Empirical assessment of case-based methods for identification of drugs associated with upper gastrointestinal bleeding in the French National Healthcare System database (SNDS).
Adult
Adverse Drug Reaction Reporting Systems
Anti-Inflammatory Agents, Non-Steroidal
/ adverse effects
Area Under Curve
Case-Control Studies
Databases, Factual
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Female
France
/ epidemiology
Gastrointestinal Hemorrhage
/ chemically induced
Humans
Male
National Health Programs
Risk Factors
Sensitivity and Specificity
calibration
case-control
case-population
claims database
pharmacoepidemiology
self-controlled case series
upper gastrointestinal bleeding
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
01
10
2019
revised:
21
02
2020
accepted:
08
05
2020
pubmed:
12
6
2020
medline:
16
6
2021
entrez:
12
6
2020
Statut:
ppublish
Résumé
Upper gastrointestinal bleeding (UGIB) is a severe and frequent drug-related event. In order to enable efficient drug safety alert generation in the French National Healthcare System database (SNDS), we assessed and calibrated empirically case-based designs to identify drug associated with UGIB risk. All cases of UGIB were extracted from SNDS (2009-2014) using two definitions. Positive and negative drug controls were used to compare 196 self-controlled case series (SCCS), case-control (CC) and case-population (CP) design variants. Each variant was evaluated in a 1/10 Using a specific UGIB definition, AUCs ranged from 0.64 to 0.80, 0.44 to 0.61 and 0.50 to 0.67, for SCCS, CC and CP, respectively. MSE ranged from 0.07 to 0.39, 0.83 to 1.33 and 1.96 to 4.6, respectively. Univariate regressions showed that high AUCs were achieved with SCCS with multiple drug adjustment and a 30-day risk window starting at exposure. The top-performing SCCS variant in the unsampled population yielded an AUC = 0.84 and MSE = 0.14, with 10/36 negative controls presenting significant estimates. SCCS adjusting for multiple drugs and using a 30-day risk window has the potential to generate UGIB-related alerts in the SNDS and hypotheses on its potential population impact. Negative control implementation highlighted that low systematic error was generated but that protopathic bias and confounding by indication remained unaddressed issues.
Substances chimiques
Anti-Inflammatory Agents, Non-Steroidal
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
890-903Informations de copyright
© 2020 John Wiley & Sons Ltd.
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