An observational study in Spondylarthritis, Inflammatory Bowel Diseases and Crohn Disease, sponsored by University Hospital, Grenoble. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by University Hospital, Grenoble · Observational
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.
600 studies on the registry are indexed under Spondylarthritis; 92 are open to participants now.
This study's planned enrollment of 220 is above the median of 177 across 240 observational studies indexed under Spondylarthritis.
Browse Spondylarthritis studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is people with inflammatory bowel disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient followed in gastro-enterology for an inflammatory bowel disease. These represent every-patient in our study.
Other: Screening questionnaire
Every patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month.
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.
Time frame: 13 months
acceptability of the instrument via the proportion of missing data for each item
Time frame: 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
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 13 months
Comparaison of reliability of the 2 questionnaire
Through comparaison of an intra-rater reliability with the intra-class correlation.
Time frame: 13 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Apr 2026, 11 months later.
Of 67 non-industry observational studies under Spondylarthritis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 201. This study's planned 11 months is below that.
Counting every sponsor, half of 89 studies reached it within 48 months; a quarter within 25 and three quarters within 116.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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