Table 1 Definitions of non-PRO COA types

Observer-reported outcome measure (ObsRO)

A measurement based on a report of observable signs, events or behaviors related to a patient’s health condition by someone other than the 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 judgment or interpretation [7].

Clinician-reported outcome measure (ClinRO)

A measurement based on a report that comes from a trained health-care professional after observation of a patient’s health condition. Most ClinRO measures involve a clinical judgment or interpretation of the observable signs, behaviors, or other manifestations related to a disease or condition. ClinRO measures cannot directly assess symptoms that are known only to the patient [7].

Performance outcome measure (PerfO)

A measurement based on standardized task(s) performed by a patient that is administered and evaluated by an appropriately trained individual or is independently completed [7].