Claire Schwartz

Effect of Self-monitoring and Medication Self-titration on Systolic Blood Pressure in Hypertensive Patients at High Risk of Cardiovascular Disease The TASMIN-SR Randomized Clinical Trial

IMPORTANCE Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups. OBJECTIVE To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease. DESIGN, SETTING, AND PATIENTS A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013. INTERVENTIONS Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary. MAIN OUTCOMES AND MEASURES The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit. RESULTS Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events. CONCLUSIONS AND RELEVANCE Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN87171227.

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial

BackgroundSelf-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care.Methods/DesignThe targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients’ views, experiences and decision making processes.DiscussionThe results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond.Trial RegistrationISRCTN87171227

Cost-effectiveness of self-management of blood pressure in hypertensive patients over 70 years with suboptimal control and established cardiovascular disease or additional cardiovascular risk diseases (TASMIN-SR)

Background A previous economic analysis of self-management, that is, self-monitoring with self-titration of antihypertensive medication evaluated cost-effectiveness among patients with uncomplicated hypertension. This study considered cost-effectiveness of self-management in those with raised blood pressure plus diabetes, chronic kidney disease and/or previous cardiovascular disease. Design and methods A Markov model-based economic evaluation was undertaken to estimate the long-term cost-effectiveness of self-management of blood pressure in a cohort of 70-year-old ‘high risk’ patients, compared with usual care. The model used the results of the TASMIN-SR trial. A cost–utility analysis was undertaken from a UK health and social care perspective, taking into account lifetime costs of treatment, cardiovascular events and quality adjusted life years. A subgroup analysis ran the model separately for men and women. Deterministic sensitivity analyses examined the effect of different time horizons and reduced effectiveness of self-management. Results Base-case results indicated that self-management was cost-effective compared with usual care, resulting in more quality adjusted life years (0.21) and cost savings (–£830) per patient. There was a 99% chance of the intervention being cost-effective at a willingness to pay threshold of £20,000 per quality adjusted life year gained. Similar results were found for separate cohorts of men and women. The results were robust to sensitivity analyses, provided that the blood pressure lowering effect of self-management was maintained for more than a year. Conclusion Self-management of blood pressure in high-risk people with poorly controlled hypertension not only reduces blood pressure, compared with usual care, but also represents a cost-effective use of healthcare resources.

Ethnicity and Differences Between Clinic and Ambulatory Blood Pressure Measurements

BACKGROUND This study investigated the relationship of ethnicity to the differences between blood pressure (BP) measured in a clinic setting and by ambulatory blood pressure monitoring (ABPM) in individuals with a previous diagnosis of hypertension (HT) and without a previous diagnosis of hypertension (NHT). METHODS A cross-sectional comparison of BP measurement was performed in 770 participants (white British (WB, 39%), South Asian (SA, 31%), and African Caribbean (AC, 30%)) in 28 primary care clinics in West Midlands, United Kingdom. Mean differences between daytime ABPM, standardized clinic (mean of 3 occasions), casual clinic (first reading on first occasion), and last routine BP taken at the general practitioner practice were compared in HT and NHT individuals. RESULTS Daytime systolic and diastolic ABPM readings were similar to standardized clinic BP (systolic: 128 (SE 0.9) vs. 125 (SE 0.9) mm Hg (NHT) and 132 (SE 0.7) vs. 131 (SE 0.7) mm Hg (HT)) and were not associated with ethnicity to a clinically important extent. When BP was taken less carefully, differences emerged: casual clinic readings were higher than ABPM, particularly in the HT group where the systolic differences approached clinical relevance (131 (SE 1.2) vs. 129 (SE 1.0) mm Hg (NHT) and 139 (SE 0.9) vs. 133 (SE 0.7) mm Hg (HT)) and were larger in SA and AC hypertensive individuals (136 (SE 1.5) vs. 133 (SE 1.2) mm Hg (WB), 141 (SE 1.7) vs. 133 (SE 1.4) mm Hg (SA), and 142 (SE 1.6) vs. 134 (SE 1.3) mm Hg (AC); mean differences: 3 (0-7), P = 0.03 and 4 (1-7), P = 0.01, respectively). Differences were also observed for the last practice reading in SA and ACs. CONCLUSIONS BP differences between ethnic groups where BP is carefully measured on multiple occasions are small and unlikely to alter clinical management. When BP is measured casually on a single occasion or in routine care, differences appear that could approach clinical relevance.

Modern Management and Diagnosis of Hypertension in the United Kingdom: Home Care and Self-care.

BACKGROUND The effective diagnosis and management of hypertension is one of the most important parts of cardiovascular prevention internationally and this is no different in the United Kingdom. Approximately 14% of the UK population currently receive treatment for hypertension. Recent UK guidelines from the National Institute of Health and Care Excellence have placed greater emphasis on the utilization of out-of-office measurement of blood pressure to more accurately diagnose hypertension. OBJECTIVE The aim of the present study was to provide a state-of-the-art review of the evidence for screening, diagnosing, and managing hypertension, as implemented in the United Kingdom, with an emphasis on the role of self-monitored and ambulatory blood pressure monitoring in routine clinical care. METHOD Consideration was given to the use of ambulatory and home monitoring to confirm a diagnosis of hypertension and the use of self-monitoring and self-management to monitor and guide treatment. The evidence for the use of self-monitoring in patients with hypertension was examined, both in isolation, and in combination with lifestyle and treatment interventions. FINDINGS There is a place for self-monitored blood pressure in specific underresearched populations such as the elderly, specialist conditions, ethnic groups, and during pregnancy and this is discussed here. CONCLUSIONS The evidence supporting the use of out-of-office monitoring in all aspects of routine clinical care has increased substantially in recent years and is reflected in increased utilization by patients and clinicians alike. Several areas require further research but it is clear that out-of-office monitoring is here to stay and is fast becoming an important part of hypertension management in the United Kingdom.

Blood pressure in different ethnic groups (BP-Eth): a mixed methods study

Introduction People of South Asian, African-Caribbean and Irish ethnicity are known to have worse cardiovascular outcomes than those from the white British group. While the reasons underpinning this are complex, the effect of hypertension is both significant and modifiable. In recent years, there has been increasing interest in and uptake of ‘out-of-office’ methods for blood pressure (BP) monitoring. However, guidance in this area has been largely based on research among the white population. This study aims to answer the following questions: (1) How often and in what ways does blood pressure (BP) monitoring occur and how does this differ between white and the above minority ethnic populations. (2) Are the thresholds for diagnosis of hypertension, and treatment targets in hypertension comparable for white British and minority ethnic populations using different measurement modalities: office blood pressure, ambulatory BP monitoring and home monitoring? (3) What preferences for BP measurement do people from white and minority ethnic populations have? Methods and analysis A mixed methods approach will be used including the following: (1) A postal survey sent to 8000 hypertensive and not-known-to-be-hypertensive people from all four ethnic groups will determine current patterns of BP monitoring. (2) A validation study will compare BP measurement by ambulatory monitoring with office standard measurement, office research measurement and home monitoring in 200 people from each of the ethnic groups concerned. (3) Focus groups organised by ethnicity and gender will gather qualitative data regarding patient preferences for and experiences of BP measurement in each of the given modalities. The data collected from these phases will be analysed appropriately in order to answer the above research questions. Ethics and dissemination Ethical approval has been gained from the Black Country Research Ethics Committee: Ref 09/H1202/114. The results of this work will be disseminated via journal publication and conference presentation.

Influence of ethnicity on acceptability of method of blood pressure monitoring: a cross-sectional study in primary care

Background Ambulatory and/or home monitoring are recommended in the UK and the US for the diagnosis of hypertension but little is known about their acceptability. Aim To determine the acceptability of different methods of measuring blood pressure to people from different minority ethnic groups. Design and setting Cross-sectional study with focus groups in primary care in the West Midlands. Method People of different ethnicities with and without hypertension were assessed for acceptability of clinic, home, and ambulatory blood pressure measurement using completion rate, questionnaire, and focus groups. Results A total of 770 participants were included, who were white British (n = 300), South Asian (n = 241), and African Caribbean (n = 229). White British participants had significantly higher successful completion rates across all monitoring modalities compared with the other ethnic groups, especially for ambulatory monitoring: white British (n = 277, 92% [95% confidence interval [CI] = 89% to 95%]) versus South Asian (n = 171, 71% [95% CI = 65% to 76%], P<0.001) and African Caribbean (n = 188, 82% [95% CI = 77% to 87%], P<0.001), respectively. There were significantly lower acceptability scores for minority ethnic participants across all monitoring methods compared with white British participants. Focus group results highlighted self-monitoring as most acceptable and ambulatory monitoring least acceptable without consistent differences by ethnicity. Clinic monitoring was seen as inconvenient and anxiety provoking but with the advantage of immediate professional input. Conclusion Reduced acceptability and completion rates among minority ethnic groups raise important questions for the implementation and interpretation of blood pressure monitoring. Selection of method of blood pressure monitoring should take into account clinical need, patient preference, and potential cultural barriers to monitoring.

1B.10: DOES THE RIGHT ARM KNOW WHAT THE LEFT ARM IS DOING? ETHNIC VARIATIONS IN CLINICAL INTERARM DIFFERENCE AND RELATIONSHIP TO WHITE COAT EFFECTS

Objective: Evidence suggests an interarm difference (IAD) of >=10mmHg in blood pressure (BP) is associated with a greater incidence of cardiovascular disease. Effect of ethnicity on the prevalence of this difference has not been reported. Design and method: The Blood Pressure in Ethnic Groups Study (BP-Eth), based in primary care, investigated the relationship between ethnicity and different methods of BP measurement. Using these data the prevalence of a significant IAD was investigated in 770 people (300 White British, 229 South Asian, 241 African-Caribbean). Repeated BP measurements were obtained simultaneously in the right and left arm using two BP-Tru machines and comparisons made between the first reading, mean of 2nd/3rd readings and mean of 2nd-6th readings for patients with and without known hypertension. Results: No significant difference was seen in the prevalence of a systolic IAD between ethnicities whichever combinations of BP measurement were used and whether or not an individual was hypertensive. Overall the prevalence of IAD fell as more measurements were used in the comparison: first measurement (n = 161, 22%), mean 2nd/3rd (113, 16%) and mean 2–6th (78, 11%) (first vs clinic and research mean p < 0.001). To investigate whether this change in IAD prevalence with repeated measurement was due to a white coat effect (WCE), the three types of measurement were compared with participants’ mean daytime ambulatory readings (ABPM). WCE was defined as Clinic BP >=10mmHg higher than ABPM. Unadjusted results show patients with a WCE were twice as likely to have an IAD on their first BP measurement (OR 2.1, 95% CI 1.4 - 3.1), mean 2nd/3rd (2.1, 95% CI 1.3 - 3.4) and mean 2–6th (2.1, 95% CI 1.2 - 3.9) compared to those without a WCE. Conclusions: Ethnicity did not affect the prevalence of IAD in people with or without hypertension. However the prevalence of IAD was affected by the number of readings suggesting an element of white coat effect and this was confirmed by comparison with ambulatory monitoring. Therefore ABPM may play an important role in the investigation of those with >=10mmHg interarm blood pressure difference.

What is the evidence base for diagnosing hypertension and for subsequent blood pressure treatment targets in the prevention of cardiovascular disease

Diagnosing and treating hypertension plays an important role in minimising the risk of cardiovascular disease and stroke. Early and accurate diagnosis of hypertension, as well as regular monitoring, is essential to meet treatment targets. In this article, current recommendations for the screening and diagnosis of hypertension are reviewed. The evidence for treatment targets specified in contemporary guidelines is evaluated and recommendations from the USA, Canada, Europe and the UK are compared. Finally, consideration is given as to how diagnosis and management of hypertension might develop in the future.

Interarm Difference in Systolic Blood Pressure in Different Ethnic Groups and Relationship to the "White Coat Effect": A Cross-Sectional Study

Abstract BACKGROUND Interarm differences (IADs) ≥10 mm Hg in systolic blood pressure (BP) are associated with greater incidence of cardiovascular disease. The effect of ethnicity and the white coat effect (WCE) on significant systolic IADs (ssIADs) are not well understood. METHODS Differences in BP by ethnicity for different methods of BP measurement were examined in 770 people (300 White British, 241 South Asian, 229 African-Caribbean). Repeated clinic measurements were obtained simultaneously in the right and left arm using 2 BPTru monitors and comparisons made between the first reading, mean of second and third and mean of second to sixth readings for patients with, and without known hypertension. All patients had ambulatory BP monitoring (ABPM). WCE was defined as systolic clinic BP ≥10 mm Hg higher than daytime ABPM. RESULTS No significant differences were seen in the prevalence of ssIAD between ethnicities whichever combinations of BP measurement were used and regardless of hypertensive status. ssIADs fell between the 1st measurement (161, 22%), 2nd/3rd (113, 16%), and 2nd–6th (78, 11%) (1st vs. 2nd/3rd and 2nd–6th, P < 0.001). Hypertensives with a WCE were more likely to have ssIADs on 1st, (odds ratio [OR] 1.73 (95% confidence interval 1.04–2.86); 2nd/3rd, (OR 3.05 (1.68–5.53); and 2nd–6th measurements, (OR 2.58 (1.22–5.44). Nonhypertensive participants with a WCE were more likely to have a ssIAD on their first measurement (OR 3.82 (1.77 to −8.25) only. CONCLUSIONS ssIAD prevalence does not vary with ethnicity regardless of hypertensive status but is affected by the number of readings, suggesting the influence of WCE. Multiple readings should be used to confirm ssIADs.