About this trial
The purpose of this study is to develop a French language version of the Compliance-Questionnaire-Rheumatology for use in French and Francophone rheumatology services
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
The patient is at least 18 years old
The patient has rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months with a stable (unchanged) dosage for at least 1 month, and a stable (unchanged) route of administration for at least 1 month. And no planned change in Methotrexate intake at least until the second study visit. Other treatments at the same time are authorized
Disqualifiers
The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
Trial population
Patients with rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months being followed in the rheumatology department of Montpellier, Toulouse, Bordeaux or Nîmes hospitals.
Trial design
Case-only
Prospective
Treatments tested in this trial
Questionnaire
Other interventionPatients are asked to complete several questionnaires
Treatment groups
Trial outcomes
Primary outcomes
Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire
Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart
Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire
Principal component analysis
Secondary outcomes
Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)
CQR ≥80% (observant) vs MTX PGs level
Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology
%
Rate of questionnaires with at least 1 missing item
%
Validation of the short form of the French Compliance Questionnaire Rheumatology
5-item questionnaire
Sponsors and contacts
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