EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference
EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference
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DOI：
10.1111/j.1398-9995.2011.02719.x
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发表时间：
2012-01-01
期刊：
影响因子：
12.4
通讯作者：
Schmitt, J.
中科院分区：
文献类型：
--
作者：
Schram, M. E.;Spuls, Ph. I.;Schmitt, J.
背景：证明足够的可靠性和有效性足以得出结论，该工具适用于描述性和预测性目的，但在我们可以自信地在临床试验中使用结果测量之前，应该知道响应性（与变化敏感性同义）和最小临床重要差异（MCID）。通过这项研究，我们旨在评估特应性湿疹中使用的四种结局指标的反应性和 MCID：特应性皮炎严重程度评分 (SCORAD)、客观 SCORAD、湿疹面积和严重程度指数 (EASI) 以及面向患者的湿疹测量 (POEM)。方法：使用三项随机对照试验的数据。为了证明响应能力，我们绘制了受试者工作特征 (ROC) 曲线。 MCID 是使用显示相关改善的患者的平均变化评分来估计的。 Bland 和 Altman 方法用于量化一致性的限度。结果：SCORAD 的 ROC 曲线下面积为 0.70 [95% 置信区间 (CI)：0.610.78]，客观 SCORAD 为 0.73（95% CI：0.700.77），EASI 为 0.67（95% CI：0.600.76），POEM 为 0.67（95% CI：0.600.76）。 0.590.75)。高于 0.70 的分数代表了良好的响应能力。 SCORAD 的 MCID 为 8.7 分，客观 SCORAD 为 8.2 分，EASI 为 6.6 分，POEM 为 3.4 分。结论：客观SCORAD 和SCORAD 表现出良好的反应性。 MCID 是解释已发表的湿疹试验以及未来试验的计划/样本量估计的重要先决条件。
Background: Demonstration of adequate reliability and validity is sufficient for concluding that an instrument is applicable for descriptive and predictive purposes, but before we can confidently use an outcome measure in clinical trials, the responsiveness (synonymous with sensitivity to change) and minimal clinically important difference (MCID) should be known. With this study, we aimed to assess responsiveness and MCID of four outcome measures used in atopic eczema: the Severity Scoring of Atopic Dermatitis (SCORAD), the objective SCORAD, Eczema Area and Severity Index (EASI), and the Patient-Oriented Eczema Measure (POEM). Methods: Data of three randomized controlled trials were used. To demonstrate responsiveness, we plotted receiver operating characteristic (ROC) curves. MCID was estimated using mean change scores of patients that showed a relevant improvement. Bland and Altman methods were used to quantify the limits of agreement. Results: Area under the ROC curve for the SCORAD was 0.70 [95% confidence interval (CI): 0.610.78], for the objective SCORAD, 0.73 (95% CI: 0.700.77), for the EASI, 0.67 (95% CI: 0.600.76), and for the POEM, 0.67 (95% CI: 0.590.75). Scores above 0.70 represent a fair responsiveness. The MCID was 8.7 points for the SCORAD, 8.2 for the objective SCORAD, 6.6 for the EASI, and 3.4 for the POEM. Conclusion: The objective SCORAD and SCORAD showed a fair responsiveness. The MCIDs are an important prerequisite for the interpretation of published eczema trials and for the planning/sample size estimation of future trials.