Home 9 Glossary Item 9 Observer reported outcome (ObsRO)

Observer reported outcome (ObsRO)

A type of clinical outcome assessment. A measurement based on a report of observable signs, events or behaviours 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). AnObsRO measure does not include medical judgment or interpretation. ObsRO measures include:

Rating scales, such as:

  • Acute Otitis Media Severity of Symptoms scale (AOM-SOS), a measure used to assess signs and behaviors related to acute otitis media in infant
  • Face, Legs, Activity, Cry, Consolability scale (FLACC), a measure used to assess signs and behaviors related to pain

Counts of events (e.g., observer-completed log of seizure episodes)

FDA-NIH Biomarker Working Group. Silver Spring (MD): Food and Drug Administration (US); Bethesda (MD): National Institutes of Health (US); 2016

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