Infants Likely to Present Febrile Convulsions Clinical Trial
Official title:
Pharmacoepidemiological Methodology to Evaluate the Vaccination Risk in Young Infants
This project is the pilot step necessary to develop a system of vaccination
pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for
this challenge and case series analysis, with the use of linked medicoadministrative data
for hospitalisations the reimbursement of healthcare costs. This linkage of
medicoadministrative data is new in France. The example of the risk of hospitalisation for
febrile convulsions in infants less than two years old following vaccination against
diphtheria, tetanus and pertussis is given as the reference association. This choice is
justified by the numerous publications over many years on the existence of this association
(Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses
have been carried out to assess this risk, the results can be compared directly (Lancet
1995). The study to determine whether the analysis tools are suitable for the data will be
tackled at the following levels:
- Validity of the selection of cases from administrative records alone using coding based
on the international classification of diseases ICD10
- Validity of the risk assessment. This methodology feasibility project must make it
possible to identify the different potential problems. This is a prerequisite necessary
for the systematic implementation.
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Observational Model: Case-Only, Time Perspective: Retrospective