Machine learning identifies factors most associated with seeking medical care for migraine: Results of the OVERCOME (US) study.

OBJECTIVE: Utilize machine learning models to identify factors associated with seeking medical care for migraine. BACKGROUND: Migraine is a leading cause of disability worldwide, yet many people with migraine do not seek medical care. METHODS: The web-based survey, ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE (US), annually recruited demographically representative samples of the US adult population (2018-2020). Respondents with active migraine were identified via a validated diagnostic questionnaire and/or a self-reported medical diagnosis of migraine, and were then asked if they had consulted a healthcare professional for their headaches in the previous 12 months (i.e., "seeking care"). This included in-person/telephone/or e-visit at Primary Care, Specialty Care, or Emergency/Urgent Care locations. Supervised machine learning (Random Forest) and Least Absolute Shrinkage and Selection Operator (LASSO) algorithms identified 13/54 sociodemographic and clinical factors most associated with seeking medical care for migraine. Random Forest models complex relationships (including interactions) between predictor variables and a response. LASSO is also an efficient feature selection algorithm. Linear models were used to determine the multivariable association of those factors with seeking care. RESULTS: Among 61,826 persons with migraine, the mean age was 41.7 years (±14.8) and 31,529/61,826 (51.0%) sought medical care for migraine in the previous 12 months. Of those seeking care for migraine, 23,106/31,529 (73.3%) were female, 21,320/31,529 (67.6%) were White, and 28,030/31,529 (88.9%) had health insurance. Severe interictal burden (assessed via the Migraine Interictal Burden Scale-4, MIBS-4) occurred in 52.8% (16,657/31,529) of those seeking care and in 23.1% (6991/30,297) of those not seeking care; similar patterns were observed for severe migraine-related disability (assessed via the Migraine Disability Assessment Scale, MIDAS) (36.7% [11,561/31,529] vs. 14.6% [4434/30,297]) and severe ictal cutaneous allodynia (assessed via the Allodynia Symptom Checklist, ASC-12) (21.0% [6614/31,529] vs. 7.4% [2230/30,297]). Severe interictal burden (vs. none, OR 2.64, 95% CI [2.5, 2.8]); severe migraine-related disability (vs. little/none, OR 2.2, 95% CI [2.0, 2.3]); and severe ictal allodynia (vs. none, OR 1.7, 95% CI [1.6, 1.8]) were strongly associated with seeking care for migraine. CONCLUSIONS: Seeking medical care for migraine is associated with higher interictal burden, disability, and allodynia. These findings could support interventions to promote care-seeking among people with migraine, encourage assessment of these factors during consultation, and prioritize these domains in selecting treatments and measuring their benefits.

Not Just One Long Vacation: Revisiting the Importance of Lifestyle Planning in the Transition to Retirement.

BACKGROUND: There is a need to further understand the nature and role of planning for one's lifestyle in retirement. OBJECTIVE: The purpose of this study was to examine retirement planning and how it impacts perceived preparedness and satisfaction with the retirement transition, as well as to explore personal experiences of retirement. METHODS: Canadians (n = 748) fully or partly retired participated in an online survey that included quantitative questions about perceived retirement preparedness and satisfaction and open-ended questions about retirement goals, fears, challenges, and advice. FINDINGS: Results determined that while both financial and lifestyle planning were significant predictors of higher perceived preparedness, only lifestyle planning was a significant predictor for satisfaction. Overall, no gender differences were detected. Open-ended comments highlighted the importance of planning for one's lifestyle in retirement, including meaningful activities and social connections. DISCUSSION: Individualized career advising as well as group-based educational programs or peer-assisted learning initiatives appear warranted to support people in planning for their lifestyle in retirement.

Migraine-Related Stigma and Its Relationship to Disability, Interictal Burden, and Quality of Life: Results of the OVERCOME (US) Study

BACKGROUND AND OBJECTIVES: This population-based analysis characterizes the relative frequency of migraine-related stigma and its cross-sectional relationship to migraine outcomes. We hypothesized that migraine-related stigma would be inversely associated with favorable migraine outcomes across headache day categories. METHODS: OVERCOME (US) is a web-based observational study that annually recruited a demographically representative US sample and then identified people with active migraine using a validated migraine diagnostic questionnaire. It also assessed how frequently respondents experienced migraine-related stigma using a novel 12-item questionnaire (Migraine-Related Stigma, MiRS) that contained 2 factors; feeling that others viewed migraine as being used for Secondary Gain (8 items, α = 0.92) and feeling that others were Minimizing disease Burden (4 items, α = 0.86). We defined 5 groups: (1) MiRS-Both (Secondary Gain and Minimizing Burden often/very often; (2) MiRS-SG (Secondary Gain often/very often); (3) MiRS-MB (Minimizing Burden often/very often); (4) MiRS-Rarely/Sometimes; (5) MiRS-Never. Using MiRS group as the independent variable, we modeled its cross-sectional relationship to disability (Migraine Disability Assessment, MIDAS), interictal burden (Migraine Interictal Burden Scale-4), and migraine-specific quality of life (Migraine Specific Quality of Life v2.1 Role Function-Restrictive) while controlling for sociodemographics, clinical features, and monthly headache day categories. RESULTS: Among this population-based sample with active migraine (n = 59,001), mean age was 41.3 years and respondents predominantly identified as female (74.9%) and as White (70.1%). Among respondents, 41.1% reported experiencing, on average, ≥4 monthly headache days and 31.7% experienced migraine-related stigma often/very often; the proportion experiencing migraine-related stigma often/very often increased from 25.5% among those with <4 monthly headache days to 47.5% among those with ≥15 monthly headache days. The risk for increased disability (MIDAS score) was significant for each MiRS group compared with the MiRS-Never group; the risk more than doubled for the MiRS-Both group (rate ratio 2.68, 95% CI 2.56-2.80). For disability, interictal burden, and migraine-specific quality of life, increased migraine-related stigma was associated with increased disease burden across all monthly headache day categories. DISCUSSION: OVERCOME (US) found that 31.7% of people with migraine experienced migraine-related stigma often/very often and was associated with more disability, greater interictal burden, and reduced quality of life.

Safety and efficacy of ubrogepant for the acute treatment of perimenstrual migraine attacks: A post hoc analysis.

OBJECTIVE: To evaluate the efficacy and safety of ubrogepant for the acute treatment of perimenstrual migraine (pmM) attacks. BACKGROUND: Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults. METHODS: After completing one of two phase 3 trials, participants could enroll in a phase 3, 52-week, open-label, long-term safety extension trial and were re-randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg. This post hoc analysis evaluated the efficacy of ubrogepant in a subset of women who treated ≥1 pmM or non-pmM attack with ubrogepant. A pmM attack started on or between 2 days before and the first 3 days of menstrual bleeding. Mean (standard deviation [SD]) percentages of ubrogepant-treated attacks achieving 2-h pain freedom and pain relief were reported, with outcomes weighted equally by participant. RESULTS: Of 734 women in the modified intent-to-treat population, 354 reported ≥1 menstrual cycle start date and a ubrogepant-treated headache day in the same month. A qualifying pmM and non-pmM attack was reported by 278 and 716 women, respectively. Pain freedom at 2 h was achieved in a mean (SD) of 28.7% (37.4) of pmM attacks and 22.1% (26.9) of non-pmM attacks treated with ubrogepant 50 mg (p = 0.054) and 29.7% (35.2) versus 25.3% (26.3) of attacks treated with ubrogepant 100 mg (p = 0.757). No difference was found in the mean percentage of ubrogepant-treated pmM and non-pmM attacks that achieved 2-h pain relief with ubrogepant 50 mg (64.8% [39.9] vs. 65.2% [32.4]; p = 0.683) and with 100 mg (67.1% [37.4] vs. 68.4% [30.2]; p = 0.273). Treatment-related treatment-emergent adverse events were reported by 8.8% (12/137) and 12.8% (18/141) in the ubrogepant 50 and 100 mg pmM subgroups, respectively. CONCLUSIONS: Ubrogepant demonstrated similar efficacy for the treatment of pmM and non-pmM attacks. No new safety signals were identified.

Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: results from the COURAGE Study.

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.

On Time, Leisure, and Health in Retirement: Implications for Public Health Services.

Various life challenges, such as widowhood, poor health, or significant caregiving responsibilities, can make the possibility of how to spend one's time in retirement seem daunting. Planning can help people feel more confident and prepared. In this paper, we review research that has examined: (1) life factors impacting fears about and adjustment to retirement, (2) access to resources and utilization of strategies that impact adaptation processes, and (3) the ways leisure and leisure education may be resources to support not only individual adaptation but practices of public health service providers in assisting people who may be struggling with this transition. The review ends with recommendations for public health practice including: (1) the inclusion of leisure and leisure education as a focus of service provision; (2) the development of partnerships or collaborations between public health and recreation-related organizations; and (3) the development and delivery of group- and individual-based leisure education programs.

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial.

OBJECTIVE: To assess long-term safety, tolerability, and efficacy of once-daily oral atogepant 60 mg in adults with migraine. BACKGROUND: Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of episodic migraine. METHODS: A 52-week, multicenter, randomized, open-label trial of adults (18-80 years) with migraine. Lead-in trial completers or newly enrolled participants with 4-14 migraine days/month were enrolled and randomized (5:2) to atogepant 60 mg once daily or oral standard care (SC) migraine preventive medication. The primary objective was to evaluate the safety and tolerability of atogepant; safety assessments included treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, vital signs, and Columbia-Suicide Severity Rating Scale scores. Efficacy assessments (atogepant only) included change from baseline in mean monthly migraine days (MMDs) and the proportion of participants with reductions from baseline of ≥50%, ≥75%, and 100% in MMDs. RESULTS: The trial included 744 participants randomized to atogepant 60 mg (n = 546) or SC (n = 198). The atogepant safety population was 88.2% female (n = 479/543) with a mean (standard deviation) age of 42.5 (12.0) years. TEAEs occurred in 67.0% (n = 364/543) of participants treated with atogepant 60 mg. The most commonly reported TEAEs (≥5%) were upper respiratory tract infection (10.3%; 56/543), constipation (7.2%; 39/543), nausea (6.3%; 34/543), and urinary tract infection (5.2%; 28/543). Serious TEAEs were reported in 4.4% (24/543) for atogepant. Mean (standard error) change in MMDs for atogepant was -3.8 (0.1) for weeks 1-4 and -5.2 (0.2) at weeks 49-52. Similarly, the proportion of participants with ≥50%, ≥75%, and 100% reductions in MMDs increased from 60.4% (310/513), 37.2% (191/513), and 20.7% (106/513) at weeks 1-4 to 84.2% (282/335), 69.9% (234/335), and 48.4% (162/335), at weeks 49-52. CONCLUSION: Daily use of oral atogepant 60 mg for preventive treatment of migraine during this 1-year, open-label trial was safe, well tolerated, and efficacious.

Leisure and Leisure Education as Resources for Rehabilitation Supports for Chronic Condition Self-Management in Rural and Remote Communities.

The potential of leisure (enjoyable free time pursuits) to be a resource for chronic condition self-management (CCSM) is well-established. Because leisure pursuits are often self-determined, they have the potential to allow people to not only address self-management goals (e.g., managing symptoms through movements or stress-reducing activities) but meet important psychosocial needs (e.g., affiliation, sense of mastery) as well as support participation in a range of meaningful life situations. In this "Perspective" piece, we advocate for the ways leisure and leisure education can be resources for rehabilitation professionals to support CCSM, especially in rural and remote communities. In particular, we focus on aspects of the Taxonomy of Everyday Self-Management Strategies [TEDSS (1)] to highlight ways that embedding leisure and leisure education into supports for CCSM can strengthen rehabilitation services offered to rural and remote dwelling adults living with chronic conditions. Recognizing the breadth of leisure-related resources available in rural and remote communities, we recommend the following strategies to incorporate a focus on leisure-based self-management within rehabilitation services: (a) enhance the knowledge and capacity of rehabilitation practitioners to support leisure-based CCSM; (b) focus on coordinated leadership, patient navigation, and building multi-sectoral partnerships to better link individuals living with chronic conditions to community services and supports; and (c) educate individuals with chronic conditions and family/carers to develop knowledge, skills, awareness and confidence to use leisure as a self-management resource.

Picturing Recreation: Newcomers' Perspectives on Experiences of Recreation.

The process of resettlement in a new country represents a significant transition in a person's or family's life, during which there are many changes to their daily activities. While involvement in recreational activities may support such transitions, further exploration of leisure experiences, as defined subjectively by newcomers themselves, is needed. Using an exploratory, community-based participatory approach drawing on photovoice methods, focus groups, and individual interviews, this research project explored the meanings of recreation among newcomers in two communities, one rural and one urban, in Eastern Canada. Forty newcomers (n = 40), originally from 13 different countries, participated in the photovoice activities. Transcripts from three focus groups and five individual interviews were analyzed, first by site to create the photo exhibits and then across sites. Across the two sites, four sub-themes were identified: (1) continuity with, and freedom from, past activities and places; (2) being in and connecting with nature; (3) staying physically and mentally well; and (4) connecting and learning with others through reciprocity. These all contributed to the overarching theme developing a sense of belonging: a series of small encounters. The findings highlight the powerful role of recreation within the resettlement process, and highlight particularly the importance of small, informal recreational experiences that are woven into everyday lives and routines. Such experiences contribute to a sense of belonging for newcomers, thus assisting the resettlement process.

A Framework for Estimating the Eligible Patient Population for New Migraine Acute Therapies in the United States.

INTRODUCTION: Migraine is associated with considerable disability for patients not adequately managed with current standards of care. New acute therapies may offer relief for this population of patients; however, population size and associated potential costs of new therapies are unclear. In this study, a conceptual framework was developed to estimate anticipated use of new acute therapies. METHODS: Targeted literature review (TLR) was conducted to identify factors affecting access to migraine-specific acute therapies, and characteristics of individuals who would be eligible for new acute therapies. Findings from the TLR were combined to create a framework for estimating the size of the eligible patient population. This framework was used to calculate two estimates of the eligible patient population by applying parameters (i) identified in the TLR and (ii) from a recent budget-impact analysis (BIA). RESULTS: The primary factors affecting access to migraine-specific acute therapies identified in the TLR were consulting a healthcare professional for headache, receiving a migraine diagnosis, and receiving a prescription for migraine-specific treatment. Characteristics of individuals likely to use new acute therapies reflected in the TLR were contraindication to triptans, or failure to respond to/tolerate at least two oral triptans. Application of the framework suggested that 15-25% of individuals with migraine would be eligible for new acute therapies. CONCLUSION: A limited number of patients currently use migraine-specific acute therapies. Among such patients, a significant proportion do not have adequate symptom control. Accordingly, a minority of individuals with migraine may be expected to use new acute therapies. The framework developed in this study is intended to facilitate estimating the eligible patient population in assessments of costs of new acute therapies. Such assessments should also consider recommendations that patients have access to multiple types of acute therapies, which may yield savings from reduced medication-overuse headache (MOH), progression to chronic migraine, and urgent-care costs.

Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II.

OBJECTIVE: To examine the safety and efficacy of ubrogepant for acute treatment of migraine across cardiovascular (CV) disease risk categories. METHODS: ACHIEVE I and II were multicenter, double-blind, single-attack, phase 3 trials in adults with migraine, with or without aura. Participants were randomized 1:1:1 to placebo or ubrogepant (50 or 100 mg in ACHIEVE I; 25 or 50 mg in ACHIEVE II), to treat one migraine attack of moderate or severe headache pain intensity. This post-hoc analysis pooled data from ubrogepant 50 mg and placebo groups from the ACHIEVE trials to examine the safety and efficacy of ubrogepant by baseline cardiovascular disease risk factors. Using a cardiovascular risk assessment algorithm, participants were categorized as having no cardiovascular risk, low cardiovascular risk or moderate-high cardiovascular risk at baseline. Treatment-emergent adverse events were documented 48 h and 30 days after taking the trial medication. Co-primary efficacy outcomes were 2-h pain freedom and 2-h absence of most bothersome migraine-associated symptom. RESULTS: Overall, 3358 participants were randomized in the ACHIEVE trials (n = 2901 safety population; n = 2682 modified intent-to-treat population). In the safety population, 11% of participants were categorized as moderate-high (n = 311), 32% low (n = 920), and 58% no cardiovascular risk factors (n = 1670). The proportion of ubrogepant participants reporting a treatment-emergent adverse event was comparable across risk categories and similar to placebo. The treatment effects of ubrogepant versus placebo were consistent across cardiovascular risk categories for all efficacy outcomes. CONCLUSION: The safety and efficacy of ubrogepant for the acute treatment of a single migraine attack did not differ by the presence of major cardiovascular risk factors. No evidence of increased treatment-emergent adverse events or cardiac system organ class adverse events with ≥2 major cardiovascular risk factors and no safety concerns were identified.Trial Registration: ACHIEVE I ClinicalTrials.gov number, NCT02828020; ACHIEVE II ClinicalTrials.gov number, NCT02867709.

Efficacy of ubrogepant based on prior exposure and response to triptans: A post hoc analysis.

OBJECTIVE: To determine the potential efficacy of ubrogepant for acute treatment of migraine based on historical experience with triptans. BACKGROUND: Although triptans have improved migraine treatment, their efficacy and tolerability may limit their utility in some individuals. Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist approved by the Food and Drug Administration for acute treatment of migraine in adults. METHODS: This post hoc analysis of pooled data from the pivotal trials ACHIEVE I and II, identically designed, randomized, double-blind, phase 3, single-attack trials of ubrogepant in adults with a history of migraine with/without aura, examined the efficacy and tolerability of ubrogepant 50 mg versus placebo based on participants' historical experience with triptans: triptan responder, triptan-insufficient responder, and triptan naïve. Co-primary efficacy endpoints were pain freedom and absence of most bothersome migraine-associated symptom (MBS) 2 h post initial dose. Adverse events (AEs) within historical triptan experience subgroups were evaluated. RESULTS: In the pooled analysis population (n = 1799), 682 (placebo, n = 350; ubrogepant 50 mg, n = 332), 451 (placebo, n = 223; ubrogepant, n = 228), and 666 (placebo, n = 339; ubrogepant, n = 327) participants were triptan responders, triptan-insufficient responders, and triptan-naïve, respectively. Response rates on co-primary efficacy endpoints were higher for ubrogepant versus placebo across all groups. Treatment-by-subgroup interaction p values based on odds ratios for pain freedom (p = 0.290) and absence of MBS (p = 0.705) indicated no significant impact of historical triptan experience on ubrogepant efficacy. AE incidence for ubrogepant did not differ appreciably across historical triptan experience subgroups. CONCLUSIONS: Ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan-naïve based on their historical experience with triptans.

Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials.

INTRODUCTION: Galcanezumab, a humanized monoclonal antibody that binds to calcitonin gene-related peptide, is approved for the preventive treatment of migraine in adults. It is self-administered once monthly as a subcutaneous injection. This paper describes the time course of effect of galcanezumab in patients with episodic and chronic migraine. METHODS: Data were based on three double-blind, placebo-controlled, phase 3 studies. Patients (1773 episodic and 1113 chronic) were randomized (2:1:1) to monthly doses of placebo, galcanezumab 120 mg with a 240 mg loading dose, or galcanezumab 240 mg (January 2016-March 2017). Onset of effect was determined using a sequential analysis approach based on earliest time point at which galcanezumab achieved and subsequently maintained statistical superiority to placebo. Maintenance of effect was a comparison of the percentages of galcanezumab- and placebo-treated patients with maintenance of at least 50% response at the individual patient level. Cessation of effect was determined during a 4-month post-treatment period on the basis of change from baseline in monthly migraine headache days. RESULTS: Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine. CONCLUSION: Galcanezumab is a novel preventive therapeutic option for adult patients with migraine that has early onset of action, maintenance of effect, and gradual reduction of effect upon treatment cessation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02614183 (EVOLVE-1); NCT02614196 (EVOLVE-2); NCT02614261 (REGAIN).

Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials.

INTRODUCTION: Ubrogepant is an oral, small-molecule calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine. The efficacy and safety of ubrogepant were demonstrated in two pivotal phase 3, single-attack, randomized, placebo-controlled trials (ACHIEVE I and ACHIEVE II). METHODS: We conducted a post hoc analysis of pooled data from the ACHIEVE trials to evaluate the efficacy, safety, and tolerability of ubrogepant 50 mg (the only dose evaluated in both trials) versus placebo across a large population of participants with migraine. The coprimary efficacy outcomes were pain freedom and absence of the most bothersome migraine-associated symptom (including photophobia, phonophobia, and nausea) at 2 h post dose. Secondary outcomes included pain relief at 2 h post dose, sustained pain relief and pain freedom from 2 to 24 h, and absence of specific migraine-associated symptoms at 2 h post dose. RESULTS: A total of 2240 eligible participants were randomized to placebo (n = 1122) or ubrogepant 50 mg (n = 1118) in the ACHIEVE trials. Pain freedom at 2 h was reported in 13.0% of participants in the pooled placebo group and 20.5% in the pooled ubrogepant 50 mg group (odds ratio [OR] 1.72; 95% confidence interval [CI] 1.34, 2.22; P < 0.001). Absence of the most bothersome migraine-associated symptom at 2 h was reported by 27.6% in the pooled placebo group and by 38.7% in the pooled ubrogepant 50 mg group (OR 1.68; 95% CI 1.37, 2.05; P < 0.001). Adverse events (AEs) within 48 h after the initial or optional second dose were reported by 11.5 and 11.2% of participants in the pooled placebo and pooled ubrogepant 50 mg groups, respectively. The most common AE was nausea (1.8 and 1.9%, respectively). No serious AEs related to treatment or discontinuations due to AEs were reported. CONCLUSION: These results further support the efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: ACHIEVE I: NCT02828020; ACHIEVE II: NCT02867709.

Managing everyday life: Self-management strategies people use to live well with neurological conditions.

OBJECTIVE: This paper uses the Taxonomy of Everyday Self-management Strategies (TEDSS) to provide insight and understanding into the complex and interdependent self-management strategies people with neurological conditions use to manage everyday life. METHODS: As part of a national Canadian study, structured telephone interviews were conducted monthly for eleven months, with 117 people living with one or more neurological conditions. Answers to five open-ended questions were analyzed using qualitative content analysis. A total of 7236 statements were analyzed. RESULTS: Findings are presented in two overarching patterns: 1) self-management pervades all aspects of life, and 2) self-management is a chain of decisions and behaviours. Participants emphasized management of daily activities and social relationships as important to maintaining meaning in their lives. CONCLUSION: Managing everyday life with a neurological condition includes a wide range of diverse strategies that often interact and complement each other. Some people need to intentionally manage every aspect of everyday life. PRACTICE IMPLICATIONS: For people living with neurological conditions, there is a need for health providers and systems to go beyond standard advice for self-management. Self-management support is best tailored to each individual, their life context and the realities of their illness trajectory.

Characterization of Acute Prescription Migraine Medication Use: Results From the CaMEO Study.

OBJECTIVE: To characterize self-reported use of acute prescription medication for migraine in a sample representing the US population. PATIENTS AND METHODS: Data were obtained from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. The CaMEO Study is an Internet-based cross-sectional longitudinal survey administered between September 17, 2012, and November 19, 2013. Demographic characteristics, migraine-related disability, symptom severity, quality of life, and psychiatric comorbidity profiles were evaluated. RESULTS: Data from 13,624 respondents were analyzed, including 3121 (22.9%) self-reported current users of acute prescription medication for migraine, 1719 (12.6%) previous/discontinued users, and 8784 (64.5%) who had never used acute prescription medication for migraine. Mean ± SD monthly headache frequency was 7.3±7.1 days for current users, 5.6±6.6 days for those who discontinued, and 3.9±4.9 days for respondents who never used acute prescription medication for migraine. Current users experienced the highest degree of migraine-related disability based on Migraine Disability Assessment scores and the highest levels of migraine symptom severity based on Migraine Symptom Severity Scale scores. Current users also had the highest scores on the depression and anxiety questionnaires. The most commonly reported prescription medications used or "kept on hand" by current users were triptans (47.2%; 1474 of 3121), opioids (37.3%; 1164 of 3121), nonsteroidal anti-inflammatory drugs (31.9%; 997 of 3121), and barbiturates (12.8%; 399 of 3121), with many people reporting more than 1 medication. CONCLUSION: Despite reporting moderate to severe migraine-related disability and impairment, many people with migraine have never used acute prescription migraine medication. The burden related to migraine is great, especially among individuals currently using acute prescription medication for migraine.

Recreation and collaboration within the Expanded Chronic Care Model: working towards social transformation.

Assisting people to live well with a chronic physical or mental health condition requires the creation of intersectoral community-based supports for chronic condition self-management. One important but underutilized resource for supporting chronic condition self-management in the community is recreation, which refers to relatively self-determined and enjoyable physical, social or expressive everyday activities. The Expanded Chronic Care Model (ECCM) provides a framework for identifying systems-level strategies to support self-management through increased access to community recreation opportunities. In this article, an occupation-based social transformation approach, which involves examining assumptions, considering contexts of daily activities and partnering to create meaningful social change, is used to examine the ECCM. Recommendations related to strengthening social change with a specific focus on collaborations and networks through recreation are provided. Through such collaborations, self-management of chronic conditions in community recreation contexts is advanced. Health providers and community-based recreation services providers are invited to be part of these intersectoral changes that will promote health amongst those living with chronic conditions.