Abstract

In biomedical and public health studies, interval-censored data arise when the failure time of interest is not exactly observed and instead only known to lie within an interval. Furthermore, the failure time and censoring time may be dependent. There may also exist a cured subgroup, meaning that a proportion of study subjects are not susceptible to the failure event of interest. Many authors have investigated inference procedure for interval-censored data. However, most existing methods either assume no cured subgroup or apply only to limited situations such that the failure time and the observation time have to be independent. To take both cured subgroups and informative censoring into consideration for regression analysis of interval-censored data, we employ a mixture cure model and propose a sieve maximum likelihood estimation approach using Bernstein Polynomials. A novel expectation-maximization algorithm with the use of subject-specific independent log-normal latent variable is developed to obtain the numerical solutions of the model. The robustness and finite-sample performance of the proposed method in terms of estimation accuracy and predictive power is evaluated by an extensive simulation study which suggest that the proposed method works well for practical situations. In addition, we provide an illustrative example using NASA’s hypobaric decompression sickness database (HDSD).

Highlights

  • This paper discusses regression analysis of intervalcensored data when there exists the informative censoring issue and a cured subpopulation

  • We considered the analysis of informatively interval-censored data when there is a cured subpopulation

  • In order to deal with informative interval-censoring and cured subpopulation at the same time, we used a log-normal frailty variable to account for the independence between censoring time and failure time

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Summary

Introduction

This paper discusses regression analysis of intervalcensored data when there exists the informative censoring issue and a cured subpopulation. Interval-censored data occur naturally and frequently in randomized clinical trials, where the exact time of event occurrence is unknown but the event time is only known to lie within an interval. It is usually assumed that every subject is susceptible to the failure event. There may exist a subpopulation which is cured or immune to the failure event. Several type of cure models are proposed to deal with this scenario [1,2,3,4]. [3], [5,6] studied the cure rate model for the analysis of interval-censored failure time data

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