ITMO Santé Publique
ITMO Santé Publique
Date de modification : 01/01/2019 | Version : 2 | ID : 165
| Général | |
| Identification | |
| Nom détaillé | Follow-up cohort of asthmatic patient treated with inhaled corticosteroid |
| Sigle ou acronyme | OCSIGEN |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CNIL |
| Thématiques générales | |
| Domaine médical |
Pneumology |
| Déterminants de santé |
Medicine |
| Mots-clés | inhaled steroids, cohort |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Pribil |
| Prénom | Céline |
| Téléphone | +33 (0)1 39 17 90 62 |
| celine.c.pribil@gsk.com | |
| Laboratoire | Laboratoire GSK |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | GSK laboratory |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Laboratoire GSK |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
| Origine du recrutement des participants |
A selection of health care professionals |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon |
GP section:
The investigating physicians will be the Thalès physicians accepting to participate in the study Pneumologist section: The investigating centers for the study will be obtained by random drawing stratified over the region. The minimum survey rate allowing for representation of each of the regions is about 4%, which corresponds to a sample of 101 pneumologists in France |
| Objectif de la base de données | |
| Objectif principal | Describe the conditions of use of the fluticasone and other inhaled corticosteroids in a pragmatic situation in general practice and in specialized pneumology, evaluate the severity of the asthma of patients cared for and measure the adequacy of the care with the national recommendations |
| Critères d'inclusion |
GP section:
The eligible population is defined by all of the asthmatic patients over the age of 15 years who have consulted at least twice in the previous year and in whom an inhaled corticotherapy is in progress (at least one prescription in the last six months). Patients defined as such who come to consult spontaneously for asthma during the period of inclusion will also be included. Refusal to participate and the association of the asthma with an OCPD are criteria for non-inclusion. Pneumologist section: Asthmatic persons cared for in liberal pneumology present in the practice of the investigators of the study and meeting the inclusion criteria |
| Type de population | |
| Age |
Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2004 |
| Année du dernier recueil | 2009 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
[1000-10 000[ individuals |
| Détail du nombre d'individus | 1691 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Données déclaratives, précisions |
Paper self-questionnaire |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health care consumption and services |
| Consommation de soins, précisions |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Modalités | |
| Mode de recueil des données | GP section:The characteristics of the patients will be collected in historical data present in the Thalès database, then at the inclusion visit and during all of the visits occurring during the follow-up period. At each visit, the stage of the severity of the patients according to GINA clinical and therapeutic classifications will be evaluatedDuring the inclusion period, at each consultation of an eligible patient, the study will be offered to him. Where applicable, the computerized inclusion questionnaire is filled out and the patient is included in the cohort. At each consultation carried out during the follow-up period, a ""pop-up"" screen containing the follow-up questionnaire will appear on the investigator's computer screen.Pneumologist section:The conditions for the use of inhaled steroids according to the stages of severity will be described through three questionnaires: a historical questionnaire (data coming from the medical dossier of the patient), an inclusion questionnaire and a follow-up questionnaire which will be implemented in computerized format. A fourth questionnaire, self-administered pertaining to the control of the asthma, will be completed by the patient at inclusion and at each visit during the follow-up. The collection of data will be carried out on a computerized support via a secure internet site devoted to the study. The physician will directly enter the information desired into the on-line forms |
| Suivi des participants |
Yes |
| Détail du suivi | GP section:Follow-up for 24 months, Pneumologist section:Follow-up for 24 months, at each new consultation carried out during the follow-up period, the pneumologist fills out the computerized on-line follow-up questionnaire |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Lien vers le document | http://tinyurl.com/pubmed-ocsigen |
| Description | Liste des publications dans Pubmed |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | Publications in progress |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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