Study design for non-recurring, time-to-event outcomes in the presence of error-prone diagnostic tests or self-reports.

ABSTRACT: Sequentially administered, laboratory-based diagnostic tests or self-reported questionnaires are often used to determine the occurrence of a silent event. In this paper, we consider issues relevant in design of studies aimed at estimating the association of one or more covariates with a non-recurring, time-to-event outcome that is observed using a repeatedly administered, error-prone diagnostic procedure. The problem is motivated by the Women's Health Initiative, in which diabetes incidence among the approximately 160,000 women is obtained from annually collected self-reported data. For settings of imperfect diagnostic tests or self-reports with known sensitivity and specificity, we evaluate the effects of various factors on resulting power and sample size calculations and compare the rela

SUBMITTER: Gu X 

PROVIDER: S-EPMC5012924 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature