Applicability of the electronic frailty index in younger and older adults in England: a population-based cohort study.

Background: The electronic frailty index (eFI) was developed in older adults (aged ≥65 years). There are currently no validated frailty scores in clinical practice for younger adults (aged 18-64 years). The aim of this study was to examine whether the eFI score in younger adults had similar or different associations with adverse health outcomes compared with older adults.

An extension of the Benefit Risk Assessment of VaccinEs toolkit to evaluate Comirnaty and Spikevax vaccination in the European Union.

Amid the global COVID-19 pandemic, vaccines were conditionally authorized for human use to protect against severe infection. The Benefit Risk Assessment of VaccinEs (BRAVE) toolkit, a user-friendly R Shiny application, was developed retrospectively together with the European Medicine Agency (EMA) with the aim of fulfilling the need for flexible tools to assess vaccine benefits and risks during and outside a pandemic situation. This study employed BRAVE to evaluate the impact of COVID-19 mRNA vaccines across 30 European Union (EU)/EEA countries by quantifying the number of prevented clinical events [i.

Corrigendum to "A pipeline for harmonising NHS Scotland laboratory data to enable national-level analyses". [J. Biomed. Inform. 162 (2025) 104771].

Objective: Medical laboratory data together with prescribing and hospitalisation records are three of the most used electronic health records (EHRs) for data-driven health research. In Scotland, hospitalisation, prescribing and the death register data are available nationally whereas laboratory data is captured, stored and reported from local health board systems with significant heterogeneity. For researchers or other users of this regionally curated data, working on laboratory datasets across regional cohorts requires effort and time.

Robustly measuring multimorbidity using disparate linked datasets.

Background: Measurement of multimorbidity, the co-occurrence of two or more conditions in the same individual, is highly variable which limits the consistency and reproducibility of research.

Methods: Using data from 172,563 UK Biobank (UKB) participants and a cross-sectional approach, we examined how choice of data source affected estimated prevalence of 80 individual long-term conditions (LTCs) and multimorbidity. We developed code-list-based algorithms to determine the prevalence of 80 LTCs in (1) primary care records, (2) UKB baseline assessment, (3) hospital/cancer registry records, and (4) all three data sources together.

Risk of Thyroid Tumors With GLP-1 Receptor Agonists: A Retrospective Cohort Study.

Objective: To assess the association between glucagon-like peptide 1 receptor agonist (GLP-1RA) use and risk of incident thyroid tumors.

Research Design And Methods: The retrospective, active-comparator new-user cohort study used international administrative claims and electronic health record databases. Participants included patients with type 2 diabetes mellitus (T2DM) with prior metformin therapy initiating a GLP-1RA versus new users of sodium-glucose cotransporter 2 inhibitors (SGLT2is), dipeptidyl peptidase 4 inhibitors (DPP-4is), and sulfonylureas (SUs).

Comparative Safety of Second-Line Antihyperglycemic Agents in Older Adults with Type 2 Diabetes: A Multinational Real-World Evidence From LEGEND-T2DM.

Background: As prescribing of newer antihyperglycemic agents expands, there remains limited comparative safety data for older adults-a population particularly vulnerable to adverse drug events and underrepresented in clinical trials. We aimed to evaluate the real-world safety of second-line antihyperglycemic agents among older adults with type 2 diabetes.

Methods: We conducted a multinational cohort study using nine harmonized electronic health record and claims databases from the U.

Utilising the Benefit Risk Assessment of Vaccines (BRAVE) toolkit to evaluate the benefits and risks of Vaxzevria in the EU: a population-based study.

Background: Several COVID-19 vaccines have been licensed. To support the assessment of safety signals, we developed a toolkit to support COVID-19 vaccine monitoring and benefit-risk assessment. We aim to show the application of our toolkit in the EU using thrombosis with thrombocytopenia syndrome (TTS) associated with the Vaxzevria (AstraZeneca) vaccine as a use case.

Health conditions in adults with atrial fibrillation compared with the general population: a population-based cross-sectional analysis.

Background: Atrial fibrillation (AF) prevalence is rising due to population ageing and comorbidity is an increasing problem. The aim of this study was to examine the prevalence and association of coexisting health conditions among adults with AF in the general population.

Methods: Cross-sectional analysis of Clinical Practice Research Datalink (CPRD) primary care electronic medical records in England linked to hospital admissions as of 30 November 2015.

Risk of aortic aneurysm or dissection following use of fluoroquinolones: a retrospective multinational network cohort study.

Background: Fluoroquinolones (FQs) are commonly used to treat urinary tract infections (UTIs), but some studies have suggested they may increase the risk of aortic aneurysm or dissection (AA/AD). However, no large-scale international study has thoroughly assessed this risk.

Methods: A retrospective cohort study was conducted using a large, distributed network analysis across 14 databases from 5 countries (United States, South Korea, Japan, Taiwan, and Australia).

Expanding the OMOP Common Data Model to Support Perinatal Research in Network Studies.

Objectives: The Observational Medical Outcomes Partnership common data model (OMOP-CDM) is a useful tool for large-scale network analysis but currently lacks a structured approach to pregnancy episodes. We aimed to develop and implement a perinatal expansion for the OMOP-CDM to facilitate perinatal network research.

Methods: We collaboratively developed a perinatal expansion with input from domain experts and stakeholders to reach consensus.

Depression and physical multimorbidity: A cohort study of physical health condition accrual in UK Biobank.

Background: Depression is associated with a range of adverse physical health outcomes. We aimed to quantify the association between depression and the subsequent rate of accrual of long-term physical health conditions in middle and older age.

Methods And Findings: We included 172,556 participants from the UK Biobank (UKB) cohort study, aged 40-71 years old at baseline assessment (2006-2010), who had linked primary care data available.

A Digital Tool for Clinical Evidence-Driven Guideline Development by Studying Properties of Trial Eligible and Ineligible Populations: Development and Usability Study.

Background: Clinical guideline development preferentially relies on evidence from randomized controlled trials (RCTs). RCTs are gold-standard methods to evaluate the efficacy of treatments with the highest internal validity but limited external validity, in the sense that their findings may not always be applicable to or generalizable to clinical populations or population characteristics. The external validity of RCTs for the clinical population is constrained by the lack of tailored epidemiological data analysis designed for this purpose due to data governance, consistency of disease or condition definitions, and reduplicated effort in analysis code.

A pipeline for harmonising NHS Scotland laboratory data to enable national-level analyses.

Objective: Medical laboratory data together with prescribing and hospitalisation records are three of the most used electronic health records (EHRs) for data-driven health research. In Scotland, hospitalisation, prescribing and the death register data are available nationally whereas laboratory data is captured, stored and reported from local health board systems with significant heterogeneity. For researchers or other users of this regionally curated data, working on laboratory datasets across regional cohorts requires effort and time.

Evidence generation throughout paediatric medicines life cycle: findings from collaborative work between European Medicines Agency (EMA) and EUnetHTA on use of extrapolation.

Drug development for children presents unique challenges and is highly regulated. Novel approaches, such as the use of extrapolation to address, for example, the need to avoid unethical studies, whilst supporting robust evidence generation have been developed in support of benefit/risk considerations by regulatory authorities. This is only one step in the decision-making process towards access, which in Europe also includes health technology assessment (HTA) bodies.

Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations.

Purpose: The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023.

Methods: We surveyed PRAC Sponsors and (Co-)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision-making.

Estimating the economic effect of harm associated with high risk prescribing of oral non-steroidal anti-inflammatory drugs in England: population based cohort and economic modelling study.

Objectives: To quantify prevalence, harms, and NHS costs in England of problematic oral non-steroidal anti-inflammatory drug (NSAID) prescribing in high risk groups.

Design: Population based cohort and economic modelling study.

Setting: Economic models estimating patient harm associated with NSAID specific hazardous prescribing events, and cost to the English NHS, over a 10 year period, were combined with trends of hazardous prescribing event to estimate national levels of patient harm and NHS costs.

Multiple adverse outcomes associated with antipsychotic use in people with dementia: population based matched cohort study.

Objective: To investigate risks of multiple adverse outcomes associated with use of antipsychotics in people with dementia.

Design: Population based matched cohort study.

Setting: Linked primary care, hospital and mortality data from Clinical Practice Research Datalink (CPRD), England.

The implications of competing risks and direct treatment disutility in cardiovascular disease and osteoporotic fracture: risk prediction and cost effectiveness analysis.

Background: Clinical guidelines commonly recommend preventative treatments for people above a risk threshold. Therefore, decision-makers must have faith in risk prediction tools and model-based cost-effectiveness analyses for people at different levels of risk. Two problems that arise are inadequate handling of competing risks of death and failing to account for direct treatment disutility (i.

Antipsychotic drug prescribing and mortality in people with dementia before and during the COVID-19 pandemic: a retrospective cohort study in Wales, UK.

Background: Concerns have been raised that antipsychotic drug prescribing, which has been associated with increased mortality in people with dementia, might have increased during the COVID-19 pandemic due to social restrictions imposed to limit the spread of SARS-CoV-2. We used multisource, routinely collected health-care data from Wales, UK to investigate prescribing and mortality variations in people with dementia before and during the COVID-19 pandemic.

Methods: In this retrospective cohort study, we used individual-level, anonymised, population-scale linked health data to identify adults aged 60 years and older with a diagnosis of dementia in Wales, UK.

External validation of the QLifetime cardiovascular risk prediction tool: population cohort study.

Background: Prediction of lifetime cardiovascular disease (CVD) risk is recommended in many clinical guidelines, but lifetime risk models are rarely externally validated. The aim of this study was to externally validate the QRiskLifetime incident CVD risk prediction tool.

Methods: Independent external validation of QRiskLifetime using Clinical Practice Research Datalink data, examining discrimination and calibration in the whole population and stratified by age, and reclassification compared to QRISK3.