Explanipedia

Semaglutide and diabetic retinopathy: an OHDSI network study Open

Cindy X. Cai, Akihiko Nishimura, Sally L. Baxter, Kerry Goetz, Michelle R. Hribar , et al. · 2025

Introduction Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA) used to treat type 2 diabetes mellitus (T2D), has potential associations with higher rates of diabetic retinopathy (DR) complications including proliferative DR…

The Role Of Drug Indication On Incidence Rate Heterogeneity: A Large-Scale, Systematic Evaluation Across An International Network Of Observational Databases Open

Hsin Yi Chen, Christopher Knoll, Elise Boventer, Nicole Pratt, Tara V. Anand , et al. · 2025

Purpose Incidence rate estimates are sensitive to a range of factors, including age, sex, and geographical setting (data source). The magnitude of the impact of drug indication on incidence rates remains underexplored. Methods We conducted…

Recommendations to Enable Broader Use of Real‐World Evidence to Inform Decision‐Making Throughout Pharmacovigilance Signal Management Open

G. Niklas Norén, Katherine Donegan, Mónica Muñoz, Thamir M. Alshammari, Nicole Pratt , et al. · 2025

Introduction Despite substantial investments in analytical infrastructure and scientific research related to the development and analysis of real‐world evidence in support of signal management, the impact on routine pharmacovigilance activ…

Evaluation of the impact of defining observable time in real-world data on outcome incidence Open

Clair Blacketer, Frank DeFalco, Mitchell M. Conover, Patrick Ryan, Martijn J. Schuemie , et al. · 2025

Objective In real-world data (RWD), defining the observation period—the time during which a patient is considered observable—is critical for estimating incidence rates (IRs) and other outcomes. Yet, in the absence of explicit enrollment in…

SelfControlledCaseSeries: Self-Controlled Case Series Open

Martijn Schuemie, Patrick Ryan, Trevor Shaddox, Marc A. Suchard · 2025

Risk of thyroid tumors with GLP-1 receptor agonists: a retrospective cohort study Open

Daniel R. Morales, Fan Bu, Benjamin Viernes, Scott L. DuVall, Michael E. Matheny , et al. · 2025

Objective: To assess the association between glucagon-like peptide-1 receptor agonists (GLP-1RA) use and risk of incident thyroid tumors.Research Design and Methods: Retrospective new user active comparator cohort study using international…

Large-scale Empirical Identification of Candidate Comparators for Pharmacoepidemiological Studies Open

Justin Bohn, James P. Gilbert, Christopher Knoll, David M. Kern, Patrick Ryan · 2025

Empirical comparator recommendations may serve as a useful aid to investigators and could ultimately enable the automated generation of new user cohort design-derived evidence, a process that has previously been limited to self-controlled …

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

Daniel R. Morales, Fan Bu, Benjamin Viernes, Scott L. DuVall, Michael E. Matheny , et al. · 2025

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 internation…

Risk of thyroid tumors with GLP-1 receptor agonists: a retrospective cohort study Open

Daniel R. Morales, Fan Bu, Benjamin Viernes, Scott L. DuVall, Michael E. Matheny , et al. · 2025

Objective: To assess the association between glucagon-like peptide-1 receptor agonists (GLP-1RA) use and risk of incident thyroid tumors.Research Design and Methods: Retrospective new user active comparator cohort study using international…

Advancing Real-World Evidence Through a Federated Health Data Network (EHDEN): Descriptive Study Open

Clair Blacketer, Martijn J. Schuemie, Maxim Moinat, Erica A. Voss, Montse Camprubi , et al. · 2025

Background Real-world data (RWD) are increasingly used in health research and regulatory decision-making to assess the effectiveness, safety, and value of interventions in routine care. However, the heterogeneity of European health care sy…

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

Chungsoo Kim, Fan Bu, Clair Blacketer, Anna Ostropolets, Talita Duarte‐Salles , et al. · 2025

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 aim…

Can we develop real-world prognostic models using observational healthcare data? Large-scale experiment to investigate model sensitivity to database and phenotypes Open

Jenna Reps, Peter R. Rijnbeek, Patrick Ryan · 2025

These results highlight the importance of validating a model developed using observational data in the clinical setting prior to using it for decision-making. Calibration and Brier score should be evaluated to prevent miscalibrated risk es…

Modern pedigree dogs in the United Kingdom Kennel Club: a journey through shifting population landscapes and demography Open

Joanna J. Ilska, Patrick Ryan, Daniel J. Tolhurst · 2025

Origami with small molecules: exploiting the C–F bond as a conformational tool Open

Patrick Ryan, Ramsha Iftikhar, Luke Hunter · 2025

When present within an organic molecule, the C–F bond tends to align in predictable ways with neighbouring functional groups, due to stereoelectronic effects such as hyperconjugation and electrostatic attraction/repulsion. These fluorine-d…

Building the Largest Federated Health Data Network in Europe: Advancing Collaboration and Real-World Evidence Generation (Preprint) Open

Clair Blacketer, Martijn J. Schuemie, Maxim Moinat, Erica A. Voss, Montse Camprubi , et al. · 2025

BACKGROUND The European Health Data & Evidence Network (EHDEN) is the largest federated health data network in Europe, designed to harmonize diverse real-world data (RWD) sources to the OMOP Common Data Model (CDM). By addressing challeng…

Characterization: Implement Descriptive Studies Using the Common Data Model Open

Jenna Reps, Patrick Ryan, Chris Knoll · 2025

Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy Open

Cindy X. Cai, Michelle R. Hribar, Sally L. Baxter, Kerry Goetz, Swarup S. Swaminathan , et al. · 2025

Importance Semaglutide, a glucagonlike peptide-1 receptor agonist (GLP-1RA), has recently been implicated in cases of nonarteritic anterior ischemic optic neuropathy (NAION), raising safety concerns in the treatment of type 2 diabetes (T2D…

Evaluating the Bias, type I error and statistical power of the prior Knowledge-Guided integrated likelihood estimation (PIE) for bias reduction in EHR based association studies Open

Naimin Jing, Yiwen Lu, Jiayi Tong, James Weaver, Patrick Ryan , et al. · 2025

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

Jack Janetzki, Jung Ho Kim, Evan Minty, Jung Ah Lee, Daniel R. Morales , et al. · 2025

CohortDiagnostics: Phenotype evaluation across a network of observational data sources using population-level characterization Open

Gowtham Rao, Azza Shoaibi, Rupa Makadia, Jill Hardin, Joel N. Swerdel , et al. · 2025

Objective This paper introduces a novel framework for evaluating phenotype algorithms (PAs) using the open-source tool, Cohort Diagnostics. Materials and methods The method is based on several diagnostic criteria to evaluate a patient coho…

Objective study validity diagnostics: a framework requiring pre-specified, empirical verification to increase trust in the reliability of real-world evidence Open

Mitchell M. Conover, Patrick Ryan, Yong Chen, Marc A. Suchard, George Hripcsak , et al. · 2025

Objective Propose a framework to empirically evaluate and report validity of findings from observational studies using pre-specified objective diagnostics, increasing trust in real-world evidence (RWE). Materials and Methods The framework …

Standardized patient profile review using large language models for case adjudication in observational research Open

Martijn J. Schuemie, Anna Ostropolets, Oleg Zhuk, Uladzislau Korsik, Seung In Seo , et al. · 2025

Using administrative claims and electronic health records for observational studies is common but challenging due to data limitations. Researchers rely on phenotype algorithms, requiring labor-intensive chart reviews for validation. This s…

Investigation on the isotopic exchange radiofluorination of the pentafluorosulfanyl group Open

Hugh G. Hiscocks, Gabrielle Weerasinghe, Wei Huang, James O. Hill, Patrick Ryan , et al. · 2025

This study reports the first radiofluorination of pentafluorosulfanyl groups via isotopic exchange, analyzes reaction conditions with AI and statistical tools, and proposes the formation of positional isotopologues.

Finding a constrained number of predictor phenotypes for multiple outcome prediction Open

Jenna Reps, Jenna Wong, Egill A. Friðgeirsson, Chungsoo Kim, Luis H. John , et al. · 2025

Background Prognostic models help aid medical decision-making. Various prognostic models are available via websites such as MDCalc, but these models typically predict one outcome, for example, stroke risk. Each model requires individual pr…

Glucagon‐Like Peptide 1 Receptor Agonists and Chronic Lower Respiratory Disease Among Type 2 Diabetes Patients: Replication and Reliability Assessment Across a Research Network Open

Mitchell M. Conover, Yasser Albogami, Jill Hardin, Christian Reich, Anna Ostropolets , et al. · 2025

Introduction The aim of this study is to use observational methods to evaluate reliability of evidence generated by a study of the effect of glucagon‐like peptide 1 receptor agonists (GLP‐1RA) on chronic lower respiratory disease (CLRD) ou…

The Impact of Evolving Endometriosis Guidelines on Diagnosis and Observational Health Studies Open

Harry Reyes Nieva, Aparajita Kashyap, Erica A. Voss, Anna Ostropolets, Adit Anand , et al. · 2024

STUDY QUESTION Do recent changes in European Society of Human Reproduction and Embryology (ESHRE) clinical guidelines result in more comprehensive diagnosis of women with endometriosis? SUMMARY ANSWER The latest shift in clinical guideline…

Hepatitis B virus (HBV) viremia despite tenofovir disoproxil fumarate-containing antiretroviral therapy in persons with HBV/HIV coinfection Open

Patrick Ryan, Elizabeth Odegard, Heidi L. Meeds, Margaret Lartey, Vincent Ganu , et al. · 2024

Development and validation of a patient-level model to predict dementia across a network of observational databases Open

Luis H. John, Egill A. Friðgeirsson, Jan A. Kors, Jenna Reps, Ross D. Williams , et al. · 2024

Knowledge-guided generative artificial intelligence for automated taxonomy learning from drug labels Open

Yilu Fang, Patrick Ryan, Chunhua Weng · 2024

Objectives To automatically construct a drug indication taxonomy from drug labels using generative Artificial Intelligence (AI) represented by the Large Language Model (LLM) GPT-4 and real-world evidence (RWE). Materials and Methods We ext…

Assessing Covariate Balance with Small Sample Sizes Open

George Hripcsak, Linying Zhang, Kelly Li, Marc A. Suchard, Patrick Ryan , et al. · 2024

Propensity score adjustment addresses confounding by balancing covariates in subject treatment groups through matching, stratification, or weighting. Diagnostics test the success of adjustment. For example, if the standardized mean differe…

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