Summary

Acute otitis media (AOM) is one of the most common causes of morbidity in paediatrics. It is estimated that about two thirds of children under the age of 3 years have had at least one episode of AOM. Around 50% of AOM have a bacterial etiology (mostly S. Pneumoniae, H. Influenzae and M. Catharralis). More than 90% of H. Influenzas infections are due to a non-type able strain. Recurrent episodes of AOM (e.g 3 episodes within 6 months) are due to the same pathogens that cause primary AOM, but in most of the cases are not relapses, but due to different organism or different strains. In light of the introduction of new vaccines protecting against S. Pneumoniae and H. Influenzae there is a continuing interest in defining the incidence and burden of AOM in the individual and population also for purposes of assigning "risk factors". 

This retrospective study cohort was conducted in the Pedianet database starting on 1st of January 2004 until 31st of December 2007. The database is suitable for both retrospective inspection of routinely collected data and for prospective data collection (outcomes, indirect costs of disease). All children were followed from the date of registration (or date of birth) with the paediatrician, start of the study period (whichever is latest) until death, moving out, or age of 6 years, whichever is earliest. 

It was calculated the incidence rate of AOM by dividing the number of cases by the accrued person–time (patients years, PY). Age, gender and season specific incidence rates were calculated. 95% confidence intervals around the rates were based on the Poisson distribution. 
Clinical management and resource use was described (including number of visit due to AOM). Risk factors for complications and recurrent AOM were identified by means of multivariate logistic regression analyses. 

The principal aims of the study are: 

1) To assess the incidence of AOM and recurrent AOM in Italy 
2) To describe the clinical presentation of AOM 
3) To describe the clinical management of children with AOM 
4) To evaluate possible risk factors for recurrent AOM and AOM 
5) To assess the hospitalization rate for AOM

Partecipants and Collaborations

Partecipants

Dr. Mariagela Berardi 
Dr. Chiara Boscardin 
Dr. Eugenia Bruzzese 
Dr. Vittoria Buccigrossi 
Dr. Andrea Lo Vecchio 
Dr. Teresa Mion 
Dr. Giusy Ranucci 
Dr. Maria Immacolata Spagnuolo 
Dr. Lisanna Tomasi 

Collaborations

Collaborators
Dr. Luigi Cantarutti 

Head statistician
Dr. Paola Baiardi 
Consorzio Valutazione Biologiche e Farmacologiche 
Pavia, Italy 

Financial Support
Mead Johnson Foundation 

Pharmacovigilance
Dott.ssa T. Corsetti

Pubblications