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OBJECTIVES: Evidence to support initiation of pharmacological treatment in patients with uncomplicated (low risk) mild hypertension is inconclusive. As such, clinical guidelines are contradictory and healthcare policy has changed regularly. The aim of this study was to determine the incidence of lifestyle advice and drug therapy in this population and whether secular trends were associated with policy changes. DESIGN: Longitudinal cohort study. SETTING: Primary care practices contributing to the Clinical Practice Research Datalink in England. PARTICIPANTS: Data were extracted from the linked electronic health records of patients aged 18-74 years, with stage 1 hypertension (blood pressure between 140/90 and 159/99 mm Hg), no cardiovascular disease (CVD) risk factors and no treatment, from 1998 to 2015. Patients exited if follow-up records became unavailable, they progressed to stage 2 hypertension, developed a CVD risk factor or received lifestyle advice/treatment. PRIMARY OUTCOME MEASURES: The association between policy changes and incidence of lifestyle advice or treatment, examined using an interrupted time-series analysis. RESULTS: A total of 108 843 patients were defined as having uncomplicated mild hypertension (mean age 51.9±12.9 years, 60.0% female). Patientsspent a median 2.6 years (IQR 0.9-5.5) in the study, after which 12.2% (95% CI 12.0% to 12.4%) were given lifestyle advice, 29.9% (95% CI 29.7% to 30.2%) were prescribed medication and 19.4% (95% CI 19.2% to 19.6%) were given both. The introduction of the quality outcomes framework (QOF) and subsequent changes to QOF indicators were followed by significant increases in the incidence of lifestyle advice. Treatment prescriptions decreased slightly over time, but were not associated with policy changes. CONCLUSIONS: Despite secular trends that accord with UK guidance, many patients are still prescribed treatment for mild hypertension. Adequately powered studies are needed to determine if this is appropriate.

Supplemental Digital Content is available in the text., Patients often have lower (white coat effect) or higher (masked effect) ambulatory/home blood pressure readings compared with clinic measurements, resulting in misdiagnosis of hypertension. The present study assessed whether blood pressure and patient characteristics from a single clinic visit can accurately predict the difference between ambulatory/home and clinic blood pressure readings (the home–clinic difference). A linear regression model predicting the home–clinic blood pressure difference was derived in 2 data sets measuring automated clinic and ambulatory/home blood pressure (n=991) using candidate predictors identified from a literature review. The model was validated in 4 further data sets (n=1172) using area under the receiver operator characteristic curve analysis. A masked effect was associated with male sex, a positive clinic blood pressure change (difference between consecutive measurements during a single visit), and a diagnosis of hypertension. Increasing age, clinic blood pressure level, and pulse pressure were associated with a white coat effect. The model showed good calibration across data sets (Pearson correlation, 0.48–0.80) and performed well-predicting ambulatory hypertension (area under the receiver operator characteristic curve, 0.75; 95% confidence interval, 0.72–0.79 [systolic]; 0.87; 0.85–0.89 [diastolic]). Used as a triaging tool for ambulatory monitoring, the model improved classification of a patient’s blood pressure status compared with other guideline recommended approaches (93% [92% to 95%] classified correctly; United States, 73% [70% to 75%]; Canada, 74% [71% to 77%]; United Kingdom, 78% [76% to 81%]). This study demonstrates that patient characteristics from a single clinic visit can accurately predict a patient’s ambulatory blood pressure. Usage of this prediction tool for triaging of ambulatory monitoring could result in more accurate diagnosis of hypertension and hence more appropriate treatment.

BackgroundEthnicity, along with a variety of genetic and environmental factors, is thought to influence the efficacy of antihypertensive therapies. Current UK guidelines use a “black versus white” approach; in doing so, they ignore the United Kingdom's largest ethnic minority: Asians from South Asia.Study designThe primary purpose of the AIM-HY INFORM trial is to identify potential differences in response to antihypertensive drugs used as mono- or dual therapy on the basis of self-defined ethnicity. A multicenter, prospective, open-label, randomized study with 2 parallel, independent trial arms (mono- and dual therapy), AIM-HY INFORM plans to enroll a total of 1,320 patients from across the United Kingdom. Those receiving monotherapy (n = 660) will enter a 3-treatment (amlodipine 10 mg od; lisinopril 20 mg od; chlorthalidone 25 mg od), 3-period crossover, lasting 24 weeks, whereas those receiving dual therapy (n = 660) will enter a 4-treatment (amlodipine 5 mg od and lisinopril 20 mg od; amlodipine 5 mg od and chlorthalidone 25 mg od; lisinopril 20 mg od and chlorthalidone 25 mg od; amiloride 10 mg od and chlorthalidone 25 mg od), 4-period crossover, lasting 32 weeks. Equal numbers of 3 ethnic groups (white, black/black British, and Asian/Asian British) will ultimately be recruited to each of the trial arms (ie, 220 participants per ethnic group per arm). Seated, automated, unattended, office, systolic blood pressure measured 8 weeks after each treatment period begins will serve as the primary outcome measure.ConclusionAIM-HY INFORM is a prospective, open-label, randomized trial which aims to evaluate first- and second-line antihypertensive therapies for multiethnic populations.

Importance: Evidence to support initiation of pharmacological treatment in patients with low-risk mild hypertension is inconclusive, with previous trials underpowered to demonstrate benefit. Clinical guidelines across the world are contradictory. Objective: Use electronic health records to examine whether treatment is safe and effective at reducing the risk of mortality and cardiovascular disease in low-risk mild hypertensives. Design: Longitudinal cohort study. Setting: Linked electronic health records from primary and secondary care in England. Participants: Data were extracted from patients in the Clinical Practice Research Datalink, between 1998-2015, aged 18-74 years, with mild hypertension (untreated blood pressure between 140/90-159/99mmHg) and no previous treatment. Anyone with a history of cardiovascular disease (CVD) or CVD risk factors was excluded. Patients exited the cohort if follow-up records became unavailable or they experienced an outcome of interest. Exposures: Prescription of antihypertensive medication. Propensity scores predicting likelihood of treatment were constructed using a logistic regression model. Individuals treated within 12 months of diagnosis were matched to untreated patients by propensity score using the nearest neighbour method. Main Outcome(s) and Measure(s): The rate of mortality, cardiovascular disease and adverse events in patients prescribed antihypertensive treatment at baseline, compared to those not, using Cox regression. Results: A total of 19,143 treated patients (mean age 54.7±11.8 years, 55.9% female) were matched to 19,143 similar untreated patients. During a median follow-up period of 5.8 years, no evidence of an association was found between antihypertensive treatment and mortality (HR 1.02, 95%CI 0.88-1.17), CVD (HR 1.09, 95%CI 0.95-1.25) or any individual cardiovascular disease endpoints. Treatment was associated with an increased risk of adverse events including hypotension (HR 1.69, 95%CI 1.30-2.20, NNH10=41), syncope (HR 1.28, 95%CI 1.10-1.50, NNH10=35), electrolyte abnormalities (HR 1.72, 95%CI 1.12-2.65, NNH10=111) and acute kidney injury (HR 1.37, 95%CI 1.00-1.88, NNH10=91).

OBJECTIVE: To prospectively validate the Predicting Out-of-OFfice Blood Pressure (PROOF-BP) algorithm to triage patients with suspected high blood pressure for ambulatory blood pressure monitoring (ABPM) in routine clinical practice. DESIGN: Prospective observational cohort study. SETTING: 10 primary care practices and one hospital in the UK. PARTICIPANTS: 887 consecutive patients aged 18 years or more referred for ABPM in routine clinical practice. All underwent ABPM and had the PROOF-BP applied. MAIN OUTCOME MEASURES: The main outcome was the proportion of participants whose hypertensive status was correctly classified using the triaging strategy compared with the reference standard of daytime ABPM. Secondary outcomes were the sensitivity, specificity, and area under the receiver operator characteristic curve (AUROC) for detecting hypertension. RESULTS: The mean age of participants was 52.8 (16.2) years. The triaging strategy correctly classified hypertensive status in 801 of the 887 participants (90%, 95% confidence interval 88% to 92%) and had a sensitivity of 97% (95% confidence interval 96% to 98%) and specificity of 76% (95% confidence interval 71% to 81%) for hypertension. The AUROC was 0.86 (95% confidence interval 0.84 to 0.89). Use of triaging, rather than uniform referral for ABPM in routine practice, would have resulted in 435 patients (49%, 46% to 52%) being referred for ABPM and the remainder managed on the basis of their clinic measurements. Of these, 69 (8%, 6% to 10%) would have received treatment deemed unnecessary had they received ABPM. CONCLUSIONS: In a population of patients referred for ABPM, this new triaging approach accurately classified hypertensive status for most, with half the utilisation of ABPM compared with usual care. This triaging strategy can therefore be recommended for diagnosis or management of hypertension in patients where ABPM is being considered, particularly in settings with limited resources.

Objectives: Triaging patients with suspected high blood pressure for ambulatory blood pressure monitoring (ABPM), on the basis of their clinic blood pressure and characteristics, may reduce the need for ABPM. This study aimed to prospectively validate this new approach using data from routine practice.Design: Prospective observational cohort study.Setting: Ten primary care practices and one hospital in the UK. Participants: Consecutive patients aged >18 years referred for ABPM in routine practice.Interventions: All patients underwent ABPM and had the new triage algorithm (PROOF-BP) applied. Main outcome measures: Proportion correctly classified with hypertension using the triaging strategy compared to the reference standard of daytime ABPM. Sensitivity, specificity and area under the receiver operator characteristic curve (AUROC) for detecting hypertension.Results: A total of 887 patients (mean age 52.8±16.2 years) were referred for ABPM and enrolled during the study period. The triaging strategy correctly classified hypertensive status in 801 patients (90%, 95% CI 88% to 92%) and had a sensitivity of 97% (95% CI 96% to 99%) and specificity of 76% (95% CI 71% to 81%) for hypertension. The AUROC was 0.86 (95% CI 0.84 to 0.89). Use of triaging, rather than uniform referral for ABPM in routine practice would have resulted in 435 patients (49%, 95% CI 46% to 52%) being referred for ABPM and the remainder managed on the basis of their clinic measurements. Of these, 69 (8%, 95% CI 6% to 10%) would have received treatment that would have been deemed unnecessary had they received ABPM. Conclusions: In a population of patients referred for ABPM, this new triaging approach accurately classified hypertensive status for most, with half the utilisation of ABPM compared with usual care. This triaging strategy can therefore be recommended for diagnosis or management of hypertension in patients where ABPM is being considered, particularly in settings where resources may be limited.

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost-utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability.

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOC 137 kb)

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost–utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability.

BACKGROUND: Self-monitoring of hypertension is associated with lower systolic blood pressure (SBP). However, evidence for the use of self-monitoring to titrate antihypertensive medication by physicians is equivocal. Furthermore, there is some evidence for the efficacy of telemonitoring in the management of hypertension but it is not clear what this adds over and above self-monitoring. This trial aims to evaluate whether GP led antihypertensive titration using self-monitoring results in lower SBP compared to usual care and whether telemonitoring adds anything to self-monitoring alone. METHODS/DESIGN: This will be a pragmatic primary care based, unblinded, randomised controlled trial of self-monitoring of BP with or without telemonitoring compared to usual care. Eligible patients will have poorly controlled hypertension (>140/90 mmHg) and will be recruited from primary care. Participants will be individually randomised to either usual care, self-monitoring alone, or self-monitoring with telemonitoring. The primary outcome of the trial will be difference in clinic SBP between intervention and control groups at 12 months adjusted for baseline SBP, gender, BP target and practice. At least 1110 patients will be sufficient to detect a difference in SBP between self-monitoring with or without telemonitoring and usual care of 5 mmHg with 90% power with an adjusted alpha of 0.017 (2-sided) to adjust for all three pairwise comparisons. Other outcomes will include adherence of anti-hypertensive medication, 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 sub study will gain insights into the views, experiences and decision making processes of patients and health care professionals focusing on the acceptability of self-monitoring and telemonitoring in the routine management of hypertension. DISCUSSION: The results of the trial will be directly applicable to primary care in the UK. If successful, self-monitoring of BP in people with hypertension would be applicable to hundreds of thousands of individuals in the UK. TRIAL REGISTRATION: ISRCTN 83571366 . Registered 17 July 2014.

Background Hypertension is a major risk factor for cardiovascular disease and prevalence varies by ethnic group. The diagnosis and management of blood pressure are informed by guidelines largely based on data from white populations. This study addressed whether accuracy of blood pressure measurement in terms of diagnosis of hypertension varies by ethnicity by comparing two measurement modalities (clinic blood pressure and home monitoring) with a reference standard of ambulatory BP monitoring in three ethnic groups. Methods Cross-sectional population study (June 2010 - December 2012) with patients (40–75 years) of white British, South Asian and African Caribbean background with and without a previous diagnosis of hypertension recruited from 28 primary care practices. The study compared the test performance of clinic BP (using various protocols) and home-monitoring (1 week) with a reference standard of mean daytime ambulatory measurements using a threshold of 140/90 mmHg for clinic and 135/85 mmHg for out of office measurement. Results A total of 551 participants had complete data of whom 246 were white British, 147 South Asian and 158 African Caribbean. No consistent difference in accuracy of methods of blood pressure measurement was observed between ethnic groups with or without a prior diagnosis of hypertension: for people without hypertension, clinic measurement using three different methodologies had high specificity (75–97%) but variable sensitivity (33–65%) whereas home monitoring had sensitivity of 68–88% and specificity of 64–80%. For people with hypertension, detection of a raised blood pressure using clinic measurements had sensitivities of 34–69% with specificity of 73–92% and home monitoring had sensitivity (81–88%) and specificity (55–65%). Conclusions For people without hypertension, ABPM remains the choice for diagnosing hypertension compared to the other modes of BP measurement regardless of ethnicity. Differences in accuracy of home monitoring and clinic monitoring (higher sensitivity of the former; higher specificity of the latter) were also not affected by ethnicity. Electronic supplementary material The online version of this article (doi:10.1186/s12872-017-0491-8) contains supplementary material, which is available to authorized users.

Diagnostic output of raw data at different BP thresholds. (DOCX 19Â kb)

Patients often have lower (white coat effect) or higher (masked effect) ambulatory/home blood pressure readings compared with clinic measurements, resulting in misdiagnosis of hypertension. The present study assessed whether blood pressure and patient characteristics from a single clinic visit can accurately predict the difference between ambulatory/home and clinic blood pressure readings (the home–clinic difference). A linear regression model predicting the home–clinic blood pressure difference was derived in 2 data sets measuring automated clinic and ambulatory/home blood pressure (n=991) using candidate predictors identified from a literature review. The model was validated in 4 further data sets (n=1172) using area under the receiver operator characteristic curve analysis. A masked effect was associated with male sex, a positive clinic blood pressure change (difference between consecutive measurements during a single visit), and a diagnosis of hypertension. Increasing age, clinic blood pressure level, and pulse pressure were associated with a white coat effect. The model showed good calibration across data sets (Pearson correlation, 0.48–0.80) and performed well-predicting ambulatory hypertension (area under the receiver operator characteristic curve, 0.75; 95% confidence interval, 0.72–0.79 [systolic]; 0.87; 0.85–0.89 [diastolic]). Used as a triaging tool for ambulatory monitoring, the model improved classification of a patient’s blood pressure status compared with other guideline recommended approaches (93% [92% to 95%] classified correctly; United States, 73% [70% to 75%]; Canada, 74% [71% to 77%]; United Kingdom, 78% [76% to 81%]). This study demonstrates that patient characteristics from a single clinic visit can accurately predict a patient’s ambulatory blood pressure. Usage of this prediction tool for triaging of ambulatory monitoring could result in more accurate diagnosis of hypertension and hence more appropriate treatment.

This is the author accepted manuscript. It is currently under an indefinite embargo pending publication by the Royal College of General Practitioners., $\textit{Background:}$ Ambulatory and/or home monitoring are recommended in the UK and North America for the diagnosis of hypertension but little is known about acceptability. $\textit{Aim:}$ To determine the acceptability of different methods of measuring blood pressure to people from different ethnic minority groups. $\textit{Design and setting:}$ Cross sectional study with focus groups in primary care. $\textit{Methods:}$ People with and without hypertension of different ethnicities were assessed for acceptability of clinic, home and ambulatory blood pressure measurement using completion rate, questionnaire and focus groups. $\textit{Results:}$ 770 participants were included comprising 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 to the other ethnic groups, especially for ambulatory monitoring: white British (277 completed, 92%[89-95%]) vs South Asian (171, 71%[65-76%], p, National Institute for Health Research (Grant ID: PB-PG-1207-15042)

Introduction The diagnosis and management of hypertension depends on accurate measurement of blood pressure (BP) in order to target antihypertensive treatment appropriately. Most BP measurements take place in a clinic setting, but it has long been recognised that readings taken out-of-office (via home or ambulatory monitoring) estimate true underlying BP more accurately. Recent studies have shown that the change in clinic BP over multiple readings is a significant predictor of the difference between clinic and out-of-office BP. Used in combination with patient characteristics, this change has been shown to accurately predict a patient's out-of-office BP level. The present study proposes to collect real-life BP data to prospectively validate this new prediction tool in routine clinical practice. Methods and analysis A prospective, multicentre observational cohort design will be used, recruiting patients from primary and secondary care. All patients attending participating centres for ambulatory BP monitoring will be eligible to participate. Anonymised clinical data will be collected from all eligible patients, who will be invited to give informed consent to permit identifiable data to be collected for data linkage to external outcome registries. Descriptive statistics will be used to calculate the sensitivity, specificity, positive and negative predictive values of the out-of-office BP prediction tool. Area under the receiver operator characteristic curve statistics will be used to examine model performance. Ethics and dissemination Ethical approval for this study has been obtained from the National Research. Ethics Service Committee South Central—Oxford A (reference; 15/SC/0184), and site-specific R&D approval has been acquired from the relevant NHS trusts. All findings will be presented at relevant conferences and published in peer-reviewed journals, on the study website and disseminated in lay and social media where appropriate.

OBJECTIVE: To prospectively validate the Predicting Out-of-OFfice Blood Pressure (PROOF-BP) algorithm to triage patients with suspected high blood pressure for ambulatory blood pressure monitoring (ABPM) in routine clinical practice. DESIGN: Prospective observational cohort study. SETTING: 10 primary care practices and one hospital in the UK. PARTICIPANTS: 887 consecutive patients aged 18 years or more referred for ABPM in routine clinical practice. All underwent ABPM and had the PROOF-BP applied. MAIN OUTCOME MEASURES: The main outcome was the proportion of participants whose hypertensive status was correctly classified using the triaging strategy compared with the reference standard of daytime ABPM. Secondary outcomes were the sensitivity, specificity, and area under the receiver operator characteristic curve (AUROC) for detecting hypertension. RESULTS: The mean age of participants was 52.8 (16.2) years. The triaging strategy correctly classified hypertensive status in 801 of the 887 participants (90%, 95% confidence interval 88% to 92%) and had a sensitivity of 97% (95% confidence interval 96% to 98%) and specificity of 76% (95% confidence interval 71% to 81%) for hypertension. The AUROC was 0.86 (95% confidence interval 0.84 to 0.89). Use of triaging, rather than uniform referral for ABPM in routine practice, would have resulted in 435 patients (49%, 46% to 52%) being referred for ABPM and the remainder managed on the basis of their clinic measurements. Of these, 69 (8%, 6% to 10%) would have received treatment deemed unnecessary had they received ABPM. CONCLUSIONS: In a population of patients referred for ABPM, this new triaging approach accurately classified hypertensive status for most, with half the utilisation of ABPM compared with usual care. This triaging strategy can therefore be recommended for diagnosis or management of hypertension in patients where ABPM is being considered, particularly in settings with limited resources.