Patient reported outcome

Patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to outcomes reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PROs are collected through self-report questionnaires.

Definition

A Patient-reported outcome (PRO) is any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. It can be measured in absolute terms (e.g., severity of a symptom, sign, or state of a disease) or as a change from a previous measure.

Importance

PROs are important in clinical trials and other healthcare settings because they provide a direct report from the patient about how they feel and function in relation to a health condition and its therapy.

Types

There are many types of PROs, including health-related quality of life (HRQoL), symptom and symptom burden, physical function, and treatment satisfaction.

Use in Clinical Trials

In clinical trials, PROs are often used as primary endpoints or secondary endpoints. They can provide valuable information about the impact of a treatment on the patient's daily life, function, and feelings.

Regulatory Use

Regulatory agencies such as the FDA and the EMA have issued guidance on the use of PROs in drug development and post-marketing studies.

See Also

• Clinical trial
• Healthcare
• Food and Drug Administration
• European Medicines Agency

Patient reported outcome Resources
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