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

NCT07580092 | Completed

• 1 other identifier: Dnr 2022-04211-01
• Study Type: observational
• Target: 6,967
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammatory Joint Disease (IJD); Ankylosing Spondylitis; Rheumatoid Arthritis (RA); Psoriatic Arthritis; Polyarthritis

Keywords

measurement properties; psychometric properties; inflammatory joint disease; eq-5d

Outcome Measures

Primary Outcomes (10)

• 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).

• 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).

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• The EuroQol Research Foundation: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (28)

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MeSH Terms

Conditions

Spondylitis, Ankylosing; Arthritis, Rheumatoid; Arthritis, Psoriatic; Arthritis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 12, 2026
• Study Start: November 30, 2023
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)