Comparing competing risk outcomes within principal strata, with application to studies of mother-to-child transmission of HIV

Details

• Alternative Title:
  Stat Med
• Personal Author:
  Long, Dustin M. ; Hudgens, Michael G.
• Description:
  In randomized trials to prevent breast milk transmission of human immunodeficiency virus (HIV) from mother to infant, investigators are often interested in assessing the effect of a treatment or intervention on the cumulative risk of HIV infection by time (age) t in infants who are alive and uninfected at a certain time point τ(0)  < t. Such comparisons are challenging for two reasons. First, infants are typically randomized at birth (time 0 < τ(0) ) such that comparisons between trial arms among the subset of infants alive and uninfected at τ(0) are subject to selection bias. Second, in most mother-to-child transmission (MTCT) trials competing risks are often present, such as death or cessation of breastfeeding prior to HIV infection. In this paper, we present methods for assessing the causal effect of a treatment on competing risk outcomes within principal strata. In MTCT trials, the causal effect of interest is that of treatment on the risk of HIV infection by time t > τ(0) within the principal stratum of infants who would be alive and uninfected by τ(0) regardless of randomization assignment. We develop large sample nonparametric bounds and a semiparametric sensitivity analysis model for drawing inference about this causal effect. We present a simulation study demonstrating that the proposed methods perform well in finite samples. We apply the proposed methods to a large, recent MTCT trial.
• Subjects:
  Breast Feeding Computer Simulation Data Interpretation, Statistical Female HIV-1 HIV Infections Humans Infant Infant, Newborn Infectious Disease Transmission, Vertical Mothers

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• Keywords:
  Causal Inference Infectious Diseases Principal Stratification Sensitivity Analysis
• Source:
  Stat Med. 2012; 31(27):3406-3418
• Pubmed ID:
  22927321
• Pubmed Central ID:
  PMC3494821
• Document Type:
  Journal Article
• Funding:
  U48 DP001944/DP/NCCDPHP CDC HHSUnited States/ ; U48DP001944/ACL/ACL HHSUnited States/ ; R01 AI085073/AI/NIAID NIH HHSUnited States/ ; R01-AI085073/AI/NIAID NIH HHSUnited States/ ; P30 AI050410/AI/NIAID NIH HHSUnited States/
• Volume:
  31
• Issue:
  27
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:22570572ec28ed250ce5d70a21b64776bcf46c1ea767c85fcef7a650e99304f0
• Download URL:
  https://stacks.cdc.gov/view/cdc/41870/cdc_41870_DS1.pdf
• File Type:
  [PDF - 792.06 KB ]