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BackgroundPeople with multiple health conditions are more likely to have poorer health outcomes and greater care and service needs; a reliable measure of multimorbidity would inform management strategies and resource allocation.AimTo develop and validate a modified version of the Cambridge Multimorbidity Score in an extended age range, using clinical terms that are routinely used in electronic health records across the world (Systematized Nomenclature of Medicine — Clinical Terms, SNOMED CT).Design and settingObservational study using diagnosis and prescriptions data from an English primary care sentinel surveillance network between 2014 and 2019.MethodIn this study new variables describing 37 health conditions were curated and the associations modelled between these and 1-year mortality risk using the Cox proportional hazard model in a development dataset (n= 300 000). Two simplified models were then developed — a 20-condition model as per the original Cambridge Multimorbidity Score and a variable reduction model using backward elimination with Akaike information criterion as the stopping criterion. The results were compared and validated for 1-year mortality in a synchronous validation dataset (n= 150 000), and for 1-year and 5-year mortality in an asynchronous validation dataset (n= 150 000).ResultsThe final variable reduction model retained 21 conditions, and the conditions mostly overlapped with those in the 20-condition model. The model performed similarly to the 37- and 20-condition models, showing high discrimination and good calibration following recalibration.ConclusionThis modified version of the Cambridge Multimorbidity Score allows reliable estimation using clinical terms that can be applied internationally across multiple healthcare settings.

BACKGROUND Recent US blood pressure (BP) guidelines recommend using ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) to screen adults for masked hypertension. However, limited evidence exists of the expected long-term effects of screening for and treating masked hypertension. METHODS We estimated the lifetime health and economic outcomes of screening for and treating masked hypertension using the Cardiovascular Disease (CVD) Policy Model, a validated microsimulation model. We simulated a cohort of 100,000 US adults aged ≥20 years with suspected masked hypertension (i.e., office BP 120–129/ RESULTS Relative to usual care, adding masked hypertension screening and treatment with ABPM and HBPM was projected to prevent 14.3 and 20.5 CVD events per 100,000 person-years, increase the proportion experiencing any treatment-related serious adverse events by 2.7 and 5.1 percentage points, and increase mean total costs by $1,076 and $1,046, respectively. Compared with usual care, adding ABPM was estimated to cost $85,164/QALY gained. HBPM resulted in lower QALYs than usual care due to increased treatment-related adverse events and pill-taking disutility. CONCLUSIONS The results from our simulation study suggest screening with ABPM and treating masked hypertension is cost-effective in US adults with suspected masked hypertension.

Objective To develop and externally validate the STRAtifying Treatments In the multi-morbid Frail elderlY (STRATIFY)-Falls clinical prediction model to identify the risk of hospital admission or death from a fall in patients with an indication for antihypertensive treatment. Design Retrospective cohort study. Setting Primary care data from electronic health records contained within the UK Clinical Practice Research Datalink (CPRD). Participants Patients aged 40 years or older with at least one blood pressure measurement between 130 mm Hg and 179 mm Hg. Main outcome measure First serious fall, defined as hospital admission or death with a primary diagnosis of a fall within 10 years of the index date (12 months after cohort entry). Model development was conducted using a Fine-Gray approach in data from CPRD GOLD, accounting for the competing risk of death from other causes, with subsequent recalibration at one, five, and 10 years using pseudo values. External validation was conducted using data from CPRD Aurum, with performance assessed through calibration curves and the observed to expected ratio, C statistic, and D statistic, pooled across general practices, and clinical utility using decision curve analysis at thresholds around 10%. Results Analysis included 1 772 600 patients (experiencing 62 691 serious falls) from CPRD GOLD used in model development, and 3 805 366 (experiencing 206 956 serious falls) from CPRD Aurum in the external validation. The final model consisted of 24 predictors, including age, sex, ethnicity, alcohol consumption, living in an area of high social deprivation, a history of falls, multiple sclerosis, and prescriptions of antihypertensives, antidepressants, hypnotics, and anxiolytics. Upon external validation, the recalibrated model showed good discrimination, with pooled C statistics of 0.833 (95% confidence interval 0.831 to 0.835) and 0.843 (0.841 to 0.844) at five and 10 years, respectively. Original model calibration was poor on visual inspection and although this was improved with recalibration, under-prediction of risk remained (observed to expected ratio at 10 years 1.839, 95% confidence interval 1.811 to 1.865). Nevertheless, decision curve analysis suggests potential clinical utility, with net benefit larger than other strategies. Conclusions This prediction model uses commonly recorded clinical characteristics and distinguishes well between patients at high and low risk of falls in the next 1-10 years. Although miscalibration was evident on external validation, the model still had potential clinical utility around risk thresholds of 10% and so could be useful in routine clinical practice to help identify those at high risk of falls who might benefit from closer monitoring or early intervention to prevent future falls. Further studies are needed to explore the appropriate thresholds that maximise the model’s clinical utility and cost effectiveness.

BackgroundIn England, most prescribing of direct-acting oral anticoagulants for atrial fibrillation (AF) is in primary care. However, there remain gaps in our understanding of dosage and disparities in use. We aimed to describe trends in direct oral anticoagulant (DOAC) prescribing, including dose reduction in people with renal impairment and other criteria, and adherence.MethodsUsing English primary care sentinel network data from 2014 to 2019, we assessed appropriate DOAC dose adjustment with creatinine clearance (CrCl). Our primary care sentinel cohort was a subset of 722 general practices, with 6.46 million currently registered patients at the time of this study.ResultsOf 6 464 129 people in the cohort, 2.3% were aged ≥18 years with a diagnosis of AF, and 30.8% of these were prescribed vitamin K antagonist and 69.1% DOACs. Appropriate DOAC prescribing following CrCl measures improved between 2014 and 2019; dabigatran from 21.3% (95% CI 15.1% to 28.8%) to 48.7% (95% CI 45.0% to 52.4%); rivaroxaban from 22.1% (95% CI 16.7% to 28.4%) to 49.9% (95% CI 48.5% to 53.3%); edoxaban from 10.0% (95% CI 0.3% to 44.5%) in 2016 to 57.6% (95% CI 54.5% to 60.7%) in 2019; apixaban from 30.8% (95% CI 9.1% to 61.4%) in 2015 to 60.5% (95% CI 57.8% to 63.2%) in 2019.Adherence was highest for factor Xa inhibitors, increasing from 50.1% (95% CI 47.7% to 52.4%) in 2014 to 57.8% (95% CI 57.4% to 58.2%) in 2019. Asian and black/mixed ethnicity was associated with non-adherence (OR 1.81, 95% CI 1.56 to 2.09) as was male gender (OR 1.19, 95% CI 1.15 to 1.22), higher socioeconomic status (OR 1.60, 95% CI 1.52 to 1.68), being an ex-smoker (OR 1.12, 95% CI 1.06 to 1.19) and hypertension (OR 1.07, 95% CI 1.03 to 1.17).ConclusionsThe volume and quality of DOAC prescribing has increased yearly. Future interventions to augment quality of anticoagulant management should target disparities in adherence.

Hypertension is an important risk factor for the development of cardiovascular disease. Both systolic and diastolic blood pressures bear a relationship to cardiovascular morbidity and mortality. The main objective in the treatment of hypertension is to reduce the risk of cardiovascular disease and its complications. This ensures patients have increased life expectancy and improved quality of life. In those at high risk of cardiovascular disease, treatment should be focused on addressing all risk factors, and not blood pressure alone. Reducing cardiovascular risk in these patients involves treating associated risk factors such as diabetes and hyperlipidemia, by medications and by encouraging healthier lifestyle choices. Medications such as antiplatelet agents and lipid lowering drugs may be beneficial in those at high risk for cardiovascular events.

The aim of this study was to assess the blood pressure (BP) measurement accuracy of the Kinetik Blood Pressure Monitor—Series 1 (BPM-1) for use in home or clinical settings according to the 2002 European Society of Hypertension International Protocol (ESH-IP). Forty-two participants were recruited to fulfil the required number of systolic and diastolic BP measurements according to the ESH-IP. Nine sequential same-arm BP readings were measured and analysed for each participant using the test device and observer mercury standard readings according to the 2002 ESH-IP. Forty one participants were used to obtain 33 sets of systolic and diastolic BP readings and were included in the analysis. Mean difference between the device measurements and the observer (mercury standard) measurements was 1.1 ± 7.2/1.1 ± 6.8 mmHg (mean ± standard deviation; systolic/diastolic). The number of systolic BP differences between the test and observer measurements that fell within 5, 10 and 15 mmHg was 65, 86 and 92. For diastolic readings, the number of test—observer measurement differences within 5, 10 and 15 mmHg was 77, 91 and 94. The number of participants with at least two out of three differences within 5 mmHg was 28 for systolic and 40 for diastolic BP readings. Three participants had no differences between the test and observer measurements within 5 mmHg in both the systolic and diastolic measurement categories. The Kinetik BPM-1 device fulfilled the requirements of the ESH-IP validation procedure and can be recommended for clinical use and self-measurement within the home.

Background A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. Objective The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. Methods This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. Results A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. Conclusions The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

BackgroundPeople with multiple health conditions are more likely to have poorer health outcomes and greater care and service needs; a reliable measure of multimorbidity would inform management strategies and resource allocation. This study aims to develop and validate a modified version of the Cambridge Multimorbidity Score in an extended age range, using clinical terms which are routinely used in electronic health records across the world (SNOMED CT).Methods and FindingsWe curated new variables describing 37 health conditions and modelled the associations between these and 1-year mortality risk using the Cox proportional hazard model in a development dataset (n=300,000). We then developed two simplified models – a 20-condition model as per the original Cambridge Multimorbidity Score, and a variable reduction model using backward elimination with Akaike information criterion as the stopping criterion. The results were compared and validated for 1-year mortality in a synchronous validation dataset (n=150,000), and for 1-year and 5-year mortality in an asynchronous validation dataset (n=150,000).Our final variable reduction model retained 21 conditions, and the conditions mostly overlapped with those in the 20-condition model. The model performed similarly to the 37- and 20-condition models, showing high discrimination and good calibration following recalibration.ConclusionsThis modified version of the Cambridge Multimorbidity Score allows reliable estimation using clinical terms which can be applied internationally across multiple healthcare settings.

Out-of-office blood pressure (BP) monitoring (eg, home BP monitoring [HBPM] or ambulatory BP monitoring) to confirm a diagnosis of hypertension before treatment initiation after initial office screening is recommended by the United States Preventive Services Task Force and 2017 American College of Cardiology and American Heart Association (ACC/AHA) BP guidelines.1,2 One tool that may be used to help identify those in need of confirmatory BP monitoring is the Predicting Out-of-Office BP (PROOF-BP) algorithm, which uses office BP measurements and clinical characteristics to predict a patient’s out-of-office BP.3 Though many providers report recommending out-of-office BP monitoring to patients, the baseline frequency of its use for specific indications, such as confirming a diagnosis of hypertension, is not known.4 Further, barriers relevant to the accessibility and affordability of out-of-office BP monitoring have led to concerns that there may be disparities in the uptake of hypertension screening recommendations.5 This analysis examined how historical use of HBPM aligns with current out-of-office BP monitoring recommendations for hypertensive US adults without a previous hypertension diagnosis, and how HBPM use varies by patient characteristics.

Hypertension is the most frequent modifiable risk factor associated with cardiovascular disease (CVD) morbidity and mortality. Even in older people, strict blood pressure (BP) control has been recommended to reduce CVD event risks. However, caution should be exercised since older hypertensive patients have increased physical vulnerability due to frailty and multimorbidity, and older patients eligible for clinical trials may not represent the general population. Medical telemonitoring systems, which enable us to monitor a patient’s medical condition remotely through digital communication, have become much more prevalent since the coronavirus pandemic. Among various physiological parameters, BP monitoring is well-suited to the use of such systems, which enable healthcare providers to deliver accurate and safe BP management, even in the presence of frailty and/or living in geographically remote areas. Furthermore, medical telemonitoring systems could help reduce nonadherence to antihypertensive medications and clinical inertia, and also enable multi-professional team-based management of hypertension. However, the implementation of medical telemonitoring systems in clinical practice is not easy, and substantial barriers, including the development of user-friendly devices, integration with existing clinical systems, data security, and cost of implementation and maintenance, need to be overcome. In this review, we focus on the potential of medical telemonitoring for the management of hypertension in older people in Japan.

Background It remains unclear to what extent reductions in urgent referrals for suspected cancer during the COVID-19 pandemic were the result of fewer patients attending primary care compared to GPs referring fewer patients. Methods Cohort study including electronic health records data from 8,192,069 patients from 663 English practices. Weekly consultation rates, cumulative consultations and referrals were calculated for 28 clinical features from the NICE suspected cancer guidelines. Clinical feature consultation rate ratios (CRR) and urgent referral rate ratios (RRR) compared time periods in 2020 with 2019. Findings Consultations for cancer clinical features decreased by 24.19% (95% CI: 24.04–24.34%) between 2019 and 2020, particularly in the 6–12 weeks following the first national lockdown. Urgent referrals for clinical features decreased by 10.47% (95% CI: 9.82–11.12%) between 2019 and 2020. Overall, once patients consulted with primary care, GPs urgently referred a similar or greater proportion of patients compared to previous years. Conclusion Due to the significant fall in patients consulting with clinical features of cancer there was a lower than expected number of urgent referrals in 2020. Sustained efforts should be made throughout the pandemic to encourage the public to consult their GP with cancer clinical features.

Supplemental Digital Content is available in the text., In recent years, national and international guidelines have recommended the use of out-of-office blood pressure monitoring for diagnosing hypertension. Despite evidence of cost-effectiveness, critics expressed concerns this would increase cardiovascular morbidity. We assessed the impact of these changes on the incidence of hypertension, out-of-office monitoring and cardiovascular morbidity using routine clinical data from English general practices, linked to inpatient hospital, mortality, and socio-economic status data. We studied 3 937 191 adults with median follow-up of 4.2 years (49% men, mean age=39.7 years) between April 1, 2006 and March 31, 2017. Interrupted time series analysis was used to examine the impact of changes to English hypertension guidelines in 2011 on incidence of hypertension (primary outcome). Secondary outcomes included rate of out-of-office monitoring and cardiovascular events. Across the study period, incidence of hypertension fell from 2.1 to 1.4 per 100 person-years. The change in guidance in 2011 was not associated with an immediate change in incidence (change in rate=0.01 [95% CI, −0.18–0.20]) but did result in a leveling out of the downward trend (change in yearly trend =0.09 [95% CI, 0.04–0.15]). Ambulatory monitoring increased significantly in 2011/2012 (change in rate =0.52 [95% CI, 0.43–0.60]). The rate of cardiovascular events remained unchanged (change in rate =−0.02 [95% CI, −0.05–0.02]). In summary, changes to hypertension guidelines in 2011 were associated with a stabilisation in incidence and no increase in cardiovascular events. Guidelines should continue to recommend out-of-office monitoring for diagnosis of hypertension.

Background Smoking is attributed to both micro- and macrovascular complications at any stage of metabolic deregulation including prediabetes. Current global diabetes prevention programmes appear to be glucocentric, and do not fully acknowledge the ramifications of cardiorenal risk factors in smokers and ex-smokers. A more holistic approach is needed to prevent vascular complications in people with prediabetes and diabetes before and after quitting. Methods A cross-sectional study was carried out on participants who agreed to take part in the UK Biobank dataset at the time of their first attendances between March 01, 2006, and December 31, 2010. Those who had their urinary albumin concentration (UAC) data available were included, and those who did not have this data, were excluded. A logistic regression model was fitted to explore the relationship between cardiorenal risk factors and albuminuria in people with prediabetes and diabetes, based on smoking status. Findings A total of 502,490 participants were included in the UK Biobank dataset. Of them, 30.4% (n=152,896) had their UAC level recorded. Compared with non-smokers, the odds of albuminuria in smokers with prediabetes and diabetes were 1.21 (95% CI 1.05 – 1.39, p=0.009), and 1.26 (95% CI 1.10 – 1.44, p=0.001), respectively. The odds declined after quitting in both groups, but it was not statistically significant (p>0.05). Each unit increase in HbA1c was associated with equivalent increased odds of albuminuria in current and ex-smokers, OR 1.035 (95% CI 1.030 – 1.039, pInterpretation Male smokers are at a higher risk of albuminuria after smoking cessation. Monitoring waist circumference in quitters may identify those who are at a higher risk of albuminuria. Combining smoking cessation intervention in smokers with prediabetes in the current diabetes prevention programmes may offset post-cessation weight gain and reduce the risk of albuminuria. Funding University of Sheffield.

Objective To assess the associations between statins and adverse events in primary prevention of cardiovascular disease and to examine how the associations vary by type and dosage of statins. Design Systematic review and meta-analysis. Data sources Studies were identified from previous systematic reviews and searched in Medline, Embase, and the Cochrane Central Register of Controlled Trials, up to August 2020. Review methods Randomised controlled trials in adults without a history of cardiovascular disease that compared statins with non-statin controls or compared different types or dosages of statins were included. Main outcome measures Primary outcomes were common adverse events: self-reported muscle symptoms, clinically confirmed muscle disorders, liver dysfunction, renal insufficiency, diabetes, and eye conditions. Secondary outcomes included myocardial infarction, stroke, and death from cardiovascular disease as measures of efficacy. Data synthesis A pairwise meta-analysis was conducted to calculate odds ratios and 95% confidence intervals for each outcome between statins and non-statin controls, and the absolute risk difference in the number of events per 10 000 patients treated for a year was estimated. A network meta-analysis was performed to compare the adverse effects of different types of statins. An E max model based meta-analysis was used to examine the dose-response relationships of the adverse effects of each statin. Results 62 trials were included, with 120 456 participants followed up for an average of 3.9 years. Statins were associated with an increased risk of self-reported muscle symptoms (21 trials, odds ratio 1.06 (95% confidence interval 1.01 to 1.13); absolute risk difference 15 (95% confidence interval 1 to 29)), liver dysfunction (21 trials, odds ratio 1.33 (1.12 to 1.58); absolute risk difference 8 (3 to 14)), renal insufficiency (eight trials, odds ratio 1.14 (1.01 to 1.28); absolute risk difference 12 (1 to 24)), and eye conditions (six trials, odds ratio 1.23 (1.04 to 1.47); absolute risk difference 14 (2 to 29)) but were not associated with clinically confirmed muscle disorders or diabetes. The increased risks did not outweigh the reduction in the risk of major cardiovascular events. Atorvastatin, lovastatin, and rosuvastatin were individually associated with some adverse events, but few significant differences were found between types of statins. An E max dose-response relationship was identified for the effect of atorvastatin on liver dysfunction, but the dose-response relationships for the other statins and adverse effects were inconclusive. Conclusions For primary prevention of cardiovascular disease, the risk of adverse events attributable to statins was low and did not outweigh their efficacy in preventing cardiovascular disease, suggesting that the benefit-to-harm balance of statins is generally favourable. Evidence to support tailoring the type or dosage of statins to account for safety concerns before starting treatment was limited. Systematic review registration PROSPERO CRD42020169955.

Analysis of urine samples using liquid chromatography-tandem mass spectrometry (LC-MS/MS) has previously revealed high rates of non-adherence to antihypertensive medication. It is unclear whether these rates represent those in the general population. This study aimed to investigate whether it is feasible to collect urine samples in a primary care setting and analyse them using LC-MS/MS to detect non-adherence to antihypertensive medication. This study used a prospective, observational cohort design. Consecutive patients were recruited opportunistically from five general practices in UK primary care. They were aged ≥65 years with hypertension and had at least one antihypertensive prescription. Participants were asked to provide a urine sample for analysis of medication adherence. Samples were sent to a laboratory via post and analysed using LC-MS/MS. Predictors of adherence to medication were explored with multivariable logistic regression. Of 349 consecutive patients approached for the study, 214 (61.3%) gave informed consent and 191 (54.7%) provided a valid urine sample for analysis. Participants were aged 76.2 ± 6.6 years and taking a median of 2 antihypertensive medications (IQR 1–3). A total of 27/191 participants (14.2%) reported not taking all of their medications on the day of urine sample collection. However, LC-MS/MS analysis of samples revealed only 4/27 (9/191 in total; 4.7%) were non-adherent to some of their medications. Patients prescribed more antihypertensive medications were less likely to be adherent (OR 0.24, 95%CI 0.09–0.65). Biochemical testing for antihypertensive medication adherence is feasible in routine primary care, although non-adherence to medication is generally low, and therefore widespread testing is not indicated.

BackgroundOptimal management of hypertension in older patients with multimorbidity is a cornerstone of primary care practice. Despite emphasis on personalised approaches to treatment in older patients, there is little guidance on how to achieve medication reduction when GPs are concerned that possible risks outweigh potential benefits of treatment. Mindlines — tacit, internalised guidelines developed over time from multiple sources — may be of particular importance in such situations.AimTo explore GPs’ decision-making on deprescribing antihypertensives in patients with multimorbidity aged ≥80 years, drawing on the concept of mindlines.Design and settingQualitative interview study set in English general practice.MethodThematic analysis of face-to-face interviews with a sample of 15 GPs from seven practices in the East of England, using a chart-stimulated recall approach to explore approaches to treatment for older patients with multimorbidity with hypertension.ResultsGPs are typically confident making decisions to deprescribe antihypertensive medication in older patients with multimorbidity when prompted by a trigger, such as a fall or adverse drug event. GPs are less confident to attempt deprescribing in response to generalised concerns about polypharmacy, and work hard to make sense of multiple sources (including available evidence, shared experiential knowledge, and non-clinical factors) to guide decision-making.ConclusionIn the absence of a clear evidence base on when and how to attempt medication reduction in response to concerns about polypharmacy, GPs develop ‘mindlines’ over time through practicebased experience. These tacit approaches to making complex decisions are critical to developing confidence to attempt deprescribing and may be strengthened through reflective practice.

Background Polypharmacy is inevitable and appropriate for many conditions, but in some cases, it can be problematic resulting in an increased risk of harm and reduced quality of life. There has been an increasing interest to reduce cardioprotective medications in older adults to potentially reduce the risk of harm due to treatment; however, there is no evidence on safety and efficacy to support this practice currently. This paper describes a protocol for a systematic review on the safety and efficacy of reducing cardioprotective medication in older populations. Methods MEDLINE (PubMed), Embase (Ovid), and CENTRAL (Cochrane Central Register of Controlled Trials) will be searched from their inception onwards for relevant studies. Randomised controlled trials and non-randomised studies on interventions (prospective, retrospective cohort, case-control) conducted in older adults (75 years or older) examining reduction of cardioprotective medications will be included. The primary outcome of this study will be all-cause hospitalisation. Secondary outcome variables of interest are all-cause hospitalisation, mortality, quality of life, serious adverse events, major adverse cardiovascular events, falls, fractures, cognitive functioning, bleeding events, renal functioning, medication burden, drug reinstatement, time-in-hospital, and frailty status. Two reviewers will independently screen all citations, full-text articles, and extract data. Confidence in cumulative evidence will be assessed using the GRADE approach; the risk of bias will be assessed by the RoB-II tool for randomised controlled studies and ROBINS-I for non-randomised studies. Where sufficient data are available, we will conduct a random effects meta-analysis by combining the outcomes of the included studies. Sub-group analysis and meta-regression are planned to assess the potential harms and risks of different drug classes and the impacts in different patient populations (e.g. sex, cognitive status, renal status, and age). Discussion The study will be a comprehensive review on all published articles identified using our search strategy on the safety and efficacy of cardioprotective medication reduction in the older population. The findings will be crucial to inform clinicians on potential health outcomes of reducing cardiovascular medication in the elderly. Systematic review registration PROSPERO CRD42020208223

Objectives To mitigate risk of mortality from coronavirus 2019 infection (COVID-19), the UK government recommended ‘shielding’ of vulnerable people through self-isolation for 12 weeks. Methods A retrospective cohort study using a nationally representative English primary care database comparing people aged >= 40 years who were recorded as being advised to shield using a fixed ratio of 1:1, matching to people with the same diagnoses not advised to shield (n = 77,360 per group). Time-to-death was compared using Cox regression, reporting the hazard ratio (HR) of mortality between groups. A sensitivity analysis compared exact matched cohorts (n = 24,752 shielded, n = 61,566 exact matches). Results We found a time-varying HR of mortality between groups. In the first 21 days, the mortality risk in people shielding was half those not (HR = 0.50, 95%CI:0.41–0.59. p

Summary Background Representativeness of antihypertensive drug trials is uncertain, as many trials recruit few or no older people. Some trials specifically recruit older participants to address this. Here, we assess the representativeness of trials focusing on older people by comparing the rates of serious adverse events in these trials with the rates in trials of a general adult population (ie, standard trials), and comparing these findings to the rate of hospitalisations and deaths in people with hypertension starting a similar treatment in routine clinical practice. Methods For this observational study, we identified randomised controlled trials (phase 2/3, 3, or 4) of renin-angiotensin-aldosterone system (RAAS) drugs for hypertension registered from 1999 onwards with ClinicalTrials.gov. Serious adverse events are routinely included in trial reports and are predominantly accounted for by all-cause hospitalisations and deaths. We compared serious adverse event rates in older-people trials (minimum inclusion age ≥60 years) and standard trials (minimum inclusion age

Hypertension has been identified as a risk factor for coronavirus disease 2019 (COVID-19) and associated adverse outcomes. This study examined the association between preinfection blood pressure (BP) control and COVID-19 outcomes using data from 460 general practices in England. Eligible patients were adults with hypertension who were tested or diagnosed with COVID-19. BP control was defined by the most recent BP reading within 24 months of the index date (January 1, 2020). BP was defined as controlled (

BACKGROUND A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. OBJECTIVE The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. METHODS This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. RESULTS A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. CONCLUSIONS The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

Introduction: Home blood pressure monitoring (HBPM) is an option recommended by the 2017 ACC/AHA guidelines to confirm a hypertension diagnosis or identify masked hypertension. Using clinic BP and patient characteristics, the Predicting Out-of-Office BP in the Clinic (PROOF-BP) algorithm can be used to guide HBPM decisions. It is unknown how existing patient use and physician recommendations for HBPM align with current screening recommendations. Methods: We used the 2009-2014 National Health and Nutrition Examination Survey (NHANES) to identify US adults aged ≥20 years without hypertension or antihypertensive medication use. We identified those who would have been recommended to undergo HBPM by ACC/AHA guidelines as those with a mean BP 120-159/ Results: We included 7,185 NHANES adults without hypertension; weighted mean (SE) age was 41.5 (0.3) years, 48% female, and mean BP 117.0 (0.3)/70.4 (0.3) mm Hg. Overall, 50.3% of adults without hypertension would have been recommended to undergo HBPM by ACC/AHA guidelines and 29.7% by PROOF-BP ( Table ). Only 13.3% of those recommended HBPM by ACC/AHA guidelines used or were told to use HBPM, compared to 11.5% of those not recommended screening. Similar results were seen among those recommended HBPM by PROOF-BP ( Table ). Conclusions: Our analysis shows that prior to 2017 guidelines, a substantial proportion of US adults may have had their hypertensive status misclassified due to a lack of HBPM or undergo unnecessary monitoring. These findings suggest an opportunity for clinicians and health systems to more clearly target HBPM to those who need it given guidelines currently in use.

Introduction: The Predicting Out-of-Office Blood Pressure in the Clinic (PROOF-BP) algorithm accurately estimates out-of-office BP to guide ambulatory BP monitoring (ABPM) among adults in the UK and Canada with suspected high BP. We tested the validity of PROOF-BP in a diverse US population and developed a US-specific algorithm. Methods: We pooled data from four US studies (CARDIA, JHS, Masked Hypertension Study, and Improving Detection of Hypertension Study) that assessed both office BP and 24-hour ABPM. We included participants with >=2 office and >=10 daytime ambulatory BP readings. PROOF-BP estimates the difference between office systolic BP (SBP) and diastolic BP (DBP) and daytime ambulatory SBP and DBP using clinic BP measurements and patient characteristics. We examined the performance of PROOF-BP in US data and then used multivariable linear regression to develop a new algorithm optimized for the US population. We tested the ability of PROOF-BP to discriminate high awake ambulatory SBP and DBP (SBP/DBP >=130/80 mm Hg) using the area under the receiver-operator curve (AUROC). Models were developed in a 70% randomly selected derivation set and tested in a 30% validation set. The optimal predicted ambulatory BP thresholds were defined as those that resulted in the smallest proportion of individuals recommended for ABPM with an overall classification error Results: We analyzed 3,080 individuals with a mean (SD) age of 52.0 (11.9) years, 38% were male, and 54% were black. Mean (SD) office SBP/DBP was 121.8 (16.6)/75.3 (9.8) mm Hg, mean (SD) awake ambulatory SBP/DBP was 127.3 (13.5)/78.6 (8.8) mm Hg, and 51% had awake ABPM >=130/80 mm Hg. The discrimination for high awake ABPM was similar between the existing (AUROC SBP = 0.77, DBP = 0.73) and US-specific models (AUROC SBP = 0.77, DBP = 0.72). Optimal predicted ambulatory BP thresholds with the US-specific algorithm were 125-134/75-84 mm Hg, resulting in 55% of the pooled cohort recommended for ABPM; compared to 66% recommended by the 2017 ACC/AHA guidelines. Conclusions: Both the original and US-specific PROOF-BP algorithms predicted high out-of-office BP among US adults. PROOF-BP may be used to guide clinical decisions and resource allocation among individuals considered for ABPM.

© 2020 The Authors. Journal of the American Geriatrics Society published by Wiley Periodicals LLC on behalf of The American Geriatrics Society. BACKGROUND/OBJECTIVES: Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people. DESIGN: Cross-sectional study. SETTING: A total of 24 general practices in England. PARTICIPANTS: Anonymized electronic health record data from all individuals aged 80 and older. MEASUREMENTS: Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial. RESULTS: Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5–2.0%), 5,290 (34.4%; 95%CI = 33.7–35.2%), and 3,940 (25.6%; 95%CI = 24.9–26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] =.44; 95%CI =.36–.54 [OPTiMISE]), cardiovascular polypharmacy (OR =.61; 95%CI =.55–.68 [SPRINT]) and multimorbidity (OR =.72; 95%CI =.64–.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials. CONCLUSION: A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity.

Background The aim of RApid community Point-of-care Testing fOR COVID-19 (RAPTOR-C19) is to assess the diagnostic accuracy of multiple current and emerging point-of-care tests (POCTs) for active and past SARS-CoV2 infection in the community setting. RAPTOR-C19 will provide the community testbed to the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR). Methods RAPTOR-C19 incorporates a series of prospective observational parallel diagnostic accuracy studies of SARS-CoV2 POCTs against laboratory and composite reference standards in patients with suspected current or past SARS-CoV2 infection attending community settings. Adults and children with suspected current SARS-CoV2 infection who are having an oropharyngeal/nasopharyngeal (OP/NP) swab for laboratory SARS-CoV2 reverse transcriptase Digital/Real-Time Polymerase Chain Reaction (d/rRT-PCR) as part of clinical care or community-based testing will be invited to participate. Adults (≥ 16 years) with suspected past symptomatic infection will also be recruited. Asymptomatic individuals will not be eligible. At the baseline visit, all participants will be asked to submit samples for at least one candidate point-of-care test (POCT) being evaluated (index test/s) as well as an OP/NP swab for laboratory SARS-CoV2 RT-PCR performed by Public Health England (PHE) (reference standard for current infection). Adults will also be asked for a blood sample for laboratory SARS-CoV-2 antibody testing by PHE (reference standard for past infection), where feasible adults will be invited to attend a second visit at 28 days for repeat antibody testing. Additional study data (e.g. demographics, symptoms, observations, household contacts) will be captured electronically. Sensitivity, specificity, positive, and negative predictive values for each POCT will be calculated with exact 95% confidence intervals when compared to the reference standard. POCTs will also be compared to composite reference standards constructed using paired antibody test results, patient reported outcomes, linked electronic health records for outcomes related to COVID-19 such as hospitalisation or death, and other test results. Discussion High-performing POCTs for community use could be transformational. Real-time results could lead to personal and public health impacts such as reducing onward household transmission of SARS-CoV2 infection, improving surveillance of health and social care staff, contributing to accurate prevalence estimates, and understanding of SARS-CoV2 transmission dynamics in the population. In contrast, poorly performing POCTs could have negative effects, so it is necessary to undertake community-based diagnostic accuracy evaluations before rolling these out. Trial registration ISRCTN, ISRCTN14226970

BackgroundIn 2011, National Institute for Health and Care Excellence (NICE) guidelines recommended the routine use of out-of-office blood pressure (BP) monitoring for the diagnosis of hypertension. These changes were predicted to reduce unnecessary treatment costs and workload associated with misdiagnosis.AimTo assess the impact of guideline change on rates of hypertension-related consultation in general practice.Design and settingA retrospective open cohort study in adults registered with English general practices contributing to the Clinical Practice Research Datalink between 1 April 2006 and 31 March 2017.MethodThe primary outcome was the rate of face-to-face, telephone, and home visit consultations related to hypertension with a GP or nurse. Age- and sex-standardised rates were analysed using interrupted time-series analysis.ResultsIn 3 937 191 adults (median follow-up 4.2 years) there were 12 253 836 hypertension-related consultations. The rate of hypertension-related consultation was 71.0 per 100 person–years (95% confidence interval [CI] = 67.8 to 74.2) in April 2006, which remained flat before 2011. The introduction of the NICE hypertension guideline in 2011 was associated with a change in yearly trend (change in trend −3.60 per 100 person–years, 95% CI = −5.12 to −2.09). The rate of consultation subsequently decreased to 59.2 per 100 person–years (95% CI = 56.5 to 61.8) in March 2017. These changes occurred around the time of diagnosis, and persisted when accounting for wider trends in all consultations.ConclusionHypertension-related workload has declined in the last decade, in association with guideline changes. This is due to changes in workload at the time of diagnosis, rather than reductions in misdiagnosis.

BackgroundThe SARS-CoV-2 pandemic has passed its first peak in Europe.AimTo describe the mortality in England and its association with SARS-CoV-2 status and other demographic and risk factors.Design and settingCross-sectional analyses of people with known SARS-CoV-2 status in the Oxford RCGP Research and Surveillance Centre (RSC) sentinel network.MethodPseudonymised, coded clinical data were uploaded from volunteer general practice members of this nationally representative network (n = 4 413 734). All-cause mortality was compared with national rates for 2019, using a relative survival model, reporting relative hazard ratios (RHR), and 95% confidence intervals (CI). A multivariable adjusted odds ratios (OR) analysis was conducted for those with known SARS-CoV-2 status (n = 56 628, 1.3%) including multiple imputation and inverse probability analysis, and a complete cases sensitivity analysis.ResultsMortality peaked in week 16. People living in households of ≥9 had a fivefold increase in relative mortality (RHR = 5.1, 95% CI = 4.87 to 5.31, PPPP = 0.0056) had higher odds of mortality.ConclusionThe first SARS-CoV-2 peak in England has been associated with excess mortality. Planning for subsequent peaks needs to better manage risk in males, those of black ethnicity, older people, people with learning disabilities, and people who live in multi-occupancy dwellings.

© 2020 The Authors Objectives: Few studies report contributors to the excess mortality in England during the first wave of coronavirus disease 2019 (COVID-19) infection. We report the absolute excess risk (AER) of mortality and excess mortality rate (EMR) from a nationally representative COVID-19 sentinel surveillance network including known COVID-19 risk factors in people aged 45 years and above. Methods: Pseudonymised, coded clinical data were uploaded from contributing primary care providers (N = 1,970,314, ≥45years). We calculated the AER in mortality by comparing mortality for weeks 2 to 20 this year with mortality data from the Office for National Statistics (ONS) from 2018 for the same weeks. We conducted univariate and multivariate analysis including preselected variables. We report AER and EMR, with 95% confidence intervals (95% CI). Results: The AER of mortality was 197.8/10,000 person years (95%CI:194.30–201.40). The EMR for male gender, compared with female, was 1.4 (95%CI:1.35–1.44, p

When someone has an infection their risk of having a heart attack or stroke rises abruptly before returning to pre-infection levels over the next few weeks.1 The increase in risk is particularly high for respiratory infections like influenza and pneumonia. There are biologically plausible mechanisms by which infections could cause cardiovascular disease (CVD). Respiratory infections could trigger CVD by functional changes, like tachycardia, blood pressure instability, and hypercoagulable states. Increased cardiac demand can be enough to cause myocardial ischaemia downstream of stenosed vessels, even if the obstruction is stable.2 Infection might worsen or trigger existing CVD. Atheroma is thought to result from inappropriate inflammation. Infection could accelerate this inflammatory process, and destabilise plaques, much as chronic inflammatory conditions worsen coronary disease. Infections are also triggers for arrhythmias, which can in turn cause myocardial infarction and stroke. But even if the association between infections and CVD is only a marker of risk and not causative, it could still be useful clinically. There are precedents for short-term interventions: for example, temporary dual antiplatelet therapy after transient ischaemic attacks (TIAs). The benefit of prevention is proportional to the risk of CVD events, so treatments can be beneficial during periods of higher risk, when the balance of risks to benefits favours intervention. A typical question GPs ask is: ‘Why has this person got this disease at this time?’ Often we focus on the diagnosis and cause but forget the temporal element, or at least don’t take it into account in our practice. At one time, even death was assumed to strike people at random. During the plague, London …

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the UK affecting 1.3 million people.1 AF is particularly common in older people, with one in ten over the age of 75 years affected.2 The prevalence of AF is projected to increase with improved survival of patients from chronic cardiac disorders that predispose to AF, such as coronary heart disease. AF increases the risk of stroke fivefold due to thromboembolism and cause 15% of all strokes.3 Anticoagulation therapy reduces the risk of ischaemic stroke in patients with AF. When deciding on treatment, the National Institute for Health and Care Excellence (NICE) AF management guidelines recommend undertaking a risk benefit analysis using the CHA2DS2-VASc score to estimate an individual’s risk of stroke and the HAS-BLED score to estimate the risk of bleeding.4 For most people, the benefit of anticoagulation outweighs the risk of bleeding and so a high HAS-BLED score should not be used to withhold stroke prophylaxis but rather prompt more careful and frequent monitoring. In recent years, the recommended type of antithrombotic as a first line therapy has changed in order to maximise stroke risk reduction while minimising the risk of bleeding. In a meta-analysis of six trials, oral anticoagulants, such as the vitamin K antagonist (VKA) warfarin, reduced the risk of ischaemic stroke by 64% and all-cause mortality by 26% compared to placebo or no treatment in individuals with non-valvular AF.5 In 2011, non-VKA oral anticoagulants (NOACs), such as dabigatran, apixaban, and rivaroxaban were licensed in the UK as alternatives to warfarin and recommended in the 2014 NICE guidelines.4 This recommendation was based on a meta-analysis of four trials demonstrating that NOACs confer additional reductions in risk of stroke or systemic thromboembolism and all-cause mortality by 19% and …

Background: There is still an urgent clinical need to develop non-invasive diagnostic tests for early ischemic heart disease because, once angina occurs, it is too late. Hypocapnia has long been known to cause coronary artery vasoconstriction. Some new cardiology tests are accompanied by the claim that they must have potential diagnostic value if hypocapnia enhances their cardiac effects in healthy subjects. But no previous study has tested whether hypocapnia produces bigger cardiac effects in patients with angina than in healthy subjects. Methods: Severe hypocapnia (a PetCO2 level of 20 mmHg) lasting >15 min was mechanically induced by facemask, while conscious and unmedicated, in 18 healthy subjects and in 10 patients with angina and angiographically confirmed coronary artery disease, awaiting by-pass surgery. Each participant was their own control in normocapnia (where CO2 was added to the inspirate) and the order of normocapnia and hypocapnia was randomized. Twelve lead electrocardiograms (ECG) were recorded and automated measurements were made on all ECG waveforms averaged over >120 beats. 2D echocardiography was also performed on healthy subjects. Results: In the 18 healthy subjects, we confirm that severe hypocapnia (a mean PetCO2 of 20 ± 0 mmHg, P < 0.0001) consistently increased the mean T wave amplitude in leads V1–V3, but by only 31% (P < 0.01), 15% (P < 0.001) and 11% (P < 0.05), respectively. Hypocapnia produced no other significant effects (p > 0.05) on their electro- or echocardiogram. All 10 angina patients tolerated the mechanical hyperventilation well, with minimal discomfort. Hypocpania caused a similar increase in V1 (by 39%, P < 0.05 vs. baseline, but P > 0.05 vs. healthy controls) and did not induce angina. Its effects were no greater in patients who did not take β-blockers, or did not take organic nitrates, or had the worst Canadian Cardiovascular Society scores. Conclusion: Non-invasive mechanical hyperventilation while awake and unmedicated is safe and acceptable, even to patients with angina. Using it to produce severe and prolonged hypocapnia alone does produce significant ECG changes in angina patients. But its potential diagnostic value for identifying patients with coronary stenosis requires further evaluation.

Background: There was excess mortality from the first wave of coronavirus 2019 infection (COVID-19), which mainly affected older people. To mitigate risk, the UK government recommended ‘shielding’ of vulnerable people through self-isolation for 12 weeks. We investigated the impact of primary care-reinforced shielding advice on all-cause mortality. Methods: We conducted a retrospective cohort study using a nationally representative English primary care database. We compare people aged >=40years who were recorded as being advised to shield using a fixed ratio of 1:1, matching (a mixture of exact and propensity score matching) to people with the same diagnoses not advised to shield (n=77,360 per group). Time-to-death was compared using Cox regression, reporting the hazard ratio (HR) of mortality between groups. A sensitivity analysis compared exact matched cohorts (n=24,752 shielded, n=61,566 exact matches). Findings: Over the follow-up period, we found a time-varying HR of mortality between groups. In the first 21 days, the mortality risk in people shielding was half those not (HR=0.50, 95%CI:0.41-0.59. p

Background High salt intake is a risk factor for hypertension and cardiovascular disease. Reducing salt intake has been shown to reduce blood pressure. Despite population-level interventions, including product reformulation and public awareness campaigns, adult salt consumption in the UK still exceeds recommendations; this is primarily due to salt consumed in processed and pre-packaged foods. Moderate or high-intensity dietary advice to encourage individuals to reduce their salt intake has been shown to be effective at reducing blood pressure, but evidence of the effectiveness of interventions that are suitable for delivery at scale in routine primary care is scarce. This feasibility trial investigates a complex behavioural change intervention to reduce dietary salt intake and blood pressure by encouraging individuals to purchase lower-salt foods when grocery shopping. Methods This randomised controlled trial will test the feasibility of a novel intervention to reduce salt intake, and the trial procedures to assess its effectiveness. We will recruit participants through UK general practices and randomise 40 participants with high blood pressure, in a 2:1 allocation to receive either the Salt Swap intervention or a control information leaflet. The primary outcomes relate to the criteria for progression to a large-scale trial. These include follow-up rates at 6 weeks, fidelity of intervention delivery and use of the intervention mobile app. Secondary outcomes include the effect of the intervention on the salt content of purchased foods (grams per 100 g), urinary sodium excretion assessed through 24-hour urine samples and blood pressure. Trial process measures will be collected and qualitative assessment will provide insights into participant engagement with the intervention content and perceived barriers to and facilitators of salt reduction dietary behavioural change. Discussion If the outcomes indicate the trial is feasible and there is evidence that behavioural change may result in salt reduction, we will proceed to a definitive trial to test the effectiveness of the intervention to lower blood pressure. If successful, this intervention approach could be applied not only to people with high blood pressure, but also to the wider population with normal blood pressure in whom dietary salt intake exceeds recommendations. Trial registration ISRCTN, 20910962. Registered on 5 April 2017.

BACKGROUND Studies have shown that self-monitoring of blood pressure (BP) is effective when combined with co-interventions, but its efficacy varies in the presence of some co-morbidities. This study examined whether self- monitoring can reduce clinic BP in patients with hyper tension-related co-morbidity. METHODS A systematic review was conducted of articles published in Medline, Embase, and the Cochrane Library up to January 2018. Randomized controlled trials of self-monitoring of BP were selected and individual patient data (IPD) were requested. Contributing studies were prospectively categorized by whether they examined a low/ high-intensity co-intervention. Change in BP and likelihood of uncontrolled BP at 12 months were examined according to number and type of hypertension-related co-morbidity in a one-stage IPD meta-analysis. RESULTS A total of 22 trials were eligible, 16 of which were able to provide IPD for the primary outcome, including 6,522 (89%) participants with fol low-up data. Self-monitoring was associated with reduced clinic systollc BP compared to usual care at 12-month follow-up, regardless of the number of hypertension-related co-morbidities (-3.12 mm Hg, [95% confidence intervals -4.78, -1.46 mm Hg]; P value for interaction with number of morbidities = 0.260). Intense interventions were more effective than low-intensity interventions in patients with obesity (P < 0,001 for ail outcomes), and possibly stroke (P < 0,004 for BP control outcome only), but this effect was not observed in patients with coronary heart disease, diabetes, or chronic kidney disease. CONCLUSIONS Self-monitoring lower BP regardless of the number of hypertensic related co-morbidities, but may only be effective in conditions such obesity or stroke when combined with high-intensity co-interventions., This research was funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR number 267) and via an National Institute for Health Research Professorship (NIHR-RP-02-12-015). JS holds a Wellcome Trust/Royal Society Sir Henry Dale Fellowship (ref 211182/Z/18/Z). RM, KT and JS have, or previously received funding from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust. JM and RMcM are NIHR Senior Investigators. HB received funds from NHLBI (R01 HL070713). KM received funds from National Heart, Lung, and Blood Institute (NHLBI) (R01 HL090965). FDRH acknowledges part support from the NIHR School for Primary Care Research (SPCR), the NIHR Collaboration for Leadership in Applied Research in Health and Care (CLARHC) Oxford, and the NIHR Biomedical Research Centre (BRC), Oxford. RM has received research funding in terms of BP monitors from Omron. RM leads a programme of research around self-monitoring/management in stroke with BMc, funded by the Stroke Association and British Heart Foundation. BMc is the clinical lead for the Scottish Government's National programme for scaling up tele-monitoring in Scotland. HB receives research funds from Otsuka pharmaceuticals, Novo Nordisk, and Sanofi, but none of these studies are related to the current study. NH is now an employee of Bristol-Myers Squibb. The authors declare no other conflicts of interest. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Background There is debate as to what extent older patients (≥80 years) should be treated for high blood pressure. Existing trials show that blood pressure lowering in this population is effective at preventing stroke and heart failure but also results in an increased risk of adverse events. However, it has been suggested that these studies enrolled healthier patients, who are less representative of the general population and more likely to benefit from treatment. Purpose This study aimed to compare the characteristics of patients eligible for three blood pressure management trials and assess the likelihood of eligibility for each trial based on common characteristics of older patients. Methods Cross-sectional study of data extracted from the medical records of 15,376 patients aged ≥80 years, registered to 24 general practices in the south of England. Anonymised patient data relating to the eligibility criteria for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE) were extracted. Patients eligible for each trial were defined according to criteria specified in each trial protocol. Descriptive statistics were used to define the characteristics of each trial population. A logistic regression model was constructed to estimate predictors of eligibility for each trial, with practice included as a random effect. Results Approximately 268 (1.7%), 5,290 (34.4%) and 3,940 (25.6%) patients were eligible for HYVET, SPRINT and OPTiMISE trials respectively. There was little overlap in eligibility for each trial (1.0% were eligible for HYVET and SPRINT; 0% were eligible for HYVET and OPTiMISE; 10.2% were eligible for SPRINT and OPTiMISE). Patients eligible for OPTiMISE were comparable to the general population in terms of frailty (eFI 0.12 [OPTiMISE] vs 0.11 [general population]), but had more morbidities (4 vs 3) and cardiovascular medications prescribed (4 vs 2). Patients in HYVET and SPRINT were less frail, multi-morbid and prescribed less cardiovascular medications. Overall, increasing frailty and a history of cardiovascular disease reduced the likelihood of being eligible for any trial. Conclusions Patients eligible for OPTiMISE appear to best represent the population aged ≥80 years attending UK primary care. Increasing frailty and/or multi-morbidity reduce the likelihood of eligibility for all three blood pressure trials. Caution should be exercised when applying the results from randomised controlled trials to management of blood pressure in frail and multi-morbid patients. Acknowledgement/Funding This study was funded by the National Institute for Health Research (NIHR) SPCR and Oxford CLAHRC