Results from this real-world assessment of the economic burden of migraine suggest that migraine imposes a substantial direct and indirect cost burden in the United States. Compared to matched nonmigraine patients, migraine patients were more likely to have work loss and longer periods of work loss, leading to significantly higher indirect costs. Migraine patients also had higher levels of healthcare utilization, despite the relatively stable prevalence of migraine and the available acute and preventive treatment options for migraine management.

BackgroundMigraine is characterized by headache with symptoms such as intense pain, nausea, vomiting, photophobia, and phonophobia that significantly impact individuals’ lives. The objective of this study was to develop a strategy to measure outcomes from the patients’ perspectives for use in evaluating preventive treatments for migraine.MethodsThis study used a multi-stage process. The first stage included concept identification research through literature review, patient-reported outcome (PRO) instrument content review, and clinician interviews, and resulted in a list of concepts relevant to understand the migraine experience. These results informed the design of the subsequent concept elicitation stage that involved qualitative interviews of adults with migraine to understand their experiences. Information from these two stages was used to develop a conceptual disease model (CDM) of the migraine experience. This CDM was used to identify concepts of interest (COI) to evaluate patient-relevant outcomes for assessing treatment benefit of migraine prophylactics. In the final stage, existing PRO instruments were reviewed to assess coverage of concepts related to the selected COI.ResultsNine articles from 563 screened abstracts underwent full review to identify migraine-relevant concepts. This concept identification and subsequent concept elicitation interviews (N = 32; 21 episodic migraine; 11 chronic migraine) indicated that people with migraine experience difficulties during and between migraine attacks with considerable day-to-day variability in the impact on movement, ability to perform every day and social activities, and emotion. The CDM organized concepts as proximal to and more distal from disease-defining migraine symptoms, and was used to identify impact on physical function as the key COI. The item level review of PRO instruments revealed that none of the existing PRO instruments were suitable to collect data on impact of migraine on physical functioning, to evaluate treatment benefit.ConclusionsThe impact of migraine includes impairments in functioning during and between migraine attacks that vary considerably on a daily basis. There is a need for novel PRO instruments that reflect patients’ migraine experience to assess treatment benefit of migraine prophylactics. These instruments must evaluate the concepts identified and be able to capture the variability of patients’ experience.

Aim To estimate the schizophrenia-related direct and indirect costs for communitydwelling Americans sampled in the Medical Expenditure Panel Survey (MEPS) from the societal perspective. Methods Patients diagnosed with a schizophrenic disorder (International Classification of Disease 9th Revision (ICD-9) code 295) or other non-organic psychoses (ICD-9 code 298) between 1 January 2005 and 31 December 2008 were identified from the MEPS database. The following categories were included in calculating the schizophrenia-related direct medical costs: inpatient hospitalizations, prescription medications and hospital outpatient, emergency department, physician office, and home healthcare visits. The indirect costs were calculated using the human capital approach and included lost productivity due to missed work, reduced employment, premature death and caregivers' costs. To account for the complex multistage sampling design of the MEPS, all statistical analyses were conducted using the survey procedure of SAS version 9.2. Results We identified 348 patients who represent 3.03 million community-dwelling schizophrenia patients in the USA between 2005 and 2008. The estimated direct cost from

BackgroundAdults with migraine experience substantial reductions in quality of life during and in-between migraine attacks. Clinical and regulatory guidelines encourage the inclusion of patient reported outcomes for the evaluation of benefits of interventions for migraine.MethodsThe conceptual framework and items for a new patient-reported outcome (PRO) instrument, the Migraine Physical Function Impact Diary (MPFID), were developed using scientific methods recommended to ensure content validity of PRO instruments. The MPFID was developed to measure the impact of migraine on physical functioning based on themes raised in concept elicitation (CE) interviews (conducted previously) with adults with migraine. Cognitive interviews were conducted with adults with migraine to further explore content validity. The instrument was modified following an interim analysis of a first round of cognitive interviews, to assess comprehensiveness and clarity of items, instructions, and response options. Refinements were subsequently tested in additional cognitive interviews.ResultsThe conceptual framework included impacts on physical functioning experienced by most adults with migraine and deemed clinically relevant for measuring the outcome of an intervention for migraine. Concepts in the framework included the impact of migraine on physical impairments (acts) and ability to complete day-to-day activities and perform everyday activities (tasks). MPFID items were generated to evaluate functioning over the past 24 h and to collect data daily, to capture experiences on days with migraine as well as the days in-between migraines. Items asked about needing to rest or lie down; ability to get out of bed, stand up, bend over, walk, perform household chores, do tasks outside the home, keep routines or schedules, get ready for the day, do activities that require concentration or clear thinking; difficulty moving head and body, doing activities requiring physical effort; avoiding interacting with others. Initial modifications based on the first round of cognitive interviews (n = 8) included clarifying instructions, updating three items to enhance specificity and clarity, and revising one item to include gender-neutral language. The second round of interviews (n = 9) confirmed acceptability of revisions and supported content validity.ConclusionsThe results provide qualitative evidence supporting the content validity of the MPFID for evaluating outcomes of interventions for migraine.Electronic supplementary materialThe online version of this article (10.1186/s12955-017-0799-1) contains supplementary material, which is available to authorized users.

The MPFID has robust psychometric properties (ie, reliability and validity). Findings supported two distinct domains about the impact of migraine on physical functioning: Impact on Everyday Activities and Physical Impairment. Both domain scores showed evidence of excellent reliability and construct validity in assessing the impacts of migraine on physical functioning.

ObjectiveTo determine the effect of erenumab, a human monoclonal antibody targeting the calcitonin gene-related peptide receptor, on health-related quality of life (HRQoL), headache impact, and disability in patients with chronic migraine (CM).MethodsIn this double-blind, placebo-controlled study, 667 adults with CM were randomized (3:2:2) to placebo or erenumab (70 or 140 mg monthly). Exploratory endpoints included migraine-specific HRQoL (Migraine-Specific Quality-of-Life Questionnaire [MSQ]), headache impact (Headache Impact Test–6 [HIT-6]), migraine-related disability (Migraine Disability Assessment [MIDAS] test), and pain interference (Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference Scale short form 6b).ResultsImprovements were observed for all endpoints in both erenumab groups at month 3, with greater changes relative to placebo observed at month 1 for many outcomes. All 3 MSQ domains were improved from baseline with treatment differences for both doses exceeding minimally important differences established for MSQ–role function-restrictive (≥3.2) and MSQ–emotional functioning (≥7.5) and for MSQ–role function-preventive (≥4.5) for erenumab 140 mg. Changes from baseline in HIT-6 scores at month 3 were −5.6 for both doses vs −3.1 for placebo. MIDAS scores at month 3 improved by −19.4 days for 70 mg and −19.8 days for 140 mg vs −7.5 days for placebo. Individual-level minimally important difference was achieved by larger proportions of erenumab-treated participants than placebo for all MSQ domains and HIT-6. Lower proportions of erenumab-treated participants had MIDAS scores of severe (≥21) or very severe (≥41) or PROMIS scores ≥60 at month 3.ConclusionsErenumab-treated patients with CM experienced clinically relevant improvements across a broad range of patient-reported outcomes.Clinicaltrials.gov identifierNCT02066415.Classification of evidenceThis study provides Class II evidence that for patients with CM, erenumab treatment improves HRQoL, headache impact, and disability.

BACKGROUND: Migraine imposes substantial economic burden on patients and the health care system. Approximately 18% of women and 6% of men suffer from migraine in the United States. This is a heterogeneous group, and little data are available to evaluate factors associated with migraine costs. OBJECTIVE: To evaluate characteristics associated with high costs among commercially insured patients with migraine. METHODS: This retrospective analysis identified patients with migraine in the Truven Health MarketScan Research Databases between January 2008 and June 2013. Patients were required to have 12 months continuous enrollment before and after migraine diagnoses and/or migraine-specific medications (index date). Patients with costs greater than the top 25th percentile of all-cause costs during the 12-month post-index period were classified into the upper quartile (UQ) cohort. Multiple logistic regression was used to evaluate demographic and clinical factors associated with being in the UQ cohort, and generalized linear models were used to estimate the incremental costs by select factors after controlling for other covariates.RESULTS: In the total population, 857,073 patients (mean [SD] age: 43.2 [12.5] years), were included, with 83.2% females. Average post-index annual all-cause costs were $13,045 (SD = $25,328) with the top 25th percentile of costs at $14,120. Overall, 44.4% and 54.8% of patients had ≥ 1 pre-index claim for opioids and triptans, respectively. Patients with ≥ 2 migraine-related emergency room visits were twice as likely to be in the UQ cohort (OR = 2.13, 95% CI = 2.02-2.25; P < 0.05

Background Migraine is a chronic neurologic disease that can be associated with significant migraine‐related impact, disability, and burden. Patient‐reported outcome measures (PRO) are included in clinical trials of migraine interventions to capture treatment effects from a patient perspective. Clinical and regulatory guidelines also encourage use of PROs in trials. The Migraine Functional Impact Questionnaire (MFIQ) is a novel PRO measure, assessing the impact of migraine on Physical Function (PF), Usual Activities (UA), Social Function (SF), and Emotional Function (EF), in the past 7 days. Scientific methods recommended to meet the requirements of the U.S. Food and Drug Administration were followed, to ensure that the MFIQ content included outcomes that were relevant to adults with migraine and were clinically relevant, specifically to evaluate preventive treatments for migraine. Objective The objective of this study was to conduct item analyses informing item reduction and scoring, and to evaluate the psychometric properties of the MFIQ. Methods In a prospective, observational study, adults with migraine completed the MFIQ as well as additional clinical and PRO instruments, including the Headache Impact Test (HIT‐6TM), Patient‐Reported Outcomes Measurement Information System Physical Function Short Form 10a (PROMIS‐PF), Migraine‐Specific Quality‐of‐Life Questionnaire (MSQ), and Patient Global Rating of Change (PGIC). Item‐level evaluation, item response theory (IRT), and factor analysis were used to select final MFIQ items, identify domains, and inform scoring. Psychometric properties of the MFIQ were evaluated to assess reliability (internal consistency and test–retest), validity (construct and known‐groups), and responsiveness. Results The study enrolled 569 adults with migraine. Subjects had an average age of 39.9 years (SD 12.0), 87.2% were female, and 80.8% were white. Five items were dropped from the draft version based on results of item‐level analyses reviewed in the context of previous qualitative research to produce the final 26‐item MFIQ (v.2). Four domain scores (PF, UA, SF, and EF) and a global item score for impact on UA were identified. Higher scores on a 0‐100 scale represent greater impact. All scores exhibited high internal consistency (α ≥ 0.89) and moderate test–retest reliability among stable subjects (ICCs ≥ 0.47). Construct validity was demonstrated by significant correlations (all P < .0001) between MFIQ domain scores, related PRO scores, and the frequency of migraine days and headache days. All domain scores differentiated between subgroups (“known groups”) defined based on established levels of clinical severity: number of monthly migraine and headache days, migraine interference levels and scores on other PRO instruments (P < .05). Improvements in MFIQ scores corresponded with clinical improvement (percent reduction in monthly migraine days), improvement in migraine interference with daily activities, and related improvements in PRO scores (P < .05), demonstrating that the MFIQ was r...