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.'
Study Type
OBSERVATIONAL
Enrollment
6,967
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.
Karolinska Institutet
Stockholm, Sweden
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).