U. Kiltz, MD, J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany.
D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands.
J Rheumatol. 2023 Jun;50(6):754-762. doi: 10.3899/jrheum.220244. Epub 2023 Feb 1.
To assess test-retest reliability, construct validity, known groups discrimination, and responsiveness 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).
Data were generated from 2 randomized, placebo-controlled, active-controlled phase III ixekizumab 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 discrimination (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 correlation 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).
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 ( = 0.40-0.61) were observed between the ASAS HI and the BASDAI. Statistically significant differences (all < 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 ( < 0.001) between ASAS, BASDAI, and ASDAS response groups.
The ASAS HI demonstrated reliability, construct validity, known groups discrimination, and responsiveness in adults with r-axSpA in 2 clinical trials.
评估 ASAS 健康指数（ASAS HI）的重测信度、结构效度、区分已知组和反应度，以评估影像学轴向脊柱关节炎（r-axSpA）患者的功能、残疾和健康。
数据来自 2 项随机、安慰剂对照、活性对照的 III 期依奇珠单抗研究（COAST-V，N=341；COAST-W，N=316）。评估包括：重测信度（即筛选和基线时 ASAS HI 评分的组内相关系数 [ICC]）；结构效度（即与标准 r-axSpA 结局测量的 Spearman 相关性）；区分已知组的能力（即 1 方差分析比较 ASAS HI 与不同疾病活动类别的差异，由强直性脊柱炎疾病活动评分 [ASDAS]测量）；反应度（即 ASAS HI 变化与 Bath 强直性脊柱炎功能指数 [BASFI]、Bath 强直性脊柱炎疾病活动指数 [BASDAI]、ASDAS 和患者总体评估 [PtGA]变化之间的 Spearman 相关性，以及方差分析比较 ASAS HI 与各种反应类别变化的相关性）。
COAST-V 的 ICC 为 0.78，COAST-W 的 ICC 为 0.76，表明一致性良好。ASAS HI 与 BASDAI 之间存在中度至高度相关性（=0.40-0.61）。在基于基线和第 16 周 ASDAS 定义的疾病活动类别的亚组中，ASAS HI 的平均得分存在显著差异（均<0.001）。从基线到第 16 周，ASAS HI 的变化与 BASFI、BASDAI、ASDAS 和 PtGA 之间存在中度至高度相关性。ASAS HI 可以区分 ASAS、BASDAI 和 ASDAS 反应组，具有统计学意义（<0.001）。
在 2 项临床试验中，ASAS HI 显示了 r-axSpA 成人的可靠性、结构效度、已知组的区分能力和反应度。
