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.
\n \n\n \n \nHypertension 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\u2019s 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.
\n \n\n \n \nOBJECTIVES: To define the relationship between arm and leg blood pressure (BP) to inform the interpretation of leg BP readings in routine clinical practice where arm readings are not available. METHODS: Systematic review of all existing studies comparing arm and leg BP measurements. A search strategy was designed in MEDLINE and adapted to be run across six further databases. Articles were deemed eligible for inclusion if they measured and reported arm and leg BP taken in the supine position and/or the difference between the two. Mean values for arm-leg BP difference and measures of precision [95% confidence intervals (CIs) or SD] were extracted and entered into a random-effects meta-analysis. RESULTS: A total of 887 articles were screened and 44 were included in the descriptive analyses, including 9771 patients. In the general population, ankle SBP was 17.0\u200ammHg (95% CI 15.4-21.3\u200ammHg) higher than arm BP in the supine position. For DBP, there was no difference between arm and ankle BP (-0.3\u200ammHg, 95% CI -1.5-1.0\u200ammHg). In patients with vascular disease, SBP was -33.3\u200ammHg (95% CI -59.1 to -7.6\u200ammHg) lower in the ankle compared with the arm. CONCLUSION: This is the first review to provide empirical data defining the difference between BP in the arm and leg in the general population. Findings suggest a diagnostic threshold of 155/90\u200ammHg could be used for diagnosing hypertension when only ankle measurements are available in routine practice.
\n \n\n \n \nHypertension is the leading risk factor for cardiovascular events globally and affects around a third of adults in the UK. Literature related to the role of pharmacists in hypertension is vast, and encompasses hypertension screening and management in community pharmacy, as well as general practice and secondary care settings. To date, the role of pharmacists in community practice does not routinely involve formally structured hypertension management or screening programmes. Several high blood pressure (BP) screening studies have been conducted in pharmacies, recording previously unidentified patients with hypertension. However, evidence relating to subsequent follow-up appears scarce, meaning that clinical outcomes for these patients compared with those not attending screening is unknown. The strongest evidence related to pharmacists in hypertension care is from research in to the management of hypertension rather than detection. Findings from systematic reviews and meta-analyses show that community pharmacist-led management of hypertension significantly changes systolic BP over usual GP care by between \u20136.1mmHg (95% confidence interval [CI] \u20138.4 to \u20133.8) and \u20137.2mmHg (95% CI \u20135.8 to \u20138.7). In addition, similar reductions can be achieved when pharmacists provide support to patients who self-monitor their BP from home. However, several factors require addressing before such services can be developed and sustained in pharmacies, including: the impact of delivering extra services on the pharmacist\u2019s time; ensuring adequate training and legal approvals; improving communication with GPs and access to clinical records; the current policy and funding landscape; and pharmacy\u2019s identity as a healthcare setting versus its commercial identity. This article summarises the findings of existing systematic reviews and meta-analyses related to both hypertension screening and management in community pharmacies. Factors for consideration prior to implementing hypertension-related services in pharmacies are also discussed.
\n \n\n \n \nObjective To quantify the impact and recovery in cardiovascular disease monitoring in primary care associated with the first COVID-19 lockdown. Design Retrospective nationwide primary care cohort study, utilising data from 1st January 2018 to 27 th September 2020. Setting We extracted primary care electronic health records data from 514 primary care practices in England contributing to the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID). These practices were representative of English primary care across urban and non-urban practices. Participants The ORCHID database included 6,157,327 active patients during the study period, and 13,938,390 patient years of observation (final date of follow-up 27 th September 2020). The mean (SD) age was 38\u00b124 years, 49.4% were male and the majority were of white ethnicity (65% [21.9% had unknown ethnicity]) Exposure The primary exposure was the first national lockdown in the UK, starting on 23 rd March 2020. Main outcome measures Records of cholesterol, blood pressure, HbA1c and International Normalised Ratio (INR) measurement derived from coded entries in the primary care electronic health record. Results Rates of cholesterol, blood pressure, HbA1c and INR recording dropped by 23-87% in the week following the first UK national lockdown, compared with the previous week. The largest decline was seen in cholesterol (IRR 0.13, 95% CI 0.11 to 0.15) and smallest for INR (IRR 0.77, 95% CI 0.72 to 0.81). Following the immediate drop, rates of recorded tests increased on average by 5-9% per week until 27 th September 2020. However, the number of recorded measures remained below that expected for the time of year, reaching 51.8% (95% CI 51.8 to 51.9%) for blood pressure, 63.7%, (95% CI 63.7% to 63.8%) for cholesterol measurement and 70.3% (95% CI 70.2% to 70.4%) for HbA1c. Rates of INR recording declined throughout the previous two years, a trend that continued after lockdown. There were no differences in the times series trends based on sex, age, ethnicity or deprivation. Conclusions Cardiovascular disease monitoring in English primary care declined substantially from the time of the first UK lockdown. Despite a consistent recovery in activity, there is still a substantial shortfall in the numbers of recorded measurements to those expected. Strategies are required to ensure cardiovascular disease monitoring is maintained during the COVID-19 pandemic.
\n \n\n \n \nHypertension 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 (<130/80 mm Hg), raised (130/80-139/89 mm Hg), stage 1 uncontrolled (140/90-159/99 mm Hg), or stage 2 uncontrolled (\u2265160/100 mm Hg). The primary outcome was death within 28 days of COVID-19 diagnosis. Secondary outcomes were COVID-19 diagnosis and COVID-19-related hospital admission. Multivariable logistic regression was used to examine the association between BP control and outcomes. Of the 45 418 patients (mean age, 67 years; 44.7% male) included, 11 950 (26.3%) had controlled BP. These patients were older, had more comorbidities, and had been diagnosed with hypertension for longer. A total of 4277 patients (9.4%) were diagnosed with COVID-19 and 877 died within 28 days. Individuals with stage 1 uncontrolled BP had lower odds of COVID-19 death (odds ratio, 0.76 [95% CI, 0.62-0.92]) compared with patients with well-controlled BP. There was no association between BP control and COVID-19 diagnosis or hospitalization. These findings suggest BP control may be associated with worse COVID-19 outcomes, possibly due to these patients having more advanced atherosclerosis and target organ damage. Such patients may need to consider adhering to stricter social distancing, to limit the impact of COVID-19 as future waves of the pandemic occur.
\n \n\n \n \nObjectives: To mitigate risk of mortality from coronavirus 2019 infection (COVID-19), the UK government recommended \u2018shielding\u2019 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\u20130.59. p < 0.0001). Over the remaining nine weeks, mortality risk was 54% higher in the shielded group (HR=1.54, 95%CI:1.41\u20131.70, p < 0.0001). Beyond the shielding period, mortality risk was over two-and-a-half times higher in the shielded group (HR=2.61, 95%CI:2.38\u20132.87, p < 0.0001). Conclusions: Shielding halved the risk of mortality for 21 days. Mortality risk became higher across the remainder of the shielding period, rising to two-and-a-half times greater post-shielding. Shielding may be beneficial in the next wave of COVID-19.
\n \n\n \n \nBackground: 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.
\n \n\n \n \nBackground: Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The participatory and informed consent (PIC) measure was developed for application to recruitment discussions to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial. Methods: This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio-recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility. Results: Application of the PIC to 18 audio-recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure. Conclusion: The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.
\n \n\n \n \nBackground People 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. Aim To 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 \u2014 Clinical Terms, SNOMED CT). Design and setting Observational study using diagnosis and prescriptions data from an English primary care sentinel surveillance network between 2014 and 2019. Method In 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 \u2014 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). Results The 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. Conclusion This modified version of the Cambridge Multimorbidity Score allows reliable estimation using clinical terms that can be applied internationally across multiple healthcare settings.
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