PSOLEMEE - Localized psoriasis: a pharmaco-economic evaluation 
Responsable(s) :
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Date de modification : 05/09/2017 | Version : 2 | ID : 2849
| Général | |
| Identification | |
| Nom détaillé | Localized psoriasis: a pharmaco-economic evaluation |
| Sigle ou acronyme | PSOLEMEE |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTI-RS 08.493bis, CNIL 908462 |
| Thématiques générales | |
| Domaine médical |
Dermatology, venereology |
| Déterminants de santé |
Medicine |
| Mots-clés | cost, pharmaco-economic study, Psoriasis, quality of life, cohort, pharmacoepidemiology, Department of Pharmacology, Bordeaux |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Moore |
| Prénom | Nicholas |
| Adresse | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Téléphone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisme | Université Bordeaux |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | Laboratoire GENEVRIER |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Statut de l’organisation |
Secteur Public |
| 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 A selection of health institutions and services |
| 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 | Two independent observational cohorts of patients with chronic plaque psoriasis were formed. The first, "physician cohort", was composed of patients from a random sample of general practitioners and dermatologists (hospital and non-hospital). The second, "association cohort", was composed of patients selected through the website of a psoriasis patient association. |
| Objectif de la base de données | |
| Objectif principal | The main objective of this study was to evaluate the cost of psoriasis care for patients corresponding to the target population of BETESIL®, i.e. those suffering from chronic plaque psoriasis, localized in areas difficult to treat (knees, elbows, and anterior surface of the tibia, not exceeding 5% of body surface area). |
| Critères d'inclusion | Patient aged 18 years or above; Patient with chronic plaque psoriasis; Patient with plaques located in places difficult to treat (knees, elbows, and anterior tibia, not exceeding 5% of the body surface area); Patient able to understand or complete the study questionnaires; patient who can be followed for 6 months; patient agreeing to participate in the study. |
| Type de population | |
| Age |
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 | Dermatologists and general practitioners in France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2009 |
| Année du dernier recueil | 2010 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 475 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data Administrative data |
| Données cliniques, précisions |
Direct physical measures |
| Données déclaratives, précisions |
Paper self-questionnaire Phone interview |
| Données administratives, précisions | Name, first name, home address, email address, phone number |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Consommation de soins, précisions |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Modalités | |
| Mode de recueil des données | The inclusion data were collected by physicians or dermatologists (medical questionnaire), by patients (self-administered questionnaire) and CRA (telephone questionnaire). During the follow-up at 3 and 6 months, data were collected by patients (self-administered questionnaire) and CRA (telephone questionnaire). |
| Suivi des participants |
Yes |
| Détail du suivi | Patients were contacted by post at 3 and 6 months to complete a standard self-administered questionnaire (general data regarding psoriasis, quality of life) and by a CRA to complete a standard telephone questionnaire (drugs and cosmetics, consultations, examinations, surgery, hospitalization, sick leave, phototherapy, spa therapy). |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | A study report was delivered to the pharmaceutical company after validation by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
