MiCOAS
Migraine Clinical Outcome Assessment System (MiCOAS)
As part of Patient Focused Drug Development efforts, the FDA’s Center for Drug Evaluation and Research initiated a pilot grant program to support the development of publicly available core set(s) of Clinical Outcome Assessments (COAs) and their related endpoints for specific diseases using patient input (Grant program: RFA-FD-19-006). In September 2019, the FDA awarded grants to three projects which focused on creating a set of endpoints with input from people living with certain diseases (and their parents in the case of infants and young children). Click here to read about all three projects: Funded projects.
One of the funded projects was the Migraine Clinical Outcome Assessment System (MiCOAS), led by RJ Wirth, PhD of VPG and Richard Lipton, MD at Albert Einstein College of Medicine and Montefiore Medical Center. The overarching purpose of this grant is to develop a publicly available core set of migraine endpoints and their related COAs for migraine, incorporating input from people living with migraine at each step of the way.
Publications
- Buse DC, Gerstein MT, Houts CR, McGinley JS, Uzumcu AA, McCarrier KP, Cooke A, Touba NM, Nishida TK, Wirth RJ, & Lipton RB. Impact of the COVID-19 pandemic on people living with migraine: Results of the MiCOAS qualitative study. Headache. 2022 Mar;62(3):284-293
- Gerstein MT, Wirth RJ, Uzumcu AA, Houts CR, McGinley JS, Buse DC, McCarrier KP, Cooke A, Touba NM, Nishida TK, Goadsby PJ, Dodick DW, & Lipton RB. Patient-reported experiences with migraine-related cognitive symptoms: Results of the MiCOAS qualitative study. Headache. 2023 Mar;63(3):441-454
- Houts CR, McGinley JS, Nishida TK, Buse DC, Wirth RJ, Dodick DW, Goadsby PJ, & Lipton RB. Systematic review of outcomes and endpoints in acute migraine clinical trials. Headache. 2021 Feb;61(2):263-275
- Mangrum R, Gerstein MT, Hall CJ, Buse DC, Houts CR, McGinley JS, McCarrier KP, Lipton RB & Wirth RJ. Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine. Headache. 2023 Jul-Aug;63(7):953-964
- Mangrum R, Bryant AL, Gerstein MT, McCarrier KP, Houts CR, McGinley JS, Buse DC, Lipton, RB & Wirth RJ. The impacts of migraine on functioning: Results from two qualitative studies of people living with migraine. 2024;64(2):156-171.
- McGinley JS, Houts CR, Nishida TK, Buse DC, Lipton RB, Goadsby PJ, Dodick DW, & Wirth RJ. Systematic review of outcomes and endpoints in preventive migraine clinical trials. Headache. 2021 Feb;61(2):253-262
- McGinley JS, Mangrum R, Gerstein MT, McCarrier KP, Houts CR, Buse DC, Bryant AL, Wirth RJ & Lipton RB. Symptoms across the phases of the migraine cycle from the patient’s perspective: Results of the MiCOAS qualitative study. Headache. 2024 (online, ahead of print).
Podium Presentations/Symposiums
- Buse DC. Direct From the Patient: The Lived Experience of Migraine During the Global Pandemic. Presented at the American Headache Society’s 63rd Annual Scientific Meeting, Virtual, 2021
- Gerstein MT. Acute and Preventive Treatment Priorities Among Persons Living with Migraine: Results of the MiCOAS Qualitative Study. Presented at the American Headache Society’s 63rd Annual Scientific Meeting, Virtual, 2021
- McGinley JS, Wirth RJ, Lipton RB, Buse DC, Mangrum R & Houts CR. Designing a longitudinal cohort study to support patient reported outcome development: A roadmap for the MiCOAS quantitative study. Presented at the American Headache Society’s 65th Annual Scientific Meeting, Austin, Texas, 2023
- Wirth RJ. What should be the primary endpoint? Presented at the American Headache Society’s 64th Annual Scientific Meeting, Aurora, Colorado, 2022
- Wirth RJ. Development of standard core sets of COAs and related endpoints: MiCOAS. Panelist at DIA 2022 Global Meeting, Chicago, IL, 2022
Poster Presentations
- Bryant AL, Mangrum R, Lipton RB & Wirth RJ. Comparisons of patient recruitment methods: Use of advocacy organizations and clinical sites in migraine studies. Poster presented at the American Headache Society’s 66th Annual Scientific Meeting, San Diego, California, 2024
- Buse DC, Gerstein MT, Wirth RJ, Uzumcu AA, McCarrier KP, Cooke A, Touba NM, Houts CR, McGinley JS & Lipton RB. Emotional/psychological symptoms reported in each phase of the migraine cycle: Results of the MiCOAS Qualitative Study. Poster presented at the American Headache Society’s 64th Annual Scientific Meeting, Aurora, Colorado, 2022
- Buse DC, Lipton RB, Gerstein MT, Houts CR, McGinley JS, Nishida TK, Uzumcu AA, McCarrier KP, Cooke A, Touba NM, & Wirth RJ. Emotional/psychological symptoms reported in each phase of the migraine cycle: Results of the MiCOAS Qualitative Study. Poster presented at the American Headache Society’s 64th Annual Scientific Meeting, Aurora, Colorado, 2022
- Gerstein MT, McGinley JS, Houts CR, Buse DC, Nishida TK, Wirth RJ, Uzumcu AA, McCarrier KP, Cooke A, Touba NM, & Lipton RB. Non-ICHD-3 migraine defining symptoms by phase of the migraine cycle: Results of the MiCOAS Qualitative Study. Poster presented at the American Headache Society’s 64th Annual Scientific Meeting, Aurora, Colorado, 2022
- Gerstein MT, Wirth RJ, Uzumcu AA, McCarrier KP, Cooke A, Touba NK, Buse DC, Houts CR, McGinley JS, & Lipton RB Assessment of cognitive interference in migraine: Results of the MiCOAS qualitative study. Poster presented at the American Headache Society’s 63rd Annual Scientific Meeting, Virtual, 2021
- Houts CR, Lipton RB & Wirth RJ. Does the impact of migraine on physical function mean the same thing for headache and non-headache days? Assessing differential item functioning in the MPFID. Poster presented at the American Headache Society’s 65th Annual Scientific Meeting, Austin, Texas, 2023
- Houts CR, McGinley JS, Nishida TK, Lipton RB & Wirth RJ. Overview of psychometrics to support the development and use of patient-reported outcome measures in migraine clinical trials. Poster presented at the American Headache Society’s 66th Annual Scientific Meeting, San Diego, California, 2024
- Lipton RB, Houts CR, McGinley JS, Gerstein MT, Buse DC, Uzumcu AA, McCarrier KP, Cooke A, Touba NM, Nishida TK, & Wirth RJ. ICHD-3 migraine defining symptoms by phase of the migraine cycle: Results of the MiCOAS Qualitative Study. Poster presented at the American Headache Society’s 64th Annual Scientific Meeting, Aurora, Colorado, 2022
- Mangrum R, Schantz K, Bryant AL, Lipton RB & Wirth RJ. Conceptual content influences patient perspectives on recall time frames and response options in migraine self-report measures. Poster presented at the American Headache Society’s 66th Annual Scientific Meeting, San Diego, California, 2024
- McGinley JS, Lipton RB, Mangrum R, Buse DC, Hall CJ, Gerstein MT, Houts CR, Nishida TK, McCarrier KP, & Wirth RJ. Exploring within-person differences in migraine-associated symptoms across phases of the migraine cycle: Results of the MiCOAS Qualitative Study. Poster presented at the American Academy of Neurology’s 75th Annual Meeting, Boston, Massachusetts, 2023
- McGinley JS, Mangrum R, Buse DC, Hall CJ, Gerstein MT, Houts CR, Nishida TK, McCarrier KP, Wirth RJ & Lipton RB. Characterizing inter- and intra-individual differences in migraine-related cognitive symptoms and impairment across the migraine cycle: An analysis of the MiCOAS Qualitative Project. Poster presented at the American Academy of Neurology’s 75th Annual Meeting, Boston, Massachusetts, 2023
- McGinley JS, Mangrum R, Houts CR, Lipton RB, Nishida TK, Buse, DC, Gerstein MT, McCarrier KP & Wirth RJ. Patterns of symptom occurrence across the phases of migraine: Findings from the MiCOAS project. Poster presented at the American Headache Society’s 66th Annual Scientific Meeting, San Diego, California, 2024
Workshops
- Hawkins, M, Gill, S, & Wirth, RJ. Arguing for Validity: Structured Evidence-Based Validation Practice to Advance PRO measurement. Pre-course presented at the International Society for Quality of Life Research’s 30th Annual Meeting, Calgary, Canada, 2023
- MiCOAS Team. Understanding Patient-Reported Outcome Measures (PROMs) for Headache Trials and Clinical Practice. Pre-course presented at the American Headache Society’s 64th Annual Scientific Meeting, Aurora, Colorado, 2022
FDA Public Meetings
- Lipton RC, & Wirth RJ. Migraine Clinical Outcomes Assessment System. Presented at FDA Public Meeting, Bethesda, Maryland, 2019
- Lipton RC, & Wirth RJ. Migraine Clinical Outcomes Assessment System. Presented at FDA Public Meeting (webcast), Bethesda, Maryland, 2020
- Wirth RJ. Advanced Discussion of Evidence-Based Rationale: MiCOAS Example. Presented at FDA Public Meeting (webcast), Bethesda, Maryland, 2022
Other
- Buse DC, Bryant L, & Mangrum R. Update on the MiCOAS Project & Thank You to CHAMP. Presented at The Coalition for Headache and Migraine Patients (CHAMP) Elevate Meeting, Virtual, 2023 (Invited).
- Buse DC, Bryant L, & Mangrum R. Update on the MiCOAS Project & Thank You to CHAMP. Presented at The Coalition for Headache and Migraine Patients (CHAMP) Retreat Migraine, Virtual, 2023 (Invited).
- Houts CR. Migraine Clinical Outcome Assessment Systems. Presented at The Coalition for Headache and Migraine Patients (CHAMP) Elevate Meeting, Virtual, 2025 (Invited).
- Lipton RB, Buse DC, Golden K, & Wirth RJ. MiCOAS Dissemination: Measuring What Matters. Presented at The Coalition for Headache and Migraine Patients (CHAMP) Retreat Migraine, Virtual, 2022 (Invited).
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