效果大小根据计算方法而异,可能会影响治疗效果的解释:使用骨关节炎随机临床试验的示例
Thomas J Schnitzer1, Philip G Conaghan2, Francis Berenbaum3
1Northwestern University Feinberg School of Medicine, Chicago, IL, USA. tjs@northwestern.edu.
Advances in rheumatology (London, England)
|April 22, 2024
概括
根据计算方法,在骨关节炎中坦涅祖马布的标准化效果大小 (ES) 显著不同. 报告个别的ES组件对于准确的解释和适当的临床试验样本大小的确定至关重要.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 药理学 药理学是指药理学的学科.
背景情况:
- 在临床试验中,标准化效果大小 (ES) 对于解释治疗疗效至关重要.
- 在ES计算方法的变化可能导致对治疗效果的不同结论.
研究的目的:
- 为了证明标准化效果大小 (ES) 如何根据计算方法不同.
- 为改善临床研究中效果大小报告提供建议.
主要方法:
- 来自三项tanezumab骨关节炎试验的数据分析.
- 计算WOMAC疼痛的ES,使用平均值之间的最小平方差除以聚合标准偏差 (SD) 的最小平方差.
- 对三种SD计算方法的评估:基线,终点和中位数聚合SDs.
主要成果:
- 效果大小 (ES) 根据所使用的SD计算方法 (基线,终点或中位数) 有很大差异.
- 使用基线SD观察到最大的ES,而终点SD则产生最小的ES.
- 这种ES变化的模式在所有研究的剂量和试验中都是一致的.
结论:
- 在ES计算中的差异可能会影响治疗有效性的解释.
- 建议对个人ES组件进行清晰的报告,以确保准确的理解.
- 不准确的ES估计可能导致由于错误的样本大小计算导致临床试验不足.
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