皮肤病生活质量指数（DLQI）的最小重要差异（MID）：慢性特发性荨麻疹患者的研究结果
Minimal important difference (MID) of the Dermatology Life Quality Index (DLQI): results from patients with chronic idiopathic urticaria.
作者信息
Shikiar Richard, Harding Gale, Leahy Michael, Lennox Richard D
机构信息
MEDTAP International, Inc., Seattle, WA, USA.
出版信息
Health Qual Life Outcomes. 2005 May 20;3:36. doi: 10.1186/1477-7525-3-36.
Abstract
BACKGROUND
The Dermatology Quality Life Index (DLQI) has seen widespread use as a health-related quality of life measure for a variety of dermatological diseases. The purpose of this study was to estimate the minimal important difference (MID) on the DLQI for patients with chronic idiopathic urticaria (CIU).
METHODS
Data from 2 Phase III clinical trials of patients (N = 476 for Study A; N = 468 for Study B) with CIU were analyzed separately to estimate the MID for the DLQI for these populations. Both distributional based and anchor based approaches were used for deriving estimates. The anchor based approach relied upon patient self assessments of pruritus severity; the distributional based approaches relied upon estimating the standard error of measurement, as well as one-half the standard deviation of the DLQI from each study.
RESULTS
The distributional approaches resulted in estimates of MID ranging from 2.24 to 3.10 for the two studies. The anchor based approach resulted in estimates of 3.21 and 2.97 for the two studies.
CONCLUSION
An MID for the DLQI in the range of 2.24 to 3.10 is recommended in interpreting results for patients with CIU.
摘要
背景
皮肤病生活质量指数（DLQI）已被广泛用作多种皮肤病的健康相关生活质量衡量指标。本研究的目的是估计慢性特发性荨麻疹（CIU）患者DLQI的最小重要差异（MID）。
方法
分别分析来自两项CIU患者III期临床试验的数据（研究A中N = 476；研究B中N = 468），以估计这些人群DLQI的MID。基于分布和基于锚定的方法均用于得出估计值。基于锚定的方法依赖于患者对瘙痒严重程度的自我评估；基于分布的方法依赖于估计测量的标准误差以及每项研究中DLQI标准差的一半。
结果
两项研究中基于分布的方法得出的MID估计值在2.24至3.10之间。基于锚定的方法得出的两项研究的估计值分别为3.21和2.97。
结论
在解释CIU患者的结果时，建议DLQI的MID范围为2.24至3.10。
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2
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Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.
3
Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening.癌症特异性生活质量评分的有意义变化：改善与恶化之间的差异。
Qual Life Res. 2002 May;11(3):207-21. doi: 10.1023/a:1015276414526.
4
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5
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6
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7
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8
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9
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10
Evaluation of clinical efficacy and safety of adapalene 0.1% gel versus tretinoin 0.025% gel in the treatment of acne vulgaris, with particular reference to the onset of action and impact on quality of life.0.1%阿达帕林凝胶与0.025%维甲酸凝胶治疗寻常痤疮的临床疗效及安全性评估，特别涉及起效时间及对生活质量的影响。
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