Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease (NCT06568029) | Clinical Trial Compass
CompletedNot Applicable
Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease
Sweden77,651 participantsStarted 2024-08-16
Plain-language 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, and ankylosing spondylitis. The study is based on retrospective registry data from the Swedish Rheumatology Registry (SRQ).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Convergent validity
Timeframe: One measurement per patient.The latest complete EQ-5D-3L and EQ VAS measurements per patient during the period 2008-2024 is used for the analysis.
2
Known-groups validity
Timeframe: One measurement per patient. The latest complete EQ-5D-3L and EQ VAS measurements per patient during the period 2008-2024 is used for the analysis.
3
Responsiveness
Timeframe: One year. The two first EQ-5D-3L and EQ VAS measurements of patients with newly diagnosed disease (having the diagnosis for ≤12 months) during the first year for patients included during the period 2008-2024