Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference
Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference
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DOI：
10.1185/03007990903167415
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发表时间：
2009-10-01
影响因子：
2.3
通讯作者：
Wallenstein, Gene V.
中科院分区：
文献类型：
--
作者：
Yang, Min;Morin, Charles M.;Wallenstein, Gene V.
目的：通过检查ISI评分差异与健康相关结局（包括健康相关生活质量、生产力和疲劳）的关联，估计失眠严重指数（ISI）的最小重要差异（MID）。方法：数据来自一项随机、安慰剂对照的临床试验，评估艾司佐匹克隆治疗原发性失眠症的长期疗效（N=828）。使用Logistic回归模型表征ISI变化评分（从基线到治疗后6个月）与SF-36健康调查、工作限制问卷（WLQ）和疲劳严重程度量表（FSS）的结果/锚点之间的关系。比值比从回归系数中导出，以计算给定结果与不同ISI变化分数相关的概率。评估了基于锚地分布的估计之间的收敛性。结果：在所有模型中，较高的ISI分数（表明更严重的失眠）与更高的负面结果概率显著相关。ISI分数降低6分（对应1个标准差）的个体在6个月时报告“感觉疲惫”（SF-36）的可能性降低48%，“无法清晰思考”（WLQ）的可能性降低46%，报告“感觉疲劳”（FSS）的可能性降低52%。在所有选定锚点的广泛范围内发现了类似的结果。结论：基于研究结果，建议减少6分代表原发性失眠症患者临床有意义的改善。本研究推荐的MID在其他患者群体和其他类型的治疗干预方面的推广研究是必要的。
Objective:To estimate the minimally important difference (MID) for the Insomnia Severity Index (ISI) by examining the association of score differences of the ISI with health-related outcomes including health-related quality of life, productivity, and fatigue.Methods:Data came from a randomized, placebo-controlled clinical trial evaluating the long-term efficacy of eszopiclone for primary insomnia (N=828). Logistic regression models were used to characterize the relationship between ISI change scores (from baseline to 6 months post-treatment) and outcomes/ anchors from the SF-36 Health Survey, Work Limitations Questionnaire (WLQ), and Fatigue Severity Scale (FSS). Odds ratios were derived from the regression coefficients to calculate the probability of a given outcome being associated with different ISI change scores. Convergence between anchorand distribution-based estimates was assessed.Results:Higher ISI scores (indicating more severe insomnia) were significantly associated with higher probabilities of negative outcome in all models. Individuals with a 6-point score reduction in ISI scores (which corresponded to 1 standard deviations) were 48% less likely to report 'feeling worn out' (SF-36) at 6 months, 46% less likely to be 'unable to think clearly' (WLQ), and 52% less likely to report 'feeling fatigued' (FSS). Similar results were found across a broad spectrum of all selected anchors.Conclusions:Based on results of the study, a 6-point reduction is recommended to represent a clinically meaningful improvement in individuals with primary insomnia. Research on generalizability of the recommended MID in this study to other patient populations and other type of treatment interventions is needed.