Study measures
migraine headache, pain, phonophobia, ICHD-3, headache, migraine, nausea and/or vomiting, Migraine, photophobia
MIGRAINE, DISEASE, MIGRAINE, MIGRAINE HEADACHE
The WPAI-Specific Health Problem version 2 is a six-item questionnaire, with a recall period of past seven days. The WPAI questionnaire was collected at the baseline and at the Month 3 visit during double-blind period to assess past one week WPAI score. The instrument includes questions on employment status, hours missed from work due to the specific health problem (i.e. migraine), hours missed from work for other reasons, hours worked, the degree that migraine affected productivity while working, and the degree that migraine affected other daily activities [Details on calculation of WPAI scores are provided in Additional file The Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) is a self-administered disease specific quality of life questionnaire [Patients enrolled in the study used an electronic daily diary to record headache features and use of acute headache medications throughout the study. The number of monthly migraine headache days (per 30-day period) was the primary measure in the CONQUER study. A migraine headache day was defined as a calendar day on which a migraine or probable migraine occurred. Migraine was defined as a headache, with or without aura, of ≥ 30 min duration with both of the following required features (A and B):At least 2 of the following headache characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity, ANDDuring headache at least one of the following: nausea and/or vomiting, photophobia and phonophobia (definition adapted from IHS ICHD-3). Probable migraine headache was defined as a headache of ≥ 30 min duration, with or without aura, but missing one of the migraine features in the IHS ICHD-3 definition [In calculating the number of migraine headache days for each period, if the period was not equal to 30 days, the number of migraine headache days was adjusted by multiplying the number of migraine headache days by (30/x) where ‘x’ was the total number of non-missing diary days in the period assuming that the proportion of days with migraine is the same for days with missing and non-missing electronic patient-reported outcomes (ePRO). If more than half ePRO diary days are missing, monthly migraine headache days for that 1-month period were considered missing. Additional patient-reported data were recorded directly by the patient on an electronic tablet at the time of clinic visits.MSQ-RFR, MSQ-RFP, and monthly migraine headache days were selected as independent anchors for this study. We have not included the Patient Global Impression of Severity (PGI-S) and Migraine Disability Assessment (MIDAS) as anchors because of lower Youden index observed in the analysis for both anchors, (Youden index < 0.25) and bimodal trends in the Youden index plots. Established responder criteria consisted of changes from baseline to Month 3 for each of these anchors, and were defined as: an improvement in MSQ-RFR by ≥ 25.71 points, an improvement in MSQ-RFP by ≥ 20.00 points [