Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID-19 Adenovirus Vector Vaccines on European Healthcare Professionals
The European Medicines Agency (EMA) issued regulatory actions and communications in 2021 on thrombosis with thrombocytopenia syndrome (TTS) associated with adenovirus vector vaccines Vaxzevria or Jcovden. This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP).
Regulatory Impact of Selected U.S. FDA Postmarketing Safety Registries Conducted for Drugs Used to Treat Inflammatory or Autoimmune Conditions
Assess the regulatory impact of selected FDA postmarketing safety registries on drug product labeling updates.
Post-Marketing Safety of Ustekinumab Based on 14-Year Follow-Up in Danish National Patient Data
Psoriasis (PsO), a chronic inflammatory skin disorder affecting a substantial proportion of populations globally, often necessitates systemic treatment including biologics. This 14-year cohort study, based on Danish national register data, aimed to investigate the enduring safety profile of ustekinumab compared to other systemic psoriasis treatments.
Handling With Vaccine Type Missing Data in a Dynamic Cohort to Assess the Link Between Time-Varying Vaccination and an Autoimmune Disease
The information about the type of vaccine administrated may be missing in patients' health records. We aimed to apply a simple strategy, based on several factors, to impute, when missing, the type of administrated human papillomavirus (HPV) vaccines to study its association with thyroiditis.
Patient Characteristics and Practice Variation Associated With New Community Prescription of Benzodiazepine and z-Drug Hypnotics After Critical Illness: A Retrospective Cohort Study Using the UK Clinical Practice Research Datalink
Survivors of critical illness are often affected by new or worsened mental health conditions and sleep disorders. We examined the incidence, practice variation and factors associated with new benzodiazepine and z-drug community prescriptions among critical illness survivors.
Validity of Pharmaceutical Claims Data for Determining Medication Exposure in Long-Term Care Facilities
To compare the accuracy of pharmaceutical claims with medication administration chart data for individuals in long-term care facilities (LTCFs).
Impact of Early Resumption of Oral Anticoagulation on Recurrence After Surgery for Chronic Subdural Hematoma in Patients With Atrial Fibrillation: A Target Trial Emulation
Clinicians treating patients with atrial fibrillation (AF) on oral anticoagulants who undergo surgery for chronic subdural hematoma (CSDH) face a dilemma: while early postoperative resumption of anticoagulation is necessary to prevent embolism, it may increase the risk of CSDH recurrence. To date, however, no study has evaluated this question while adequately addressing common biases in observational studies. Here, we assessed this issue using target trial emulation framework.
Real-World Evidence BRIDGE: A Tool to Connect Protocol With Code Programming
To enhance documentation on programming decisions in Real World Evidence (RWE) studies.
Severe Cutaneous Adverse Reactions in Hospitalized Children: A Pilot Validation Study
Core Concepts in Pharmacoepidemiology: New-User Designs
In this article, we review the history and key reasons for new-user comparisons in pharmacoepidemiology, highlighting the target trial framework as a unifying framework. We describe three distinct pharmacoepidemiological new-user study designs: (1) new-user versus non-user; (2) active comparator new-user; (i.e., ACNU) and (3) prevalent new-user (i.e., PNU) designs, and discuss how each relates to key issues of defining time zero, choosing appropriate comparator groups, and potential sources of bias they do and do not account for. We use a clinical example of hormone replacement therapy and the risk of coronary heart disease to illustrate practical considerations surrounding the application of the three designs presented.
Determining Line of Therapy from Real-World Data in Non-Small Cell Lung Cancer
Determining lines of therapy (LOT) using real-world data is crucial to inform clinical decisions and support clinical research. Existing rules for determining LOT in patients with metastatic non-small cell lung cancer (mNSCLC) do not incorporate the growing number of targeted therapies used in treatment today. Therefore, we propose rules for determining LOT from real-world data of patients with mNSCLC treated with targeted therapies.
Oxymorphone and Oxycodone Pharmacy Purchases in US Counties: Prelude to the Largest Rural Human Immunodeficiency Virus Outbreak in US History
The largest rural outbreak of human immunodeficiency virus (HIV) in the US was centered in Scott County, Indiana, and linked to injection practices involving the opioid Opana ER (oxymorphone extended release [ER] reformulated). We examined supply trends using pharmacy transactions of Opana ER in Scott and all US counties from January 2007 to December 2019.
Effectiveness of the Additional Risk Minimisation Measures for Valproate Among Healthcare Professionals and Patients: A Cross-Sectional Survey in Six European Countries
To assess the impact of the 2018 European additional risk minimisation measures (aRMMs) regarding the use of valproate in women of childbearing potential (WCBP) and during pregnancy.
Standardised and Reproducible Phenotyping Using Distributed Analytics and Tools in the Data Analysis and Real World Interrogation Network (DARWIN EU)
The generation of representative disease phenotypes is important for ensuring the reliability of the findings of observational studies. The aim of this manuscript is to outline a reproducible framework for reliable and traceable phenotype generation based on real world data for use in the Data Analysis and Real-World Interrogation Network (DARWIN EU). We illustrate the use of this framework by generating phenotypes for two diseases: pancreatic cancer and systemic lupus erythematosus (SLE).
Real-World Evidence of Indapamide-Induced Rhabdomyolysis: A Retrospective Analysis of Electronic Health Records
Previous research and pharmacovigilance monitoring activities have suggested a potential association between indapamide use and rhabdomyolysis. This study aims to investigate the potential causal relationship between the use of indapamide and rhabdomyolysis.
Investigating the Safety Profile of Fast-Track COVID-19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study
The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID-19) drugs as a medical countermeasure during the COVID-19 pandemic. Despite these drugs' fast-track nature, concerns persist regarding their efficacy and potential adverse effects. Thus, the continuous surveillance and understanding of these drugs' safety profiles are crucial in such scenarios.
Data Resource Profile: The Danish National Hospital Medicine Register
The Danish National Hospital Medicine Register (SMR) was established in 2018 to centralize and standardize medication use data across Danish hospitals. This task was previously managed by individual hospital registration systems across the five regions. This initiative addresses the need for a unified, detailed understanding of hospital medication use to monitor healthcare delivery, improve patient outcomes, and support research.
Prenatal and Early-Life Anti-Infectives and Obesity at Age 7 Years
To examine associations of prenatal and early-life anti-infective exposures with obesity at 7 years.
Development and Validation of Claims-Based Algorithms for Conjunctivitis and Keratitis
Ocular surface disorders have been reported among patients with various medical conditions, including atopic dermatitis (AD). Nonetheless, validated algorithms to identify conjunctivitis and keratitis in claims data are lacking.
Abstracts of ISPEs 2024, 40th international conference, 24-28 August 2024, Germany