83 Effect of COVID vaccination on monthly migraine days 4 METHODS For this longitudinal cohort study, we identified patients whose E-headache diaries were collected during the COVID-19 pandemic, covering a period between February 2020 and August 2022.2, 4 Patients were included if they had a confirmed diagnosis of migraine at the Leiden Headache Center, were aged ≥ 18 years and filled out the E-headache diary for at least three subsequent months with at least 80% compliance per month. This study was approved by the medical ethics committee of the Leiden University Medical Center (LUMC) and all patients provided informed consent. During the study period, each morning at 08.00 h, an alert was sent to all patients, which could be accessed on a mobile device or a computer. The questionnaire contained from six to 31 questions, depending on the answers provided, about the presence of headache including its detailed characteristics and associated symptoms (one sided, throbbing, intensity, increasing with physical activities, photophobia/ phonophobia, nausea, vomiting), presence of visual aura symptoms and their characteristics, use of acute medication, change in preventive medication, presence of menstruation, general wellbeing and pain coping. Questions covered the 24 h of the previous day (from midnight to midnight), enabling patients to enter data first thing in the morning. If the E-diary was not completed by the end of the afternoon, a reminder was sent. Entries could not be edited after completion of the questionnaire and questionnaires were time-locked after 48 h. Patients were encouraged to enter data daily. An automated algorithm based on ICHD-3 criteria verified for each day whether criteria for headache and migraine were met.25 A headache day was defined as a day with headache symptoms lasting ≥1 h. Migraine days were defined based on detailed characteristics as described in the ICHD-3 criteria, including all days with triptan intake.3 Additionally, days with visual aura symptoms lasting 5–60 min and days with triptan intake were considered migraine days. By definition, each migraine day was also considered a headache day. An online questionnaire was sent to acquire information about a potential COVID-19 infection or vaccination. First, the patients were asked if they had noticed an increase in migraine days after infection or vaccination, both in the case of COVID-19 and for other pathogens, using a three-point scale. Second, patients were asked to report the number of COVID-19 infections, the method of testing and the corresponding date(s). Finally, they were asked to report the number and type of vaccinations and the corresponding date(s), which could be found in the “Corona check” app or website (https://coronacheck.nl), developed by the Dutch Ministry of Public Health, Welfare and Sport.
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