Swedish Medical Center and University of Washington, Seattle, WA 98104, USA.
J Rheumatol. 2011 Nov;38(11):2461-5. doi: 10.3899/jrheum.110546. Epub 2011 Sep 1.
To evaluate changes in function as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) and the meaningfulness of the changes, in importance and satisfaction, in patients with psoriatic arthritis (PsA).
HAQ-DI was assessed at baseline and at Weeks 4, 12, and 24 in a randomized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo. Concurrently, patients rated the importance of and satisfaction with their change in function on a 7-point scale (1 = not at all important/satisfied; 7 = extremely important/satisfied). Mean HAQ-DI improvement corresponding to ratings of minimally (2-3) or very (6-7) important or satisfied was determined using a posthoc linear mixed-model analysis. Patient importance ratings were used as an anchor to estimate minimally important difference (MID) for HAQ-DI; distribution-based estimates were also calculated.
A total of 161 patients (69 placebo; 92 etanercept) had ≥ 1 HAQ-DI scores showing improvement from baseline and a corresponding importance or satisfaction rating. HAQ-DI improvements corresponding to importance scale ratings of 2 or 3 were 0.335 (95% CI 0.214, 0.455) and 0.360 (95% CI 0.263, 0.456), respectively, suggesting an MID of about 0.35. HAQ-DI improvements corresponding to satisfaction scale ratings of 2 and 3 were 0.293 (95% CI 0.230, 0.357) and 0.360 (95% CI 0.307, 0.413). For a given change in HAQ-DI, nearly two-thirds of patients indicated a lower rating for satisfaction than for importance. This trial was registered in the ClinicalTrials.gov registry (NCT00317499).
Our study suggests the MID for HAQ-DI in PsA is about 0.35. The results may also provide insight into patient satisfaction with changes in function and expectations for therapy.
评估健康评估问卷残疾指数 (HAQ-DI) 测量的功能变化,以及在接受依那西普 25mg 每周两次或安慰剂治疗的活动性银屑病关节炎 (PsA) 患者中,重要性和满意度变化的意义。
在一项 205 例活动性 PsA 患者的随机双盲研究中,于基线和第 4、12 和 24 周评估 HAQ-DI。同时,患者在 7 分制上对其功能变化的重要性和满意度进行评分(1 = 完全不重要/不满意;7 = 非常重要/满意)。使用事后线性混合模型分析确定与非常重要或非常满意(6-7)或最小重要度(2-3)评分对应的平均 HAQ-DI 改善程度。使用患者重要性评分作为 HAQ-DI 的最小重要差异(MID)的锚点进行估计;还计算了基于分布的估计值。
共有 161 例患者(69 例安慰剂;92 例依那西普)有≥1 次 HAQ-DI 评分显示从基线开始改善,并有相应的重要性或满意度评分。与重要性评分 2 或 3 对应的 HAQ-DI 改善分别为 0.335(95% CI 0.214,0.455)和 0.360(95% CI 0.263,0.456),表明 MID 约为 0.35。与满意度评分 2 和 3 对应的 HAQ-DI 改善分别为 0.293(95% CI 0.230,0.357)和 0.360(95% CI 0.307,0.413)。对于给定的 HAQ-DI 变化,近三分之二的患者对满意度的评分低于对重要性的评分。本试验在 ClinicalTrials.gov 注册(NCT00317499)。
我们的研究表明,PsA 中 HAQ-DI 的 MID 约为 0.35。研究结果还可以为患者对功能变化的满意度和对治疗的期望提供一些见解。