Patient-Drivent Outcome Selection (PDOS): a patient-focused approach for selecting outcomes using patient-generated data

Patient-Reported Outcomes (PROs) are increasingly used to support the development and the
evaluation of health products and services. Due to the wide variety of instruments available,
identifying the most suitable Patient-Reported Outcome Measures (PROMs) to use in a specific
context might be complex. There is no consensus on a standardized method to choose PROs
considering the scientific context and the regulatory recommendations. This research aimed at
developing a patient-centric, structured, replicable and generalizable method for PROs selection
and development using patient-generated data.