ITMO public health
Last update : 07/23/2015 | Version : 2 | ID : 60147
| General | |
| Identification | |
| Detailed name | Cross-cultural Validation of Systemic Lupus Activity (SLAQ) and Lupus Quality of Life (Lupus QOL) Questionnaires in French |
| Sign or acronym | FRESH QOLA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 28/01/2009 |
| General Aspects | |
| Medical area |
Immunology |
| Health determinants |
Occupation Social and psychosocial factors |
| Keywords | Advancement, translation, French, quality of life, questionnaire |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bonithon-Kopp |
| Surname | Claire |
| Address | 21000 DIJON |
| bonithon@u-bourgogne.fr | |
| Unit | CHU DIJON / INSERM CIE 1 UNIVERSITÉ DE BOURGOGNE |
| Organization | CHU |
| Name of the director | Devilliers |
| Address | 21000 DIJON |
| Phone | + 33 (0)3 80 39 33 79 |
| Organization | CHU |
| Name of the director | Guillemin |
| Surname | Francis |
| Address | 54035 NANCY |
| Unit | CHU NANCY / INSERM CIE6 |
| Organization | CHU |
| Name of the director | Besancenot |
| Address | 21000 DIJON |
| Organization | CHU |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | LUPUS FRANCE |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Dijon |
| Organisation status |
Public |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective |
| Database objective | |
| Main objective | General objective: To translate and validate the Systemic Lupus Activity questionnaire and the Lupus Quality of Life into French |
| Inclusion criteria | - Patients fulfilling ACR 1997 criteria for systemic lupus erythematosus classification; - patients that understand written and spoken French; - patients between 18 and 75 years of age; - patients who received oral and written information regarding research. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Alsace Champagne-Ardenne Lorraine Bourgogne Franche-Comté |
| Detail of the geography area | Multicentric cohort throughout the Eastern Region of France (6 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 02/2009 |
| Date of last collection (YYYY or MM/YYYY) | 01/2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 13 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: from a paper questionnaire (manual input) with double data entry Interview: from a paper questionnaire (manual input) with double data entry Clinical Examinations: handwritten (manual input) with double data entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 6 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-FRESH-QOLA |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-FRESH-QOLA |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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