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Patient-reported outcome (PRO)

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. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims)