RESUMEN
Objective: The RA foot disease activity index (RADAI-F5) is a valid, reliable and clinically feasible patient-reported outcome measure (PROM) for the measurement of RA foot disease activity. Further validation of the RADAI-F5 against musculoskeletal ultrasonography (MSUS) for foot disease activity is necessary before clinical implementation. The aim of this study was to examine the construct validity of the RADAI-F5 in relationship to MSUS and clinical examination. Methods: Participants with RA completed the RADAI-F5. MSUS was used to evaluate disease activity (synovial hypertrophy/synovitis/tenosynovitis/bursitis) and joint damage (erosion) using greyscale (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 (s.d.) age of 62.6 (9.96) years 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 the good measurement properties of this instrument. With greater confidence in the utility of the RADAI-F5, clinical use of this new instrument as an adjunct to the disease activity score for 28 joints (DAS-28) could help to identify RA patients at risk for poor functional and radiological outcomes.
RESUMEN
Although patient-reported outcome measures (PROMs) are recommended in clinical practice, their application in routine care is limited. The Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5) is a validated PROM for assessing foot disease in rheumatoid arthritis (RA). To explore patient and clinician opinions and perceptions of the clinical utility of the Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5), eight RA patients and eight clinicians routinely involved in the management of RA patients participated in one semi-structured remote video-based interview. They provided their perspectives on the barriers and facilitators to clinical implementation of the RADAI-F5. Three global themes were identified; 'Feet are a priority' as the impact of RA on the feet negatively impacted upon patient quality of life. The second theme was 'Need for a clinically feasible foot PROM' as participants recognised the current lack of a clinically feasible tool to determine RA foot disease. The third global theme of 'Implementation' was drawn together to form two subordinate themes: 'Facilitators to RADAI-F5 implementation' as the tool can promote communication, guide management, help screen foot symptoms, monitor foot disease status and treatments, and promote patient education and; 'Barriers to RADAI-F5 implementation' as there were associated practical difficulties, including lack of appointment time, administrative burdens, IT barriers and preference for further RADAI-F5 validation using imaging. The RADAI-F5 has significant potential as a clinical tool to aid foot disease management. However, implementation challenges must be overcome before broad adoption in rheumatology clinics.
Asunto(s)
Artritis Reumatoide , Enfermedades del Pie , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/terapia , Humanos , Calidad de Vida , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: Omission of foot joints from composite global disease activity indices may lead to underestimation of foot and overall disease in rheumatoid arthritis (RA) and under-treatment. The aim of this study was to evaluate the measurement properties of the Rheumatoid Arthritis Foot Disease Activity Index-5 (RADAI-F5), a newly developed patient-reported outcome measure for capturing foot disease activity in people with RA. METHODS: Participants with RA self-completed the RADAI-F5, modified Rheumatoid Arthritis Disease Activity Index (mRADAI-5), Foot Function Index (FFI), and Foot Impact Scale (FIS) impairment/footwear and activity/participation subscales. The 28-joint Disease Activity Score using the erythrocyte sedimentation rate (DAS28-ESR) was also recorded. Subgroups completed the RADAI-F5 at 1 week and 6 months. Psychometric properties, including construct, content and longitudinal validity, internal consistency, 1-week reproducibility, and responsiveness over 6 months were evaluated. RESULTS: Of 142 respondents, 103 were female, with a mean ± SD age of 55 ± 12.5 years and median RA disease duration of 10 (interquartile range 3.6-20.8) months. Theoretically consistent associations confirming construct validity were observed with mRADAI-5 (0.789 [95% confidence interval (95% CI) 0.73, 0.85]), FFI (0.713 [95% CI 0.62, 0.79]), FIS impairment/footwear (0.695 [95% CI 0.66, 0.82], P < 0.001), FIS activity/participation (0.478 [95% CI 0.37, 0.63], P < 0.001), and the DAS28-ESR (0.379 [95% CI 0.26, 0.57], P < 0.001). The RADAI-F5 demonstrated high internal consistency (Cronbach's α = 0.90) and good reproducibility (intraclass correlation coefficient = 0.868 [95% CI 0.80, 0.91], P < 0.001, smallest detectable change = 2.69). Content validity was confirmed, with 82% rating the instrument relevant and easy to understand. CONCLUSION: The RADAI-F5 is a valid, reliable, responsive, clinically feasible patient-reported outcome measure for measuring foot disease activity in RA.