RADAI-F5: Validation study
Research type
Research Study
Full title
Evaluation of associations between clinical and imaging measures of foot disease in rheumatoid arthritis (RA).
IRAS ID
296058
Contact name
Anika Hoque
Contact email
Sponsor organisation
Glasgow Caledonian University
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Foot disease is common in rheumatoid arthritis (RA) and can negatively impact a patients’ quality of life. Questionnaires are often given to individuals with RA in order to measure different aspects of their condition such as overall health or impact of the disease. The main aims of most health-related questionnaires are to measure changes in health status either as a result of disease over a period of time or as a result of treatment. As current questionnaires can be long and time-consuming, they are not often used in clinical practice. There are also concerns about these questionnaires ability to accurately measure changes in foot health in patients with RA. Due to a lack of validated patient-reported outcome measures (PROMs) focused on foot disease activity, it is currently hard to evaluate RA foot therapies. The Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5) was therefore developed to measure local foot disease activity in RA patients and has shown largely desirable measurement properties and also has the potential to inform outcome-driven care. Furthermore, as the RADAI-F5 is a short tool it demonstrates clinical feasibility and low burden for patients and clinicians. However, further validation of RADAI-F5 is required to assess the potential clinical usefulness of RADAI-F5 in the evaluation of foot disease in patients with RA.
Musculoskeletal ultrasound (MSUS) is a validated and reliable method that is being increasingly used for the evaluation of joint diseases such as RA. Nonetheless, limited evidence exists regarding the association between PROMs and inflammatory lesions on US imaging in patients with RA. Further assessment using the US can help us to understand more about the RADAI-F5’s relevance in routine clinical practice. Accordingly, the overall objective of this study is to evaluate the potential clinical utility of the RADAI-F5 for evaluating foot disease in RA when compared to MSUS.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0130
Date of REC Opinion
26 Jul 2021
REC opinion
Further Information Favourable Opinion