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Impact of diagnostic coding schemas on major bleeding risk assessment for oral anticoagulants in patients with atrial fibrillation using administrative claims data.
J Thromb Haemost
December 2024
Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan; School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address:
Background: Reliable diagnostic coding schemas are essential for accurately assessing bleeding risks in patients on oral anticoagulants, particularly in observational studies.
Objectives: This study evaluated how different published diagnostic coding schemas impact the assessment of major bleeding risks associated with direct oral anticoagulants (DOACs) and warfarin.
Methods: This retrospective cohort study included patients with atrial fibrillation who initiated DOACs or warfarin between 2012 and 2019 using Taiwan's national claims database.
Use of Antidiabetic drugs during pregnancy among U.S. women with Livebirth deliveries in the Mini-Sentinel system.
BMC Pregnancy Childbirth
November 2019
Meyers Primary Care Institute (Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School), Worcester, MA, USA.
Background: As the prevalence of diabetes mellitus increases in the population, the exposure to antidiabetic drugs (ADDs) during pregnancies is expected to grow, as has been seen over the last decade. The objective of this study was to estimate the prevalence of ADD use during pregnancy among women in the Mini-Sentinel Distributed Database (MSDD) who delivered a liveborn infant.
Methods: We identified qualifying livebirth pregnancies among women aged 10 to 54 years in the MSDD from 2001 to 2013.
Evaluating automated approaches to anaphylaxis case classification using unstructured data from the FDA Sentinel System.
Pharmacoepidemiol Drug Saf
October 2018
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD, USA.
Introduction: In May 2008, the Food and Drug Administration launched the Sentinel Initiative, a multi-year program for the establishment of a national electronic monitoring system for medical product safety that led, in 2016, to the launch of the full Sentinel System. Under the Mini-Sentinel pilot, several algorithms for identifying health outcomes of interest, including one for anaphylaxis, were developed and evaluated using data available from the Sentinel common data model.
Purpose: To evaluate whether features extracted from unstructured narrative data using natural language processing (NLP) could be used to classify anaphylaxis cases.
Agreement between coding schemas used to identify bleeding-related hospitalizations in claims analyses of nonvalvular atrial fibrillation patients.
Clin Cardiol
January 2018
Real-World Evidence Strategy and Outcomes Data Generation, Bayer AG, Berlin, Germany.
Background: Schemas to identify bleeding-related hospitalizations in claims data differ in billing codes used and coding positions allowed. We assessed agreement across bleeding-related hospitalization coding schemas for claims analyses of nonvalvular atrial fibrillation (NVAF) patients on oral anticoagulation (OAC).
Hypothesis: We hypothesized that prior coding schemas used to identify bleeding-related hospitalizations in claim database studies would provide varying levels of agreement in incidence rates.
Replication of Mini-Sentinel Study Assessing Mirabegron and Cardiovascular Risk in Non-Mini-Sentinel Databases.
Drugs Real World Outcomes
March 2018
Safety Science, Astellas Pharma US, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.
Background: In 2014, the US Food and Drug Administration (FDA) initiated a prospective routine surveillance using the Mini-Sentinel (M-S) program to assess potential signals of acute myocardial infarction (AMI) and stroke with use of mirabegron, indicated for the treatment of overactive bladder (OAB), compared with oxybutynin.
Purpose: To replicate the FDA M-S analysis of mirabegron using datasets that did not contribute to the M-S program.
Methods: IMS PharMetrics Plus and Truven MarketScan claims data from 2012-2015 were converted to the M-S Common Data Model.
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