ABSTRACT

National Institute of Allergy and Infectious Diseases, National Cancer Insti-

tute, Bethesda, Maryland, USA

13.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346

13.2 Description of Interval-Censored Data and Assumptions for

Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346

13.2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 347

13.2.2 Basic Notation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348

13.2.3 Assessment of Simple Endpoints . . . . . . . . . . . . . . . . . . . . . . . . 349

13.2.4 Composite Endpoints and Interval Censoring . . . . . . . . . . . 351

13.2.5 Informative Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 352

13.3 Rank Tests for Interval-Censored Data . . . . . . . . . . . . . . . . . . . . . . . . . . 353

13.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353

13.3.2 Practical Proposal: Ignoring Unscheduled Assessments . 354

13.3.3 Likelihood for Grouped Continuous Model . . . . . . . . . . . . . 355

13.3.4 Permutation-Based Rank Tests . . . . . . . . . . . . . . . . . . . . . . . . . 357

13.3.5 Score Tests with a High-Dimensional Nuisance

Parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 359

346 Interval-Censored Time-to-Event Data: Methods and Applications

13.3.6 Multiple Imputation Approaches . . . . . . . . . . . . . . . . . . . . . . . . 360

13.3.7 Other Closely Related Methods . . . . . . . . . . . . . . . . . . . . . . . . . 361

13.4 Software: “Interval” R Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 362

13.4.1 Using the “Interval” R Package . . . . . . . . . . . . . . . . . . . . . . . . . . 362

13.4.2 Validation of the “Interval” Package . . . . . . . . . . . . . . . . . . . . . 365

13.5 Simulation with Regular Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 365

13.6 Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 370

Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 371

In this chapter we consider two-sample or k-sample rank tests for interval-

censored responses. As with right-censored responses, the most common type

of test is a logrank test or some weighted version of the logrank test such as

a generalization of the Wilcoxon rank sum test for censoring. We focus on

the tests available in the interval R package (Fay and Shaw, 2010) and the

tests proposed in Freidlin et al. (2007). We additionally show that the tests

of Zhao and Sun (2004) and Sun et al. (2005) calculated in the SAS macros

described in So et al. (2010) are closely related to tests available in the interval

R package. We focus on practical aspects of the analysis.