癌症化疗诱导的恶心和吐的针随机对照试验中的高结果报告偏差:系统性审查和超流行病学研究
Rachele Penati1,2, Riccardo Vecchio3, Roberto Gatto2
1Villa Beretta Rehabilitation Center, Valduce Hospital, 23845 Costa Masnaga, Italy.
Current oncology (Toronto, Ont.)
|August 27, 2025
概括
选择性结果报告偏差是针研究中化学疗法的副作用的一个问题. 大多数研究缺乏有效的注册,阻碍了结果的透明度,并可能扭曲结果.
科学领域:
- 癌症学
- 综合医学
- 研究方法
背景情况:
- 选择性结果报告偏差是科学研究中的一个关键方法限制.
- 癌症化疗引起的恶心和吐 (CINV) 是影响患者生活质量的重大不良影响.
- 针作为治疗CINV的补充疗法正在探索,但需要有力的证据.
研究的目的:
- 评估预防CINV的针研究中选择性结果报告偏差的风险.
- 评估这些研究的试验记录的可用性和有效性.
- 分析报告结果的完整性与已公布的方案相比.
主要方法:
- 对CINV针的英语研究进行系统审查.
- 搜索并评估研究记录的有效性.
- 使用七个特定项目的研究结果 (类型,领域,测量,度量,数据,聚合,时间点).
主要成果:
- 评估了1987年至2019年间发表的11项研究.
- 只有36% (4/11) 的研究有登记;只有2个是前性和有效的.
- 在结果测量和指标中发现了差异; 由于缺少数据, 许多数据是无价的. 没有研究报告了所有预期的结果.
结论:
- 在癌症针研究中存在选择性结果报告偏差的高风险.
- 不完整的报告和缺乏有效的潜在注册是重要的问题.
- 强制注册预期试验并详细报告结果对于提高透明度和减少偏见至关重要.
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