Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease

Recruiting

• Conditions: Rheumatoid Arthritis; Polyarthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Rheumatic Diseases

• Registration Number: NCT06568029
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 years and older at the time of first included measurement<br><br> - A diagnosis of RA, polyarthritis, PsA, or AS<br><br> - Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on<br> at least one time point in SRQ<br><br> - For patients with RA: At least one measurement with Disease Activity Score 28<br> (DAS28) reported in relation to the same visit as EQ-5D-3L<br><br> - For patients with polyarthritis: At least one measurement with DAS28 reported in<br> relation to the same visit as EQ-5D-3L<br><br> - For patients with PsA: At least one measurement with DAS28 or Disease Activity in<br> Psoriatic Arthritis (DAPSA) reported in relation to the same visit as EQ-5D-3L<br><br> - For patients with AS: At least one measurement with the Bath Ankylosing Spondylitis<br> Disease Activity Index (BASDAI) reported in relation to the same visit as EQ-5D-3L<br><br>For the analyses of construct validity, the latest measurement will be used if the<br>individual patients have multiple complete registrations with EQ-5D-3L and the other<br>required measure. The hypotheses for responsiveness will be tested in patients with newly<br>diagnosed disease (having the diagnosis for =12 months), as changes in disease activity<br>are likely to be present in this group. For the analysis of responsiveness, the two first<br>measurements during the first year will be used.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Convergent validity;Known-groups validity;Responsiveness