失明对针随机临床试验预计治疗效果的影响:一项超流行病学研究
Youlin Long1,2,3, Na Zhang1,2,3, Xinyao Wang1,2,3
1Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.
Journal of evidence-based medicine
|March 11, 2024
概括
在针随机对照试验 (RCT) 中,使患者和结果评估人员失明并不会显著影响治疗疗效. 在未来的研究中改进失明方法对于提高RCT可靠性至关重要.
科学领域:
- 整合和补充医学是整合和补充医学.
- 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:
- 失明是严格的随机对照试验 (RCT) 的关键组成部分,以尽量减少偏差.
- 针RCT中盲目的有效性,特别是患者和结果评估者盲目的有效性,需要仔细评估.
- 了解失明对治疗效果的影响对于准确解释研究结果至关重要.
研究的目的:
- 评估针RCT中患者和结果评估人员盲目的孤立影响对治疗疗效的孤立影响.
- 分析不同类型的结果指标 (二进制,连续,患者报告,主观) 如何影响失明的影响.
- 提供关于针研究中盲目的实际挑战的见解.
主要方法:
- 进行了一项系统的搜索,对比盲目和非盲目针RCT的元分析.
- 混合效应元回归模型被用来估计几率比率 (ROR) 和标准化平均差异差异 (dSMD) 的比率.
- 分析特别检查了患者失明和结果评估者失明对各种结果措施的影响.
主要成果:
- 该分析包括96个元分析,涵盖1012个试验.
- 缺乏患者失明显示,对于患者报告的二进制结果 (95% CI 0.79-1.49),平均ROR为1.08.
- 缺乏结果评估者盲目显示,对二元主观结果 (95% CI 0.77-1.24) 的平均ROR为0.98.
- 连续的结果还显示了对失明状态的非显著影响 (dSMD -0.38和-0.13).
结论:
- 参与者和结果评估人员的失明并没有显著改变针治疗的感知有效性.
- 这些发现突出了在针RCT中实施有效盲目的实际挑战.
- 未来的研究应该专注于改善失明质量和评估,以提高针RCT的内部有效性和可靠性.
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