The MiCOAS Project and the Importance of Patient-Reported Outcomes in Migraine

Richard B. Lipton, MD

Based on data from a qualitative study of the Migraine Clinical Outcome Assessment System (MiCOAS) project, individuals with migraine report varying emotions and psychological symptoms along the phases of the migraine cycle: preheadache, headache, postheadache, and interictal.¹

Presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, June 9-11, in Denver, Colorado, by Dawn C. Buse, PhD, and colleagues, including Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology, vice-chair, Saul R. Korey Department of Neurology, and director, Montefiore Headache Center, the study included input from those living with migraine via qualitative interviews that tackled topics such as cognitive and physical functioning, ICHD-3 symptoms, and psychological and emotional symptoms.

To find out more about MiCOAS and the state of patient-reported evaluations in migraine care, NeurologyLive^® spoke with Lipton. He shared some background information on the project and offered his insight into the findings that were presented at the AHS meeting

NeurologyLive^®: Could you offer a little background on the MiCOAS tool, and how it might have an impact in migraine trials?

Richard B. Lipton, MD: The MiCOAS project is an FDA-funded project that's part of a broader effort to incorporate the patient voice into clinical trials. The idea is that, in clinical trials, we want to measure what matters most to key stakeholders. And, of course, the single most important stakeholder in migraine therapeutics is the patient. We're engaged in a multiyear process that includes qualitative interviews of people with migraine to find out what's important to them, in terms of the burden of illness, and when they take acute and preventive treatments. We're also doing this project in partnership with CHAMP, which is a very large patient organization, because the idea is that to incorporate the patient voice, you actually want to partner with patient groups.

My partner in this project is RJ Wirth, PhD, who is a psychometrician from a company called Vector Psychometrics. Thus far, we've done a couple of rounds of qualitative interviewing and a very deep review of the clinical trials literature on migraine. From our qualitative work, there were a few surprises. We found that cognitive interference—which is not routinely measured in clinical trials—is very important to patients that patients. Very often, they find difficulty thinking clearly, feeling like they're in a fog, feeling like they're unable to function, or unable to drive. These are big parts of the migraine burden, that are not well captured in trials currently, so one focus we have is better measuring cognitive interference.

We also did a lot of work characterizing the burden of migraine by headache phase, looking at the preheadache phase—which includes traditional prodrome and aura—the headache phase, the postheadache phase, and even the interictal period. Lots of evidence is emerging that shows us that, in focusing exclusively on the headache phase, we may have left a big part of the burden of migraine unaddressed, and also may have failed to capture some of the major benefits of treatment.

We're quite interested in doing a better job of measuring the burden of migraine across all 4 phases of the attack, particularly in that period between active headache attacks. Now, we've developed a large set of questions, which we've taken back to patients for evaluation. Our plan is to continue the validation process, and hope that we develop measures that the FDA will find acceptable and that will be incorporated in clinical trials.

That ability to work hand-in-hand with the patient community on that—has that given you insights that perhaps you were unaware of?

I think that's right. Having spent the last 30 years seeing and treating lots of patients, it's astonishing to me how much we've learned from the qualitative work. I think part of the reason is that when clinicians interview patients, we’re often guided by experience and preconceived notions. Sometimes that's very helpful, but sometimes that may—speaking for myself—make me less able to see obvious important things. I never really saw how important difficulty with driving was during migraine attacks until we did this current round of qualitative work. I didn't really appreciate how, before pain begins, so many people have trouble with concentration, focus, and with making decisions. Without a doubt, I've learned a lot from this process, and learned by listening better to patients and looking at verbatim transcripts of what people with migraine tell us when we interview them.

What should the clinical community who perhaps aren't aware of this, know about this project at this point?

I actually gave a talk at an AHS workshop on improving outcome measurements in trials and in practice. What I would say is that there are a number of patient-reported outcome variables that currently play a role in clinical practice. One of them is Migraine Disability Assessment Scale, or MIDAS, which measures lost time due to migraine. That's a measure I developed, but its weakness is that it only measures burden during headache. But still, it's widely used in trials in practice. Another one is the Headache Impact Test, or HIT-6, which is a 6-item questionnaire, which has certain advantages.

The other thing to know is that in regulatory trials, the FDA has included in the package inserts of marketed drugs, only 3 patient-reported outcomes. One is called the Migraine Specific Quality of Life Role Function, Restrictive Measure. That's a very brief measure suitable for practice that you give every 4 weeks, or you could give at 3-month follow-up visits, to track how patients are doing. The 2 other measures that are included in drug labels are AIM-D [or Activity Impairment in Migraine Diary], and the other is called MPFID [or Migraine Physical Function Impact Diary]. There are both daily diary measures, and they're great for measuring the benefit of treatment in trials. But keeping a daily diary, where you have to answer more than 10 questions every day is burdensome for practice. The bottom line is we're trying to develop better measures, but clinicians should, in my view, use patient-reported outcomes in practice and look for better patient-reported outcomes that could be incorporated into clinical trials and clinical practice over the next couple of years.

Transcript edited for clarity. Click here for more coverage of AHS 2022.

REFERENCE
1. Buse DC, Lipton RB, Gerstein MT, et al. Emotional/psychological symptoms reported in each phase of the migraine cycle: Results of the MiCOAS qualitative study. Presented at: AHS Annual Scientific Meeting; June 9-11, 2022; Denver, CO. P-123