用于评估癌症试验中的皮肤学不良事件的结果测量仪器:系统性审查
Sheila Shaigany1,2,3, Nicole Mastacouris1, Rachel Tannenbaum1
1Northwell Health, New Hyde Park, New York.
JAMA dermatology
|March 20, 2024
概括
在癌症治疗中,临床医生报告和患者报告的皮肤学不良事件 (DAE) 的结局指标具有有限的有效性和特异性. 需要对当前框架进行重新评估,以改善对这些常见化疗副作用的评估.
科学领域:
- 在瘤学瘤学.
- 皮肤病学 皮肤病学
- 临床试验 临床试验
- 健康 结果 研究 研究 结果
背景情况:
- 皮肤学不良事件 (DAE) 是系统性癌症治疗的常见且具有影响力的副作用.
- 准确评估DAE需要经过验证的临床医生报告的结果措施 (ClinROMs) 和患者报告的结果措施 (PROMs).
- 现有的措施往往缺乏评估粘膜皮肤毒性影响的特异性和一致性.
研究的目的:
- 评估用于系统性癌症治疗中评估DAE的ClinROM和PROM的异质性和质量.
- 在临床试验中发现DAE测量属性和报告DAE的漏洞.
主要方法:
- 使用PubMed和Embase数据库进行了两次系统审查.
- 包括的研究是随机临床试验和观察性研究,报告了系统性癌症治疗的DAE.
- 验证评估的方法质量使用基于共识的健康测量仪器选择标准风险偏差工具进行了评估.
主要成果:
- 在83.8%的纳入研究中使用了不良事件的共同术语标准 (CTCAE).
- 与皮肤相关的PROM很少使用 (20.0%),皮肤病生命质量指数 (DLQI) 和Skindex-16是最常见的.
- 许多研究报告了具有低特异性的DAE (例如"皮疹"),对于常用的仪器,关于内容有效性,可靠性和响应性的验证数据有限.
结论:
- 在全身化疗试验中,ClinROM和PROM的频谱很窄,对测量DAE的有效性有限.
- 在试验中报告DAE往往缺乏具体性和有意义的解释.
- 由于现有的测量和报告差距,对在瘤学试验中评估皮肤毒性影响的框架进行合作重新评估是有必要的.
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