PASS-ARTHROSE - Patient Acceptable Symptomatic State 
Head :
VIGNAL Franck, Sanofi Aventis
Last update : 01/01/2020 | Version : 1 | ID : 93
| General | |
| Identification | |
| Detailed name | Patient Acceptable Symptomatic State |
| Sign or acronym | PASS-ARTHROSE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Numéro CNIL 909039, Numéro CPP = NA, Afssaps = NA |
| General Aspects | |
| Medical area |
General practice Rheumatology |
| Others (details) | Arthrosis of the lower limbs |
| Keywords | evaluation of the pain and response to antalgic treatment, PASS, Minimal Clinically Important Improvement (MCII) |
| Scientific investigator(s) (Contact) | |
| Name of the director | VIGNAL |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi-aventis.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-aventis France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals An administrative base or a register |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Determine, in patients suffering from arthrosis of the lower limbs, the percentage of patients that find their pain "acceptable" at rest and when movement, after one week of treatment, according to the PASS concept (Patient Acceptable Symptomatic State). |
| Inclusion criteria |
Patients must: • be ambulatory, • be aged 50 years or older, • consult for a defined gonarthrosis and/or coxarthrosis according to the clinical or radiological criteria of the American College of Rheumatology, • be symptomatic with pain greater or equal to 3 on a numerical pain scale from 0 to 10, at rest or during movement, in the 24 hours preceding entry in the study, • requiring the taking of an antalgic treatment for a duration of at least one week, • be able and accept to complete a self-evaluation questionnaire, • accepting to participate in the survey. |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | French territory (France+overseas possessions) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 3329 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Administrative data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Administrative data (detail) | • age, sex, • weight, height, • social and occupational category (INSEE classification), |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | general practice, evaluation of the pain and response to antalgic treatment, arthrosis of the lower limbs Doctor's questionnaire patient self-questionnaire |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | methods for accessing the database are currently being defined SFR 2010 poster. Publication scheduled in 2011. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
