Fidelity to and utility of a home blood pressure self-monitoring regime in people with pre-hypertension: results from the REVERSE study.

INTRODUCTION: Around 40% of adults have pre-hypertension (120-139/80-89mmHg) increasing their risk of developing hypertension and associated cardiovascular conditions. Guidance on pre-hypertension management focuses on improving lifestyle. Self-monitoring may improve awareness and understanding of blood pressure (BP) for people with pre-hypertension, allowing them to modify their lifestyle risks. AIM: To determine the fidelity to and utility of a home BP self-monitoring regime in people with pre-hypertension. METHOD: This sub-study is part of a larger prospective, non-randomised feasibility study. Individuals with pre-hypertension were identified via GP records and pharmacy NHS Health Checks in Northwest England. Participants received training for home BP self-monitoring. They were asked to complete two readings (leaving a 5-minute interval) on the first three days of the month for six months, colour-code their readings and take action using a simple algorithm, then send them to the research team within 7 days. RESULTS: Eighty participants (aged 40-79, mean=59) enrolled. The majority were female (n=45, 56%), White British (n=79, 99%), and had not previously monitored their BP (n=55, 69%). Seventy-five (94%) participants completed the training. Sixty-one (81%) received online training and 14 (19%) opted for a face-to-face session. Sixty-one (81%) completed all six months of readings, 51 (68%) also returned them on time. All in-person training participants completed all six months of readings on time. Reasons for non-compliance to the protocol included battery issues, forgetting, and struggling to find a consistent time for readings. CONCLUSION: Home BP self-monitoring can be feasible and easily implementable for people with pre-hypertension - however, some barriers were identified.

Non-pharmacological interventions for the reduction and maintenance of blood pressure in people with prehypertension: a systematic review protocol.

INTRODUCTION: Prehypertension is defined as blood pressure that is above the normal range but not high enough to be classed as hypertension. Prehypertension is a warning of development of hypertension as well as a risk for cardiovascular disease, heart attack and stroke. In the UK, non-pharmacological interventions are recommended for prehypertension management but no reviews have focused on the effectiveness of these types of interventions solely in people with prehypertension. Therefore, the proposed systematic review will assess the clinical effectiveness and cost-effectiveness of non-pharmacological interventions in reducing or maintaining blood pressure in prehypertensive people. METHODS AND ANALYSIS: This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The databases/trial registries that will be searched to identify relevant randomised controlled trials (RCTs) and economic evaluations include Medline, EMBASE, CINAHL, PsycINFO, CENTRAL, the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, Cochrane Library, Scopus and the International HTA Database. Search terms have been identified by the team including an information specialist. Three reviewers will be involved in the study selection process. Risk of bias will be evaluated using the Cochrane risk-of-bias tool for RCTs and the Consensus Health Economic Criteria list for economic evaluations. Findings from the included studies will be tabulated and synthesised narratively. Heterogeneity will be assessed through visual inspection of forest plots and the calculation of the χ2 and I2 statistics and causes of heterogeneity will be assessed where sufficient data are available. If possible, we plan to investigate differential effects on specific subgroups and from different types of interventions using meta-regression. Where relevant, the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) will be used to assess the certainty of the evidence found. ETHICS AND DISSEMINATION: Ethical approval is not needed. Results will be published in a peer-reviewed journal, disseminated via the wider study website and shared with the study sites and participants. REGISTRATION DETAILS: The review is registered with PROSPERO (CRD420232433047).

Psychological interventions for weight reduction and sustained weight reduction in adults with overweight and obesity: a scoping review protocol.

INTRODUCTION: Overweight and obesity are growing public health problems worldwide. Both diet and physical activity have been the primary interventions for weight reduction over the past decade. With increasing rates of overweight and obesity, it is evident that a primary focus on diet and exercise has not resulted in sustained obesity reduction within the global population. There is now a case to explore other weight management strategies, focusing on psychological factors that may underpin overweight and obesity. Psychological therapy interventions are gaining recognition for their effectiveness in addressing underlying emotional factors and promoting weight loss. However, there is a dearth of literature that has mapped the types of psychological interventions and the characteristics of these interventions as a means of achieving weight reduction and sustained weight reduction in adults with overweight or obesity. METHODS AND ANALYSIS: The review will combine the methodology outlined by Arksey and O'Malley with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A total of six databases will be searched using a comprehensive search strategy. Intervention studies will be included if participants are 18 years and over, classified as overweight or obese (body mass index ≥25 kg/m2), and have received a psychological therapy intervention. The review will exclude studies that are not available in English, not full text, none peer reviewed or combine a lifestyle and/or pharmacological intervention with a psychological intervention. Data will be synthesised using a narrative synthesis approach. ETHICS AND DISSEMINATION: Ethical approval is not required to conduct this scoping review. The findings will be disseminated through journal publication(s), social media and a lay summary for key stakeholders.

Risk reduction intervention for raised blood pressure (REVERSE): protocol for a mixed-methods feasibility study.

INTRODUCTION: Around 40% of adults have pre-hypertension (blood pressure between 120-139/80-89), meaning they are at increased risk of developing hypertension and other cardiovascular disease-related conditions. There are limited studies on the management of pre-hypertension; however, guidance recommends that it should be focused on lifestyle modification rather than on medication. Self-monitoring of blood pressure could allow people to monitor and manage their risk status and may allow individuals to modify lifestyle factors. The purpose of this study is to determine the feasibility and acceptability, to both healthcare professionals and people with pre-hypertension, of blood pressure self-monitoring. METHODS AND ANALYSIS: A prospective, non-randomised feasibility study, with a mixed-methods approach will be employed. Eligible participants (n=114) will be recruited from general practices, pharmacies and community providers across Lancashire and South Cumbria. Participants will self-monitor their blood pressure at home for 6 months and will complete questionnaires at three timepoints (baseline, 6 and 12 months). Healthcare professionals and participants involved in the study will be invited to take part in follow-up interviews and a focus group. The primary outcomes include the willingness to engage with the concept of pre-hypertension, the acceptability of self-monitoring, and the study processes. Secondary outcomes will inform the design of a potential future trial. A cost-analysis and cost-benefit analysis will be conducted. ETHICS AND DISSEMINATION: Ethics approval has been obtained from London-Fulham NHS Research Ethics Committee, the University of Central Lancashire Health Ethics Review Panel and the HRA. The results of the study will be disseminated via peer-reviewed publications, feedback to service users and healthcare professionals, and to professional bodies in primary care and pharmacy. TRIAL REGISTRATION NUMBER: ISRCTN13649483.

Factors influencing implementation of aerobic exercise after stroke: a systematic review.

OBJECTIVES: This systematic review aimed to explore the perspectives of healthcare, exercise, and fitness professionals working with people post-stroke regarding the factors affecting the implementation of aerobic exercise after stroke. DATA SOURCES: OVID SP MEDLINE, OVID SP EMBASE, and CINAHL were searched from inception to December 2018 using a combination of search terms with synonyms of stroke, aerobic exercise and barriers/facilitators. REVIEW METHODS: Studies focusing on the factors affecting implementation of aerobic exercise after stroke from staff perspectives were included with no restriction on the types of study design. For inclusivity, a broad definition of aerobic exercise was used. Review authors independently extracted data from included studies using domains from the Consolidated Framework for Implementation Research, then synthesised using a framework synthesis approach. Retrospective automated screening was conducted using Rayyan software. RESULTS: Twenty studies were included. Four reported on implementation of aerobic exercise, sixteen on general exercise interventions, all post-stroke. Factors identified as influencing implementation of aerobic exercise after stroke included professionals' self-efficacy and knowledge about stroke, patients' needs, communication and collaboration within and between organisations and resources such as equipment, staff and training. CONCLUSIONS: Key factors influencing the implementation of aerobic exercise after stroke included characteristics of the staff and intervention and system-level issues, some of which are modifiable. Further research should evaluate strategies which specifically target these modifiable factors to facilitate implementation in practice.IMPLICATIONS FOR REHABILITATIONAerobic exercise after stroke is an effective intervention but there are challenges to implementation from a staff and system perspective.Any changes to the identified factors should be tailored to suit the staff group and setting.Provision of training and knowledge-sharing could improve staff's confidence in the prescription and delivery of aerobic exercise after stroke though other implementation strategies should also be considered.

Etiologic Workup in Cases of Cryptogenic Stroke: A Systematic Review of International Clinical Practice Guidelines.

Background and Purpose- Identifying the etiology of acute ischemic stroke is essential for effective secondary prevention. However, in at least one third of ischemic strokes, existing investigative protocols fail to determine the underlying cause. Establishing etiology is complicated by variation in clinical practice, often reflecting preferences of treating clinicians and variable availability of investigative techniques. In this review, we systematically assess the extent to which there exists consensus, disagreement, and gaps in clinical practice recommendations on etiologic workup in acute ischemic stroke. Methods- We identified clinical practice guidelines/consensus statements through searches of 4 electronic databases and hand-searching of websites/reference lists. Two reviewers independently assessed reports for eligibility. We extracted data on report characteristics and recommendations relating to etiologic workup in acute ischemic stroke and in cases of cryptogenic stroke. Quality was assessed using the AGREE II tool (Appraisal of Guidelines for Research & Evaluation). Recommendations were synthesized according to a published algorithm for diagnostic evaluation in cryptogenic stroke. Results- We retrieved 16 clinical practice guidelines and 7 consensus statements addressing acute stroke management (n=12), atrial fibrillation (n=5), imaging (n=5), and secondary prevention (n=1). Five reports were of overall high quality. For all patients, guidelines recommended routine brain imaging, noninvasive vascular imaging, a 12-lead ECG, and routine blood tests/laboratory investigations. Additionally, ECG monitoring (>24 hours) was recommended for patients with suspected embolic stroke and echocardiography for patients with suspected cardiac source. Three reports recommended investigations for rarer causes of stroke. None of the reports provided guidance on the extent of investigation needed before classifying a stroke as cryptogenic. Conclusions- While consensus exists surrounding standard etiologic workup, there is little agreement on more advanced investigations for rarer causes of acute ischemic stroke. This gap in guidance, and in the underpinning evidence, demonstrates missed opportunities to better understand and protect against ongoing stroke risk. Registration- URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019127822.

Etiologic workup in cases of cryptogenic stroke: protocol for a systematic review and comparison of international clinical practice guidelines.

BACKGROUND: Stroke is a leading cause of death and disability worldwide. Identifying the aetiology of ischaemic stroke is essential in order to initiate appropriate and timely secondary prevention measures to reduce the risk of recurrence. For the majority of ischaemic strokes, the aetiology can be readily identified, but in at least 30% of cases, the exact aetiology cannot be determined using existing investigative protocols. Such strokes are classed as 'cryptogenic' or as a stroke of unknown origin. However, there exists substantial variation in clinical practice when investigating cases of seemingly cryptogenic stroke, often reflecting local service availability and the preferences of treating clinicians. This variation in practice is compounded by the lack of international consensus as to the optimum level and timing of investigations required following a stroke. To address this gap, we aim to systematically review and compare recommendations in evidence-based clinical practice guidelines (CPGs) that relate to the assessment and investigation of the aetiology of ischaemic stroke, and any subsequent diagnosis of cryptogenic stroke. METHOD: We will search for CPGs using electronic databases (MEDLINE, Health Management Information Consortium (HMIC), EMBASE, and CINAHL), relevant websites and search engines (e.g. guideline specific websites, governmental, charitable, and professional practice organisations) and hand-searching of bibliographies and reference lists. Two reviewers will independently screen titles, abstracts and CPGs using a pre-defined relevance criteria form. From each included CPG, we will extract definitions and terms for cryptogenic stroke; recommendations related to assessment and investigation of the aetiology of stroke, including the grade of recommendations and underpinning evidence. The quality of the included CPGs will be assessed using the AGREE II (Appraisal of Guidelines for Research and Evaluation) tool. Recommendations across the CPGs will be summarised descriptively highlighting areas of convergence and divergence between CPGs. DISCUSSION: To our knowledge, this will be the first review to systematically compare recommendations of international CPGs on investigating the aetiology of ischaemic stroke. The findings will allow for a better understanding of international perspectives on the optimum level of investigations required following a stroke and thus contribute to achieving greater international consensus on best practice in this important and complex area. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019127822.

Schedules for Self-monitoring Blood Pressure: A Systematic Review.

BACKGROUND: Self-monitoring of blood pressure better predicts prognosis than clinic measurement, is popular with patients, and endorsed in hypertension guidelines. However, there is uncertainty over the optimal self-monitoring schedule. We therefore aimed to determine the optimum schedule to predict future cardiovascular events and determine "true" underlying blood pressure. METHODS: Six electronic databases were searched from November 2009 (updating a National Institute for Health and Care Excellence [NICE] systematic review) to April 2017. Studies that compared aspects of self-monitoring schedules to either prognosis or reliability/reproducibility in hypertensive adults were included. Data on study and population characteristics, self-monitoring regime, and outcomes were extracted by 2 reviewers independently. RESULTS: From 5,164 unique articles identified, 25 met the inclusion criteria. Twelve studies were included from the original NICE review, making a total of 37 studies. Increasing the number of days of measurement improved prognostic power: 72%-91% of the theoretical maximum predictive value (asymptotic maximum hazard ratio) was reached by 3 days and 86%-96% by 7 days. Increasing beyond 3 days of measurement did not result in better correlation with ambulatory monitoring. There was no convincing evidence that the timing or number of readings per day had an effect, or that ignoring the first day's measurement was necessary. CONCLUSIONS: Home blood pressure should be measured for 3 days, increased to 7 only when mean blood pressure is close to a diagnostic or treatment threshold. Other aspects of a monitoring schedule can be flexible to facilitate patient uptake of and adherence with self-monitoring.

Do patients actually do what we ask: patient fidelity and persistence to the Targets and Self-Management for the Control of Blood Pressure in Stroke and at Risk Groups blood pressure self-management intervention.

OBJECTIVE: Self-management of hypertension can reduce and control blood pressure (BP) compared with clinic monitoring. However, self-management relies on patients following an algorithm, which may be variably adhered to. This study reports fidelity of high-risk patients to the self-management algorithm set by the TASMIN-SR trial. METHODS: Patients with hypertension, above target clinic BP and one or more of stroke, diabetes, coronary heart disease or chronic kidney disease, were invited to self-monitor following an individualized self-titration algorithm. Home BP readings and medication change details were submitted monthly for 12 months. Readings downloaded from patients' electronic monitors were compared with written submissions, and protocol fidelity was assessed. RESULTS: Two hundred and seventy-six patients were randomized to self-management and 225 (82%) completed the required training sessions. Of these, 166 (74%) completed self-management. A total of 11385 (89.6%) submitted readings were accurate compared with corresponding downloaded monitor readings. Mean error rate was 5.2% per patient, which increased with age but not comorbidities. Patients made 475 of 683 (69.5%) algorithm-recommended medication changes, equating to nearly three medication changes per patient. Mean SBP for patients who completed training and made all recommended changes dropped from 141 mmHg (95% CI 138.26-144.46) to 121 mmHg (95% CI 118.30-124.17 mmHg) compared with 129 mmHg (95% CI 125.27-136.73 mmHg) for patients who made none. CONCLUSION: Most patients randomized to self-management completed training; however, 36% of these had dropped out by 12 months. Self-monitoring was largely undertaken properly and accurately recorded. Fidelity with self-management was associated with lower achieved SBP. Successful implementation of self-management into daily practice requires careful training and should be accompanied by monitoring of fidelity.

Self-monitoring of blood pressure in hypertension: A systematic review and individual patient data meta-analysis.

BACKGROUND: Self-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension. METHODS AND FINDINGS: Medline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (June 2016). Two reviewers independently assessed articles for eligibility and the authors of eligible trials were approached requesting IPD. Of 2,846 articles in the initial search, 36 were eligible. IPD were provided from 25 trials, including 1 unpublished study. Data for the primary outcomes-change in mean clinic or ambulatory BP and proportion controlled below target at 12 months-were available from 15/19 possible studies (7,138/8,292 [86%] of randomised participants). Overall, self-monitoring was associated with reduced clinic systolic blood pressure (sBP) compared to usual care at 12 months (-3.2 mmHg, [95% CI -4.9, -1.6 mmHg]). However, this effect was strongly influenced by the intensity of co-intervention ranging from no effect with self-monitoring alone (-1.0 mmHg [-3.3, 1.2]), to a 6.1 mmHg (-9.0, -3.2) reduction when monitoring was combined with intensive support. Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg. No differences in efficacy were seen by sex or by most comorbidities. Ambulatory BP data at 12 months were available from 4 trials (1,478 patients), which assessed self-monitoring with little or no co-intervention. There was no association between self-monitoring and either lower clinic or ambulatory sBP in this group (clinic -0.2 mmHg [-2.2, 1.8]; ambulatory 1.1 mmHg [-0.3, 2.5]). Results for diastolic blood pressure (dBP) were similar. The main limitation of this work was that significant heterogeneity remained. This was at least in part due to different inclusion criteria, self-monitoring regimes, and target BPs in included studies. CONCLUSIONS: Self-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counselling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions.

BKV-specific T cells in the treatment of severe refractory haemorrhagic cystitis after HLA-haploidentical haematopoietic cell transplantation.

BACKGROUND: Haemorrhagic cystitis caused by BK virus (BKV) is a known complication of allogeneic haematopoietic cell transplantation (HCT) and is relatively common following HLA-haploidentical transplantation. Adoptive immunotransfer of virus-specific T cells from the donor is a promising therapeutic approach, although production of these cells is challenging, particularly when dealing with low-frequency T cells such as BKV-specific T cells. CASE REPORT: Here, we present a patient who, following haploidentical HCT, developed severe BKV haemorrhagic cystitis, resistant to standard therapy. He responded well to adoptive transfer of donor cells enriched in BKV-specific T cells using the new second-generation CliniMACS Prodigy and the Cytokine Capture System from Miltenyi Biotec. Treatment led to full resolution of both the symptoms and viraemia without unwanted complications. CONCLUSION: Our observations suggest that use of products enriched with BKV-specific T cells generated using this system is safe and efficient in HLA-haploidentical HCT where BKV cystitis can be a serious complication.

What Drives Responses to Willingness-to-pay Questions? A Methodological Inquiry in the Context of Hypertension Self-management.

Background: The use of economic evaluation to determine the cost-effectiveness of health interventions is recommended by decision-making bodies internationally. Understanding factors that explain variations in costs and benefits is important for policy makers. Objective: This work aimed to test a priori hypotheses defining the relationship between benefits of using self-management equipment (measured using the willingness-to-pay (WTP) approach) and a number of demographic and other patient factors. Methods: Data for this study were collected as part of the first major randomised controlled trial of self-monitoring combined with self-titration in hypertension (TASMINH2). A contingent valuation framework was used with patients asked to indicate how much they were willing to pay for equipment used for self-managing hypertension. Descriptive statistics, simple statistical tests of differences and multivariate regression were used to test six a priori hypotheses. Results: 393 hypertensive patients (204 in the intervention and 189 in the control) were willing to pay for self-management equipment and 85% of these (335) provided positive WTP values. Three hypotheses were accepted: higher WTP values were associated with being male, higher household incomes and satisfaction with the equipment. Prior experiences of using this equipment, age and changes in blood pressure were not significantly related to WTP. Conclusion: The majority of hypertensive patients who had taken part in a self-management study were prepared to purchase the self-monitoring equipment using their own funds, more so for men, those with higher incomes and those with greater satisfaction. Further research based on bigger and more diverse populations is recommended.

Self-monitoring blood pressure in patients with hypertension: an internet-based survey of UK GPs.

BACKGROUND: Previous research suggests that most GPs in the UK use self-monitoring of blood pressure (SMBP) to monitor the control of hypertension rather than for diagnosis. This study sought to assess current practice in the use of self-monitoring and any changes in practice following more recent guideline recommendations. AIM: To survey the views and practice of UK GPs in 2015 with regard to SMBP and compare them with a previous survey carried out in 2011. DESIGN AND SETTING: Web-based survey of a regionally representative sample of 300 UK GPs. METHOD: GPs completed an online questionnaire concerning the use of SMBP in the management of hypertension. Analyses comprised descriptive statistics, tests for between-group differences (z, Wilcoxon signed-rank, and χ2 tests), and multivariate logistic regression. RESULTS: Results were available for 300 GPs (94% of those who started the survey). GPs reported using self-monitoring to diagnose hypertension (169/291; 58%; 95% confidence interval (CI) = 52 to 64) and to monitor control (245/291; 84%; 95% CI = 80 to 88), the former having significantly increased since 2011 (from 37%; 95% CI = 33 to 41; P<0.001) with no change in monitoring for control. More than half of GPs used higher systolic thresholds for diagnosis (118/169; 70%; 95% CI = 63 to 77) and treatment (168/225; 75%; 95% CI = 69 to 80) than recommended in guidelines, and under half (120/289; 42%; 95% CI = 36 to 47) adjusted the SMBP results to guide treatment decisions. CONCLUSION: Since new UK national guidance in 2011, GPs are more likely to use SMBP to diagnose hypertension. However, significant proportions of GPs continue to use non-standard diagnostic and monitoring thresholds. The use of out-of-office methods to improve the accuracy of diagnosis is unlikely to be beneficial if suboptimal thresholds are used.

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.

Individual patient data meta-analysis of self-monitoring of blood pressure (BP-SMART): a protocol.

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.

Predicting out-of-office blood pressure level using repeated measurements in the clinic: an observational cohort study.

OBJECTIVES: Identification of people with lower (white-coat effect) or higher (masked effect) blood pressure at home compared to the clinic usually requires ambulatory or home monitoring. This study assessed whether changes in SBP with repeated measurement at a single clinic predict subsequent differences between clinic and home measurements. METHODS: This study used an observational cohort design and included 220 individuals aged 35-84 years, receiving treatment for hypertension, but whose SBP was not controlled. The characteristics of change in SBP over six clinic readings were defined as the SBP drop, the slope and the quadratic coefficient using polynomial regression modelling. The predictive abilities of these characteristics for lower or higher home SBP readings were investigated with logistic regression and repeated operating characteristic analysis. RESULTS: The single clinic SBP drop was predictive of the white-coat effect with a sensitivity of 90%, specificity of 50%, positive predictive value of 56% and negative predictive value of 88%. Predictive values for the masked effect and those of the slope and quadratic coefficient were slightly lower, but when the slope and quadratic variables were combined, the sensitivity, specificity, positive and negative predictive values for the masked effect were improved to 91, 48, 24 and 97%, respectively. CONCLUSION: Characteristics obtainable from multiple SBP measurements in a single clinic in patients with treated hypertension appear to reasonably predict those unlikely to have a large white-coat or masked effect, potentially allowing better targeting of out-of-office monitoring in routine clinical practice.

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.

Telemonitoring and self-management in the control of hypertension (TASMINH2): a cost-effectiveness analysis.

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.

Patient self-monitoring of blood pressure and self-titration of medication in primary care: the TASMINH2 trial qualitative study of health professionals' experiences.

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.

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

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.