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Factors that have shaped the practice of federal program evaluation in Canada are discussed, including accountability, federal policy issues, political actors, organizational structures, and political and governmental changes. A key issue is that of promise versus performance. (SLD)

Objectives: To assess real‐world effectiveness, safety, and usage of erenumab in Canadian patients with episodic and chronic migraine with prior ineffective prophylactic treatments. Background: In randomized controlled trials, erenumab demonstrated efficacy for migraine prevention in patients with ≤4 prior ineffective prophylactic migraine therapies. The "Migraine prevention with AimoviG: Informative Canadian real‐world study" (MAGIC) assessed real‐world effectiveness of erenumab in Canadian patients with migraine. Methods: MAGIC was a prospective open‐label, observational study conducted in Canadian patients with chronic migraine (CM) and episodic migraine (EM) with two to six categories of prior ineffective prophylactic therapies. Participants were administered 70 mg or 140 mg erenumab monthly based on physician's assessment. Migraine attacks were self‐assessed using an electronic diary and patient‐reported outcome questionnaires. The primary outcome was the proportion of subjects achieving ≥50% reduction in monthly migraine days (MMD) after the 3‐month treatment period. Results: Among the 95 participants who mostly experienced two (54.7%) or three (32.6%) prior categories of ineffective prophylactic therapies and who initiated erenumab, treatment was generally safe and well tolerated; 89/95 (93.7%) participants initiated treatment with 140 mg erenumab. At week 12, 32/95 (33.7%) participants including 17/64 (26.6%) CM and 15/32 (48.4%) EM achieved ≥50% reduction in MMD while 30/86 (34.9%) participants including 19/55 (34.5%) CM and 11/31 (35.5%) EM achieved ≥50% reduction in MMD at week 24. Through patient‐reported outcome questionnaires, 62/95 (65.3%) and 45/86 (52.3%) participants reported improvement of their condition at weeks 12 and 24, respectively. Physicians observed improvement in the condition of 78/95 (82.1%) and 67/86 (77.9%) participants at weeks 12 and 24, respectively. Conclusion: One‐third of patients with EM and CM achieved ≥50% MMD reduction after 3 months of erenumab treatment. This study provides real‐world evidence of erenumab effectiveness, safety, and usage for migraine prevention in adult Canadian patients with multiple prior ineffective prophylactic treatments. [ABSTRACT FROM AUTHOR]

Objective.- To examine whether major depressive episodes (MDEs) are associated with an increased risk of migraine in the general population and to examine whether migraine is associated with an increase risk of MDE. Background.- Population-based cross-sectional studies have consistently reported an association between migraine and depression. However, longitudinal studies about this potentially bidirectional association are inconsistent. Methods.- This retrospective cohort study used 12 years of follow-up data from the Canadian National Population Health Survey (15,254 respondents, age >12). Stratified analysis, logistic regression, and proportional hazard modeling were used to quantify the effect of migraine on subsequent MDE status and vice versa. Results.- After adjusting for sex, age, and other chronic health conditions, respondents with migraine were 60% more likely (HR 1.6, 95% confidence interval 1.3-1.9) to develop MDE compared with those without migraine. Similarly adjusting for sex and age, respondents with MDE were 40% more likely (HR 1.4, 95% confidence interval 1.0-1.9) to develop migraine compared with those without MDE. However, the latter association disappeared after adjustment for stress and childhood trauma. Conclusions.- The current study provides substantial evidence that migraine is associated with the later development of MDEs, but does not provide strong causal evidence of an association in the other direction. Environmental factors such as childhood trauma and stress may shape the expression of this bidirectional relationship; however, the precise underlying mechanisms are not yet known. ( Headache 2012;52:422-432) [ABSTRACT FROM AUTHOR]

The article examines and compares healthcare resource utilization and related costs among patients with chronic migraine and episodic migraine in the U.S. and Canada. Headache-specific medication, healthcare provider visits, emergency department visits, and diagnostic testing were the common medical services utilized. Chronic migraine was determined to be linked to higher medical resource use and total costs compared with episodic migraine.

As elsewhere in the world, migraine and other headache disorders have always produced very significant disability amongst Canadians. Over the last 50 years, progress has been made by health professionals to improve the care received by patients with headache, and to reduce the headache-related burden carried by patients and their families. Milestones in this progress have included programs for better education for the public, for neurologists, and for other physicians about migraine. Highlights in the Canadian battle against migraine and other headaches include those listed below: [ABSTRACT FROM AUTHOR]

Background: PREDICT was a Canadian, multicenter, prospective, observational study in adults naïve to onabotulinumtoxinA treatment for chronic migraine (CM). We descriptively assess health resource utilization, work productivity, and acute medication use., Methods: OnabotulinumtoxinA (155-195 U) was administered every 12 weeks over 2 years (≤7 treatment cycles). Participants completed a 4-item health resource utilization questionnaire and 6-item Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0. Acute medication use was recorded in daily headache diaries. Treatment-emergent adverse events were recorded throughout the study., Results: A total of 197 participants were enrolled, and 184 received ≥1 treatment with onabotulinumtoxinA and were included in the analysis. Between baseline and the final visit, there were decreases in the percentage of participants who reported headache-related healthcare professional visit(s) (96.2% to 76.8%) and those who received headache-related diagnostic testing (37.5% to 9.9%). Reductions from baseline were also observed in the mean number of headache-related visits to an emergency room/urgent care clinic (2.5 to 1.4) and median headache-related hospital admissions (4.0 to 1.0). OnabotulinumtoxinA improved work productivity and reduced the mean (standard deviation) number of hours missed from work over a 7-day period (6.1 [9.7] to 3.0 [6.8]). Mean (standard deviation) acute medication use decreased from baseline (15.2 [7.6] to 9.1 [6.5] days). No new safety signals were identified., Conclusions: Real-world evidence from PREDICT demonstrates that onabotulinumtoxinA treatment for CM in the Canadian population reduces health resource utilization and acute medication use and improves workplace productivity, supporting the long-term benefits of using onabotulinumtoxinA for CM.

Background: The PREDICT study assessed real-world, long-term health-related quality of life in adults with chronic migraine (CM) receiving onabotulinumtoxinA., Methods: Canadian, multicenter, prospective, observational study in adults naïve to onabotulinumtoxinA for CM. OnabotulinumtoxinA (155-195 U) was administered every 12 weeks over 2 years (≤7 treatment cycles). Primary endpoint: mean change in Migraine-Specific Quality of Life Questionnaire (MSQ) at treatment 4 (Tx4) versus baseline. Secondary endpoints: mean change in MSQ at final visit versus baseline, and headache days., Results: 184 participants (average age 45 years; 84.8% female; 94.6% Caucasian) received ≥1 onabotulinumtoxinA treatment; 150 participants completed 4 treatments (1 year) and 123 completed all 7 treatment cycles (2 years). Mean (SD) onabotulinumtoxinA dose per treatment cycle was 171 (18) U and treatment interval was 13.2 (1.8) weeks. Baseline mean (SD) 20.9 (6.7) headache days/month decreased (Tx1: -3.5 [6.3]; Tx4: -6.5 [6.6]; p < 0.0001 versus baseline). Mean (SD) increased from baseline in MSQ at Tx4 (restrictive: 21.5 [24.3], preventive: 19.5 [24.7], emotional: 22.9 [32.9]) and the final visit (restrictive: 21.3 [23.0], preventive: 19.2 [23.7], emotional: 27.4 [30.7]), exceeding minimal important differences (all p < 0.0001). Seventy-seven (41.8%) participants reported 168 treatment-emergent adverse events (TEAEs); 38 TEAEs (12.0%) were considered treatment-related. Four (2.2%) participants reported six serious TEAEs; none were considered treatment-related. No new safety signals were identified., Conclusions: Real-world evidence from PREDICT demonstrates that onabotulinumtoxinA for CM in Canada improved MSQ scores and reduced headache frequency and severity, adding to the body of evidence on the long-term safety and effectiveness of onabotulinumtoxinA for CM.

Objectives: The primary objective of this guideline is to assist the practitioner in choosing an appropriate prophylactic medication for an individual with migraine, based on current evidence in the medical literature and expert consensus. This guideline is focused on patients with episodic migraine (headache on ≤ 14 days a month)., Methods: Through a comprehensive search strategy, randomized, double blind, controlled trials of drug treatments for migraine prophylaxis and relevant Cochrane reviews were identified. Studies were graded according to criteria developed by the US Preventive Services Task Force. Recommendations were graded according to the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group. In addition, a general literature review and expert consensus were used for aspects of prophylactic therapy for which randomized controlled trials are not available., Results: Prophylactic drug choice should be based on evidence for efficacy, side-effect profile, migraine clinical features, and co-existing disorders. Based on our review, 11 prophylactic drugs received a strong recommendation for use (topiramate, propranolol, nadolol, metoprolol, amitriptyline, gabapentin, candesartan, butterbur, riboflavin, coenzyme Q10, and magnesium citrate) and 6 received a weak recommendation (divalproex sodium, flunarizine, pizotifen, venlafaxine, verapamil, and lisinopril). Quality of evidence for different medications varied from high to low. Prophylactic treatment strategies were developed to assist the practitioner in selecting a prophylactic drug for specific clinical situations. These strategies included: first time strategies for patients who have not had prophylaxis before (a beta-blocker and a tricyclic strategy), low side effect strategies (including both drug and herbal/vitamin/mineral strategies), a strategy for patients with high body mass index, strategies for patients with co-existent hypertension or with co-existent depression and /or anxiety, and additional monotherapy drug strategies for patients who have failed previous prophylactic trials. Further strategies included a refractory migraine strategy and strategies for prophylaxis during pregnancy and lactation., Conclusions: There is good evidence from randomized controlled trials for use of a number of different prophylactic medications in patients with migraine. Medication choice for an individual patient requires careful consideration of patient clinical features.

Background: The prevalence of migraine headache varies somewhat across geographic regions. The last Canadian population-based study of migraine was in 1994. We report the findings of the Canadian Women and Migraine Survey. In addition to reporting migraine prevalence in Canadian women, the survey identified current consultation and treatment practices of women with migraine, and the psychological burden of migraine., Methods: The survey was conducted with a population-based sample of 1210 women using standard telephone research methods. Headache diagnoses were based on the International Headache Society (IHS) Classification., Results: Calculated prevalence of migraine headache was 26%. Only 51% of women with migraine had consulted a physician about their headaches. Women with migraines rely on over-the-counter medications and non-specific prescription medications. Less than 10% of women with migraine use triptans/dihydroergotamine for primary treatment. Ninety seven percent of women with migraine reported at least one psychosocial impact resulting from migraines., Conclusions: The prevalence of migraine in Canadian women appears static, and is again shown to be slightly higher than that reported in the United States. As in other epidemiologic studies, many women with migraine do not seek medical help for their headaches and perhaps as a result, few are using migraine-specific medications to treat their headaches. The impact of migraine on Canadian women is substantial with almost all women with migraine reporting adverse psychosocial effects of migraines on their lives.

Background/objectives: Multidisciplinary treatment programs are seen as an effective way to treat patients with chronic illness. The purpose of this study was to describe a multidisciplinary headache program which was developed in the Canadian public healthcare setting, and to report on patient perceptions of the program and patient treatment outcomes., Methods: The Calgary Headache Assessment and Management Program (CHAMP) was developed with initial funding from Alberta Health, and continued with function from the Calgary Health Region. Patient perceptions of the program were obtained with questionnaires. Outcome measures for a cohort of patients who completed the Self-Management Workshop were obtained using standard headache related disability measures., Results: Patient perceptions of the education session, the Lifestyle Assessment, and the Self-Management Workshop were very positive. Headache Disability Inventory scores fell from 56.2 to 46.3 from baseline to three months post Self-Management Workshop (p < .001). Corresponding scores for the HIT-6 were 63.6 and 58.2 (p < .001)., Conclusions: Multidisciplinary headache treatment programs can be developed in the Canadian public healthcare system. The program described here was well accepted by many patients and perceived to be useful by them. Headache related disability as measured by standard measures was significantly reduced after participation in the program.

The goal of the Canadian Migraine Forum was to work towards improving the lives of Canadians with migraine by reducing their migraine-related disability. Migraine has been ranked 19th by the World Health Organization among causes of years of life lived with disability. To improve management of migraine in Canada, the participants in the forum identified several important needs and strategies. There is a need for more leaders in the field of migraine to work with other stakeholders to obtain funding and develop treatment programs across Canada. Leadership is also required to address the under use of both migraine specific symptomatic medications and prophylactic medications in Canada. More non-physician health professionals are required to work with physicians in migraine treatment teams. This could assist with a shortage of physician resources, and could also help to better meet the needs of the migraine patient. Individuals with migraine need to be identified who could work with health care professionals to help meet the needs of the migraine patients in our communities. Application of the chronic disease management model for migraine treatment was also seen as an important factor for the management of migraine. Programs are needed to promote earlier diagnosis, long-term follow-up, comprehensive patient education, and the use of multidisciplinary treatment teams where appropriate. Also considered important was the need to increase knowledge about migraine through public awareness campaigns, websites, medical education, and appropriate reading material for patients. The public needs to be aware that migraine is a biological disorder that can cause significant disability and suffering. Lastly, there is a pressing need to promote more migraine research, including careful outcome assessments for treatment programs that involve non-pharmacological treatments and a team based approach to migraine management. There are many challenges that must be overcome if we are to be successful in reducing migraine related disability in Canada. Success will depend upon the joint efforts of physicians, other healthcare professionals, individuals with migraine, and the public at large.

The goal of the Canadian Migraine Forum was to work towards improving the lives of Canadians with migraine by reducing their migraine-related disability. This paper focuses on migraine treatment in its many aspects, including symptomatic therapy of individual migraine headache attacks, prophylactic drug therapy, non-pharmacological interventions, and diagnosis and management of symptomatic medication overuse. Many patients with difficult migraine experience significant frustration in trying to obtain the help they need from our current medical system. Although many symptomatic medications are available for use in migraine, migraine specific medications are still underutilized. An ideal migraine preventative medication does not yet exist, but currently available preventatives do have utility, and are also thought to be underutilized. Behavioral approaches to migraine management as an adjunct to medication therapy show promise, but the availability of programs to bring these to patients is limited, and more research is needed on their efficacy. Symptomatic medication overuse in migraine sufferers remains a large problem in Canada, and better defined treatment paradigms and programs are needed both to prevent and to treat this problem. Such programs should include strong elements of public, patient, and health professional education. A potential solution to some of these problems may be to develop treatment approaches to migraine similar to those that are being developed for other chronic medical disorders. For patients with severe migraine, these would optimally include multidisciplinary teams so that the multiple facets of migraine management can be adequately addressed.

Objective: To examine demographic characteristics and clinical features of headache patients referred to neurologists specializing in headache in Canada., Methods: Demographic and clinical data were collected at the time of consultation for 865 new headache patients referred to five headache-specialty clinics in Canada. The Headache Impact Test (HIT-6) and Migraine Disability Questionnaire (MIDAS) were used to measure headache impact and disability. Data were analyzed as part of the Canadian Headache Outpatient Registry and Database (CHORD) Project., Results: The average age of the patients was 40 years and the majority were female (78%). Most were employed either full time (49%) or part time (13%). The majority of patients were diagnosed with either migraine or tension-type headache (78%). Over a third of patients experienced headache every day, and half had experienced a headache in the previous month which was of severe intensity. Most (80%) scored in the "very severe" category of the HIT-6 and over half (55%) were severely disabled as measured by the MIDAS., Conclusion: Patients referred to headache specialists in Canada are severely disabled by their headache disorders. These patients are in the most productive phase of their lives in terms of age and employment. It is important to provide the best available treatment to headache patients in order to minimize the disability and impact of their headache disorders.

Background: Care of a secondary patient (an individual other than the primary patient for an outpatient visit) is common in family practice, but the content of care of this type of patient has not been described., Methods: In a cross-sectional study, 170 volunteer primary care clinicians in 50 practices in the Ambulatory Sentinel Practice Network reported all occurrences of care of a secondary patient during 1 week of practice. These clinicians reported the characteristics of the primary patient and the secondary patient and the content of care provided to the secondary patient. Content of care was placed in 6 categories (advice, providing a prescription, assessment or explanation of symptoms, follow-up of a previous episode of care, making or authorizing a referral, and general discussion of a health condition)., Results: Physicians reported providing care to secondary patients during 6% of their office visits. This care involved more than one category of service for the majority of visits involving care of a secondary patient. Advice was provided during more than half the visits. A prescription, assessment or explanation of symptoms, or a general discussion of condition were provided during approximately 30% of the secondary care visits. Secondary care was judged to have substituted for a separate visit 60% of the time, added an average of 5 minutes to the visit, and yielded no reimbursement for 95% of visits., Conclusions: Care of a secondary patient reflects the provision of potentially intensive and complex services that require additional time and are largely not reimbursed or recognized by current measures of primary care. This provision of secondary care may facilitate access to care and represent an added value provided by family physicians.

Background: Problem drinking is common, and a 15-minute intervention can help some patients reduce drinking to safe levels. Little is known, however, about the frequency and duration of alcohol-related discussions in primary care., Methods: Nineteen clinicians in the Ambulatory Sentinel Practice Network (ASPN) collected data about alcohol-related discussions for 1 week following their usual office routine (Phase 1) and for 1 week with the addition of routine screening for problem drinking (Phase 2). Of those, 15 clinicians collected data for a third week after receiving training in brief interventions with problem drinkers (Phase 3). Clinicians collected data on standard ASPN reporting cards., Results: In Phase 1 the clinicians discussed alcohol during 9.6% of all visits. Seventy-three percent of those discussions were shorter than 2 minutes long, and only 10% lasted longer than 4 minutes. When routine screening was added (Phase 2), clinicians were more likely to discuss alcohol at acute-illness visits, but the frequency, duration, and intensity of such discussions did not change. Only 32% of Phase 2 discussions prompted by a positive screening result lasted longer than 2 minutes. After training, the duration increased (P <.004). In Phase 3, 58% of discussions prompted by a positive screening result lasted longer than 2 minutes, but only 26% lasted longer than 4 minutes., Conclusion: Routine screening changed the kinds of visits during which clinicians discussed alcohol use. Training in brief-intervention techniques significantly increased the duration of alcohol-related discussions, but most discussions prompted by a positive screening result were still shorter than effective interventions reported in the literature.