Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests
Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests
复制标题
DOI：
10.1111/j.0006-341x.2000.00779.x
复制
发表时间：
2000-09-01
期刊：
影响因子：
1.9
通讯作者：
Finkelstein, DM
中科院分区：
文献类型：
--
作者：
Robins, JM;Finkelstein, DM
艾滋病临床试验小组(ACTG)进行了021项随机试验，比较了巴曲姆和喷雾剂喷雾剂(AP)预防艾滋病患者肺炎(PCP)的效果。尽管被随机分配到BACTRIM组的患者接受PCP的时间显著延迟，但两组患者的生存体验没有显著差异(p=.32)。在这篇文章中，我们提出了Bactrim疗法提高存活率的证据，但标准的意向治疗比较未能发现这种生存优势，因为很大一部分受试者要么改用其他疗法，要么完全停止治疗。我们通过人为地将受试者视为在受试者第一次停止或切换治疗时被依赖审查，从而获得了有益的Bactrim对生存影响的证据；然后，我们分析了数据，并使用通过利用收集的关于时间相关预后因素的数据来调整依赖审查的Robins加权Kaplan-Meier和Cox偏似然估计量的反向概率(1993，生物制药学会学报，美国统计协会，第24-33页)。
AIDS Clinical Trial Group (ACTG) randomized trial 021 compared the effect of bactrim versus aerosolized pentamidine (AP) as prophylaxis therapy for pneumocystis pneumonia (PCP) in AIDS patients. Although patients randomized to the bactrim arm experienced a significant delay in time to PCP, the survival experience in the two arms was not significantly different (p =.32). In this paper, we present evidence that bactrim therapy improves survival but that the standard intent-to-treat comparison failed to detect this survival advantage because a large fraction of the subjects either crossed over to the other therapy or stopped therapy altogether. We obtain our evidence of a beneficial bactrim effect on survival by artificially regarding the subjects as dependently censored at the first time the subject either stops or switches therapy; we then analyze the data with the inverse probability of censoring weighted Kaplan-Meier and Cox partial likelihood estimators of Robins (1993, Proceedings of the Biopharmaceutical Section, American Statistical Association, pp. 24-33) that adjust for dependent censoring by utilizing data collected on time-dependent prognostic factors.