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BACKGROUND: Several countries restricted the administration of ChAdOx1 to older age groups in 2021 over safety concerns following case reports and observed versus expected analyses suggesting a possible association with cerebral venous sinus thrombosis (CVST). Large datasets are required to precisely estimate the association between Coronavirus Disease 2019 (COVID-19) vaccination and CVST due to the extreme rarity of this event. We aimed to accomplish this by combining national data from England, Scotland, and Wales. METHODS AND FINDINGS: We created data platforms consisting of linked primary care, secondary care, mortality, and virological testing data in each of England, Scotland, and Wales, with a combined cohort of 11,637,157 people and 6,808,293 person years of follow-up. The cohort start date was December 8, 2020, and the end date was June 30, 2021. The outcome measure we examined was incident CVST events recorded in either primary or secondary care records. We carried out a self-controlled case series (SCCS) analysis of this outcome following first dose vaccination with ChAdOx1 and BNT162b2. The observation period consisted of an initial 90-day reference period, followed by a 2-week prerisk period directly prior to vaccination, and a 4-week risk period following vaccination. Counts of CVST cases from each country were tallied, then expanded into a full dataset with 1 row for each individual and observation time period. There was a combined total of 201 incident CVST events in the cohorts (29.5 per million person years). There were 81 CVST events in the observation period among those who a received first dose of ChAdOx1 (approximately 16.34 per million doses) and 40 for those who received a first dose of BNT162b2 (approximately 12.60 per million doses). We fitted conditional Poisson models to estimate incidence rate ratios (IRRs). Vaccination with ChAdOx1 was associated with an elevated risk of incident CVST events in the 28 days following vaccination, IRR = 1.93 (95% confidence interval (CI) 1.20 to 3.11). We did not find an association between BNT162b2 and CVST in the 28 days following vaccination, IRR = 0.78 (95% CI 0.34 to 1.77). Our study had some limitations. The SCCS study design implicitly controls for variables that are constant over the observation period, but also assumes that outcome events are independent of exposure. This assumption may not be satisfied in the case of CVST, firstly because it is a serious adverse event, and secondly because the vaccination programme in the United Kingdom prioritised the clinically extremely vulnerable and those with underlying health conditions, which may have caused a selection effect for individuals more prone to CVST. Although we pooled data from several large datasets, there was still a low number of events, which may have caused imprecision in our estimates. CONCLUSIONS: In this study, we observed a small elevated risk of CVST events following vaccination with ChAdOx1, but not BNT162b2. Our analysis pooled information from large datasets from England, Scotland, and Wales. This evidence may be useful in risk-benefit analyses of vaccine policies and in providing quantification of risks associated with vaccination to the general public.
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Vacuna BNT162 , COVID-19/prevención & control , ChAdOx1 nCoV-19 , SARS-CoV-2/patogenicidad , Trombosis de los Senos Intracraneales/etiología , Adulto , Anciano , Vacuna BNT162/efectos adversos , Vacunas contra la COVID-19/efectos adversos , Estudios de Casos y Controles , ChAdOx1 nCoV-19/efectos adversos , Estudios de Cohortes , Humanos , Masculino , Persona de Mediana Edad , Reino Unido , Vacunación/estadística & datos numéricos , GalesRESUMEN
BACKGROUND: It remains unclear to what extent reductions in urgent referrals for suspected cancer during the COVID-19 pandemic were the result of fewer patients attending primary care compared to GPs referring fewer patients. METHODS: Cohort study including electronic health records data from 8,192,069 patients from 663 English practices. Weekly consultation rates, cumulative consultations and referrals were calculated for 28 clinical features from the NICE suspected cancer guidelines. Clinical feature consultation rate ratios (CRR) and urgent referral rate ratios (RRR) compared time periods in 2020 with 2019. FINDINGS: Consultations for cancer clinical features decreased by 24.19% (95% CI: 24.04-24.34%) between 2019 and 2020, particularly in the 6-12 weeks following the first national lockdown. Urgent referrals for clinical features decreased by 10.47% (95% CI: 9.82-11.12%) between 2019 and 2020. Overall, once patients consulted with primary care, GPs urgently referred a similar or greater proportion of patients compared to previous years. CONCLUSION: Due to the significant fall in patients consulting with clinical features of cancer there was a lower than expected number of urgent referrals in 2020. Sustained efforts should be made throughout the pandemic to encourage the public to consult their GP with cancer clinical features.
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COVID-19 , Neoplasias , COVID-19/epidemiología , Estudios de Cohortes , Control de Enfermedades Transmisibles , Humanos , Neoplasias/epidemiología , Neoplasias/terapia , Pandemias , Atención Primaria de Salud , Derivación y ConsultaRESUMEN
BACKGROUND: The BNT162b2 mRNA (Pfizer-BioNTech) and ChAdOx1 nCoV-19 (Oxford-AstraZeneca) COVID-19 vaccines have shown high efficacy against disease in phase 3 clinical trials and are now being used in national vaccination programmes in the UK and several other countries. Studying the real-world effects of these vaccines is an urgent requirement. The aim of our study was to investigate the association between the mass roll-out of the first doses of these COVID-19 vaccines and hospital admissions for COVID-19. METHODS: We did a prospective cohort study using the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19-EAVE II-database comprising linked vaccination, primary care, real-time reverse transcription-PCR testing, and hospital admission patient records for 5·4 million people in Scotland (about 99% of the population) registered at 940 general practices. Individuals who had previously tested positive were excluded from the analysis. A time-dependent Cox model and Poisson regression models with inverse propensity weights were fitted to estimate effectiveness against COVID-19 hospital admission (defined as 1-adjusted rate ratio) following the first dose of vaccine. FINDINGS: Between Dec 8, 2020, and Feb 22, 2021, a total of 1 331 993 people were vaccinated over the study period. The mean age of those vaccinated was 65·0 years (SD 16·2). The first dose of the BNT162b2 mRNA vaccine was associated with a vaccine effect of 91% (95% CI 85-94) for reduced COVID-19 hospital admission at 28-34 days post-vaccination. Vaccine effect at the same time interval for the ChAdOx1 vaccine was 88% (95% CI 75-94). Results of combined vaccine effects against hospital admission due to COVID-19 were similar when restricting the analysis to those aged 80 years and older (83%, 95% CI 72-89 at 28-34 days post-vaccination). INTERPRETATION: Mass roll-out of the first doses of the BNT162b2 mRNA and ChAdOx1 vaccines was associated with substantial reductions in the risk of hospital admission due to COVID-19 in Scotland. There remains the possibility that some of the observed effects might have been due to residual confounding. FUNDING: UK Research and Innovation (Medical Research Council), Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK.
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Vacunas contra la COVID-19 , COVID-19/prevención & control , Hospitalización/estadística & datos numéricos , Vacunación Masiva , Pandemias/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Vacuna BNT162 , COVID-19/epidemiología , ChAdOx1 nCoV-19 , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Escocia/epidemiología , Clase Social , Adulto JovenRESUMEN
PsA is a complex, heterogeneous disease that can place a large burden on patients' psychological and physical well-being. The multifaceted nature of PsA poses a significant assessment challenge, both in randomized control trials and in clinical practice. In recent years, there has been much progress in the development of unidimensional and composite measures of disease activity, as well as of questionnaires that capture the patient's perspective of the condition. Despite these advances, there remains uncertainty around which tools to implement within a research setting. This review aims to summarize the currently available clinical and patient-derived assessment tools, providing a practical and informative resource for the assessment of PsA. This review will also explore recent advancements in digital approaches to the assessment of rheumatological conditions. This will highlight the potential for digitalization in the assessment and monitoring of PsA, outlining innovative means of capturing disease activity and treatment response.
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Artritis Psoriásica/tratamiento farmacológico , Artritis Psoriásica/psicología , Informática Médica/instrumentación , Encuestas y Cuestionarios/estadística & datos numéricos , Artritis/complicaciones , Artritis Psoriásica/patología , Costo de Enfermedad , Entesopatía/complicaciones , Humanos , Evaluación de Resultado en la Atención de Salud , Dimensión del Dolor/estadística & datos numéricos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Espondiloartropatías/complicaciones , Telemedicina/métodosRESUMEN
Common to all inflammatory arthritides, namely rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and juvenile idiopathic arthritis, is a potential for reduced mobility that manifests through joint pain, swelling, stiffness, and ultimately joint damage. Across these conditions, consensus has been reached on the need to capture outcomes related to mobility, such as functional capacity and physical activity, as core domains in randomised controlled trials. Existing endpoints within these core domains rely wholly on self-reported questionnaires that capture patients' perceptions of their symptoms and activities. These questionnaires are subjective, inherently vulnerable to recall bias, and do not capture the granularity of fluctuations over time. Several early adopters have integrated sensor-based digital health technology (DHT)-derived endpoints to measure physical function and activity in randomised controlled trials for conditions including Parkinson's disease, Duchenne's muscular dystrophy, chronic obstructive pulmonary disease, and heart failure. Despite these applications, there have been no sensor-based DHT-derived endpoints in clinical trials recruiting patients with inflammatory arthritis. Borrowing from case studies across medicine, we outline the opportunities and challenges in developing novel sensor-based DHT-derived endpoints that capture the symptoms and disease manifestations most relevant to patients with inflammatory arthritis.
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BACKGROUND: Digital technologies, such as wearable devices and smartphone applications (apps), can enable the decentralisation of clinical trials by measuring endpoints in people's chosen locations rather than in traditional clinical settings. Digital endpoints can allow high-frequency and sensitive measurements of health outcomes compared to visit-based endpoints which provide an episodic snapshot of a person's health. However, there are underexplored challenges in this emerging space that require interdisciplinary and cross-sector collaboration. A multi-stakeholder Knowledge Exchange event was organised to facilitate conversations across silos within this research ecosystem. METHODS: A survey was sent to an initial list of stakeholders to identify potential discussion topics. Additional stakeholders were identified through iterative discussions on perspectives that needed representation. Co-design meetings with attendees were held to discuss the scope, format and ethos of the event. The event itself featured a cross-disciplinary selection of talks, a panel discussion, small-group discussions facilitated via a rolling seating plan and audience participation via Slido. A transcript was generated from the day, which, together with the output from Slido, provided a record of the day's discussions. Finally, meetings were held following the event to identify the key challenges for digital endpoints which emerged and reflections and recommendations for dissemination. RESULTS: Several challenges for digital endpoints were identified in the following areas: patient adherence and acceptability; algorithms and software for devices; design, analysis and conduct of clinical trials with digital endpoints; the environmental impact of digital endpoints; and the need for ongoing ethical support. Learnings taken for next generation events include the need to include additional stakeholder perspectives, such as those of funders and regulators, and the need for additional resources and facilitation to allow patient and public contributors to engage meaningfully during the event. CONCLUSIONS: The event emphasised the importance of consortium building and highlighted the critical role that collaborative, multi-disciplinary, and cross-sector efforts play in driving innovation in research design and strategic partnership building moving forward. This necessitates enhanced recognition by funders to support multi-stakeholder projects with patient involvement, standardised terminology, and the utilisation of open-source software.
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Ensayos Clínicos como Asunto , Determinación de Punto Final , Participación de los Interesados , Humanos , Ensayos Clínicos como Asunto/métodos , Conducta Cooperativa , Comunicación Interdisciplinaria , Aplicaciones Móviles , Dispositivos Electrónicos Vestibles , Proyectos de Investigación , Teléfono InteligenteRESUMEN
Background: Psoriatic arthritis (PsA) is associated with sleep disturbance, depression and a lifetime risk of obesity and cardiovascular disease. To date, there have been no studies investigating the relationship between objectively-measured physical activity (PA) levels and circadian rhythm disturbance with disease activity, daily symptoms and mood in patients with PsA. Objective: This pilot study aimed to investigate the relationship between disease activity, daily symptoms and mood on PA and circadian rhythm in PsA. Design: A prospective cohort study recruiting adults with PsA from rheumatology clinics at a single centre in the UK. Methods: Participants wore an actigraph and recorded their symptoms and mood on a daily basis via a smartphone app for 28 days. Time spent in sedentary, light and moderate-to-vigorous physical activity (MVPA) and parameters reflecting the circadian rhythm of the rest-activity pattern were derived. This included the onset time of the least active 5-h (L5) and most active 10-h (M10) daily consecutive periods and the relative amplitude (RA). The relationship factors between baseline clinical status, daily symptoms, PA and circadian measures were examined using linear mixed effect regression models. Results: Nineteen participants (8/19 female) were included. Participants with active PsA spent 63.87 min (95% CI: 18.5-109.3, p = 0.008) more in inactivity and 30.78 min (95% CI: 0.4-61.1, p = 0.047) less in MVPA per day compared to those in minimal disease activity (MDA). Age, body mass index and disease duration were also associated with PA duration. Participants with worse functional impairment had an M10 onset time 1.94 h (95% CI: 0.05-3.39, p = 0.011) later than those with no reported functional impairment. No differences were detected for L5 onset time or RA. Higher scores for positive mood components such as feeling energetic, cheerful and elated were associated with less time in inactivity and greater time spent in MVPA overall. Conclusion: Our study highlights differences in PA and circadian rest-activity pattern timing based on disease activity, disability and daily mood in PsA. Reduced PA levels in patients with active disease may contribute to the observed increased risk of cardiovascular and metabolic sequelae, with further studies exploring this need.
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PURPOSE: Psoriatic arthritis (PsA) is a multisystem inflammatory disorder associated with significant mortality and morbidity, including functional impairment and psychological disability. Although evidence-based treatment recommendations are available for the use of drug treatments in PsA, there is little guidance for health professionals on nonpharmacologic and psychological interventions that may be useful in PsA. The objective of this systematic review (SR) was to identify how lifestyle modifications and the use of nonpharmacologic and psychological interventions may improve the outcomes of patients with PsA. METHODS: Studies were included if they evaluated adults diagnosed with PsA and included exposure to nonpharmacologic interventions, psychological interventions, and lifestyle modifications. The outcomes used needed to have been validated in PsA. A systematic literature search was run on May 28, 2021, in the Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), EMBASE, Global Health, MEDLINE, and PsycINFO databases to identify articles related to lifestyle modifications and nonpharmacologic or psychological interventions for adults with PsA published between 2010 and 2021. Two review authors independently screened and selected full-text studies for inclusion in the SR. Risk of bias was assessed with either the Risk of Bias 2 (ie, RoB 2) tool or Critical Appraisal Skills Program checklist depending on the study type. FINDINGS: The search strategy identified 26,132 references. Eight studies examining lifestyle modifications and the effect on PsA were eligible to be included in the SR. Three of the 8 studies were randomized controlled trials, and 5 were nonrandomized studies. Three studies assessed physical activity, 3 assessed diet, 1 study assessed smoking, and another study assessed mud bath therapy. There was large heterogeneity between studies, and the measures of disease activity, and psychological and functional outcomes varied widely between studies. IMPLICATIONS: Although this SR identified 8 relevant studies, these studies did not provide high-quality evidence to guide patients for non-drug treatments of PsA. The effectiveness of these interventions has therefore not been established. We found that physical activity seems to have a positive impact on disease activity and psychological well-being. Further well-designed research studies are needed to develop treatment recommendations. PROSPERO identifier: CRD42021257404.
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Artritis Psoriásica , Adulto , Humanos , Artritis Psoriásica/tratamiento farmacológico , Terapia Conductista , Estilo de VidaRESUMEN
INTRODUCTION: The novel coronavirus SARS-CoV-2, which emerged in December 2019, has caused millions of deaths and severe illness worldwide. Numerous vaccines are currently under development of which a few have now been authorised for population-level administration by several countries. As of 20 September 2021, over 48 million people have received their first vaccine dose and over 44 million people have received their second vaccine dose across the UK. We aim to assess the uptake rates, effectiveness, and safety of all currently approved COVID-19 vaccines in the UK. METHODS AND ANALYSIS: We will use prospective cohort study designs to assess vaccine uptake, effectiveness and safety against clinical outcomes and deaths. Test-negative case-control study design will be used to assess vaccine effectiveness (VE) against laboratory confirmed SARS-CoV-2 infection. Self-controlled case series and retrospective cohort study designs will be carried out to assess vaccine safety against mild-to-moderate and severe adverse events, respectively. Individual-level pseudonymised data from primary care, secondary care, laboratory test and death records will be linked and analysed in secure research environments in each UK nation. Univariate and multivariate logistic regression models will be carried out to estimate vaccine uptake levels in relation to various population characteristics. VE estimates against laboratory confirmed SARS-CoV-2 infection will be generated using a generalised additive logistic model. Time-dependent Cox models will be used to estimate the VE against clinical outcomes and deaths. The safety of the vaccines will be assessed using logistic regression models with an offset for the length of the risk period. Where possible, data will be meta-analysed across the UK nations. ETHICS AND DISSEMINATION: We obtained approvals from the National Research Ethics Service Committee, Southeast Scotland 02 (12/SS/0201), the Secure Anonymised Information Linkage independent Information Governance Review Panel project number 0911. Concerning English data, University of Oxford is compliant with the General Data Protection Regulation and the National Health Service (NHS) Digital Data Security and Protection Policy. This is an approved study (Integrated Research Application ID 301740, Health Research Authority (HRA) Research Ethics Committee 21/HRA/2786). The Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub meets NHS Digital's Data Security and Protection Toolkit requirements. In Northern Ireland, the project was approved by the Honest Broker Governance Board, project number 0064. Findings will be made available to national policy-makers, presented at conferences and published in peer-reviewed journals.
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Vacunas contra la COVID-19 , COVID-19 , Estudios de Casos y Controles , Humanos , Estudios Observacionales como Asunto , Estudios Prospectivos , Estudios Retrospectivos , SARS-CoV-2 , Escocia/epidemiología , Medicina EstatalRESUMEN
The aims of treatment for psoriatic arthritis (PsA) are to control inflammation, normalise functions and impacts on patients and prevent complications of the disease and its treatment. Over the past decade, treatment options for PsA have expanded with the availability of many more novel therapeutic agents. However, the treatment decisions and pathways for the use of these drugs are not always straightforward. There is a need to tailor the choice of medication to the individual patient, taking into account the type of their disease and consideration of other factors such as their co-morbidities. A treat to target approach is recommended with the aim to get the patient into a state of remission or low disease activity (whichever target is chosen). Both European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) have recently published updated guidance in 2018-2019. In this section, we will summarise the evidence for therapies in PsA and review the similarities and differences in these two sets of recommendations.
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Antirreumáticos , Artritis Psoriásica , Reumatología , Antirreumáticos/uso terapéutico , Artritis Psoriásica/diagnóstico , Artritis Psoriásica/tratamiento farmacológico , HumanosRESUMEN
OBJECTIVES: To mitigate risk of mortality from coronavirus 2019 infection (COVID-19), the UK government recommended 'shielding' of vulnerable people through self-isolation for 12 weeks. METHODS: A retrospective cohort study using a nationally representative English primary care database comparing people aged >= 40 years who were recorded as being advised to shield using a fixed ratio of 1:1, matching to people with the same diagnoses not advised to shield (nâ¯=â¯77,360 per group). Time-to-death was compared using Cox regression, reporting the hazard ratio (HR) of mortality between groups. A sensitivity analysis compared exact matched cohorts (nâ¯=â¯24,752 shielded, nâ¯=â¯61,566 exact matches). RESULTS: We found a time-varying HR of mortality between groups. In the first 21 days, the mortality risk in people shielding was half those not (HRâ¯=â¯0.50, 95%CI:0.41-0.59. p < 0.0001). Over the remaining nine weeks, mortality risk was 54% higher in the shielded group (HR=1.54, 95%CI:1.41-1.70, p < 0.0001). Beyond the shielding period, mortality risk was over two-and-a-half times higher in the shielded group (HR=2.61, 95%CI:2.38-2.87, p < 0.0001). CONCLUSIONS: Shielding halved the risk of mortality for 21 days. Mortality risk became higher across the remainder of the shielding period, rising to two-and-a-half times greater post-shielding. Shielding may be beneficial in the next wave of COVID-19.
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COVID-19 , Estudios de Cohortes , Humanos , Atención Primaria de Salud , Estudios Retrospectivos , SARS-CoV-2RESUMEN
Hypertension has been identified as a risk factor for coronavirus disease 2019 (COVID-19) and associated adverse outcomes. This study examined the association between preinfection blood pressure (BP) control and COVID-19 outcomes using data from 460 general practices in England. Eligible patients were adults with hypertension who were tested or diagnosed with COVID-19. BP control was defined by the most recent BP reading within 24 months of the index date (January 1, 2020). BP was defined as controlled (<130/80 mm Hg), raised (130/80-139/89 mm Hg), stage 1 uncontrolled (140/90-159/99 mm Hg), or stage 2 uncontrolled (≥160/100 mm Hg). The primary outcome was death within 28 days of COVID-19 diagnosis. Secondary outcomes were COVID-19 diagnosis and COVID-19-related hospital admission. Multivariable logistic regression was used to examine the association between BP control and outcomes. Of the 45 418 patients (mean age, 67 years; 44.7% male) included, 11 950 (26.3%) had controlled BP. These patients were older, had more comorbidities, and had been diagnosed with hypertension for longer. A total of 4277 patients (9.4%) were diagnosed with COVID-19 and 877 died within 28 days. Individuals with stage 1 uncontrolled BP had lower odds of COVID-19 death (odds ratio, 0.76 [95% CI, 0.62-0.92]) compared with patients with well-controlled BP. There was no association between BP control and COVID-19 diagnosis or hospitalization. These findings suggest BP control may be associated with worse COVID-19 outcomes, possibly due to these patients having more advanced atherosclerosis and target organ damage. Such patients may need to consider adhering to stricter social distancing, to limit the impact of COVID-19 as future waves of the pandemic occur.
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Presión Sanguínea/efectos de los fármacos , COVID-19/epidemiología , Hipertensión/epidemiología , Pandemias , SARS-CoV-2 , Adulto , Anciano , Anciano de 80 o más Años , Antihipertensivos/uso terapéutico , Aterosclerosis/epidemiología , COVID-19/prevención & control , Comorbilidad , Inglaterra/epidemiología , Etnicidad/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Hospitalización/estadística & datos numéricos , Humanos , Hipertensión/tratamiento farmacológico , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Atención Primaria de Salud/estadística & datos numéricos , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
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.
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Protocolos Clínicos , Gripe Humana/prevención & control , Infecciones del Sistema Respiratorio/prevención & control , Vacunas/uso terapéutico , COVID-19/prevención & control , Femenino , Humanos , Gripe Humana/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Vigilancia de la Población/métodos , Salud Pública , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Infecciones del Sistema Respiratorio/virología , Reino Unido , Tratamiento Farmacológico de COVID-19RESUMEN
BACKGROUND: There is an urgent need for epidemiological research in primary care to develop risk assessment processes for patients presenting with COVID-19, but lack of a standardised approach to data collection is a significant barrier to implementation. AIM: To collate a list of relevant symptoms, assessment items, demographics, and lifestyle and health conditions associated with COVID-19, and match these data items with corresponding SNOMED CT clinical terms to support the development and implementation of consultation templates. DESIGN & SETTING: Published and preprint literature for systematic reviews, meta-analyses, and clinical guidelines describing the symptoms, assessment items, demographics, and/or lifestyle and health conditions associated with COVID-19 and its complications were reviewed. Corresponding clinical concepts from SNOMED CT, a widely used structured clinical vocabulary for electronic primary care health records, were identified. METHOD: Guidelines and published and unpublished reviews (N = 61) were utilised to collate a list of relevant data items for COVID-19 consultations. The NHS Digital SNOMED CT Browser was used to identify concept and descriptive identifiers. Key implementation challenges were conceptualised through a Normalisation Process Theory (NPT) lens. RESULTS: In total, 32 symptoms, eight demographic and lifestyle features, 25 health conditions, and 20 assessment items relevant to COVID-19 were identified, with proposed corresponding SNOMED CT concepts. These data items can be adapted into a consultation template for COVID-19. Key implementation challenges include: 1) engaging with key stakeholders to achieve 'buy in'; and 2) ensuring any template is usable within practice settings. CONCLUSION: Consultation templates for COVID-19 are needed to standardise data collection, facilitate research and learning, and potentially improve quality of care for COVID-19.
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BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in a rapid change in workload across healthcare systems. Factors related to this adaptation in UK primary care have not yet been examined. AIM: To assess the responsiveness and prioritisation of primary care consultation type for older adults during the COVID-19 pandemic. DESIGN AND SETTING: A cross-sectional database study examining consultations between 17 February and 10 May 2020 for patients aged ≥65 years, drawn from primary care practices within the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network, UK. METHOD: The authors reported the proportion of consultation type across five categories: clinical administration, electronic/video, face-to-face, telephone, and home visits. Temporal trends in telephone and face-to-face consultations were analysed by polypharmacy, frailty status, and socioeconomic group using incidence rate ratios (IRR). RESULTS: Across 3 851 304 consultations, the population median age was 75 years (interquartile range [IQR] 70-82); and 46% (n = 82 926) of the cohort (N = 180 420) were male. The rate of telephone and electronic/video consultations more than doubled across the study period (106.0% and 102.8%, respectively). Face-to-face consultations fell by 64.6% and home visits by 62.6%. This predominantly occurred across week 11 (week commencing 9 March 2020), coinciding with national policy change. Polypharmacy and frailty were associated with a relative increase in consultations. The greatest relative increase was among people taking ≥10 medications compared with those taking none (face-to-face IRR 9.90, 95% CI = 9.55 to 10.26; telephone IRR 17.64, 95% CI = 16.89 to 18.41). CONCLUSION: Primary care has undergone an unprecedented in-pandemic reorganisation while retaining focus on patients with increased complexity.
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Betacoronavirus , Infecciones por Coronavirus/terapia , Visita Domiciliaria/estadística & datos numéricos , Neumonía Viral/terapia , Atención Primaria de Salud/organización & administración , Anciano , COVID-19 , Infecciones por Coronavirus/epidemiología , Estudios Transversales , Femenino , Médicos Generales/organización & administración , Humanos , Masculino , Pandemias , Neumonía Viral/epidemiología , SARS-CoV-2 , Reino Unido/epidemiologíaRESUMEN
BACKGROUND: The SARS-CoV-2 pandemic has passed its first peak in Europe. AIM: To describe the mortality in England and its association with SARS-CoV-2 status and other demographic and risk factors. DESIGN AND SETTING: Cross-sectional analyses of people with known SARS-CoV-2 status in the Oxford RCGP Research and Surveillance Centre (RSC) sentinel network. METHOD: Pseudonymised, coded clinical data were uploaded from volunteer general practice members of this nationally representative network (n = 4 413 734). All-cause mortality was compared with national rates for 2019, using a relative survival model, reporting relative hazard ratios (RHR), and 95% confidence intervals (CI). A multivariable adjusted odds ratios (OR) analysis was conducted for those with known SARS-CoV-2 status (n = 56 628, 1.3%) including multiple imputation and inverse probability analysis, and a complete cases sensitivity analysis. RESULTS: Mortality peaked in week 16. People living in households of ≥9 had a fivefold increase in relative mortality (RHR = 5.1, 95% CI = 4.87 to 5.31, P<0.0001). The ORs of mortality were 8.9 (95% CI = 6.7 to 11.8, P<0.0001) and 9.7 (95% CI = 7.1 to 13.2, P<0.0001) for virologically and clinically diagnosed cases respectively, using people with negative tests as reference. The adjusted mortality for the virologically confirmed group was 18.1% (95% CI = 17.6 to 18.7). Male sex, population density, black ethnicity (compared to white), and people with long-term conditions, including learning disability (OR = 1.96, 95% CI = 1.22 to 3.18, P = 0.0056) had higher odds of mortality. CONCLUSION: The first SARS-CoV-2 peak in England has been associated with excess mortality. Planning for subsequent peaks needs to better manage risk in males, those of black ethnicity, older people, people with learning disabilities, and people who live in multi-occupancy dwellings.
Asunto(s)
COVID-19 , Enfermedades no Transmisibles/epidemiología , SARS-CoV-2/aislamiento & purificación , Factores de Edad , COVID-19/diagnóstico , COVID-19/epidemiología , Registros Electrónicos de Salud/estadística & datos numéricos , Inglaterra/epidemiología , Etnicidad , Composición Familiar , Femenino , Humanos , Masculino , Persona de Mediana Edad , Mortalidad , Medición de Riesgo/métodos , Factores de Riesgo , Vigilancia de Guardia , Factores SexualesRESUMEN
BACKGROUND: Creating an ontology for COVID-19 surveillance should help ensure transparency and consistency. Ontologies formalize conceptualizations at either the domain or application level. Application ontologies cross domains and are specified through testable use cases. Our use case was an extension of the role of the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) to monitor the current pandemic and become an in-pandemic research platform. OBJECTIVE: This study aimed to develop an application ontology for COVID-19 that can be deployed across the various use-case domains of the RCGP RSC research and surveillance activities. METHODS: We described our domain-specific use case. The actor was the RCGP RSC sentinel network, the system was the course of the COVID-19 pandemic, and the outcomes were the spread and effect of mitigation measures. We used our established 3-step method to develop the ontology, separating ontological concept development from code mapping and data extract validation. We developed a coding system-independent COVID-19 case identification algorithm. As there were no gold-standard pandemic surveillance ontologies, we conducted a rapid Delphi consensus exercise through the International Medical Informatics Association Primary Health Care Informatics working group and extended networks. RESULTS: Our use-case domains included primary care, public health, virology, clinical research, and clinical informatics. Our ontology supported (1) case identification, microbiological sampling, and health outcomes at an individual practice and at the national level; (2) feedback through a dashboard; (3) a national observatory; (4) regular updates for Public Health England; and (5) transformation of a sentinel network into a trial platform. We have identified a total of 19,115 people with a definite COVID-19 status, 5226 probable cases, and 74,293 people with possible COVID-19, within the RCGP RSC network (N=5,370,225). CONCLUSIONS: The underpinning structure of our ontological approach has coped with multiple clinical coding challenges. At a time when there is uncertainty about international comparisons, clarity about the basis on which case definitions and outcomes are made from routine data is essential.
Asunto(s)
Ontologías Biológicas , COVID-19/epidemiología , Atención Primaria de Salud/métodos , Vigilancia de Guardia , Humanos , PandemiasRESUMEN
OBJECTIVES: Few studies report contributors to the excess mortality in England during the first wave of coronavirus disease 2019 (COVID-19) infection. We report the absolute excess risk (AER) of mortality and excess mortality rate (EMR) from a nationally representative COVID-19 sentinel surveillance network including known COVID-19 risk factors in people aged 45 years and above. METHODS: Pseudonymised, coded clinical data were uploaded from contributing primary care providers (Nâ¯=â¯1,970,314, ≥45years). We calculated the AER in mortality by comparing mortality for weeks 2 to 20 this year with mortality data from the Office for National Statistics (ONS) from 2018 for the same weeks. We conducted univariate and multivariate analysis including preselected variables. We report AER and EMR, with 95% confidence intervals (95% CI). RESULTS: The AER of mortality was 197.8/10,000 person years (95%CI:194.30-201.40). The EMR for male gender, compared with female, was 1.4 (95%CI:1.35-1.44, p<0.00); for our oldest age band (≥75 years) 10.09 (95%CI:9.46-10.75, p<0.00) compared to 45-64 year olds; Black ethnicity's EMR was 1.17 (95%CI: 1.03-1.33, p<0.02), reference white; and for dwellings with ≥9 occupants 8.01 (95%CI: 9.46-10.75, p<0.00). Presence of all included comorbidities significantly increased EMR. Ranked from lowest to highest these were: hypertension, chronic kidney disease, chronic respiratory and heart disease, and cancer or immunocompromised. CONCLUSIONS: The absolute excess mortality was approximately 2 deaths per 100 person years in the first wave of COVID-19. More personalised shielding advice for any second wave should include ethnicity, comorbidity and household size as predictors of risk.