Division of International and Environmental Health, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
PLoS One. 2010 Nov 30;5(11):e14149. doi: 10.1371/journal.pone.0014149.
Evaluation of antiretroviral treatment (ART) programmes in sub-Saharan Africa is difficult because many patients are lost to follow-up. Outcomes in these patients are generally unknown but studies tracing patients have shown mortality to be high. We adjusted programme-level mortality in the first year of antiretroviral treatment (ART) for excess mortality in patients lost to follow-up.
Treatment-naïve patients starting combination ART in five programmes in Côte d'Ivoire, Kenya, Malawi and South Africa were eligible. Patients whose last visit was at least nine months before the closure of the database were considered lost to follow-up. We filled missing survival times in these patients by multiple imputation, using estimates of mortality from studies that traced patients lost to follow-up. Data were analyzed using Weibull models, adjusting for age, sex, ART regimen, CD4 cell count, clinical stage and treatment programme. A total of 15,915 HIV-infected patients (median CD4 cell count 110 cells/µL, median age 35 years, 68% female) were included; 1,001 (6.3%) were known to have died and 1,285 (14.3%) were lost to follow-up in the first year of ART. Crude estimates of mortality at one year ranged from 5.7% (95% CI 4.9-6.5%) to 10.9% (9.6-12.4%) across the five programmes. Estimated mortality hazard ratios comparing patients lost to follow-up with those remaining in care ranged from 6 to 23. Adjusted estimates based on these hazard ratios ranged from 10.2% (8.9-11.6%) to 16.9% (15.0-19.1%), with relative increases in mortality ranging from 27% to 73% across programmes.
Naïve survival analysis ignoring excess mortality in patients lost to follow-up may greatly underestimate overall mortality, and bias ART programme evaluations. Adjusted mortality estimates can be obtained based on excess mortality rates in patients lost to follow-up.
评估撒哈拉以南非洲的抗逆转录病毒治疗（ART）项目非常困难，因为许多患者失去了随访。这些患者的结局通常是未知的，但追踪患者的研究表明死亡率很高。我们针对随访失访患者的超额死亡率调整了第一年抗逆转录病毒治疗（ART）的项目死亡率。
在科特迪瓦、肯尼亚、马拉维和南非的五个项目中，符合条件的是开始联合 ART 的初治患者。最后一次就诊至少在数据库关闭前九个月的患者被认为是失访。我们使用追踪失访患者的研究中死亡率的估计值，通过多次插补来填补这些患者的缺失生存时间。使用 Weibull 模型进行数据分析，同时调整年龄、性别、ART 方案、CD4 细胞计数、临床分期和治疗方案。共纳入 15915 名 HIV 感染患者（中位 CD4 细胞计数为 110 个/µL，中位年龄 35 岁，68%为女性）；1001 名（6.3%）患者已知死亡，1285 名（14.3%）在 ART 治疗的第一年失访。五个项目中，一年时的死亡率估计值范围为 5.7%（95%CI 4.9-6.5%）至 10.9%（9.6-12.4%）。与留在治疗中的患者相比，随访失访患者的死亡率风险比范围为 6 至 23。基于这些风险比的调整估计值范围为 10.2%（8.9-11.6%）至 16.9%（15.0-19.1%），死亡率的相对增加范围为 27%至 73%，在不同项目之间。
忽略随访失访患者超额死亡率的初治生存分析可能会大大低估总体死亡率，并对 ART 项目评估产生偏差。可以根据随访失访患者的超额死亡率获得调整后的死亡率估计值。
