在III期随机瘤学试验中的治疗组特定推断
Alexander D Sherry1, Adina H Passy2, Joseph Abi Jaoude3
1Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. alexanderdsherry@gmail.com.
Acta oncologica (Stockholm, Sweden)
|March 24, 2025
概括
大多数III期瘤学试验报告了治疗组特定的推断,尽管缺乏统计支持,并且与CONSORT指南相矛盾. 这些推断可能具有误导性;相反,建议使用可变性测量.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 在随机试验中,对比治疗效果的估计是强大的.
- 由于选择性患者招募,对治疗组特定的推断在统计学上具有挑战性.
- CONSORT的指导方针不鼓励对治疗组进行特定的推断.
研究的目的:
- 评估III期瘤学试验中呈现治疗组特异性推断的比例.
- 评估随着时间的推移报告治疗组特定推断的趋势.
主要方法:
- 从clinicaltrials.gov.gov.gov网站上对已发表的第三期随机瘤学试验进行查.
- 通过存在95%的置信区间或对结果的标准错误来定义治疗组特定的推断.
- 分析这些推断的频率和趋势.
主要成果:
- 在774项III期瘤学试验中的58% (568,080名患者) 提出了治疗组特定的推断.
- 这些推断的报道随着时间的推移而增加 (OR=1.11,p<0.0001).
- 在剩余的试验中,6%报告了具有可变性指标的特定组结果,36%仅提供了点估计.
结论:
- 大多数III期瘤学试验报告没有支持的治疗组特定推断,与CONSORT指导方针相冲突.
- 从使用传统方法的随机试验中概括治疗特异性结果可能会误导.
- 建议描述治疗组特异性结果,并测量可变性,而不是推断.
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