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[edit | edit source]
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[edit | edit source]
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[edit | edit source]
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[edit | edit source]
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[edit | edit source]
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[edit | edit source]
Patient reported outcome Resources | ||
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