Ankylosing Spondylitis, Rheumatoid Arthritis (RA), Psoriatic Arthritis, Polyarthritis, Inflammatory Joint Disease (IJD)
Conditions
Keywords
measurement properties, psychometric properties, inflammatory joint disease, eq-5d
Brief summary
The aim of this study is to compare the construct validity (convergent validity and known-groups validity) and responsiveness of EQ-5D-3L and EQ-5D-5L in patients with inflammatory joint disease. The study is based on prospectively collected data through the Swedish Rheumatology Quality Register (SRQ).
Detailed description
A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'
Interventions
OTHEREQ-5D-5L
EQ-5D is a generic instrument used to measure, value, and compare health across symptoms and diagnoses. There are two versions of the EQ-5D, the EQ-5D-3L and the EQ-5D-5: Patients with inflammatory joint disease already complete patient-reported measures (PROMs), including EQ-5D-3L, routinely in conjunction with their follow-up healthcare visits, and patients who consent to participate in the study will also complete the EQ-5D-5L. The order in which the patient responds to the EQ-5D-3L and EQ-5D-5L is randomised so that participants answer one version of the EQ-5D before the other routinely collected PROMs, and the other EQ-5D version at the end. When data collection with EQ-5D-5L is concluded, all data necessary for analyses will be retrieved from the SRQ.
Sponsors
Karolinska Institutet
Karolinska University Hospital
The EuroQol Research Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Agreed to participate in the study * ≥18 years at the time of the first measurement * A diagnosis of rheumatoid arthritis (RA), polyarthritis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS) * Complete registration of responses in the EQ-5D-3L and EQ-5D-5L descriptive system at least at one time point (one visit) * For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as the EQ-5D was registered * For patients with polyarthritis: At least one measurement with DAS28 reported in relation to the same visit as the EQ-5D was registered * 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 the EQ-5D was registered * For patients with AS: At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or the Axial Spondyloarthritis Disease Activity Score (ASDAS) reported in relation to the same visit as the EQ-5D was registered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-3L | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Instrument used to measure and value health-related quality of life. The instrument consists of five items/dimensions that can be answered from 1-3. A higher score indicates more problems. The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead. |
| EQ-5D-5L | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Instrument used to measure and value health-related quality of life. The instrument consists of five items/dimensions that can be answered from 1-5. A higher score indicates more problems. The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead. |
| Disease activity score 28 (DAS28) | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Measure of disease activity. 0 indicates no disease activity and 10 indicates the highest disease activity. |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Measure of disease activity. 0 indicates no disease activity and 10 highest disease activity. |
| Ankylosing Spondylitis Disease Activity Score (ASDAS) | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Measure of disease activity. 0 indicates no disease activity. There is no upper limit, but a higher score indicates higher disease activity. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Measure of physical function. Ranges between 0 and 3. A higher score indicates more problems with physical function. |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Measure of physical function. Ranges between 0 and 10. A higher score indicates more problems with physical function. |
| Pain measured with a visual analogue scale | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Visual analogue scale measuring pain. 0 indicates no pain and 100 indicates the worst possible pain. |
| Fatigue measured with a visual analogue scale | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Visual analogue scale measuring fatigue. 0 indicates no problem with fatigue and 100 indicates the worst possible fatigue. |
| General health measured with a visual analogue scale | Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26). | Visual analogue scale measuring general health. 0 indicates no problems with general health and 100 indicates worst possible general health. |
Countries
Sweden
Outcome results
None listed