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. 2023 Jul-Aug;63(7):953-964.
doi: 10.1111/head.14521. Epub 2023 May 4.

Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine

Rikki Mangrum  1 , Maya T Gerstein  2 , Calvin J Hall 3rd  1 , Dawn C Buse  1   3 , Carrie R Houts  1 , James S McGinley  1 , Kelly P McCarrier  2 , Richard B Lipton  3 , R J Wirth  1
Affiliations

Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine

Rikki Mangrum et al. Headache. 2023 Jul-Aug.

Abstract

Background: There is renewed emphasis on including patients in determining, defining, and prioritizing outcomes for migraine treatment.

Objectives: To obtain insights directly from people living with migraine on their priorities for treatment.

Methods: A total of 40 qualitative interviews were conducted as part of the Migraine Clinical Outcome Assessment System project, a United States Food and Drug Administration grant-funded program to develop a core set of patient-centered outcome measures for migraine clinical trials. Interviews included a structured exercise in which participants rank-ordered pre-defined lists of potential benefits for acute and preventive migraine therapy. The 40 study participants who reported being diagnosed with migraine by a clinician ranked the benefits and explained their rationale.

Results: Study participants consistently ranked either pain relief or absence of pain as their top priority for acute treatment. Relief/absence of other migraine symptoms and improved functioning were also prioritized. For preventive treatment, participants prioritized reductions in migraine frequency, symptom severity, and attack duration. Few differences were found between participants with episodic migraine and those with chronic migraine. However, participants with chronic migraine ranked "increased predictability of attacks" much higher than those with episodic migraine. Participants' rankings were influenced by prior expectations and experiences of migraine treatments, which caused many participants to deprioritize desired benefits as unrealistic. Participants also identified several additional priorities, including limited side-effects and reliable treatment efficacy in both acute and preventive treatments.

Conclusion: The results showed the participants prioritized treatment benefits aligned with existing core clinical outcomes used in migraine research, but also valued benefits that are not typically assessed, such as predictability. Participants also deprioritized important benefits when they believed treatment was unlikely to deliver those outcomes.

Keywords: migraine therapy; patient reported outcomes; qualitative research; quality of life.

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Conflict of interest statement

Conflict of interest statement: Rikki Mangrum is a full-time employee of Vector Psychometric Group, LLC, which in turn received funds from the FDA to conduct the research detailed in the manuscript. Maya T. Gerstein was a full-time employee of Pharmerit/OPEN Health, which in turn received funds from Vector Psychometric Group LLC and the FDA to conduct the research detailed in the manuscript. Calvin J. Hall, III, is a full-time employee of Vector Psychometric Group, LLC, which in turn received funds from the FDA to conduct the research detailed in the manuscript. Dawn C. Buse is a part-time employee of Vector Psychometric Group LLC, which in turn received funds from the FDA to conduct the research detailed in the manuscript. In addition, she receives research funding from the National Headache Foundation and Amgen. She has been a consultant to Allergan/Abbvie, Amgen, Lilly, Lundbeck, and Teva Pharmaceuticals. Carrie R. Houts is a full-time employee of Vector Psychometric Group LLC, which in turn received funds from the FDA to conduct the research detailed in the manuscript. James S. McGinley is a full-time employee of Vector Psychometric Group LLC, which in turn received funds from the FDA to conduct the research detailed in the manuscript. James S. McGinley has received honoraria/payment/reimbursement from the journal Cephalalgia (biostatistics editor). James S. McGinley has also received research grants/support from Amgen, Inc. and the National Headache Foundation. Kelly P. McCarrier is a full-time employee of Pharmerit/OPEN Health, which in turn received funds from Vector Psychometric Group LLC and the FDA to conduct the research detailed in the manuscript. Richard B. Lipton received research support from the FDA on the MiCOAS project. In addition, he receives research funding from the NIH, the National Headache Foundation, and the Marx Foundation. He also receives research support from Allergan/Abbvie, Amgen, Biohaven, Eli Lilly, and Electrocore. He receives personal fees as a consultant or advisor from Allergan/Abbvie, Amgen, Biohaven Holdings, Dr. Reddy’s, GSK, Grifols, Eli Lilly, Lundbeck, Merck, Novartis, and Teva Pharmaceuticals. He holds stock or options in Biohaven Holdings and CtrlM Health. In addition, he receives royalties for Wolff’s Headache, 7th and 8th editions. R. J. Wirth is a full-time employee of Vector Psychometric Group LLC, which in turn received funds from the FDA to conduct the research detailed in the manuscript.

Figures

Figure 1.
Figure 1.
Benefits of acute and preventive treatments provided to interview participants for ranking exercise
FIGURE 2.
FIGURE 2.
Average (mean) priority rankings for acute treatment benefits reported by interview participants (N = 40) during virtual ranking exercise (lower value = higher ranking).
FIGURE 3.
FIGURE 3.
Average (mean) priority rankings for preventive treatment benefits reported by interview participants (N = 40) during virtual ranking exercise (lower value = higher ranking).
FIGURE 4.
FIGURE 4.
Comparison of average priority rankings for acute treatment benefits reported by participants with episodic (n = 20) and chronic (n = 20) migraine.
FIGURE 5.
FIGURE 5.
Comparison of average priority rankings for preventive treatment benefits reported by participants with episodic (n = 20) and chronic (n = 20) migraine.
See this image and copyright information in PMC

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