VALIDATION DATA

MEASUREMENT PROPERTIES
Limitations <5 European languages (English)
Observations

For the validation study, the RADAI- F5 was collected at baseline, 1 week from baseline, and 6 months from baseline. Foot-related impairments and disability were evaluated using the FFI, and the FIS.
Global disease activity were measured using the DAS-28 ESR and Modified RADAI-F5.

1. RELIABILITY
A. Internal Consistency Tested
Cronbach's (Describe)

High inter-item correlations (>0.8) were observed for questions 2 and 3, 2 and 4, and 3 and 4 of the questionnaire. Moderate inter-item correlations (>0.6) were observed for questions 1 and 2, and 2 and 5. All other inter-item correlations were between 0.4 and 0.6. Cronbach’s α = 0.90, indicating a high level of internal consistency.

B. Reliability intraobserver or test-retest Tested
Continuous scores: intraclass
correlation coefficient (ICC)
Dichotomus: Cohen kappa (Describe)

The 1-week (test–retest) reliability was examined using a 2-way mixed intraclass correlation coefficient (ICC) with corre-sponding 95% CIs for baseline and 1- week scores. Mean ± SD RADAI- F5 scores for baseline and 1 week were 4.8 ± 2.58 and 4.91 ± 2.74, respectively. The mean ± SD difference between baseline and 1 week for the RADAI- F5 was 0.11 ± 1.37. The ICC for 1- week reproducibility was 0.87 (95% CI 0.80, 0.91; P ≤ 0.001), indicating very good reproducibility.

C. Reliability interobserver or Measurement error Tested
Standard error of measurement (SEM),
smallest detectable change (SDC) or
Limits of agreement (LoA) (Describe)

Absolute measurement error was evaluated using the standard error of measurement (SEm). The SEm value calculated for the RADAI-F5 from baseline and 1- week data was 0.97. The limits of agreement were – 2.57 and 2.80.

2. VALIDITY
A. Content validity: face validity Tested
Expert opinion (relevance and
comprehensiveness) (Describe)

To evaluate the content validity and practical burden of the RADAI- F5, 3 items were evaluated: a 5- point Likert scale regarding questionnaire relevance to participants (ranging from extremely irrelevant to extremely relevant), a 5- point Likert scale regarding participants’ opinions on the readability/understanding of the new questionnaire (ranging from very difficult to very easy), and the time taken to complete the questionnaire. Participants largely considered the RADAI- F5 to be relevant for measuring foot disease activity in RA, with 53% and 29% indicating that it was rel-evant and extremely relevant, respectively. Participants largely considered the RADAI- F5 to be easy to read and understand, with 45.8% and 40% indicating that it was easy and very easy to read/understand, respectively.

B. Construct Validity:
Structural validity
Tested
Hypotheses-testing Tested
Cross-cultural validity Not Tested
Brief Description

The Kaiser-Meyer-Olkin value of 0.83 and highly significant Bartlett’s test (P < 0.001) indicated sampling adequacy and suitability for structure detection and factor analysis. Both Kaiser’s “eignenvalue >1” rule and scree plot examination suggested a 1- factor solution, and this solution explained 73.18% of the common variance. Item loadings on the factor were uniformly >0.4, indicating that all items contributed significantly to the aggregate score.

C. Criterion validity Not Tested
Comparison with a 'gold standard' Continuous scores:
correlations, ROC curves Dichotomus:
Sensitivity & Specificity (Describe)