Patient-Reported Outcome Measures (PROMs)

Patient-Reported Outcome Measures (PROMs), also known as patient-reported outcome instruments (more commonly in the US), are psychometrically validated tools, such as questionnaires, used to collect patient-reported outcomes (PROs). These tools are essential for gathering data directly from patients about their health status, quality of life, and the impact of diseases and treatments from their perspective.

Key aspects of PROMs include:

– Validated Tools: PROMs are rigorously tested to ensure they accurately and reliably capture patient-reported data.

– Clinical Trials: In clinical trials, PROMs are used to collect PRO data, which can help pharmaceutical companies (sponsors) support claims in product labeling (in the US) or in the summary of product characteristics (SmPC) in Europe.

– Patient-Centered Data: PROMs provide valuable insights into how patients perceive their health and the effectiveness of treatments, offering a patient-centered perspective that complements clinical and objective measures.

PROMs are crucial for demonstrating the real-world impact of medical interventions on patients’ lives, supporting regulatory approvals, and informing healthcare decisions that prioritize patient well-being.