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The impact of primary care supported shielding on the risk of mortality in people vulnerable to COVID-19: English sentinel network matched cohort study
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 < 0.0001). Over the remaining nine weeks, mortality risk was 54% higher in the shielded group (HR=1.54, 95%CI:1.41–1.70, 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:2.38–2.87, 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.
The Salt Swap intervention to reduce salt intake in people with high blood pressure: Protocol for a feasibility randomised controlled trial
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.
Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure
Background: 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.
Development of a modified Cambridge Multimorbidity Score for use with SNOMED CT: an observational English primary care sentinel network study
Background 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 — 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 — 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.
Predictors of the Home-Clinic Blood Pressure Difference: A Systematic Review and Meta-Analysis
BACKGROUND: Patients may have lower (white coat hypertension) or higher (masked hypertension) blood pressure (BP) at home compared to the clinic, resulting in misdiagnosis and suboptimal management of hypertension. This study aimed to systematically review the literature and establish the most important predictors of the home-clinic BP difference. METHODS: A systematic review was conducted using a MEDLINE search strategy, adapted for use in 6 literature databases. Studies examining factors that predict the home-clinic BP difference were included in the review. Odds ratios (ORs) describing the association between patient characteristics and white coat or masked hypertension were extracted and entered into a random-effects meta-analysis. RESULTS: The search strategy identified 3,743 articles of which 70 were eligible for this review. Studies examined a total of 86,167 patients (47% female) and reported a total of 60 significant predictors of the home-clinic BP difference. Masked hypertension was associated with male sex (OR 1.47, 95% confidence interval (CI) 1.18-1.75), body mass index (BMI, per kg/m2 increase, OR 1.07, 95% CI 1.01-1.14), current smoking status (OR 1.32, 95% CI 1.13-1.50), and systolic clinic BP (per mm Hg increase, OR 1.10, 95% CI 1.01-1.19). Female sex was the only significant predictor of white coat hypertension (OR 3.38, 95% CI 1.64-6.96). CONCLUSIONS: There are a number of common patient characteristics that predict the home-clinic BP difference, in particular for people with masked hypertension. There is scope to incorporate such predictors into a clinical prediction tool which could be used to identify those patients displaying a significant masked or white coat effect in routine clinical practice.
Prevalence and predictors of hospital prealerting in acute stroke: A mixed methods study
Background Thrombolysis can significantly reduce the burden of stroke but the time window for safe and effective treatment is short. In patients travelling to hospital via ambulance, the sending of a 'prealert' message can significantly improve the timeliness of treatment. Objective Examine the prevalence of hospital prealerting, the extent to which prealert protocols are followed and what factors influence emergency medical services (EMS) staff's decision to send a prealert. Methods Cohort study of patients admitted to two acute stroke units in West Midlands (UK) hospitals using linked data from hospital and EMS records. A logistic regression model examined the association between prealert eligibility and whether a prealert message was sent. In semistructured interviews, EMS staff were asked about their experiences of patients with suspected stroke. Results Of the 539 patients eligible for this study, 271 (51%) were recruited. Of these, only 79 (29%) were eligible for prealerting according to criteria set out in local protocols but 143 (53%) were prealerted. Increasing number of Face, Arm, Speech Test symptoms (1 symptom, OR 6.14, 95% CI 2.06 to 18.30, p=0.001; 2 symptoms, OR 31.36, 95% CI 9.91 to 99.24, p<0.001; 3 symptoms, OR 75.84, 95% CI 24.68 to 233.03, p<0.001) and EMS contact within 5 h of symptom onset (OR 2.99, 95% CI 1.37 to 6.50 p=0.006) were key predictors of prealerting but eligibility for prealert as a whole was not (OR 1.92, 95% CI 0.85 to 4.34 p=0.12). In qualitative interviews, EMS staff displayed varying understanding of prealert protocols and described frustration when their interpretation of the prealert criteria was not shared by ED staff. Conclusions Up to half of the patients presenting with suspected stroke in this study were prealerted by EMS staff, regardless of eligibility, resulting in disagreements with ED staff during handover. Aligning the expectations of EMS and ED staff, perhaps through simplified prealert protocols, could be considered to facilitate more appropriate use of hospital prealerting in acute stroke.
Modern Management and Diagnosis of Hypertension in the United Kingdom: Home Care and Self-care
Background The effective diagnosis and management of hypertension is one of the most important parts of cardiovascular prevention internationally and this is no different in the United Kingdom. Approximately 14% of the UK population currently receive treatment for hypertension. Recent UK guidelines from the National Institute of Health and Care Excellence have placed greater emphasis on the utilization of out-of-office measurement of blood pressure to more accurately diagnose hypertension. Objective The aim of the present study was to provide a state-of-the-art review of the evidence for screening, diagnosing, and managing hypertension, as implemented in the United Kingdom, with an emphasis on the role of self-monitored and ambulatory blood pressure monitoring in routine clinical care. Method Consideration was given to the use of ambulatory and home monitoring to confirm a diagnosis of hypertension and the use of self-monitoring and self-management to monitor and guide treatment. The evidence for the use of self-monitoring in patients with hypertension was examined, both in isolation, and in combination with lifestyle and treatment interventions. Findings There is a place for self-monitored blood pressure in specific underresearched populations such as the elderly, specialist conditions, ethnic groups, and during pregnancy and this is discussed here. Conclusions The evidence supporting the use of out-of-office monitoring in all aspects of routine clinical care has increased substantially in recent years and is reflected in increased utilization by patients and clinicians alike. Several areas require further research but it is clear that out-of-office monitoring is here to stay and is fast becoming an important part of hypertension management in the United Kingdom.
Prospective Register of patients undergoing repeated OFfice and Ambulatory Blood Pressure Monitoring (PROOF-ABPM): Protocol for an observational cohort study
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-ofoffice (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 outof-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.
A comparison of blood pressure in community pharmacies with ambulatory, home and general practitioner office readings: Systematic review and meta-analysis
Background: Blood pressure (BP) readings are traditionally taken in a clinic setting, with treatment recommendations based on these measurements. The clinical interpretation of BP readings taken in community pharmacies is currently unclear. This study aimed to systematically review all literature comparing community pharmacy BP (CPBP) readings with ambulatory BP monitoring (ABPM), home BP monitoring and general practitioner clinic readings. Method: Studies were included if they compared CPBP with at least one other measurement modality used for the diagnosis or management of hypertension. Mean CPBP readings were compared with other measurement modalities and summarized using random-effects meta-analyses. The primary outcome was to compare CPBP with gold standard ABPM readings. Results: Searches generated 3815 studies of which eight were included in the meta-analyses. The mean systolic CPBP-daytime ABPM difference was small [+1.6 mmHg (95% confidence interval-1.2 to 4.3) three studies, n = 319]. CPBP was significantly higher than 24-h ABPM [+7.8 mmHg (95% confidence interval 1.5-14.1) three studies n = 429]. Comparisons with general practitioner clinic readings (six studies, n = 2100) were inconclusive with significant heterogeneity between studies. CPBP and home BP monitoring readings (five studies, n = 1848) were nonsignificantly different. Diastolic comparisons mirrored systolic comparisons in all but the CPBP-daytime ABPM comparison, where CPBP was significantly higher. Conclusion: Current evidence around the clinical interpretation of CPBP is inconclusive. Although this review suggests that adopting the 135/85 mmHg threshold for hypertension might be reasonable and potentially result in a higher sensitivity for detecting patients with truly raised BP in pharmacies, the impact of this lower threshold on increased referrals to general practice clinics must be considered.