评估局部前列腺癌随机对照试验中核心结果集的吸收:一个横截面研究
Carson L Wright1, Joseph Case1, Trevor Magee1
1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK.
Urologic oncology
|July 31, 2025
概括
研究人员评估了局部性前列腺癌 (LPC) 随机对照试验 (RCT) 中的核心结果集 (COS) 完成. 遵守COS在2017年之前出现了无意义的下降,并在之后出现了无意义的增加,这表明试验一致性有所改善.
科学领域:
- 在瘤学瘤学.
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
背景情况:
- 局部性前列腺癌 (LPC) 管理依赖于随机对照试验 (RCT) 的一致数据.
- 核心结果集 (COS) 在临床研究中标准化结果测量.
- 评估2017年LPC COS的采用对于评估研究质量至关重要.
研究的目的:
- 评估随机对照试验 (RCT) 中局部性前列腺癌 (LPC) 确定的核心结果组 (COS) 的完成率.
- 分析COS出版前后的遵守趋势.
主要方法:
- 确定了2017年LPC的成本.
- 搜索了临床试验.gov和ICTRP (2013-2023) 的LPCRCT.
- 提取了关于COS结果完成的数据 (生存,功能,生活质量,治疗特异性结果).
- 使用中断时间序列分析分析了COS吸收.
主要成果:
- 分析了82个LPCRCT.
- "疾病进展"是最常见的结果 (92.68%).
- "需要救生疗法"是报告最少的结果 (32.93%).
结论:
- 观察到2017年之前的COS遵守率有不显著的下降,随后在出版后有不显著的增加.
- 建议试验人员遵守LPC COS.
- 建议进行进一步的研究,以监测未来的COS遵守情况.
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