Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology)

Study Overview
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Brief Summary
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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

Official Title
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Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment

Conditions
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Rheumatoid Polyarthritis

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 The subject has a contraindication to taking methotrexate (including a patient with a desire to become pregnant).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with rheumatoid polyarthritis<br> | Other: Questionnaire<br>* Patients are asked to complete several questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire | Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart | 40 minutes | 
| Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire | Principal component analysis | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration) | CQR ≥80% (observant) vs MTX PGs level | Baseline | 
| Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology |  | Baseline | 
| Rate of questionnaires with at least 1 missing item |  | Baseline | 
| Validation of the short form of the French Compliance Questionnaire Rheumatology | 5-item questionnaire | Baseline | 
| Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8) | Sensitivity and specificity compared against MTX PGs level | Baseline | 
| Sex of observant versus non-observant patients | male/female | Month 1 | 
| Age of observant versus non-observant patients | years | Month 1 | 
| education level of observant versus non-observant patients | school graduation | Month 1 | 
| profession of observant versus non-observant patients | name of the profession | Month 1 | 
| marital status of observant versus non-observant patients | Married, single, divorced, widowed | Month 1 | 
| Number patients observing medication | Blood MTX PG concentration nmol/L by LC-MS/MS | Month 1 | 
| Quality of life in observant versus non-observant patients | Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Month 1 | 
| Health-related quality of life in observant versus non-observant patients | Euroqol 5 dimension 3 level questionnaire (EQ5D-3L) | Month 1 | 
| Functional incapacity in observant versus non-observant patients | Health Assessment Questionnaire (HAQ) | Month 1 | 
| Pain experience in observant versus non-observant patients | Pain Catastrophizing Scale (PCS-CF) | Month 1 | 
| Cognitive representations of medication in observant versus non-observant patients | Beliefs about Medicines Questionnaire | Month 1 |