underestimation of resource use costs. ConClusions: The study findings indicate that manufacturers should consider providing data supporting OS benefit versus relevant comparators. Also, a robust economic model including sensitivity analysis to adjust for uncertainties, and incorporating appropriate cost and utility values could be beneficial to gain access in CEA markets.objeCtives: Patient-reported outcomes (PROs) are designed to measure the unique patient perspective on an aspect(s) of a disease or the impact of treatment. After the development and validation of a PRO measure, often the next step is to understand how the PRO scores and changes are related to the clinical endpoints in order to better inform and interpret the newly developed PRO for clinician use or to provide greater insights into disease burden or treatment efficacy. Our objective is to review commonly used statistical Methods when assessing the association of PRO and clinical endpoints and to introduce alternate statistical applications. Methods: A review of the literature revealed several statistical Methods used to define and quantify the association between PROs and clinical endpoints including correlation analysis, responder/categorical analysis, linear and logistic regression and receiveroperating curves. However, these methodologies typically examine the relationship at a single time-point, ignoring the longitudinal nature of the study design. Our research will use simulated longitudinal data to examine the association between PROs and clinical endpoints across multiple time-points and introduce alternate applications using mixed-models for repeated measures. We will provide a series of examples based on the simulated data to show how each method uniquely demonstrates the relationship between these endpoints. ConClusion: To help stakeholders understand the relevance of PROs, it is often an important step to assess the association of a PRO to existing clinical endpoints. Our research introduces alternate approaches to examine this association across multiple time-points which account for the longitudinal design found in most trials.
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