Spondylo-arthritis Screening Tool Among Patient Suffering From Inflammatory Bowel Disease (QUESAM)
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Treatments
Details and patient eligibility
About
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.
Full description
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
- "The DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire: development and preliminary testing of a new tool to screen patients with inflammatory bowel disease for the presence of spondyloarthritis, Di Carlo et al (2017)"
- "The IBIS-Q [IBd Identification of Spondyloarthritis Questionnaire]: A Novel Tool to Detect Both Axial and Peripheral Arthritis in Inflammatory Bowel Disease Patients, Variola et al (2020) From english to french, with a specialized company in scientific translation.
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
- sex
- age
- study level
- type of inflammatory bowel disease
- presence of musculoskeletal pain
- duration of articulary and bowel disease
- previous treatment by biologic
- known spondylo-arthritis
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patient with an inflammatory bowel disease according to gastroenterologist
Exclusion criteria
- No exclusion criteria
- Difficulty for understanding or reading french
- Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code
- Patients with no social security coverage.
- Patients refusing to participate voluntarily.
Trial design
220 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Xavier R university hospital practitioner, PhD; Rejane R ARC, nursing diploma
Data sourced from clinicaltrials.gov
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