title: Validation of the French national health insurance information system as a tool in vaccine safety assessment: application to febrile convulsions after pediatric measles/mumps/rubella immunization.
abstract: In the French national health insurance information system (SNIIR-AM), routine records of health claimed reimbursements are linked to hospital admissions for the whole French population. The main focus of this work is the usability of this system for vaccine safety assessment programme. Self-controlled case series analyses were performed using an exhaustive SNIIR-AM extraction of French children aged less than 3 years, to investigate the relationship between MMR immunization and children hospitalizations for febrile convulsions, a well-documented rare adverse event, over 2009-2010. The results suggest a significant increase of febrile convulsions during the 6-11 days period following any MMR immunization (IRR=1.49, 95% CI=1.22, 1.83; p=0.0001) and no increase 15-35 days post any MMR immunization (IRR=1.03, 95% CI=0.89, 1.18; p=0.72). These results are in accordance with other results obtained from large epidemiologic studies, which suggest the usability of the SNIIR-AM as a relevant database to study the occurrence of adverse events associated with immunization. For future use, results associated with risk of convulsion during the day of vaccination should nevertheless be considered with particular caution.
authors.affiliation: Biostatistics, CESP Centre for Research in Epidemiology and Population Health, U1018, Inserm, Villejuif, France; Université Paris Sud 11, UMRS 1018, Villejuif, France.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Hanf
authors.forename: Catherine
authors.initials: C
authors.lastname: Quantin
authors.forename: Paddy
authors.initials: P
authors.lastname: Farrington
authors.forename: Eric
authors.initials: E
authors.lastname: Benzenine
authors.forename: N Mounia
authors.initials: NM
authors.lastname: Hocine
authors.forename: Michel
authors.initials: M
authors.lastname: Velten
authors.forename: Pascale
authors.initials: P
authors.lastname: Tubert-Bitter
authors.forename: Sylvie
authors.initials: S
authors.lastname: Escolano
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002675:Child, Preschool; D005602:France; D006760:Hospitalization; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D022542:Measles-Mumps-Rubella Vaccine / Q000009:adverse effects*; D009313:National Health Programs; D011358:Product Surveillance, Postmarketing; D012306:Risk; D003294:Seizures, Febrile / Q000139:chemically induced*
chemical_list: D022542:Measles-Mumps-Rubella Vaccine
keywords: FC; Febrile convulsions; French national health insurance information system; French national health insurance regime information system; GP; ICD-10; IRR; International Statistical Classification of Diseases, Tenth Revision; MMR; Measles/mumps/rubella vaccine; PCV; Pharmacoepidemiology; SCCS; SNIIR-AM; Self controlled case series; Vaccine safety; febrile convulsion; general practitioner; incidence rate ratio; measles/mumps/rubella; pneumococcal conjugate vaccine; self-controlled case series