Construct validity and responsiveness of feasible composite disease activity measures for use in daily clinical practice in patients with psoriatic arthritis

Abstract

Objective: There is a need for a widely accepted comprehensive disease activity measure for use in daily practice in patients with psoriatic arthritis (PsA). For this reason, the 3-item Visual Analogue Scale (3VAS) and 4-item Visual Analogue Scale (4VAS) were developed. This study aimed to test construct validity and responsiveness of the 3VAS and 4VAS in a population of patients with newly diagnosed PsA receiving usual care.

Methods: Components of the 3VAS (physician global, patient global, patient skin) and 4VAS (physician global, patient pain, patient joint, patient skin) were scored on 0-10 VAS scales. Agreement of low disease activity (LDA) state between 3VAS/4VAS and other composite measures was tested using Venn diagrams. Construct validity and responsiveness (3-month interval) were assessed using Spearman correlation coefficients and standardised response means (SRM) with effect sizes (ES), respectively, following hypothesis generation. Both 3VAS/4VAS were also compared with several patient-reported outcome measures.

Results: Data from 629 patients were used. Both 3VAS (ES=0.48, SRM 0.52) and 4VAS (ES=0.48, SRM=0.50) showed responsiveness similar to Disease Activity in PSoriatic Arthritis (DAPSA) and Disease Activity Score-28 (DAS28). Both measures had a strong correlation with DAPSA (r=0.80-0.87), Psoriatic Arthritis Disease Activity Score (PASDAS) (r=0.89) and Routine Assessment of Patient Index Data 3 (RAPID3) (r=0.84-0.92). 3VAS and 4VAS had the highest agreement with PASDAS in categorising patients to LDA at 12 months.

Conclusion: This is the first study assessing the performance of the 3VAS and 4VAS in an observational cohort of patients with early PsA. Both measures have promising performance characteristics, showing strong correlations and good discrimination with existing composite measures. The 4VAS may be the preferred version with better face validity.

Keywords: autoimmune diseases; patient reported outcome measures; psoriatic arthritis.

Figure 1

Agreement between LDA (including VLDA) according to various composite disease activity measures and 3-item VAS (A) and 4-item VAS (B) at 12 months (n=466).DAPSA, Disease Activity in PSoriatic Arthritis; DAS28, Disease Activity Score-28; LDA, low disease activity; PASDAS, Psoriatic Arthritis Disease Activity Score; VAS, Visual Analogue Scale; VLDA, very low disease activity.

Figure 2

Agreement between LDA (including VLDA) according to 3-item VAS (A) and 4-item VAS (B) and MDA at 12 months (n=466). LDA, low disease activity; MDA, minimal disease activity; VAS, Visual Analogue Scale; VLDA, very low disease activity.