Patient Reported Outcome Measures (PROMs) in Migraine and Headache

Abstract

Patient reported outcome measures (PROMs) are individual questions or validated multi-item instruments which gather data directly from people living with a disease reflecting some aspect of their disease experience. A range of PROMs are available for use in migraine and headache clinical care and/or clinical trials. Some of them meet regulatory guidance on the development and psychometric properties of PROMs for use in clinical trials and only a small number meet the FDA’s guidance of “Fit for Purpose” and have been included in the package inserts of approved treatments by the FDA and/or EMA. Herein we provide an overview and general framework for PROM development and evaluation. Generally, the PROM development process can be divided into five major phases: the Exploratory Phase, the Qualitative Phase, the Quantitative Observational Phase, the Randomized Trial Validation Phase, and the Implementation Phase. We also provide an overview of the uses and interpretation of PROMs in migraine clinical trials and opportunities for use in clinical care.