On the analysis of tuberculosis studies with intermittent missing sputum data

Daniel Scharfstein, Andrea Rotnitzky, Maria Abraham, Aidan McDermott, Richard Chaisson, Lawrence Geiter

Research output: Contribution to journalArticlepeer-review

Abstract

In randomized studies evaluating treatments for tuberculosis (TB), individuals are scheduled to be routinely evaluated for the presence of TB using sputum cultures. One important endpoint in such studies is the time of culture conversion, the first visit at which a patient’s sputum culture is negative and remains negative. This article addresses how to draw inference about treatment effects when sputum cultures are intermittently missing on some patients. We discuss inference under a novel benchmark assumption and under a class of assumptions indexed by a treatment-specific sensitivity parameter that quantify departures from the benchmark assumption. We motivate and illustrate our approach using data from a randomized trial comparing the effectiveness of two treatments for adult TB patients in Brazil.

Original languageEnglish (US)
Pages (from-to)2215-2236
Number of pages22
JournalAnnals of Applied Statistics
Volume9
Issue number4
DOIs
StatePublished - Dec 2015

Keywords

  • Culture conversion
  • Curse of dimensionality
  • Exponential tilting
  • Reversetime hazard
  • Sensitivity analysis

ASJC Scopus subject areas

  • Statistics and Probability
  • Modeling and Simulation
  • Statistics, Probability and Uncertainty

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