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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 timing of events is a common indicator of efficacy in clinical observation and is used to measure how quickly interventions work in one area. Compared with other indicators of curative effect evaluation, these indicators have differences in research design, original data entry, data verification and statistical analysis. There are two ways to obtain the time of the incident, which can be filled in directly by the investigator when the clinical observation is done or by the statistician after the clinical observation. Fill in the original data and data verification, pay attention to the incident occurred with the visit point and the associated indicators of the logical relationship. When conducting statistical analyzes, care should be taken in the treatment of cases in which no event was observed. Understanding these differences can make the objective and truthful presentation of the effects and effects of interventions objectively and objectively in order to make the clinical observations scientifically, objectively and reliably.