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Table 3 Inclusion/exclusion criteria

From: Establishing content validity for the migraine Global Impression Item (mGI-I) assessment: a modified single-item migraine symptom severity questionnaire

Population

Inclusion criteria

Exclusion criteria

Patient

• Adults aged ≥18 years old

• History of migraines ≥12 months according to International Classification of Headache Disorders III (ICHDIII)

• Patients currently on preventative treatment for their migraines

• ≥4 migraines/month in the last 3 months

• Must identify a KFM that meets criteria/definition (and that KFM must consent)

• Able and willing to provide informed consent and participate in one-on-one telephone interviews in English

• Able and willing to obtain clinical confirmation of diagnosis from their treating physician

• History of cluster headache or hemiplegic migraine headache

• Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain)

• Taken an opioid or butalbital-containing analgesics on ≥4 days per month for any indication in any month during the two months prior to the start of the study

• History of major psychiatric disorder or drug use that would impact the subject’s ability to complete the consent or interview procedures

KFMs

• Target is to be the KFM of an enrolled patient (but this is not a requirement)

° The KFM population was identified through the enrolled patient sample via the patient screening form with the following language:

▪ Part of this is asking you to nominate your “key family member” - the person in your life that you interact with the most on a day-to-day basis. This person should have a deep understanding of the impact migraine has on you. They should also be able to provide their perspective of change in your migraines over time. The person you choose to nominate can be anyone 18 years or older such as your spouse/partner, your daughter or son, a parent, sibling, other relative or the person you are in a defacto relationship with.

• Age ≥ 18 years old

• Able and willing to provide informed consent and participate in one-to-one interviews

There were no specified exclusion criteria for the KFMs.

Migraine Treating HCPs

• Licensed and practicing HCPs (i.e., neurologist, headache specialist, primary care physician, nurse practitioner, physician assistant) in the US

• Minimum of 5 years of clinical experience

• Currently treating at least 30 migraine patients/month

• Able and willing to provide informed consent and participate in one-on-one telephone interviews in English

There were no specified exclusion criteria for the HCPs.