Back to top


A patient-reported outcome (PRO) is a status report of a patient’s health condition, or health behavior that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. This definition reflects the key domains of

  • health-related quality of life (including functional status)
  • symptoms and symptom burden (e.g., pain, fatigue)
  • health behaviors (e.g., smoking, diet, exercise)

(Adapted from the Food and Drug Administration. (2009). Guidance for industry PRO measures: Use in medical product development to support labeling claims.

Last Updated: Jun 16, 2022