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

5 maggio 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Effettivo)

6967

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svezia
      • Stockholm, Svezia
        • Karolinska Institutet

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EQ-5D-3L
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Karolinska Institutet

Collaboratori

Karolinska University Hospital
The EuroQol Research Foundation

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 novembre 2023

Completamento primario (Effettivo)

5 marzo 2026

Completamento dello studio (Effettivo)

5 marzo 2026

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Dnr 2022-04211-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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