临床结局观察性研究中的领先时间偏倚及控制

摘要

Lead time bias might exist in observational study for clinical outcomes.This paper summarizes the concept of lead time bias,causes and control of lead time bias by using the studies of influences of screening diagnostic test on cancer patients' survival and highly active antiretroviral therapy on HIV/AIDS patients' survival as examples for the purpose of providing thinking and methods in the control of lead time bias for the accurate evaluation of the effects of interventions,such as test and treatment,on the diseases with multi courses or phases.%临床结局观察性研究中可能存在领先时间偏倚.本文以筛检诊断试验对肿瘤患者生存时间的影响研究、高效抗反转录病毒治疗对HIV/AIDS生存时间的影响研究,两个实例阐述领先时间偏倚的概念、产生原因及控制,为准确分析评价检测、治疗等干预措施对存在多个疾病病程或分期疾病的作用效果时提供控制该偏倚的思路和方法.