Demonstrating Measurement Equivalence of the Electronic and Paper Formats of the Urticaria Patient Daily Diary in Patients with Chronic Idiopathic Urticaria
Demonstrating Measurement Equivalence of the Electronic and Paper Formats of the Urticaria Patient Daily Diary in Patients with Chronic Idiopathic Urticaria
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DOI：
10.1007/s40271-013-0021-4
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发表时间：
2013-09-01
影响因子：
3.6
通讯作者：
Devlen, Jennifer
中科院分区：
文献类型：
--
作者：
Flood, Emuella M.;Zazzali, James L.;Devlen, Jennifer
荨麻疹患者每日日记（CIU）最初是在纸上开发的，是慢性特发性荨麻疹（CIU）关键症状的衡量标准。电子版的发展（eCIU D）涉及适度修改的外观的纸质版本。本研究评估了测量等效性的电子和纸质版本的ECIU D在CIU患者的样本。这是一项交叉研究的患者中重度CIU难治性H1抗组胺药。患者被随机分配到ePDD，然后是纸PDD，反之亦然。CNOD包括早晨和晚上的问题;这两组在本研究中一起进行。在纸质和电子管理之间进行了一小时的填充任务。两次评估之间症状稳定的患者纳入分析。计算Cohen的kappa系数和组内相关系数（ICC），以评估等效性。共有91例患者参与（平均年龄43岁，79.1%为女性）。67-74例（74- 81%）患者的症状在评估之间稳定（因症状而异）。Kappa系数范围为0.82至1.00的个别CRDD项目。对于荨麻疹活动性评分（“瘙痒严重程度”和“荨麻疹数量”项目评分之和），早晨ICC为0.90（Wilcoxon p = 0.331），晚上ICC为0.95（Wilcoxon p = 0.836）。本研究中的所有重测统计量均远高于可接受的阈值，表明两种给药方法之间具有极好的一致性。研究结果支持测量等效的电子和纸质版本的CIU症状的测量的CIU的症状。
The Urticaria Patient Daily Diary (UPDD), originally developed on paper, is a measure of key symptoms of chronic idiopathic urticaria (CIU). The development of the electronic version (eUPDD) involved moderate modifications to the appearance of the paper version.This study assessed the measurement equivalence of the electronic and paper versions of the UPDD in a sample of patients with CIU.This was a cross-over study of patients with moderate-severe CIU refractory to H1 antihistamines. Patients were randomized to either the eUPDD followed by the paper UPDD or vice versa. The UPDD includes morning and evening questions; both sets were administered together in this study. An hour-long filler task was given between paper and electronic administrations. Patients with stable symptoms between the two assessments were included in the analyses. Cohen's kappa coefficients and intraclass correlation coefficients (ICC) were computed as applicable to assess equivalence.A total of 91 patients participated (mean age 43 years, 79.1 % female). Symptoms were stable between assessments for 67-74 (74-81 %) patients (varied by symptom). Kappa coefficients ranged from 0.82 to 1.00 for the individual UPDD items. For the Urticaria Activity Score (the sum of the 'itch severity' and 'number of hives' item scores) the ICC was 0.90 for the morning (Wilcoxon p = 0.331) and 0.95 for the evening (Wilcoxon p = 0.836).All test-retest statistics in this study were well above the accepted threshold, indicating excellent agreement between the two administration methods. Findings support the measurement equivalence of the electronic and paper versions of the UPDD to measure CIU symptoms.