Dataset Information

Retrospective cohort study to evaluate medication use in patients hospitalised with COVID-19 in Scotland: protocol for a national observational study

ABSTRACT:

Introduction

COVID-19 has caused millions of hospitalisations and deaths globally. A range of vaccines have been developed and are being deployed at scale in the UK to prevent SARS-CoV-2 infection, which have reduced risk of infection and severe COVID-19 outcomes. Those with COVID-19 are now being treated with several repurposed drugs based on evidence emerging from recent clinical trials. However, there is currently limited real-world data available related to the use of these drugs in routine clinical practice. The purpose of this study is to address the prevailing knowledge gaps regarding the use of dexamethasone, remdesivir and tocilizumab by conducting an exploratory drug utilisation study, aimed at providing in-depth descriptions of patients receiving these drugs as well as the treatment patterns observed in Scotland.

Methods and analysis

Retrospective cohort study, comprising adult patients admitted to hospital with confirmed or suspected COVID-19 across five Scottish Health Boards using data from in-hospital ePrescribing linked to the Early Estimation of Vaccine and Anti-Viral Effectiveness (EAVE II) COVID-19 surveillance platform. The primary outcome will be exposure to the medicines of interest (dexamethasone, remdesivir, tocilizumab), either alone or in combination; exposure will be described in terms of drug(s) of choice; prescribed and administered dose; treatment duration; and any changes in treatment, for example, dose escalation and/or switching to an alternative drug. Analyses will primarily be descriptive in nature.

Ethics and dissemination

Ethical and information governance approvals have been obtained by the National Research Ethics Service Committee, South East Scotland 02 and the Public Benefit and Privacy Panel for Health and Social Care, respectively. Findings from this study will be presented at academic and clinical conferences, and to the funders and other interested parties as appropriate; study findings will also be published in peer-reviewed journals. Publications will be available on the EAVE II website (https://www.ed.ac.uk/usher/eave-ii/key-outputs/our-publications), alongside lay summaries and infographics aimed at the general public. Press releases will also be considered, if appropriate.

SUBMITTER: Mueller T

PROVIDER: S-EPMC8609490 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:INTRODUCTION:Asthma has a considerable, but potentially, avoidable burden on many populations globally. Scotland has some of the poorest health outcomes from asthma. Although ambient pollution, weather changes and sociodemographic factors have been associated with asthma attacks, it remains unclear whether modelled environment data and geospatial information can improve population-based asthma predictive algorithms. We aim to create the afferent loop of a national learning health system for asthma in Scotland. We will investigate the associations between ambient pollution, meteorological, geospatial and sociodemographic factors and asthma attacks. METHODS AND ANALYSIS:We will develop and implement a secured data governance and linkage framework to incorporate primary care health data, modelled environment data, geospatial population and sociodemographic data. Data from 75 recruited primary care practices (n=500?000 patients) in Scotland will be used. Modelled environment data on key air pollutants at a horizontal resolution of 5?km×5?km at hourly time steps will be generated using the EMEP4UK atmospheric chemistry transport modelling system for the datazones of the primary care practices' populations. Scottish population census and education databases will be incorporated into the linkage framework for analysis. We will then undertake a longitudinal retrospective observational analysis. Asthma outcomes include asthma hospitalisations and oral steroid prescriptions. Using a nested case-control study design, associations between all covariates will be measured using conditional logistic regression to account for the matched design and to identify suitable predictors and potential candidate algorithms for an asthma learning health system in Scotland.Findings from this study will contribute to the development of predictive algorithms for asthma outcomes and be used to form the basis for our learning health system prototype. ETHICS AND DISSEMINATION:The study received National Health Service Research Ethics Committee approval (16/SS/0130) and also obtained permissions via the Public Benefit and Privacy Panel for Health and Social Care in Scotland to access, collate and use the following data sets: population and housing census for Scotland; Scottish education data via the Scottish Exchange of Data and primary care data from general practice Data Custodians. Analytic code will be made available in the open source GitHub website. The results of this study will be published in international peer reviewed journals.

Project description:IntroductionThe effects of SARS-CoV-2 in pregnancy are not fully delineated. We will describe the incidence of COVID-19 in pregnancy at population level in Scotland, in a prospective cohort study using linked data. We will determine associations between COVID-19 and adverse pregnancy, neonatal and maternal outcomes and the proportion of confirmed cases of SARS-CoV-2 infection in neonates associated with maternal COVID-19.Methods and analysisProspective cohort study using national linked data sets. We will include all women in Scotland, UK, who were pregnant on or became pregnant after, 1 March 2020 (the date of the first confirmed case of SARS-CoV-2 infection in Scotland) and all births in Scotland from 1 March 2020 onwards. Individual-level data will be extracted from data sets containing details of all livebirths, stillbirth, terminations of pregnancy and miscarriages and ectopic pregnancies treated in hospital or attending general practice. Records will be linked within the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform, which includes primary care records, virology and serology results and details of COVID-19 Community Hubs and Assessment Centre contacts and deaths. We will perform analyses using definitions for confirmed, probable and possible COVID-19 and report serology results (where available). Outcomes will include congenital anomaly, miscarriage, stillbirth, termination of pregnancy, preterm birth, neonatal infection, severe maternal disease and maternal deaths. We will perform descriptive analyses and appropriate modelling, adjusting for demographic and pregnancy characteristics and the presence of comorbidities. The cohort will provide a platform for future studies of the effectiveness and safety of therapeutic interventions and immunisations for COVID-19 and their effects on childhood and developmental outcomes.Ethics and disseminationCOVID-19 in Pregnancy in Scotland is a substudy of EAVE II(, which has approval from the National Research Ethics Service Committee. Findings will be reported to Scottish Government, Public Health Scotland and published in peer-reviewed journals.

Project description:BackgroundChildhood depression is relatively common, under-researched and can impact social and cognitive function and self-esteem.MethodsRecord linkage of routinely collected Scotland-wide administrative databases covering prescriptions [prescribing information system (PIS)], hospitalizations (Scottish Morbidity Records 01 and 04), maternity records (Scottish Morbidity Records 02), deaths (National Records of Scotland), annual pupil census, school absences/exclusions, special educational needs (Scottish Exchange of Educational Data; ScotXed), examinations (Scottish Qualifications Authority) and (un)employment (ScotXed) provided data on 766 237 children attending Scottish schools between 2009 and 2013 inclusively. We compared educational and health outcomes of children receiving antidepressant medication with their peers, adjusting for confounders (socio-demographic, maternity and comorbidity) and explored effect modifiers and mediators.ResultsCompared with peers, children receiving antidepressants were more likely to be absent [adjusted incidence rate ratio (IRR) 1.90, 95% confidence interval (CI) 1.85-1.95] or excluded (adjusted IRR 1.48, 95% CI 1.29-1.69) from school, have special educational needs [adjusted odds ratio (OR) 1.77, 95% CI 1.65-1.90], have the lowest level of academic attainment (adjusted OR 3.00, 95% CI 2.51-3.58) and be unemployed after leaving school (adjusted OR 1.88, 95% CI 1.71-2.08). They had increased hospitalization [adjusted hazard ratio (HR) 2.07, 95% CI 1.98-2.18] and mortality (adjusted HR 2.73, 95% CI 1.73-4.29) over 5 years' follow-up. Higher absenteeism partially explained poorer attainment and unemployment. Treatment with antidepressants was less common among boys than girls (0.5% vs 1.0%) but the associations with special educational need and unemployment were stronger in boys.ConclusionsChildren receiving antidepressants fare worse than their peers across a wide range of education and health outcomes. Interventions to reduce absenteeism or mitigate its effects should be investigated.

Project description:IntroductionSkin and soft tissue infections of the eye can be classified based on anatomic location as either anterior to the orbital septum (ie, periorbital cellulitis) or posterior to the orbital septum (ie, orbital cellulitis). These two conditions are often considered together in hospitalised children as clinical differentiation is difficult, especially in young children. Prior studies have identified variation in management of hospitalised children with orbital cellulitis; however, they have been limited either as single centre studies or by the use of administrative data which lacks clinical details important for interpreting variation in care. We aim to describe the care and outcomes of Canadian children hospitalised with periorbital and orbital cellulitis.Method and analysisThis is a multisite retrospective cohort study including previously healthy children aged 2 months to 18 years admitted to hospital with periorbital or orbital cellulitis from 2009 to 2018. Clinical data from medical records from multiple Canadian hospitals will be collected, including community and academic centres. Demographic characteristics and study outcomes will be summarised using descriptive statistics, including diagnostic testing, antibiotic therapy, adjunctive therapy, surgical intervention and clinical outcomes. Variation will be described and evaluated using ?² test or Kruskal-Wallis test. Generalised linear mixed models will be used to identify predictors of surgical intervention and longer length of stay.Ethics and disseminationApproval of the study by the Research Ethics Board at each participating site has been obtained prior to data extraction. Study results will be disseminated by presentations at national and international meetings and by publications in high impact open access journals. By identifying important differences in management and outcomes by each hospital, the results will identify areas where care can be improved, practice standardised, unnecessary diagnostic imaging reduced, pharmacotherapy rationalised and where trials are needed.

Project description:ObjectivesTo compare the mortality in those previously hospitalised for mental disorder in Scotland to that experienced by the general population.DesignPopulation-based historical cohort study using routinely available psychiatric hospital discharge and death records.SettingAll Scotland.ParticipantsIndividuals with a first hospital admission for mental disorder between 1986 and 2009 who had died by 31 December 2010 (34 243 individuals).OutcomesThe main outcome measure was death from any cause, 1986-2010. Excess mortality was presented as standardised mortality ratios (SMRs) and years of life lost (YLL). Excess mortality was assessed overall and by age, sex, main psychiatric diagnosis, whether the psychiatric diagnosis was 'complicated' (ie, additional mental or physical ill-health diagnoses present), cause of death and time period of first admission.Results111 504 people were included in the study, and 34 243 had died by 31 December 2010. The average reduction in life expectancy for the whole cohort was 17 years, with eating disorders (39-year reduction) and 'complicated' personality disorders (27.5-year reduction) being worst affected. 'Natural' causes of death such as cardiovascular disease showed modestly elevated relative risk (SMR1.7), but accounted for 67% of all deaths and 54% of the total burden of YLL. Non-natural deaths such as suicide showed higher relative risk (SMR5.2) and tended to occur at a younger age, but were less common overall (11% of all deaths and 22% of all YLL). Having a 'complicated' diagnosis tended to elevate the risk of early death. No worsening of the overall excess mortality experienced by individuals with previous psychiatric admission over time was observed.ConclusionsEarly death for those hospitalised with mental disorder is common, and represents a significant inequality even in well-developed healthcare systems. Prevention of suicide and cardiovascular disease deserves particular attention in the mentally disordered.