Oosterhaven J A F, Schuttelaar M L A
Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Br J Dermatol. 2020 Apr;182(4):932-939. doi: 10.1111/bjd.18295. Epub 2019 Sep 5.
The Hand Eczema Severity Index (HECSI) is used to measure the severity of hand eczema. It is unclear what HECSI scores mean and what is the minimally important change (MIC). Furthermore, its responsiveness has not been studied.
To study the responsiveness and interpretability of the HECSI.
This was a prospective study covering two time points: baseline and after 4-12 weeks. Responsiveness was assessed using a criterion approach, with at least one-step improvement on the 'Photographic guide for severity of hand eczema' as the anchor for important improvement. Interpretability of single scores was determined by defining severity bands based on agreement with the anchor. For change scores, the smallest detectable change (SDC) was calculated in patients indicating no change and the MIC was obtained in patients indicating that they had changed using three methods: mean cutoff, receiver operating characteristic (ROC) curve and 95% limit.
In total, 294 patients participated (160 male, mean age 44·9 years). HECSI scores improved or deteriorated in parallel with the anchor. The area under the ROC curve was 0·86 (95% confidence interval 0·81-0·91). The final severity band for single scores had a κ-coefficient of agreement of 0·694: clear, 0; almost clear, 1-16; moderate, 17-37; severe, 38-116; very severe, ≥ 117. The SDC in 93 unchanged patients was 40·3 points. The obtained MIC values were all smaller than the SDC.
The HECSI has good responsiveness. This study gives meaning to HECSI scores, which can be applied to clinical decision making and the design of clinical trials. We recommend that an improvement of 41 points on the HECSI is regarded as the minimally measurable true change. What's already known about this topic? The Hand Eczema Severity Index (HECSI) is one of the most widely used measurement instruments to measure the severity of hand eczema. The HECSI has good reliability, but its responsiveness and interpretability have not been studied. What does this study add? This study shows good responsiveness of the HECSI. A severity grading for single scores is proposed. The smallest detectable change and minimally important change for improvement are determined. What are the clinical implications of this work? The obtained values help to interpret HECSI scores in daily practice and clinical studies, and may facilitate researchers in the calculation of sample sizes for clinical trials.
手部湿疹严重程度指数（HECSI）用于衡量手部湿疹的严重程度。目前尚不清楚HECSI评分的意义以及最小重要变化（MIC）是什么。此外，其反应性尚未得到研究。
研究HECSI的反应性和可解释性。
这是一项前瞻性研究，涵盖两个时间点：基线和4-12周后。使用标准方法评估反应性，以“手部湿疹严重程度摄影指南”上至少有一步改善作为重要改善的锚定。通过根据与锚定的一致性定义严重程度带，确定单个评分的可解释性。对于变化评分，在表示无变化的患者中计算最小可检测变化（SDC），并在表示有变化的患者中使用三种方法获得MIC：平均截断值、受试者操作特征（ROC）曲线和95%界限。
共有294例患者参与（160例男性，平均年龄44.9岁）。HECSI评分与锚定平行改善或恶化。ROC曲线下面积为0.86（95%置信区间0.81-0.91）。单个评分的最终严重程度带的κ一致性系数为0.694：清晰，0；几乎清晰，1-16；中度，17-37；重度，38-116；极重度，≥117。93例无变化患者的SDC为40.3分。获得的MIC值均小于SDC。
HECSI具有良好的反应性。本研究赋予了HECSI评分意义，可应用于临床决策和临床试验设计。我们建议将HECSI提高41分视为最小可测量的真实变化。关于该主题已知的信息有哪些？手部湿疹严重程度指数（HECSI）是测量手部湿疹严重程度最广泛使用的测量工具之一。HECSI具有良好的可靠性，但其反应性和可解释性尚未得到研究。本研究增加了什么？本研究显示了HECSI良好的反应性。提出了单个评分的严重程度分级。确定了改善的最小可检测变化和最小重要变化。这项工作的临床意义是什么？获得的值有助于在日常实践和临床研究中解释HECSI评分，并可能有助于研究人员计算临床试验的样本量。
