患者报告结果报告中缺少什么? 在瘤学随机对照试验中完成率的范围审查和综合试验级分析
Daniela Krepper1, Niclas J Hubel1, Samuel M Vorbach2
1Health Outcomes Research Unit, University Hospital of Psychiatry II, Medical University of Innsbruck, Innrain 52, Innsbruck, Austria.
Critical reviews in oncology/hematology
|December 25, 2025
概括
在癌症试验中,患者报告结果 (PRO) 完成率在基线后下降,并且经常报告不充分. 工业赞助和双盲设计与更高的PRO完成相关,强调需要更好的数据捕获.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 健康 结果 研究 研究 结果
背景情况:
- 缺少患者报告的结果 (PRO) 数据影响了癌症随机对照试验 (RCT) 的结论.
- 对PRO完成率和相关试验特征的系统评估对于提高数据稳定性至关重要.
研究的目的:
- 系统地审查癌症RCT中的PRO完成率.
- 为了确定影响PRO完成的特定试验特征.
主要方法:
- 对PubMed发表的涉及固体瘤的RCT (2019-2023) 进行了范围审查.
- 用回归模型提取和分析了PRO完成率 (基线和基线后),缺失原因和试验特征的数据.
主要成果:
- 包括222个RCT;平均PRO完成率从基线时的~91-92%下降到基线后的~82%.
- 工业赞助和双盲试验显示了更高的PRO完成率.
- 缺少数据的原因仅在18%的试验中报告;电子PRO评估显示没有与完成有显著的关联.
结论:
- 癌症RCT中的PRO完成率低于最佳,特别是基线后,缺少数据的报告不足.
- 在所有试验设计中,改善报告标准和优先考虑PRO完成是必要的.
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