Objectives
The Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5) is a valid, reliable, and clinically feasible patient-reported outcome measure (PROM) for the measurement of rheumatoid arthritis (RA) foot disease activity. Further validation of the RADAI-F5 against musculoskeletal ultrasonography (MSUS) for foot disease activity are necessary prior to clinical implementation. This study aimed to examine the construct validity of the RADAI-F5 in relation to MSUS and clinical examination.
Method
Participants with RA completed the RADAI-F5. MSUS was employed to evaluate disease activity (synovial hypertrophy/synovitis/tenosynovitis/bursitis) and joint damage (erosion) utilising grayscale (GS) and power Doppler (PD) at 16 regions in each foot, including joints and soft tissues. These same regions were examined clinically for swelling and tenderness. The construct validity of the RADAI-F5 was assessed using correlation coefficients and a priori-specified hypotheses for the strength of associations.
Results
Of 60 participants, 48 were female, with a mean [standard deviation, ± SD] age of 62.6 ± 9.96 and median disease duration of 15.49 (interquartile range 6–20.5) years. Theoretically consistent associations confirming construct validity [95% CI] were observed between the RADAI-F5 and MSUS GS (0.76 [0.57-0.82]; strong), MSUS PD (0.55 [0.35-0.71]; moderate), MSUS-detected erosions (0.41 [0.18-0.61]; moderate), clinical tenderness (0.52 [0.31-0.68]; moderate), and clinical swelling (0.36 [0.13-0.55]; weak).
Conclusion
Moderate-to-strong correlations between RADAI-F5 and MSUS demonstrate this instrument's good measurement properties. With greater confidence in the utility of the RADAI-F5, clinical use of this novel instrument as an adjunct to the DAS-28 could help identify RA patients at risk for poor functional and radiological outcomes.
Lay summary
What does this mean for patients?
Rheumatoid arthritis (RA) is a condition that commonly affects the feet. It is important to have a reliable way to measure the activity of RA in the feet. One such measure is called the Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5), which is a five item questionnaire completed by patients. However, the RADAI-F5 still needs to be validated against other methods of assessing foot disease activity, such as musculoskeletal ultrasonography (MSUS) and clinical examination. In this study, 60 participants with RA were enrolled. Participants completed the RADAI-F5 questionnaire. Thereafter, MSUS was used to evaluate disease activity and joint damage in the participants' feet. Clinical examinations to assess swelling and tenderness were also conducted at this appointment. The results showed that there were strong-to-moderate consistent associations between the RADAI-F5 scores and MSUS grayscale images, MSUS Power Doppler and the presence of joint damage. The RADAI-F5 scores also correlated moderately with clinical tenderness and weakly with clinical swelling. These findings suggest that the RADAI-F5 is a reliable tool for measuring foot disease activity in RA patients. The tools implementation in clinical practice may help better identify RA patients who are at risk for poor outcomes and may require more targeted treatment.