在随机试验中选择性报告结果的经验证据:将协议与已发表的文章进行比较
An-Wen Chan1, Asbjørn Hróbjartsson, Mette T Haahr
1Centre for Statistics in Medicine, Institute of Health Sciences, Headington, Oxford, England. anwen.chan@utoronto.ca
JAMA
|May 27, 2004
概括
随机试验中选择性结果报告是常见的,显著的结果更有可能被完全报告. 这种偏见可以使发表的研究变得不可靠,需要试验注册和公开协议以实现透明度.
科学领域:
- 临床研究方法论临床研究方法论
- 生物统计学 生物统计学
- 基于证据的医学是基于证据的医学.
背景情况:
- 怀疑有选择性结果报告偏见,但除了案例报告外,缺乏强有力的经验证据.
- 关于随机试验中这种偏差的程度和性质的数据有限.
研究的目的:
- 在一组随机试验中实证地调查结果报告偏差的流行率和特征.
- 评估报告和未报告结果之间的差异及其与统计学意义的关系.
主要方法:
- 一项队列研究分析了102个随机试验 (1994-1995) 将协议与已发表的报告进行比较并调查试验参与者.
- 如果出版物中没有足够的数据用于元分析,结果被归类为不完全报告.
- 计算了几率比率,以量化与统计学显著性和初级结果报告一致性相关的偏差.
主要成果:
- 50%的疗效和65%的危害结果在试验中不完全报告.
- 从统计学上显著的结果比非显著的结果更有可能被完全报告 (ORs为2.4的疗效,4.7的危害).
- 62%的试验显示了协议和出版物之间主要结果的差异,许多试验者否认未报告的结果.
结论:
- 随机试验中的结果报告经常不完整,有偏见,与最初的协议不一致.
- 由于这种报告偏见,已发表的研究可能会高估干预效益.
- 试验的注册和公开可用的协议对于提高透明度和可靠性至关重要.
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