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Recorded
Recorded

Next Generation Patient Reported Outcome Measures (PROMs) for Migraine Trials: The MiCOAS Program

Saturday, June 21, 2025
8:00am - 8:20am CST
Location: Ballroom B

    Faculty(s)

  • RL

    Richard B. Lipton, MD

    Professor
    The Saul R. Korey Department of Neurology, Department of Psychiatry and Behavioral Science, and Department of Epidemiology and Population Health, Montefiore Headache Centre, Albert Einstein College of Medicine, New York, NY, USA
    Bronx, New York, United States

The MiCOAS Program is an FDA-funded initiative designed to develop novel Patient Reported Outcome Measures for use in migraine clinical trials. After several rounds of qualitative research, we concluded that the most important domains ot measure include: 1. Migraine symptoms; 2. Cognition, 3. Physical function; 4 Social function. I will describe the development of our measures of each of these domains, the challenges we faced, and the solutions we find. I will describe the psychometric validation of these measures using the cognitive domain as an example and close with thoughts about how to use these measures, not just in clinical trials, but also in clinical practice.

Learning Objectives:

  • Understand the FDA approach to developing patient reported outcome measures suitable for inclusion in migraine trials.
  • Discuss the domains measured by MiCOAS for clinical trials.
  • Be able to consider MiCOAS measures that may be useful in clinical practice.