评估SPIRIT在随机试验中对参与者保留的使用:报告中的挑战和对实践的影响
Amy O'Connor1,2, Ellen Murphy1,2, Frances Shiely1,2
1Trials Research and Methodologies Unit (TRAMS), Health Research Board Clinical Research Facility, University College Cork, Cork, Ireland.
PloS one
|August 12, 2025
概括
标准协议项目:对干预试验的建议 (SPIRIT) 准则项目18b没有显著改善随机对照试验中的参与者保留. 关于保留策略的不一致报告妨碍了评估.
科学领域:
- 临床试验方法论 临床试验方法论
- 研究伦理和诚信研究.
背景情况:
- 参与者保留对于随机对照试验 (RCT) 的有效性至关重要.
- 该SPIRIT (标准协议项目:干预试验建议) 的指导方针旨在提高试验协议质量.
- 在SPIRIT项目18b中,专门讨论了参与者留住策略的规划.
研究的目的:
- 为了确定是否遵守SPIRIT项目18b影响参与者在RCT中的保留率.
- 调查记录的保留计划与实际的参与者保留之间的关联.
主要方法:
- 从2014年至2019年对506个RCT协议进行了回顾性分析.
- 试验中参与者保留率的比较,这些试验在试验记录中明确提到和没有明确提到SPIRIT项目18b.
主要成果:
- 两组之间没有观察到参与者整体保留率的显著差异.
- SPIRIT第18b项的遵守没有影响主要结果指标的保留率.
- 该研究没有发现SPIRIT 18b对参与者保留的统计学意义上的影响.
结论:
- 根据协议报告的SPIRIT项目18b,似乎没有提高参与者在RCT中的保留率.
- 引用的保留策略的有效性可能受到缺乏高确定性证据的限制.
- 试验协议中关于保留策略的不一致和不完整的报告使评估复杂化,需要改进.
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