Patient Reported Outcome

Patient Reported Outcome

USA: FDA’s Framework for Real-World Evidence Program – A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of the patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview, provided that the interviewer records only the patient’s response (as per Framework for FDA’s Real-World Evidence Program – Glossary)