Gender and contemporary risk of adverse events in atrial fibrillation.

BACKGROUND AND AIMS: The role of gender in decision-making for oral anticoagulation in patients with atrial fibrillation (AF) remains controversial. METHODS: The population cohort study used electronic healthcare records of 16 587 749 patients from UK primary care (2005-2020). Primary (composite of all-cause mortality, ischaemic stroke, or arterial thromboembolism) and secondary outcomes were analysed using Cox hazard ratios (HR), adjusted for age, socioeconomic status, and comorbidities. RESULTS: 78 852 patients were included with AF, aged 40-75 years, no prior stroke, and no prescription of oral anticoagulants. 28 590 (36.3%) were women, and 50 262 (63.7%) men. Median age was 65.7 years (interquartile range 58.5-70.9), with women being older and having other differences in comorbidities. During a total follow-up of 431 086 patient-years, women had a lower adjusted primary outcome rate with HR 0.89 vs. men (95% confidence interval [CI] 0.87-0.92; P < .001) and HR 0.87 after censoring for oral anticoagulation (95% CI 0.83-0.91; P < .001). This was driven by lower mortality in women (HR 0.86, 95% CI 0.83-0.89; P < .001). No difference was identified between women and men for the secondary outcomes of ischaemic stroke or arterial thromboembolism (adjusted HR 1.00, 95% CI 0.94-1.07; P = .87), any stroke or any thromboembolism (adjusted HR 1.02, 95% CI 0.96-1.07; P = .58), and incident vascular dementia (adjusted HR 1.13, 95% CI 0.97-1.32; P = .11). Clinical risk scores were only modest predictors of outcomes, with CHA2DS2-VA (ignoring gender) superior to CHA2DS2-VASc for primary outcomes in this population (receiver operating characteristic curve area 0.651 vs. 0.639; P < .001) and no interaction with gender (P = .45). CONCLUSIONS: Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation.

Thromboembolic events and vascular dementia in patients with atrial fibrillation and low apparent stroke risk.

The prevention of thromboembolism in atrial fibrillation (AF) is typically restricted to patients with specific risk factors and ignores outcomes such as vascular dementia. This population-based cohort study used electronic healthcare records from 5,199,994 primary care patients (UK; 2005-2020). A total of 290,525 (5.6%) had a diagnosis of AF and were aged 40-75 years, of which 36,340 had no history of stroke, a low perceived risk of stroke based on clinical risk factors and no oral anticoagulant prescription. Matching was performed for age, sex and region to 117,298 controls without AF. During 5 years median follow-up (831,005 person-years), incident stroke occurred in 3.8% with AF versus 1.5% control (adjusted hazard ratio (HR) 2.06, 95% confidence interval (CI) 1.91-2.21; P < 0.001), arterial thromboembolism 0.3% versus 0.1% (HR 2.39, 95% CI 1.83-3.11; P < 0.001), and all-cause mortality 8.9% versus 5.0% (HR 1.44, 95% CI 1.38-1.50; P < 0.001). AF was associated with all-cause dementia (HR 1.17, 95% CI 1.04-1.32; P = 0.010), driven by vascular dementia (HR 1.68, 95% CI 1.33-2.12; P < 0.001) rather than Alzheimer's disease (HR 0.85, 95% CI 0.70-1.03; P = 0.09). Death and thromboembolic outcomes, including vascular dementia, are substantially increased in patients with AF despite a lack of conventional stroke risk factors.

Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial.

Aims: Improving the efficiency of clinical trials is key to their continued importance in directing evidence-based patient care. Digital innovations, in particular the use of electronic healthcare records (EHRs), allow for large-scale screening and follow up of participants. However, it is critical these developments are accompanied by robust and transparent methods that can support high-quality and high clinical value research. Methods and results: The DaRe2THINK trial includes a series of novel processes, including nationwide pseudonymized pre screening of the primary-care EHR across England, digital enrolment, remote e-consent, and 'no-visit' follow up by linking all primary- and secondary-care health data with patient-reported outcomes. DaRe2THINK is a pragmatic, healthcare-embedded randomized trial testing whether earlier use of direct oral anticoagulants in patients with prior or current atrial fibrillation can prevent thromboembolic events and cognitive decline (www.birmingham.ac.uk/dare2think). This study outlines the systematic approach and methodology employed to define patient information and outcome events. This includes transparency on all medical code lists and phenotypes used in the trial across a variety of national data sources, including Clinical Practice Research Datalink Aurum (primary care), Hospital Episode Statistics (secondary care), and the Office for National Statistics (mortality). Conclusion: Co-designed by a patient and public involvement team, DaRe2THINK presents an opportunity to transform the approach to randomized trials in the setting of routine healthcare, providing high-quality evidence generation in populations representative of the community at risk.

EarLy Surveillance for Autoimmune diabetes: protocol for a qualitative study of general population and stakeholder perspectives on screening for type 1 diabetes in the UK (ELSA 1).

OBJECTIVE: Type 1 diabetes (T1D) is the most common form of diabetes in children, accounting for 96% of cases, with 29 000 children affected in the UK. Studies have recently identified immunotherapies that safely delay the development of T1D for at least 3 years, and further therapies are in development. General population screening programs in other countries can now accurately identify children with presymptomatic T1D who can be entered into prevention studies. The UK does not have such a system in place. We aim to explore whether parents and children in the UK would want to be part of such a program of testing for T1D in the general population, how they would want to be informed and participate in such a program, and how any barriers to recruitment and participation can be addressed. Additionally, the views of stakeholders who would be involved in the testing program will be collected and analyzed. RESEARCH DESIGN AND METHODS: We will interview parents/guardians and children aged 3-13 years about their views on screening for T1D. We will recruit purposefully to ensure representation across ethnicities and socioeconomic groups. Interviews will be transcribed, analyzed and used to inform iterative co-design work with additional families to address any issues raised. Similar qualitative work will be undertaken with professional stakeholders who would be involved in implementing any future screening program. Where possible, all aspects of this study will be performed remotely by phone or online to minimize infection risk. CONCLUSIONS: This qualitative study will provide the first insights into acceptability of testing and monitoring for T1D in the general population from the perspective of families and stakeholders in the UK. Co-design work will help establish the barriers and identify strategies to mitigate and overcome these issues, as an important step towards consideration of national testing for T1D.

Impact of COVID-19 on the digital divide: a rapid review.

OBJECTIVE: The increased reliance on digital technologies to deliver healthcare as a result of the COVID-19 pandemic has meant pre-existing disparities in digital access and utilisation of healthcare might be exacerbated in disadvantaged patient populations. The aim of this rapid review was to identify how this 'digital divide' was manifest during the first wave of the pandemic and highlight any areas which might be usefully addressed for the remainder of the pandemic and beyond. DESIGN: Rapid review and narrative synthesis. DATA SOURCES: The major medical databases including PubMed and Embase and Google Scholar were searched alongside a hand search of bibliographies. ELIGIBILITY CRITERIA: Original research papers available in English which described studies conducted during wave 1 of the COVID pandemic and reported between 1 March 2020 and 31 July 2021. RESULTS: The search was described using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and identified nine studies. The results are presented within a refined framework describing the three key domains of the digital divide: (1) digital access, within which one study described continuing issues with internet connectivity among vulnerable patients in the UK; (2) digital literacy, where seven studies described how ethnic minorities and the elderly were less likely to use digital technologies in accessing care; (3) digital assimilation, where one study described how video technologies can reduce feelings of isolation and another how elderly black males were the most likely group to share information about COVID-19 on social media platforms. CONCLUSIONS: During the early phase of the pandemic in the developed world, familiar difficulties in utilisation of digital healthcare among the elderly and ethnic minorities continued to be observed. This is a further reminder that the digital divide is a persistent challenge that needs to be urgently addressed when considering the likelihood that in many instances these digital technologies are likely to remain at the centre of healthcare delivery.

Can process mining automatically describe care pathways of patients with long-term conditions in UK primary care? A study protocol.

INTRODUCTION: In the UK, primary care is seen as the optimal context for delivering care to an ageing population with a growing number of long-term conditions. However, if it is to meet these demands effectively and efficiently, a more precise understanding of existing care processes is required to ensure their configuration is based on robust evidence. This need to understand and optimise organisational performance is not unique to healthcare, and in industries such as telecommunications or finance, a methodology known as 'process mining' has become an established and successful method to identify how an organisation can best deploy resources to meet the needs of its clients and customers. Here and for the first time in the UK, we will apply it to primary care settings to gain a greater understanding of how patients with two of the most common chronic conditions are managed. METHODS AND ANALYSIS: The study will be conducted in three phases; first, we will apply process mining algorithms to the data held on the clinical management system of four practices of varying characteristics in the West Midlands to determine how each interacts with patients with hypertension or type 2 diabetes. Second, we will use traditional process mapping exercises at each practice to manually produce maps of care processes for the selected condition. Third, with the aid of staff and patients at each practice, we will compare and contrast the process models produced by process mining with the process maps produced via manual techniques, review differences and similarities between them and the relative importance of each. The first pilot study will be on hypertension and the second for patients diagnosed with type 2 diabetes. ETHICS AND DISSEMINATION: Ethical approval has been provided by East Midlands-Leicester South Regional Ethics Committee (REC reference 18/EM/0284). Having refined the automated production of maps of care processes, we can explore pinch points and bottlenecks, process variants and unexpected behaviour, and make informed recommendations to improve the quality and efficiency of care. The results of this study will be submitted for publication in peer-reviewed journals.