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Objective: To assess the prevalence and impact of neck pain during headache among respondents with migraine in the multicountry Chronic Migraine Epidemiology and Outcomes – International (CaMEO‐I) Study. Background: Neck pain among individuals with migraine is highly prevalent and contributes to disability. Methods: The CaMEO‐I was a prospective, cross‐sectional, web‐based study conducted in Canada, France, Germany, Japan, United Kingdom, and the United States. A demographically representative sample of participants from each country completed a screening survey to evaluate headache characteristics. Respondents with headache were identified as having migraine or non‐migraine headache based on modified International Classification of Headache Disorders, third edition, criteria; those with migraine completed a detailed survey with migraine‐specific assessments. Results were stratified by the presence or absence of neck pain with headache (NPWH). For these analyses, data were pooled across the six countries. Results: Of 51,969 respondents who reported headache within the past 12 months, 14,492 (27.9%) were classified as having migraine; the remaining 37,477 (72.1%) had non‐migraine headache. Overall, 9896/14,492 (68.3%) of respondents with migraine headache reported NPWH, which was significantly higher (p < 0.001) than the proportion of respondents with non‐migraine headache who reported NPWH (13,536/37,477 [36.1%]). Among respondents with migraine, moderate‐to‐severe disability was significantly more prevalent for those with NPWH versus without (47.7% [4718/9896] vs. 28.9%, p < 0.001). Respondents with NPWH versus without also had significantly greater work productivity losses, at a median (interquartile range [IQR]) of 50.0 (20.0, 71.3) vs. 30.0 (0.0, 60.0) (p < 0.001), lower quality of life (Migraine‐Specific Quality of Life questionnaire version 2.1, median [IQR] Role Function–Restrictive domain score 60.0 [42.9, 74.3] vs. 68.6 [54.3, 82.9], p < 0.001), higher prevalence of depression and anxiety symptoms (depression, 40.2% [3982/9896] vs. 28.2% [1296/4596], p < 0.001); anxiety, 41.2% [4082/9896] vs. 29.2% [1343/4596], p < 0.001), higher prevalence of cutaneous allodynia during headache (54.0% [5345/9896] vs. 36.6% [1681/4596], p < 0.001), and higher prevalence of poor acute treatment optimization (61.1% [5582/9129] vs. 53.3% [2197/4122], p < 0.001). Conclusions: Nearly 70% of respondents with migraine reported NPWH. Individuals with migraine with neck pain during their headaches had greater disability, depression, anxiety, and cutaneous allodynia (during headache) than those without neck pain during their headaches. They also had diminished quality of life and work productivity, and poorer response to acute treatment compared with those without neck pain. Plain Language Summary: We looked at data from a web‐based study of over 51,000 people across Canada, France, Germany, Japan, United Kingdom, and the United States to understand how neck pain affects people with migraine. We found that neck pain is common in people with migraine, and that those who have neck pain during their headaches have more disability, worse symptoms, more anxiety and depression, and poorer quality of life than those without neck pain. Our results show that neck pain is a serious problem for people with migraine, and it can worsen the negative impacts of migraine. [ABSTRACT FROM AUTHOR]

Objective: To characterize the long‐term (56‐week) benefits of continuous onabotulinumtoxinA treatment response in individuals with chronic migraine (CM) who achieved reduction to <15 headache days/month with treatment. Background: There are limited data exploring reductions in monthly headache days to levels consistent with episodic migraine among those experiencing CM. Understanding the impact of sustained preventive treatment response in CM can provide important information about the impact of successful therapy. Methods: The two Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy trials of onabotulinumtoxinA in adults included a 24‐week, randomized, double‐blind, placebo‐controlled phase and a 32‐week open‐label phase. Data were pooled to determine proportions of individuals with <15 headache days/month while on treatment during several time periods in the double‐blind phase (Weeks 21–24; any 12 consecutive weeks; Weeks 13–24) and the entire study (Weeks 53–56; any 12 consecutive weeks; any 4‐week period). We assessed the long‐term impact on mean monthly headache days and changes from baseline on the six‐item Headache Impact Test (HIT‐6) and Migraine‐Specific Quality of Life questionnaire version 2.1 (MSQv2.1). Results: We analyzed 1384 participants with chronic migraine (double‐blind: onabotulinumtoxinA, n = 688; placebo, n = 696; open‐label: n = 688 [onabotulinumtoxinA]). The discontinuation rates prior to the completion of the full 56‐week treatment period for onabotulinumtoxinA and placebo were 25.4% (n = 175) and 29.3% (n = 204), respectively. During Weeks 13–24 of the double‐blind phase, significantly more onabotulinumtoxinA‐treated (386/688 [56.1%]) than placebo‐treated (342/696 [49.1%]) individuals had <15 headache days/month (p = 0.010), with fewer monthly headache days for onabotulinumtoxinA versus placebo responders. The proportions of participants achieving <15 monthly headache days with onabotulinumtoxinA were 60.9% (419/688) at Weeks 25–56, 81.1% (558/688) at Weeks 53–56, and 79.4% (546/688) during any consecutive 12‐week period. Mean changes from baseline on the HIT‐6 and MSQv2.1 questionnaire surpassed within‐group minimal important difference thresholds in all periods. At Week 24, onabotulinumtoxinA‐treated participants who achieved <15 monthly headache days during Weeks 21–24 had a greater mean HIT‐6 score reduction (−6.5 vs. −1.4) and greater mean MSQv2.1 Role‐Function Restrictive score improvements (21.3 vs. 6.4) than those who did not achieve <15 monthly headache days during the same period. Conclusions: Participants who achieved <15 monthly headache days with onabotulinumtoxinA treatment achieved meaningful benefits in headache‐related disability and migraine‐specific quality of life compared with those who remained at or above the 15–monthly headache days threshold. Sustained benefits observed over 56 weeks support long‐term onabotulinumtoxinA use for the prevention of CM. Plain Language Summary: It is not always clear how we should define if a preventive treatment for chronic migraine (CM) is successful. People with CM have ≥15 headache days/month, so we looked at data from two groups of patients who received long‐term treatment with onabotulinumtoxinA: the first group decreased to <15 headache days/month, and the second group continued to have ≥15 headache days/month. We found that the patients whose headaches decreased to <15 headache days/month, which we called the response threshold, said that their headaches impacted their lives much less and that they had better quality of life compared to the group who still met CM diagnostic criteria at the end of treatment. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) risk factors are highly prevalent among Hispanic/Latino adults, while the prevalence of MRI infarcts is not well-documented. We, therefore, sought to examine the relationships between CVD risk factors and infarcts with brain structure among Hispanic/Latino individuals. Methods: Participants included 1,886 Hispanic/Latino adults (50-85 years) who underwent magnetic resonance imaging (MRI) as part of the Study of Latinos--Investigation of Neurocognitive Aging-MRI (SOL-INCA-MRI) study. CVD risk was measured approximately 10.5 years before MRI using the Framingham cardiovascular risk score, a measure of 10-year CVD risk (low (<10%), medium (10 - < 20%), and high (≥20%)). MR infarcts were determined as present or absent. Outcomes included total brain, cerebral and lobar cortical gray matter, hippocampal, lateral ventricle, and total white matter hyperintensity (WMH) volumes. Linear regression models tested associations between CVD risk and infarct with MRI outcomes and for modifications by age and sex. Results: Sixty percent of participants were at medium or high CVD risk. Medium and high CVD risk were associated with lower total brain and frontal gray matter and higher WMH volumes compared to those with low CVD risk. High CVD risk was additionally associated with lower total cortical gray matter and parietal volumes and larger lateral ventricle volumes. Men tended to have greater CVDRF-related differences in total brain volumes than women. The association of CVD risk factors on total brain volumes increased with age, equal to an approximate 7-year increase in total brain aging among the high-CVD-risk group compared to the low-risk group. The presence of infarct(s) was associated with lower total brain volumes, which was equal to an approximate 5-year increase in brain aging compared to individuals without infarcts. Infarcts were also associated with smaller total cortical gray matter, frontal and parietal volumes, and larger lateral ventricle and WMH volumes. Conclusion: The high prevalence of CVD risk among Hispanic/Latino adults may be associated with accelerated brain aging. [ABSTRACT FROM AUTHOR]

Objective: To analyze data from the Chronic Migraine Epidemiology and Outcomes‐International (CaMEO‐I) Study in order to characterize preventive medication use and identify preventive usage gaps among people with migraine across multiple countries. Background: Guidelines for the preventive treatment of migraine are available from scientific organizations in various countries. Although these guidelines differ among countries, eligibility for preventive treatment is generally based on monthly headache day (MHD) frequency and associated disability. The overwhelming majority of people with migraine who are eligible for preventive treatment do not receive it. Methods: The CaMEO‐I Study was a cross‐sectional, observational, web‐based panel survey study performed in six countries: Canada, France, Germany, Japan, the United Kingdom, and the United States. People were invited to complete an online survey in their national language(s) to identify those with migraine according to modified International Classification of Headache Disorders, 3rd edition, criteria. People classified with migraine answered questions about current and ever use of both acute and preventive treatments for migraine. Available preventive medications for migraine differed by country. MHD frequency and associated disability data were collected. The American Headache Society (AHS) 2021 Consensus Statement algorithm was used to determine candidacy for preventive treatment (i.e., ≥3 monthly MHDs with severe disability, ≥4 MHDs with some disability, or ≥6 MHDs regardless of level of disability). Results: Among 90,613 valid completers of the screening survey, 14,492 met criteria for migraine and completed the full survey, with approximately 2400 respondents from each country. Based on the AHS consensus statement preventive treatment candidacy algorithm, averaging across countries, 36.2% (5246/14,492) of respondents with migraine qualified for preventive treatment. Most respondents (84.5% [4431/5246]) who met criteria for preventive treatment according to the AHS consensus statement were not using a preventive medication at the time of the survey. Moreover, 19.3% (2799/14,492) of respondents had ever used preventive medication (ever users); 58.1% (1625/2799) of respondents who reported ever using a preventive medication for migraine were still taking it. Of the respondents who were currently using a preventive medication, 50.2% (815/1625) still met the criteria for needing preventive treatment based on the AHS consensus statement. Conclusions: Most people with migraine who qualify for preventive treatment are not currently taking it. Additionally, many people currently taking preventive pharmacologic treatment still meet the algorithm criteria for needing preventive treatment, suggesting inadequate benefit from their current regimen. Plain Language Summary: People with migraine who experience frequent headaches or some level of disability may benefit from using a preventive medication for migraine. We collected data on the use of preventive medication for migraine in Canada, France, Germany, Japan, the United Kingdom, and the United States. These data demonstrated that many people who qualified for the use of a preventive treatment in the six participating countries were not currently taking a preventive medication for migraine. [ABSTRACT FROM AUTHOR]

Objective: The role of subjective cognitive concerns (SCC) as a diagnostic criterion for MCI remains uncertain and limits the development of a universally (or widely)-accepted MCI definition. The optimal MCI definition should define an at-risk state and accurately predict the development of incident dementia. Questions remain about operationalization of definitions of self- and informantreported SCCs and their individual and joint associations with incident dementia. Methods: The present study included Einstein Aging Study participants who were non-Hispanic White or Black, free of dementia at enrollment, had follow-up, and completed neuropsychological tests and self-reported SCC at enrollment to determine MCI status. Informant-reported SCC at baseline were assessed via the CERAD clinical history questionnaire. Self-reported SCC were measured using the CERAD, items from the EAS Health Self-Assessment, and the single memory item from the Geriatric Depression Scale. Cox proportional hazards models examined the association of different operationalizations of SCC with Petersen and Jak/Bondi MCI definitions on the risk of dementia, further controlling for age, sex, education, and race/ethnicity. Time-dependent sensitivity and specificity at specific time points for each definition, and Youden’s index were calculated as an accuracy measure. Cox proportional hazards models were also used to evaluate the associations of combinations of self- and informant-reported SCC with the risk of incident dementia. Results: 91% of the sample endorsed at least one SCC. Youden’s index showed that not including SCC in either Jak/Bondi or Petersen classifications had the best balance between sensitivity and specificity across follow-up. A subset of individuals with informants, on average, had a lower proportion of non-Hispanic Blacks and 94% endorsed at least one self-reported SCC. Both informant-reported and self-reported SCC were significantly associated with incident dementia. Conclusion: Our findings suggest that the SCC criterion may not improve the predictive validity for dementia when included in widely-employed definitions of MCI. Consistent with some prior research, informant-reported SCC was more related to risk of incident dementia than self-reported SCC. Given that requiring informant report as a diagnostic criterion may unintentionally exclude health disparate groups, additional consideration is needed to determine how best to utilize informant-report in MCI diagnosis. [ABSTRACT FROM AUTHOR]

Objective: To characterize the direct impact of monthly headache days (MHDs) on health‐related quality of life (HRQoL) in people with migraine and the potential mediating effects of anxiety, depression, and allodynia. Background: Although the general relationship between increased migraine frequency (i.e., MHDs) and reduced HRQoL is well established, the degree to which reduced HRQoL is due to a direct effect of increased MHDs or attributable to mediating factors remains uncertain. Methods: Cross‐sectional baseline data from participants with migraine who completed the Core and Comorbidities/Endophenotypes modules in the 2012–2013 US Chronic Migraine Epidemiology and Outcomes (CaMEO) study, a longitudinal web‐based survey study, were analyzed. The potential contribution of depression, anxiety, and/or allodynia to the observed effects of MHDs on HRQoL as measured by the Migraine‐Specific Quality‐of‐Life Questionnaire version 2.1 (MSQ) was evaluated. Results: A total of 12,715 respondents were included in the analyses. The MSQ domain scores demonstrated progressive declines with increasing MHD categories (B = −1.23 to −0.60; p < 0.001). The observed HRQoL decrements associated with increasing MHDs were partially mediated by the presence of depression, anxiety, and allodynia. The MHD values predicted 24.0%–32.4% of the observed variation in the MSQ domains. Depression mediated 15.2%–24.3%, allodynia mediated 9.6%–16.1%, and anxiety mediated 2.3%–6.0% of the observed MHD effects on the MSQ. Conclusions: Increased MHD values were associated with lower MSQ scores; the impact of MHDs on the MSQ domain scores was partially mediated by the presence of depression, anxiety, and allodynia. MHDs remain the predominant driver of the MSQ variation; moreover, most of the variation in the MSQ remains unexplained by the variables we analyzed. Future longitudinal analyses and studies may help clarify the contribution of MHDs, comorbidities, and other factors to changes in HRQoL. [ABSTRACT FROM AUTHOR]

Background: Individuals using onabotulinumtoxinA as a preventive migraine treatment often use acute treatments for breakthrough attacks. Data on real-world effectiveness of the small-molecule calcitonin gene–related peptide (CGRP) receptor antagonist ubrogepant in combination with onabotulinumtoxinA are limited. Methods: COURAGE, a prospective, multiple attack, observational study, evaluated the real-world effectiveness of ubrogepant (50 or 100 mg) for acute treatment of migraine in people receiving onabotulinumtoxinA, an anti-CGRP monoclonal antibody (mAb), or both. This analysis focused only on onabotulinumtoxinA users. The Migraine Buddy app was used to identify eligible participants and track response to treated attacks. For each ubrogepant-treated attack, meaningful pain relief (MPR) and return to normal function (RNF) at 2 and 4 h post-dose over 30 days was assessed. MPR was defined as a level of relief that is meaningful to the participant, usually occurring before the pain is all gone. After 30 days, satisfaction was reported on a 7-point scale and overall acute treatment optimization was evaluated using the migraine Treatment Optimization Questionnaire-4 (mTOQ-4). Results: This analysis included 122 participants who received ubrogepant and onabotulinumtoxinA and reported on 599 ubrogepant-treated attacks. Following the first ubrogepant-treated attack, MPR was achieved in 53.3% of participants 2 h post-dose and in 76.2% of participants 4 h post-dose. RNF was achieved in 25.4% of participants 2 h post-dose and in 45.9% of participants 4 h post-dose. MPR and RNF results were similar across up to 10 ubrogepant-treated attacks. After 30 days, satisfaction with ubrogepant in combination with onabotulinumtoxinA was reported by 69.8% of participants and acute treatment optimization (defined as mTOQ-4 score ≥ 4) was achieved in 77.6%. Conclusions: In this prospective real-world effectiveness study, ubrogepant treatment in onabotulinumtoxinA users with self-identified migraine was associated with high rates of MPR and RNF at 2 and 4 h as well as satisfaction and acute treatment optimization. Although the lack of a contemporaneous control group limits causal inference, these findings demonstrate the feasibility of using a novel, app-based design to evaluate the real-world effectiveness and satisfaction of treatments. [ABSTRACT FROM AUTHOR]

Background: There is renewed emphasis on including patients in determining, defining, and prioritizing outcomes for migraine treatment. Objectives: To obtain insights directly from people living with migraine on their priorities for treatment. Methods: A total of 40 qualitative interviews were conducted as part of the Migraine Clinical Outcome Assessment System project, a United States Food and Drug Administration grant‐funded program to develop a core set of patient‐centered outcome measures for migraine clinical trials. Interviews included a structured exercise in which participants rank‐ordered pre‐defined lists of potential benefits for acute and preventive migraine therapy. The 40 study participants who reported being diagnosed with migraine by a clinician ranked the benefits and explained their rationale. Results: Study participants consistently ranked either pain relief or absence of pain as their top priority for acute treatment. Relief/absence of other migraine symptoms and improved functioning were also prioritized. For preventive treatment, participants prioritized reductions in migraine frequency, symptom severity, and attack duration. Few differences were found between participants with episodic migraine and those with chronic migraine. However, participants with chronic migraine ranked "increased predictability of attacks" much higher than those with episodic migraine. Participants' rankings were influenced by prior expectations and experiences of migraine treatments, which caused many participants to deprioritize desired benefits as unrealistic. Participants also identified several additional priorities, including limited side‐effects and reliable treatment efficacy in both acute and preventive treatments. Conclusion: The results showed the participants prioritized treatment benefits aligned with existing core clinical outcomes used in migraine research, but also valued benefits that are not typically assessed, such as predictability. Participants also deprioritized important benefits when they believed treatment was unlikely to deliver those outcomes. [ABSTRACT FROM AUTHOR]

Background: No available studies demonstrate validity and meaningful change thresholds of Work Productivity and Activity Impairment (WPAI) questionnaire in patients with migraine. In this post-hoc analysis, we assessed reliability, validity, responsiveness, and meaningful within-patient change from baseline to Month 3 for Work Productivity and Activity Impairment (WPAI) domain scores in patients with episodic migraine (EM) or chronic migraine (CM). Method: The Phase 3, multicenter, randomized, double-blind, placebo-controlled CONQUER study (NCT03559257, N = 462) enrolled patients with EM or CM who failed two to four categories of prior preventive medication in past ten years. The analyses were performed for WPAI domain scores (absenteeism, presenteeism, overall work productivity, and non-work-related activity impairment). Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) domain scores (Role Function-Restrictive [RFR] and Role Function-Preventive [RFP]), and monthly migraine headache days were used as anchors. Responder criteria were changes from baseline to Month 3 for each of these anchors and were defined as: increase in MSQ-RFR by ≥ 25.71 points and MSQ-RFP by ≥ 20.00 points and a 50% reduction in monthly migraine headache days. Assessments were performed for overall population, and patients with EM or CM. The meaningful change threshold was determined based on Youden index, Phi coefficient and sensitivity. Results: Of 462 randomized patients, 444 who completed WPAI questionnaire were included in post-hoc analysis. Test–retest reliability over 3 months in a stable subgroup revealed moderate correlations for non-work-related Activity Impairment (ICC = 0.446) presenteeism (ICC = 0.438) and a fair correlation for overall work productivity loss (ICC = 0.360). At baseline, all correlations between WPAI domain scores and continuous anchor variables exceeded recommended threshold of ≥ 0.30, except for WPAI domain scores with number of monthly migraine headache days. Patients achieving pre-specified responsiveness thresholds for monthly migraine headache days, and MSQ-RFP, MSQ-RFR from baseline to Month 3 (responders) showed significant improvements in WPAI domain scores compared with non-responders (P < 0.001). The meaningful change thresholds of -20 (% unit) were identified for WPAI domain scores. Conclusion: In conclusion, WPAI has sufficient validity, reliability, responsiveness, and appropriate interpretation standards to assess the impact of EM or CM on presenteeism and overall work productivity loss and non-work-related activity impairment. Trial registration: NCT number of CONQUER study, NCT03559257. [ABSTRACT FROM AUTHOR]

Objective: To identify predictors of acute treatment optimization for migraine with "over‐the‐counter" (OTC) or prescription nonsteroidal anti‐inflammatory drugs (NSAIDs) as well as other widely used OTCs including acetaminophen, caffeine combination products (CCP), and acetylsalicylic acid (ASA, aspirin) among people with episodic migraine and to develop models that predict treatment response to each class of OTCs. Background: Efficacy of acute OTC medications for migraine varies greatly. Identifying predictors of treatment response to particular classes of medication is a step toward evidence‐based personalized therapy. Methods: For this prediction model development study, we used data from 2224 participants from the American Migraine Prevalence and Prevention (AMPP) study who were aged ≥18 years, met criteria for migraine, had <15 monthly headache days, and reported being on monotherapy for acute migraine attacks with one of the following classes medications: CCP (N = 711), acetaminophen (N = 643), ASA (N = 110), and prescription or OTC NSAIDs (N = 760). The primary outcome measures of treatment optimization were adequate 2‐h pain freedom (2hPF) and adequate 24‐h pain relief (24hPR), which were defined by responses of half the time or more to the relevant items on the Migraine Treatment Optimization Questionnaire‐6. Results: The mean (SD) age of the participants was 46.2 (13.1) years, 79.4% (1765/2224) were female, 43.7% (972/2224) reported adequate 2hPF, and 46.1% (1025/2224) reported adequate 24hPR. Those taking CCP had better 2hPF and 24PR outcomes. For those taking NSAIDs, better outcomes were associated with lower average pain intensity (2hPF: odds ratio [OR] 0.89, 95% confidence interval [CI] 0.80–0.99; 24PR: OR 0.86, 95% CI 0.77–0.96), cutaneous allodynia (2hPF: OR 0.92, 95% CI 0.89–0.96; 24PR: OR 0.91, 95% CI 0.87–0.95), depressive symptoms (2hPF: OR 0.95, 95% CI 0.92–0.98; 24PR: OR 0.95, 95% CI 0.91–0.99), and Migraine Disability Assessment Scale (MIDAS) grade (2hPF: OR 0.76, 95% CI 0.64–0.90; 24PR: OR 0.79, 95% CI 0.65–0.95). Adequate 2hPF for those taking CCP was associated with male gender (OR 1.83, 95% CI 1.21–2.77), lower average pain intensity (OR 0.80, 95% CI 0.70–0.91), lower cutaneous allodynia (OR 0.94, 95% CI 0.90–0.97), and lower Migraine Symptom Severity Scale Score (MSSS; OR 0.91, 95% CI 0.86–0.97). Adequate 24hPR for those taking CCP was associated with lower average pain intensity (OR 0.85, 95% CI 0.75–0.96), lower cutaneous allodynia (OR 0.92, 95% CI 0.89–0.96), and lower MIDAS grade (OR 0.81, 95% CI 0.68–0.96). Participants who were married (OR 1.51, 95% CI 1.05–2.19), had lower average pain intensity (OR 0.79, 95% CI 0.70–0.89), lower MSSS (OR 0.93, 95% CI 0.88–0.99), less depression (OR 0.96, 95% CI 0.93–0.99), and lower MIDAS grade (OR 0.72, 95% CI 0.59–0.87) had adequate 2hPF after taking acetaminophen. Participants who were married (OR 1.50, 95% CI 1.02–2.21), had lower pain intensity (OR 0.78, 95% CI 0.69–0.88), less depression (OR 0.95, 95% CI 0.91–0.98) and lower MIDAS grade (OR 0.53, 95% CI 0.42–0.67) had higher 24hPR following use of acetaminophen. A lower MSSS was the only factor associated with higher 2hPF and 24PR after using ASA (OR 0.78, 95% CI 0.67–0.92 and OR 0.79, 95% CI 0.67–0.93). Predictive models had modest performance in identifying responders to each class of OTC. Conclusion: A large subgroup of people with migraine had an inadequate response to their usual acute OTC migraine treatment 2‐ and 24‐h after dosing. These findings suggest a need to improve OTC treatment for some and to offer prescription acute medications for others. Predictive models identified several factors associated with better treatment‐response in each OTC class. Selecting OTC treatment based on factors predictive of treatment optimization might improve patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Stigma is increasingly recognized as an important social feature of living with migraine. Methods: Adults with migraine recruited from neurology offices completed the validated Stigma Scale for Chronic Illnesses 8‐item version (SSCI‐8); two outcome measures (the Migraine Disability Assessment [MIDAS] and the Migraine‐Specific Quality of Life Questionnaire v 2.1 [MSQ]); and measures of allodynia (Allodynia Symptom Checklist [ASC‐12]), pain cognition (Pain Catastrophizing Scale [PCS]), and psychiatric symptoms (Patient Reported Measurement Information System Anxiety [PROMIS‐A] and Depression [PROMIS‐D]). Pearson and Spearman correlations evaluated bivariate relationships, and linear (MSQ) and logistic (MIDAS Severe Disability, scores ≥21) regressions evaluated the unique variance associated with SSCI‐8 beyond other study variables. Conditional process analysis evaluated mediation hypotheses between study variables. Results: Participants (n = 121) reported levels of stigma on par with other chronic illnesses (SSCI‐8 M = 53.0, standard deviation [SD] = 7.8), with 25/127 (19.6%) reporting clinically significant levels of stigma (SSCI‐8 T‐score ≥ 60). Higher SSCI‐8 scores were associated with higher monthly headache day frequency (r = 0.35), MIDAS (ρ = 0.41), ASC‐12 (r = 0.24, p < 0.01), PCS (r = 0.46), both PROMIS‐A (r = 0.43) and D (r = 0.42), and lower MSQ subscale scores (Role Restriction r = −0.50; Role Prevention r = −0.48; Emotion Function r = −0.50), all ps <0.001 unless otherwise noted. The SSCI‐8 contributed significantly beyond migraine symptoms and other psychological factors for MSQ Emotion Function (5% unique variance) and MIDAS Severe Disability (6% of unique variance). The SSCI‐8 mediated relationships between headache frequency and the MSQ subscales and MIDAS Severe Disability. The PCS mediated relationships between the SSCI‐8 and MSQ subscales. The PROMIS‐D mediated relationships between the SSCI‐8 and MSQ Role Restriction and MSQ Role Prevention. Conclusions: Migraine stigma has medium to large associations with migraine outcomes and psychiatric symptoms and is independently associated with migraine disability and emotion‐related quality of life. Migraine stigma is an important contributor to the relationship between headache frequency and migraine outcomes. [ABSTRACT FROM AUTHOR]

Objective: To identify predictors of acute treatment response for nonprescription (over‐the‐counter [OTC]) medications among people with migraine and develop improved models for predicting treatment response. Background: Pain freedom and sustained pain relief are important priorities in the acute treatment of migraine. OTC medications are widely used for migraine; however, it is not clear which treatment works best for each patient without going through the trial and error process. Methods: A prediction model development study was completed using the 2006 American Migraine Prevalence and Prevention Study survey, from participants who were aged ≥18, met criteria and headache day frequency for episodic migraine, did not take prescription medication for migraine, and used ≥1 of the following acute migraine medication classes: acetaminophen, aspirin, NSAIDs, or caffeine containing combination products (CCP). Two items from the Migraine Treatment Optimization Questionnaire were used to evaluate treatment response, adequate 2‐h pain freedom (2hPF) and 24‐h pain relief (24hPR), which were defined by a response to treatment ≥half the time at 2 h and 24 h post treatment, respectively. We identified predictors of adequate treatment response and developed models to predict probability of treatment response to each medication class. Results: The sample included 3852 participants (3038 [79.0%] females) with an average age of 45.0 years (SD = 12.8). Only 1602/3852 (41.6%) and 1718/3852 (44.6%) of the participants reported adequate 2hPF and 24hPR, respectively. Adequate treatment‐response was significantly predicted by lower average headache pain intensity, less cutaneous allodynia, and lower depressive symptom scores. Lower migraine symptom severity was predictive of adequate 2hPF and fewer monthly headache days was predictive of adequate 24hPR. Among participants reporting OTC monotherapy (n = 2168, 56.3%) individuals taking CCP were more likely to have adequate 2hPF (OR = 1.55, 95% CI 1.23–1.95) and 24hPR (OR = 1.79, 95% CI 1.18–1.88) in comparison with those taking acetaminophen. Predictive models were modestly predictive of responders to OTC medications (c‐statistics = 0.65; 95% CI 0.62–0.68). Conclusion: These results show that response to acute migraine treatments is not optimized in the majority of people with migraine treating with OTC medications. Predictive models can improve our ability to choose the best therapeutic option for individuals with episodic migraine and increase the proportion of patients with optimized response to treatments. [ABSTRACT FROM AUTHOR]

Background: PROMISE-1 and PROMISE-2 evaluated the preventive efficacy, tolerability, and safety of eptinezumab, a calcitonin gene-related peptide–targeted monoclonal antibody, in adults with episodic (EM) and chronic migraine (CM), finding significant reductions in migraine frequency. This post hoc analysis compared patient-reported outcomes (PROs), health-related quality of life (HRQoL) and acute medication use in patients with a ≥ 75% migraine responder rate (MRR) after treatment with eptinezumab to patients with a ≥ 50– < 75% MRR. Methods: PROMISE-1 and PROMISE-2 were phase 3, randomized, double-blind, placebo-controlled studies. This analysis included patients from both studies treated with eptinezumab 100 mg or 300 mg who experienced ≥ 75% and ≥ 50–< 75% MRR over Weeks 1–12 (wks1–12). In both studies, HRQoL was measured by the 36-item Short-Form Health Survey (SF-36) and acute medication usage. PROMISE-2 also included the 6-item Headache Impact Test (HIT-6), patient-identified most bothersome symptom (PI-MBS), and Patient Global Impression of Change (PGIC). Results: In PROMISE-1, a total of 115/443 (26.0%; 100 mg, n = 49, 300 mg, n = 66) and 120/443 (27.0%; 100 mg, n = 61, 300 mg, n = 59) eptinezumab-treated patients achieved ≥ 75% and ≥ 50–< 75% MRR over wks1–12, respectively. In PROMISE-2, a total of 211/706 (30.0%; 100 mg, n = 95; 300 mg, n = 116) and 209/706 (29.6%; 100 mg, n = 110, 300 mg, n = 99) eptinezumab-treated patients achieved ≥ 75% and ≥ 50–< 75% MRR over wks1–12, respectively. EM and CM patients with ≥ 75% and ≥ 50–< 75% MRR over wks1–12 showed reduced use of acute headache medication and increased HRQoL to normative levels across SF-36 domains of bodily pain, social functioning, and physical functioning. In CM patients with ≥ 75% and ≥ 50–< 75% MRR over wks1–12, the mean change in HIT-6 total score with eptinezumab (pooled) was − 11.7 and − 7.6, respectively. "Very much" or "much" improvement responses were reported in 41.8% and 16.5% on PI-MBS and 36.2% and 20.0% on PGIC in ≥ 75% and ≥ 50–< 75% MRR, respectively. Conclusion: Eptinezumab treatment induced a ≥ 75% MRR over wks1–12 in the majority of patients. This patient subgroup reported substantial improvements in PROs associated with headache-related life impact and HRQoL, and reductions in acute headache medication use, which were more marked than those in the ≥ 50–< 75% responders. This study supports the clinical meaningfulness of ≥ 75% MRR for patients with either EM or CM. Trial registration: ClinicalTrials.gov identifiers: NCT02559895 (PROMISE-1), NCT02974153 (PROMISE-2). [ABSTRACT FROM AUTHOR]

Background: Demonstrating therapeutic value from the patient perspective is important in patient-centered migraine management. The objective of this study was to investigate the impact of eptinezumab, a preventive migraine treatment, on patient-reported headache impact, acute medication optimization, and perception of disease change when initiated during a migraine attack. Methods: RELIEF was a randomized, double-blind, placebo-controlled trial conducted between 2019 and 2020 in adults with ≥1-year history of migraine and 4–15 migraine days per month in the 3 months prior to screening. Patients were randomized (1:1) to a 30-min infusion of eptinezumab 100 mg or placebo within 1–6 h of a qualifying migraine attack onset. The 6-item Headache Impact Test (HIT-6) and 6-item Migraine Treatment Optimization Questionnaire (mTOQ-6) were administered at baseline and week 4, and the Patient Global Impression of Change (PGIC) at week 4. A post hoc analysis of these measures was conducted in patients who reported headache pain freedom at 2 h after infusion start. Results: Of 480 patients enrolled and treated, 476 completed the study and are included in this analysis. Mean baseline HIT-6 total scores indicated severe headache impact (eptinezumab, 65.1; placebo, 64.8). At week 4, the eptinezumab-treated group demonstrated clinically meaningful improvement in HIT-6 total score compared with placebo (mean change from baseline: eptinezumab, − 8.7; placebo, − 4.5; mean [95% CI] difference from placebo: − 4.2 [− 5.75, − 2.63], P <.0001), with greater reductions in each item score vs placebo (P <.001 all comparisons). Change in HIT-6 total score in the subgroup with 2-h headache pain freedom was − 13.8 for the eptinezumab group compared with − 4.9 for the placebo group. mTOQ-6 total score mean change from baseline favored eptinezumab (change, 2.1) compared with placebo (1.2; mean [95% CI] difference: 0.9 [0.3, 1.5], P <.01). More eptinezumab-treated patients rated PGIC as much or very much improved than placebo patients (59.3% vs 25.9%). Conclusions: When administered during a migraine attack, eptinezumab significantly improved patient-reported outcomes after 4 weeks compared with placebo, with particularly pronounced effects in patients reporting headache pain freedom at 2 h after infusion start. Trial registration: ClinicalTrials.gov Identifier: NCT04152083. November 5, 2019. [ABSTRACT FROM AUTHOR]

Objective: The ObserVational survey of the Epidemiology, tReatment and Care of MigrainE (OVERCOME; United States) study is a multicohort, longitudinal web survey that assesses symptomatology, consulting, diagnosis, treatment, and impact of migraine in the United States. Background: Regularly updating population‐based views of migraine in the United States provides a method for assessing the quality of ongoing migraine care and identifying unmet needs. Methods: The OVERCOME (US) 2018 migraine cohort involved: (I) creating a demographically representative sample of US adults using quota sampling (n = 97,478), (II) identifying people with active migraine in the past year via a validated migraine diagnostic questionnaire and/or self‐reported medical diagnosis of migraine (n = 24,272), and (III) assessing consultation, diagnosis, and treatment of migraine (n = 21,143). The current manuscript evaluated whether those with low frequency episodic migraine (LFEM; 0–3 monthly headache days) differed from other categories on outcomes of interest. Results: Among the migraine cohort (n = 21,143), 19,888 (94.1%) met our International Classification of Headache Disorders, 3rd edition‐based case definition of migraine and 12,905 (61.0%) self‐reported a medical diagnosis of migraine. Respondents' mean (SD) age was 42.2 (15.0) years; 15,697 (74.2%) were women. Having at least moderate disability was common (n = 8965; 42.4%) and around half (n = 10,783; 51.0%) had consulted a medical professional for migraine care in the past year. Only 4792 (22.7%) of respondents were currently using a triptan. Overall, 8539 (40.4%) were eligible for migraine preventive medication and 3555 (16.8%) were currently using migraine preventive medication. Those with LFEM differed from moderate and high frequency episodic migraine and chronic migraine on nearly all measures of consulting, diagnosis, and treatment. Conclusion: The OVERCOME (US) 2018 cohort revealed slow but steady progress in diagnosis and preventive treatment of migraine. However, despite significant impact among the population, many with migraine have unmet needs related to consulting for migraine, migraine diagnosis, and getting potentially beneficial migraine treatment. Moreover, it demonstrated the heterogeneity and varying unmet needs within episodic migraine. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to examine changes in the functional impact of migraine following treatment with erenumab, as measured by the Migraine Functional Impact Questionnaire (MFIQ). Background: The MFIQ, a novel patient‐reported outcome (PRO) measuring the impact of migraine on four domains (physical function, social function, and emotional function [PF, SF, and EF]; usual activities [UAs]) and a single item assessing overall impact on UA, was included in phase III trials evaluating erenumab 70 and 140 mg monthly for migraine prevention among people with episodic migraine (EM). Methods: In the ARISE study, 577 patients with EM were randomized to erenumab 70 mg or placebo. In the STRIVE study, 955 patients with EM were randomized to erenumab, 70 mg or 140 mg or placebo. Pairwise comparisons of least‐squares mean (LSM) change from baseline in MFIQ scores (with associated 95% confidence interval [CI]) were assessed for each active treatment versus placebo. Results: In ARISE, greater reductions from baseline to month 3 were observed for 70 mg versus placebo for PF (LSM [95% CI]: −3.2 [−6.4 to −0.1]; p = 0.046) and EF (−4.0 [−7.3 to −0.7]; p = 0.019) domain scores. In STRIVE, between‐group differences also reflected reductions from baseline to the average of months 4–6 that favored erenumab on all four MFIQ domain scores. Reductions in impact for 70 mg compared to placebo were −4.3 (95% CI: −6.8 to −1.7; p < 0.001) for PF, −4.0 (−6.3 to −1.7; p < 0.001) for UA, −3.7 (−6.1 to −1.2; p = 0.003) for SF, and −5.3 (−7.9 to −2.6; p < 0.001) for EF domain scores. Improvements were also observed for 140 mg versus placebo with between‐group differences of −5.7 (95% CI: −8.2 to −3.2; p < 0.001) in PF, −5.1 (−7.5 to −2.8; p < 0.001) in UA, −5.0 (−7.4 to −2.6; p < 0.001) in SF, and −7.2 (−9.9 to −4.5; p < 0.001) in EF domain scores. There were also greater improvements in the overall impact on UA score for 70 mg (LSM [95% CI]: −4.3 [−7.0 to −1.7]; p = 0.001) and 140 mg (−5.3 [−8.5 to −3.2]; p < 0.001) versus placebo. Conclusions: The MFIQ measures the frequency of impacts and level of difficulty on multiple functional domains that provide a more complete picture of the effects of migraine. MFIQ scores showed that in comparison with placebo, patients treated with erenumab had greater reductions in the functional impact of migraine, providing insight into treatment benefits that extend beyond improvements in clinical status and health‐related quality of life previously reported based on clinical end points and other PROs. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the content validity and psychometric properties of the Activity Impairment in Migraine Diary (AIM‐D). Background: Measuring treatment effects on migraine impairment requires a psychometrically sound patient‐reported outcome (PRO) measure developed consistent with U.S. Food and Drug Administration guidance. Methods: The AIM‐D was created from concepts that emerged during qualitative interviews with five clinicians experienced in treating migraine and concept elicitation (CE) interviews with 40 adults with episodic migraine (EM) or chronic migraine (CM). The initial version was refined based on three waves of cognitive interviews with 38 adults with EM or CM and input from a panel of clinical and measurement experts. The AIM‐D was psychometrically evaluated using data from 316 adults with EM or CM who participated in a 13‐week prospective observational study. Study participants completed PRO assessments including the AIM‐D and a daily headache diary. Exploratory and confirmatory factor analysis were used to determine the factor structure. The reliability, validity, and responsiveness of the AIM‐D were assessed. Additional PRO measures including the Patient Global Impression – Severity (PGI‐S), Migraine Specific Quality of Life Questionnaire, Version 2.1 Role Function‐Restrictive domain, and Headache Impact Test were used for psychometric evaluation of the AIM‐D. Results: Based on CE interviews with adults with migraine and input from an expert panel, activity impairment was identified as the target in the preliminary conceptual framework, which had two domains: performance of daily activities (PDAs) and physical impairment (PI). Revision of the draft AIM‐D through multiple rounds of cognitive interviews and expert panel meetings resulted in a content valid 11‐item version. Exploratory factor analysis supported both one‐ and two‐domain structures for the AIM‐D, which were further supported by confirmatory factor analysis (factor loadings all >0.90). The AIM‐D domains (PDA and PI) and total score showed high internal consistency reliability (Cronbach's alpha 0.95–0.97), acceptable test–retest reliability for weekly average scores (intraclass correlation coefficient >0.60 for participants with no change in PGI‐S between baseline and week 2), and good convergent and known‐groups validity. There was evidence of responsiveness based on changes in PGI‐S score and monthly migraine days. Conclusion: The AIM‐D is a content valid and psychometrically sound measure designed to evaluate activity impairment and is suitable for use in clinical trials of preventive treatments for EM or CM. [ABSTRACT FROM AUTHOR]

Background: Electronic health records (EHR) data can be used to understand population level quality of care especially when supplemented with patient reported data. However, survey non-response can result in biased population estimates. As a case study, we demonstrate that EHR and survey data can be combined to estimate primary care population prescription treatment status for migraine stratified by migraine disability, without and with adjustment for survey non-response bias. We selected disability as it is associated with survey participation and patterns of prescribing for migraine. Methods: A stratified random sample of Sutter Health adult primary care (PC) patients completed a digital survey about headache, migraine, and migraine related disability. The survey data from respondents with migraine were combined with their EHR data to estimate the proportion who had prescription orders for acute or preventive migraine treatments. Separate proportions were also estimated for those with mild disability (denoted "mild migraine") versus moderate to severe disability (denoted mod-severe migraine) without and with correction, using the inverse propensity weighting method, for non-response bias. We hypothesized that correction for non-response bias would result in smaller differences in proportions who had a treatment order by migraine disability status. Results: The response rate among 28,268 patients was 8.2%. Among survey respondents, 37.2% had an acute treatment order and 16.8% had a preventive treatment order. The response bias corrected proportions were 26.2% and 11.6%, respectively, and these estimates did not differ from the total source population estimates (i.e., 26.4% for acute treatments, 12.0% for preventive treatments), validating the correction method. Acute treatment orders proportions were 32.3% for mild migraine versus 37.3% for mod-severe migraine and preventive treatment order proportions were 12.0% for mild migraine and 17.7% for mod-severe migraine. The response bias corrected proportions for acute treatments were 24.8% for mild migraine and 26.6% for mod-severe migraine and the proportions for preventive treatment were 8.1% for mild migraine and 12.0% for mod-severe migraine. Conclusions: In this study, we combined survey data with EHR data to better understand treatment needs among patients diagnosed with migraine. Migraine-related disability is directly related to preventive treatment orders but less so for acute treatments. Estimates of treatment status by self-reported disability status were substantially over-estimated among those with moderate to severe migraine-related disability without correction for non-response bias. [ABSTRACT FROM AUTHOR]

Objective: To investigate the association of psychiatric and cognitive comorbidities with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI). Methods: A total of 100 patients with persistent PTH attributed to mild TBI and 100 age- and gender-matched healthy controls free of mild TBI were enrolled between July 2018 and June 2019. Quality of sleep was evaluated using the Pittsburgh Sleep Quality Index, while symptoms of anxiety and depression were assessed using the Hospital Anxiety and Depression Scale. Cognitive impairment was evaluated using the Montreal Cognitive Assessment questionnaire, while post-traumatic stress disorder (PTSD) was assessed using the Harvard Trauma Questionnaire. Results: In 100 patients with persistent PTH, 85% reported poor quality sleep, compared with 42% of healthy controls (P < 0.01). The relative frequency of probable to high risk of anxiety was 52% in the persistent PTH group vs. 8% in healthy controls (P < 0.01), while the relative frequency of probable to high risk of depression was 42% in the persistent PTH group vs. 2% in healthy controls (P < 0.01). Furthermore, 27% of the patients with persistent PTH had mild cognitive impairment while 10% had probable PTSD. Conclusions: Poor quality of sleep as well as symptoms suggestive of anxiety and depression were more common in patients with persistent PTH than healthy controls. Clinicians should screen patients with persistent PTH for these comorbidities and develop treatment plans that account for their presence. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether the 15‐day threshold of headache days per month adequately reflects substantial differences in disability across the full spectrum of migraine. Background: The monthly frequency of headache days defines migraine subtypes and has crucial implications for epidemiological and clinical research as well as access to care. Methods: The patients with migraine (N = 836) who participated in the American Registry for Migraine Research, which is a multicenter, longitudinal patient registry, between February 2016 and March 2020, were divided into four groups based on monthly headache frequency: Group 1 (0–7 headache days/month, n = 286), Group 2 (8–14 headache days/month, n = 180), Group 3 (15–23 headache days/month, n = 153), Group 4 (≥24 headache days/month, n = 217). Disability (MIDAS), Pain intensity (NRS), Work Productivity and Activity Impairment (WPAI), Pain Interference (PROMIS‐PI), Patient Health Questionnaire‐4 (PHQ‐4), and General Anxiety Disorder‐7 (GAD‐7) scores were compared. Results: Mean (standard deviation [SD]) age was 46 (13) years (87.9% [735/836] female). The proportion of patients in each group was as follows: Group 1 (34.2% [286/836]), Group 2 (21.5% [180/836]), Group 3 (18.3% [153/836]), and Group 4 (26.0% [217/836]). There were significant relationships with increasing disability, lost productive time, and pain interference in higher headache frequency categories. There were no significant differences between Group 2 and Group 3 for most measures (NRS, all WPAI scores, PROMIS‐PI, GAD‐7, and PHQ‐4), although MIDAS scores differed (median [interquartile range (IQR)]; 38 [20–58] vs. 55 [30–90], p < 0.001). Patients in Group 1 had significantly lower MIDAS (median [IQR];16 [7–30], p < 0.001), WPAI‐% total active impairment (mean (SD): Group 1 [30.9 (26.8)] vs. Group 2 [39.2 (24.5), p = 0.017], vs. Group 3 [45.9 (24.1), p < 0.001], vs. Group 4 [55.3 (23.0), p < 0.001], and PROMIS‐PI‐T score (Group 1 [60.3 (7.3)] vs. Group 2 [62.6 (6.4), p = 0.008], vs. Group 3 [64.6 (5.6), p < 0.001], vs. Group 4 [66.8 (5.9), p < 0.001]) compared to all other groups. Patients in Group 4 had significantly higher MIDAS (median (IQR): Group 4 [90 (52–138)] vs. Group 1 [16 (7–30), p < 0.001], vs. Group 2 [38 (20–58), p < 0.001], vs. Group 3 [55 (30–90), p < 0.001], WPAI‐%Presenteeism (Group 4 [50.4 (24.4)] vs. Group 1 [28.8 (24.9), p < 0.001], vs. Group 2 [34.9 (22.3), p < 0.001], vs. Group 3 [40.9 (22.3), p = 0.048], WPAI‐% total work productivity impairment (Group 4 [55.9 (26.1)] vs. Group 1 [32.1 (37.6), p < 0.001], vs. Group 2 [38.3 (24.0), p < 0.001], vs. Group 3 [44.6 (24.4), p = 0.019]), and WPAI‐%Total activity impairment (Group 4 [55.3 (23.0)] vs. Group 1 [30.9 (26.8), p < 0.001], vs. Group 2 [39.2 (24.5), p < 0.001], vs. Group 3 [45.9 (24.1), p = 0.025]) scores compared with all other groups. Conclusion: Our data suggest that the use of a 15 headache day/month threshold to distinguish episodic and chronic migraine does not capture the burden of illness nor reflect the treatment needs of patients. These results have important implications for future refinements in the classification of migraine. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of fremanezumab in patients with chronic migraine (CM) and moderate to severe depression. Background: Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene–related peptide, has been approved for the preventive treatment of migraine in adults. CM and depression are highly comorbid. Methods: The 12‐week, Phase 3 HALO trial randomized patients with CM to fremanezumab quarterly (675 mg/placebo/placebo), fremanezumab monthly (675/225/225 mg), or placebo. Post hoc analyses evaluated the effects of fremanezumab in patients with moderate to severe depression (baseline 9‐item Patient Health Questionnaire sum score ≥10) on monthly number of headache days of at least moderate severity; monthly migraine days; Patient Global Impression of Change (PGIC); 6‐item Headache Impact Test (HIT‐6) scores; and depression. Results: For the 219/1121 (19.5%) patients with moderate to severe depression at baseline, fremanezumab was associated with a significant reduction in monthly number of headache days of at least moderate severity for active treatment versus placebo (least‐squares mean change ± standard error for quarterly dosing: −5.3 ± 0.77; for monthly dosing: −5.5 ± 0.72; and for placebo: −2.2 ± 0.81; both p < 0.001). More patients achieved a ≥50% reduction in headache days of at least moderate severity with fremanezumab (quarterly: 31/78 [39.7%]; monthly: 39/96 [40.6%]) than placebo (9/67 [13.4%]; both p < 0.001). Compared with placebo, fremanezumab improved PGIC and HIT‐6 scores. Conclusions: Fremanezumab demonstrated efficacy in the preventive treatment of CM and reduced headache impact in patients with comorbid depression. [ABSTRACT FROM AUTHOR]

Background: The ultimate validation of a clinical marker for Alzheimer's disease (AD) is its association with AD neuropathology.Objective: To examine how well the Stages of Objective Memory Impairment (SOMI) system predicts intermediate/high AD neuropathologic change and extent of neurofibrillary tangle (NFT) pathology defined by Braak stage, in comparison to the Clinical Dementia Rating (CDR) Scale sum of boxes (CDR-SB).Methods: 251 well-characterized participants from the Knight ADRC clinicopathologic series were classified into SOMI stage at their last assessment prior to death using the free recall and total recall scores from the picture version of the Free and Cued Selective Reminding Test with Immediate Recall (pFCSRT + IR). Logistic regression models assessed the predictive validity of SOMI and CDR-SB for intermediate/high AD neuropathologic change. Receiver operating characteristics (ROC) analysis evaluated the discriminative validity of SOMI and CDR-SB for AD pathology. Ordinal logistic regression was used to predict Braak stage using SOMI and CDR-SB in separate and joint models.Results: The diagnostic accuracy of SOMI for AD diagnosis was similar to that of the CDR-SB (AUC: 85%versus 83%). In separate models, both SOMI and CDR-SB predicted Braak stage. In a joint model SOMI remained a significant predictor of Braak stage but CDR-SB did not.Conclusion: SOMI provides a neuropathologically validated staging system for episodic memory impairment in the AD continuum and should be useful in predicting tau positivity based on its association with Braak stage. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the sensitivity and specificity of the 6‐item Identify Chronic Migraine screener (ID‐CM[6]), designed to improve the detection of chronic migraine (CM). Background: CM is often undertreated and underdiagnosed. Survey‐based studies have found that approximately 75–80% of people meeting criteria for CM do not report having received an accurate diagnosis. Methods: This study used claims data of patients enrolled in a large medical group who had at least one medical claim with an International Classification of Diseases 9th/10th revision diagnostic code for migraine in the 12‐month prescreening period. The Identify Chronic Migraine survey was administered by e‐mail, in‐person, or over the telephone to all enrolled patients. A Semi‐Structured Diagnostic Interview (SSDI) was administered by telephone by a trained physician. The ID‐CM(6) and SSDI classifications of CM status were compared to evaluate sensitivity and specificity of the ID‐CM(6) screening tool. Results: The analysis of the ID‐CM(6) screening tool included 109 patients, with 65/109 (59.6%) positive for CM based on the SSDI. The mean (standard deviation) age of the patient sample was 49 (15) years and 100/109 (91.7%) were female. Using the SSDI as the diagnostic gold standard, the ID‐CM(6) had a sensitivity of 70.8% (46/65) and a specificity of 93.2% (41/44). Conclusion: The ID‐CM(6) demonstrated acceptable sensitivity and good specificity in determining CM status. The results of this analysis support the real‐world utility of the ID‐CM(6) as a simple and useful tool to identify patients with CM. [ABSTRACT FROM AUTHOR]

Aims: To investigate the effectiveness of single and concomitant treatment of migraine and temporomandibular disorders (TMD) in women with the comorbidity. Methods: Eligible female patients met International Classification of Headache Disorders, second edition (ICHD-2) criteria for migraine with or without aura and the Research Diagnostic Criteria for myofascial TMD (Grade ll or lll). After a run-in period (30 days), women with both migraine and TMD were enrolled into a four-arm, double-blind, placebocontrolled, factorial study testing the separate and joint effects of a migraine treatment (propranolol 90 mg) and a TMD treatment (stabilization splint [SS]) in four groups of patients. The four treatment groups were propranolol and SS (n = 22); propranolol placebo and SS (n = 23); propranolol and non-occlusal splint (NOS) (n = 23); and propranolol placebo and NOS (n = 21). The primary endpoint for migraine was change in headache days from baseline to the third month, and the secondary endpoint was change in days with at least moderate headache in the same period. The TMD endpoints included pain threshold and mandibular vertical range of motion. Data were analyzed using analysis of variance (ANOVA, Dunn's post-hoc test) or Kruskal-Wallis test. Results: For the primary endpoint, in intention-to-treat (ITT) analyses (n = 94), propranolol and SS were associated with a nonsignificant reduction in the number of headache days, relative to all other groups. For per-protocol (PP) Completer analyses (n = 89), differences in the number of headache days reached significance (P < .05). The propranolol and SS group was significantly superior to the other groups on all other headache endpoints and in disability, in both ITT and PP analyses. No significant differences among groups were seen for the TMD parameters. Conclusion: In women with TMD and migraine, migraine significantly improved only when both conditions were treated. The best treatment choice for TMD pain in women with migraine is yet to be defined. [ABSTRACT FROM AUTHOR]

Background: Migraine is typically divided into 2 headache frequency denominated categories, episodic migraine (EM) and chronic migraine (CM). Characterizing more narrow headache day frequency groups may be of value for better understanding the broad range of migraine experience and making treatment decisions. Objective: To characterize the impact and burden of migraine in 4 monthly headache day (MHD) categories. Methods: Respondents to the American Migraine Prevalence and Prevention Study 2005 survey who met criteria for migraine were categorized into low frequency episodic migraine (LFEM) 0‐3, moderate frequency episodic migraine (MFEM) 4‐7, high frequency episodic migraine (HFEM) 8‐14, and CM with ≥15 headache days per month. Data including sociodemographics, headache features and symptomology, comorbidities, cutaneous allodynia, and severe migraine‐related disability were compared among groups. We combined the low‐ and medium‐frequency EM groups (L/MFEM) and compared them with the HFEM group in 1 set of models and compared the HFEM and CM groups in a second set of models. Binary logistic regression, linear regression, and ordered logistic regression were used depending upon the variable type and adjusted for sociodemographics. Results: Among 11,603 eligible respondents with migraine, 67.7% (7860/11,603) were categorized with LFEM, 17.7% (2051/11,603) with MFEM, 7.8% (898/11,603) with HFEM, and 6.8% (794/11,603) with CM. The mean age was 46 (SD 13.7), 80.2% (9301/11,603) were female, and 90.0% (10,187/11,323) were White, 6.9% were Black (784/11,323), and 3.1% (352/11,323) were identified as Other race(s). Individuals with HFEM differed from L/MFEM on a wide range of sociodemographic variables in the categories of headache features, disability, and comorbidities while few differences were found when modeling HFEM vs CM. In comparison with L/MFEM and HFEM, the HFEM group was more likely to have severe disability (P <.001 OR = 1.74 [1.42, 2.15]), chronic pain (P ≤.007 OR = 1.35 [1.09, 1.69]), arthritis (P =.001 OR = 1.44 [1.15, 1.80]), high cholesterol (P =.005, OR = 1.37 [1.10, 1.70]), ulcers (P =.016, OR = 1.44 [1.07, 1.93]), and depression (Patient Health Questionnaire [PHQ‐9]) (P <.001 OR = 1.50 [1.22, 1.84]). Conclusion: While rates of migraine symptoms, headache impact and disability, and comorbidities generally increased with increases in MHD frequency, respondents with HFEM and CM were remarkably similar on a broad range of variables including sociodemographics, disability/impact, and comorbidities. There were many more significant differences between the HFEM and L/MFEM groups on the same variables. Future work should use empirical strategies to identify naturally occurring groups and possibly reconsider the boundary between CM and HFEM. [ABSTRACT FROM AUTHOR]

Objective: To examine the influences of depression and anxiety on headache‐related disability in people with episodic migraine or chronic migraine. Background: Depression and anxiety are common comorbidities in people with migraine, especially among those with chronic migraine. Methods: This cross‐sectional analysis of data from the longitudinal, internet‐based Chronic Migraine Epidemiology and Outcomes Study assessed sociodemographic and headache features, and headache‐related disability (Migraine Disability Assessment Scale). Four groups were defined based on scores from validated screeners for depression (9‐item Patient Health Questionnaire) and anxiety (7‐item Generalized Anxiety Disorder Scale): depression alone, anxiety alone, both, or neither. Results: Respondents (N = 16,788) were predominantly women (74.4% [12,494/16,788]) and white (84.0% [14,044/16,788]); mean age was 41 years. Depression was more likely in persons with chronic migraine vs episodic migraine (56.6% [836/1476] vs 30.0% [4589/15,312]; P <.001), as were anxiety (48.4% [715/1476] vs 28.1% 4307/15,312]; P <.001) and coexisting depression and anxiety (42.0% [620/1476] vs 20.8% [3192/15,312]; P <.001). After controlling for headache frequency and other covariates, depression alone, and anxiety alone were associated with 56.0% (rate ratio [RR], 1.56; 95% confidence interval [CI], 1.46‐1.66) and 39.0% (RR, 1.39; 95% CI, 1.30‐1.50) increased risks of moderate/severe migraine‐related disability (both P <.001), respectively; the combination had an even greater effect on risk of moderate/severe disability (79.0% increase; RR, 1.79; 95% CI, 1.71‐1.87; P <.001). Conclusions: Depression alone and anxiety alone are associated with greater headache‐related disability after controlling for sociodemographic and headache features. Coexisting depression and anxiety are more strongly associated with disability than either comorbidity in isolation. Interventions targeting depression and anxiety as well as migraine itself may improve headache‐related disability in people with migraine. [ABSTRACT FROM AUTHOR]

Objective: The primary aim of this exploratory study was to assess the relationship between anxiety sensitivity and emotional disorders, migraine characteristics, and migraine‐related fear and avoidance behaviors in women with probable migraine. Background: Anxiety and depressive disorders are the most frequent comorbid psychiatric conditions in migraine, particularly in women; however, the underlying reasons for these comorbidities are uncertain. Anxiety sensitivity, the tendency to catastrophically appraise anxiety and bodily sensations in terms of their physical, social, or cognitive consequences, is a psychological factor that may contribute to the comorbidity of anxiety and depressive disorders and migraine. It was hypothesized that anxiety sensitivity would be associated with greater migraine severity and psychiatric symptoms. Method: Participants were women (n = 100) who screened positive for migraine on the validated IDMigraine Screener participated in an anonymous single‐session online survey‐based study on migraine. The Anxiety Sensitivity Index‐3 total and subscales scores were used to assess anxiety sensitivity. Anxiety and depression symptoms were assessed with the brief Patient Health Questionnaire. Results: On average, anxiety sensitivity was clinically elevated (mean ± SD: 24.0 ± 15.2). Anxiety sensitivity cognitive and social concerns were most strongly correlated with severity of anxiety (r's = .38‐.46) and depressive symptoms (r = .35‐.39, P's < .001), and all anxiety sensitivity facets were related to fear of head pain (r's = .35‐.38, P's < .001). Anxiety sensitivity cognitive concern facet was uniquely related to headache patterns, including longer migraine attack duration (r = .22, P = .029) and pain intensity (r = .24, P = .029), pain‐related avoidance, including avoiding movement and more frequent misuse of prescribed or non‐prescribed pain medication (r's = .20‐.21, P's < .01). Conclusions: These novel findings indicate that anxiety sensitivity, specifically fearful appraisal of bodily sensations, are linked to both psychiatric symptoms and migraine severity in women. In this cross‐sectional study, causal sequence cannot be determined. If anxiety sensitivity leads to more severe pain and psychiatric distress, targeting anxiety sensitivity could lead to better headache outcomes. [ABSTRACT FROM AUTHOR]

Objectives: To assess the measurement properties of the Migraine‐Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) electronic patient‐reported outcome (ePRO) Role Function‐Restrictive (RFR) domain to evaluate the functional impact of migraine in patients with episodic (EM) or chronic migraine (CM) enrolled in clinical trials. Methods: The 7‐item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG [n = 851] and CGAH [n = 909]) and 1 CM (CGAI [n = 1090]) Phase 3 galcanezumab clinical trials. Anchor‐ and distribution‐based analyses were utilized to derive a responder threshold for clinical interpretation of change over time. The Migraine Disability Assessment (MIDAS), Patient Global Impression of Severity (PGI‐S), Patient Global Impression of Improvement (PGI‐I), and migraine headache days (MHD) served as anchors. Responsiveness and responder threshold analyses were completed from baseline to the average of months 4‐6 for EM studies, and from baseline to month 3 for the CM study; timeframes selected were based on the primary endpoints in these studies. Results: Cronbach's alpha values for internal consistency reliability were 0.93, 0.92, and 0.92, for CGAG, CGAH, and CGAI, respectively. Test–retest reliability intra‐class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients. Convergent validity was supported by moderate to strong correlations (≥0.30) between the RFR and both MIDAS and PGI‐S. Known‐groups validity was established between subgroups stratified by baseline PGI‐S and MHD (P < .05; δ = 0.35‐1.96). For the EM studies, anchor variables suggested a change of ≥25 points (equivalent to 9 points/state changes on raw scale) in the RFR was an appropriate threshold to interpret a treatment benefit. For the CM study a change of ≥17.14 points (6 points/state changes on raw scale) was an appropriate threshold. In all 3 studies, significantly (P < .01) more galcanezumab patients achieved the responder definition thresholds, as compared to placebo (odds ratios of 1.98, 2.45, 2.27, 2.44, 1.64, and 1.66 for the 120 and 240 mg arms in the CGAG, CGAH, and CGAI trials, respectively). Conclusion: The MSQv2.1 ePRO RFR has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in EM and CM clinical trials to assess the functional impact of migraine. [ABSTRACT FROM AUTHOR]

Objectives: We examined the cross‐sectional association of sleep apnea and indices of sleep quality with both episodic migraine (EM) and chronic migraine (CM). Background: Sleep apnea and abnormal patterns of sleep, such as insomnia, were associated with migraine onset, severity, and progression in previous research. Methods: The Chronic Migraine Epidemiology & Outcomes Study, a longitudinal study, used a series of web‐based surveys to assess migraine symptoms, burden, and patterns of health care utilization. Quota sampling was used from September 2012 to November 2013 to generate a representative sample of the US population. Persons who screened positive for sleep apnea on the Berlin Questionnaire are said to be at "high risk" for sleep apnea. Respondents indicated if they believed that they had sleep apnea, if a physician had diagnosed it, and if and how they were treated. Other aspects of sleep quality were assessed using the Medical Outcomes Study (MOS) Sleep Measures. Results: Of 12,810 eligible respondents with migraine and data on sleep, 11,699 with EM (91.3%) and 1111 with CM (8.7%) provided valid data for this analyses. According to the Berlin Questionnaire, 4739/12,810 (37.0%) were at "high risk" for sleep apnea, particularly persons with CM vs EM (575/1111 [51.8%] vs 4164/11,699 [35.6%]), men vs women (1431/3220 [44.4%] vs 3308/9590 [34.5%]), people with higher body mass index, and older people (all P < .001). Among respondents to the MOS Sleep Measures, persons with CM were more likely to report poor sleep quality than those with EM, including sleep disturbance (mean [SD] values: 53.2 [26.9] vs 37.9 [24.3]), snoring (38.0 [33.9] vs 31.0 [32.1]), shortness of breath (34.9 [29.8] vs 15.3 [20.6]), somnolence (44.1 [23.4] vs 32.2 [21.2]), and less likely to report sleep adequacy (34.0 [24.2] vs 39.2 [22.1]). Conclusions: Compared with respondents with EM, a larger proportion of those with CM were at "high risk" for sleep apnea and reported poor sleep quality. This reflects an association between CM vs EM and sleep apnea and poor sleep quality; the potential relationships are discussed. [ABSTRACT FROM AUTHOR]

The effects of soccer-related head impacts, beyond overt concussions, on Patient Reported Outcomes (PROs) have not been explored to date. Generalized estimating equations were employed to determine the association between soccer-related head impacts (headers in the prior 2 weeks, unintentional head impacts in the prior 2 weeks, headers in the prior 12 months and lifetime concussions) on PROs including depression, anxiety, sleep disturbance and sleep impairment. Compared to players with no unintentional head impacts in the prior 2 weeks, players with one unintentional exposure reported more symptoms of anxiety (p = 0.002) and players with 2+ exposures reported more symptoms of depression (p = 0.006) and anxiety (p < 0.001). In contrast, players in the 3rd Quartile of 12 mo. headers reported less anxiety (p = 0.001), sleep disturbance (p = 0.002) and sleep impairment (p < 0.001) compared to those in the 1st quartile. Unintentional head impacts are associated with worse PROs while more headers are paradoxically associated with better PROs. [ABSTRACT FROM AUTHOR]

Background: Emergency department (ED) visits for migraine are burdensome to patients and to the larger healthcare system and society. Thus, it is important to determine strategies used to prevent ED visits and the common communication patterns between headache specialists and the ED team. Objective: We sought to understand: (1) Whether headache specialists use headache management protocols. (2) The strategies they use to try and reduce the number of ED visits for headache. (3) Whether protocols are used in the EDs with which they are affiliated. (4) The level of satisfaction with the coordination of care between headache physicians and the ED. Methods: We surveyed via SurveyMonkey members of the American Headache Society Emergency Department/Refractory/Inpatient (EDRI) Section to understand their practice regarding patients who call their office to be seen urgently, and to understand their communication with their local EDs. Results: There were 96 eligible AHS members, 50 of whom responded to questionnaires either by email or in person (52%). Of these, 59% of respondents reported giving rescue treatment to their patients to manage acute attacks. Fifty‐four percent reported using standard protocols for outpatients not responding to usual acute treatments. In the event of a request for urgent care, 12% of specialists reported bringing patients into the office most or all of the time, and 20% reported sending patients to the ED some or most of the time for headache management. Thirty‐six percent reported prescribing a new medicine and 30% reported providing telephone counseling some/most/all of the time. Sixty percent reported that their ED has a protocol for migraine management. Overall, 38% were usually or very satisfied with the headache care in the ED. Conclusions: A substantial number of headache specialists are dissatisfied with the care their patients receive in the ED. More standardized protocols for ED visits by patients with known headache disorders, and clear guidelines for communication between ED providers and treating physicians, along with better methods for follow‐up following discharge from the ED, might appear to improve this issue. [ABSTRACT FROM AUTHOR]

Background We evaluated the effect of erenumab, a fully human monoclonal antibody that inhibits the canonical calcitonin gene-related peptide receptor, on migraine-related disability, impact, and health-related quality of life among patients with episodic migraine. Methods Patients enrolled in a phase 3, 6-month, double-blind, placebo-controlled study of once-monthly erenumab 70 and 140 mg for migraine prevention (STRIVE) used an eDiary during the baseline and double-blind treatment phases to complete validated, specific questionnaires, including the modified (monthly) Migraine Disability Assessment Questionnaire; Headache Impact Test; and Migraine-Specific Quality of Life Questionnaire-role function-restrictive (MSQ-RFR), -role function-preventive (MSQ-RFP), and -emotional function (MSQ-EF). Results A total of 955 patients were randomized to receive erenumab 70 mg (n = 317), erenumab 140 mg (n = 319), or placebo (n = 319). Erenumab versus placebo resulted in significantly greater improvements in all patient-reported outcomes; changes from baseline were numerically higher with 140 mg erenumab. Improvements occurred rapidly and were maintained over 6 months of treatment. Between-group differences from placebo over months 4-6 for the 70- and 140-mg dose groups were, respectively, -2.1 and -2.8 for modified (monthly) Migraine Disability Assessment Questionnaire, -2.1 and -2.3 for Headache Impact Test, 5.1 and 6.5 for MSQ-RFR, 4.2 and 5.4 for MSQ-RFP, and 5.2 and 6.7 for MSQ-EF ( p < 0.001 for all). Erenumab also significantly reduced the proportion of patients with severe and very severe migraine-related disability and increased the proportion of patients with clinically meaningful improvements in migraine-related impact and health-related quality of life. Conclusion Erenumab reduced migraine disability and impact and improved patients' health-related quality of life, reinforcing its role as a promising new therapy for migraine prevention. [ABSTRACT FROM AUTHOR]

Abstract: Objective – To evaluate 12‐week changes from baseline of 2 disease‐specific patient‐reported outcome (PRO) measures in adults with migraine treated with galcanezumab, an investigational humanized antibody binding calcitonin gene‐related peptide (CGRP), or placebo. Background – Preventing headache‐related functional impairment is an important goal of migraine preventive treatment and a measurement target for PROs. Understanding which drugs have the potential to improve patient functioning in addition to preventing migraine headaches is vital to lessening patient burden. Design/Methods – This Phase 2b double‐blind, randomized, placebo‐controlled study enrolled adults with episodic migraine. Galcanezumab (120 mg subcutaneous injection; n = 60) or placebo (n = 127) was administered every 28 days for 12 weeks. Post hoc secondary analyses were conducted for those who completed 12 weeks of treatment on 2 PROs: The Migraine‐Specific Quality of Life Questionnaire (MSQ) v2.1 and the Headache Impact Test™ (HIT‐6). Results – Analysis of covariance revealed significant differences in least square mean changes from baseline between galcanezumab and placebo for all MSQ domains including total mean change placebo of 18.63, galcanezumab of 27.36 (95% CI 2.449, 15.008; P‐value of .0067); Role Function‐Restrictive mean change placebo of 22.40, galcanezumab of 31.92 (95% CI 2.636, 16.518; P‐value of .0071); Role Function‐Preventive mean change placebo of 13.43, galcanezumab of 19.76 (95% CI 0.476, 12.185; P‐value of .0342); and Emotional Function mean change placebo of 16.88, galcanezumab of 26.61 (95% CI 2.789, 16.674; P‐value of .0063). At baseline, mean number of migraine headache days (MHDs) did not correlate with MSQ total scores or HIT‐6. At 12 weeks post‐treatment, MHD correlated with MSQ and HIT‐6 scores (all P < .0001). Change in MHD was associated with change in MSQ domains and change in HIT‐6 scores (all P < .0001). Conclusions – In comparison with placebo, treatment with galcanezumab was associated with significant functional improvements as reflected by changes in MSQ scores. Change in MHD was associated with improvements in MSQ and reductions in HIT‐6 scores, indicating the clinical importance of these changes in relation to PROs that measure function. [ABSTRACT FROM AUTHOR]

Objective: To identify natural subgroups of people with migraine based on profiles of comorbidities and concomitant conditions, hereafter referred to as comorbidities. Background: Migraine is a heterogeneous disease. Identifying natural subgroups (endophenotypes) may facilitate biological and genetic characterization and the development of personalized treatment. Methods: The Chronic Migraine Epidemiology and Outcomes Study is a prospective web‐based survey study designed to characterize the course of migraine and related comorbidities in a systematic US sample of people with migraine. Respondents were asked if they ever had a specific comorbidity and, if present, whether the comorbidity was confirmed/diagnosed by a “doctor”; 62 comorbidities were available for analysis. Latent class analysis (LCA) modeling determined the optimal number of classes and a parsimonious set of comorbidities. Results: Of the 12,810 respondents with migraine, 11,837 reported ≥1 comorbidity and were included in this analysis. After statistical analysis and clinical judgment reduced the number of comorbidities, we selected an 8‐class model based on 22 comorbidities. Each class had a distinct pattern summarized as follows: Class 1, Most Comorbidities; Class 2, Respiratory/Psychiatric; Class 3, Respiratory/Pain; Class 4, Respiratory; Class 5, Psychiatric; Class 6, Cardiovascular; Class 7, Pain; Class 8, Fewest Comorbidities. The distribution of individuals across models was variable, with one‐third of respondents in Class 8 (Fewest Comorbidities) and <10% in Class 1 (Most Comorbidities). Demographic and headache characteristics, not used in assigning class membership, varied across classes. For example, comparing Class 1 (Most Comorbidities) and Class 8 (Fewest Comorbidities), Class 1 had a greater proportion of individuals with severe disability (Migraine Disability Assessment grade IV; 48.1% vs 22.3% of overall individuals) and higher rates of allodynia (67.6% vs 47.0%), medication overuse (36.4% vs 15.0%), chronic migraine (23.1% vs 9.1%), and aura (40.1% vs 28.8%). Conclusions: LCA modeling identified 8 natural subgroups of persons with migraine based on comorbidity profiles. These classes show differences in demographic and headache features not used to form the classes. Subsequent research will assess prognostic and biologic differences among the classes. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of parental migraine on adolescents (aged 13‐21 years) living within the parental home from the adolescent's perspective. Background: Family members are affected by their parent's migraine. We surveyed adolescents on the social, academic, and emotional effects of their parent's migraine. Methods: The Chronic Migraine Epidemiology and Outcomes (CaMEO) study was a longitudinal Web‐based study with cross‐sectional modules designed to assess migraine symptoms, severity, frequency, and disability; migraine‐related consulting practices, healthcare utilization, medication use, comorbid health conditions, and family related burden associated with migraine. The Family Burden Module (adolescent version; FBM‐A) from the CaMEO study assessed parents with migraine and adolescent household members (dyads). Adolescents ranged in age from 13‐21 years and were living at home with their parent. The initial FBM‐A survey included 52 items covering five domains, which was refined and reduced by confirmatory factor analysis to 36 items covering four domains. Depression (9‐item Patient Health Questionnaire) and anxiety (7‐item Generalized Anxiety Disorder scale) were assessed. Item responses were stratified by parent migraine status (episodic migraine [EM], <15 headache days/month; chronic migraine [CM], ≥15 headache days/month). Frequencies of activities/events missed because of parental headache were categorized as ≥1 time or ≥4 times/previous 30 days. Results: The sample included 1,411 parent‐adolescent dyads (parent with EM, n = 1,243 [88.1%]; parent with CM, n = 168 [11.9%]). Burden due to a parent's migraine was reported in four domains based on 36 items including: Loss of Parental Support and Reverse Caregiving (5 items); Emotional Experience (13 items); Interference with School (4 items); and Missed Activities and Events (14 items). Across domains, perceived burden was greater for adolescents of parents with CM vs EM. Rates of moderate‐to‐severe anxiety symptoms were higher among adolescents of parents with CM (6.2 vs 11.3%, P = .01), while moderate‐to‐severe depression symptom rates were similar (5.5 vs 8.9%, P = .08). More adolescents of CM vs EM parents reported having a headache within the previous 3 months (P < .001). Conclusions: Parental migraine negatively impacts adolescent children, extending our understanding of the family burden of migraine and emphasizing the potential benefit to children of optimizing migraine care. [ABSTRACT FROM AUTHOR]

Objective In a population sample of persons with migraine treating with a single category of acute migraine medication, to identify rates and factors associated with acute treatment outcomes, including 2-hour pain freedom (2hPF), 24-hour pain response (24hPR), and 24-hour sustained pain response (24hSPR). Key predictors include acute treatment type (triptans and other medication categories), the influence of allodynia on response to medication, and the interaction between medication category and presence of allodynia in response to treatment among people with migraine. Background Cutaneous allodynia was previously associated with inadequate 2hPF, 24hPR, and 24hSPR (sustained response at 24 hours among those with adequate 2hPF) among people with migraine in the American Migraine Prevalence and Prevention (AMPP) Study. Methods The AMPP Study obtained data from a representative US sample of persons with migraine by mailed questionnaire. The 2006 survey included 8233 people with migraine aged 18 or over who completed the Migraine Treatment Optimization Questionnaire (mTOQ). mTOQ was used to assess acute treatment outcomes including 2hPF, 24hPR, and 24hSPR. Eligible individuals used only a single category of acute prescription migraine treatments (n = 5236, 63.6%). This sample was stratified into 5 categories of type of acute prescription headache medication used (triptans, nonsteroidal anti-inflammatory drugs, barbiturate-combinations, opioids, and opioid combinations and ergot alkaloids). Separate binary logistic regression models evaluated: (1) triptans vs other medication types; (2) presence of allodynia vs no allodynia; and (3) the interaction of medication category with allodynia. Sociodemographic variables, health insurance status, over-the-counter and preventive medication use were included as covariates. Odds ratios (OR) and 95% confidence intervals (CI) were generated for each acute treatment outcome. Results Among eligible participants, the mean age was 46 years, and 82.5% were women. The triptan use group had better outcomes than other medication groups for 2hPF (OR range: 2.00-2.63, all significant except ergot alkaloids) and 24hPR (OR range: 2.10-6.22, all significant). No significant medication effects were found for the 24hSPR outcome. The presence of allodynia was associated with significantly worse outcomes for both 2hPF (OR range: 1.42-1.55, all significant) and 24hPR (OR range: 1.30-1.32, all significant, except for ergot alkaloids, P = .051). Allodynia effects were not significant for the 24hSPR. The interaction between medication and allodynia was also not significant (OR range for 2hPF: .68-2.02; OR range for 2hPR: .35-1.34; OR range for 24hSPR: 1.21-2.72) in any of the models, suggesting allodynia is an important predictor of treatment response regardless of the medication group prescribed. Conclusions The use of triptan medication was associated with significantly better 2hPF (except vs ergot alkaloids) and significantly better 24hPR outcomes compared with other acute medication categories. The presence of allodynia significantly increased the likelihood of an inadequate treatment response for both of these outcomes. Triptan use was generally associated with the best outcomes. Because allodynia was associated with inadequate outcomes for all medication groups, we suggest that allodynia is an area of unmet treatment need. [ABSTRACT FROM AUTHOR]

Background Pain acceptance involves willingness to experience pain and engaging in valued activities while pain is present. Though pain acceptance could limit both headache-related disability and pain interference in individuals with migraine, few studies have addressed this issue. This study evaluated whether higher levels of total pain acceptance and its two subcomponents, pain willingness and activity engagement, were associated with lower levels of headache-related impairment in women who had both migraine and overweight/obesity. Methods In this cross-sectional study, participants seeking weight loss and headache relief in the Women's Health and Migraine trial completed baseline measures of pain acceptance (Chronic Pain Acceptance Questionnaire [CPAQ]), headache-related disability (Headache Impact Test-6), and pain interference (Brief Pain Inventory). Migraine headache frequency and pain intensity were assessed daily via smartphone diary. Using CPAQ total and subcomponent (pain willingness and activity engagement) scores, headache frequency, pain intensity, and body mass index (BMI) as predictors in linear regression, headache-related disability, and pain interference were modeled as outcomes. Results On average, participants (n = 126; age = 38.5 ± 8.2 years; BMI = 35.3 ± 6.6 kg/m2) reported 8.4 ± 4.7 migraine days/month and pain intensity of 6.0 ± 1.5 on a 0-10 scale on headache days. After correcting for multiple comparisons (adjusted α = .008), pain willingness was independently associated with both lower headache-related disability ( P < .001; β = −0.233) and pain interference ( P < .001; β = −0.261). Activity engagement was not associated with headache-related disability ( P = .128; β = −0.138) and pain interference ( P = .042; β = −0.154). CPAQ total score was not associated with headache-related disability ( P = .439; β = 0.066) and pain interference ( P = .305; β = 0.074). Pain intensity was significantly associated with outcomes in all analyses ( Ps < .001; βs 0.343-0.615). Conclusions Higher pain willingness, independent of degree of both migraine severity and overweight, is associated with lower headache-related disability and general pain interference in treatment-seeking women with migraine and overweight/obesity. Future studies are needed to clarify direction of causality and test whether strategies designed to help women increase pain willingness, or relinquish ineffective efforts to control pain, can improve functional outcomes in women who have migraine and overweight/obesity. [ABSTRACT FROM AUTHOR]

Objective To evaluate the relationships among modifiable psychological factors and chronic migraine and severe migraine-related disability in a clinic-based sample of persons with migraine. Background Evidence evaluating relationships between modifiable psychological factors and chronic migraine and severe migraine-related disability is lacking in people with migraine presenting for routine clinical care. Methods Adults with migraine completed surveys during routinely scheduled visits to a tertiary headache center. Participants completed surveys assessing chronic migraine (meeting criteria for migraine with ≥15 headache days in the past month), severe migraine disability (Migraine Disability Assessment Scale score ≥ 21), and modifiable psychological factors (depressive symptoms [Patient Health Questionnaire-9], anxious symptoms [Generalized Anxiety Disorder-7], Pain Catastrophizing Scale and Headache Specific Locus of Control). Logistic regression evaluated relationships between modifiable psychological factors and chronic migraine and severe migraine disability. Results Among 90 eligible participants the mean age was 45.0 (SD = 12.4); 84.8% were women. One-third (36.0%) met study criteria for chronic migraine; half of participants (51.5%) reported severe migraine-related disability. Higher depressive symptoms (OR = 1.99, 95% CI = 1.11, 3.55) and chance HSLC (OR = 1.85, 95% CI = 1.13, 1.43) were associated with chronic migraine. Higher depressive symptoms (OR = 3.54, 95%CI = 1.49, 8.41), anxiety symptoms (OR = 3.65, 95% CI = 1.65, 8.06), and pain catastrophizing (OR = 1.95, 95% CI = 1.14, 3.35), were associated with severe migraine-related disability. Conclusions Psychiatric symptoms and pain catastrophizing were strongly associated with severe migraine-related disability. Depression and chance locus of control were associated with chronic migraine. This study supports the need for longitudinal observational studies to evaluate the relationships among naturalistic variation in psychological factors, migraine-related disability, and migraine chronification. [ABSTRACT FROM AUTHOR]

Background/Objective Previous studies suggest that migraine might be associated with female sexual dysfunction (FSD), although this association may be complicated by overweight/obesity. To disentangle relationships of migraine and obesity with FSD, we examined: (1) FSD rates in women who had migraine and obesity with a matched sample of women with obesity who were free of migraine and (2) associations between indices of migraine severity and FSD in a larger sample of participants with migraine and overweight/obesity, controlling for important confounders. Methods Women with migraine and obesity seeking behavioral weight loss treatment to decrease headaches ( n = 37) and nonmigraine controls ( n = 37) with obesity seeking weight loss via bariatric surgery were matched on age (±5 years), body mass index (BMI; ±3 kg/m2), and reported sexual activity during the past month. Both groups completed the Female Sexual Function Index (FSFI), with a validated FSFI-total cutoff score used to define FSD. In participants with migraine and overweight/obesity ( n = 105), separate logistic regression models evaluated associations of migraine attack frequency, intensity, and duration with odds of having FSD, controlling for age, BMI, depression, and anxiety. Results On average, participants and matched controls had severe obesity (BMI = 42.4 ± 3.8 kg/m2; range = 35-49.9) and were 37.3 ± 7.2 years of age (range = 22-50). FSD rate did not differ between migraine participants and controls (56.8% vs. 54.1%, P = .82). In the larger sample of participants with migraine and overweight/obesity (38.2 ± 7.8 years of age; BMI = 34.8 ± 6.4 [range = 25-50 kg/m2]; 8.0 ± 4.3 migraine days/month, maximum pain intensity = 5.9 ± 1.4 on 0-10 scale; average attack duration = 18.3 ± 9.7 hours), FSD was not associated with attack frequency ( P = .31), pain intensity ( P = .92), or attack duration ( P = .35) but was associated with more severe anxiety symptoms ( Ps < .017). Conclusions Rates of sexual dysfunction did not differ in severely obese women with and without migraine. Moreover, indices of migraine severity were not associated with increased risk of FSD in women with overweight/obesity. Replication of present findings in wider populations of women with migraine and of both normal-weight and overweight/obese status are warranted. [ABSTRACT FROM AUTHOR]

Background: Among older adults, pain intensity and pain interference are more common in women than men and associated with obesity and inflammatory markers.Objective: We examined whether the obesity and pain relationship is mediated by the high-sensitivity C-reactive protein (hsCRP), a nonspecific marker of systemic inflammation, and whether this relationship differs by sex.Methods: Items from Medical Outcomes Study Short Form-36 were used to measure pain intensity and pain interference in daily life. Ordinal logistic regression was used to assess the cross-sectional association among body mass index (BMI), hsCRP levels, pain intensity and pain interference using gender-stratified models adjusted for demographic variables.Results: Participants included 667 community-residing adults over the age of 70 years, free of dementia, enrolled in the Einstein Aging Study (EAS). In women (n = 410), pain intensity was associated with obesity [BMI ≥30 vs. normal, odds ratio (OR) = 2.29, 95% confidence interval (CI) 1.43-3.68] and higher hsCRP (OR = 1.28, 95% CI 1.08-1.51). In a model with obesity and hsCRP, both remained significant, but the association between hsCRP and pain intensity was somewhat attenuated. Obesity (OR = 3.04, 95% CI 1.81-5.11) and higher hsCRP levels (OR = 1.30, 95% CI 1.08-1.56) were also independently associated with greater pain interference in women. After adjustment for pain intensity and BMI, hsCRP was no longer associated with pain interference in women. Greater pain intensity and being overweight or obese continued to be significantly associated with pain interference in women. In men (n = 257), obesity and hsCRP were not associated with pain intensity or pain interference.Conclusions: In women, the relationship between obesity and higher levels of pain intensity or interference may be accounted for by factors related to hsCRP. [ABSTRACT FROM AUTHOR]

Background Pain freedom at 2 hours and sustained pain response at 24 hours are important outcomes of acute migraine therapy. Some studies have examined rates and predictors of successful treatment outcomes for single attacks in clinical trials. However, little is known about predictors of typical response to acute treatment over multiple attacks in the population. Objectives To identify sociodemographic features, headache characteristics, comorbidities and treatment-related factors that predict acute treatment success or failure at 2 hours and 24 hours post dose in a US population sample of persons with episodic migraine. Methods Eligible respondents completed the 2006 American Migraine Prevalence and Prevention Study survey, met criteria for episodic migraine, reported the use of acute treatment for migraine and answered questions on acute treatment outcomes from the Migraine Treatment Optimization Questionnaire (mTOQ). One question focused on 2 hour pain free (2hPF) response and the other focused on pain relief at 2 hours and 24 hours (24hPR). For each question, responses were considered adequate if they were achieved 'half the time or more' and inadequate if they were achieved 'never,' 'rarely,' or 'less than half the time.' Models were run to identify predictors of outcomes in relation to usual acute treatment: (1) Inadequate 2hPF response; (2) Inadequate 24hPR response; and (3) Inadequate 24 hour Sustained Pain Freedom (24hSPF), which was a conditional analysis of pain freedom at 24 hours among those who initially had an adequate pain freedom response at 2 hours. Binary logistic regression models were used to separately predict each of the 3 outcomes adjusting for covariates. Potential predictor variables were analyzed independently and variables that did not contribute significantly to outcome prediction were trimmed. The retained variables were entered into a final multivariable binary logistic regression that included age, sex, and the covariates that survived the trimming process. Odds ratio (OR) and 95% confidence interval (CI) statistics were generated for each variable. A value of P ≤ .05 was used to identify statistically significant variables. Results Among 8233 eligible respondents with episodic migraine, 56.0% of respondents reported Inadequate 2hPF response to usual acute treatment and 53.7% reported Inadequate 24hPR. Among the 44.0% of individuals who achieved Adequate 2hPF (N = 3621), 25.7% reported Inadequate 24hSPR or recurrence. Significant predictors of Inadequate 2hPF response included demographic variables (male sex and higher body mass index [BMI]), headache features (higher headache pain intensity, cutaneous allodynia, more headache days per month), comorbidity (depression), and migraine pharmacologic treatment factors (not using preventive migraine medications). Significant predictors of Inadequate 24hPR included headache features (more headache days per month, higher migraine symptom severity composite score, cutaneous allodynia), comorbidity (depression), and migraine pharmacologic treatment factors (medication overuse). Significant predictors of Inadequate 24hSPR were greater monthly headache day frequency, cutaneous allodynia, depression, medication overuse, and higher migraine symptom severity composite score. Conclusions These results provide a snapshot of the effectiveness of usual acute treatment as well as predictors of inadequate acute treatment response in a large population sample of people with episodic migraine. These results highlight the high rates of unmet treatment needs in people with migraine. Similarities and differences in predictors vary with outcome for reasons that are discussed. [ABSTRACT FROM AUTHOR]

Objectives To examine the association between diet and executive function, episodic memory and global verbal cognition in the Einstein Aging Study ( EAS) cohort and determine whether race modifies this relationship. Design Cross-sectional. Setting Community. Participants EAS participants without dementia who completed the Rapid Eating and Activity Assessment for Patients ( REAP) (N = 492). Measurements The previously validated REAP is based on the 2000 U.S. dietary guidelines. REAP scores were dichotomized as less-healthy (

Objective To compare the methods and baseline characteristics of the American Migraine Prevalence and Prevention (AMPP) and Chronic Migraine Epidemiology and Outcomes (CaMEO) studies. Background The AMPP and CaMEO studies are the largest longitudinal efforts designed to improve our understanding of episodic and chronic migraine in the United States. The studies have complementary strengths and weaknesses. Methods This analysis compares and contrasts the study methods and participation rates of the AMPP and CaMEO studies. We then compare and contrast baseline results in terms of demographic characteristics, headache features, and disability as measured by the Migraine Disability Assessment Scale (MIDAS) among people with episodic and chronic migraine. Results AMPP and CaMEO sampled from panels constructed to be representative of the US population. The AMPP Study collected data using a mailed questionnaire while CaMEO relied on a web survey methodology. Response rates were higher in AMPP (64.8%) than in CaMEO (16.5%). Both studies assessed headache features using the American Migraine Study/AMPP diagnostic module. Both identified persons with episodic (<15 headache days/month) and chronic migraine (≥15 headache days/month) based on the International Classification of Headache Disorders. AMPP collected data annually over 5 years, while CaMEO collected data quarterly over 15 months. Baseline demographic distribution was generally similar, indicating that each study was broadly representative of the US population. The proportion of persons with migraine who had chronic migraine was similar (AMPP, 6.6%; CaMEO, 8.8%). Respondents had similar median headache frequency (days/month) by sex for chronic migraine (AMPP: men = 21.7, women = 20.0; CaMEO: men = 20.0, women = 20.0) and episodic migraine (AMPP: men = 1.7, women = 2.0; CaMEO: men = 2.0, women = 3.0). Median MIDAS scores were substantially higher in both studies for chronic migraine (severe disability [Grade IV]; AMPP: men = 33.0, women = 45.0; CaMEO: men = 32.0, women = 38.0) than episodic migraine (little/mild disability [Grade I/II]; AMPP: men = 3.0, women = 6.0; CaMEO: men = 4.0, women = 7.0). Rates of moderate/severe disability (Grade III/IV) were substantially higher in both studies for chronic migraine (AMPP: men = 66.9%, women = 78.9%; CaMEO: men = 71.0%, women = 82.6%) than episodic migraine (AMPP: men = 23.0%, women = 31.8%; CaMEO: men = 26.7%, women = 37.9%). More women than men respondents in both studies experienced moderate/severe disability. Conclusions AMPP and CaMEO are longitudinal cohort studies that used different methods, but yielded similar results for demographic features, headache frequency, and headache-related disability. Both studies found more severe headache-related disability in those with chronic versus episodic migraine. [ABSTRACT FROM AUTHOR]

Objective To assess the rates and predictors of traversing steps essential to good medical care for chronic migraine, including: (1) medical consultation, (2) accurate diagnosis, and (3) minimal pharmacologic treatment. Candidate predictors included socioeconomic, demographic, and headache-specific variables. Background Previous research has established that barriers to effective management for episodic migraine include the absence of health insurance, lack of appropriate medical consultation, failure to receive an accurate diagnosis, and not being offered a regimen with acute and preventive treatments. Methods/Design The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a longitudinal web-based panel study of migraine, included a cross-sectional module focused on patterns of and barriers to medical care. Participants eligible for this analysis met the study criteria for chronic migraine, had evidence of headache-related disability, and provided data on health insurance status. The main outcomes in the current analysis included the proportion of respondents who sought consultation for headache with a designated healthcare professional, self-reported receiving a diagnosis of chronic or transformed migraine, and received minimal pharmacologic treatment for headache with a focus on prescribed acute and preventive treatments. Results In the CaMEO Study, 80,783 respondents provided study data, 16,789 (20.8% of respondents) met criteria for migraine, and 1476 (8.8% of those with migraine) met chronic migraine criteria. In total, 1254 participants (85.0% of those with chronic migraine) met inclusion criteria for this analysis. Of those, 512 respondents (40.8%) reported currently consulting with a healthcare professional for headache. Odds of consulting increased with increasing age (OR 1.02; 95% CI 1.01-1.03), body mass index (BMI) (OR 1.01; 95% CI 1.00-1.03), migraine-related disability (OR 1.02; 95% CI 1.00-1.04), and migraine severity (OR 1.16; 95% CI 1.11-1.22) and presence of health insurance (OR 4.61; 95% CI 3.05-6.96). Among those consulting a healthcare professional, 126 (24.6%) received an accurate diagnosis and 56 of those with a correct diagnosis (44.4%) received both acute and preventive pharmacologic treatments; odds of a CM diagnosis were higher for women (OR 1.93; 95% CI 1.03-3.61), those with greater migraine severity (OR 1.25; 95% CI 1.14-1.37), and those currently consulting a specialist (OR 2.38; 95% CI 1.54-3.69). No predictors of receiving appropriate treatment were identified among those currently consulting. Among our sample of people with chronic migraine, only 56 (4.5%) individuals successfully traversed the series of 3 barriers to successful chronic migraine care (ie, consulted a healthcare professional for migraine, received an accurate diagnosis, and were prescribed minimal acute and preventive pharmacologic treatments). Conclusion Our findings suggest that <5% of persons with chronic migraine traversed 3 barriers to receiving care for headache (consultation, diagnosis, and treatment), representing a large unmet need for improving care in this population. Predictors of consulting a healthcare professional included age, having health insurance, greater migraine-related disability, and greater migraine symptom severity. Among those consulting, predictors of an appropriate diagnosis included consulting a specialist, female sex, and greater migraine severity. Public health efforts are needed to improve outcomes for patients with chronic migraine by a range of interventions and educational efforts aimed at improving consultation rates, diagnostic accuracy, and adherence to minimal pharmacologic treatment. [ABSTRACT FROM AUTHOR]

Objective: The aim of this paper was to assess the relationship between pain and sleep in older adults taking depression, stress, and medical comorbidities into account.Methods: A cross-sectional analysis was performed using Einstein Aging Study, a community-based cohort study of adults aged 70 years and older. Ratings of pain intensity and interference from the Medical Outcomes Study (MOS) Short-Form 36 were used to assign individuals to low-pain versus high-pain severity. Sleep disturbance was assessed using the nine-item sleep problems index from the Medical Outcomes Study Sleep Scale. Other measures included the Geriatric Depression Scale and Perceived Stress Scale (PSS). Linear regression models were used to assess the association between pain grade and sleep disturbance adjusted for demographics, PSS, Geriatric Depression Scale, and other comorbidities.Results: Five hundred sixty-two eligible participants with a mean age of 78.22 years (standard deviation = 5.43) were included; 64% were women. Pain grade [β = 5.40, 95% confidence interval (CI) 2.56-8.21, p < 0.001] was associated with sleep disturbance after adjusting for demographic variables. In models including pain grade (β = 3.08, 95% CI 0.32-5.85, p = 0.03) and PSS (β = 0.57, 95% CI 0.39-0.75, p < 0.001), both were associated with sleep disturbance, although the PSS attenuated the relationship between pain and sleep by 34%. Depression, when added to previous model, was also associated with sleep (β = 2.17, 95% CI 1.48-2.85, p < 0.001) and attenuated the relationship between pain (β = 2.41, 95% CI -0.25 to 5.08, p = 0.07) and sleep by 22%. Stratified for depression, we found that pain, stress, and other medical comorbidities were significantly associated with sleep disturbance in non-depressed individuals but not individuals with depression.Conclusions: Pain, stress, and medical comorbidities are associated with sleep disturbance, especially in non-depressed older adults. [ABSTRACT FROM AUTHOR]

Background: Episodic memory testing is fundamental for the diagnosis of Alzheimer's disease (AD). Although the Free and Cued Selective Reminding Test (FCSRT) is widely used for this purpose, it may not be sensitive enough for early detection of subtle decline in preclinical AD. The Memory Binding Test (MBT) intends to overcome this limitation.Objectives: To analyze the test-retest reliability of the MBT and its convergent validity with the FCRST.Methods: 36 cognitively healthy participants of the ALFA Study, aged 45 to 65, were included for the test-retest study and 69 for the convergent analysis. They were visited twice in a period of 6 ± 2 weeks. Test-retest reliability was determined by the calculation of the intra-class correlation coefficient (ICC). Score differences were studied by computing the mean percentage of score variation between visits and visualized by Bland-Altman plots. Convergent validity was determined by Pearson's correlations.Results: ICC values in the test-retest reliability analysis of the MBT direct scores ranged from 0.64 to 0.76. Subjects showed consistent practice effects, with mean amounts of score increasing between 10% and 26%. Pearson correlation between MBT and FCSRT direct scores showed r values between 0.40 and 0.53. The FCSRT displayed ceiling effects not observed in the MBT.Conclusions: The MBT shows adequate test-retest reliability and overall moderate convergent validity with the FCSRT. Unlike the FCSRT, the MBT does not have ceiling effects and it may therefore be especially useful in longitudinal studies, facilitating the measurement of subtle memory performance decline and the detection of very early AD. [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to compare the societal direct and indirect costs of chronic and episodic migraine in the United States. Background Episodic and chronic migraine are distinguished by the frequency of headache-days. Chronic migraine has a greater overall impact on quality of life than does episodic migraine. Individuals with chronic migraine also use more healthcare resources (resulting in higher direct costs) and experience greater decreases in productivity (resulting in higher indirect costs) than those with episodic migraine as shown in the American Migraine Prevalence and Prevention (AMPP) Study. Methods The International Burden of Migraine Study utilized a web-based questionnaire to elicit data on several topics related to the burden of migraine illness, including health resource utilization and productivity losses. Potential survey participants were identified by Synovate Healthcare (Chicago, IL, USA) from a pool of registered panelists from various countries. The panelists were screened online to determine eligibility and to identify individuals with migraine (episodic or chronic), based on reported symptoms. Participants from the United States were divided into episodic and chronic migraine groups, based on reported headache-day per month frequency. Direct and indirect costs were estimated by applying estimated unit costs to reported headache-related productivity losses and resource use. Costs were compared between participants with episodic and chronic migraine. Results Mean [standard deviation] total annual cost of headache among people with chronic migraine ($8243 [$10,646]) was over three times that of episodic migraine ($2649 [$4634], P < .001). Participants with chronic migraine had significantly greater direct medical costs ($4943 [$6382]) and indirect (lost productivity) costs ($3300 [$6907]) than did participants with episodic migraine (direct, $1705 [$3591]; indirect, $943 [$2084]) ( P < .001 for each). Unlike previous findings, direct medical costs constituted the majority of total headache-related costs for both chronic migraine (60.0%, $4943 of $8243) and episodic migraine (64.3%, $1705 of $2649) participants. A large portion of direct medical costs are attributable to pharmaceutical utilization among both chronic migraine (80%, $3925 of 4943) and episodic migraine (70%, $1196 of $1705) participants. Conclusion The results of this study build on previous results of the AMPP Study, demonstrating that headache-related direct, indirect, and total costs are significantly greater among individuals with chronic migraine than with episodic migraine in the United States. [ABSTRACT FROM AUTHOR]

Objectives To examine the relationship of headache frequency to the stages of the menopausal transition in mid-life women with migraine. Background Past studies suggest that the perimenopause is associated with an increased prevalence of migraine, particularly in those with a history of premenstrual syndrome. The effect of the menopausal transition on the frequency of headache attacks in women with migraine has not been explored. Methods This was a cross-sectional observational study. Using data from the 2006 American Migraine, Prevalence and Prevention study survey, women meeting modified ICHD-3 beta criteria for migraine between the ages of 35-65 years were included in analyses. Women who had never menstruated or were pregnant, breastfeeding, or using exogenous sex hormones were excluded. The 2006 survey was selected because it included detailed questions on the menstrual cycle. The stages of the menopausal transition were defined based upon the self-reported cycle length and/or duration of amenorrhea. The primary outcome, high vs low headache frequency, was defined using a cut score of ≥10 headache days per month. Binary logistic regression models were used to assess the influence of menopausal stage on headache frequency category using premenopause as the reference group. Adjustments for stage of menopausal transition and sociodemographics (eg, age and income) were included in the first model, while the second model included sociodemographics, depression, body mass index, preventative medications, and medication overuse. Results The study sample included 3664 women at a mean age of 46 years. Among women who were premenopausal, 8.0% (99/1242) were in the high frequency headache group in comparison with 12.2% (154/1266) of perimenopausal and 12.0% (131/1095) of postmenopausal women. Compared with premenopausal women, the adjusted odds of being in the high frequency headache group was 1.62 (95% CI = 1.23, 2.12) for perimenopausal and 1.76 (95% CI = 1.23, 2.52) for postmenopausal women (Model 1). In model 2, high frequency headache was only increased in perimenopausal women with an OR of 1.42 (95% CI = 1.03, 1.94). Conclusions The risk of high frequency headache is increased in women during the perimenopause compared to premenopause in the fully adjusted model. The fact that the increased risk of high frequency headache was not statistically significant for menopause in the fully adjusted models suggests that different mechanisms might account for the increased risk for this stage of the menopausal transition. Recognition of the increased risk of high frequency headache during the menopausal transition suggests a need for optimized preventive treatment of migraine during this time of women's life. [ABSTRACT FROM AUTHOR]

Objectives To test the hypothesis that in persons with episodic migraine (EM), asthma is a risk factor for the onset of chronic migraine (CM). Background Migraine and asthma are comorbid chronic disorders with episodic attacks thought to involve inflammatory and neurological mechanisms. Herein, we assess the influence of asthma on the clinical course of EM. Methods To be eligible for this observational cohort study, AMPP Study participants had to meet criteria for EM in 2008, complete the validated six-item asthma questionnaire from the European Community Respiratory Health Survey (ECRHS) in 2008, and provide follow-up data in 2009. Using the ECRHS, we defined asthma as a binary variable (present or absent) based on an empirical cut score and developed a Respiratory Symptom Severity Score (RSSS) based on the number of positive responses (no severity = 0 positive responses, low severity = 1-2 positive responses, moderate severity = 3-4 positive responses, high severity = 5-6 positive responses). Chronic migraine was the primary outcome measure and was defined as those with ≥15 headache days per month on the 2009 AMPP Study survey. We used logistic regression in separate models to assess the influence of asthma as a binary variable (Model 1) and RSSS score categories (Model 2 using no respiratory symptoms as the reference) on CM onset after adjusting for sociodemographic factors, headache day frequency, migraine preventive medication use, and medication overuse. Results The eligible sample for this study included 4446 individuals with EM in 2008 of whom 17% had asthma. This group had a mean age of 50.4 and was 80.8% female. In 2009, new onset CM developed in 2.9% (131/4446) of the 2008 EM cohort, including 5.4% (40/746) of the asthma subgroup and 2.5% (91/3700) of the non-asthma subgroup. In comparison to those without asthma, the adjusted odds for individuals with asthma and EM in 2008 to develop CM in 2009 were greater than two (adjusted odds ratio [aOR] 2.1; 95% CI: 1.4-3.1). Using the RSSS, the aOR for CM onset increased with the number of asthma symptoms, but only those in the high RSSS category showed a statistically significant increase in the odds of chronic migraine onset in comparison with the no RSSS reference group (aOR 3.3; 95% CI 1.7-6.2). Conclusions Asthma is associated with an increased risk of new onset CM 1 year later among individuals with EM, with the highest risk being among those with the greatest number of respiratory symptoms. The exact mechanisms underlying this association are unknown, but could suggest mast cell degranulation, autonomic dysfunction, or shared genetic or environmental factors. [ABSTRACT FROM AUTHOR]

Research increasingly suggests that subjective cognitive decline (SCD) in older adults, in the absence of objective cognitive dysfunction or depression, may be a harbinger of non-normative cognitive decline and eventual progression to dementia. Little is known, however, about the key features of self-report measures currently used to assess SCD. The Subjective Cognitive Decline Initiative (SCD-I) Working Group is an international consortium established to develop a conceptual framework and research criteria for SCD (Jessen et al., 2014, Alzheimers Dement 10, 844-852). In the current study we systematically compared cognitive self-report items used by 19 SCD-I Working Group studies, representing 8 countries and 5 languages. We identified 34 self-report measures comprising 640 cognitive self-report items. There was little overlap among measures- approximately 75% of measures were used by only one study. Wide variation existed in response options and item content. Items pertaining to the memory domain predominated, accounting for about 60% of items surveyed, followed by executive function and attention, with 16% and 11% of the items, respectively. Items relating to memory for the names of people and the placement of common objects were represented on the greatest percentage of measures (56% each). Working group members reported that instrument selection decisions were often based on practical considerations beyond the study of SCD specifically, such as availability and brevity of measures. Results document the heterogeneity of approaches across studies to the emerging construct of SCD. We offer preliminary recommendations for instrument selection and future research directions including identifying items and measure formats associated with important clinical outcomes. [ABSTRACT FROM AUTHOR]