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Self-Measured Blood Pressure Monitoring

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1 Self-Measured Blood Pressure Monitoring
Prepared for: Agency for Healthcare Research and Quality (AHRQ) Self-Measured Blood Pressure Monitoring This slide set is based on a comparative effectiveness review titled Self-Measured Blood Pressure Monitoring, which was developed by Tufts Evidence-based Practice Center, Tufts Medical Center, Boston, MA, for the Agency for Healthcare Research and Quality (AHRQ) under Contract No. HHSA I and is available online at Comparative effectiveness reviews (CERs) are comprehensive systematic reviews of the literature that usually compare two or more types of interventions with usual care for the same disease. For this CER, the existing body of evidence on the relative benefits of self-measured blood pressure (SMBP) monitoring, compared to usual care, in the management of hypertension was reviewed. The literature included in this review was identified in searches for studies that included terms for self-measurement, home measurement, telemonitoring, self-care, and relevant research designs. Studies of adults and children were included. Searches were conducted for studies published through July 19, The review addressed SMBP monitoring performed by the patient or caregiver at home. It did not include monitoring done at the office/clinic/pharmacy or health unit at work, nor did it include BP monitoring done by nurses or other healthcare professionals at home. Additionally, the review did not address pregnant women or individuals with hypertension who were on dialysis.

2 Outline of Material Introduction to self-measured blood pressure (SMBP) monitoring Systematic review methods The clinical questions addressed by the comparative effectiveness review Results of studies and evidence-based conclusions about the effectiveness of SMBP in hypertension management, and predictors of SMBP adherence Gaps in knowledge and future research needs What to discuss with patients and their caregivers Outline of Material The material in this presentation covers the results and conclusions from a comparative effectiveness review entitled Self-Measured Blood Pressure Monitoring. It begins with an introduction to SMBP monitoring. It also covers methods used to plan and execute the systematic review; clinically important questions the review sought to answer; results of the review; evidence-based conclusions about the effectiveness of SMBP in managing hypertension; predictors of SMBP adherence; gaps in knowledge; and the future research needs uncovered by the systematic review. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

3 Background: Definition of Hypertension and Its Prevalence
High BP or hypertension is defined as persistently elevated BP 140/90 mmHg in otherwise healthy adults. The World Health Report 2002 estimated that more than 1 billion people have high BP and that 7 million people die from high BP annually. It is anticipated that the prevalence of BP will continue to rise as the population ages. Background: Definition of Hypertension and Its Prevalence High BP or hypertension is defined as BP that is persistently elevated and >140/90 mmHg in otherwise healthy individuals. The Seventh Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline recommends a BP goal of 140/90 mmHg in the general population, and a goal of 130/80 in patients with diabetes or chronic kidney disease. Hypertension is long-term health condition that is common among older adults, although it affects people of all age groups. In The World Health Report 2002—Reducing Risks, Promoting Healthy Life, the World Health Organization estimated the worldwide prevalence of high BP to be 1 billion and annual deaths resulting directly from this condition to be 7 million. Despite an improvement in the quality of health care, it is predicted that the prevalence of BP will continue to rise due to the aging of the population. References: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint Nation Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003 Dec;42(6): PMID: World Health Organization. The world health report 2002—reducing risks, promoting healthy life. Geneva, Switzerland: World Health Organization; Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at: Chobanian AV, Bakris GL, Black HR, et al. Hypertension 2003 Dec;42(6): PMID: World Health Organization. The World Health Report 2002 —Reducing Risks, Promoting Healthy Life. Available at:

4 Background: Disease Burden of Hypertension
Hypertension has been identified as a major risk factor for cardiovascular disease and mortality. Hypertension is also an important modifiable risk factor for several diseases including: Coronary artery disease Stroke Congestive heart failure Chronic kidney disease Peripheral vascular disease Background: Disease Burden of Hypertension Hypertension significantly enhances the risk of cardiovascular disease and accounts for nearly 14 percent of deaths associated with cardiovascular disease. In addition, hypertension increases the risk of developing other serious conditions such as coronary artery disease, stroke, congestive heart failure and chronic kidney disease. References: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Ezzati M, Oza S, Danaei G, et al. Trends and cardiovascular mortality effects of state-level blood pressure and uncontrolled hypertension in the United States. Circulation 2008 Feb 19;117(7): PMID: Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint Nation Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003 Dec;42(6): PMID: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at: Ezzati M, Oza S, Danaei G, et al. Circulation 2008 Feb 19;117(7): PMID: Chobanian AV, Bakris GL, Black HR, et al. Hypertension 2003 Dec;42(6): PMID:

5 Background: Importance of Blood Pressure Control in the Management of Hypertension
Strategies for the management of hypertension involve a combination of antihypertensive medication and lifestyle modifications such as: Smoking cessation Moderation of alcohol consumption Salt restriction and other dietary modifications Regular exercise Weight loss in obese persons Effective BP control has been shown to significantly improve health outcomes and reduce mortality. A decrease of 5 mmHg in systolic BP is estimated to reduce mortality due to stroke heart disease by 14% and 9% respectively, and all-cause mortality by 7%. Background: Importance of Blood Pressure Control in the Management of Hypertension Health professional and government organizations have developed recommended for BP management that include lifestyle and behavior modifications (such as smoking cessation, moderation of alcohol consumption, salt restriction and other dietary changes, regular exercise, and weight loss in obese patients), usually in combination with pharmacological treatment for hypertension. Effective control of blood pressure has been shown to significantly improve health outcomes and reduce mortality. Control of blood pressure has been shown to decrease the incidence of stroke by 35 to 40 percent, myocardial infarction by 20 to 25 percent, and heart failure by more than 50 percent. A decrease of 5 mmHg in systolic BP is estimated to result in a 14 percent reduction in mortality due to stroke, a 9 percent reduction in mortality due to heart disease, and a 7 percent reduction in all-cause mortality. References: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint Nation Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003 Dec;42(6): PMID: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at: Chobanian AV, Bakris GL, Black HR, et al. Hypertension 2003 Dec;42(6): PMID:

6 Background: BP Measurement Strategies — Measurement in the Health Care Setting
For the diagnosis and effective management of hypertension, accurate measurement of BP is crucial. Strategies for BP measurement include measurement in the health care setting and at home. Measurement of BP in the clinic or other health care settings has the following limitations: The need for a period of rest before measurement to obtain reliable readings The possibility that a patient’s BP may rise as a result of being in the health care setting (termed “white coat” hypertension) The possibility that a patient’s BP is normal in the clinic, but not outside; (termed “masked” hypertension) Background: BP Measurement Strategies — Measurement in the Health Care Setting Accurate measurement of BP is critical to the appropriate diagnosis and management of this condition. Measurement of BP can be performed in a health care setting such as a physician’s office, clinic, or hospital. Measurement of BP can also be performed outside the health care setting such as at the patient’s home (by the patient, the patient’s companion, or a health care worker), at the patient’s workplace, or at the pharmacy. However, only measurement of BP at home by the patient or the patient’s companion will be discussed here. Measurement of BP in the health care setting is the most common strategy for BP measurement. However, it has several limitations including: 1. The need for the patient to have adequately rested before the measurement to obtain reliable and consistent readings. 2. The possibility that a patient’s BP may rise as a result of being in the health care setting . This is termed “white coat” hypertension, and its prevalence is estimated to be from 10 to 20 percent. 3. The possibility that a patient’s BP is normal in the clinic but not outside it. This is termed “masked” hypertension, and its prevalence is estimated to be 40 percent. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF . Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

7 Background: BP Measurement Strategies — Measurement at Home
There are two BP measurement strategies that can be used at home: Ambulatory BP monitoring A noninvasive, fully automated technique in which BP is recorded over an extended period of time. Requires a technologist to set up and download readings. Mainly used to diagnose white coat or masked hypertension, or to monitor patients whose BP is hard to control, or is highly variable. Self-measured BP (SMBP) monitoring Regular self-measurement of BP by the patient (or a companion). Readings can be stored and taken to the doctor’s office or transmitted electronically. Used to detect white coat and masked hypertension, and avoid over-treatment in patients with orthostatic BP changes or hypotensive episodes. Only SMBP monitoring will be discussed here. Background: BP Measurement Strategies — Measurement at Home There are two types of BP measurement strategies that can be used at home: Ambulatory BP monitoring — a noninvasive, fully automated technique in which BP is recorded over an extended period of time. A BP cuff is placed around the upper arm and left in place for about 24 hours. A connected monitor records BP, usually every 15 to 20 minutes while awake and every 20 to 30 minutes while asleep. This approach is expensive; it requires a technologist to program the machine, fit it on the patient, remove it, and download the results and a physician to interpret the results. Additionally, recording BP over an extended period may interfere with the patient’s daily activities and sleep. Ambulatory BP monitoring, therefore, is mainly used to diagnose white coat or masked hypertension or to monitor patients whose BP is hard to control or is highly variable. Self-measured BP (SMBP) monitoring — regular measurement by the patient (or a companion) of his or her own BP. Readings can be stored and taken to the doctor’s office or transmitted electronically. SMBP measurements can be obtained from the upper arm, wrist, fingers, or lower extremity. However, experts recommend the use of upper arm devices because of their greater accuracy. Patients can measure their own BP and provide written lists of readings to their health care provider at office visits. Newer SMBP devices can automatically store readings, and some are equipped to electronically transmit readings to a health care provider. SMBP is used to aid diagnosis in patients suspected of having white coat or masked hypertension, and to prevent over-treatment in patients with orthostatic BP changes or hypotensive episodes associated with medication. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012 Available at:

8 Background: SMBP Monitoring Devices
Types of SMBP monitoring devices include: “Manual” devices — sphygmomanometers that require manual inflation and auscultation “Semiautomated” devices — manually inflated sphygmomanometers with automated display “Automated” devices — inflation of sphygmomanometers and BP measurement are both automated Many devices are commercially available and have been validated by leading organizations. Patients may require some instruction on device use. Background: SMBP Monitoring Devices Types of SMBP monitoring devices include “manual” devices, “semiautomated” devices, and “automated” devices. Many devices are commercially available and have been validated by leading organizations such as the American Association of Medical Instrumentation, the European Society of Hypertension, and the British Hypertension Society. Depending on the type of SMBP monitoring device, patients may need instruction or training on how to use the device. References: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: MedlinePlus Web site. Blood pressure monitors for home. Updated June 10, Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012 Available at: MedlinePlus Web site. Blood pressure monitors for home. Updated June 10, Available at:

9 Background: Aims of using SMBP Monitoring in the Management of Hypertension
The aims of using SMBP monitoring in hypertension management are: Avoiding undertreatment of hypertension Enhancing patient self-participation in disease management Enhancing adherence to lifestyle and pharmacological interventions Avoiding overtreatment in patients with lower BP outside the clinic than in it. Background: Aims of using SMBP Monitoring in the Management of Hypertension The proposed advantages of using SMBP monitoring to manage hypertension are: Avoiding undertreatment of hypertension — SMBP monitoring can provide more frequent BP measurements. If transmitted to the health care provider, this can permit more rapid adjustments in antihypertensive medication and more effective BP control. Enhancing patient self-participation in disease management and adherence to lifestyle and pharmacological interventions — long-term adherence to lifestyle modification strategies and antihypertensive medication is a key challenge in hypertension management. SMBP monitoring may help address this challenge by enhancing patient participation in disease management. Avoiding overtreatment in patients with lower BP outside the clinic than in it — SMBP may be useful in identifying individuals with white coat hypertension, orthostatic BP changes, or hypotensive episodes from medication and thereby prevent overtreatment in these individuals. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

10 Uncertainties in Existing Biomedical Literature about the role of SMBP Monitoring in Managing Hypertension It is unclear from existing biomedical literature if SMBP monitoring improves key outcomes related to the management of hypertension including: BP control Clinical outcomes Health care utilization outcomes It is also uncertain how other support, in addition to SMBP monitoring, affects these key outcomes, when compared with usual care or with SMBP without additional support. To gain insight into these knowledge gaps, this topic was nominated and developed for comparative effectiveness review with the AHRQ Effective Healthcare Program. Background: Uncertainties Associated With SMBP Monitoring in Managing Hypertension It is currently not known if SMBP monitoring alone, when compared with usual care, improves BP control, clinical outcomes such as cardiovascular events and mortality, or health care utilization outcomes. Usual care is the standard of care management of hypertension in outpatient and general practice settings. It is also currently unknown if SMBP monitoring combined with additional support measures better improves BP control, clinical outcomes, and health care utilization outcomes when compared with usual care or with SMBP monitoring without additional support. Additional support measures frequently used in conjunction with SMBP monitoring include transmission of measurements to a health care provider, regular nursing contact, and regular contact with a health care provider regarding hypertension management. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

11 Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development
Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, members of the public, and others.  A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment.  The results of these reviews are summarized into Clinician Research Summaries and Consumer Research Summaries for use in decisionmaking and in discussions with patients. The Summaries and the full report, with references for included and excluded studies, are available at Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, members of the public, and others. A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment. The results of these reviews are summarized into Clinician Research Summaries and Consumer Research Summaries for use in decisionmaking and in discussions with patients. The guides and the full report, with references for included and excluded studies, are available at

12 Clinical Questions Addressed by the CER (1 of 2)
Key Question (KQ) 1: In people with hypertension (adults and children), does SMBP monitoring, compared to usual care or other interventions without SMBP, have an effect on clinically important outcomes? How does SMBP monitoring compare to usual care or other interventions without SMBP in its effect on relevant clinical outcomes (cardiovascular events, mortality, patient satisfaction, quality of life, and adverse events related to antihypertensive agents)? How does SMBP monitoring compare to usual care or other interventions without SMBP in its effect on relevant surrogate outcomes (cardiac measures: left ventricular hypertrophy, left ventricular mass, and left ventricular mass index ) and intermediate outcomes (BP control, BP treatment adherence, or health care process measures)? Clinical Questions Addressed by the CER (1 of 2) In preparing the report on which this continuing medical education (CME) activity is based, the authors aimed to answer seven Key Questions (KQs). KQ 1 is listed below: KQ1. In people with hypertension (adults and children), does SMBP monitoring, compared to usual care or other interventions without SMBP, have an effect on clinically important outcomes? How does SMBP monitoring compare to usual care or other interventions without SMBP in its effect on relevant clinical outcomes (cardiovascular events, mortality, patient satisfaction, quality of life, and adverse events related to antihypertensive agents)? How does SMBP monitoring compare to usual care or other interventions without SMBP in its effect on relevant surrogate outcomes (cardiac measures: left ventricular hypertrophy, left ventricular mass, and left ventricular mass index) and intermediate outcomes (BP control, BP treatment adherence, or health care process measures)? Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012 Available at:

13 Clinical Questions Addressed by the CER (2 of 2)
KQ 2: In studies of SMBP monitoring, how do clinical, surrogate, and intermediate outcomes (including SMBP monitoring adherence) vary by the type of additional support provided? KQ 3: How do different devices for SMBP monitoring compare with each other (specifically semiautomatic or automatic vs. manual) in their effects on clinical, surrogate, and intermediate outcomes (including SMBP monitoring adherence)? KQ 4: In studies of SMBP monitoring, how does achieving BP control relate to clinical and surrogate outcomes? KQ 5: How does adherence with SMBP monitoring vary by patient factors? Clinical Questions Addressed by the CER (2 of 2) In preparing the report on which this CME activity is based, the authors aimed to answer seven KQs. KQs 2–5 are listed below: KQ 2. In studies of SMBP monitoring, how do clinical, surrogate, and intermediate outcomes (including SMBP monitoring adherence) vary by the type of additional support provided? KQ 3. How do different devices for SMBP monitoring compare with each other (specifically semiautomatic or automatic vs. manual) in their effects on clinical, surrogate, and intermediate outcomes (including SMBP monitoring adherence)? KQ 4. In studies of SMBP monitoring, how does achieving BP control relate to clinical and surrogate outcomes? KQ 5. How does adherence with SMBP monitoring vary by patient factors? Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No.45. January 2012 Available at:

14 Rating the Strength of Evidence From the CER
The strength of evidence was classified into four broad categories: High ●●● Further research is very unlikely to change the confidence in the estimate of effect. Moderate ●●○ Further research may change the confidence in the estimate of effect and may change the estimate. Low ●○○ Further research is likely to change the confidence in the estimate of effect and is likely to change the estimate. Insufficient ○○○ Evidence either is unavailable or does not permit estimation of an effect. Rating the Strength of Evidence From the CER Throughout this slide set, strength of evidence ratings are assigned to findings of the report. Strength of evidence is typically assigned to reviews of medical treatments after assessing four domains: risk of bias, consistency, directness, and precision. Although these categories were developed for assessing the strength of treatment studies, the domains apply also to studies of prevalence and screening. Available evidence for each KQ was assessed for each of these four domains; the domains were combined qualitatively to develop the strength of evidence for each KQ. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

15 Comparative Effectiveness of SMBP Monitoring Versus Usual Care (1 of 2)
SMBP improved clinic systolic BP and diastolic BP at 6 months and 12 months when compared with usual care. SBP net change at 6 months -3.1 mmHg (95% CI ‑5, ‑1.2; P = 0.002) DBP net change at 6 months -2.0 mmHg (95% CI ‑3.2, ‑0.8; P = 0.001) SBP net change at 12 months -1.2 mmHg (95% CI ‑3.5, 1.2) DBP net change at 6 months -0.8 mmHg (95% CI ‑2.5, 1.0) Strength of evidence: moderate Comparative Effectiveness of SMBP Monitoring Versus Usual Care (1 of 2) There is a moderate strength of evidence that SMBP alone improved BP control by a small amount when compared with usual care. Meta-analyses showed that, at 6 months, SMBP monitoring yielded a modest but statistically significant net reduction of 3.1 mmHg in clinic systolic BP and a net reduction of 2.0 mmHg in clinic diastolic BP when compared with usual care. At 12 months, SMBP monitoring yielded a net reduction of 1.2 mmHg in clinic systolic BP and a net reduction of 0.8 mm Hg in clinic diastolic BP when compared with usual care. The net reductions in systolic BP and diastolic BP at 12 months were, however, not statistically significant. References: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No.45. January 2012. Available at:

16 Comparative Effectiveness of SMBP Monitoring Versus Usual Care (2 of 2)
Evidence failed to support a difference between SMBP alone versus usual care for the following outcomes: Quality of life Number of medications used and medication dosage Medication adherence Left ventricular mass index Patient satisfaction with health care services Strength of evidence: low Evidence failed to support a difference between SMBP alone versus usual care for health care encounters. Comparative Effectiveness of SMBP Monitoring Versus Usual Care (2 of 2) Overall, SMBP monitoring and usual care had similar effects on intermediate and surrogate outcomes, including medication number and dosage, medication adherence, quality of life, patient satisfaction, and left ventricular mass index. Inconsistency in findings and heterogeneity in definitions resulted in the strength of evidence being rated low for this finding. Overall, SMBP monitoring and usual care had similar effects on health care encounters. Of the six studies that reported on outcomes of health care encounters, the majority found no difference in number of physician visits, hypertension-related telephone calls, or medical procedures received between groups. A limited number of studies found SMBP to be associated with a greater or lesser number of office visits, respectively. Inconsistency in findings and heterogeneity in definitions resulted in the strength of evidence being rated low for this finding. References: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

17 Comparative Effectiveness of SMBP Monitoring Plus Additional Support Versus Usual Care (1 of 2)
SMBP plus some form of additional support improves BP control when compared with usual care, at least up to 12 months. The superiority of one form of additional support over another could not be assessed given the heterogeneity in types of additional support used. Strength of evidence: high Evidence failed to support a difference between SMBP plus additional support versus usual care for the following outcomes: Quality of life Number of medications used and medication dosage Medication adherence Adverse drug reactions Strength of evidence: low Comparative Effectiveness of SMBP Monitoring Plus Additional Support Versus Usual Care (1 of 2) There is high strength of evidence that SMBP plus additional support improved BP control when compared with usual care. Eleven trials, including six trials that were rated as being high in quality, reported statistically significant reductions in systolic BP or diastolic BP in the SMBP group. The additional support examined in these 11 trials were telecounseling; Web training with pharmacist counseling; self-titration plus provider alert; education; medication monitoring with provider alert; personalized Web site plus videoconference counseling; pharmacist counseling; and combined medication-behavioral management (as needed whenever there was inadequate BP control). For a follow-up period of upto12 months, there was a significant mean net reduction in in-clinic systolic BP ranging from 1.6 to 8.5 mmHg and a significant mean net reduction in diastolic BP ranging from 1.9 to 4.4 mmHg—both favoring SMBP plus additional support. Meta-analyses of the studies was not possible because of the high level of heterogeneity in the types of additional support interventions used. There was no difference between SMBP monitoring with some form of additional support and usual care for intermediate and surrogate outcomes, including medication number and dosage, medication adherence, quality of life, and adverse drug reactions. Inconsistency in findings and heterogeneity in definitions resulted in the strength of evidence being rated low for this finding. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

18 Comparative Effectiveness of SMBP Monitoring Plus Additional Support Versus Usual Care (2 of 2)
Evidence failed to support a difference between SMBP plus additional support versus usual care for the number of health care encounters. Strength of evidence: low Comparative Effectiveness of SMBP Monitoring Plus Additional Support Versus Usual Care (2 of 2) There was no difference between SMBP monitoring with some form of additional support and usual care for number of health care encounters. Of the 8 studies that reported on health care encounters, 6 studies found no difference in number of visits, 1 found fewer visits, and 1 found more visits with SMBP plus additional support when compared to usual care. Inconsistency in findings and the low quality of the studies resulted in the strength of evidence being rated low for this finding. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

19 Comparative Effectiveness of SMBP Monitoring With or Without Additional Support (1 of 2)
Evidence fails to support a difference between SMBP with additional support versus SMBP without additional support or with less-intensive additional support for BP control. Strength of evidence: low Evidence failed to support a difference between SMBP with additional support versus SMBP without additional support or with less-intensive additional support for the following outcomes: Quality of life Mental health (anxiety) Number of medications used and medication dosage Medication adherence Adverse drug reactions Comparative Effectiveness of SMBP Monitoring With or Without Additional Support (1 of 2) Evidence failed to support a difference between SMBP plus additional support versus SMBP without additional support or with less-intensive additional support for BP control; the strength of evidence for this finding was rated as low. This was based on data from 12 trials. Additional support in these trials consisted of a mixture of behavioral interventions by a nurse or pharmacist, medication management, educational interventions, electronic transmission of BP measurements, Web sites/training for patient-provider communication, telemonitoring, BP recording cards, BP and medication tracking tool, or home visits. Four trials found statistically significant benefits for the more-intensive additional support for systolic BP, diastolic BP, or overall BP control or combinations thereof. The results of the other eight trials were indeterminate for a difference. Meta-analyses could not be performed due to clinical heterogeneity. The small number of studies and their distribution across different categories of additional support makes it impossible to draw conclusions regarding the potential effects of specific additional support or its interactions with SMBP. There was no difference between SMBP with additional support versus SMBP without additional support or with less-intensive additional support for intermediate and surrogate outcomes, including medication number and dosage, medication adherence, quality of life, mental health, and adverse drug reactions. Inconsistency in findings and heterogeneity in definitions resulted in the strength of evidence being rated low for this finding. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

20 Comparative Effectiveness of SMBP Monitoring With or Without Additional Support (2 of 2)
Evidence failed to support a difference between SMBP with additional support versus SMBP without additional support or with less-intensive additional support for health care encounters. Strength of evidence: low Comparative Effectiveness of SMBP Monitoring With or Without Additional Support (2 of 2) There was no difference between SMBP with additional support versus SMBP without additional support or with less-intensive additional support for health care encounters. None of the five studies that reported on health care encounters found a difference in the numbers of outpatient visits or hospital admissions between patients receiving SMBP with or without additional support. Despite the consistency across trials, the overall strength of evidence was rated as low because of the small number and the poor quality of the studies. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No.45. January 2012. Available at:

21 Strength of evidence: insufficient
Findings Related to Predictors of SMBP Adherence, Types of SMBP Monitors, and Correlation Between BP Control and Clinical Outcomes Evidence was insufficient to determine the predictors of SMBP adherence. Strength of evidence: insufficient Evidence comparing SMBP monitors was insufficient. Evidence was insufficient to determine how achieving BP control relates to clinical and surrogate outcomes under an SMBP monitoring regime. Findings Related to Predictors of SMBP Adherence, Types of SMBP Monitors, and Correlation Between BP Control and Clinical Outcomes For predictors of SMBP adherence, a single study of Korean Americans was eligible for inclusion in the review. Older age was independently associated with greater adherence to SMBP monitoring, and the presence of depression was independently associated with lower adherence. Other tested factors were not associated with adherence. As data are limited to that of a single study, the strength of evidence was insufficient regarding predictors of adherence with SMBP monitoring. Studies comparing SMBP monitors that were of a priori interest to the reviewers could not be identified. The evidence comparing SMBP monitors was, therefore, rated as insufficient. For correlation between BP control and clinical and surrogate outcomes, a single study was eligible for inclusion. The study provided no data on number of patients who achieved BP control or other relevant data. The evidence is, therefore, insufficient to determine how achieving BP control relates to clinical and surrogate outcomes under an SMBP monitoring regime. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

22 Conclusions (1 of 2) In the management of hypertension, SMBP alone versus usual care yielded a modest net reduction in in-clinic systolic BP and diastolic BP at 6 months and at 12 months. Adding clinical support to SMBP led to a consistently greater BP reduction when compared to usual care at up to 12 months of followup. The evidence was too limited to determine the superiority of any one form of additional clinical support strategy, as modalities varied widely across studies. Conclusions (1 of 2) SMBP alone, when compared to usual care, yielded a net reduction in clinic systolic BP and diastolic BP at 6 months and at 12 months. Meta-analysis showed that the net reduction in systolic BP and diastolic BP was statistically significant at 6 months but not at 12 months. SMBP monitoring, in conjunction with some form of additional support strategy, resulted in a consistently greater BP reduction up to 12 months, when compared to usual care. Given the wide variability in the additional support strategy used in the studies reviewed, the effectiveness of one strategy relative to the other could not be determined. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No.45. January 2012. Available at:

23 Conclusions (2 of 2) The evidence is weak or insufficient to determine if SMBP monitoring with or without additional support has an impact on other outcomes including: Mortality Quality of life Number of medications used and medication dosage Medication adherence Health care encounters Additional research is needed to determine the effect of SMBP monitoring on BP control beyond 12 months and to determine long-term clinical consequences of SMBP monitoring. Conclusions (2 of 2) There is insufficient evidence to evaluate the effectiveness of SMBP monitoring with or without additional support on other surrogate and intermediate outcomes and on health care encounters. Effects of SMBP monitoring on BP control and clinical outcomes in the long term remain to be elucidated in future research studies. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No.45. January 2012. Available at:

24 Knowledge Gaps and Future Research Needs (1 of 3)
The following limitations identified in existing trials should be addressed in future trials: Short duration of followup (<1 year in most studies) Heterogeneity in SMBP monitoring and additional support protocols used Limited evidence on the effect of SMBP monitoring on BP control as a predictor of clinical and surrogate outcomes such as mortality, quality of life, and left ventricular hypertrophy Lack of studies in children with high BP Knowledge Gaps and Future Research Needs (1 of 3) Most of the studies included in this review were heterogeneous in the SMBP monitoring and additional support strategies used and had a followup duration of <1 year. Future trials with more uniform and well-defined SMBP monitoring and additional support strategies and with followup beyond 12 months would help clarify the effectiveness of these strategies, particularly in the long term. Studies on children with high BP were lacking. Additionally, current research also provides limited evidence on the correlation between BP control with SMBP monitoring and clinical and surrogate outcomes. It is hoped that this will be addressed in future studies. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at: http;//

25 Knowledge Gaps and Future Research Needs (2 of 3)
In future studies, SMBP monitoring may be used to characterize a patient’s BP abnormality as uncontrolled or white coat hypertension before trial inclusion to enable appropriate assessment and management. SMBP monitoring can be burdensome over time. Future studies should help determine the least burdensome protocol(s). Studies should also be conducted to examine the effects of SMBP monitoring on clinical events. Knowledge Gaps and Future Research Needs (2 of 3) Existing trials may have included varying proportions of individuals with uncontrolled hypertension or white coat hypertension, which may have masked the potential benefits of SMBP monitoring. In future trials, SMBP monitoring may be used to stratify patients on the basis of their BP abnormality as uncontrolled hypertension or masked hypertension. In patients with consistently elevated BP at home and in the clinic, SMBP monitoring should be examined for its effects on BP control and adherence. In patients with white coat hypertension, SMBP should be examined for the adequacy of BP control achieved and avoidance of overtreatment. Given that SMBP monitoring can be burdensome over time, future research studies should compare different monitoring schedules with the goal of finding the least burdensome protocol. There is a paucity of data for clinical event outcomes in this review; future studies should examine the effects of SMBP monitoring on clinical events in addition to BP control. This will require durations of followup >1 year. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No. 45. January 2012. Available at:

26 Knowledge Gaps and Future Research Needs (3 of 3)
Other important areas for future research include: Identifying predictors of adherence to SMBP monitoring. Approaches for improving adherence to SMBP monitoring. Improving ways to transmit SMBP results for decisionmaking. Telemedicine as a means for patient-provider interaction regarding results of SMBP monitoring. Comparing the ability of SMBP monitoring versus ambulatory BP monitoring to diagnose hypertension. Knowledge Gaps and Future Research Needs (3 of 3) The effectiveness of SMBP monitoring may vary by patient characteristics or attitudes. Future studies should, therefore, examine characteristics that are associated with adherence with SMBP monitoring. Data gathered should encompass demographic, psychosocial, educational, economic, and geographic factors, in addition to clinical variables. Other important areas for future research include examining the role of various measures for improving the accuracy of and adherence with SMBP monitoring, as well as improving the transmission of SMBP information for decisionmaking. Investigations should also be made into further use of telemedicine for patient-provider interaction regarding results of SMBP monitoring and medication management. Additionally, the relative ability of SMBP and ambulatory BP monitoring to diagnose hypertension should be studied. Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at:

27 What To Discuss With Your Patients and Their Caregivers
The importance of effectively controlling high BP The link between measuring BP and controlling high BP The importance of adherence to strategies aimed at managing hypertension such as lifestyle and dietary modifications and medication How SMBP monitoring allows patients to participate more actively in managing their BP The types of SMBP devices available and how to operate the device selected for the patient What To Discuss With Your Patients and Their Caregivers Things you should discuss with your patients and their caregivers regarding SMBP monitoring to help manage hypertension: - The importance of effectively controlling high BP - The link between measuring BP and controlling high BP - The importance of adherence to strategies aimed at managing hypertension such as lifestyle and dietary modifications and medication - How SMBP monitoring allows patients to participate more actively in managing their BP - The types of SMBP devices available and how to operate the device selected for the patient Reference: Uhlig K, Balk EM, Patel K, et al. Self-Measured Blood Pressure Monitoring. Comparative Effectiveness Review No. 45 (Prepared by Tufts Evidence-based Practice Center under Contract No. HHSA I). Rockville, MD: Agency for Healthcare Research and Quality; January AHRQ Publication No.12-EHC002-EF. Available at: Uhlig K, Balk EM, Patel K, et al. AHRQ Comparative Effectiveness Review No.45. January 2012. Available at:


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