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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., (© The European Society of Cardiology 2015.)

Introduction: Self-monitoring of blood pressure is effective in reducing blood pressure in hypertension. However previous meta-analyses have shown a considerable amount of heterogeneity between studies, only part of which can be accounted for by meta-regression. This may be due to differences in design, recruited populations, intervention components or results among patient subgroups. To further investigate these differences, an individual patient data (IPD) meta-analysis of self-monitoring of blood pressure will be performed., Methods and Analysis: We will identify randomised trials that have compared patients with hypertension who are self-monitoring blood pressure with those who are not and invite trialists to provide IPD including clinic and/or ambulatory systolic and diastolic blood pressure at baseline and all follow-up points where both intervention and control groups were measured. Other data requested will include measurement methodology, length of follow-up, cointerventions, baseline demographic (age, gender) and psychosocial factors (deprivation, quality of life), setting, intensity of self-monitoring, self-monitored blood pressure, comorbidities, lifestyle factors (weight, smoking) and presence or not of antihypertensive treatment. Data on all available patients will be included in order to take an intention-to-treat approach. A two-stage procedure for IPD meta-analysis, stratified by trial and taking into account age, sex, diabetes and baseline systolic BP will be used. Exploratory subgroup analyses will further investigate non-linear relationships between the prespecified variables. Sensitivity analyses will assess the impact of trials which have and have not provided IPD., Ethics and Dissemination: This study does not include identifiable data. Results will be disseminated in a peer-reviewed publication and by international conference presentations., Conclusions: IPD analysis should help the understanding of which self-monitoring interventions for which patient groups are most effective in the control of blood pressure., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Aims: Self-monitoring and self-titration of antihypertensives (self-management) is a novel intervention which improves blood pressure control. However, little evidence exists regarding the cost-effectiveness of self-monitoring of blood pressure in general and self-management in particular. This study aimed to evaluate whether self-management of hypertension was cost-effective., Design and Methods: A cohort Markov model-based probabilistic cost-effectiveness analysis was undertaken extrapolating to up to 35 years from cost and outcome data collected from the telemonitoring and self-management in hypertension trial (TASMINH2). Self-management of hypertension was compared with usual care in terms of lifetime costs, quality adjusted life years and cost-effectiveness using a UK Health Service perspective. Sensitivity analyses examined the effect of different time horizons and reduced effectiveness over time from self-management., Results: In the long-term, when compared with usual care, self-management was more effective by 0.24 and 0.12 quality adjusted life years (QALYs) gained per patient for men and women, respectively. The resultant incremental cost-effectiveness ratio for self-management was £1624 per QALY for men and £4923 per QALY for women. There was at least a 99% chance of the intervention being cost-effective for both sexes at a willingness to pay threshold of £20,000 per QALY gained. These results were robust to sensitivity analyses around the assumptions made, provided that the effects of self-management lasted at least two years for men and five years for women., Conclusion: Self-monitoring with self-titration of antihypertensives and telemonitoring of blood pressure measurements not only reduces blood pressure, compared with usual care, but also represents a cost-effective use of health care resources., (© The European Society of Cardiology 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

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.

Background: Self-monitoring with self-titration of antihypertensives leads to reduced blood pressure. Patients are keen on self-monitoring but little is known about healthcare professional views., Aim: To explore health professionals' views and experiences of patient self-management, particularly with respect to future implementation into routine care., Design and Setting: Qualitative study embedded within a randomised controlled trial of healthcare professionals participating in the TASMINH2 trial of patient self-monitoring with self-titration of antihypertensives from 24 West Midlands general practices., Method: Taped and transcribed semi-structured interviews with 13 GPs, two practice nurses and one healthcare assistant. Constant comparative method of analysis., Results: Primary care professionals were positive about self-monitoring, but procedures for ensuring patients measured blood pressure correctly were haphazard. GPs interpreted home readings variably, with many not making adjustment for lower home blood pressure. Interviewees were satisfied with patient training and arrangements for blood pressure monitoring and self-titration of medication during the trial, but less sure about future implementation into routine care. There was evidence of a need for training of both patients and professionals for successful integration of self-management., Conclusion: Health professionals wanted more patient involvement in hypertension care but needed a framework to work within. Consideration of how to train patients to measure blood pressure and how home readings become part of their care is required before self-monitoring and self-titration can be implemented widely. As home monitoring becomes more widespread, the development of patient self-management, including self-titration of medication, should follow but this may take time to achieve.

Background: Self-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/design: The 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., Discussion: The 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 Registration: ISRCTN87171227.

Background: Self-management of hypertension, comprising self-monitoring of blood pressure with self-titration of medication, improves blood pressure control, but little is known regarding the views of patients undertaking it., Aim: To explore patients' views of self-monitoring blood pressure and self-titration of antihypertensive medication., Design and Setting: Qualitative study embedded within the randomised controlled trial TASMINH2 (Telemonitoirng and Self Management in the Control of Hypertension) trial of patient self-management of hypertension from 24 general practices in the West Midlands., Method: Taped and transcribed semi-structured interviews with 23 intervention patients were used. Six family members were also interviewed. Analysis was by a constant comparative method., Results: Patients were confident about self-monitoring and many felt their multiple home readings were more valid than single office readings taken by their GP. Although many patients self-titrated medication when required, others lacked the confidence to increase medication without reconsulting with their GP. Patients were more comfortable with titrating medication if their blood pressure readings were substantially above target, but were reluctant to implement such a change if readings were borderline. Many planned to continue self-monitoring after the study finished and report home readings to their GP, but few wished to continue with a self-management plan., Conclusion: Participants valued the additional information and many felt confident in both self-monitoring blood pressure and self-titrating medication. The reluctance to change medication for borderline readings suggests behaviour similar to the clinical inertia seen for physicians in analogous circumstances. Additional support for those lacking in confidence to implement prearranged medication changes may allow more patients to undertake self-management.

Background: Control of blood pressure is a key component of cardiovascular disease prevention, but is difficult to achieve and until recently has been the sole preserve of health professionals. This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care., Methods: This randomised controlled trial was undertaken in 24 general practices in the UK. Patients aged 35-85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension. Participants were randomly assigned in a 1:1 ratio to self-management, consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs, combined with telemonitoring of home blood pressure measurements or to usual care. Randomisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex, baseline systolic blood pressure, and presence or absence of diabetes or chronic kidney disease. Neither participants nor investigators were masked to group assignment. The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point (6 months and 12 months). All randomised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis, without imputation for missing data. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN17585681., Findings: 527 participants were randomly assigned to self-management (n=263) or control (n=264), of whom 480 (91%; self-management, n=234; control, n=246) were included in the primary analysis. Mean systolic blood pressure decreased by 12.9 mm Hg (95% CI 10.4-15.5) from baseline to 6 months in the self-management group and by 9.2 mm Hg (6.7-11.8) in the control group (difference between groups 3.7 mm Hg, 0.8-6.6; p=0.013). From baseline to 12 months, systolic blood pressure decreased by 17.6 mm Hg (14.9-20.3) in the self-management group and by 12.2 mm Hg (9.5-14.9) in the control group (difference between groups 5.4 mm Hg, 2.4-8.5; p=0.0004). Frequency of most side-effects did not differ between groups, apart from leg swelling (self-management, 74 patients [32%]; control, 55 patients [22%]; p=0.022)., Interpretation: Self-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care., Funding: Department of Health Policy Research Programme, National Coordinating Centre for Research Capacity Development, and Midlands Research Practices Consortium., (Copyright 2010 Elsevier Ltd. All rights reserved.)

Introduction: Self-monitoring of blood pressure (BP) is an increasingly common part of hypertension management. The objectives of this systematic review were to evaluate the systolic and diastolic BP reduction, and achievement of target BP, associated with self-monitoring., Methods: MEDLINE, Embase, Cochrane database of systematic reviews, database of abstracts of clinical effectiveness, the health technology assessment database, the NHS economic evaluation database, and the TRIP database were searched for studies where the intervention included self-monitoring of BP and the outcome was change in office/ambulatory BP or proportion with controlled BP. Two reviewers independently extracted data. Meta-analysis using a random effects model was combined with meta-regression to investigate heterogeneity in effect sizes., Results: A total of 25 eligible randomized controlled trials (RCTs) (27 comparisons) were identified. Office systolic BP (20 RCTs, 21 comparisons, 5,898 patients) and diastolic BP (23 RCTs, 25 comparisons, 6,038 patients) were significantly reduced in those who self-monitored compared to usual care (weighted mean difference (WMD) systolic -3.82 mmHg (95% confidence interval -5.61 to -2.03), diastolic -1.45 mmHg (-1.95 to -0.94)). Self-monitoring increased the chance of meeting office BP targets (12 RCTs, 13 comparisons, 2,260 patients, relative risk = 1.09 (1.02 to 1.16)). There was significant heterogeneity between studies for all three comparisons, which could be partially accounted for by the use of additional co-interventions., Conclusion: Self-monitoring reduces blood pressure by a small but significant amount. Meta-regression could only account for part of the observed heterogeneity.

Background: Controlling blood pressure with drugs is a key aspect of cardiovascular disease prevention, but until recently has been the sole preserve of health professionals. Self-management of hypertension is an under researched area in which potential benefits for both patients and professionals are great., Methods and Design: The telemonitoring and self-management in hypertension trial (TASMINH2) will be a primary care based randomised controlled trial with embedded economic and qualitative analyses in order to evaluate the costs and effects of increasing patient involvement in blood pressure management, specifically with respect to home monitoring and self titration of antihypertensive medication compared to usual care. Provision of remote monitoring results to participating practices will ensure that practice staff are able to engage with self management and provide assistance where required. 478 patients will be recruited from general practices in the West Midlands, which is sufficient to detect clinically significant differences in systolic blood pressure between self-management and usual care of 5 mmHg with 90% power. Patients will be excluded if they demonstrate an inability to self monitor, their blood pressure is below 140/90 or above 200/100, they are on three or more antihypertensive medications, have a terminal disease or their blood pressure is not managed by their general practitioner. The primary end point is change in mean systolic blood pressure (mmHg) between baseline and each follow up point (6 months and 12 months). Secondary outcomes will include change in mean diastolic blood pressure, costs, adverse events, health behaviours, illness perceptions, beliefs about medication, medication compliance and anxiety. Modelling will evaluate the impact of costs and effects on a system wide basis. The qualitative analysis will draw upon the views of users, informal carers and professionals regarding the acceptability of self-management and prerequisites for future widespread implementation should the trial show this approach to be efficacious., Discussion: The TASMINH2 trial will provide important new evidence regarding the costs and effects of self monitoring with telemonitoring in a representative primary care hypertensive population.