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IntroductionLong COVID (LC), the persistent symptoms [≥]12 weeks following acute COVID-19, presents major threats to individual and public health across countries, affecting over 1.5 million people in the UK alone. Evidence-based interventions are urgently required and an integrated care pathway (ICP) approach in pragmatic trials, which include investigations, treatments and rehabilitation for LC, could provide scalable and generalisable solutions at pace. Methods and analysisThis is a pragmatic, multi-centre, cluster-randomised clinical trial of two components of an ICP (Coverscan, a multi-organ MRI, and Living with COVID Recovery, a digitally enabled rehabilitation platform) with a nested, Phase III, open label, platform randomised drug trial in individuals with LC. Cluster randomisation is at level of primary care networks so that ICP interventions are delivered as "standard of care" in that area. The drug trial randomisation is at individual level and initial arms are rivaroxaban, colchicine, famotidine/loratadine, compared with no drugs, with potential to add in further drug arms. The trial is being carried out in 6-10 NHS LC clinics in the UK and is evaluating the effectiveness of a pathway of care for adults with LC in reducing fatigue and other physical, psychological and functional outcomes (e.g. EQ-5D-5L, GAD-7, PHQ-9, WSAS, PDQ-5, CFQ, SF-12, MRC Dyspnoea score) at 3 months. The trial also includes an economic evaluation which will be described separately. Ethics and disseminationThe protocol was reviewed by South Central - Berkshire Research Ethics Committee (reference: 21/SC/0416). All participating sites obtained local approvals prior to recruitment. Coverscan has UKCA certification (752965). The first participant was recruited in July 2022 and interim/final results will be disseminated in 2023, in a plan co-developed with public and patient representatives. The results will be presented at national and international conferences, published in peer reviewed medical journals, and shared via media (mainstream and social) and patient support organisations. Trial registration numberISRCTN10665760
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IntroductionIndividuals with Long Covid represent a new and growing patient population. In England, fewer than 90 Long Covid clinics deliver assessment and treatment informed by NICE guidelines. However, a paucity of clinical trials or longitudinal cohort studies means that the epidemiology, clinical trajectory, healthcare utilisation and effectiveness of current Long Covid care are poorly documented, and that neither evidence-based treatments nor rehabilitation strategies exist. In addition, and in part due to pre-pandemic health inequalities, access to referral and care varies, and patient experience of the Long Covid care pathways can be poor. In a mixed methods study, we therefore aim to: (1) describe the usual healthcare, outcomes and resource utilisation of individuals with Long Covid; (2) assess the extent of inequalities in access to Long Covid care, and specifically to understand Long Covid patients experiences of stigma and discrimination. Methods and analysisA mixed methods study will address our aims. Qualitative data collection from patients and health professionals will be achieved through surveys, interviews and focus group discussions, to understand their experience and document the function of clinics. A patient cohort study will provide an understanding of outcomes and costs of care. Accessible data will be further analysed to understand the nature of Long Covid, and the care received. Ethics and disseminationEthical approval was obtained from South Central - Berkshire Research Ethics Committee (reference 303958). The dissemination plan will be decided by the patient and public involvement and engagement (PPIE) group members and study Co-Is, but will target 1) policy makers, and those responsible for commissioning and delivering Long Covid services, 2) patients and the public, and 3) academics.
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BackgroundAssessing relative needs for COVID-19 vaccines across countries has been challenging. The objective of this study was to identify the most important factors for assessing countries needs for vaccines, and to weight each, generating a scoring tool for prioritising countries. MethodsThe study was conducted between March and November 2021. The first stage involved a Delphi survey with a purposive and snowball sample of public health experts, to reach consensus on country-level factors for assessing relative needs for COVID-19 vaccines. The second stage involved a discrete choice experiment (DCE) to determine weights for the factors. ResultsThe study included 28 experts working across 13 different countries and globally. The Delphi survey found 37 factors related to needs. Nine of the most important factors were included in the DCE. Among these, the most important factor was the proportion of overall population not fully vaccinated with a mean weight of 19.5, followed by proportion of high-risk population not fully vaccinated (16.1), health system capacity (14.2), capacity to purchase vaccines (11.9) and the proportion of the population clinically vulnerable (11.3). ConclusionsBy assessing relative needs, this scoring tool can build on existing methods to further the role of equity in global COVID-19 vaccine allocation.
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IntroductionAs mortality rates from COVID-19 disease fall, the high prevalence of long-term sequelae (Long COVID) is becoming increasingly widespread, challenging healthcare systems globally. Traditional pathways of care for Long Term Conditions (LTCs) have tended to be managed by disease-specific specialties, an approach that has been ineffective in delivering care for patients with multi-morbidity. The multi-system nature of Long COVID and its impact on physical and psychological health demands a more effective model of holistic, integrated care. The evolution of integrated care systems (ICSs) in the UK presents an important opportunity to explore areas of mutual benefit to LTC, multi-morbidity and Long COVID care. There may be benefits in comparing and contrasting ICPs for Long COVID with ICPs for other LTCs. Methods and analysisThis study aims to evaluate health services requirements for ICPs for Long COVID and their applicability to other LTCs including multi-morbidity and the overlap with medically not yet explained symptoms (MNYES). The study will follow a Delphi design and involve an expert panel of stakeholders including people with lived experience, as well as clinicians with expertise in Long COVID and other LTCs. Study processes will include expert panel and moderator panel meetings, surveys, and interviews. The Delphi process is part of the overall STIMULATE-ICP programme, aimed at improving integrated care for people with Long COVID. Ethics and disseminationEthical approval for this Delphi study has been obtained (Research Governance Board of the University of York) as have approvals for the other STIMULATE-ICP studies. Study outcomes are likely to inform policy for ICPs across LTCs. Results will be disseminated through scientific publication, conference presentation and communications with patients and stakeholders involved in care of other LTCs and Long COVID. RegistrationResearchregistry: https://www.researchregistry.com/browse-the-registry#home/registrationdetails/6246bfeeeaaed6001f08dadc/.
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ObjectivesTo estimate the impact of the COVID-19 pandemic on cardiovascular disease (CVD) and CVD management using routinely collected medication data as a proxy. DesignDescriptive and interrupted time series analysis using anonymised individual-level population-scale data for 1.32 billion records of dispensed CVD medications across 15.8 million individuals in England, Scotland and Wales. SettingCommunity dispensed CVD medications with 100% coverage from England, Scotland and Wales, plus primary care prescribed CVD medications from England (including 98% English general practices). Participants15.8 million individuals aged 18+ years alive on 1st April 2018 dispensed at least one CVD medicine in a year from England, Scotland and Wales. Main outcome measuresMonthly counts, percent annual change (1st April 2018 to 31st July 2021) and annual rates (1st March 2018 to 28th February 2021) of medicines dispensed by CVD/ CVD risk factor; prevalent and incident use. ResultsYear-on-year change in dispensed CVD medicines by month were observed, with notable uplifts ahead of the first (11.8% higher in March 2020) but not subsequent national lockdowns. Using hypertension as one example of the indirect impact of the pandemic, we observed 491,203 fewer individuals initiated antihypertensive treatment across England, Scotland and Wales during the period March 2020 to end May 2021 than would have been expected compared to 2019. We estimated that this missed antihypertension treatment could result in 13,659 additional CVD events should individuals remain untreated, including 2,281 additional myocardial infarctions (MIs) and 3,474 additional strokes. Incident use of lipid-lowering medicines decreased by an average 14,793 per month in early 2021 compared with the equivalent months prior to the pandemic in 2019. In contrast, the use of incident medicines to treat type-2 diabetes (T2DM) increased by approximately 1,642 patients per month. ConclusionsManagement of key CVD risk factors as proxied by incident use of CVD medicines has not returned to pre-pandemic levels in the UK. Novel methods to identify and treat individuals who have missed treatment are urgently required to avoid large numbers of additional future CVD events, further adding indirect cost of the COVID-19 pandemic.
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BackgroundSeveral countries paused their rollouts of the Oxford-AstraZeneca COVID-19 vaccine in mid-March 2021 due to concerns about vaccine-induced thrombosis and thrombocytopenia. Many warned that this risked damaging public confidence during a critical period of pandemic response. This study investigated whether the pause in the use of the Oxford-AstraZeneca vaccine had an impact on subsequent vaccine uptake in European countries. MethodsWe used a difference-in-differences approach capitalizing on the fact that some countries halted their rollouts whilst others did not. A longitudinal panel was constructed for European Economic Area countries spanning 15 weeks in early 2021. Media reports were used to identify countries that paused the Oxford-AstraZeneca vaccine and the timing of this. Data on vaccine uptake were available through the European Centre for Disease Control and Prevention COVID-19 Vaccine Tracker. Difference-in-differences linear regression models controlled for key confounders that could influence vaccine uptake, and country and week fixed effects. Further models and robustness checks were performed. ResultsThe panel included 28 countries, with 19 in the intervention group and 9 in the control group. Pausing the Oxford-AstraZeneca vaccine was associated with a 0.52% decrease in uptake for the first dose of a COVID-19 vaccine and a 1.49% decrease in the uptake for both doses, comparing countries that paused to those that did not. These estimates are not statistically significant (p=0.86 and 0.39 respectively). For the Oxford-AstraZeneca vaccine only, the pause was associated with a 0.56% increase in uptake for the first dose and a 0.07% decrease in uptake for both doses. These estimates are also not statistically significant (p= 0.56 and 0.51 respectively). All our findings are robust to sensitivity analyses. ConclusionAs new COVID-19 vaccines emerge, regulators should be cautious to deviate from usual protocols if further investigation on clinical or epidemiological grounds is warranted.
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BackgroundPopulation groups to be prioritized for COVID-19 vaccinations in the U.S. have been determined at the Federal level. Evidence suggests that there is variation in how States have implemented this guidance. This review examines how the position of population groups in vaccine priority lists varies between Federal guidance and State practice. MethodsAn online search of State vaccination prioritization plans was conducted. Data were extracted on each population group included and their relative position. A standardized ranking method was applied to provide a directional measure of variability in prioritization between State and Federal guidance, for each population group. ResultsHealthcare workers and those in long-term care facilities were largely prioritized in line with Federal guidance. Aside from early education staff, essential workers were often excluded at State level. Of the 37 States including frontline essential workers, 12 assigned them to a lower priority than recommended. Almost all States included the 65-74 year age group and most assigned them to a higher position than recommended in Federal guidance. Those with underlying medical conditions were similarly highly prioritized, although there was more variability across States. Some socially vulnerable groups (not included in Federal guidance) were highly prioritized by many States. ConclusionsAcross the U.S, the prioritization of groups for COVID-19 vaccination has been highly variable. Essential workers were the most often excluded or less highly prioritised group compared to Federal guidance. Some socially vulnerable groups were highly prioritized in State plans, whilst others were mentioned in only a few States. Future guidance must be relevant to local needs and values, to minimise any unwarranted heterogeneity in vaccine access across populations.
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BackgroundOlder adults and those with underlying health conditions were advised to stay at home to help reduce the spread of COVID-19 however little advice on regular physical activity was given to those at risk. We modelled the effects of enforced inactivity on diabetes burden using published evidence. MethodsUsing Health Survey for England data, we estimated the prevalence of pre-diabetes and physical activity in adults aged 70 and older. The number of new diabetes cases directly attributed to lockdown were calculated using population attributable risk. Unit cost estimates of the additional burden on primary care and the cost of complications to secondary care were taken from the literature. ResultsFrom 9 million older ([≥]70yrs) people living in England, 2.1 million could be defined as pre-diabetic (glycated haemoglobin 42<48 mmol/mol). The estimated population attributable fraction (0.281) (assuming relative risk of diabetes from inactivity=3.3, 40% physically active) would give rise to 392,948 new cases of diabetes which we argue are directly attributed to a prolonged period of lockdown. We estimate that the cost of screening and testing these patients in primary care ({pound}35m), their subsequent treatment and management ({pound}229m), and complications ({pound}909m) would equate to an additional {pound}1.17bn to the health care system. ConclusionsInactivity related to lockdown in previously active older adults may contribute up to {pound}1.17b in additional healthcare costs through a potential increase in diabetes. Clear advice about the importance of physical activity may reduce this potential economic burden during global pandemics.
