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Completed

NCT Number: NCT07580092

Construct Validity and Responsiveness of EQ-5D-3L and EQ-5D-5L in Patients With Inflammatory Joint Disease

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).

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Inflammatory Joint Disease (IJD) Joint Diseases Musculoskeletal Diseases Polyarthritis Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis (RA) Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Sweden

About this study

A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. EQ-5D-3L

    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).

    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.

  2. EQ-5D-5L

    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).

    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.

  3. Disease activity score 28 (DAS28)

    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).

    Measure of disease activity. 0 indicates no disease activity and 10 indicates the highest disease activity.

  4. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    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).

    Measure of disease activity. 0 indicates no disease activity and 10 highest disease activity.

  5. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    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).

    Measure of disease activity. 0 indicates no disease activity. There is no upper limit, but a higher score indicates higher disease activity.

  6. Health Assessment Questionnaire Disability Index (HAQ-DI)

    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).

    Measure of physical function. Ranges between 0 and 3. A higher score indicates more problems with physical function.

  7. Bath Ankylosing Spondylitis Functional Index (BASFI)

    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).

    Measure of physical function. Ranges between 0 and 10. A higher score indicates more problems with physical function.

  8. Pain measured with a visual analogue scale

    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).

    Visual analogue scale measuring pain. 0 indicates no pain and 100 indicates the worst possible pain.

  9. Fatigue measured with a visual analogue scale

    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).

    Visual analogue scale measuring fatigue. 0 indicates no problem with fatigue and 100 indicates the worst possible fatigue.

  10. General health measured with a visual analogue scale

    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).

    Visual analogue scale measuring general health. 0 indicates no problems with general health and 100 indicates worst possible general health.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital
  • The EuroQol Research Foundation

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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