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).