Status:
COMPLETED
Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease
Lead Sponsor:
Karolinska Institutet
Conditions:
Rheumatoid Arthritis
Polyarthritis
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to investigate the construct validity (convergent and known-groups) and responsiveness of EQ-5D-3L in patients with rheumatoid arthritis, polyarthritis, psoriatic arthritis, a...
Detailed Description
Background Patient-reported outcome measures (PROMs) are used to measure how patients themselves experience their health and health related quality of life (HRQoL) (Sveriges kommuner och regioner 202...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 years and older at the time of first included measurement
- A diagnosis of RA, polyarthritis, PsA, or AS
- Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ
- For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as EQ-5D-3L
- For patients with polyarthritis: At least one measurement with DAS28 reported in relation to the same visit as EQ-5D-3L
- For patients with PsA: At least one measurement with DAS28 or Disease Activity in Psoriatic Arthritis (DAPSA) reported in relation to the same visit as EQ-5D-3L
- For patients with AS: At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) reported in relation to the same visit as EQ-5D-3L
- For the analyses of construct validity, the latest measurement will be used if the individual patients have multiple complete registrations with EQ-5D-3L and the other required measure. The hypotheses for responsiveness will be tested in patients with newly diagnosed disease (having the diagnosis for ≤12 months), as changes in disease activity are likely to be present in this group. For the analysis of responsiveness, the two first measurements during the first year will be used.
Exclusion
Key Trial Info
Start Date :
August 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
77651 Patients enrolled
Trial Details
Trial ID
NCT06568029
Start Date
August 16 2024
End Date
September 30 2024
Last Update
March 6 2025
Active Locations (1)
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1
It is an observational study based on the The Swedish Rheumatology Quality Register
Stockholm, Sweden