临床观察中事件发生时间类疗效评价指标相关问题的探讨

Correlative issues summary about time-to-event evaluation index in clinical observation

事件发生时间是临床观察中常见的疗效评价指标,用来衡量干预措施在某方面发挥作用的快慢。这类指标与其他疗效评价指标相比,在研究设计、原始资料填写、数据核查和统计分析方面,都有着不同之处。事件发生时间的获得方式有2种,可以由研究者进行临床观察时直接填写,也可以由统计人员在临床观察结束后通过计算得到。填写原始资料和数据核查时,要注意事件发生时间与访视点以及相关联指标的逻辑关系。进行统计分析时,应注意对未观察到事件发生时间的病例的处理。认清这些不同之处,才能使事件发生时间客观、真实地体现干预措施的作用和效果,才能使临床观察结果科学、客观、可靠。

The time-to-event index is a kind of common evaluation index. It measures the speed of intervention effect. It is different from other index in research design, source material filling, data checking and statistical analysis. To obtain the time-to-event index, investigators can fill in the table directly and statistical analyst can compute after clinical observation. When filling in the source material or data checking, it is should be noticed that the logical relation between the time-to-event index and the visiting point and between the time-to-event index and the correlative other indicator. When statistical analyzing, it is an important issue how to deal with the cases whose time-to-event index does not appear till the observation period ends. Understanding the difference clearly can make the time-to-event index evaluate the effect of the intervention truly and make the clinical observation results reliable.