Construct Validity and Responsiveness of EQ-5D-3L and EQ-5D-5L in Patients With Inflammatory Joint Disease
5 maj 2026 uppdaterad av: Emelie Heintz, Karolinska Institutet
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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'
Studietyp
Observationell
Inskrivning (Faktisk)
6967
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Stockholm, Sverige
- Karolinska Institutet
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
EQ-5D-3L
Tidsram: 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.
|
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
Tidsram: 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.
|
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)
Tidsram: 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.
|
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)
Tidsram: 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.
|
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)
Tidsram: 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.
|
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)
Tidsram: 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.
|
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)
Tidsram: 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.
|
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
Tidsram: 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.
|
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
Tidsram: 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.
|
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
Tidsram: 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.
|
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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Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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- van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, Lloyd A, Scalone L, Kind P, Pickard AS. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012 Jul-Aug;15(5):708-15. doi: 10.1016/j.jval.2012.02.008. Epub 2012 May 24.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 november 2023
Primärt slutförande (Faktisk)
5 mars 2026
Avslutad studie (Faktisk)
5 mars 2026
Studieregistreringsdatum
Först inskickad
21 april 2026
Först inskickad som uppfyllde QC-kriterierna
5 maj 2026
Första postat (Faktisk)
12 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Axial spondyloartrit
- Skelettsjukdomar
- Muskuloskeletala sjukdomar
- Ledsjukdomar
- Reumatiska sjukdomar
- Bindvävssjukdomar
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Spinal sjukdomar
- Spondylarthropatier
- Ankylos
- Hudsjukdomar, Papulosquamous
- Hudsjukdomar
- Spondylartrit
- Spondylit
- Psoriasis
- Hud- och bindvävssjukdomar
- Artrit
- Spondylit, ankyloserande
- Artrit, reumatoid
- Artrit, psoriasis
Andra studie-ID-nummer
- Dnr 2022-04211-01
Plan för individuella deltagardata (IPD)
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