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Patient-reported outcomes (PROs) are defined as any report of the status 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 (FDA) Guidance for Industry PRO Measures: Use in Medical Product Development to Support Labeling Claims

Patient-Reported Outcome
Patient-Reported Outcomes
Last Updated: Apr 01, 2021