Headache Assessment via Digital Platform in United States: Baseline study characteristics, diagnosis, and treatment patterns.

OBJECTIVES/BACKGROUND: This study was undertaken 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. HeAD-US is a new, ongoing cohort study of patients with migraine in the United States, 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 app completed baseline surveys for approximately 3 months starting in September 2023, assessing demographics, headache characteristics, and treatment use. Migraine diagnosis was determined using the American Migraine Study/American Migraine Prevalence and Prevention diagnostic module, and treatment effectiveness was evaluated using the migraine Treatment Optimization Questionnaire-6 (defined as scores ≥ 6 indicating moderate-to-maximum effectiveness).

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, 73.7% 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 2421 patients on monotherapy with acute medications, the most common categories were triptans (42.2%), over-the-counter medications (30.5%), and gepants (23.8%). For patients on prescription monotherapy, individuals using gepants reported the highest rate of effective treatment (53.3%) in head-to-head comparison with triptans (47.8%, p = 0.036) and opioid/barbiturates (27.1%, p < 0.001).

CONCLUSION: 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 patients with migraine, their treatment patterns, and outcomes.