Patient-reported outcome measure (PROM)

Patient-reported outcome measures (PROMs) or instruments (more commonly used in the US) are psychometrically validated tools (e.g. questionnaires) used to collect patient-reported outcomes. In clinical trials, PROMs may be used to collect PRO data to enable a pharmaceutical company (“sponsor”) to support a claim in the product labelling (US) or summary of product characteristics (SmPC, Europe).