Results 111 to 120 of about 2,261 (201)

Best Practices and Gaps in Current Regulatory and Health Technology Assessment Real‐World Evidence Policies for Medicines and Medical Devices: Current State of Play and Next Steps

Clinical and Translational Science, Volume 19, Issue 3, March 2026.
ABSTRACT Real‐world data (RWD) offers a valuable opportunity to access vast information that can drive research and generate real‐world evidence (RWE), offering insights into the actual delivery of care and patient outcomes beyond the limitations of traditional clinical trials.
Katharine Cresswell, Ravinder Claire, Laila Issa, Luke Kubehl, Omnia Bilal, Rose Purcell, Amaya Clemente, Jakob Wested, Lotte Groth Jensen, Medha Sasane, Rita Peeters, Bethany Shinkins, Heather Colvin   +12 more
wiley   +1 more source

Enhancing Severe Neutropenia Prediction: PKPD‐Informed Labeling for Machine Learning Models Trained on Real‐World Data

Clinical Pharmacology &Therapeutics, Volume 119, Issue 2, Page 427-436, February 2026.
Accurately labeling outcomes in real‐world data for machine learning is challenging due to data sparsity and imbalances. This study developed and evaluated a pharmacokinetic–pharmacodynamic (PKPD)‐informed labeling strategy to enhance the risk prediction of docetaxel‐induced neutropenia.
Conor J O’Hanlon, Jonas Denck, Elif Ozkirimli, Stefanie Bendels, Candice Jamois, Clarisse Chavanne, Dirk Fey, Kimmo Porkka, Oscar Brück, Ken Wang   +9 more
wiley   +1 more source

Augmenting Medical Device Evaluation Using a Reusable Unique Device Identifier Interoperability Solution Based on the OHDSI Common Data Model

Medinfo, 2019
The objective of the study is to augment safety and effectiveness evaluation of medical devices through building a reusable unique device identifier (UDI) interoperability solution.
Guoqian Jiang, Yue Yu, Paul R. Kingsbury, N. Shah   +3 more
semanticscholar   +1 more source

Medications Used Among Nonhospitalized Pregnant Women With COVID‐19: A Prospective Individual Patient Data Meta‐Analysis in Europe and North America

Pharmacoepidemiology and Drug Safety, Volume 35, Issue 1, January 2026.
ABSTRACT Aim To estimate the prevalence of medication use in nonhospitalized pregnant women with COVID‐19. Methods A prospective two‐stage individual patient meta‐analysis across 10 data sources in Europe and North America studied medication use among nonhospitalized pregnant women with COVID‐19 between January 2020 and December 2022.
Odette de Bruin, Emeline Maisonneuve, Eimir Hurley, Hedvig M. E. Nordeng, Anick Bérard, Odile Sheehy, Padma Kaul, Mayura U. Shinde, Austin Cosgrove, Jennifer G. Lyons, Elizabeth Messenger‐Jones, Maria E. Kempner, Sengwee Toh, Wei Hua, José J. Hernández‐Muñoz, Leyla Sahin, Carolyn E. Cesta, David Hägg, Rosa Gini, Olga Paoletti, Beatriz Poblador‐Plou, Sue Jordan, Daniel Thayer, Clara L. Rodríguez‐Bernal, Francisco Sánchez‐Sáez, Régis Lassalle, Marie‐Agnès Bernard, Ema Alsina, Fariba Ahmadizar, Guillaume Favre, Alice Panchaud, Kitty W. M. Bloemenkamp, Kelly Plueschke, Corinne de Vries, Satu J. Siiskonen, Miriam C. J. M. Sturkenboom, on behalf of the CONSIGN Collaboration Group, Benjamin P. Geisler, Mark Walker, Steven Hawken, Sasha Bernatsky, Sherif Eltonsy, Emma Hoffman, Andrew B. Petrone, Jolene Mosley, Jenice Ko, Claudia Bartolini, Giuseppe Roberto, Giorgio Limoncella, Anna Girardi, Giulia Hyeraci, Antonio Gimeno‐Miguel, Jonás Carmona‐Pírez, Antonio Poncel‐Falcó, Aida Moreno‐Juste, Alexandra Prados‐Torres, Ian Farr, Saira Ahmed, Ieuan Scanlon, Gabriel Sanfélix‐Gimeno, Isabel Hurtado, Anibal Garcia‐Sempere, Salvador Peiro, Jérémy Jové, Dunia Sakr, Cécile Droz‐Perroteau, David Baum, Hilde M. Engjom, Judit Riera-Arnau, Mònica Sabaté Gallego, Elena Ballarín Alins, Cristina Aguilera Martin, Melissa Kampman, Celline Brasil   +73 more
wiley   +1 more source

Safety of hydroxychloroquine, alone and in combination with azithromycin, in light of rapid wide-spread use for COVID-19: a multinational, network cohort and self-controlled case series study [PDF]

, 2020
Background: Hydroxychloroquine has recently received Emergency Use Authorization by the FDA and is currently prescribed in combination with azithromycin for COVID-19 pneumonia.
Prieto-Alhambra, Daniel, Newby, Danielle, Kostka, Kristin, Prats Uribe, Albert, Weaves, James, Lane, Jennifer CE, Alser , Osaid   +6 more
core   +1 more source

CohortContrast: Enrichment-based methodology for identification of clinically relevant concepts in real-world data

Informatics in Medicine Unlocked
Objective: Selecting cohort-relevant clinical concepts from high-dimensional observational health data remains a persistent bottleneck in trajectory analysis, phenotyping, and real-world evidence studies.
Markus Haug, Neeme Ilves, Nikita Umov, Hendrik Šuvalov, Kerli Mooses, Sirli Tamm, Helene Loorents, Marek Oja, Sulev Reisberg, Jaak Vilo, Raivo Kolde   +10 more
doaj   +1 more source

Mapping Drug Terms via Integration of a Retrieval-Augmented Generation Algorithm with a Large Language Model [PDF]

Healthcare Informatics Research
Objectives This study evaluated the efficacy of integrating a retrieval-augmented generation (RAG) model and a large language model (LLM) to improve the accuracy of drug name mapping across international vocabularies.
Eizen Kimura, Yukinobu Kawakami, Shingo Inoue, Ai Okajima   +3 more
doaj   +1 more source

Development and Validation of Phenotype Classifiers across Multiple Sites in the Observational Health Sciences and Informatics (OHDSI) Network

bioRxiv, 2019
Objective Accurate electronic phenotyping is essential to support collaborative observational research. Supervised machine learning methods can be used to train phenotype classifiers in a high-throughput manner using imperfectly labeled data.
M. Kashyap, Martin G. Seneviratne, J. Banda, T. Falconer, Borim Ryu, Sooyoung Yoo, G. Hripcsak, N. Shah   +7 more
semanticscholar   +1 more source

A comparative patient-level prediction study in OMOP CDM: applicative potential and insights from synthetic data

Scientific Reports
The emergence of collaborations, which standardize and combine multiple clinical databases across different regions, provide a wealthy source of data, which is fundamental for clinical prediction models, such as patient-level predictions. With the aid of
Najia Ahmadi, Quang Vu Nguyen, Martin Sedlmayr, Markus Wolfien   +3 more
doaj   +1 more source

2354

Journal of Clinical and Translational Science, 2017
OBJECTIVES/SPECIFIC AIMS: Hepatitis C viral (HCV) infections are rising significantly both in young adults and as newly diagnosed cases in “baby boomers.” New HCV therapeutics cure over 95% of cases, and a call has been made for elimination of the ...
Dawn A Fishbein, Ian Brooks, Emanuel Villa Baca, Ozgur Ozmen, Mallikarjun Shankar, Gil Weigand, Kristina Thiagarajan, Randy Estes, Alex Geboy, Hala Deeb, Mamta Jain, Lesley Miller   +11 more
doaj   +1 more source