OMA - Evaluation of the management of acute otitis media in children aged ≤ 6 years in France ARCHIVE

Head :
Leclerc-Zwirn Christel, Laboratoire GSK

Last update : 01/01/2019 | Version : 1 | ID : 157

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Evaluation of the management of acute otitis media in children aged ≤ 6 years in France
Sign or acronym OMA
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 770 334
General Aspects
Medical area Infectious diseases
Others (details) Acute otitis media
Keywords epidemiology, care
Scientific investigator(s) (Contact)
Name of the director Leclerc-Zwirn
Surname Christel
Phone +33 (0)1 39 17 86 96
Email christel.c.leclerc-zwirn@gsk.com
Unit Laboratoire GSK
Collaborations
Funding
Funding status Private
Details GSK laboratory
Governance of the database
Sponsor(s) or organisation(s) responsible Laboratoire GSK
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health care professionals
A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Sending of an email presenting the study to all GPs and pediatricians in the Thalès network offering them to participate in the study. The Thalès network to date has 1,200 general practitioners and 100 pediatricians.
• Doctors interested in the study can identify themselves on the Internet website and confirm their participation agreement.
A random drawing will then be done to recruit the necessary number of participating doctors.
• 1st phase: For a period of 15 days, the first children (3 on the average) consulting for an episode of AOM will be included in the study and will be followed.
Database objective
Main objective Describe in general practice the care for AOM in children aged 0 to 6 years in France.
Inclusion criteria • Child aged 0 to 6 years
• Child with an episode of AOM diagnosed by a doctor
• Parent(s)/tutor(s) who accept the inclusion of the child in the study
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2008
Date of last collection (YYYY or MM/YYYY) 2009
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 439
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Presence of a biobank No
Health parameters studied Health care consumption and services
Quality of life/health perception
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Medicines consumption
Procedures
Data collection method Medical questionnaire, parent questionnaire, follow-up questionnaire
Participant monitoring Yes
Details on monitoring of participants Each child will be followed for 2 weeks (medical follow-up questionnaire and parent questionnaire). In the case of a relapse appearing in the week following the AOM episode, a follow-up questionnaire will be completed.
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Publications in progress
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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