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1.
Lancet Respir Med ; 2021 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-34599903

RESUMO

BACKGROUND: The UK COVID-19 vaccination programme has prioritised vaccination of those at the highest risk of COVID-19 mortality and hospitalisation. The programme was rolled out in Scotland during winter 2020-21, when SARS-CoV-2 infection rates were at their highest since the pandemic started, despite social distancing measures being in place. We aimed to estimate the frequency of COVID-19 hospitalisation or death in people who received at least one vaccine dose and characterise these individuals. METHODS: We conducted a prospective cohort study using the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) national surveillance platform, which contained linked vaccination, primary care, RT-PCR testing, hospitalisation, and mortality records for 5·4 million people (around 99% of the population) in Scotland. Individuals were followed up from receiving their first dose of the BNT162b2 (Pfizer-BioNTech) or ChAdOx1 nCoV-19 (Oxford-AstraZeneca) COVID-19 vaccines until admission to hospital for COVID-19, death, or the end of the study period on April 18, 2021. We used a time-dependent Poisson regression model to estimate rate ratios (RRs) for demographic and clinical factors associated with COVID-19 hospitalisation or death 14 days or more after the first vaccine dose, stratified by vaccine type. FINDINGS: Between Dec 8, 2020, and April 18, 2021, 2 572 008 individuals received their first dose of vaccine-841 090 (32·7%) received BNT162b2 and 1 730 918 (67·3%) received ChAdOx1. 1196 (<0·1%) individuals were admitted to hospital or died due to COVID-19 illness (883 hospitalised, of whom 228 died, and 313 who died due to COVID-19 without hospitalisation) 14 days or more after their first vaccine dose. These severe COVID-19 outcomes were associated with older age (≥80 years vs 18-64 years adjusted RR 4·75, 95% CI 3·85-5·87), comorbidities (five or more risk groups vs less than five risk groups 4·24, 3·34-5·39), hospitalisation in the previous 4 weeks (3·00, 2·47-3·65), high-risk occupations (ten or more previous COVID-19 tests vs less than ten previous COVID-19 tests 2·14, 1·62-2·81), care home residence (1·63, 1·32-2·02), socioeconomic deprivation (most deprived quintile vs least deprived quintile 1·57, 1·30-1·90), being male (1·27, 1·13-1·43), and being an ex-smoker (ex-smoker vs non-smoker 1·18, 1·01-1·38). A history of COVID-19 before vaccination was protective (0·40, 0·29-0·54). INTERPRETATION: COVID-19 hospitalisations and deaths were uncommon 14 days or more after the first vaccine dose in this national analysis in the context of a high background incidence of SARS-CoV-2 infection and with extensive social distancing measures in place. Sociodemographic and clinical features known to increase the risk of severe disease in unvaccinated populations were also associated with severe outcomes in people receiving their first dose of vaccine and could help inform case management and future vaccine policy formulation. FUNDING: UK Research and Innovation (Medical Research Council), Research and Innovation Industrial Strategy Challenge Fund, Scottish Government, and Health Data Research UK.

3.
PLoS Med ; 18(8): e1003728, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34464384

RESUMO

BACKGROUND: Unexpected weight loss (UWL) is a presenting feature of cancer in primary care. Existing research proposes simple combinations of clinical features (risk factors, symptoms, signs, and blood test data) that, when present, warrant cancer investigation. More complex combinations may modify cancer risk to sufficiently rule-out the need for investigation. We aimed to identify which clinical features can be used together to stratify patients with UWL based on their risk of cancer. METHODS AND FINDINGS: We used data from 63,973 adults (age: mean 59 years, standard deviation 21 years; 42% male) to predict cancer in patients with UWL recorded in a large representative United Kingdom primary care electronic health record between January 1, 2000 and December 31, 2012. We derived 3 clinical prediction models using logistic regression and backwards stepwise covariate selection: Sm, symptoms-only model; STm, symptoms and tests model; Tm, tests-only model. Fifty imputations replaced missing data. Estimates of discrimination and calibration were derived using 10-fold internal cross-validation. Simple clinical risk scores are presented for models with the greatest clinical utility in decision curve analysis. The STm and Tm showed improved discrimination (area under the curve ≥ 0.91), calibration, and greater clinical utility than the Sm. The Tm was simplest including age-group, sex, albumin, alkaline phosphatase, liver enzymes, C-reactive protein, haemoglobin, platelets, and total white cell count. A Tm score of 5 balanced ruling-in (sensitivity 84.0%, positive likelihood ratio 5.36) and ruling-out (specificity 84.3%, negative likelihood ratio 0.19) further cancer investigation. A Tm score of 1 prioritised ruling-out (sensitivity 97.5%). At this threshold, 35 people presenting with UWL in primary care would be referred for investigation for each person with cancer referred, and 1,730 people would be spared referral for each person with cancer not referred. Study limitations include using a retrospective routinely collected dataset, a reliance on coding to identify UWL, and missing data for some predictors. CONCLUSIONS: Our findings suggest that combinations of simple blood test abnormalities could be used to identify patients with UWL who warrant referral for investigation, while people with combinations of normal results could be exempted from referral.

4.
Lancet ; 398(10303): 843-855, 2021 09 04.
Artigo em Inglês | MEDLINE | ID: mdl-34388395

RESUMO

BACKGROUND: A previous efficacy trial found benefit from inhaled budesonide for COVID-19 in patients not admitted to hospital, but effectiveness in high-risk individuals is unknown. We aimed to establish whether inhaled budesonide reduces time to recovery and COVID-19-related hospital admissions or deaths among people at high risk of complications in the community. METHODS: PRINCIPLE is a multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial done remotely from a central trial site and at primary care centres in the UK. Eligible participants were aged 65 years or older or 50 years or older with comorbidities, and unwell for up to 14 days with suspected COVID-19 but not admitted to hospital. Participants were randomly assigned to usual care, usual care plus inhaled budesonide (800 µg twice daily for 14 days), or usual care plus other interventions, and followed up for 28 days. Participants were aware of group assignment. The coprimary endpoints are time to first self-reported recovery and hospital admission or death related to COVID-19, within 28 days, analysed using Bayesian models. The primary analysis population included all eligible SARS-CoV-2-positive participants randomly assigned to budesonide, usual care, and other interventions, from the start of the platform trial until the budesonide group was closed. This trial is registered at the ISRCTN registry (ISRCTN86534580) and is ongoing. FINDINGS: The trial began enrolment on April 2, 2020, with randomisation to budesonide from Nov 27, 2020, until March 31, 2021, when the prespecified time to recovery superiority criterion was met. 4700 participants were randomly assigned to budesonide (n=1073), usual care alone (n=1988), or other treatments (n=1639). The primary analysis model includes 2530 SARS-CoV-2-positive participants, with 787 in the budesonide group, 1069 in the usual care group, and 974 receiving other treatments. There was a benefit in time to first self-reported recovery of an estimated 2·94 days (95% Bayesian credible interval [BCI] 1·19 to 5·12) in the budesonide group versus the usual care group (11·8 days [95% BCI 10·0 to 14·1] vs 14·7 days [12·3 to 18·0]; hazard ratio 1·21 [95% BCI 1·08 to 1·36]), with a probability of superiority greater than 0·999, meeting the prespecified superiority threshold of 0·99. For the hospital admission or death outcome, the estimated rate was 6·8% (95% BCI 4·1 to 10·2) in the budesonide group versus 8·8% (5·5 to 12·7) in the usual care group (estimated absolute difference 2·0% [95% BCI -0·2 to 4·5]; odds ratio 0·75 [95% BCI 0·55 to 1·03]), with a probability of superiority 0·963, below the prespecified superiority threshold of 0·975. Two participants in the budesonide group and four in the usual care group had serious adverse events (hospital admissions unrelated to COVID-19). INTERPRETATION: Inhaled budesonide improves time to recovery, with a chance of also reducing hospital admissions or deaths (although our results did not meet the superiority threshold), in people with COVID-19 in the community who are at higher risk of complications. FUNDING: National Institute of Health Research and United Kingdom Research Innovation.


Assuntos
Budesonida/administração & dosagem , COVID-19/tratamento farmacológico , Glucocorticoides/administração & dosagem , Administração por Inalação , Idoso , Teorema de Bayes , COVID-19/mortalidade , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , SARS-CoV-2 , Resultado do Tratamento
5.
BMJ ; 374: n1840, 2021 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-34404631

RESUMO

OBJECTIVE: To determine if the characteristics of behavioural weight loss programmes influence the rate of change in weight after the end of the programme. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Trial registries, 11 electronic databases, and forward citation searching (from database inception; latest search December 2019). Randomised trials of behavioural weight loss programmes in adults with overweight or obesity, reporting outcomes at ≥12 months, including at the end of the programme and after the end of the programme. REVIEW METHODS: Studies were screened by two independent reviewers with discrepancies resolved by discussion. 5% of the studies identified in the searches met the inclusion criteria. One reviewer extracted the data and a second reviewer checked the data. Risk of bias was assessed with Cochrane's risk of bias tool (version 1). The rate of change in weight was calculated (kg/month; converted to kg/year for interpretability) after the end of the programme in the intervention versus control groups by a mixed model with a random intercept. Associations between the rate of change in weight and prespecified variables were tested. RESULTS: Data were analysed from 249 trials (n=59 081) with a mean length of follow-up of two years (longest 30 years). 56% of studies (n=140) had an unclear risk of bias, 21% (n=52) a low risk, and 23% (n=57) a high risk of bias. Regain in weight was faster in the intervention versus the no intervention control groups (0.12-0.32 kg/year) but the difference between groups was maintained for at least five years. Each kilogram of weight lost at the end of the programme was associated with faster regain in weight at a rate of 0.13-0.19 kg/year. Financial incentives for weight loss were associated with faster regain in weight at a rate of 1-1.5 kg/year. Compared with programmes with no meal replacements, interventions involving partial meal replacements were associated with faster regain in weight but not after adjustment for weight loss during the programme. Access to the programme outside of the study was associated with slower regain in weight. Programmes where the intensity of the interaction reduced gradually were also associated with slower regain in weight in the multivariable analysis, although the point estimate suggested that the association was small. Other characteristics did not explain the heterogeneity in regain in weight. CONCLUSION: Faster regain in weight after weight loss was associated with greater initial weight loss, but greater initial weight loss was still associated with reduced weight for at least five years after the end of the programme, after which data were limited. Continued availability of the programme to participants outside of the study predicted a slower regain in weight, and provision of financial incentives predicted faster regain in weight; no other clear associations were found. STUDY REGISTRATION: PROSPERO CRD42018105744.


Assuntos
Terapia Comportamental/métodos , Trajetória do Peso do Corpo , Obesidade/terapia , Sobrepeso/terapia , Programas de Redução de Peso/métodos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/fisiopatologia , Sobrepeso/fisiopatologia , Avaliação de Programas e Projetos de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Perda de Peso
7.
Lancet Respir Med ; 9(9): 1010-1020, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34329624

RESUMO

BACKGROUND: Doxycycline is often used for treating COVID-19 respiratory symptoms in the community despite an absence of evidence from clinical trials to support its use. We aimed to assess the efficacy of doxycycline to treat suspected COVID-19 in the community among people at high risk of adverse outcomes. METHODS: We did a national, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in older people (PRINCIPLE) across primary care centres in the UK. We included people aged 65 years or older, or 50 years or older with comorbidities (weakened immune system, heart disease, hypertension, asthma or lung disease, diabetes, mild hepatic impairment, stroke or neurological problem, and self-reported obesity or body-mass index of 35 kg/m2 or greater), who had been unwell (for ≤14 days) with suspected COVID-19 or a positive PCR test for SARS-CoV-2 infection in the community. Participants were randomly assigned using response adaptive randomisation to usual care only, usual care plus oral doxycycline (200 mg on day 1, then 100 mg once daily for the following 6 days), or usual care plus other interventions. The interventions reported in this manuscript are usual care plus doxycycline and usual care only; evaluations of other interventions in this platform trial are ongoing. The coprimary endpoints were time to first self-reported recovery, and hospitalisation or death related to COVID-19, both measured over 28 days from randomisation and analysed by intention to treat. This trial is ongoing and is registered with ISRCTN, 86534580. FINDINGS: The trial opened on April 2, 2020. Randomisation to doxycycline began on July 24, 2020, and was stopped on Dec 14, 2020, because the prespecified futility criterion was met; 2689 participants were enrolled and randomised between these dates. Of these, 2508 (93·3%) participants contributed follow-up data and were included in the primary analysis: 780 (31·1%) in the usual care plus doxycycline group, 948 in the usual care only group (37·8%), and 780 (31·1%) in the usual care plus other interventions group. Among the 1792 participants randomly assigned to the usual care plus doxycycline and usual care only groups, the mean age was 61·1 years (SD 7·9); 999 (55·7%) participants were female and 790 (44·1%) were male. In the primary analysis model, there was little evidence of difference in median time to first self-reported recovery between the usual care plus doxycycline group and the usual care only group (9·6 [95% Bayesian Credible Interval [BCI] 8·3 to 11·0] days vs 10·1 [8·7 to 11·7] days, hazard ratio 1·04 [95% BCI 0·93 to 1·17]). The estimated benefit in median time to first self-reported recovery was 0·5 days [95% BCI -0·99 to 2·04] and the probability of a clinically meaningful benefit (defined as ≥1·5 days) was 0·10. Hospitalisation or death related to COVID-19 occurred in 41 (crude percentage 5·3%) participants in the usual care plus doxycycline group and 43 (4·5%) in the usual care only group (estimated absolute percentage difference -0·5% [95% BCI -2·6 to 1·4]); there were five deaths (0·6%) in the usual care plus doxycycline group and two (0·2%) in the usual care only group. INTERPRETATION: In patients with suspected COVID-19 in the community in the UK, who were at high risk of adverse outcomes, treatment with doxycycline was not associated with clinically meaningful reductions in time to recovery or hospital admissions or deaths related to COVID-19, and should not be used as a routine treatment for COVID-19. FUNDING: UK Research and Innovation, Department of Health and Social Care, National Institute for Health Research.


Assuntos
Antibacterianos/administração & dosagem , COVID-19/tratamento farmacológico , Doxiciclina/administração & dosagem , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/efeitos adversos , COVID-19/diagnóstico , COVID-19/mortalidade , COVID-19/virologia , Doxiciclina/efeitos adversos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Diferença Mínima Clinicamente Importante , Fatores de Risco , SARS-CoV-2/isolamento & purificação , Autorrelato/estatística & dados numéricos , Resultado do Tratamento , Reino Unido/epidemiologia
8.
Glob Heart ; 16(1): 41, 2021 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-34211827

RESUMO

The World Heart Federation (WHF) commenced a Roadmap initiative in 2015 to reduce the global burden of cardiovascular disease and resultant burgeoning of healthcare costs. Roadmaps provide a blueprint for implementation of priority solutions for the principal cardiovascular diseases leading to death and disability. Atrial fibrillation (AF) is one of these conditions and is an increasing problem due to ageing of the world's population and an increase in cardiovascular risk factors that predispose to AF. The goal of the AF roadmap was to provide guidance on priority interventions that are feasible in multiple countries, and to identify roadblocks and potential strategies to overcome them. Since publication of the AF Roadmap in 2017, there have been many technological advances including devices and artificial intelligence for identification and prediction of unknown AF, better methods to achieve rhythm control, and widespread uptake of smartphones and apps that could facilitate new approaches to healthcare delivery and increasing community AF awareness. In addition, the World Health Organisation added the non-vitamin K antagonist oral anticoagulants (NOACs) to the Essential Medicines List, making it possible to increase advocacy for their widespread adoption as therapy to prevent stroke. These advances motivated the WHF to commission a 2020 AF Roadmap update. Three years after the original Roadmap publication, the identified barriers and solutions were judged still relevant, and progress has been slow. This 2020 Roadmap update reviews the significant changes since 2017 and identifies priority areas for achieving the goals of reducing death and disability related to AF, particularly targeted at low-middle income countries. These include advocacy to increase appreciation of the scope of the problem; plugging gaps in guideline management and prevention through physician education, increasing patient health literacy, and novel ways to increase access to integrated healthcare including mHealth and digital transformations; and greater emphasis on achieving practical solutions to national and regional entrenched barriers. Despite the advances reviewed in this update, the task will not be easy, but the health rewards of implementing solutions that are both innovative and practical will be great.

9.
BMJ ; 374: n1537, 2021 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-34261627

RESUMO

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 Emax 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 Emax 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.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Prevenção Primária/métodos , Idoso , Comorbidade , Relação Dose-Resposta a Droga , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco
10.
Prim Care Diabetes ; 2021 Jun 16.
Artigo em Inglês | MEDLINE | ID: mdl-34147402

RESUMO

AIMS: To pilot two dashboards to monitor prescribing of metformin and aspirin according to the National Institute for Health and Care Excellence (NICE) 'Do-Not-Do' recommendations. METHODS: This quality assurance programme was conducted in twelve general practices of the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. We developed dashboards to flag inappropriate prescribing of metformin and aspirin to people with type 2 diabetes mellitus (T2DM). In Phase 1, six practices (Group A) received a dashboard flagging suboptimal metformin prescriptions in people with reduced renal function. The other six practices (Group B) were controls. In Phase 2, Group B were provided a dashboard to flag inappropriate aspirin prescribing and Group A were controls. We used logistic regression to explore associations between dashboard exposure and inappropriate prescribing. RESULTS: The cohort comprised 5644 individuals (Group A, n = 2656; Group B, n = 2988). Half (51.6%, n = 2991) were prescribed metformin of which 15 (0.5%) were inappropriate (Group A, n = 10; Group B, n = 5). A fifth (17.6%, n = 986) were prescribed aspirin of which 828 (84.0%) were inappropriate. During Phase 1, metformin was stopped in 50% (n = 5) of people in Group A, compared with 20% (n = 1) in the control group (Group B); in Phase 2, the odds ratio of inappropriate aspirin prescribing was significantly lower in practices that received the dashboard versus control (0.44, 95%CI 0.27-0.72). CONCLUSIONS: It was feasible to use a dashboard to flag inappropriate prescribing. Whilst underpowered to report a change in metformin, we demonstrated a reduction in inappropriate aspirin prescribing.

11.
BMJ Open ; 11(6): e046799, 2021 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-34145016

RESUMO

INTRODUCTION: There is an urgent need to idenfy treatments for COVID-19 that reduce illness duration and hospital admission in those at higher risk of a longer illness course and complications. METHODS AND ANALYSIS: The Platform Randomised trial of INterventions against COVID-19 In older peoPLE trial is an open-label, multiarm, prospective, adaptive platform, randomised clinical trial to evaluate potential treatments for COVID-19 in the community. A master protocol governs the addition of new interventions as they become available, as well as the inclusion and cessation of existing intervention arms via frequent interim analyses. The first three interventions are hydroxychloroquine, azithromycin and doxycycline. Eligible participants must be symptomatic in the community with possible or confirmed COVID-19 that started in the preceding 14 days and either (1) aged 65 years and over or (2) aged 50-64 years with comorbidities. Recruitment is through general practice, health service helplines, COVID-19 'hot hubs' and directly through the trial website. Participants are randomised to receive either usual care or a study drug plus usual care, and outcomes are collected via daily online symptom diary for 28 days from randomisation. The research team contacts participants and/or their study partner following days 7, 14 and 28 if the online diary is not completed. The trial has two coprimary endpoints: time to first self-report of feeling recovered from possible COVID-19 and hospital admission or death from possible COVID-19 infection, both within 28 days from randomisation. Prespecified interim analyses assess efficacy or futility of interventions and to modify randomisation probabilities that allocate more participants to interventions with better outcomes. ETHICS AND DISSEMINATION: Ethical approval Ref: 20/SC/0158 South Central - Berkshire Research Ethics Committee; IRAS Project ID: 281958; EudraCT Number: 2020-001209-22. Results will be presented to policymakers and at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN86534580.


Assuntos
COVID-19 , Idoso , Humanos , Hidroxicloroquina , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento
12.
Thromb Haemost ; 2021 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-34020487

RESUMO

OBJECTIVE: To systematically identify and appraise existing evidence surrounding economic aspects of anticoagulation service interventions for patients with atrial fibrillation. METHODS: We searched the published and grey literature up to October 2019 to identify relevant economic evidence in any health care setting. A narrative-synthesis approach was taken to summarise evidence by economic design and type of service intervention, with costs expressed in pound sterling and valued at 2017 to 2018 prices. RESULTS: A total of 13 studies met our inclusion criteria from 1,168 papers originally identified. Categories of interventions included anticoagulation clinics (n = 4), complex interventions (n = 4), decision support tools (n = 3) and patient-centred approaches (n = 2). Anticoagulation clinics were cost-saving compared with usual care (range for mean cost difference: £188-£691 per-patient per-year) with equivalent health outcomes. Only one economic evaluation of a complex intervention was conducted; case management was more expensive than usual care (mean cost difference: £255 per-patient per-year) and the probability of its cost-effectiveness did not exceed 70%. There was limited economic evidence surrounding decision support tools or patient-centred approaches. Targeting service interventions at high-risk groups and those with suboptimal treatment was most likely to result in cost savings. CONCLUSION: This review revealed some evidence to support the cost-effectiveness of anticoagulation clinics. However, summative conclusions are constrained by a paucity of economic evidence, a lack of direct comparisons between interventions, and study heterogeneity in terms of intervention, comparator and study year. Further research is urgently needed to inform commissioning and service development. Data from this review can inform future economic evaluations of anticoagulation service interventions.

13.
Artigo em Inglês | MEDLINE | ID: mdl-33837414

RESUMO

AIMS: This study aimed to measure physical activity (PA) in participants with suspected heart failure with preserved ejection fraction (HFpEF) and assess associations between PA and participant characteristics. METHODS AND RESULTS: Adults with presumed HFpEF were recruited and received diagnostic evaluation and clinical assessment. Physical activity was objectively measured using accelerometers over 7 days. To examine predictors of PA, a best subset analysis was used, with the optimal model defined as that with the lowest Bayesian information criterion. One hundred and twenty-four participants with presumed HFpEF who had valid accelerometer data were included in this study. Seventy-six were confirmed by a cardiologist as meeting the European Society of Cardiology diagnosis criteria for HFpEF. The median age of all participants was 80.1 years, and 47.4% were female. Patients spent most of each 24-h period at low-intensity PA and few or no durations at high-intensity PA, with lower activity for those with HFpEF. Gait speed was the best univariate correlate of activity levels (adjusted R2 0.29). The optimal model using best subsets regression included six variables and improved adjusted R2 to 0.47. In the model, lower levels of PA were associated with slower gait speed, lower levels of anxiety, higher levels of depression, past smoking history, a confirmed HFpEF diagnosis, and higher body mass index. CONCLUSION: Participants demonstrated very low PA levels. The study has identified important patient characteristics associated with PA, which may help to identify those most in need of interventions. Notably, participants with confirmed HFpEF were more inactive than participants with other heart failure phenotypes.

14.
Front Immunol ; 12: 643321, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33746986

RESUMO

Aging is associated with a decline in many components of the immune system (immunosenescence). Probiotics may improve the immune response in older people. The objective was to determine the effect of the combination of two probiotic organisms [Lacticaseibacillus (previously known as Lactobacillus) rhamnosus GG (LGG) and Bifidobacterium animalis subsp. lactis, BB-12 (BB-12)] on a range of immune biomarkers measured in the blood of older people resident in care homes in the UK. In a randomized controlled trial, older people [aged 67-97 (mean 86) years] resident in care homes received the combination of LGG+BB-12 (1.3-1.6 × 109 CFU per day) or placebo for up to 12 months. Full blood count, blood immune cell phenotypes, plasma immune mediator concentrations, phagocytosis, and blood culture responses to immune stimulation were all measured. Response to seasonal influenza vaccination was measured in a subset of participants. Paired samples (i.e., before and after intervention) were available for 30 participants per group. LGG and BB-12 were more likely to be present in feces in the probiotic group and were present at higher numbers. There was no significant effect of the probiotics on components of the full blood count, blood immune cell phenotypes, plasma immune mediator concentrations, phagocytosis by neutrophils and monocytes, and blood culture responses to immune stimulation. There was an indication that the probiotics improved the response to seasonal influenza vaccination with significantly (p = 0.04) higher seroconversion to the A/Michigan/2015 vaccine strain in the probiotic group than in the placebo group (47 vs. 15%).


Assuntos
Bifidobacterium animalis , Controle de Infecções , Infecções , Lactobacillus rhamnosus , Casas de Saúde , Probióticos/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Biomarcadores , Fezes/microbiologia , Feminino , Humanos , Infecções/imunologia , Infecções/microbiologia , Masculino
15.
ESC Heart Fail ; 8(3): 2193-2201, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33755352

RESUMO

AIMS: Natriuretic peptides are helpful in detecting chronic heart failure (HF) in primary care; however, there are a lack of data evaluating thresholds recommended by clinical guidelines. This study assesses the diagnostic accuracy of N-terminal pro-B-type natriuretic peptide (NT-proBNP) using combined individual patient data from two studies in the UK and the Netherlands. METHODS AND RESULTS: Random effects methods were used to estimate the performance characteristics of NT-proBNP thresholds recommended by the European Society of Cardiology (ESC) and the UK National Institute for Health and Care Excellence (NICE) guidelines. New onset HF was diagnosed in 313 of 1073 (29.2%) participants. Age, sex, and atrial fibrillation-adjusted NT-proBNP was a better predictor of HF with reduced ejection fraction (HFrEF) than HF preserved ejection fraction (HFpEF), with area under receiver operating characteristic curve of 0.82 95% CI (0.78 to 0.86) vs. 0.71 (0.66 to 0.75). In persons aged 70 years and over, the ESC threshold at 125 ng/L for detection of all-cause HF had summary negative predictive value (NPV) of 84.9% (81.6 to 88.2), positive predictive value (PPV) 68.1% (63.1 to 73.3), sensitivity 74.9% (69.5 to 80.3), and specificity 80.1% (76.9 to 83.4); the NICE threshold at 400 ng/L had summary NPV of 74.7% (72.1 to 77.2), PPV 81.8% (73.3 to 89.5), sensitivity 43.5% (37.2 to 49.8), and specificity 94.5% (92.3 to 96.7). CONCLUSIONS: N-terminal pro-B-type natriuretic peptide is better at detecting HFrEF than HFpEF in a primary care setting. In persons aged 70 and over, the ESC threshold of 125 ng/L is more accurate at detecting and excluding HF than the higher level suggested in NICE guidelines. More prospective data are required to establish the optimal NP threshold for detecting chronic HF in general practice.


Assuntos
Insuficiência Cardíaca , Idoso , Idoso de 80 Anos ou mais , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Humanos , Países Baixos , Atenção Primária à Saúde , Estudos Prospectivos , Volume Sistólico
16.
JMIR Public Health Surveill ; 7(2): e24341, 2021 02 19.
Artigo em Inglês | MEDLINE | ID: mdl-33605892

RESUMO

BACKGROUND: The Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) and Public Health England (PHE) are commencing their 54th season of collaboration at a time when SARS-CoV-2 infections are likely to be cocirculating with the usual winter infections. OBJECTIVE: The aim of this study is to conduct surveillance of influenza and other monitored respiratory conditions and to report on vaccine uptake and effectiveness using nationally representative surveillance data extracted from primary care computerized medical records systems. We also aim to have general practices collect virology and serology specimens and to participate in trials and other interventional research. METHODS: The RCGP RSC network comprises over 1700 general practices in England and Wales. We will extract pseudonymized data twice weekly and are migrating to a system of daily extracts. First, we will collect pseudonymized, routine, coded clinical data for the surveillance of monitored and unexpected conditions; data on vaccine exposure and adverse events of interest; and data on approved research study outcomes. Second, we will provide dashboards to give general practices feedback about levels of care and data quality, as compared to other network practices. We will focus on collecting data on influenza-like illness, upper and lower respiratory tract infections, and suspected COVID-19. Third, approximately 300 practices will participate in the 2020-2021 virology and serology surveillance; this will include responsive surveillance and long-term follow-up of previous SARS-CoV-2 infections. Fourth, member practices will be able to recruit volunteer patients to trials, including early interventions to improve COVID-19 outcomes and point-of-care testing. Lastly, the legal basis for our surveillance with PHE is Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002; other studies require appropriate ethical approval. RESULTS: The RCGP RSC network has tripled in size; there were previously 100 virology practices and 500 practices overall in the network and we now have 322 and 1724, respectively. The Oxford-RCGP Clinical Informatics Digital Hub (ORCHID) secure networks enable the daily analysis of the extended network; currently, 1076 practices are uploaded. We are implementing a central swab distribution system for patients self-swabbing at home in addition to in-practice sampling. We have converted all our primary care coding to Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) coding. Throughout spring and summer 2020, the network has continued to collect specimens in preparation for the winter or for any second wave of COVID-19 cases. We have collected 5404 swabs and detected 623 cases of COVID-19 through extended virological sampling, and 19,341 samples have been collected for serology. This shows our preparedness for the winter season. CONCLUSIONS: The COVID-19 pandemic has been associated with a groundswell of general practices joining our network. It has also created a permissive environment in which we have developed the capacity and capability of the national primary care surveillance systems and our unique public health institute, the RCGP and University of Oxford collaboration.


Assuntos
Protocolos Clínicos , Influenza Humana/prevenção & controle , Infecções Respiratórias/prevenção & controle , Vacinas/uso terapêutico , COVID-19/tratamento farmacológico , COVID-19/prevenção & controle , Feminino , Humanos , Influenza Humana/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Vigilância da População/métodos , Saúde Pública , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/virologia , Reino Unido
17.
BMJ ; 372: n189, 2021 02 10.
Artigo em Inglês | MEDLINE | ID: mdl-33568342

RESUMO

OBJECTIVE: To examine the association between antihypertensive treatment and specific adverse events. DESIGN: Systematic review and meta-analysis. ELIGIBILITY CRITERIA: Randomised controlled trials of adults receiving antihypertensives compared with placebo or no treatment, more antihypertensive drugs compared with fewer antihypertensive drugs, or higher blood pressure targets compared with lower targets. To avoid small early phase trials, studies were required to have at least 650 patient years of follow-up. INFORMATION SOURCES: Searches were conducted in Embase, Medline, CENTRAL, and the Science Citation Index databases from inception until 14 April 2020. MAIN OUTCOME MEASURES: The primary outcome was falls during trial follow-up. Secondary outcomes were acute kidney injury, fractures, gout, hyperkalaemia, hypokalaemia, hypotension, and syncope. Additional outcomes related to death and major cardiovascular events were extracted. Risk of bias was assessed using the Cochrane risk of bias tool, and random effects meta-analysis was used to pool rate ratios, odds ratios, and hazard ratios across studies, allowing for between study heterogeneity (τ2). RESULTS: Of 15 023 articles screened for inclusion, 58 randomised controlled trials were identified, including 280 638 participants followed up for a median of 3 (interquartile range 2-4) years. Most of the trials (n=40, 69%) had a low risk of bias. Among seven trials reporting data for falls, no evidence was found of an association with antihypertensive treatment (summary risk ratio 1.05, 95% confidence interval 0.89 to 1.24, τ2=0.009). Antihypertensives were associated with an increased risk of acute kidney injury (1.18, 95% confidence interval 1.01 to 1.39, τ2=0.037, n=15), hyperkalaemia (1.89, 1.56 to 2.30, τ2=0.122, n=26), hypotension (1.97, 1.67 to 2.32, τ2=0.132, n=35), and syncope (1.28, 1.03 to 1.59, τ2=0.050, n=16). The heterogeneity between studies assessing acute kidney injury and hyperkalaemia events was reduced when focusing on drugs that affect the renin angiotensin-aldosterone system. Results were robust to sensitivity analyses focusing on adverse events leading to withdrawal from each trial. Antihypertensive treatment was associated with a reduced risk of all cause mortality, cardiovascular death, and stroke, but not of myocardial infarction. CONCLUSIONS: This meta-analysis found no evidence to suggest that antihypertensive treatment is associated with falls but found evidence of an association with mild (hyperkalaemia, hypotension) and severe adverse events (acute kidney injury, syncope). These data could be used to inform shared decision making between doctors and patients about initiation and continuation of antihypertensive treatment, especially in patients at high risk of harm because of previous adverse events or poor renal function. REGISTRATION: PROSPERO CRD42018116860.


Assuntos
Anti-Hipertensivos/efeitos adversos , Injúria Renal Aguda/epidemiologia , Idoso , Anti-Hipertensivos/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Causalidade , Gota/epidemiologia , Humanos , Hiperpotassemia/epidemiologia , Hipopotassemia/epidemiologia , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
PLoS One ; 16(1): e0245131, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33449936

RESUMO

OBJECTIVES: To establish the prevalence of multimorbidity in people with chronic kidney disease (CKD) stages 1-5 and transiently impaired renal function and identify factors associated with multimorbidity. DESIGN AND SETTING: Prospective cohort study in UK primary care. PARTICIPANTS: 861 participants aged 60 and older with decreased renal function of whom, 584 (65.8%) had CKD and 277 (32.2%) did not have CKD. INTERVENTIONS: Participants underwent medical history and clinical assessment, and blood and urine sampling. PRIMARY AND SECONDARY OUTCOME MEASURES: Multimorbidity was defined as presence of ≥2 chronic conditions including CKD. Prevalence of each condition, co-existing conditions and multimorbidity were described and logistic regression was used to identify predictors of multimorbidity. RESULTS: The mean (±SD) age of participants was 74±7 years, 54% were women and 98% were white. After CKD, the next most prevalent condition was hypertension (n = 511, 59.3%), followed by obesity (n = 265, 30.8%) ischemic heart disease (n = 145, 16.8%) and diabetes (n = 133, 15.4%). Having two co-existing conditions was most common (27%), the most common combination of which was hypertension and obesity (29%). One or three conditions was the next most prevalent combination (20% and 21% respectively). The prevalence of multimorbidity was 73.9% (95%CI 70.9-76.8) in all participants and 86.6% (95%CI 83.9-89.3) in those with any-stage CKD. Logistic regression found a significant association between increasing age (OR 1.07, 95%CI 1.04-0.10), increasing BMI (OR 1.15, 95%CI 1.10-1.20) and decreasing eGFR (OR 0.99, 95%CI 0.98-1.00) with multimorbidity. CONCLUSIONS: This analysis is the first to provide an accurate estimate of the prevalence of multimorbidity in a screened older primary care population living with or at risk of CKD across all stages. Hypertension and obesity were the most common combination of conditions other than CKD that people were living with, suggesting that there may be multiple reasons for closely monitoring health status in individuals with CKD.


Assuntos
Nefropatias Diabéticas/epidemiologia , Hipertensão/epidemiologia , Multimorbidade , Obesidade/epidemiologia , Insuficiência Renal Crônica/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Prevalência , Atenção Primária à Saúde , Estudos Prospectivos , Fatores de Risco
20.
Eur J Heart Fail ; 23(1): 3-12, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32892471

RESUMO

AIMS: To understand gender differences in the prognosis of women and men with heart failure, we compared mortality, cause of death and survival trends over time. METHODS AND RESULTS: We analysed UK primary care data for 26 725 women and 29 234 men over age 45 years with a new diagnosis of heart failure between 1 January 2000 and 31 December 2017 using the Clinical Practice Research Datalink, inpatient Hospital Episode Statistics and the Office for National Statistics death registry. Age-specific overall survival and cause-specific mortality rates were calculated by gender and year. During the study period 15 084 women and 15 822 men with heart failure died. Women were on average 5 years older at diagnosis (79.6 vs. 74.8 years). Median survival was lower in women compared to men (3.99 vs. 4.47 years), but women had a 14% age-adjusted lower risk of all-cause mortality [hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.84-0.88]. Heart failure was equally likely to be cause of death in women and men (HR 1.03, 95% CI 0.96-1.12). There were modest improvements in survival for both genders, but these were greater in men. The reduction in mortality risk in women was greatest for those diagnosed in the community (HR 0.83, 95% CI 0.80-0.85). CONCLUSIONS: Women are diagnosed with heart failure older than men but have a better age-adjusted prognosis. Survival gains were less in women over the last two decades. Addressing gender differences in heart failure diagnostic and treatment pathways should be a clinical and research priority.

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