CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77,651 enrolled
Drug / intervention
Questionnaireother
Likely dose
Not stated in record
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Search/NCT06568029
NCT06568029N/ACompleted

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

Karolinska Institutet·observational·Posted Aug 23, 2024·Updated Mar 6, 2025

In Brief

An observational study evaluating Questionnaire for Rheumatoid Arthritis and 4 related conditions. Completed, enrolled 77,651 participants across 1 site.

Detailed 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. The study is based on retrospective registry data from the Swedish Rheumatology Registry (SRQ).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedAug 23, 2024
Enrollment StartAug 16, 2024
Primary CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 1.9 years ago

Interventions

Questionnaireother

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).