ImportanceAssessment of type, severity, and impact of dermatologic adverse events (DAEs) necessitates well-developed and validated clinician-reported outcome measures (ClinROMs) and patient-reported outcome measures (PROMs) that evaluate concepts specific to mucocutaneous toxic effects and that allow appropriate interpretation and comparison of DAEs across trials.ObjectiveTo evaluate heterogeneity and quality of ClinROMs and PROMs used to assess DAEs from systemic cancer therapy.Evidence ReviewTwo systematic reviews were conducted by searching PubMed and Embase databases from inception through March 7, 2023, and April 12, 2023. The first search included randomized clinical trials and observational studies reporting systemic cancer treatment–induced DAEs assessed by a ClinROM or PROM. The second included studies evaluating measurement properties of frequently used ClinROM and PROM instruments. The Consensus-Based Standards for the Selection of Health Measurement Instruments risk of bias tool was used to evaluate methodologic quality of validation assessments.FindingsA total of 395 studies were included. The Common Terminology Criteria for Adverse Events (CTCAE) was utilized in 331 studies meeting inclusion criteria (83.8%). At least 1 skin-related PROM was infrequently utilized in systemic chemotherapy clinical trials (79 studies [20.0%]). Most frequently utilized PROMs were the Dermatology Life Quality Index (DLQI; 34 studies [8.6%]) and Skindex-16 (20 studies [5.1%]). Among studies capturing DAEs, 115 (29.1%) reported a nondescript term (ie, rash) as the only DAE. Eight studies described 44 property assessments of the CTCAE, DLQI, and Skindex. There were no studies evaluating content validity, intrarater reliability, or measurement error for the CTCAE, DLQI, or Skindex. There were no studies evaluating structural validity, internal consistency, and responsiveness of DLQI or Skindex. Interrater reliability and responsiveness were each assessed for 1 DAE-related component of the CTCAE. Construct validity for CTCAE, DLQI, and Skindex was evaluated in 29 (65.9%), 3 (6.8%), and 9 (20.5%) assessments, respectively.Conclusions and RelevanceIn this systematic review, there was a narrow spectrum of ClinROMs and PROMs with limited validity for the measurement of DAEs in the context of systemic chemotherapy interventions in clinical trials. Report of trial DAEs often had low morphologic specificity and meaning. Based on existing gaps in measurement and report of DAEs, a frequent and impactful adverse event to chemotherapy, the framework for evaluating cutaneous toxic effects in oncology trials may need collaborative reevaluation.

中文翻译：

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用于评估癌症试验中皮肤不良事件的结果测量仪器

重要性评估皮肤不良事件 (DAE) 的类型、严重程度和影响需要完善和验证的临床医生报告的结果测量 (ClinROM) 和患者报告的结果测量 (PROM)，以评估特定于粘膜皮肤毒性作用的概念，并允许适当的评估。跨试验 DAE 的解释和比较。目的评估用于评估全身癌症治疗 DAE 的 ClinROM 和 PROM 的异质性和质量。证据审查通过搜索 PubMed 和 Embase 数据库从开始到 2023 年 3 月 7 日和 4 月 12 日进行了两次系统审查， 2023 年。第一次检索包括随机临床试验和观察性研究，报告由 ClinROM 或 PROM 评估的系统性癌症治疗诱发的 DAE。第二项包括评估常用 ClinROM 和 PROM 仪器测量特性的研究。使用基于共识的健康测量工具选择标准偏倚风险工具来评估验证评估的方法学质量。结果共纳入 395 项研究。符合纳入标准 (83.8%) 的 331 项研究使用了不良事件通用术语标准 (CTCAE)。至少 1 项与皮肤相关的 PROM 很少在全身化疗临床试验中使用（79 项研究 [20.0%]）。最常用的 PROM 是皮肤病生活质量指数（DLQI；34 项研究 [8.6%]）和 Skindex-16（20 项研究 [5.1%]）。在捕获 DAE 的研究中，115 项 (29.1%) 报告称，唯一的 DAE 是一个不起眼的术语（即皮疹）。八项研究描述了 CTCAE、DLQI 和 Skindex 的 44 项属性评估。没有研究评估 CTCAE、DLQI 或 Skindex 的内容有效性、评估者内可靠性或测量误差。没有研究评估 DLQI 或 Skindex 的结构有效性、内部一致性和反应性。针对 CTCAE 的 1 个 DAE 相关组成部分分别评估了评估者间的可靠性和响应性。 CTCAE、DLQI 和 Skindex 的构建有效性分别在 29 项 (65.9%)、3 项 (6.8%) 和 9 项 (20.5%) 评估中进行了评估。结论和相关性在本次系统评价中，ClinROM 和 PROM 的范围很窄在临床试验中全身化疗干预背景下测量 DAE 的有效性有限。试验 DAE 的报告通常形态特异性和意义较低。基于 DAE（一种常见且有影响的化疗不良事件）测量和报告方面现有的差距，肿瘤学试验中评估皮肤毒性作用的框架可能需要合作重新评估。