论文标题
复合端点的决策工具和样本量计算器
Decision tool and Sample Size Calculator for Composite Endpoints
论文作者
论文摘要
摘要点： - 本文考虑了两个二进制或两个事件终点的组合，以形成领导试验的主要综合终点。 - 它讨论了选择复合端点上的相对效率，从以下方面的一个组件之一来讨论：观察每个组件的频率；测试疗法的相对治疗效果；以及两个组件之间的关联。 - 我们强调了组件之间关联在选择主要用作主要端点方面的关联的非常重要的作用。 - 对于更好的未来试验，我们建议试验人员始终报告复合端点的组成部分之间的关联。 - 使用复合端点时要注意的常见谬误：i）复合终点总是意味着更高的功率； ii）对复合终点的治疗效果类似于其成分的平均影响； iii）观察主要终点的概率显着增加。
Summary points: - This article considers the combination of two binary or two time-to-event endpoints to form the primary composite endpoint for leading a trial. - It discusses the relative efficiency of choosing a composite endpoint over one of its components in terms of: the frequencies of observing each component; the relative treatment effect of the tested therapy; and the association between both components. - We highlight the very important role of the association between components in choosing the most efficient endpoint to use as primary. - For better grounded future trials, we recommend trialists to always reporting the association between components of the composite endpoint. - Common fallacies to note when using composite endpoints: i) composite endpoints always imply higher power; ii) treatment effect on the composite endpoint is similar to the average effects of its components; and iii) the probability of observing the primary endpoint increases significantly.
