (Kosmala et al. JACC 2016,16;67(6):659-70). An abnormal response to exercise in HFpEF has been demonstrated for diastolic (E/e'), systolic (global longitudinal strain, EF) and ventricular-arterial coupling parameters, and represents an important part of diagnostic evaluation in this condition. The inclusion of exertional assessment of cardiac functional and hemodynamic profile in future studies addressing the adequacy of BP control might be an interesting idea, but this should encompass exercise measurements of BP rather, since, as demonstrated in our previous research (data not published yet), exercise capacity and LV exertional reserve are associated with BP increments during exercise, not with BP values at rest. Given the entire spectrum of evaluated target organ disease indicators, the cut-point of e 3 of abnormal BP readings seems to be optimal and restricting the range to e 4 would exclude the number of patients that require the modification of antihypertensive pharmacotherapy.

    The threshold values to denote hypertension based on 24-hour ambulatory BP (average over 24 hours, 130/80 mmHg; or average during the daytime, 135/85 mmHg) were derived from international guideline consensus that BP values above these thresholds increase risk for hypertension-related end organ disease (eg LV hypertrophy, increased aortic stiffness), cardiovascular events and mortality. These thresholds are regarded as the equivalent to 140/90 mmHg for clinic BP (Mancia G et al European Hypertension Guidelines J Hypertens 2013;31:1281-357).

    Finally, our decision to focus on systolic BP rather than diastolic BP was largely based on greater clinical importance of systolic BP (Tin L et al J Hum Hypertens. 2002 Mar;16(3):147-50), particularly after 50 years of age, where systolic BP tends to rise with increasing age, but diastolic BP tends to fall (increasing pulse pressure). Thus, overall, there is a higher likelihood of detecting risk related to hypertension from systolic BP readings alone. In addition, we felt that for the sake of practicality and rapid simplicity of the method, it was important to use only one BP variable. However, we accept that using this approach may result in some people slipping through the net of appropriate categorization.

    Competing interests: None declared

    Show Less
    Competing Interests: None declared.
  • Published on: (1 March 2016)
    Page navigation anchor for Journal Club discussion, "Pragmatic Method Using Blood Pressure Diaries to Assess Blood Pressure Control"
    Journal Club discussion, "Pragmatic Method Using Blood Pressure Diaries to Assess Blood Pressure Control"
    • Jordan Sharlin, Medical Student
    • Other Contributors:

    The purpose of this study was to provide physicians with a pragmatic method to quickly and accurately assess blood pressure control from patient home blood pressure (HBP) diaries. The superior prognostic utility of HBP and ambulatory blood pressure (ABP, the reference standard) monitoring over clinical blood pressure (CBP) has been well documented. However, these methods are limited by physician time constraints in the s...

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    The purpose of this study was to provide physicians with a pragmatic method to quickly and accurately assess blood pressure control from patient home blood pressure (HBP) diaries. The superior prognostic utility of HBP and ambulatory blood pressure (ABP, the reference standard) monitoring over clinical blood pressure (CBP) has been well documented. However, these methods are limited by physician time constraints in the standard consultation, notably the requirement for manual calculation of the average of multiple values from patient diaries. The authors sought to determine the optimal percentage of home systolic blood pressure readings above threshold (>135 mm Hg) for the last 10 recorded to denote blood pressure control (confirmed by ABP). The best predictor of uncontrolled blood pressure was >3 elevations of the last 10 home systolic blood pressure readings (>30%), and patients meeting this criterion also demonstrated statistically significant differences in markers of target organ disease associated with hypertension. The authors propose that physicians utilize this method to assess data from HBP diaries and tailor management accordingly.

    In the introduction, the authors acknowledge that CBP is widely used for patient management despite its potential limitations in accurately reflecting true underlying blood pressure. The student discussion group unanimously supported this statement. One student shared that his own blood pressure is consistently elevated when taken in a clinical setting, while another student expressed discomfort with altering management based on one reading. Also in the introduction, the authors reference alternative methods of blood pressure assessment (i.e. 7-day HMP and 24-hour ABP) with superior prognostic utility with respect to target organ disease. Interestingly, many of the students were not familiar with these alternative methods, despite the claim that "HMP has an advantage of already being in wide use." The group, aware that this study was conducted in Australia, discussed the possibility that variations in clinical practice between our country (U.S.) and other countries could factor into our limited breadth of knowledge of the subject matter. This notion is supported by the fact that HBP is ignored as a clinical tool in U.S. guidelines for the management of high blood pressure in adults, as alluded to by the authors in their discussion. However, at least two students were able to empathize with the study: both presented with a HBP diary the past week, and neither with a pragmatic method to interpret the data.

    This is a cross-sectional study; measurements of mean ABP, HMP values, and markers of target organ disease were consecutively acquired in the shortest time frame possible (approximately 10 days). A total of 286 patients being treated for hypertension by their primary care physicians were recruited in 3 Australian centers as part of a randomized clinical trial. Patients were recruited through general practice clinics and community advertisements. The authors did not specify how general practice clinics were targeted, which increases the difficulty to reproduce the study. Additionally, the group would have liked to see what percentage of patients recruited agreed to participate as a means to assess motivation to commit to undertaking HBP (duplicate readings 3 times per day for 7 days per protocol). Sample size was rather small, although the group recognized the potential burden in evaluating markers of target organ disease. Patients were eligible for inclusion if they were non-pregnant adults receiving antihypertensive therapy for noncomplicated essential hypertension and taking no more than 3 antihypertensive drugs. These inclusion criteria may induce some selection bias (e.g. elderly patients are more likely to be seen by a physician for all causes, in turn increasing the likelihood that hypertension is identified, diagnosed, and treated), and this bias may be supported by the fact that 80% of study participants were >60 years old. The group felt the exclusion criteria were appropriate.

    In defining uncontrolled blood pressure, the authors considered two definitions: 24-hour ABP systolic blood pressure >130 mm Hg or 24-hour ABP daytime systolic blood pressure >135 mm Hg. While the student discussion group was able to recognize the value of this approach in determining the optimal cut point, it was unclear as to how these thresholds were chosen; the group would have benefited from an explanation of this (and the validity of these values). Similarly, the group assumed that diastolic blood pressure was not included in the analysis because it is less associated with markers of target organ disease, although this was never explained. The rationale for restriction to the last 10 (rather than 14) home systolic blood pressure readings was thorough. Students were in agreement that this adjustment would make interpretation of HBP diaries more feasible and implementation more practical.

    While beyond the scope of most students, the use of multiple indices to compare accuracy of predictions at different binary classifications (Table 2) increased group consensus that the results obtained are reliable and reproducible. The student discussion group also agreed with the authors' reconciliation of the optimal cut point (validation analysis) using markers of target organ disease associated with hypertension. However, many students did not fully understand the clinical utility of these markers. One student mentioned that the inclusion of normal values in Table 1 or Table 3 would have helped him interpret the meaning of these markers of target organ disease in addition to their relationship to the cut points.

    Students also probed the validity of the cardiovascular measures selected by the authors to assess target organ disease, cardiovascular events, and cardiovascular and all-cause mortality. Heart failure may be due to either systolic or diastolic dysfunction of the left ventricle. While both are characterized by elevated left ventricular filling pressure, ejection fraction can be reduced (HFrEF) or preserved (HFpEF) depending on the underlying etiology. HFpEF is characterized by diastolic dysfunction and mild systolic dysfunction, and is an increasingly common form of cardiac disease associated with aging (64 + 8 years in present study), obesity (BMI 29.4 + 4.8 in present study), and hypertension. Although ejection fraction is preserved at rest, enhancement in ejection fraction with stress is markedly limited in HFpEF.[1] In the present study, all cardiovascular measures of target organ damage were obtained at rest; consequently, the data may be inadequate in identifying significant pathologies that exist. If this study were to be repeated, the prognostic yield could be greatly increased by including measurements of ejection fraction during locomotion. Furthermore, population-based studies over the past decade have shown that many patients with HFpEF have either concentric remodeling in the absence of hypertrophy, or even normal LV geometry.[2,3,4] These findings may limit the prognostic utility of certain cardiovascular measures (e.g. relative wall thickness, left ventricular ejection fraction, etc.) with respect to cardiovascular and all-cause mortality. Such limitations warrant discussion by the authors, and may even support the recommendation of >4 elevations of the last 10 home systolic blood pressure readings (>40%) as the best predictor based on the fact that this cut point produced the greatest difference of means for left ventricular filling pressure (an acceptable marker of HFpEF).

    1. Borlaug, B. A. Pathophysiology of HFpEF. Nat. Rev. Cardiol. 11, 507-515 (2014).
    2. Lam, C. S. et al. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation 115, 1982-1990 (2007).
    3. Borlaug, B. A., Lam, C. S., Roger, V. L., Rodeheffer, R. J. & Redfield, M. M. Contractility and ventricular systolic stiffening in hypertensive heart disease insights into the pathogenesisof heart failure with preserved ejection fraction. J. Am. Coll. Cardiol. 54, 410-418 (2009).
    4. Zile, M. R. et al. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation 124, 2491-2501 (2011).

    Competing interests: None declared

    Show Less
    Competing Interests: None declared.
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Pragmatic Method Using Blood Pressure Diaries to Assess Blood Pressure Control
James E. Sharman, Leigh Blizzard, Wojciech Kosmala, Mark R. Nelson
The Annals of Family Medicine Jan 2016, 14 (1) 63-69; DOI: 10.1370/afm.1883

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Pragmatic Method Using Blood Pressure Diaries to Assess Blood Pressure Control
James E. Sharman, Leigh Blizzard, Wojciech Kosmala, Mark R. Nelson
The Annals of Family Medicine Jan 2016, 14 (1) 63-69; DOI: 10.1370/afm.1883
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Keywords

  • classification
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  • blood pressure monitoring, ambulatory
  • hypertension
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