Abstract
BackgroundEvaluation 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.Methods and FindingsTreatment-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.ConclusionsNaïve 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.
Highlights
Loss to follow-up (LTFU) is an important problem both for the care of individual patients and the evaluation of antiretroviral treatment (ART) programmes in low- and middle-income countries
Naıve 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
Summary
Loss to follow-up (LTFU) is an important problem both for the care of individual patients and the evaluation of antiretroviral treatment (ART) programmes in low- and middle-income countries. LTFU is a problem for estimating outcomes at the level of the ART programme: a meta-analysis of studies that traced patients lost to follow-up to ascertain their vital status showed that in subSaharan Africa 46% of those traced had died [5]. These deaths generally occurred within the first months of ART, and death rates in the first year of ART are considerably higher in patients lost to follow-up than the 7% to 13% commonly reported for ART programmes in lower-income countries [2,6,7,8]. We adjusted programme-level mortality in the first year of antiretroviral treatment (ART) for excess mortality in patients lost to follow-up
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