Validity and feasability of self-assessment of joints by patients with rheumatoid arthritis and the influence of elaborate training.
- Conditions
- Rheumatoid Arthritis, reumatoïde artritis, patient reported outcomes, patiënt gerapporteerde uitkomsten, self assessed joint counts, zelfonderzoek, training,PDASII, validation, validatie, clinimetrics, klinimetrie
- Registration Number
- NL-OMON20270
- Lead Sponsor
- Radboud University Nijmegen medical Centre.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Early RA patients seen 3 months post diagnosis or;
2. Patients starting on immunomodulating therapy (biological).
Exclusion Criteria
1.Patients younger than 18 years of age;
2.Patients totally incapable of performing the PDASII evaluation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concurrent longitudinal validity of the PDASII with the DAS28 at 6, 9 and 12 months follow-up by means of a random effect model with training yes/no as a independent variable.
- Secondary Outcome Measures
Name Time Method Validity:<br /><br>1. Face/content: Percentage found to be comprehensive versus missing elements;<br /><br>2. Construct: Convergent correlation analysis with other measures of disease activity and related components of health assessment questionnaires, discriminant correlation analysis with non-related components of health assessment questionnaires measures of disease activity and health state measures;<br /><br>3. Predictive analysis of PDASII with joint damage progression.<br><br /><br /><br>Reliability:<br /><br>1. PDASII intrarater intra-class correlation coefficient.<br><br /><br /><br>Sensitivity to change:<br /><br>1. Standardised response mean;<br /><br>2. Effect size;<br /><br>3. Minimal important difference (ROC + 75th percentile).<br><br /><br /><br>Training:<br /><br>The above mentioned analyses can be performed with ‘training’ as an covariate to assess the effect of having received training on the measurement properties of the PDASII.