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PROs are defined by the Food and Drug Administration (FDA) Guidance for Industry PRO Measures: Use in Medical Product Development to Support Labeling Claims as “any report of the status of a patient’s health condition, health behavior, or experience with healthcare 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)
  • Experience with care
  • Health behaviors (e.g., smoking, diet, exercise)

Patient-Reported Outcome
Patient-Reported Outcomes
Last Updated: Jan 18, 2021