随机试验中的复合结果:更高的精度但更大的不确定性?
Nick Freemantle1, Melanie Calvert, John Wood
1Department of Primary Care and General Practice, University of Birmingham, Birmingham, England. N.Freemantle@bham.ac.uk
JAMA
|May 22, 2003
概括
临床试验中的复合结果提高了统计效率,但也带来了解释挑战. 报告通常是不充分的,需要修订指南,以更好地明确单个组件与整体组合结果的结果.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 医学研究报告报告 医学研究报告
背景情况:
- 综合结果经常用于随机试验,以提高统计效率.
- 在解释复合结果的结果方面存在挑战.
- 本研究涉及主要医学期刊中复合结果的应用和报告.
研究的目的:
- 系统地审查高影响性临床试验中复合结果的发生率和报告质量.
- 评估支持和反对使用复合结果的论点.
- 为综合结果的应用和报告提供指导.
主要方法:
- 1997-2001年间在九个主要医学期刊上发表的随机试验的系统综述.
- 包括具有综合初级结局的试验,包括所有原因死亡率.
- 对167项涉及300276名患者的试验进行了分析.
主要成果:
- 38%的试验在复合结果和死亡率方面均中立.
- 36%的人表示复合的意义,但没有死亡率.
- 13%的试验报告不足,这表明结果可能适用于单个组件,而不是整体组合.
结论:
- 临床试验中综合结果的报告往往不充分.
- 当前的指导方针可能需要修订,以解决复合结果的共同使用和解释.
- 改善报告对于准确理解试验结果至关重要,特别是关于单个组件的结果.
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