Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database

Autor: Daniel Weibel, Carmen Ferrajolo, Caitlin Dodd, Benedikt F.H. Becker, Alexandra Pacurariu, Jan A. Kors, Dang H. Vo, Osemeke U. Osokogu, Miriam C. J. M. Sturkenboom
Přispěvatelé: Medical Informatics, Dodd, Caitlin, Pacurariu, Alexandra, Osokogu, Osemeke U., Weibel, Daniel, Ferrajolo, Carmen, Vo, Dang H., Becker, Benedikt, Kors, Jan A., Sturkenboom, Miriam
Rok vydání: 2018
Předmět:
Male
pharmacoepidemiology
Epidemiology
computer.software_genre
Pediatrics
030226 pharmacology & pharmacy
Masking (Electronic Health Record)
Pharmacovigilance
0302 clinical medicine
Pharmacology (medical)
030212 general & internal medicine
Child
media_common
Vaccines
Database
Vaccination
Age Factors
Pharmacoepidemiology
Pediatric drug
Child
Preschool
Data Interpretation
Statistical
drug safety surveillance
spontaneous reporting system
Female
Spontaneous reporting system
Cart
Drug
medicine.medical_specialty
Adolescent
Drug-Related Side Effects and Adverse Reactions
media_common.quotation_subject
Drug safety surveillance
03 medical and health sciences
SDG 3 - Good Health and Well-being
medicine
Adverse Drug Reaction Reporting Systems
Humans
European Union
business.industry
Infant
Newborn
Infant
Odds ratio
masking
pediatric
Masking
business
computer
Zdroj: Pharmacoepidemiology and Drug Safety, 27(11), 1249-1256. John Wiley & Sons Ltd.
Pharmacoepidemiology and Drug Safety, 27(11), 1249. John Wiley and Sons Ltd
ISSN: 1053-8569
Popis: Purpose: Postmarketing drug safety surveillance relies upon measures of disproportionate reporting in spontaneous reporting systems. It has been hypothesized that products or events reported frequently may "mask" signals. Methods: We analyzed the masking effect of vaccines in pediatrics in the EudraVigilance database by conducting disproportionality analysis in the full database (containing vaccine exposures) and in a restricted set (excluding vaccine exposures). We measured performance of the reporting odds ratio (ROR) in both data sets using a pediatric-specific drug reference set and in the absence of a reference set. We assessed masking effects across age groups and conducted a classification tree (CART) analysis. Results: Removal of vaccines decreased the ROR values both in negative and positive controls. Exceptions were drug-event combinations including outcomes frequent in vaccine reports. When restricted to positive control associations, removal of vaccine-related events resulted in increased ROR values for events commonly reported following vaccination. For events rarely associated with vaccination, ROR values decreased for all age groups, especially infants. Analysis in the absence of a reference set showed decrease in ROR following vaccine removal and CART revealed that change in ROR with vaccine removal depended upon age and proportion of reports including a vaccine. Conclusions: Removal of vaccines for signal detection in a pediatric population has an impact on ROR, dependent upon the reporting frequency of the event of interest in combination with vaccines. We recommend stratification by age and removal of vaccine exposures if the investigated adverse drug reactions include those typically reported in association with vaccines for the age strata.
Databáze: OpenAIRE
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