单个单项的整体副作用影响:与临床医生报告的不良事件和全球健康的关联
Jessica Roydhouse1, Anne Zola2, Monique Breslin1
1Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Clinical trials (London, England)
|January 6, 2026
概括
全球患者5 (GP5) 问题有效地捕捉了癌症试验中患者报告的副作用烦. 它与临床医生评估的不良事件和患者的整体健康相关,支持其在耐受性评估中的使用.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 对患者报告的耐受性在癌症治疗安全性方面的认识越来越大.
- 监管指南强调了整体副作用的影响作为核心患者报告的结果.
- 慢性疾病治疗功能评估中的GP5项目测量了整体副作用的情况.
研究的目的:
- 扩大GP5项目的证据基础.
- 检查GP5和临床医生报告的治疗出现的不良事件之间的关联.
- 评估GP5与患者报告的全球健康之间的关系.
主要方法:
- 对六项商业癌症临床试验的分析,其中包括3,557名患者.
- 临床医生报告的不良事件的分类为症状或任何类型.
- 使用奇平方测试和皮尔森相关性来检查GP5,不良事件和全球健康之间的关联.
主要成果:
- 大多数患者经历了一些不良事件 (71.7%-94.2%),但较少的人有3级+事件 (17.1%-44.4%).
- 中度至严重的烦 (GP5评分2至4) 报告了20.6%-44.2%的患者;严重的烦 (评分3至4) 报告了5.8%-17%的患者.
- 在GP5和不良事件之间发现了一致的关联,GP5/全球健康相关性范围从-0.17到-0.41.
结论:
- 该GP5项目证明了在癌症试验中的有效性和有用性.
- GP5与临床医生报告的不良事件和患者报告的症状有关.
- 在瘤学临床试验中,GP5支持全面的耐受性评估.
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