Introduction: The Radiography Research Ethics Standards for Europe (RRESFE) project aimed to provide a cross-sectional view of the current state of radiography research ethics across Europe. This included investigating education and training in research ethics, and identifying the key challenges and potential improvements associated with using existing research ethics frameworks. Methods: This cross-sectional online survey targeting radiography researchers in Europe was conducted between April 26 and July 12, 2021. Descriptive and analytical statistics were used to identify research ethics education and training trends. Content analysis of qualitative responses was employed to identify significant challenges and proposed improvements in research ethics frameworks of practice. Results: There were 232 responses received across 33 European countries. Most (n ¼ 132; 57%) respondents had received some research ethics training; however, fewer participants had received training on safeguarding vulnerable patients (n ¼ 72; 38%), diversity and inclusivity (n ¼ 62; 33%), or research with healthy volunteers (n ¼ 60; 32%). Training was associated with a greater perceived importance of the need for research ethics review (p ¼ 0.031) and with the establishment of EQF Level 6 training (p ¼ 0.038). The proportion of formally trained researchers also varied by region (p ¼ <0.001). Time-toethics-approval was noted as the biggest challenge for professionals making research ethics applications. Conclusion: Early and universal integration of research-oriented teaching within the radiography education framework which emphasises research ethics is recommended. Additionally, study findings suggest research ethics committee application and approval processes could be further simplified and streamlined. Implications for practice: The survey contributes to a growing body of knowledge surrounding the importance of education and training in research ethics for assuring a high standard of research outputs
As robotic assisted surgery (RAS) expands to smaller centres, platforms are shared between specialities. Healthcare providers must consider case volume and mix required to maintain quality and cost-effectiveness. This can be informed, in-part, by the volume-outcome relationship. We perform a systematic review to describe the volume-outcome relationship in intra-abdominal robotic assisted surgery to report on suggested minimum volumes standards. A literature search of Medline, NICE Evidence Search, Health Technology Assessment Database and Cochrane Library using the terms: “robot*”, “surgery”, “volume” and “outcome” was performed. The included procedures were gynaecological: hysterectomy, urological: partial and radical nephrectomy, cystectomy, prostatectomy, and general surgical: colectomy, oesophagectomy. Hospital and surgeon volume measures and all reported outcomes were analysed. 41 studies, including 983149 procedures, met the inclusion criteria. Study quality was assessed using the Newcastle-Ottawa Quality Assessment Scale and the retrieved data was synthesised in a narrative review. Significant volume-outcome relationships were described in relation to key outcome measures, including operative time, complications, positive margins, lymph node yield and cost. Annual surgeon and hospital volume thresholds were described. We concluded that in centres with an annual volume of fewer than 10 cases of a given procedure, having multiple surgeons performing these procedures led to worse outcomes and, therefore, opportunities should be sought to perform other complimentary robotic procedures or undertake joint cases.
Recently England and Netherlands have changed their consent system from Opt In to Opt Out. The reflections shared in this paper give insight and may be helpful for other nation considering likewise. Strong support in England for the change in legislation led to Opt Out being introduced without requiring a vote in parliament in 2019. In Netherlands the bill passed by the smallest possible majority in 2018. Both countries implemented a public campaign to raise awareness. In England registration on the Donor Register is voluntary. Registration was required in Netherlands for all residents 18 years and older. For those not already on the register, letters were sent by the Dutch Government to ask individuals to register. If people did not respond they would be legally registered as having “no objection.” After implementation of Opt Out in England 42.3% is registered Opt In, 3.6% Opt Out, and 54.1% has no registration. In contrast in Netherlands the whole population is registered with 45% Opt In, 31% Opt Out and 24% “No Objection.” It is too soon to draw conclusions about the impact on the consent rate and number of resulting organ donors. However, the first signs are positive.
Background People with kidney failure have high risk of postoperative morbidity and mortality. Although the Revised Cardiac Risk Index (RCRI) is used to estimate the risk of major postoperative events, it has not been validated in this population. We aimed to externally validate the RCRI and determine whether updating the model improved predictions for people with kidney failure. Methods We derived a retrospective, population-based cohort of adults with kidney failure (maintenance dialysis or sustained estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m²) who had surgery in Alberta, Canada between 2005 and 2019. We categorized participants based on RCRI variables and assigned risk estimates of death or major cardiac events, and then estimated predictive performance. We re-estimated the coefficients for each RCRI variable and internally validated the updated model. Net benefit was estimated with decision curve analysis. Results After 38,541 surgeries, 1,204 (3.1%) events occurred. The estimated C-statistic for the original RCRI was 0.64 (95% confidence interval [CI]: 0.62, 0.65). Examination of calibration revealed significant risk overestimation. In the re-estimated RCRI model, discrimination was marginally different (C-statistic 0.67 [95%CI 0.66, 0.69]), though calibration was improved. There was net benefit when examined with decision curve analysis, while the original RCRI was associated with harm. Conclusions The RCRI performed poorly in a Canadian kidney failure cohort and significantly overestimated risk, suggesting RCRI use in similar kidney failure populations should be limited. A re-estimated kidney failure specific RCRI may be promising, though needs external validation. Novel perioperative models for this population are urgently needed.
Introduction: Understanding the effectiveness and durability of protection against SARS-CoV-2 infection conferred by previous infection and COVID-19 is essential to inform ongoing management of the pandemic. This study aims to determine whether prior SARS-CoV-2 infection or COVID-19 vaccination in healthcare workers protects against future infection. Methods and analysis: This is a prospective cohort study design in staff members working in hospitals in the UK. At enrolment, participants are allocated into cohorts, positive or naïve, dependent on their prior SARS-CoV-2 infection status, as measured by standardised SARS-CoV-2 antibody testing on all baseline serum samples and previous SARS-CoV-2 test results. Participants undergo monthly antibody testing and fortnightly viral RNA testing during follow-up and based on these results may move between cohorts. Any results from testing undertaken for other reasons (eg, symptoms, contact tracing) or prior to study entry will also be captured. Individuals complete enrolment and fortnightly questionnaires on exposures, symptoms and vaccination. Follow-up is 12 months from study entry, with an option to extend follow-up to 24 months.The primary outcome of interest is infection with SARS-CoV-2 after previous SARS-CoV-2 infection or COVID-19 vaccination during the study period. Secondary outcomes include incidence and prevalence (both RNA and antibody) of SARS-CoV-2, viral genomics, viral culture, symptom history and antibody/neutralising antibody titres. Ethics and dissemination: The study was approved by the Berkshire Research Ethics Committee, Health Research Authority (IRAS ID 284460, REC reference 20/SC/0230) on 22 May 2020; the vaccine amendment was approved on 12 January 2021. Participants gave informed consent before taking part in the study.Regular reports to national and international expert advisory groups and peer-reviewed publications ensure timely dissemination of findings to inform decision making. Trial registration number: ISRCTN11041050.
The main objective of this guideline is to assist practitioners in managing individuals diagnosed with Trichomonas vaginalis (TV). It offers recommendations on the diagnostic tests, treatment regimens and health promotion principles needed for the effective management of TV. It covers the management of the initial presentation, as well as how to prevent transmission and future re-infection. It is aimed primarily at people aged 16 years or older presenting to health care professionals, working in departments offering specialist care in sexually transmitted infection (STI) management within the United Kingdom. However, the principles of the recommendations are applicable across all levels of STI care providers (N.B. non-specialist services may need to develop, where appropriate, local care pathways).
Background: Impaired kidney function is associated with an increased risk of vascular events in acute stroke patients, when assessed by single measurements of estimated glomerular filtration rate (eGFR). It is unknown whether repeated measurements provide additional information for risk prediction. Methods: The Systematic Monitoring for Detection of Atrial Fibrillation in Patients with Acute Ischemic Stroke (MonDAFIS) study randomly assigned 3,465 acute ischemic-stroke patients to either standard procedures or an additive Holter-ECG. Baseline eGFR (CKD-epi formula) were dichotomized into values <vs.≥60ml/min/1.73m2 . eGFR dynamics were classified based on two in-hospital values: "stable normal" (≥60ml/min/1.73m2 ), "increasing" (by at least 15% from baseline, 2nd value ≥60ml/min/1.73m2 ), "decreasing" (by at least 15% from baseline ≥60ml/min/1.73m2 ), and "stable decreased" (<60ml/min/1.73m2 ). The composite endpoint (stroke, major-bleeding, myocardial-infarction, all-cause death) was assessed after 24 months. We estimated hazard ratios in confounder adjusted models. Results: eGFR at baseline was available in 2,947 and a 2nd value in 1,623 patients. After adjusting for age, stroke severity, cardiovascular risk factors, and randomization, eGFR <60ml/min/1.73m2 at baseline (HR 2.2; 95%CI 1.40-3.54) as well as "decreasing" (HR 1.79; 95%CI: 1.07-2.99) and "stable decreased" eGFR (HR 1.64; 95%CI: 1.20-2.24) were independently associated with the composite endpoint. In addition, eGFR<60ml/min/1.732 at baseline (HR 3.02; 95%CI: 1.51-6.10) and "decreasing" eGFR were associated with all-cause death (HR 3.12; 95%CI: 1.63-5.98). Conclusions: In addition to patients with low eGFR levels at baseline also those with decreasing eGFR have an increased risk for vascular events and death, hence, repeated estimates of eGFR might add relevant information to risk prediction. Trial registration number Clinicaltrials.gov NCT02204267.
Objective: The aim of this systematic scoping review is to identify and categorize the outcome measures that have been reported in clinical studies, where therapeutic plasma exchange (TPE) has been used as an intervention in any clinical settings, excluding thrombotic thrombocytopenic purpura (TTP). Methods: We searched electronic databases using a predefined search strategy from inception to October 9, 2020. Two reviewers independently screened and extracted data. Results: We included 42 studies (37 RCTs and 5 prospective cohort studies) grouped into six main categories (neurology, immunology, renal, rheumatology, hematology, and dermatology). Primary outcomes were defined in eight studies (19%, 8/42) and were categorized as efficacy (five studies) or patient reported outcomes (three studies). A power calculation was reported in six studies (75%, 6/8): five neurology studies (mainly patient reported outcomes) and a single immunological study (efficacy outcome). Disease-specific efficacy outcomes were dependent on the clinical setting of the population receiving TPE. Most of the trials (43%, 18/42) were undertaken in patients with neurology conditions where clear, disease-specific, clinical outcome measures were used, including neurological disability scales (11/18, 61%), change in neurological examination (9/18, 50%), and functional improvement scores (7/18, 39%). For other conditions, the reporting of disease-specific outcomes was poorly reported. Safety outcomes were mainly related to replacement fluid type rather than being disease-specific. The most common outcome reported was hypotension (19%, 8/42), and this was primarily in patients exchanged with albumin. Conclusion: Future clinical studies to determine which fluid replacement option is most efficacious and safe should use disease-specific outcomes, as a trial in one therapeutic area may not necessarily translate to another therapeutic area. Patient reported outcomes are not universally reported for all disease areas. Safety measures focused primarily on fluid safety.
Background: Although child mortality has decreased over the last few decades, around 4,500 infants and children die in the UK every year, many of whom require palliative care. There is, however, little evidence on paediatric end-of-life care services. The current National Institute for Health and Care Excellence (NICE) guidance provides recommendations about what should be offered, but these are based on low quality evidence. The ENHANCE study aims to identify and investigate the different models of existing end-of-life care provision for infants, children, and young people in the UK, including an assessment of the outcomes and experiences for children and parents, and the cost implications to families and healthcare providers. Methods: This mixed methods study will use three linked workstreams and a cross-cutting health economics theme to examine end-of-life care models in three exemplar clinical settings: infant, children and young adult cancer services (PTCs), paediatric intensive care units (PICUs), and neonatal units (NNUs). Workstream 1 (WS1) will survey current practice in each setting and will result in an outline of the different models of care used. WS2 is a qualitative comparison of the experiences of staff, parents and patients across the different models identified. WS3 is a quantitative assessment of the outcomes, resource use and costs across the different models identified. Discussion: Results from this study will contribute to an understanding of how end-of-life care can provide the greatest benefit for children at the end of their lives. It will also allow us to understand the likely benefits of additional funding in end-of-life care in terms of patient outcomes.
Feeding disorders and eating disorders (FEEDs) are serious mental and behavioural disorders in adults with intellectual disabilities (ID) and autistic spectrum disorders (ASD). FEEDs are often chronic, complex and associated with significant underweight, overweight or obesity. FEEDs are also associated with considerable physical ill health and psychiatric comorbidity. The DC-LD concept of FEEDs is then outlined. The possible personal psychological meanings of the ‘mainstream’ EDs (anorexia nervosa, bulimia nervosa and binge eating disorder) in adults with ID and ASD are considered. The prevalence of such ‘mainstream EDs’ have increased in recent decades. The caregiver and service delivery burdens of FEEDs such as pica, regurgitation/rumination disorder and food faddiness/refusal (ARFID) are high. The diagnosis and conceptualization of FEEDs in adults with ID and ASD using the DC-LD 2000, DSM 5 2005 and evolving ICD-11 2015 classification systems are evaluated. The 2005 Eating Disorders in Adults with Learning Disabilities (EDALD) clinical research data are summarized to outline the prevalence, types and aetiological associations of FEEDs in a selected mostly community ID service user sample (n = 214). Lessons learnt from the EDALD clinical research methodology and data are discussed to support evidence based multi-level and multi-professional screening, clinical assessment and management. Finally future clinical, research and service development directions are suggested for FEEDs in adults with ID and ASD.
Background Cases of human monkeypox are rarely seen outside of west and central Africa. There are few data regarding viral kinetics or the duration of viral shedding and no licensed treatments. Two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated efficacy against monkeypox in animals. Our aim was to describe the longitudinal clinical course of monkeypox in a high-income setting, coupled with viral dynamics, and any adverse events related to novel antiviral therapies. Methods In this retrospective observational study, we report the clinical features, longitudinal virological findings, and response to off-label antivirals in seven patients with monkeypox who were diagnosed in the UK between 2018 and 2021, identified through retrospective case-note review. This study included all patients who were managed in dedicated high consequence infectious diseases (HCID) centres in Liverpool, London, and Newcastle, coordinated via a national HCID network. Findings We reviewed all cases since the inception of the HCID (airborne) network between Aug 15, 2018, and Sept 10, 2021, identifying seven patients. Of the seven patients, four were men and three were women. Three acquired monkeypox in the UK: one patient was a health-care worker who acquired the virus nosocomially, and one patient who acquired the virus abroad transmitted it to an adult and child within their household cluster. Notable disease features included viraemia, prolonged monkeypox virus DNA detection in upper respiratory tract swabs, reactive low mood, and one patient had a monkeypox virus PCR-positive deep tissue abscess. Five patients spent more than 3 weeks (range 22–39 days) in isolation due to prolonged PCR positivity. Three patients were treated with brincidofovir (200 mg once a week orally), all of whom developed elevated liver enzymes resulting in cessation of therapy. One patient was treated with tecovirimat (200mg twice daily for 2 weeks orally), experienced no adverse effects, and had a shorter duration of viral shedding and illness (10 days hospitalisation) compared with the other six patients. One patient experienced a mild relapse 6 weeks after hospital discharge. Interpretation Human monkeypox poses unique challenges, even to well resourced health-care systems with HCID networks. Prolonged upper respiratory tract viral DNA shedding after skin lesion resolution challenged current infection prevention and control guidance. There is an urgent need for prospective studies of antivirals for this disease. Funding None.
Background: Patients at risk for sexually transmitted infections (STI) frequently receive care at non-specialized outpatient clinics staffed by physicians and advanced practice clinicians (APCs).Methods: Retrospective cohort study including adult patients diagnosed with chlamydia and/or gonorrhea at urgent care (UC), family medicine (FM), internal medicine (IM) or obstetrics and gynecology (Ob-Gyn) clinics. The effect of type of clinician on guideline-adherent treatment was estimated using logistic regression adjusted for age, type of clinic, type of infection, and (in female patients) pregnancy status.Results: A total of 1021 patients were identified, 654 (64.1%) females and 367 (35.9%) males. Overall, 12.8% (84/654) of female patients and 19.1% (70/367) of male patients received inadequate antibiotic therapy. Among females, 63.5% (415/654) were treated by APCs and 36.5% (239/654) by physicians. Odds of inadequate therapy did not differ when comparing APCs to physicians (OR 0.83 [95% CI 0.52-1.32; p = .42]). Variables independently associated with inadequate therapy were pregnancy (OR 3.80 [95% CI 1.55-6.10; p < .001]), infection with gonorrhea (OR 2.91 [95% CI 1.65-5.10; p < .0001]) and co-infection (OR 2.63 [95% CI 1.24-5.58; p = .01]) compared to infection with chlamydia alone. Compared to UC clinics, female patients treated at Ob-Gyn clinics had lower odds of inadequate therapy (OR 0.45 [95% CI 0.22-0.90; p = .02]). Among males, odds of inadequate therapy did not differ by clinician type.Conclusions: Inadequate antibiotic therapy for chlamydia and/or gonorrhea was not associated with type of clinician. These results can help guide educational strategies and resources towards the clinical settings with the greatest gaps in adequacy of management of chlamydia and gonorrhea.
Background The incidence of invasive disease caused by group A streptococcus (GAS) has increased in multiple countries in the past 15 years. However, despite these reports, to the best of our knowledge, no systematic reviews and combined estimates of the incidence of invasive GAS have been done in key high-risk groups. To address this, we estimated the incidence of invasive GAS disease, including death and disability outcomes, among two high-risk groups—namely, pregnant women and children younger than 5 years. Methods We did a systematic review and meta-analyses on invasive GAS outcomes, including incidence, case fatality risks, and neurodevelopmental impairment risk, among pregnant women, neonates (younger than 28 days), infants (younger than 1 year), and children (younger than 5 years) worldwide and by income region. We searched several databases for articles published from Jan 1, 2000, to June 3, 2020, for publications that reported invasive GAS outcomes, and we sought unpublished data from an investigator group of collaborators. We included studies with data on invasive GAS cases, defined as laboratory isolation of Streptococcus pyogenes from any normally sterile site, or isolation of S pyogenes from a non-sterile site in a patient with necrotising fasciitis or streptococcal toxic shock syndrome. For inclusion in pooled incidence estimates, studies had to report a population denominator, and for inclusion in pooled estimates of case fatality risk, studies had to report aggregate data on the outcome of interest and the total number of cases included as a denominator. We excluded studies focusing on groups at very high risk (eg, only preterm infants). We assessed heterogeneity with I². Findings Of the 950 published articles and 29 unpublished datasets identified, 20 studies (seven unpublished; 3829 cases of invasive GAS) from 12 countries provided sufficient data to be included in pooled estimates of outcomes. We did not identify studies reporting invasive GAS incidence among pregnant women in low-income and middle-income countries (LMICs) nor any reporting neurodevelopmental impairment after invasive GAS in LMICs. In nine studies from high-income countries (HICs) that reported invasive GAS in pregnancy and the post-partum period, invasive GAS incidence was 0·12 per 1000 livebirths (95% CI 0·11 to 0·14; I²=100%). Invasive GAS incidence was 0·04 per 1000 livebirths (0·03 to 0·05; I²=100%; 11 studies) for neonates, 0·13 per 1000 livebirths (0·10 to 0·16; I²=100%; ten studies) for infants, and 0·09 per 1000 person-years (95% CI 0·07 to 0·10; I²=100%; nine studies) for children worldwide; 0·12 per 1000 livebirths (95% CI 0·00 to 0·24; I²=100%; three studies) in neonates, 0·33 per 1000 livebirths (−0·22 to 0·88; I²=100%; two studies) in infants, and 0·22 per 1000 person-years (0·13 to 0·31; I²=100%; two studies) in children in LMICs; and 0·02 per 1000 livebirths (0·00 to 0·03; I²=100%; eight studies) in neonates, 0·08 per 1000 livebirths (0·05 to 0·11; I²=100%; eight studies) in infants, and 0·05 per 1000 person-years (0·03 to 0·06; I²=100%; seven studies) in children for HICs. Case fatality risks were high, particularly among neonates in LMICs (61% [95% CI 33 to 89]; I²=54%; two studies). Interpretation We found a substantial burden of invasive GAS among young children. In LMICs, little data were available for neonates and children and no data were available for pregnant women. Incidences of invasive GAS are likely to be underestimates, particularly in LMICs, due to low GAS surveillance. It is essential to improve available data to inform development of prevention and management strategies for invasive GAS. Funding Wellcome Trust.
A hospital outbreak of carbapenem-resistant Enterobacterales was detected by routine surveillance. Whole genome sequencing and subsequent analysis revealed a conserved promiscuous bla OXA-48 carrying plasmid as the defining factor within this outbreak. Four different species of Enterobacterales were involved in the outbreak. Escherichia coli ST399 accounted for 35 of all the 55 isolates. Comparative genomics analysis using publicly available E. coli ST399 genomes showed that the outbreak E. coli ST399 isolates formed a unique clade. We developed a mathematical model of pOXA-48-like plasmid transmission between host lineages and used it to estimate its conjugation rate, giving a lower bound of 0.23 conjugation events per lineage per year. Our analysis suggests that co-evolution between the pOXA-48-like plasmid and E. coli ST399 could have played a role in the outbreak. This is the first study to report carbapenem-resistant E. coli ST399 carrying blaOXA-48 as the main cause of a plasmid-borne outbreak within a hospital setting. Our findings suggest complementary roles for both plasmid conjugation and clonal expansion in the emergence of this outbreak.
Background: Acupuncture is rapidly rising in popularity within western populations since its development and consequently there is increasing interest from a variety of clients. Purpose: To evaluate the effectiveness of acupuncture on orthopaedic pain within a vocational rehabilitation setting in London, United Kingdom. Method: A retrospective service evaluation design. A pre- and post-acupuncture questionnaire was utilised as the data collection tool. Result: Eighty-six clients were included in this evaluation because they met the criteria for inclusion. Analysis on the age differences between males and females were not statistically significant (p=0.05). The conditions that were most frequently seen at the clinic included: 57% (49/86) spinal pain; 28% (24/86) upper limb pain; and 15% (13/86) lower limb pain. The mean number of treatment sessions for acupuncture was three (range=1-6). Overall each session of treatment lasted on average twenty minutes (range=15-30). The total number of needles used during each session of treatment averaged five (range=3-8). The reported benefit of treatment was 44% (38/86) excellent, 49% (42/86) good, and 7% (6/86) poor. Conclusion: This evaluation has demonstrated that acupuncture is effective on orthopaedic pain within a vocational rehabilitation setting. Repeat audits and larger sample sizes are needed for confirmation the findings.
Objective/purpose: To describe the frequency of long-term morphological features and their relationships with visual function in participants who exited the inhibition of VEGF in age-related choroidal neovascularization (IVAN: ISRCTN92166560) trial. Design: Multicenter cohort study up to 7 years after enrolment. Participants: Patients enrolled in IVAN excluding participants who died or withdrew during the trial. Methods: Multimodal fundus images, best corrected (BCVA) and low luminance visual acuity (LLVA) were obtained in a subset of 199 participants who attended a research visit. Clinical sites (n=20) also provided all visual acuity and clinical information from usual care records for 532 participants and submitted most recent color, OCT and other fundus images for 468 participants to a reading center. Main outcome measures: Assessed from most recent images: intralesional macular atrophy (ILMA) within the footprint of the neovascular lesion; hyperreflective material (HRM); intraretinal fluid (IRF); subretinal fluid (SRF); pigment epithelial detachment (PED); disorganization of outer retinal layers (DROL). Cross sectional relationships between morphological features and BCVA/LLVA were estimated. Results: ILMA was present in 31.8% of study eyes at IVAN exit (mean follow-up 1.96 years) and 89.5% at the most recent imaging visit (6.18 years). HRM, IRF, SRF, PED and DROL were present in 78.8%, 47.7%, 7.6%, 94.5% and 55% respectively. In the subset with complete imaging data, in eyes without DROL, BCVA was worst in the thinnest outer fovea tertile (thinnest minus middle and thickest tertiles, -19.7 and -19.5 letters respectively) whereas in eyes with DROL, BCVA was worst in the thickest (thinnest and middle tertiles minus thickest, 12.5 and 12.2 respectively). Regression models showed that presence of ILMA and HRM were independently associated with BCVA (22 letters worse (95% CI 11.2, 32.8, p<0.001) and 9.8 letters worse (95% CI 0.1, 19.4, p=0.047), respectively). SRF and foveal PED were associated with better BCVA (5.9 letters, 95% CI -7.9, 19.7, p<0.399; and 6.4 letters, 95% CI -1.1, 14.0, p=0.094 respectively). The model with LLVA was similar. Sensitivity analysis including the entire eligible cohort yielded similar estimates. Conclusions: Macular atrophy and HRM were common after 7 years of follow-up and strongly associated with visual outcomes.
Objective To evaluate antithrombotic (AT) use in individuals with atrial fibrillation (AF) and at high risk of stroke (CHA 2 DS 2 -VASc score ≥2) and investigate whether pre-existing AT use may improve COVID-19 outcomes. Methods Individuals with AF and CHA 2 DS 2 -VASc score ≥2 on 1 January 2020 were identified using electronic health records for 56 million people in England and were followed up until 1 May 2021. Factors associated with pre-existing AT use were analysed using logistic regression. Differences in COVID-19-related hospitalisation and death were analysed using logistic and Cox regression in individuals with pre-existing AT use versus no AT use, anticoagulants (AC) versus antiplatelets (AP), and direct oral anticoagulants (DOACs) versus warfarin. Results From 972 971 individuals with AF (age 79 (±9.3), female 46.2%) and CHA 2 DS 2 -VASc score ≥2, 88.0% (n=856 336) had pre-existing AT use, 3.8% (n=37 418) had a COVID-19 hospitalisation and 2.2% (n=21 116) died, followed up to 1 May 2021. Factors associated with no AT use included comorbidities that may contraindicate AT use (liver disease and history of falls) and demographics (socioeconomic status and ethnicity). Pre-existing AT use was associated with lower odds of death (OR=0.92, 95% CI 0.87 to 0.96), but higher odds of hospitalisation (OR=1.20, 95% CI 1.15 to 1.26). AC versus AP was associated with lower odds of death (OR=0.93, 95% CI 0.87 to 0.98) and higher hospitalisation (OR=1.17, 95% CI 1.11 to 1.24). For DOACs versus warfarin, lower odds were observed for hospitalisation (OR=0.86, 95% CI 0.82 to 0.89) but not for death (OR=1.00, 95% CI 0.95 to 1.05). Conclusions Pre-existing AT use may be associated with lower odds of COVID-19 death and, while not evidence of causality, provides further incentive to improve AT coverage for eligible individuals with AF.
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