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.
