报告和解释随机对照试验的统计学上非显著的结果,主要的结果
Isabelle Boutron1, Susan Dutton, Philippe Ravaud
1Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom. isabelle.boutron@htd.aphp.fr
JAMA
|May 27, 2010
概括
作者经常扭曲已发表的随机对照试验 (RCT) 中的发现,结果不显著. 这种"旋转"误导了读者对治疗有效性的看法,影响了基于证据的医学.
科学领域:
- 医学研究报告 医学研究报告
- 临床试验分析临床试验分析
- 科学出版物的完整性科学出版物完整性
背景情况:
- 发表的试验结果可能会因为作者偏见而被误解.
- 了解"旋转"对于准确的科学解释至关重要.
研究的目的:
- 在随机对照试验 (RCT) 中确定"旋转"的患病率和性质.
- 调查作者如何呈现统计学上非显著的初级结果.
主要方法:
- 通过PubMed在MEDLINE上搜索2006年12月发表的RCT.
- 包括具有统计学上不显著的初级结果的并行组RCT (P > 或 = .05).
- 两名审稿人使用标准化表格评估了72篇符合条件的文章.
主要成果:
- "旋转"存在于18%的标题,37.5%的抽象结果和58.3%的抽象结论中.
- 主要文本部分也显示了"旋转":在结果中占29.2%,在讨论中占43.1%,在结论中占50%.
- 超过40%的报告至少在两个主要文本部分显示"旋转".
结论:
- 报告和解释具有非显著初级结果的RCT中发现的结果通常与实际结果不一致.
- 这种普遍的"旋转"可以误导读者并影响临床决策.
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