What are they?
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.1 ePROs are simply PROs collected via electronic platforms as opposed to paper-based forms.
Typically, PROs are used to assess symptoms, side effects of treatment, and health-related quality-of-life (HRQoL) measures—like pain, nausea, fatigue, physical function, mobility, depression, and anxiety. Depending on the clinical context, a PRO can be a primary or secondary outcome metric. For example, PROs describing a patient’s physical functioning are a primary outcome for orthopedic surgery, but could be a secondary outcome in cancer care, where the primary outcome is tumor shrinkage, but physical functioning is still relevant.
Stakeholders frequently use the terms patient-reported outcomes, patient-centered outcomes, and patient-generated data interchangeably. While there is some overlap, the terms are distinct.
Key terms related to PROs
1. FDA’s and NQF’s definition of patient-reported outcomes, which is widely adopted as the industry-standard definition.