Article

The increasing use of real-world evidence (RWE) in regulatory, reimbursement, and clinical decision making has highlighted the need for high quality patient reported outcomes (PROs) collected outside traditional trial environments. Although PROs are well established in controlled clinical trials, their application in prospective real-world studies introduces methodological and operational challenges not fully addressed in existing guidance. As a result, stakeholders face uncertainty about how to generate real world PRO (RW-PRO) data that are both feasible to collect in routine care and sufficiently robust for decision use. 

This Task Force reviewed emerging methodological considerations relevant to the prospective collection of PROs in real world settings and examined how RW-PROs can complement clinical outcomes to capture patients lived experience and treatment effectiveness in everyday practice. The Task Force identified 9 interrelated methodological considerations when planning or implementing RW-PRO studies: defining clear study objectives; engaging patients as partners; ensuring representativeness; selecting fit for purpose instruments; supporting data quality; implementing feasible assessment strategies; applying rigorous analytical approaches; using technology responsibly; and engaging early with regulatory and HTA bodies.