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Clinical outcome assessment (COA)

What is a clinical outcome assessment (COA)?

A COA describes how a person functions, feels, or survives. It may be reported by a patient, healthcare provider, a non-clinical observer (e.g., a parent or caregiver), or through the performance of a task or activity.  

There are four types of COAs, and while each focus on the patient, they describe the different perspectives on the patient’s health status: 

  • Clinician-reported outcomes (ClinROs): reports from a trained healthcare professional that include their interpretation of observable behavior and signs. 
  • Patient-reported outcomes (PROs): information on the patient’s health condition as reported by the patient, without outside interpretation from others. These are often assessed using numeric rating scales, questionnaires, or diaries.
  • Observer-reported outcomes (ObsROs): reports from those who observe the patient in daily life (e.g., parent, caregiver) on observable events, signs, or behaviors. 
  • Performance outcomes (PerfOs): measurements collected when the patient is asked to complete a standardized task.

How are COAs used to advance healthcare?

COAs can aid the risk-benefit assessment of medical devices and pharmaceuticals since they can report any improvements in the patient’s health or the development of side effects after using a medical device or taking a medication. Additionally, COAs can be used to determine who is eligible for a clinical study, how well a medical device treats or diagnoses a condition, or how safe a device is.