TY - JOUR
T1 - Clinimetric Validation of the Assessment of Spondyloarthritis International Society Health Index in Patients With Radiographic Axial Spondyloarthritis in Ixekizumab Trials
AU - Kiltz, Uta
AU - Heijde, Desiree van der
AU - Boonen, Annelies
AU - Gensler, Lianne S.
AU - Gibble, Theresa Hunter
AU - Guo, Jiaying
AU - Carlier, Hilde
AU - Braun, Juergen
PY - 2023/6/1
Y1 - 2023/6/1
N2 - Objective. To assess test-retest reliability, construct validity, known groups discrimination, and responsive-ness of the Assessment of the SpondyloArthritis international Society Health Index (ASAS HI) to evaluate functioning, disability, and health in patients with radiographic axial spondyloarthritis (r-axSpA).Methods. Data were generated from 2 randomized, placebo-controlled, active-controlled phase III ixeki-zumab studies (COAST-V, N = 341; COAST-W, N = 316). Assessments included the following: test-retest reliability (ie, intraclass correlation coefficients [ICCs] between ASAS HI scores at screening and baseline), construct validity (ie, Spearman correlation with standard r-axSpA outcome measures), known groups dis-crimination (ie, 1-way ANOVA comparing the ASAS HI with different disease activity categories, measured by the Ankylosing Spondylitis Disease Activity Score [ASDAS]), and responsiveness (ie, Spearman correla-tion between changes in the ASAS HI and changes in the Bath Ankylosing Spondylitis Functional Index [BASFI], the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], the ASDAS, and the Patient Global Assessment [PtGA] as well as ANOVA comparing changes in the ASAS HI with various responder categories).Results. The ICC for test-retest reliability was 0.78 for COAST-V and 0.76 for COAST-W, indicating adequate agreement. Moderate-to-large correlations (r = 0.40-0.61) were observed between the ASAS HI and the BASDAI. Statistically significant differences (all P < 0.001) between mean ASAS HI scores were observed for subgroups based on ASDAS-defined disease activity categories at baseline and week 16. Moderate-to-large correlations existed between changes in the ASAS HI and the BASFI, BASDAI, ASDAS, and PtGA from baseline to week 16. The ASAS HI differentiated statistically (P < 0.001) between ASAS, BASDAI, and ASDAS response groups.Conclusion. The ASAS HI demonstrated reliability, construct validity, known groups discrimination, and responsiveness in adults with r-axSpA in 2 clinical trials.
AB - Objective. To assess test-retest reliability, construct validity, known groups discrimination, and responsive-ness of the Assessment of the SpondyloArthritis international Society Health Index (ASAS HI) to evaluate functioning, disability, and health in patients with radiographic axial spondyloarthritis (r-axSpA).Methods. Data were generated from 2 randomized, placebo-controlled, active-controlled phase III ixeki-zumab studies (COAST-V, N = 341; COAST-W, N = 316). Assessments included the following: test-retest reliability (ie, intraclass correlation coefficients [ICCs] between ASAS HI scores at screening and baseline), construct validity (ie, Spearman correlation with standard r-axSpA outcome measures), known groups dis-crimination (ie, 1-way ANOVA comparing the ASAS HI with different disease activity categories, measured by the Ankylosing Spondylitis Disease Activity Score [ASDAS]), and responsiveness (ie, Spearman correla-tion between changes in the ASAS HI and changes in the Bath Ankylosing Spondylitis Functional Index [BASFI], the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], the ASDAS, and the Patient Global Assessment [PtGA] as well as ANOVA comparing changes in the ASAS HI with various responder categories).Results. The ICC for test-retest reliability was 0.78 for COAST-V and 0.76 for COAST-W, indicating adequate agreement. Moderate-to-large correlations (r = 0.40-0.61) were observed between the ASAS HI and the BASDAI. Statistically significant differences (all P < 0.001) between mean ASAS HI scores were observed for subgroups based on ASDAS-defined disease activity categories at baseline and week 16. Moderate-to-large correlations existed between changes in the ASAS HI and the BASFI, BASDAI, ASDAS, and PtGA from baseline to week 16. The ASAS HI differentiated statistically (P < 0.001) between ASAS, BASDAI, and ASDAS response groups.Conclusion. The ASAS HI demonstrated reliability, construct validity, known groups discrimination, and responsiveness in adults with r-axSpA in 2 clinical trials.
KW - ankylosing spondylitis
KW - reproducibility of results
KW - spondyloarthropathy
KW - ACTIVITY SCORE ASDAS
KW - ANKYLOSING-SPONDYLITIS
KW - DISEASE STATUS
KW - ASAS
KW - IMPROVEMENT
KW - BASDAI
KW - BASFI
U2 - 10.3899/jrheum.220244
DO - 10.3899/jrheum.220244
M3 - Article
C2 - 36725056
SN - 0315-162X
VL - 50
SP - 754
EP - 762
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 6
ER -