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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| The EuroQol Research Foundation | OTHER |
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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).
A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EQ-5D-5L | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-3L | 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. | 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). |
| EQ-5D-5L | 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. | 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). |
| Disease activity score 28 (DAS28) | Measure of disease activity. 0 indicates no disease activity and 10 indicates the highest disease activity. | 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). |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Measure of disease activity. 0 indicates no disease activity and 10 highest disease activity. | 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). |
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Inclusion Criteria:
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Patients with inflammatory joint disease complete PROMs routinely in conjunction with their follow-up healthcare visits, through an online platform called Patients Own Registration (PER). Patients who meet the inclusion criteria will be asked whether they want to participate in the study when they access PER.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25355653 | Background | Buchholz I, Thielker K, Feng YS, Kupatz P, Kohlmann T. Measuring changes in health over time using the EQ-5D 3L and 5L: a head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample. Qual Life Res. 2015 Apr;24(4):829-35. doi: 10.1007/s11136-014-0838-x. Epub 2014 Oct 30. | |
| 20623685 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2026 | Apr 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Ankylosing Spondylitis Disease Activity Score (ASDAS) | Measure of disease activity. 0 indicates no disease activity. There is no upper limit, but a higher score indicates higher disease activity. | 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). |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Measure of physical function. Ranges between 0 and 3. A higher score indicates more problems with physical function. | 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). |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | Measure of physical function. Ranges between 0 and 10. A higher score indicates more problems with physical function. | 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). |
| Pain measured with a visual analogue scale | Visual analogue scale measuring pain. 0 indicates no pain and 100 indicates the worst possible pain. | 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). |
| Fatigue measured with a visual analogue scale | Visual analogue scale measuring fatigue. 0 indicates no problem with fatigue and 100 indicates the worst possible fatigue. | 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). |
| General health measured with a visual analogue scale | Visual analogue scale measuring general health. 0 indicates no problems with general health and 100 indicates worst possible general health. | 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). |
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| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |