Objectives To summarize the baseline methods for the Headache Assessment Via Digital Platform in United States (Head-US) study and report accuracy of self- reported diagnosis of migraine on the platform, and patterns of acute and preventive treatment use among participants with migraine.

Background The HeAD-US is a new, ongoing cohort study of patients with migraine in the US, centered around comprehensive data collection via the Migraine Buddy platform, a smartphone app. Data from such platforms can be used to provide real-world insights, capturing patients’ voices directly.

Methods Participants from the Migraine Buddy app completed baseline surveys assessing demographics, headache characteristics, and treatment use. Migraine diagnosis was determined using the AMS/AMPP diagnostic module, and treatment effectiveness was evaluated using the migraine Treatment Optimization Questionnaire (mTOQ-6, defined as scores ≥ 6 indicating moderate-to-maximum efficacy).

Results Of 6810 participants who completed the baseline questionnaire, 6267 (92.0%) met migraine criteria and were included in the rest of the study. Participants had an average age of 41.5 years (SD=13.1, range 18-88), 5692 (90.8%) were female, 3924 (62.6%) met criteria for episodic migraine and 2343 (37.4%) met criteria for chronic migraine. Of the participants, 52.6% were using acute over-the-counter (OTC) medications, 73.2% were using acute prescription medications, 2.4% were using medical devices, and 60.1% were on preventive treatments. There was no significant difference in treatment effectiveness between participants on polytherapy (37.6%) and those on monotherapy (39.5%, p = 0.168). Among the 2621 patients on monotherapy with acute medications, the most common categories were triptans (39.0%), OTCs (28.2%), and gepants (20.8%). For patients on prescription monotherapy, individuals using gepants reported the highest rate of effective treatment (53.3%) in head-to-head comparison with triptans (47.28%, p=0.036), and opioid/barbiturates (27.1%, p<0.001).

Conclusions HeAD-US participants have higher rates of chronic migraine and headache-related disability in comparison with large-scale epidemiologic studies. The HeAD-US study offers a valuable opportunity to leverage real-world data for understanding migraine patients, their treatment patterns, and outcomes.

The authors have declared no competing interest.

This study did not receive any funding

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IRB of Advarra, Inc. gave ethical approval for this work.

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