Observer-reported outcomes (ObsRO) is a clinical outcome assessment based on a report of observable signs, events, or behaviors related to a patient’s health condition by someone other than that patient or a health professional. Generally, ObsROs are reported by a parent, caregiver, or someone who observes the patient in daily life and are particularly useful for patients who cannot report for themselves (e.g., infants or individuals who are cognitively impaired). An ObsRO measure does not include medical judgement or interpretation. Examples of ObsROs include a parent report of a child’s vomiting episodes or a report of wincing thought to be the result of pain in patients who are unable to report for themselves.
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary
NCATS Toolkit for Patient-Focused Therapy Development: Clinical Outcome Assessments
U.S. Food and Drug Administration (FDA): Clinical Outcome Assessment (COA) – Frequently Asked Questions