Search results
Found 5236 matches for
A new review, launched by the Department for Health and Social Care and Led by NIHR ARC OxTV supported Dr Ben Goldacre, will focus on the more efficient and safe use of health data for research and analysis for the benefit of patients and the healthcare sector.
Mortality among Care Home Residents in England during the first and second waves of the COVID-19 pandemic: an analysis of 4.3 million adults over the age of 65
Background Residents in care homes have been severely impacted by the COVID-19 pandemic. We describe trends in risk of mortality among care home residents compared to residents in private homes in England. Methods On behalf of NHS England, we used OpenSAFELY-TPP, an analytics platform running across the linked electronic health records of approximately a third of the English population, to calculate monthly age-standardised risks of death due to all causes and COVID-19 among adults aged >=65 years between 1/2/2019 and 31/03/2021. Care home residents were identified using linkage to the Care and Quality Commission. Findings We included 4,329,078 people aged 65 years or older on the 1st of February 2019, 2.2% of whom were classified as residing in a care or nursing home. Age-standardised mortality risks were approximately 10 times higher among care home residents compared to non-residents in February 2019 residents (CMF = 10.59, 95%CI = 9.51, 11.81 among women, CMF = 10.82, 95%CI = 9.89, 11.84 among men). This increased to more than 17 times in April 2020 (CMF = 17.52, 95%CI = 16.38, 18.74 among women, CMF = 18.12, 95%CI = 17.17 – 19.12 among men) before returning to pre-pandemic levels in June 2020. CMFs did not increase during the second wave, despite a rise in the absolute age-standardised COVID-19 mortality risks. Interpretation The first COVID-19 wave had a disproportionate impact on care home residents in England compared to older private home residents. A degree of immunity, improved protective measures or changes in the underlying frailty of the populations may explain the lack of an increase in the relative mortality risks during the second wave. The care home population should be prioritised for measures aimed at controlling the spread of COVID-19. Funding Medical Research Council MR/V015737/1
What Drives Responses to Willingness-to-pay Questions? A Methodological Inquiry in the Context of Hypertension Self-management.
Background: The use of economic evaluation to determine the cost-effectiveness of health interventions is recommended by decision-making bodies internationally. Understanding factors that explain variations in costs and benefits is important for policy makers. Objective: This work aimed to test a priori hypotheses defining the relationship between benefits of using self-management equipment (measured using the willingness-to-pay (WTP) approach) and a number of demographic and other patient factors. Methods: Data for this study were collected as part of the first major randomised controlled trial of self-monitoring combined with self-titration in hypertension (TASMINH2). A contingent valuation framework was used with patients asked to indicate how much they were willing to pay for equipment used for self-managing hypertension. Descriptive statistics, simple statistical tests of differences and multivariate regression were used to test six a priori hypotheses. Results: 393 hypertensive patients (204 in the intervention and 189 in the control) were willing to pay for self-management equipment and 85% of these (335) provided positive WTP values. Three hypotheses were accepted: higher WTP values were associated with being male, higher household incomes and satisfaction with the equipment. Prior experiences of using this equipment, age and changes in blood pressure were not significantly related to WTP. Conclusion: The majority of hypertensive patients who had taken part in a self-management study were prepared to purchase the self-monitoring equipment using their own funds, more so for men, those with higher incomes and those with greater satisfaction. Further research based on bigger and more diverse populations is recommended.
Use of Anticoagulants and Antiplatelet Agents in Stable Outpatients with Coronary Artery Disease and Atrial Fibrillation. International CLARIFY Registry.
BACKGROUND: Few data are available regarding the use of antithrombotic strategies in coronary artery disease patients with atrial fibrillation (AF) in everyday practice. We sought to describe the prevalence of AF and its antithrombotic management in a contemporary population of patients with stable coronary artery disease. METHODS AND FINDINGS: CLARIFY is an international, prospective, longitudinal registry of outpatients with stable coronary artery disease, defined as prior (≥12 months) myocardial infarction, revascularization procedure, coronary stenosis >50%, or chest pain associated with evidence of myocardial ischemia. Overall, 33,428 patients were screened, of whom 32,954 had data available for analysis at baseline; of these 2,229 (6.7%) had a history of AF. Median (interquartile range) CHA2DS2-VASc score was 4 (3, 5). Oral anticoagulation alone was used in 25.7%, antiplatelet therapy alone in 52.8% (single 41.8%, dual 11.0%), and both in 21.5%. OAC use was independently associated with permanent AF (p<0.001), CHA2DS2-VASc score (p=0.006), pacemaker (p<0.001), stroke (p=0.04), absence of angina (p=0.004), decreased left ventricular ejection fraction (p<0.001), increased waist circumference (p=0.005), and longer history of coronary artery disease (p=0.008). History of percutaneous coronary intervention (p=0.004) and no/partial reimbursement for cardiovascular medication (p=0.01, p<0.001, respectively) were associated with reduced oral anticoagulant use. CONCLUSIONS: In this contemporary cohort of patients with stable coronary artery disease and AF, most of whom are theoretical candidates for anticoagulation, oral anticoagulants were used in only 47.2%. Half of the patients received antiplatelet therapy alone and one-fifth received both antiplatelets and oral anticoagulants. Efforts are needed to improve adherence to guidelines in these patients. TRIAL REGISTRATION: ISRCTN registry of clinical trials: ISRCTN43070564.
Co-design and evaluation of a youth-informed organisational tool to enhance trauma-informed practices in the UK public sector: a study protocol.
INTRODUCTION: A trauma-informed approach (TIA) means working with awareness that people's histories of trauma may shape the way they engage with services, organisations or institutions. Young people with adverse childhood experiences may be at risk of retraumatisation by organisational practices in schools and universities and by employers and health agencies when they seek support. There are limited evidence-based resources to help people working in the public sector to work with adolescents in trauma-informed ways and the needs of adolescents have not been central in resource development. This study contributes to public sector capacity to work in trauma-informed ways with adolescents by codesigning and evaluating the implementation of a youth-informed organisational resource. METHODS AND ANALYSIS: This is an Accelerated Experience-based Co-design (AEBCD) Study followed by pre-post evaluation. Public sector organisations or services, and adolescents connected with them, will collaboratively reflect on lived experience data assembled through creative arts practice, alongside data from epidemiological national data sets. These will present knowledge about the impact of adverse childhood experiences on adolescents' mental health (stage 1). Collaboratively, priorities (touch points) for organisational responses will be identified (stage 2), and a low-burden resource will be codesigned (stage 3) and offered for implementation (stage 4) and evaluation (stage 5) in diverse settings. The study will provide insights into what adolescents and public sector organisations in the UK want from a TIA resource, the experience of services/organisations in implementing this and recommendations for resource development and implementation. ETHICS AND DISSEMINATION: The UK National Health Service Health Research Authority approved this study (23/WM/0105). Learning will be shared across study participants in a workshop at the end of the study. Knowledge products will include a website detailing the created resource and a youth-created film documenting the study process, the elements of the codesigned resource and experiences of implementation. Dissemination will target academic, healthcare, education, social care, third sector and local government settings via knowledge exchange events, social media, accessible briefings, conference presentations and publications.
The impact of the COVID-19 pandemic on children and adolescent mental health in-patient service use in England: interrupted time-series analysis of national patient records.
BACKGROUND: During the initial phases of the COVID-19 pandemic, children and young people (CYP) faced significant restrictions. The virus and mitigation approaches significantly impacted how health services could function and be safely delivered. AIMS: To investigate the impact of COVID-19 lockdowns on CYP psychiatric admission trends during lockdown 1 (started 23 Mar 2020) and lockdown 2 (started 5 Nov 2020) of the COVID-19 pandemic in England. METHOD: Routinely collected, retrospective English administrative data regarding psychiatric hospital admissions, length of stay and patient demographic factors were analysed using an interrupted time series analysis (ITSA) to estimate the impact of COVID-19 lockdowns 1 and 2 on service use trends. We analysed data of 6250 CYP (up to 18 years of age) using ordinary least squares (OLS) regression analysis with Newey-West standard errors to handle autocorrelation and heteroscedasticity. RESULTS: Psychiatric hospital admissions for CYP significantly fell during lockdown 1, and then fell even further during lockdown 2. A greater proportion of admissions during lockdown were out of area or to independent sector units. During lockdown, the average age of CYP admitted was higher, and a greater proportion were female. There was also a significant increase in the proportion of looked-after children and CYP from the most socioeconomically deprived areas admitted during lockdown 2. CONCLUSIONS: During both lockdowns, fewer CYP had psychiatric admissions. The subsequent rise in admissions for more socioeconomically deprived CYP and looked-after children suggests that these CYP may have been disproportionately affected by the pandemic, or overlooked during earlier phases.
Suicide risk assessment tools and prediction models: new evidence, methodological innovations, outdated criticisms.
The number of prediction models for suicide-related outcomes has grown substantially in recent years. These models aim to assist in stratifying risk, improve clinical decision-making, and facilitate a personalised medicine approach to the prevention of suicidal behaviour. However, there are contrasting views as to whether prediction models have potential to inform and improve assessment of suicide risk. In this perspective, we discuss common misconceptions that characterise criticisms of suicide risk prediction research. First, we discuss the limitations of a classification approach to risk assessment (eg, categorising individuals as low-risk vs high-risk), and highlight the benefits of probability estimation. Second, we argue that the preoccupation with classification measures (such as positive predictive value) when assessing a model's predictive performance is inappropriate, and discuss the importance of clinical context in determining the most appropriate risk threshold for a given model. Third, we highlight that adequate discriminative ability for a prediction model depends on the clinical area, and emphasise the importance of calibration, which is almost entirely overlooked in the suicide risk prediction literature. Finally, we point out that conclusions about the clinical utility and health-economic value of suicide prediction models should be based on appropriate measures (such as net benefit and decision-analytic modelling), and highlight the role of impact assessment studies. We conclude that the discussion around using suicide prediction models and risk assessment tools requires more nuance and statistical expertise, and that guidelines and suicide prevention strategies should be informed by the new and higher quality evidence in the field.
How has the COVID-19 pandemic affected the delivery of preventive healthcare? An interrupted time series analysis of adults in English primary care from 2018 to 2022.
OBJECTIVE: Offering advice and support for smoking, obesity, excess alcohol, and physical inactivity is an evidence-based component of primary care. The objective was to quantify the impact of the pandemic on the rate of advice or referral for these four risk factors. METHODS: A retrospective cohort study using primary care data from 1847 practices in England and 21,191,389 patients contributing to the Oxford Clinical Informatics Digital Hub. An interrupted time series analysis was undertaken with a single change point (March 2020). Monthly trends were modelled from 1st January 2018 - 30th June 2022 using segmented linear regression. RESULTS: There was an initial step reduction in advice and referrals for smoking, obesity, excess alcohol, and physical inactivity in March 2020. By June 2022, advice on smoking (slope change -0.02 events per hundred patient years/month (EPH/month); 95% confidence interval (CI) -0.17, 0.21), obesity (0.06 EPH/month; 95% CI 0.01, 0.12), alcohol (0.02 EPH/month; 95% CI -0.01, 0.05) and physical inactivity (0.05 EPH/month; 95% CI 0.01, 0.09) had not returned to pre-pandemic levels. Similarly, smoking cessation referral remained lower (0.01 EPH/month; 95% CI -0.01, 0.09), excess alcohol referral returned to similar levels (0.0005 EPH/month; 95% CI 0.0002, 0.0008), while referral for obesity (0.14 EPH/month; 95% CI 0.10, 0.19) and physical inactivity (0.01 EPH/month; 95% CI 0.01, 0.02) increased relative to pre-pandemic rates. CONCLUSION: Advice and support for smoking, and advice for weight, excess alcohol and physical inactivity have not returned to pre-pandemic levels. Clinicians and policy makers should prioritise preventive care in COVID-19 recovery plans.
A Prognostic Model for Critically Ill Children in Locations With Emerging Critical Care Capacity.
OBJECTIVES: To develop a clinical prediction model to risk stratify children admitted to PICUs in locations with limited resources, and compare performance of the model to nine existing pediatric severity scores. DESIGN: Retrospective, single-center, cohort study. SETTING: PICU of a pediatric hospital in Siem Reap, northern Cambodia. PATIENTS: Children between 28 days and 16 years old admitted nonelectively to the PICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Clinical and laboratory data recorded at the time of PICU admission were collected. The primary outcome was death during PICU admission. One thousand five hundred fifty consecutive nonelective PICU admissions were included, of which 97 died (6.3%). Most existing severity scores achieved comparable discrimination (area under the receiver operating characteristic curves [AUCs], 0.71-0.76) but only three scores demonstrated moderate diagnostic utility for triaging admissions into high- and low-risk groups (positive likelihood ratios [PLRs], 2.65-2.97 and negative likelihood ratios [NLRs], 0.40-0.46). The newly derived model outperformed all existing severity scores (AUC, 0.84; 95% CI, 0.80-0.88; p < 0.001). Using one particular threshold, the model classified 13.0% of admissions as high risk, among which probability of mortality was almost ten-fold greater than admissions triaged as low-risk (PLR, 5.75; 95% CI, 4.57-7.23 and NLR, 0.47; 95% CI, 0.37-0.59). Decision curve analyses indicated that the model would be superior to all existing severity scores and could provide utility across the range of clinically plausible decision thresholds. CONCLUSIONS: Existing pediatric severity scores have limited potential as risk stratification tools in resource-constrained PICUs. If validated, our prediction model would be a readily implementable mechanism to support triage of critically ill children at admission to PICU and could provide value across a variety of contexts where resource prioritization is important.
Enoxaparin for symptomatic COVID-19 managed in the ambulatory setting: An individual patient level analysis of the OVID and ETHIC trials.
BACKGROUND: Antithrombotic treatment may improve the disease course in non-critically ill, symptomatic COVID-19 outpatients. METHODS: We performed an individual patient-level analysis of the OVID and ETHIC randomized controlled trials, which compared enoxaparin thromboprophylaxis for either 14 (OVID) or 21 days (ETHIC) vs. no thromboprophylaxis for outpatients with symptomatic COVID-19 and at least one additional risk factor. The primary efficacy outcome included all-cause hospitalization and all-cause death within 30 days from randomization. Both studies were prematurely stopped for futility. Secondary efficacy outcomes were major symptomatic venous thromboembolic events, arterial cardiovascular events, or their composite occurring within 30 days from randomization. The same outcomes were assessed over a 90-day follow-up. The primary safety outcome was major bleeding (ISTH criteria). RESULTS: A total of 691 patients were randomized: 339 to receive enoxaparin and 352 to the control group. Over 30-day follow-up, the primary efficacy outcome occurred in 6.0 % of patients in the enoxaparin group vs. 5.8 % of controls for a risk ratio (RR) of 1.05 (95%CI 0.57-1.92). The incidence of major symptomatic venous thromboembolic events and arterial cardiovascular events was 0.9 % vs. 1.8 %, respectively (RR 0.52; 95%CI 0.13-2.06). Most cardiovascular thromboembolic events were represented by symptomatic venous thromboembolic events, occurring in 0.6 % vs. 1.5 % of patients, respectively. A similar distribution of outcomes between the treatment groups was observed over 90 days. No major bleeding occurred in the enoxaparin group vs. one (0.3 %) in the control group. CONCLUSIONS: We found no evidence for the clinical benefit of early administration of enoxaparin thromboprophylaxis in outpatients with symptomatic COVID-19. These results should be interpreted taking into consideration the relatively low occurrence of events.
AZD1222 effectiveness against severe COVID-19 in individuals with comorbidity or frailty: The RAVEN cohort study.
OBJECTIVES: Despite being prioritized during initial COVID-19 vaccine rollout, vulnerable individuals at high risk of severe COVID-19 (hospitalization, intensive care unit admission, or death) remain underrepresented in vaccine effectiveness (VE) studies. The RAVEN cohort study (NCT05047822) assessed AZD1222 (ChAdOx1 nCov-19) two-dose primary series VE in vulnerable populations. METHODS: Using the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub, linked to secondary care, death registration, and COVID-19 datasets in England, COVID-19 outcomes in 2021 were compared in vaccinated and unvaccinated individuals matched on age, sex, region, and multimorbidity. RESULTS: Over 4.5 million AZD1222 recipients were matched (mean follow-up ∼5 months); 68% were ≥50 years, 57% had high multimorbidity. Overall, high VE against severe COVID-19 was demonstrated, with lower VE observed in vulnerable populations. VE against hospitalization was higher in the lowest multimorbidity quartile (91.1%; 95% CI: 90.1, 92.0) than the highest quartile (80.4%; 79.7, 81.1), and among individuals ≥65 years, higher in the 'fit' (86.2%; 84.5, 87.6) than the frailest (71.8%; 69.3, 74.2). VE against hospitalization was lowest in immunosuppressed individuals (64.6%; 60.7, 68.1). CONCLUSIONS: Based on integrated and comprehensive UK health data, overall population-level VE with AZD1222 was high. VEs were notably lower in vulnerable groups, particularly the immunosuppressed.
Innovative methods of recruitment through the NIHR Clinical Research Network (CRN) into large-scale pandemic trials in primary care: the PANORAMIC trial experience
BACKGROUND: In the summer of 2021, after 18 months of the COVID-19 pandemic, there were still no clear evidence-based interventions for COVID-19 infection in the community. Recruiting large numbers at pace was a challenge to urgently generate the evidence needed to inform care within the pandemic. AIM: To develop efficient, user-friendly recruitment methods to offer large numbers of acutely unwell, infectious people with COVID-19 UK the opportunity to participate in a priority trial and test the clinical and cost-effectiveness of molnupiravir. METHOD: PANORAMIC was an adaptive platform clinical trial with participants randomised to either a novel antiviral or usual care. Participants needed to start antiviral medication within 5 days of symptom onset. Innovative methods of identifying positive individuals within general practice were developed, as well as online research procedures for delivery and follow-up, including through www.panoramictrial.org. RESULTS: Novel methods of recruitment were developed in collaboration between the study team and the NIHR Clinical Research Network (CRN), and continually adapted during the study. These included virtual recruitment through the study website combined with GP recruitment via hub and spoke models: this was supported by data, stakeholder, and workforce infrastructure across devolved administration. PANORAMIC was the fastest recruiting study ever delivered by primary care in the NIHR CRN. There were 26 411 participants recruited. Final molnupiravir results will also be presented. CONCLUSION: Large-scale, at-pace recruitment supported by the English CRN and equivalent networks across the UK, is achievable in a pandemic situation, producing potentially game-changing results of national and international importance.
SARS-CoV2 in public spaces in West London, UK during COVID-19 pandemic.
BACKGROUND: Spread of SARS-CoV2 by aerosol is considered an important mode of transmission over distances >2 m, particularly indoors. OBJECTIVES: We determined whether SARS-CoV2 could be detected in the air of enclosed/semi-enclosed public spaces. METHODS AND ANALYSIS: Between March 2021 and December 2021 during the easing of COVID-19 pandemic restrictions after a period of lockdown, we used total suspended and size-segregated particulate matter (PM) samplers for the detection of SARS-CoV2 in hospitals wards and waiting areas, on public transport, in a university campus and in a primary school in West London. RESULTS: We collected 207 samples, of which 20 (9.7%) were positive for SARS-CoV2 using quantitative PCR. Positive samples were collected from hospital patient waiting areas, from hospital wards treating patients with COVID-19 using stationary samplers and from train carriages in London underground using personal samplers. Mean virus concentrations varied between 429 500 copies/m3 in the hospital emergency waiting area and the more frequent 164 000 copies/m3 found in other areas. There were more frequent positive samples from PM samplers in the PM2.5 fractions compared with PM10 and PM1. Culture on Vero cells of all collected samples gave negative results. CONCLUSION: During a period of partial opening during the COVID-19 pandemic in London, we detected SARS-CoV2 RNA in the air of hospital waiting areas and wards and of London Underground train carriage. More research is needed to determine the transmission potential of SARS-CoV2 detected in the air.