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

An observational study of Rheumatoid Arthritis and Polyarthritis, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to investigate the construct validity (convergent and known-groups) and responsiveness of EQ-5D-3L in patients with rheumatoid arthritis, polyarthritis, psoriatic arthritis, and ankylosing spondylitis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis, Polyarthritis, Psoriatic Arthritis
What is being tested?: Questionnaire
How many people: 77,651 participants
Where: 1 siteSweden
Study dates: 16 Aug 2024to 30 Sep 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study is based on retrospective registry data from the Swedish Rheumatology Registry (SRQ) and includes patients with rheumatoid arthritis, polyarthritis, psoriatic arthritis, and ankylosing spondylitis. The analyses will be conducted independently for the different patient groups.

Who may be able to join

18 years and older at the time of first included measurement
A diagnosis of RA, polyarthritis, PsA, or AS
Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ
For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as EQ-5D-3L
For patients with polyarthritis: At least one measurement with DAS28 reported in relation to the same visit as EQ-5D-3L
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 EQ-5D-3L
For patients with AS: At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) reported in relation to the same visit as EQ-5D-3L
For the analyses of construct validity, the latest measurement will be used if the individual patients have multiple complete registrations with EQ-5D-3L and the other required measure. The hypotheses for responsiveness will be tested in patients with newly diagnosed disease (having the diagnosis for ≤12 months), as changes in disease activity are likely to be present in this group. For the analysis of responsiveness, the two first measurements during the first year will be used.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

It is an observational study based on the The Swedish Rheumatology Quality Register
Stockholm

Other trials in Sweden

About this study

Read the detailed description

Background

Patient-reported outcome measures (PROMs) are used to measure how patients themselves experience their health and health related quality of life (HRQoL) (Sveriges kommuner och regioner 2023). One of the most commonly used PROMs is EQ-5D, which is a generic instrument used to measure, value and compare health across symptoms and diagnoses (Devlin and Brooks 2017). When choosing a PROM to follow-up care from the patient perspective and to assess HRQoL in patients with rheumatic disease, it is important to know that the instrument is valid and responsive. An instrument with low validity and responsiveness might not capture and describe patients' health and changes in their health accurately. The aim of the study is therefore to investigate the validity and responsiveness of EQ-5D-3L. The research questions are: 1. What is the construct validity of EQ-5D-3L in patients with rheumatic disease? 2. What is the responsiveness of EQ-5D-3L in patients with rheumatic disease?

Methodology

Study design and data collection

This study will assess the construct validity and responsiveness of EQ-5D-3L among patients with rheumatoid arthritis (RA), polyarthritis, psoriatic arthritis (PsA), and ankylosing spondylitis (AS) based on retrospective registry data. The design of the study will follow the established guidelines from COSMIN on how to assess validity and responsiveness of PROMs (Mokkink, Prinsen et al. 2019).

Construct validity refers to the degree to which an instrument measures the constructs it intends to measure (Fayers and Machin 2007). Construct validity will be assessed in two ways, convergent validity and known-groups validity. Convergent validity refers to how well the instrument under study (EQ-5D-3L and EQ VAS) correlates with other outcome measures (Fayers and Machin 2007). Known-groups validity refers to how well the instrument can find differences between groups known to differ. Responsiveness refers to the ability of the instrument to capture change over time in the construct that is measured (Mokkink, Terwee et al. 2010).

Historical registry data from the Swedish Rheumatology Register (SRQ) will be used to assess the construct validity and responsiveness of EQ-5D-3L and EQ VAS. Data on EQ-5D-3L has been collected since 2008 (Ernstsson, Janssen et al. 2020) and the study will include data from 2008 until the time of data extraction. The analyses will be conducted independently for the different patient groups.

Ethical approval has been granted for the project (2023-04394-01).

Outcome measures

EQ-5D-3L and EQ VAS (see text about intervention). DAS28, DAPSA, BASDAI, ASDAS. The Health Assessment Questionnaire Disability Index (HAQ-DI), the Bath Ankylosing Spondylitis Functional Index (BASFI) VAS questions (pain, fatigue, and global score)

Convergent validity EQ-5D-3L

Convergent validity will be assessed by testing hypotheses regarding the expected direction and magnitude of correlation between the EQ-5D-3L and the other outcome measures (see hypotheses in document Study Protocol and Statistical Analysis Plan). Constructs that are considered to be related are expected to have at least a moderate correlation and constructs that are considered to be similar are expected to have a strong correlation (Prinsen, Mokkink et al. 2018).

Known-groups validity EQ-5D-3L

In the assessment of known-groups validity, patients will be divided into groups for which there is an expected difference in HRQoL (see hypotheses in document Study Protocol and Statistical Analysis Plan). The groups represent patients with different levels of disease activity or functional ability.

Responsiveness EQ-5D-3L

Responsiveness will be assessed in two ways. One way is by assessing the relationship between individual changes in EQ-5D-3L index value and dimensions over time with changes in other outcome measures over the same time period (see hypotheses in document Study Protocol and Statistical Analysis Plan). The second way is to assess whether EQ-5D-3L can discriminate between patients who have improved over time and those that have not, based on changes in disease activity or functional ability. The relationship between changes in the EQ-5D-3L and changes in other outcome measures will be assessed by analysing the correlation between the changes in the variables between the two first measurements of each individual during the first year after diagnosis (see hypotheses in document Study Protocol and Statistical Analysis Plan).

To assess whether EQ-5D-3L can discriminate between patients who have improved and those that have not, the area under the receiver operating curve ROC curve (AUC) will be calculated. Patients will be considered to have improved based on results from the measures of disease activity (DAS28, DAPSA, ASDAS or BASDAI) and functional ability (BASFI and HAQ-DI) using criteria for what is defined as a response from previous studies (see hypotheses in document Study Protocol and Statistical Analysis Plan).

Convergent validity EQ VAS

Convergent validity of EQ VAS will be assessed with the same analyses used for EQ-5D-3L (see the section about convergent validity EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan).

Known-groups validity EQ VAS

Known-groups validity of EQ VAS will be assessed for the same groups as the EQ-5D-3L index (see section about Known-groups validity EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan).

Responsiveness EQ VAS

Responsiveness of EQ VAS will be assessed with the same analyses used for EQ-5D-3L (see the section about responsiveness EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan).

Conditions: Rheumatoid Arthritis, Polyarthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Rheumatic Diseases
Being tested: Questionnaire
Keywords: EQ-5D, Validity, Responsiveness, Psychometric, Patient-reported outcome, PROM, EQ VAS
Medical subject headings: Arthritis, Rheumatoid, Arthritis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnaireOther
Also called EQ-5D-3L
In the study, the validity and responsiveness of EQ-5D-3L will be assessed. The EQ-5D-3L measures HRQoL and consists of two parts. The first part contains five questions about mobility, daily activities, self-care, pain/discomfort, and anxiety/depression (EuroQoL 1990, Brooks 1996). Each question can be answered with no problem (1), some/moderate problem (2) unable to perform certain activities/having extreme problems (3). The answers can be summarized in an index value based on an existing preference-based value set. In this study, the EQ-5D-3L value set by Dolan (Dolan 1997) will be used for the main analyses and a Swedish experience-based value set in a sensitivity analysis (Burström, Sun et al. 2014). For the EQ-5D-3L index, 1 represents full health and 0 represents a value equal to being dead. EQ VAS measures the persons health today on a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health) (EuroQoL 1990, Brooks 1996).

Study groups in NCT06568029
Study group	Role	What they receive
Patient with rheumatoid arthritis		18 years and older at the time of first included measurement. A diagnosis of RA. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as EQ-5D-3L. Receives: Other: Questionnaire
Patient with polyarthritis		18 years and older at the time of first included measurement. A diagnosis of polyarthritis. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with DAS28 reported in relation to the same visit as EQ-5D-3L. Receives: Other: Questionnaire
Patients with psoriatic arthritis		18 years and older at the time of first included measurement. A diagnosis of psoriatic arthritis. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with DAS28 or Disease Activity in Psoriatic Arthritis (DAPSA) reported in relation to the same visit as EQ-5D-3L. Receives: Other: Questionnaire
Patient with ankylosing spondylitis		18 years and older at the time of first included measurement. A diagnosis of ankylosing spondylitis. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) reported in relation to the same visit as EQ-5D-3L. Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Convergent validity
Convergent validity refers to how well the instrument under study (EQ-5D-3L and EQ VAS) correlates with other outcome measures (Fayers and Machin 2007). According to COSMIN guidelines, convergent validity should be assessed by formulating and testing hypotheses regarding the expected direction and magnitude of the correlation between the measurement being studied (EQ-5D-3L and EQ VAS) and other outcome measures measuring the same or similar constructs (Mokkink, Prinsen et al. 2019). The constructs measured by the other outcome measures should be clearly described (Mokkink, Prinsen et al. 2019). See hypotheses in document Study Protocol and Statistical Analysis Plan.
Measured: One measurement per patient.The latest complete EQ-5D-3L and EQ VAS measurements per patient during the period 2008-2024 is used for the analysis.
Known-groups validity
Known-groups validity refers to how well the instrument can find differences between groups known to differ. Known-groups validity should be assessed by formulating and testing hypotheses regarding expected directions and magnitude of the differences between subgroups (Mokkink, Prinsen et al. 2019). See hypotheses in document Study Protocol and Statistical Analysis Plan.
Measured: One measurement per patient. The latest complete EQ-5D-3L and EQ VAS measurements per patient during the period 2008-2024 is used for the analysis.
Responsiveness
Responsiveness refers to the ability of the instrument to capture change over time in the construct that is measured (Mokkink, Terwee et al. 2010). According to COSMIN guidelines, responsiveness can be assessed by comparing changes in EQ-5D-3L and EQ VAS, with changes in other outcome measures, similar to convergent validity explained above (Mokkink, Prinsen et al. 2019). The hypotheses should include the expected direction and magnitude of the correlations, and the constructs should be clearly described. Responsiveness can also be assessed by analysing weather EQ-5D-3L and EQ VAS can discriminate between patients who have improved and those that have not, based on changes in another outcome, such as changes in disease activity or functional ability (Mokkink, Prinsen et al. 2019). See hypotheses in document Study Protocol and Statistical Analysis Plan.
Measured: One year. The two first EQ-5D-3L and EQ VAS measurements of patients with newly diagnosed disease (having the diagnosis for ≤12 months) during the first year for patients included during the period 2008-2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 202430 Sep 2024

First posted23 Aug 2024
Study start16 Aug 2024
Primary completion30 Sep 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Karolinska InstitutetThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 77,651 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06568029
Sponsor's protocol ID: 2023-04394-01
Other IDs: 2023
Status last verified: Mar 2025
First submitted: 19 Aug 2024
Last updated: 6 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Aletaha D, Smolen JS. The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) to monitor patients in standard clinical care. Best Pract Res Clin Rheumatol. 2007 Aug;21(4):663-75. doi: 10.1016/j.berh.2007.02.004.
PubMed 17678828
Boonen A, van der Heijde D, Landewe R, van Tubergen A, Mielants H, Dougados M, van der Linden S. How do the EQ-5D, SF-6D and the well-being rating scale compare in patients with ankylosing spondylitis? Ann Rheum Dis. 2007 Jun;66(6):771-7. doi: 10.1136/ard.2006.060384. Epub 2007 Jan 9.
PubMed 17213254
Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
PubMed 12831398
Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
PubMed 10158943
Burstrom K, Sun S, Gerdtham UG, Henriksson M, Johannesson M, Levin LA, Zethraeus N. Swedish experience-based value sets for EQ-5D health states. Qual Life Res. 2014 Mar;23(2):431-42. doi: 10.1007/s11136-013-0496-4. Epub 2013 Aug 22.
PubMed 23975375
Calin A, Nakache JP, Gueguen A, Zeidler H, Mielants H, Dougados M. Defining disease activity in ankylosing spondylitis: is a combination of variables (Bath Ankylosing Spondylitis Disease Activity Index) an appropriate instrument? Rheumatology (Oxford). 1999 Sep;38(9):878-82. doi: 10.1093/rheumatology/38.9.878.
PubMed 10515650
Campbell, M., D. Machin and S. Walters (2007). Medical Statistics, Wiley-Blackwell.
Coolican, H. (2014). Research methods and statistics in psychology, 6th ed. New York, NY, US, Psychology Press.
Copay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007 Sep-Oct;7(5):541-6. doi: 10.1016/j.spinee.2007.01.008. Epub 2007 Apr 2.
PubMed 17448732
Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.
PubMed 28194657
Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
PubMed 9366889
Ernstsson O, Janssen MF, Heintz E. Collection and use of EQ-5D for follow-up, decision-making, and quality improvement in health care - the case of the Swedish National Quality Registries. J Patient Rep Outcomes. 2020 Sep 16;4(1):78. doi: 10.1186/s41687-020-00231-8.
PubMed 32936347
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801
Fayers, P. M. and D. Machin (2007). Quality of life : the assessment, analysis and interpretation of patient-reported outcomes. Chichester, J. Wiley.
Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137-45. doi: 10.1002/art.1780230202.
PubMed 7362664

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease
ClinicalTrials.gov ID: NCT06568029
Acronym / sponsor ID: 2023-04394-01
Conditions: Rheumatoid Arthritis, Polyarthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Rheumatic Diseases
Keywords: EQ-5D, Validity, Responsiveness, Psychometric, Patient-reported outcome, PROM, EQ VAS
Study type: Observational
Recruitment status: Completed
Enrolment: 77,651 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Study start: 16 Aug 2024 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 23 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background

Methodology

Study design and data collection

Ethical approval has been granted for the project (2023-04394-01).

Outcome measures

Convergent validity EQ-5D-3L

Known-groups validity EQ-5D-3L

Responsiveness EQ-5D-3L

Convergent validity EQ VAS

Known-groups validity EQ VAS

Responsiveness EQ VAS

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Patient with rheumatoid arthritis	–	Other: Questionnaire18 years and older at the time of first included measurement. A diagnosis of RA. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as EQ-5D-3L.
Patient with polyarthritis	–	Other: Questionnaire18 years and older at the time of first included measurement. A diagnosis of polyarthritis. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with DAS28 reported in relation to the same visit as EQ-5D-3L.
Patients with psoriatic arthritis	–	Other: Questionnaire18 years and older at the time of first included measurement. A diagnosis of psoriatic arthritis. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with DAS28 or Disease Activity in Psoriatic Arthritis (DAPSA) reported in relation to the same visit as EQ-5D-3L.
Patient with ankylosing spondylitis	–	Other: Questionnaire18 years and older at the time of first included measurement. A diagnosis of ankylosing spondylitis. Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ. At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) reported in relation to the same visit as EQ-5D-3L.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study is based on retrospective registry data from the Swedish Rheumatology Registry (SRQ) and includes patients with rheumatoid arthritis, polyarthritis, psoriatic arthritis, and ankylosing spondylitis. The analyses will be conducted independently for the different patient groups.

Key inclusion criteria (8 listed)

18 years and older at the time of first included measurement
A diagnosis of RA, polyarthritis, PsA, or AS
Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ
For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as EQ-5D-3L
For patients with polyarthritis: At least one measurement with DAS28 reported in relation to the same visit as EQ-5D-3L

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnaireAlso: EQ-5D-3LIn the study, the validity and responsiveness of EQ-5D-3L will be assessed. The EQ-5D-3L measures HRQoL and consists of two parts. The first part contains five questions about mobility, daily activities, self-care, pain/discomfort, and anxiety/depression (EuroQoL 1990, Brooks 1996). Each question can be answered with no problem (1), some/moderate problem (2) unable to perform certain activities/having extreme problems (3). The answers can be summarized in an index value based on an existing preference-based value set. In this study, the EQ-5D-3L value set by Dolan (Dolan 1997) will be used for the main analyses and a Swedish experience-based value set in a sensitivity analysis (Burström, Sun et al. 2014). For the EQ-5D-3L index, 1 represents full health and 0 represents a value equal to being dead. EQ VAS measures the persons health today on a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health) (EuroQoL 1990, Brooks 1996).	Other	Patient with ankylosing spondylitis, Patient with polyarthritis, Patient with rheumatoid arthritis, Patients with psoriatic arthritis

Primary outcome

Convergent validity
Time frame: One measurement per patient.The latest complete EQ-5D-3L and EQ VAS measurements per patient during the period 2008-2024 is used for the analysis.
Convergent validity refers to how well the instrument under study (EQ-5D-3L and EQ VAS) correlates with other outcome measures (Fayers and Machin 2007). According to COSMIN guidelines, convergent validity should be assessed by formulating and testing hypotheses regarding the expected direction and magnitude of the correlation between the measurement being studied (EQ-5D-3L and EQ VAS) and other outcome measures measuring the same or similar constructs (Mokkink, Prinsen et al. 2019). The constructs measured by the other outcome measures should be clearly described (Mokkink, Prinsen et al. 2019). See hypotheses in document Study Protocol and Statistical Analysis Plan.
Known-groups validity
Time frame: One measurement per patient. The latest complete EQ-5D-3L and EQ VAS measurements per patient during the period 2008-2024 is used for the analysis.
Known-groups validity refers to how well the instrument can find differences between groups known to differ. Known-groups validity should be assessed by formulating and testing hypotheses regarding expected directions and magnitude of the differences between subgroups (Mokkink, Prinsen et al. 2019). See hypotheses in document Study Protocol and Statistical Analysis Plan.
Responsiveness
Time frame: One year. The two first EQ-5D-3L and EQ VAS measurements of patients with newly diagnosed disease (having the diagnosis for ≤12 months) during the first year for patients included during the period 2008-2024
Responsiveness refers to the ability of the instrument to capture change over time in the construct that is measured (Mokkink, Terwee et al. 2010). According to COSMIN guidelines, responsiveness can be assessed by comparing changes in EQ-5D-3L and EQ VAS, with changes in other outcome measures, similar to convergent validity explained above (Mokkink, Prinsen et al. 2019). The hypotheses should include the expected direction and magnitude of the correlations, and the constructs should be clearly described. Responsiveness can also be assessed by analysing weather EQ-5D-3L and EQ VAS can discriminate between patients who have improved and those that have not, based on changes in another outcome, such as changes in disease activity or functional ability (Mokkink, Prinsen et al. 2019). See hypotheses in document Study Protocol and Statistical Analysis Plan.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Background: PubMed 17678828Aletaha D, Smolen JS. The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) to monitor patients in standard clinical care. Best Pract Res Clin Rheumatol. 2007 Aug;21(4):663-75. doi: 10.1016/j.berh.2007.02.004.
Background: PubMed 17213254Boonen A, van der Heijde D, Landewe R, van Tubergen A, Mielants H, Dougados M, van der Linden S. How do the EQ-5D, SF-6D and the well-being rating scale compare in patients with ankylosing spondylitis? Ann Rheum Dis. 2007 Jun;66(6):771-7. doi: 10.1136/ard.2006.060384. Epub 2007 Jan 9.
Background: PubMed 12831398Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
Background: PubMed 10158943Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
Background: PubMed 23975375Burstrom K, Sun S, Gerdtham UG, Henriksson M, Johannesson M, Levin LA, Zethraeus N. Swedish experience-based value sets for EQ-5D health states. Qual Life Res. 2014 Mar;23(2):431-42. doi: 10.1007/s11136-013-0496-4. Epub 2013 Aug 22.
Background: PubMed 10515650Calin A, Nakache JP, Gueguen A, Zeidler H, Mielants H, Dougados M. Defining disease activity in ankylosing spondylitis: is a combination of variables (Bath Ankylosing Spondylitis Disease Activity Index) an appropriate instrument? Rheumatology (Oxford). 1999 Sep;38(9):878-82. doi: 10.1093/rheumatology/38.9.878.
BackgroundCampbell, M., D. Machin and S. Walters (2007). Medical Statistics, Wiley-Blackwell.
BackgroundCoolican, H. (2014). Research methods and statistics in psychology, 6th ed. New York, NY, US, Psychology Press.
Background: PubMed 17448732Copay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007 Sep-Oct;7(5):541-6. doi: 10.1016/j.spinee.2007.01.008. Epub 2007 Apr 2.
Background: PubMed 28194657Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.
Background: PubMed 9366889Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
Background: PubMed 32936347Ernstsson O, Janssen MF, Heintz E. Collection and use of EQ-5D for follow-up, decision-making, and quality improvement in health care - the case of the Swedish National Quality Registries. J Patient Rep Outcomes. 2020 Sep 16;4(1):78. doi: 10.1186/s41687-020-00231-8.
National Ankylosing Spondylitis Society. (2004). "Ankylosing Spondylitis (Axial Spondyloarthritis) (AS) The Bath Indices."Link provided by the sponsor.
Lindqvist, U. (2022). "Axial spondylartrit (ankyloserande spondylit, pelvospondylit, Bechterews sjukdom)."Link provided by the sponsor.
Lindqvist, U. (2022). "Psoriasisartrit."Link provided by the sponsor.
Mokkink, L., C. Prinsen, D. Patrick, K. Alonso, L. Bouter, H. de Vet and C. Terwee. (2019). "COSMIN Study Design checklist for Patient-reported outcome measurement instruments."Link provided by the sponsor.
Svensk Reumatologis Kvalitetsregister (SRQ). "PER - Patientens Egen Registrering."Link provided by the sponsor.
Svensk Reumatologisk Förening. (2022). "Riktlinjer för läkemedelsbehandling vid axial spondylartrit och psoriasisartrit 2022"Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emelie Heintz, PhD principal investigator

Karolinska Institutet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Polyarthritis, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Convergent validity (time frame: One measurement per patient.The latest complete EQ-5D-3L and EQ VAS measurements per patient during the period 2008-2024 is used for the analysis.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06568029, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.