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Giuliana Cortese

Publications and source records attributed to Giuliana Cortese.

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The Ghosh-Lin and Fine-Gray models for a mix of administrative and random censoring

Recurrent events or competing risks regression models are often applied in the bio-medical setting and both can be considered as marginal models. In presence of right-censoring, such models need to be adjusted to give consistent estimators. When censoring is administrative, marginal regression models are particularly easy to estimate. However, when censoring is instead acting randomly, inverse probability of censoring weighting (IPCW) adjustments are typically considered to obtain parameter estimates. This technique relies on a censoring-weights adjustment via a correct censoring model, but for administrative censoring the adjustment is done correctly simply by modifying the risk-set. In practice for large central registries or some clinical trials, the administrative censoring time will be known for all subjects, but there will typically also be a proportion of subjects that are censored at random. In this work, we consider two frequently used regression approaches, the Ghosh-Lin model for recurrent events with terminal events and the Fine-Gray model for competing events. For these two settings, when both administrative and random censoring are present, we demonstrate how to obtain correct estimation by dealing with the combination of the two different types of censoring relying on a minimum of modeling assumptions.

stat.ME

Monte Carlo modified profile likelihood in models for clustered data

The main focus of the analysts who deal with clustered data is usually not on the clustering variables, and hence the group-specific parameters are treated as nuisance. If a fixed effects formulation is preferred and the total number of clusters is large relative to the single-group sizes, classical frequentist techniques relying on the profile likelihood are often misleading. The use of alternative tools, such as modifications to the profile likelihood or integrated likelihoods, for making accurate inference on a parameter of interest can be complicated by the presence of nonstandard modelling and/or sampling assumptions. We show here how to employ Monte Carlo simulation in order to approximate the modified profile likelihood in some of these unconventional frameworks. The proposed solution is widely applicable and is shown to retain the usual properties of the modified profile likelihood. The approach is examined in two instances particularly relevant in applications, i.e. missing-data models and survival models with unspecified censoring distribution. The effectiveness of the proposed solution is validated via simulation studies and two clinical trial applications.

stat.ME