62 Chapter 3 to 4 hours in the current clinical trial guidelines, possibly also taking into account that effective non-migraine-specific acute medication may lead to a shorter duration.1, 2 The aim of the current study was to formulate recommendations to standardize the definition of a migraine day for clinical and research purposes by comparing different definitions of migraine days in a large cohort of patients with migraine. METHODS Study population and headache E-diary Headache E-diary data were collected between August 2018 and March 2021 from diagnosed patients with migraine at the Leiden Headache Center, aged ≥ 18 years.10, 11 Ethical consideration for this study was obtained from the Medical Ethical committee of the Leiden University Medical Center (LUMC), who identified no ethical concerns. Therefore, participants did not have to provide additional informed consent. All data was analyzed in a fully anonymized setting. Participants were followed using a headache E-diary over the course of at least three subsequent months.6 Subjects received a daily alert at 8 a.m. and reported on headache, aura and associated symptoms of the previous day (from midnight to midnight). Questions included the presence or absence of headaches, (visual) aura symptoms, use of (migraine-specific and non-migraine-specific) acute medication, and, if applicable, additional questions on the severity (on a scale from 1-3), duration of the headache, and associated symptoms (unilateral location, pulsating quality, pain intensity, increasing with routine physical activities, nausea, vomiting, photophobia, and phonophobia). Also questions on (change of) preventive medication use and general wellbeing were asked for each day. Participants received a reminder at 6 p.m. if the E-diary was not yet completed that day. After completion or if the E-diary was not completed within 48 hours the response was locked and could not be altered. Patients were considered eligible for this study if they were followed with the E-diary for at least three subsequent months with at least 80% compliance per month. Definitions of a migraine day We evaluated four definitions of a migraine day, as listed in Table 1. The first two definitions of a migraine day were based on the typical migraine characteristics, where a distinguishment was made between (A) a headache duration of at least 4 hours and (B) a headache duration of at least 30 minutes. The other two definitions of a migraine day were based on acute medication use, where a distinguishment was made between (C) days with triptan intake and (D) days with effective triptan intake.
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