Abstract

Some treatment strategies may negatively impact psychosocial functioning while striving for good clinical and physical outcomes. Patient-reported outcome measures (PROMs) are increasingly incorporated into the clinical development of new treatment to understand the patients' perspective of treatment effects in clinical trials. However, it is sometimes difficult for researchers and healthcare professionals to review PROM data, as meaningful interpretation requires a different mindset from looking at traditional clinical endpoint data. This article provides assistance for reading and interpreting PROM endpoints. It proposes that the reader firstly looks for evidence of no detriment with the experimental therapy, then for improvement, and where study design and prior analyses support it, a comparison of change in PROM scores between the experimental and control therapies. The article provides explanation and rationale for this hierarchy of PROM interpretation.

Keyword: Patient reported outcome measures, clinical trials, diabetes, treatment