COMPARISON OF PROVIDER-ASSESSED AND PATIENT-REPORTED OUTCOME MEASURES OF ACUTE SKIN TOXICITY DURING A PHASE III TRIAL OF MOMETASONE CREAM VERSUS PLACEBO DURING BREAST RADIOTHERAPY: THE NORTH CENTRAL CANCER TREATMENT GROUP (N06C4)
COMPARISON OF PROVIDER-ASSESSED AND PATIENT-REPORTED OUTCOME MEASURES OF ACUTE SKIN TOXICITY DURING A PHASE III TRIAL OF MOMETASONE CREAM VERSUS PLACEBO DURING BREAST RADIOTHERAPY: THE NORTH CENTRAL CANCER TREATMENT GROUP (N06C4)
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DOI：
10.1016/j.ijrobp.2010.05.065
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发表时间：
2011-10-01
影响因子：
7
通讯作者：
Miller, Robert C.
中科院分区：
文献类型：
--
作者：
Neben-Wittich, Michelle A.;Atherton, Pamela J.;Miller, Robert C.
目的：在测量主观症状时，提供者之间以及提供者和患者之间存在相当大的观察者间差异。在最近发表的莫米松乳膏与安慰剂预防放射性皮炎的III期N 06 C4试验中，使用不良事件通用毒性标准（CTCAE）的主要提供者评估（PA）终点为阴性。然而，使用Skindex-16和皮肤毒性评估工具（STAT）对患者报告结局（PRO）进行的前瞻性计划次要分析结果为阳性。本研究评估PA的结果和PROs.Methods和材料之间的关系：皮尔逊相关系数计算比较三种工具。统计学相关性定义如下：0.7，强。结果：CTCAE皮炎与STAT红斑中度相关，CTCAE瘙痒与STAT瘙痒强相关。CTCAE瘙痒与Skindex-16瘙痒中度相关。比较2种PRO工具，Skindex-16瘙痒与STAT瘙痒中度相关。Skindex-16烧伤，伤害，刺激和持久性都表现出最强的相关性与STAT燃烧，他们表现出中度相关性与STAT瘙痒和tenting.Conclusions：PRO Skindex-16相关性以及PRO部分STAT，但没有工具相关性以及与CTCAE。PRO描述的毒性范围比PA指标更广，并且与皮疹和瘙痒症的CTCAE结果相比，提供了更多关于皮疹、发红、瘙痒症和烦恼指标的信息。在评估辐射皮肤毒性的临床试验中，PRO可以提供比单一症状、PA终点更完整的患者体验测量。(C)2011 Elsevier Inc.
Purpose: Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs.Methods and Materials: Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: 0.7, strong.Results: CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness.Conclusions: The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity. (C) 2011 Elsevier Inc.