OBJECTIVES:This research evaluated the psychometric properties of a new Psoriasis Symptom Diary, identified diary responder definitions for use in determining whether a patient has experienced clinically meaningful change, and refined diary item content for use in future clinical trials. METHODS:The Psoriasis Symptom Diary was administered in a phase 2 clinical trial of AIN457 to US adult outpatients (N = 172) with physician-diagnosed moderate to severe chronic plaque-type psoriasis. Participant compliance with daily diary administration and item score variability, reliability, construct and discriminant validity, sensitivity to change, and interpretation were all evaluated. RESULTS:Participants completed 94% of scheduled diary assessments across 12 study weeks. Diary items were generally normally distributed, and no floor or ceiling effects were observed. Item reliability (reproducibility) was acceptable (intraclass correlation coefficients > 0.80), with an exception for one item (skin color). At week 12, items significantly related to criterion measures as predicted (Psoriasis Area and Severity Index r = 0.27-0.57; Investigator's Global Assessment r = 0.25-0.59), with the exception of items that measured skin color and difficulty using hands. Most items generated change scores that were synchronous to changes as measured by the Psoriasis Area and Severity Index, Investigator's Global Assessment, Dermatology Life Quality Index (r > 0.37), as well as the Patient Global Impression of Change. Responders experienced a 2- to 3-point and 3- to 5-point change in item scores for minimal and large improvements, respectively. Four items that did not perform well were dropped from the diary. CONCLUSIONS:The 16-item Psoriasis Symptom Diary demonstrated favorable psychometric properties and is a brief, useful tool for measuring patient-based symptoms and the impact of chronic plaque psoriasis.

译文

目的:本研究评估了一种新的牛皮癣症状日记的心理计量学特性,确定了日记应答者定义以用于确定患者是否经历了具有临床意义的变化,并完善了日记项的内容以用于未来的临床试验。
方法:银屑病症状日记是在AIN457的2期临床试验中向美国诊断为中度至重度慢性斑块型牛皮癣的成年门诊患者(N = 172)服用的。评估参与者对日常日记管理的依从性以及项目评分的可变性,可靠性,结构和判别有效性,变化的敏感性以及解释性。
结果:参与者在12个研究周中完成了计划的日记评估的94%。日记物品通常呈正态分布,没有观察到地板或天花板的影响。物品的可靠性(可重复性)是可以接受的(类内相关系数> 0.80),但一件物品(肤色)除外。在第12周时,与预测的标准措施显着相关的项目(牛皮癣面积和严重性指数r = 0.27-0.57;研究者的全球评估r = 0.25-0.59),但使用双手测量肤色和困难程度的项目除外。大多数项目产生的变化评分与银屑病面积和严重性指数,研究者的总体评估,皮肤病生活质量指数(r> 0.37)以及患者对变化的整体印象所衡量的变化是同步的。响应者在项目得分上经历了2到3分和3到5分的变化,分别实现了最小和较大的改进。表现不佳的四个项目从日记中删除。
结论:16项牛皮癣症状日记显示出良好的心理测量特性,是一种简短,有用的工具,可用于测量基于患者的症状和慢性斑块状牛皮癣的影响。

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