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| Name | Class |
|---|---|
| Clinique des Cèdres, Echirolles | UNKNOWN |
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The QUESAM study aims to translate into French and validate the traduction of 2 screening questionnaires for spondylo-arthritis among people with inflammatory bowel disease.
DETAIL (DETection of Arthritis in Inflammatory boweL diseases) and IBIS-Q (Inflammatory Bowel disease Identification of Spondyloarthritis Questionnaire) questionnaires are built to determine which patients might benefit from a rheumatologic consultation, for a potential rheumatologic inflammatory disease.
The investigators will translate the 2 questionnaire in french thanks to an external translation company, from english to french, then back to english to make sure the translation is correct.
Then, the main question is:
is there a conceptual and semantic equivalence beetween the original english questionnaire and the french-translated one.
Participant will answer the 2 screening questionnaire, one initial time during a consultation, and a second time after 1 month.
This is not an actual interventionnal or observationnal study. Investigators will try to provide a statistical validation of 2 questionnaires on people followed in gastro-enterology for an inflammatory bowel disease.
In the first place, investigators will translate the 2 questionnaires
Investigators will then, with the help of 5 patients, determine if the translated final version is easy to understand, and eventually adjust the questionnaires if needed.
If a modification is needed, 5 other patients will be reached to look for any unclear formulation.
If no modification is needed, the questionnaire will be given to eligible patients until 200 answers are reached. People will be recruited during a standard care consultation or a one day-hospitalization for biological treatment
Invistigators will, on top of the questionnaires, be collecting the
At 1 month, participants will be contacted by mail, so that they fill the questionnaires again.
At last, with the answers to the 400 hundreds questionnaires (200 patients, baseline questionnaire + the one month reminder), investigators will be able to make the statistic analyzes required for the statistical validation of the questionnaires, in french.
Outside of the statistical validation, if the questionnaire are in favor of a rheumatologic disease, the gastro-enterologist can address patients to a rheumatology department.
General praticionner will then receive a report of the evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with inflammatory bowel disease | Patient followed in gastro-enterology for an inflammatory bowel disease. These represent every-patient in our study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening questionnaire | Other | Every patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| translation and cross-cultural adaptation in french of the questionnaires developped by Di Marco et al (2017) and Variola et al (2020) | This is a composite criterion combining conceptual equivalence and semantic equivalence of items between the transcultural adaptation of the scale and its original version. Conceptual equivalence will be judged on the results of factorial analysis (exploratory and confirmatory). Semantic equivalence of items will be based on evaluation by a panel of experts. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| acceptability of the instrument via the proportion of missing data for each item | Baseline and one month later | |
| Evaluation of the internal consistency assessed by the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is people with inflammatory bowel disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier R university hospital practitioner, PhD | Contact | 04 76 76 54 58 | xromand@chu-grenoble.fr | |
| Rejane R ARC, nursing diploma | Contact | 04 76 76 72 23 | Rgruel@chu-grenoble.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Grenoble | France |
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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These tests aim to determine if the different items are close enough to measure the same thing and still different enough not to be redundant.
| baseline and one month later |
| evaluation of the reliability of the questionnaire through an intra-rater reliability with the intra-class correlation. | Aims to determine if one rater answers the same questions the same way at two different moments. | Baseline and one month later |
| Comparaison of the acceptability of the instrument via the proportion of missing data for each item | this will be done by comparing the proportion of missing data for the 2 questionnaires | 13 months |
| Comparaison of internal consistency of the 2 questionnaires | Through the comparaison of the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient | 13 months |
| Comparaison of reliability of the 2 questionnaire | Through comparaison of an intra-rater reliability with the intra-class correlation. | 13 months |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D000844 | Ankylosis |