VALIDATION DATA

MEASUREMENT PROPERTIES
Limitations <5 European languages (English)
Observations

The EASi-QoL questionnaire is validated and reliable disease-specific for the assessment of QoL in patients with AS/nr-axSpA.

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

Physical function α = 0.90

Disease activity α = 0.88

Emotional well-being α = 0.91

Social participation α = 0.92

In a systematic review, the pooled Cronbach’s α coefficients scored as high and moderate quality of evidence of these scale was 0.91 (95% CI 0.88 to 0.93).

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

ICCs calculated for patients indicating no change in AS-specific health at 2 weeks:

Physical function ICC = 0.93

Disease activity ICC = 0.88

Emotional well-being ICC = 0.90

Social participation ICC = 0.90

Very good reliability of moderate quality was found for the EASi-QoL questionnaire in a systematic review (ICC range from 0.88 to 0.935).

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

The MIC for the EASi-QoL domains was defined as a change of 10% from baseline for the PF domain (sensitivity 66%, specificity 63%); a change of 20% from baseline for the DA domain (sensitivity 70%, specificity 71%); a change of 15% for the EWB domain (sensitivity 62%, specificity 61%) and a change of 25% for the SP domain (sensitivity 67%, specificity 67%).

The 10% minimal important change (MIC) for the EASi-QoL PF domain (score 0-24) relates to a change score of 1 for scores of ≤10 at baseline, 2 for scores of 11-20 and 3 for scores of 21-24.

The 20% MIC for the EASi-QoL DA domain (score 0-16) relates to a change of 1 point for those scores of ≤5 at baseline, 2 points for scores of 6-10, 3 points for scores of 11-15 and 4 points for scores of 16.

The 15% MIC for the EASi-QoL EWB domain (score 0-20) relates to a change of 1 point for scores ≤6 at baseline, 2 points for scores 7-13 and 3 points for scores 14-20.

The 25% MIC for the EASi-QoL SP domain (score 0-20) relates to a change of 1 point for scores of ≤4 at baseline, 2 points for scores 5-8, 3 points for scores 9-12, 4 points for scores 13-16 and 5 points for scores 17-20.

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

Patient interviews, a literature review, and completion of an individualized measure of AS quality of life during clinic-based and pilot surveys were used to derive questionnaire content.

B. Construct Validity:
Structural validity
Tested
Hypotheses-testing Tested
Cross-cultural validity Tested
Brief Description

Classical and modern psychometrics were used to evaluate the questionnaire using data from a large UK-based postal survey of 1000 patients with AS. Confirmatory factor analysis and Rasch analysis were performed. The EASi-QOL questionnaire focuses on four dimensions: physician function, disease activity, emotional well-being, and social participation. 

Two publications chose the exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) models for the EASi-QOL . It showed that the factor loadings were higher than 0.40 and the item-total correlations were ranged from 0.66 to 0.84. Principle component analysis (PCA) was performed in five studies to assess the dimensionality of instruments. A 2-parameter Rasch model confirmed unidimensionality (chi-square fit p = 0.86) with good item discrimination of the RLDQ.

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