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对非显著初级结果的传播扭曲:多发性硬化症试验中的旋转策略

Marta Mascareñas-García^1,2, Alejandro Rivero-de-Aguilar^1,3, Cristina Candal-Pedreira^1,4,5

¹Department of Preventive Medicine and Public Health, Universidade de Santiago de Compostela. Rúa San Francisco s/n, Santiago de Compostela, Spain.

Annals of neurology

|January 26, 2026

概括

在多发性硬化症 (MS) 药物试验中,旋转很普遍,结果不显著,可能会影响临床决策. 这种报告偏差与较小的样本规模和非顶级期刊有关.

科学领域:

临床试验临床试验
药学研究药学研究
神经学神经学

背景情况:

旋转,一个强调积极方面或淡化无关紧要发现的报告策略,可能会影响实验治疗的解释.
在对多发性硬化症 (MS) 制药的随机对照试验 (RCT) 中评估旋转对于准确的临床决策至关重要.

研究的目的:

评估关于MS中药物疗效的RCT中旋转的流行率.
确定与这些试验中旋转存在相关的因素.

主要方法:

一项系统的文献搜索确定了在2013年至2024年期间发表的第3期和第4期多发性硬化症RCT,其主要结果不显著.
在文章的多个部分评估了旋转,包括标题,摘要,结果,讨论和结论.
探索性双变物流回归分析了旋转和样本大小,期刊四分位数和作者归属等变量之间的关联.

主要成果:

在包括的40件物品中,在62.5%的物品中检测到旋转,其中47.5%的物品呈现出三个或更多部分的旋转.
旋转的频繁地点包括抽象的结论,讨论和结论.
旋转与较小的样本大小 (OR=7.00),非Q1期刊 (OR=4.38) 和欧洲/美国以外的作者 (OR=5.09) 有关.

结论:

旋转是MS RCT报告非显著初级结果的常见问题.
旋转的存在可能会在治疗决策中误导临床医生.
需要进一步的研究和遵守报告准则,以减轻制药试验报告中的旋转.

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