The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study.
The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study.
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DOI：
10.1186/1477-7525-4-71
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发表时间：
2006-09-27
影响因子：
3.6
通讯作者：
Revicki, Dennis A.
中科院分区：
文献类型：
--
作者：
Shikiar, Richard;Willian, Mary Kaye;Okun, Martin M.;Thompson, Christine S.;Revicki, Dennis A.
患者报告结果(PROS)方法越来越多地被用于中度至重度斑块型银屑病治疗的调查研究。本研究的目的是检验皮肤病生活质量指数(DLQI)、简表36(SF-36)和欧洲质量5D(EQ-5D)之间的关系，并评估它们的有效性、响应性和最小重要差异的估计。一项II期随机、双盲、平行组、安慰剂对照、多中心临床试验，评估两剂阿达利单抗与安慰剂皮下注射治疗147例中重度斑块型银屑病的临床疗效和安全性，疗程为12周。这项研究为评估PROS仪器的有效性和对临床状态变化的响应性提供了机会。患者在基线和12周时完成DLQI、SF-36和EQ-5D问卷。盲目调查人员评估了入选患者的银屑病面积和严重程度指数(PASI)评分和医生总体评估(PGA)评分。评估这些措施对从基线到第12周的临床终点变化的反应性。得出了最小重要差异(MID)的估计值。所有的分析都是用盲法数据进行的；结果和结论没有基于治疗条件的偏见。皮肤病特异性DLQI在基线和12周时与临床终点高度相关，是对终点变化最敏感的PRO。与SF-36相比，EQ-5D指数评分和VAS评分与临床终点的相关性更高，但表现出大致相同的反应程度。对SF-36量表反应最敏感的是躯体疼痛和社会功能量表。DLQI的MID估计值在2.3-5.7之间，SF-36物理成分概要(PCS)分数的估计值在2.5-3.9之间。这项研究为DLQI和SF-36PCS在银屑病治疗评估中的继续使用提供了支持。根据这项试验的结果，EQ-5D应该被认为是未来对中到重度斑块型银屑病患者进行的临床试验中的一般PRO指标。
Patient-reported outcome (PROs) measures are being used more frequently in investigational studies of treatments for moderate to severe plaque psoriasis. The objective of this study was to examine the relationships among the Dermatology Life Quality Index (DLQI), the Short Form 36 (SF-36), and the EuroQOL 5D (EQ-5D) and to assess their validity, responsiveness, and estimates of minimum important differences. A Phase II, randomized, double-blind, parallel group, placebo-controlled, multi-center clinical trial assessed the clinical efficacy and safety of two doses of subcutaneously administered adalimumab vs. placebo for 12 weeks in the treatment of 147 patients with moderate to severe plaque psoriasis. This study provided the opportunity to evaluate the validity and responsiveness to change in clinical status of PROs instruments. Patients completed the DLQI, SF-36, and EQ-5D questionnaires at baseline and at 12 weeks. Blinded investigators assessed the Psoriasis Area and Severity Index (PASI) scores and the Physician's Global Assessment (PGA) scores of enrolled patients. The responsiveness of the measures to changes in the clinical endpoints from baseline to Week 12 was assessed. Estimates of minimum important differences (MID) were derived. All analyses were performed with blinded data; findings and conclusions were not biased based on treatment condition. The dermatology-specific DLQI was highly correlated to clinical endpoints at baseline and at Week 12, and was the most responsive PRO to changes in endpoints. Compared with the SF-36, the EQ-5D index score and VAS scores were generally more highly correlated with clinical endpoints, but displayed about the same degree of responsiveness. The most responsive SF-36 scales were the Bodily Pain and Social Functioning scales. Estimates of the MID for the DLQI ranged from 2.3–5.7 and for the SF-36 Physical Component Summary (PCS) score ranged from 2.5–3.9. This study provides support for the continued use of the DLQI and SF-36 PCS in the assessment of treatments for psoriasis. On the basis of the results from this trial, the EQ-5D should be considered as a general PRO measure in future clinical trials of patients with moderate to severe plaque psoriasis.
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