1. Basic information on PROMs
Definition of PROs
As PROs have become increasingly important to evaluate medical interventions and products as well as the quality of therapy and care, national and international organisations have defined them.
Pros of the Food and Drug Administration
Food and Drug Administration (FDA) PROs are measures of a patient’s health status as reported directly from the patient without added interpretation by a healthcare worker or anyone else.
Pros of European Medicines Agency (EMA)
A PRO includes any outcome evaluated directly by the patient himself and based on patients’ perception of a disease and its treatment(s).
PROs are
…measures of a patient’s health status as reported directly from the patient without added interpretation by a healthcare worker or anyone else.
European Medicines Agency (EMA):
EMA, 2014; FDA, 2022; eunethta, 2023; European Commission, 2021