统计能力,样本大小,以及它们在随机对照试验中的报告
D Moher1, C S Dulberg, G A Wells
1Clinical Epidemiology Unit, Loeb Medical Research Institute, Ottawa Civic Hospital, Ontario, Canada.
JAMA
|July 13, 1994
概括
大多数带有负结果的随机对照试验 (RCT) 缺乏足够的统计能力和适当的样本大小计算. 报告样本大小计算的情况有所改善,但随着时间的推移,检测有意义差异的能力仍然很低.
科学领域:
- 医学研究方法学 医学研究方法学
- 临床试验设计 临床试验设计
- 医学中的统计分析.
背景情况:
- 随机对照试验 (RCT) 对基于证据的医学至关重要.
- 随机试验中的负结果需要对统计能力和样本大小进行仔细的解释.
- 评估报告统计能力和样本大小计算的趋势对于提高研究质量至关重要.
研究的目的:
- 分析统计能力和样本大小计算报告的趋势,在公布的RCT中报告负结果.
- 评估随着时间的推移在负面RCT中样本大小的充分性.
- 评估负面RCT中临床意义的报告.
主要方法:
- 1975年,1980年,1985年和1990年在主要医学期刊 (JAMA,Lancet,NEJM) 上发表的RCT的描述性调查.
- 用简单的两组并行设计对负结果试验的统计功率进行计算.
- 制定标准来分类试验结果并确定主要结果.
主要成果:
- 27%的经过审查的RCT产生了负面结果,这一比例保持稳定.
- 只有16%和36%的负结果试验具有足够的功率 (80%) 来分别检测25%和50%的相对差异.
- 报告样本大小计算的情况从1975年的0%提高到1990年的43%,但只有20%的负面试验讨论了临床意义.
结论:
- 大多数负面的RCT没有能力检测出临床相关的差异,这种情况随着时间的推移而没有变化.
- 报告样本大小计算有所改善,但统计能力仍然不足.
- 需要加强对负面RCT的统计能力,样本大小计算和临床意义的报告.
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