Edwards Jessie K, Cole Stephen R, Westreich Daniel, Moore Richard, Mathews Christopher, Geng Elvin, Eron Joseph J, Mugavero Michael J
Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
School of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America.
PLoS One. 2014 Jul 10;9(7):e102305. doi: 10.1371/journal.pone.0102305. eCollection 2014.
Missing outcome data due to loss to follow-up occurs frequently in clinical cohort studies of HIV-infected patients. Censoring patients when they become lost can produce inaccurate results if the risk of the outcome among the censored patients differs from the risk of the outcome among patients remaining under observation. We examine whether patients who are considered lost to follow up are at increased risk of mortality compared to those who remain under observation. Patients from the US Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) who newly initiated combination antiretroviral therapy between January 1, 1998 and December 31, 2009 and survived for at least one year were included in the study. Mortality information was available for all participants regardless of continued observation in the CNICS. We compare mortality between patients retained in the cohort and those lost-to-clinic, as commonly defined by a 12-month gap in care. Patients who were considered lost-to-clinic had modestly elevated mortality compared to patients who remained under observation after 5 years (risk ratio (RR): 1.2; 95% CI: 0.9, 1.5). Results were similar after redefining loss-to-clinic as 6 months (RR: 1.0; 95% CI: 0.8, 1.3) or 18 months (RR: 1.2; 95% CI: 0.8, 1.6) without a documented clinic visit. The small increase in mortality associated with becoming lost to clinic suggests that these patients were not lost to care, rather they likely transitioned to care at a facility outside the study. The modestly higher mortality among patients who were lost-to-clinic implies that when we necessarily censor these patients in studies of time-varying exposures, we are likely to incur at most a modest selection bias.
在HIV感染患者的临床队列研究中,因失访导致结局数据缺失的情况屡见不鲜。如果被截尾患者的结局风险与仍在观察中的患者的结局风险不同,那么在患者失访时将其截尾会产生不准确的结果。我们研究了被视为失访的患者与仍在观察中的患者相比,死亡风险是否增加。研究纳入了美国综合临床系统艾滋病研究网络(CNICS)中在1998年1月1日至2009年12月31日期间新开始联合抗逆转录病毒治疗且存活至少一年的患者。无论是否在CNICS中持续观察,所有参与者的死亡信息均可用。我们比较了队列中保留的患者与通常定义为护理间隔12个月的失访患者之间的死亡率。与仍在观察中的患者相比,被视为失访的患者在5年后的死亡率略有升高(风险比(RR):1.2;95%置信区间:0.9,1.5)。在将失访重新定义为6个月(RR:1.0;95%置信区间:0.8,1.3)或18个月(RR:1.2;95%置信区间:0.8,1.6)且无记录就诊的情况下,结果相似。与失访相关的死亡率小幅上升表明,这些患者并非失去了护理,而是可能转到了研究之外的机构接受护理。失访患者中略高的死亡率意味着,在我们对随时间变化的暴露进行研究时必然对这些患者进行截尾时,我们可能最多只会产生适度的选择偏倚。