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Migraine Frequency and Health Utilities: Findings from a Multisite Survey
Abstract
Assess the relationship between migraine frequency and health utility.
Patients aged >/=18 years diagnosed with episodic migraine were enrolled at three US sites representing varied models of health-care delivery. All subjects completed a questionnaire that included demographic and clinical information, a migraine-specific disability questionnaire, and the Health Utilities Index Mark 3 (HUI3). The HUI3 is a generic health status and health-related quality-of-life measure. HUI3 health status data are translated into utility scores anchored by 0 (dead) and 1 (perfect health).
The study enrolled 150 patients. The mean age was 44 years and 87% were female. Mean (+/-SD) monthly migraine frequency was 4.4 +/- 3.6, with 34% reporting </=2 migraines per month and 20% reporting >6 migraines per month. The mean (+/-SD) HUI3 score was 0.62 +/- 0.26. After controlling for study center, demographics, comorbidities, migraine characteristics, and level of migraine disruptiveness, migraine frequency was found to be significantly (P < 0.05) and negatively associated with HUI3 scores. Subjects with >6 migraines per month had an adjusted mean HUI3 score of 0.41; the corresponding mean for those reporting </=2 migraines per month was 0.67. Migraine frequency was positively associated with higher levels of disability for the emotion, cognition, and pain components of the HUI3.
Among this group of care-seeking patients, migraineurs' health utilities were inversely related to headache frequency. Although these data may not be generalizable to the entire migraine population, they may be useful in assessing the comparative cost-effectiveness of preventive migraine therapies.
... To our knowledge, previous studies in the literature evaluated utilities for migraine only by the indirect approach, e.g. EuroQol 5 dimensions (EQ-5D), Health Utilities Index Mark 3 (HUI3) [8][9][10] and direct utility assessment was applied only in a few methodological studies involving small sample sizes [11][12][13]. Thus, it is still remaining unclear whether the direct approach is feasible and able to distinguish between different severities of migraine. ...
... Consequently, our utility findings can contribute to economic evaluations of preventive therapies. Brown et al. [10] assessed HRQOL in 150 episodic migraine patients with HUI3 and discussed that migraineurs' health utilities were inversely related to their headache frequency. Depending on number of self-reported migraines per month (n) authors observed: n B 2 U = 0.68 (SD 0.25), n = 3-4 U = 0.63 (SD 0.26), n = 5-6 U = 0.60 (SD 0.21), and n [ 6 U = 0.55 (SD 0.22), respectively [10]. ...
... Brown et al. [10] assessed HRQOL in 150 episodic migraine patients with HUI3 and discussed that migraineurs' health utilities were inversely related to their headache frequency. Depending on number of self-reported migraines per month (n) authors observed: n B 2 U = 0.68 (SD 0.25), n = 3-4 U = 0.63 (SD 0.26), n = 5-6 U = 0.60 (SD 0.21), and n [ 6 U = 0.55 (SD 0.22), respectively [10]. By comparison, we assessed only two frequencies, two or eight migraines per month on average but identified the same trend, notwithstanding that our study resulted higher utility scores. ...
... sed quality of life associated with a migraine, the temporary nature of a migraine attack has rendered it difficult to capture patients' utility during a migraine attack, as well as any changes in patient utility that might occur within a migraine attack. Very few studies to date have measured utility for migraine pain severity levels and outcomes. Brown et al. (2008) elicited utilities using the HUI Mark 3 (HUI3) in a United States (US) cohort of migraine patients with a 4-week recall period (potentially covering time within and outside of a migraine episode), and reported that utility was inversely related to headache frequency [11]. Xu et al. (2010) reported the relationship between migraine pain ...
... Very few studies to date have measured utility for migraine pain severity levels and outcomes. Brown et al. (2008) elicited utilities using the HUI Mark 3 (HUI3) in a United States (US) cohort of migraine patients with a 4-week recall period (potentially covering time within and outside of a migraine episode), and reported that utility was inversely related to headache frequency [11]. Xu et al. (2010) reported the relationship between migraine pain and health utility based on the analysis of clinical trial data on the EQ-5D in a sample of US patients [12]. ...
... Thus, these states were regarded by members of the UK general public as being less desirable than a loss of life for that time span. Another analysis eliciting migraine-related utilities from a US adult patient sample with 4-week recall (potentially covering time with and without migraine) using the HUI3 found migraine severity (self-assessed on a scale of 1 to 10) was not a significant predictor of utility [11] . However, authors note that this lack of a relationship between migraine-related pain and utility may have been due to the low variation in pain seen in the dataset. ...
To estimate utility values for different levels of migraine pain severity from a United Kingdom (UK) sample of migraineurs.
One hundred and six migraineurs completed the EQ-5D to evaluate their health status for mild, moderate and severe levels of migraine pain severity for a recent migraine attack, and for current health defined as health status within seven days post-migraine attack. Statistical tests were used to evaluate differences in mean utility scores by migraine severity.
Utility scores for each health state were significantly different from 1.0 (no problems on any EQ-5D dimension) (p < 0.0001) and one another (p < 0.0001). The lowest mean utility, - 0.20 (95% confidence interval [CI]: -0.27 - -0.13), was for severe migraine pain. The smallest difference in mean utility was between mild and moderate migraine pain (0.13) and the largest difference in mean utility was between current health (without migraine) and severe migraine pain (1.07).
Results indicate that all levels of migraine pain are associated with significantly reduced utility values. As severity worsened, utility decreased and severe migraine pain was considered a health state worse than death. Results can be used in cost-utility models examining the relative economic value of therapeutic strategies for migraine in the UK.
... We aimed to examine the humanistic and economic burden among migraineurs experiencing C 4MHDS (categorized in subgroups of [4][5][6][7][8][9][10][11][12][13][14], and C 15 MHDs, respectively) compared with those experiencing 1-3 MHDs, in terms of health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), and healthcare resource utilization (HRU) in five European countries (EU5). ...
... The Global Burden of Disease 2015 Study reported migraine as the leading cause of years lived with disability worldwide in adults aged 15-49 years, indicating that the burden of migraine is particularly high during the prime years of productivity [6]. Therefore, migraine and an increase in the number of monthly headache days (MHDs) can have an immense impact on the functional abilities of the affected population [7,8]. ...
Introduction:
Prior studies have estimated the burden of migraine in patients suffering from ≥ 4 monthly headache days (MHDs), but the burden experienced by migraineurs suffering from one to three (1-3) MHDs is unknown. The aim of this study was to examine the incremental burden of migraine in terms of health-related quality of life (HRQoL), impairments to work and daily activities, and healthcare resource utilization (HRU) in five European countries (France, Germany, Italy, Spain, and the UK (EU5]), by comparing migraineurs with ≥ 4 MHDs and migraineurs with 1-3 MHDs.
Methods:
The sample for this retrospective cross-sectional study was collected from the 2017 National Health and Wellness Survey (N = 62,000). The Short-Form 12-Item Health Survey Instrument, version-2 physical and mental component summary (PCS and MCS) scores, Short-Form 6-dimensions (SF-6D), EuroQoL 5-dimensions (EQ-5D) and EuroQoL visual analog scale (VAS) scores, impairments to work productivity and daily activities (Work Productivity and Activity Impairment [WPAI] Questionnaire) scores, and HRU were compared between migraineur groups with ≥ 4 MHDs (4-7, intermediate-frequency episodic migraine; 8-14, high-frequency episodic migraine; ≥ 15 chronic migraine) and the migraineur subgroup with 1-3 MHDs (low-frequency episodic migraine) using generalized linear modeling after adjusting for covariates.
Results:
Data from a total of 62,000 survey respondents were examined, of whom 1323 and 1569 were considered to have 1-3 MHDs and ≥ 4 MHDs (4-7 MHDs [n = 783]; 8-14 MHDs [n = 429]; ≥ 15 MHDs [n = 357]), respectively. The adjusted HRQoL was significantly lower in the 4-7 MHDs (for MCS and SF-6D scores; p < 0.0001) and 8-14 MHDs subgroups (for MCS, SF-6D, EQ-5D, and EuroQoL VAS scores, p < 0.0001; for PCS scores, p = 0.0007) than in the 1-3 MHDs subgroup. Migraineurs with 4-7 and 8-14 MHDs reported higher activity impairment and more frequent visits to healthcare providers (all p < 0.0001) and neurologists (p = 0.0006 and p < 0.0001, respectively) compared to the 1-3 MHDs subgroup. Migraineurs with ≥ 15 MHDs had significantly lower HRQoL and increased WPAI scores and HRU than the 1-3 MHDs subgroup.
Conclusions:
This study provides evidence supporting the incremental burden of migraine, characterized by poorer HRQoL and increased WPAI scores and greater HRU, among migraineurs experiencing ≥ 4 MHDs compared with migraineurs experiencing 1-3 MHDs in the EU5.
... These considerations are particularly relevant to migraine, a chronic neurological disorder with episodic attacks of headache and an array of other symptoms [12]. Migraine is a debilitating disease in which utilities are typically measured via the Health Utilities Index (HUI) or the EQ-5D [13][14][15][16]. Migraine has considerable negative effects on a person's HRQoL, in addition to a high economic burden due to high direct costs (physician visits, emergency department visits, etc.) and indirect costs (lost work days, decreased productivity at work, etc.) [17]. ...
... Reduction in the frequency of monthly migraine days (MMD) is an important measure in the efficacy of migraine prophylaxis; however, there are limited data on the relationship between migraine frequency and health status [15]. Furthermore, patient-level data collected within the time frame of a clinical study often cover too short a duration to assess the likely costs and benefits that may yield over an individual's entire lifetime [10]. ...
Background:
Cost-effectiveness analyses in patients with migraine require estimates of patients' utility values and how these relate to monthly migraine days (MMDs). This analysis examined four different modelling approaches to assess utility values as a function of MMDs.
Methods:
Disease-specific patient-reported outcomes from three erenumab clinical studies (two in episodic migraine [NCT02456740 and NCT02483585] and one in chronic migraine [NCT02066415]) were mapped to the 5-dimension EuroQol questionnaire (EQ-5D) as a function of the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Headache Impact Test (HIT-6™) using published algorithms. The mapped utility values were used to estimate generic, preference-based utility values suitable for use in economic models. Four models were assessed to explain utility values as a function of MMDs: a linear mixed effects model with restricted maximum likelihood (REML), a fractional response model with logit link, a fractional response model with probit link and a beta regression model.
Results:
All models tested showed very similar fittings. Root mean squared errors were similar in the four models assessed (0.115, 0.114, 0.114 and 0.114, for the linear mixed effect model with REML, fractional response model with logit link, fractional response model with probit link and beta regression model respectively), when mapped from MSQ. Mean absolute errors for the four models tested were also similar when mapped from MSQ (0.085, 0.086, 0.085 and 0.085) and HIT-6 and (0.087, 0.088, 0.088 and 0.089) for the linear mixed effect model with REML, fractional response model with logit link, fractional response model with probit link and beta regression model, respectively.
Conclusions:
This analysis describes the assessment of longitudinal approaches in modelling utility values and the four models proposed fitted the observed data well. Mapped utility values for patients treated with erenumab were generally higher than those for individuals treated with placebo with equivalent number of MMDs. Linking patient utility values to MMDs allows utility estimates for different levels of MMD to be predicted, for use in economic evaluations of preventive therapies.
Trial registration:
ClinicalTrials.gov numbers of the trials used in this study: STRIVE, NCT02456740 (registered May 14, 2015), ARISE, NCT02483585 (registered June 12, 2015) and NCT02066415 (registered Feb 17, 2014).
... To calculate quality-adjusted life years (QALYs), these economic models require utilities, which are values representing the strength of preference for health states on a scale anchored to 0 (dead) and 1 (full health) [7]. Utilities are available to represent levels of migraine severity defined in terms of headache frequency or pain severity [1,3,4,[8][9][10][11][12][13]. However, little is known about the utility impact of other aspects of migraine preventive therapies that could be important to patients, such as route of administration and adverse events (AEs). ...
... Generic preference-based measures such as the EQ-5D and Health Utilities Index are useful for estimating utilities associated with migraine severity [8,13], but these instruments were not designed to be sensitive to specific treatment attributes. Route of administration could be important to patients and have an impact on treatment preference and quality of life. ...
Purpose
While previous studies have estimated health state utilities associated with migraine severity and frequency, migraine treatments vary in other ways that may have an impact on patients’ quality of life, preference, and utility. The purpose of this study was to estimate utilities associated with migraine treatment attributes including route of administration and treatment-related adverse events (AEs).
Methods
In time trade-off interviews, migraine patients and general population participants in the UK valued health state vignettes drafted based on literature, medication labels, and clinician interviews. All respondents valued migraine health states varying in route of administration. Each participant also valued eight health states (randomly selected from a total of 15) that added the description of an AE to a migraine health state.
Results
A total of 400 participants completed interviews (200 general population [49.0% female; mean age = 43.6 years]; 200 migraine patients [74.5% female; mean age = 45.8 years]). In the general population sample, mean utilities of health states without aura were 0.79 with daily oral medication, 0.78 with one injection per month, and 0.72 with 31–39 injections once every 3 months. The greatest disutilities (i.e., decreases in utility) were for AEs associated with oral medications (e.g., − 0.060 [fatigue] and − 0.098 [brain fog]). Differences among health states followed the same pattern in the patient sample as in the general population sample.
Conclusions
Utilities estimated from the general population sample may be used to represent route of administration and AEs in cost-utility models. Results from the patient sample indicate that these treatment characteristics have an impact on patient preference.
... 5 As a result, migraine may have an adverse impact on the functional abilities of affected populations. 6,7 Normally, management of migraine includes the prevention and treatment of migraine. However, migraines are very difficult to be cured successfully, and current therapeutic options have many undesirable side effects and may even intensify the headache pain in patients with chronic migraines. ...
Introduction:
Migraine is a common neurovascular disorder disease often characterized by episodic headaches that can develop chronic disorders. Acupuncture as a non-pharmacological therapy has been extensively used to manage migraine prevention and treatment in clinical practice. Many studies focused on acupuncture therapy for migraine, but none analyzed the publications quantitatively and qualitatively. The aim of this study is to show the recent researches and trend of advances in this field based on quantitative and qualitative analyses.
Methods:
Publications related to acupuncture research about migraine were retrieved from the Web of Science (WoS) Core Collection and Scopus database. The quantitative data analysis was performed to show the recent researches and trend of advances from six perspectives: annual scientific production, countries, institutions, authors, journals, and keywords. For the qualitative analysis, acupuncture research about migraine was analyzed from the top twenty most highly cited articles.
Results:
The number of annual scientific production steadily increased with some fluctuations over the years. The country and institutions contributing most to this field are China and Chengdu University of Traditional Chinese Medicine. Zhao Ling was the most relevant author in this field, Linde Klaus was the highly co-cited author. The leading journal regarding the number of selected articles was "Zhongguo Zhen Jiu". The top twenty most highly cited articles were divided into two categories: original articles and reviews. Among these two categories, original articles occupied the vast majority. Moreover, the real effectiveness of acupuncture for migraine prevention and treatment was the research frontier and hot spot.
Conclusion:
Results of our analysis indicate that the number of publications showed an overall increasing trend, demonstrating that this research field still has a promising future. In addition, more researchers will probably focus their work on the difference between verum acupuncture and usual care for preventing and treating migraine.
... Migraine is the second-highest cause of disability globally, in individuals across all age groups and becomes more burdensome with increased frequency of monthly migraine days (MMD) [3]. Those with more frequent MMD have reduced quality of life, are less productive, have lower income and higher rates of unemployment, increased disability, increased comorbidity rates, and higher health care resource utilization and direct costs [4][5][6][7][8][9][10][11][12][13][14][15][16]. ...
Background
The objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks.
Methods
Eligible subjects were adults with ≥1 year history of migraine and ≥ 6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000–201; NCT03266588). Mean MMD were calculated at each 4-week period, along with mean monthly tablets taken. Migraine-specific quality of life (MSQv2) data were mapped to EQ-5D utilities and used to characterize HRQoL over time. A published network meta-analysis was used to characterize pain hours as well as time periods spent migraine free.
Results
One thousand forty four subjects were included in this post-hoc analysis. Overall mean MMD were 10.9 at baseline and decreased to 8.9 by week 52. Tablet use remained stable over the follow-up period. A total of 0.08 incremental QALYs were associated with rimegepant use.
Conclusion
For subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one-year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks.
Trial registration
ClinicalTrials.gov identifier NCT03266588.
... Several studies have shown that migraine leads to an extensive socio-economic burden in terms of direct costs, i.e. resources required for health care and treatment [9], indirect costs, i.e. the value of the lost production resulting from migraine-related absenteeism and presenteeism (reduced productivity at work related to migraine) [10,11] and reduced quality of life (QoL) [11][12][13][14][15]. An earlier European study has reported yearly health care costs related to migraine between € 500 and 3700 per person depending on country and migraine frequency [9]. ...
Background:
Migraine is a disabling, chronic neurological disease leading to severe headache episodes affecting 13.2% of the Swedish population. Migraine leads to an extensive socio-economic burden in terms of healthcare costs, reduced workforce and quality of life (QoL) but studies of the health-economic consequences in a Swedish context are lacking. The objective of this study is to map the health-economic consequences of migraine in a defined patient population in terms of healthcare consumption, production loss and QoL in Sweden.
Methods:
The study is based on data from a web-based survey to members in the Swedish patients' association suffering from migraine. The survey was conducted in May 2018 and included people with migraine aged 18 years or older. The survey included questions on health resource consumption, lost production resulting from migraine-related absenteeism and presenteeism, and QoL as measured by the EuroQol 5 dimensions questionnaire (EQ-5D-5 L) and the Headache Impact Test (HIT-6). The results are presented in yearly costs per patient and losses in quality adjusted life years (QALYs).
Results:
The results are based on answers from 630 individuals with migraine and are presented by number of migraine days per month. The total cost per patient and year increased with the number of migraine days per month (p < 0.001) and varied between approximately €5000 for those with less than 3 migraine days per month and €24,000 per year for those with 21-28 migraine days per month. Production loss represented the main part of the costs, approximately 80%. The average loss in QALYs per year also increased with the monthly number of migraine days (p = 0.023).
Conclusions:
Migraine leads to significant societal costs and loss of quality of life. There appears to be an unmet need and a potential for both cost savings and QoL benefits connected with a reduction in the number of migraine days.
... Migraine headache is thought to affect 12 million individuals in the United States alone [21]. Migraine headache can occur at any age with some children suffering not only from the symptoms of headache, but with unique symptoms such as cyclical vomiting, vertigo, motion sickness [22,23]. ...
Headache is a one of the most common problems encountered in clinical practice. Over 90 per cent of headaches fall into one of four diagnostic categories: (1) Tension-type headache; (2) Migraine headache; (3) Cluster headache; and (4) Medication overuse headache. The mainstay of diagnosis of these common headaches is the taking of a careful targeted headache history. The physical examination in patients suffering from these common headaches is almost always normal and abnormalities identified on physical examination in this patient population should raise concern. Appropriate use of diagnostic imaging including magnetic resonance imaging of the brain and cervical spine is indicated in those patients with a recent onset of headaches and in those patients in whom a previously stable headache pattern has changed. Laboratory testing will also help the clinician rule out co-existent or occult disease that may be contributing to the patient’s headache symptomatology. In most cases, treatment plans should be aimed at preventing headache rather than aborting the headache after symptoms have already occurred. Care must be taken to identify overuse or misuse of medications prescribed to treat headache, as many of these medications have the propensity to cause medication overuse headaches.
... Migraine is a chronic episodic disorder characterized by headache attacks accompanied by neurological, gastrointestinal and autonomic symptoms (1)(2)(3). Patients with frequent and severe migraine attacks can be prescribed prophylactic medication to reduce the frequency, duration, and severity of attacks. Clinical trials on the prophylactic effect of propranolol and metoprolol show divergent results concerning the magnitude of decrease in use of attack medication after starting these medications. ...
Clinical trials on the prophylactic effect of propranolol and metoprolol for migraine show that starting this medication leads to a decrease in the use of attack medication of 0.9-8.9 doses per month. However, studies in daily practice are lacking.
We compared the number of triptans prescribed in the six months before and the six months after the start of propranolol/metoprolol in a Dutch national representative primary care cohort.
Of the 168 triptan-using patients who started with propranolol or metoprolol, the number of triptans prescribed before starting was 4.6 doses per month. The number of triptans prescribed six months before compared with six months after starting propranolol/metoprolol decreased with 1.0 dose per month (Wilcoxon rank test; P = 0.000).
In this primary care population, although the number of triptans prescribed decreased after starting propranolol or metoprolol, the decrease is relatively small compared to data from clinical trials.
... Their estimation can be particularly useful for health-economic evaluations of interventions that have an impact on improving patient quality of life, such as prophylactic or acute medications for migraine. A number of studies have been published describing health utility values among individuals with migraine [3][4][5][6][7][8][9][10][11][12][13]; however, all have reflected assessments essentially conducted at random time points (i.e., mixing together patients and/or periods during which migraine attacks were and were not experienced). These studies are useful for understanding the general chronic burden of migraine in the population. ...
Previous studies have reported health utilities for migraine patients as generally measured between migraine attacks, but health utility data for within a migraine attack are unavailable. We evaluated within-attack health utilities among acute migraine patients experiencing different grades of headache severity.
We examined data for 330 20-65-year-old adults, in good physical health, who had 1-6 moderate/severe migraine attacks per month in the 2 months prior to the screening visit. Data were collected from a multicenter, double-blind study of a treatment for acute migraine in the United States. The EQ-5D system was used to measure generic health status at baseline and 24 h post-treatment within an acute migraine attack, and patients were also asked to rate their pain level at these time points (no, mild, moderate, or severe pain). The D1 time-trade-off scoring algorithm for the U.S. population was applied. Confidence intervals were estimated by bootstrap methods.
The study population was 88% women and 78% white ethnicity, with 60% of subjects over age 40. The disutility of mild migraine pain was estimated to be 0.140 (95% CI: 0.0848, 0.1940), with a disutility for moderate migraine pain of 0.186 (95% CI: 0.1645, 0.2053) and for severe migraine pain of 0.493 (95% CI: 0.4100, 0.5654).
Within-attack disutilities estimated for migraine in this study are much greater than those reported for migraine when evaluated as a chronic health condition (e.g., valuations collected at random time points). These data can be of value in adapting results from clinical trials of migraine interventions to cost-utility policy analyses.
... On the other hand, Brown et al, who studied the utility associated with migraine, found a utility of 0.62 (assessed with the Health Utilities Index 3 (HUI3)). 32 This value is close to the 0.66 we found. Similar to our results, a study focusing on respiratory conditions reported utilities ranging from 0.63 (in a sample of individuals with non-controlled asthma) to 0.80 (in individuals whose asthma was controlled). ...
The World Health Organization (WHO) has stated that the three leading causes of burden of disease in 2030 are projected to include HIV/AIDS, unipolar depression and ischaemic heart disease.
To estimate health-related quality of life (HRQoL) and quality-adjusted life-year (QALY) losses associated with mental disorders and chronic physical conditions in primary healthcare using data from the diagnosis and treatment of mental disorders in primary care (DASMAP) study, an epidemiological survey carried out with primary care patients in Catalonia (Spain).
A cross-sectional survey of a representative sample of 3815 primary care patients. A preference-based measure of health was derived from the 12-item Short Form Health Survey (SF-12): the Short Form-6D (SF-6D) multi-attribute health-status classification. Each profile generated by this questionnaire has a utility (or weight) assigned. We used non-parametric quantile regressions to model the association between both mental disorders and chronic physical condition and SF-6D scores.
Conditions associated with SF-6D were: mood disorders, beta = -0.20 (95% CI -0.18 to -0.21); pain, beta = -0.08 (95%CI -0.06 to -0.09) and anxiety, beta = -0.04 (95% CI -0.03 to -0.06). The top three causes of QALY losses annually per 100 000 participants were pain (5064), mood disorders (2634) and anxiety (805).
Estimation of QALY losses showed that mood disorders ranked second behind pain-related chronic medical conditions.
Background:
This post hoc analysis aimed to estimate eptinezumab's therapeutic effect on health utilities and determined to which extent monthly migraine days (MMDs) explain changes in health utilities.
Research design/methods:
DELIVER, a randomized, double-blind, placebo-controlled phase 3b trial (NCT04418765), investigated eptinezumab efficacy and safety in patients with 2‒4 prior migraine treatment failures. Regression analysis explored the relationship between utility scores and MMDs, with eptinezumab treatment as a covariate along with MMDs to identify any MMD-independent effect on utilities. Path analysis quantified eptinezumab's impact as mediated through MMD reduction.
Results:
The base case model showed that each reduction in MMD was associated with a mean utility score increase (0.0189; 95% CI: 0.0180, 0.0198; P< 0.001). Mean utility score was generally higher for eptinezumab versus placebo, justifying addition of treatment effect to the base case model. Patients administered eptinezumab had on average 0.0562 (95% CI: 0.0382, 0.0742; P< 0.001) higher utility versus placebo when controlling for number of MMDs. From path analysis, MMD reduction resulting from eptinezumab treatment accounted for 53% additional utility gain observed in patients.
Conclusions:
Changes in MMDs alone inadequately captured migraine's impact on patient utility, as there was also a positive eptinezumab-driven, treatment-specific impact on utility score.
Trial registration:
The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04418765).
The assertion that primary headaches are a social disease is now out of the question, being established both by a high prevalence rate and by the impact they produce on the person and society. The negative loop of these premises is overturned on the vertical economic damage they cause, another solid evidence in the scientific literature. This expansion from personal to social damage, in terms of current expenditure of the national health systems, requires as a natural consequence a more efficient organization of the health services dedicated to control, education, rehabilitation, to achieve social care equity. Migraine represents the perfect paradigm of this path.
BACKGROUND: The objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks.
METHODS: Eligible subjects were adults with ≥1 year history of migraine and ≥6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000-201; NCT03266588). Mean MMD were calculated at each 4-week period, along with mean monthly tablets taken. Migraine-specific quality of life (MSQv2) data were mapped to EQ-5D utilities and used to characterize HRQoL over time. A published network meta-analysis was used to characterize pain hours as well as time periods spent migraine free.
RESULTS: 1,044 subjects were included in this post-hoc analysis. Overall mean MMD were 10.9 at baseline and decreased to 8.9 by week 52. Tablet use remained stable over the follow-up period. A total of 0.08 incremental QALYs were associated with rimegepant use.
CONCLUSION: For subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks.
ClinicalTrials.gov identifier: NCT03266588
Introduction
There are increasing demands for studies of cost-effectiveness to allocate resources for disease prevention and treatment strategies. The aim of this study is to measure quality of life in migraineurs, based on the Migraine-Specific Questionnaire (MSQ) and EQ-5D-5L, and thereafter map an algorithm to estimate health-state utility values from the MSQ in individuals with migraine.
Methods
In this cross-sectional study conducted between May and July 2018 in a tertiary headache clinic in Tehran, Iran, migraineurs diagnosed based on International Classification of Headache Disorders (ICHD)-3β were enrolled and were asked to complete the MSQ questionnaire and EQ-5D questionnaire. The Spearman correlation coefficient (ρ) was calculated to measure the correlation between the EQ-5D-5L and MSQ v2.1 domains’ score. A P value of <.05 was considered statistically significant. After statistical analysis, several regression models were presented to map the results of the MSQ domains to the utility index, and the preferred model was achieved based on goodness of fit and the model’s predictive performance.
Results
The preferred MSQ algorithm had approximately the same prediction errors in all migraineurs, episodic and chronic migraine (root mean square error 0.24, 0.24, and 0.23, respectively). The preferred MSQ model explained a variance of 0.26 (R²) in episodic and 0.38 in chronic migraine in the EQ-5D-5L questionnaire.
Conclusion
The preferred MSQ mapping algorithm will be suitable in estimating health state utilities in trials of patients with migraine that contain MSQ scores but lack utility values.
Aim:
To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine.
Background:
Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioral lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise).
Design:
The study is a prospective, randomized, controlled, single-blinded trial with parallel arms.
Methods:
The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed.
Discussion:
Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. This article is protected by copyright. All rights reserved.
Aims
To critically appraise, compare and synthesise the quality and acceptability of multi-item patient reported outcome measures for adults with chronic or episodic headache.
Methods
Systematic literature searches of major databases (1980–2016) to identify published evidence of PROM measurement and practical properties. Data on study quality (COSMIN), measurement and practical properties per measure were extracted and assessed against accepted standards to inform an evidence synthesis.
Results
From 10,903 reviewed abstracts, 103 articles were assessed in full; 46 provided evidence for 23 PROMs: Eleven specific to the health-related impact of migraine (n = 5) or headache (n = 6); six assessed migraine-specific treatment response/satisfaction; six were generic measures. Evidence for measurement validity and score interpretation was strongest for two measures of impact, Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) and Headache Impact Test 6-item (HIT-6), and one of treatment response, the Patient Perception of Migraine Questionnaire (PPMQ-R). Evidence of reliability was limited, but acceptable for the HIT-6. Responsiveness was rarely evaluated. Evidence for the remaining measures was limited. Patient involvement was limited and poorly reported.
Conclusion
While evidence is limited, three measures have acceptable evidence of reliability and validity: HIT-6, MSQ v2.1 and PPMQ-R. Only the HIT-6 has acceptable evidence supporting its completion by all “headache” populations.
This study aims to evaluate health state utilities for migraine based on attack frequency from a mixed population sample consisting of migraineurs and non-migraineurs. A cross-sectional questionnaire survey was designed to measure health-related quality of life (HRQOL) in migraine without aura by time trade-off method (TTO). A convenience sample of university students and staff was recruited regardless of having ever experienced migraine or not. Subjects were asked to elicit two hypothetical health states characterised by different migraine frequencies ('m': two migraines lasting 4 h each month and 'w': each week) within two hypothetical lifetime frames (20 years left to live/lives until the age of 80 years). Utilities were calculated for the four tasks (U20m, U80m, U20w, U20w) and compared amongst subgroups. Overall 180 respondents were included in the analysis. Mean age was 25.6 years (SD 6.4), 128 (71 %) were female and 110 (61 %) were self-reported migraineurs. Mean utilities for two migraines each month were U20m = 0.84 (SD 0.26) and U80m = 0.89 (SD 0.14), and for each week were U20w = 0.79 (SD 0.27) and U80w = 0.83 (SD 0.17), respectively. Self-reported migraineurs and females attached higher mean utilities for U80m and older respondents for U20m, respectively (p < 0.05). To our knowledge, this is the first study that provides HRQOL results measured by TTO methodology for migraine. Utility loss ranged from 0.1 to 0.2 depending on attack frequency. HRQOL impairment of having two migraine attacks per week was found similar to living with low back pain (0.77-0.79).
Smelt AFH, Blom JW, Dekker F, Van den Akker ME, Knuistingh Neven A,Zitman FG, Ferrari MD, Assendelft WJJ. Proactieve benadering van migraine.Huisarts Wet 2012;55(8):336-40.
Doel
Bepalen of een proactieve benadering van migrainepatiënten leidt tot minder hoofdpijnklachten en kosten.
Methode
Een pragmatisch, clustergerandomiseerd onderzoek in 64 Nederlandse huisartsenpraktijken onder patiënten die minstens twee triptanen per maand voorgeschreven kregen. Onze primaire uitkomstmaat was de score op de Headache Impact Test (HIT-6) na zes maanden (klinisch relevante verbetering van 2,3 punten). Daarnaast maten wij psychische klachten met behulp van de K10-vragenlijst. Interventiehuisartsen kregen nascholing over diagnostiek en behandeling van migraine. Zij nodigden patiënten uit voor een evaluatieconsult om te beoordelen of de migrainebehandeling kon worden verbeterd. Controlehuisartsen continueerden hun gebruikelijke zorg.
Resultaten
Na zes maanden was de score van de interventiegroep (n = 233) op de HIT-6 0,81 punten meer verbeterd dan die van de controlegroep (n = 258; p =0,07). In de subgroep van patiënten die geen profylaxe gebruikten en twee of meer aanvallen per maand rapporteerden, was het verschil 1,37 punten (p = 0,04). De verbetering was groter bij patiënten met weinig psychische klachten (–1,51; p = 0,008) dan bij patiënten met veel psychische klachten (0,16; p = 0,494).
Conclusie
Een proactief beleid had bij onze onderzoekspopulatie geen klinisch relevant effect. Toekomstig onderzoek moet zich richten op patiënten die geen profylaxe gebruiken en twee of meer migraineaanvallen per maand rapporteren. De interventie had meer effect bij patiënten met weinig psychische klachten.
Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs.
We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participants were prescribed two or more doses of triptan per month. General practitioners in the intervention group received training on treating migraine and invited participating patients for a consultation and evaluation of the therapy they were receiving. Physicians in the control group continued with usual care. Our primary outcome was patients' scores on the Headache Impact Test (HIT-6) at six months. We considered a reduction in score of 2.3 points to be clinically relevant. We used the Kessler Psychological Distress Scale (K10) questionnaire to determine if such distress was a possible effect modifier. We also examined the interventions' cost-effectiveness.
We enrolled 490 patients in the trial (233 to the intervention group and 257 to the control group). Of the 233 patients in the intervention group, 192 (82.4%) attended the consultation to evaluate the treatment of their migraines. Of these patients, 43 (22.3%) started prophylaxis. The difference in change in score on the HIT-6 between the intervention and control groups was 0.81 (p = 0.07, calculated from modelling using generalized estimating equations). For patients with low levels of psychological distress (baseline score on the K10 ≤ 20) this change was -1.51 (p = 0.008), compared with a change of 0.16 (p = 0.494) for patients with greater psychological distress. For patients who were not using prophylaxis at baseline and had two or more migraines per month, the mean HIT-6 score improved by 1.37 points compared with controls (p = 0.04). We did not find the intervention to be cost-effective.
An educational intervention for general practitioners and a proactive approach to patients with migraine did not result in a clinically relevant improvement of symptoms. Psychological distress was an important confounder of success. (Current Controlled Trials registration no. ISRCTN72421511.).
Early, aggressive treatment of rheumatoid arthritis (RA) improves outcomes but confers increased risk. Risk stratification to target aggressive treatment of high-risk individuals with early RA is considered important to optimize outcomes while minimizing clinical and monetary costs. Some advocate the addition of magnetic resonance imaging (MRI) to standard RA risk stratification with clinical markers for patients early in the disease course. Our objective was to determine the incremental cost-effectiveness of adding MRI to standard risk stratification in early RA.
Using a decision analysis model of standard risk stratification with or without MRI, followed by escalated standard treatment protocols based on treatment response, we estimated 1-year and lifetime quality-adjusted life-years, RA-related costs, and incremental cost-effectiveness ratios (with MRI vs without MRI) for RA patients with fewer than 12 months of disease and no baseline radiographic erosions. Inputs were derived from the published literature. We assumed a societal perspective with 3.0% discounting.
One-year and lifetime incremental cost-effectiveness ratios for adding MRI to standard testing were $204,103 and $167,783 per quality-adjusted life-year gained, respectively. In 1-way sensitivity analyses, model results were insensitive to plausible ranges for every variable except MRI specificity, which published data suggest is below the threshold for MRI cost-effectiveness. In probabilistic sensitivity analyses, most simulations produced lifetime incremental cost-effectiveness ratios in excess of $100,000 per quality-adjusted life-year gained, a commonly cited threshold.
Under plausible clinical conditions, adding MRI is not cost-effective compared with standard risk stratification in early-RA patients.
There are few data about the cost effectiveness of prophylactic medications for migraine. Clinical trials have shown several preventive agents to be useful in reducing the frequency of migraine attack while having tolerable side effects.
To compare the cost effectiveness of adding preventive treatment to abortive therapy for acute migraine with abortive therapy for acute migraine alone in the primary care setting.
A Markov decision analytic model with a cycle length of 1 day, a time horizon of 365 days and three health states was used to perform an analysis comparing the cost effectiveness and utility of five treatments for migraine prophylaxis (amitriptyline 75 mg/day, topiramate 100 and 200 mg/day, timolol 20 mg/day, divalproex sodium 1000 mg/day or propranolol 160 mg/day) with treatment of acute migraine alone for the management of migraine in the primary care setting. One-way and probabilistic sensitivity analyses were performed to test the robustness of the results.
The expected total annual cost for the use of preventive agents ranged from $US2932 to $US3887, compared with $US3960 for the use of abortive medications only. In the baseline analysis, use of each of the five preventive agents generated more quality-adjusted life-years (QALYs) and incurred lower costs compared with abortive medications only. Monte Carlo Simulation suggested that amitriptyline 75 mg/day was most likely to be considered a cost-effective option versus the other five therapies, followed by timolol 20 mg/day, topiramate 200 mg/day, topiramate 100 mg/day, divalproex sodium 1000 mg/day and propranolol 160 mg/day when the willingness-to-pay (WTP) for society is <$US18 000 per QALY gained.
Preventive medications appear to be a cost-effective approach to the management of migraine in the primary care setting compared with the approach of abortive treatment only. Among those preventive agents, probabilistic sensitivity analysis suggests that, when the societal WTP is <$US18 000 per QALY gained, amitriptyline 75 mg/day is most likely to be considered a cost-effective option.
Background
Migraine is a common disabling disease but its economic burden has not been adequately quantified.
Objective
To estimate the burden of migraine in the United States with respect to disability and economic costs.
Methods
The following data sources were used: published data, the Baltimore County Migraine Study, MEDSTAT's MarketScan medical claims data set, and statistics from the Census Bureau and the Bureau of Labor Statistics. Disability was expressed as bedridden days. Charges for migraine-related treatment were used as direct cost inputs. The human capital approach was used in the estimation of indirect costs.
Results
Migraineurs required 3.8 bed rest days for men and 5.6 days for women each year, resulting in a total of 112 million bedridden days. Migraine costs American employers about $13 billion a year because of missed workdays and impaired work function; close to $8 billion was directly due to missed workdays. Patients of both sexes aged 30 to 49 years incurred higher indirect costs compared with younger or older employed patients. Annual direct medical costs for migraine care were about $1 billion and about $100 was spent per diagnosed patient. Physician office visits accounted for about 60% of all costs; in contrast, emergency department visits contributed less than 1% of the direct costs.
Conclusions
The economic burden of migraine predominantly falls on patients and their employers in the form of bedridden days and lost productivity. Various screening and treatment regimens should be evaluated to identify opportunities to reduce the disease burden.
To describe the prevalence, sociodemographic profile, and the burden of migraine in the United States in 1999 and to compare results with the original American Migraine Study, a 1989 population-based study employing identical methods.
A validated, self-administered questionnaire was mailed to a sample of 20 000 households in the United States. Each household member with severe headache was asked to respond to questions about symptoms, frequency, and severity of headaches and about headache-related disability. Diagnostic criteria for migraine were based on those of the International Headache Society. This report is restricted to individuals 12 years and older.
Of the 43 527 age-eligible individuals, 29 727 responded to the questionnaire for a 68.3% response rate. The prevalence of migraine was 18.2% among females and 6.5% among males. Approximately 23% of households contained at least one member suffering from migraine. Migraine prevalence was higher in whites than in blacks and was inversely related to household income. Prevalence increased from aged 12 years to about aged 40 years and declined thereafter in both sexes. Fifty-three percent of respondents reported that their severe headaches caused substantial impairment in activities or required bed rest. Approximately 31% missed at least 1 day of work or school in the previous 3 months because of migraine; 51% reported that work or school productivity was reduced by at least 50%.
Two methodologically identical national surveys in the United States conducted 10 years apart show that the prevalence and distribution of migraine have remained stable over the last decade. Migraine-associated disability remains substantial and pervasive. The number of migraineurs has increased from 23.6 million in 1989 to 27.9 million in 1999 commensurate with the growth of the population. Migraine is an important target for public health interventions because it is highly prevalent and disabling.
Although an association between migraine and epilepsy has long been discussed, it has rarely been studied systematically. According to the evidence from the large epidemiologic study reviewed in this article, individuals with epilepsy are 2.4 times more likely to develop migraine than their relatives without epilepsy. Risk of migraine is elevated in patients with partial-onset and generalized-onset seizures. The comorbidity of migraine and epilepsy may be explained by a state of neuronal hyperexcitability that increases the risk of both disorders. Clinical and EEG features useful in the differential diagnosis of migraine and epilepsy as well as in the diagnosis of both conditions when they occur concurrently are reviewed. When migraine and epilepsy occur together, therapy with agents effective for both conditions should be considered.
Migraine is a common disabling disease but its economic burden has not been adequately quantified.
To estimate the burden of migraine in the United States with respect to disability and economic costs.
The following data sources were used: published data, the Baltimore County Migraine Study, MEDSTAT's MarketScan medical claims data set, and statistics from the Census Bureau and the Bureau of Labor Statistics. Disability was expressed as bedridden days. Charges for migraine-related treatment were used as direct cost inputs. The human capital approach was used in the estimation of indirect costs.
Migraineurs required 3.8 bed rest days for men and 5.6 days for women each year, resulting in a total of 112 million bedridden days. Migraine costs American employers about $13 billion a year because of missed workdays and impaired work function; close to $8 billion was directly due to missed workdays. Patients of both sexes aged 30 to 49 years incurred higher indirect costs compared with younger or older employed patients. Annual direct medical costs for migraine care were about $1 billion and about $100 was spent per diagnosed patient. Physician office visits accounted for about 60% of all costs; in contrast, emergency department visits contributed less than 1% of the direct costs.
The economic burden of migraine predominantly falls on patients and their employers in the form of bedridden days and lost productivity. Various screening and treatment regimens should be evaluated to identify opportunities to reduce the disease burden.
To examine the relationship of migraine and other severe headaches with panic disorder.
Representative samples of persons with migraine, non-migrainous severe headaches, and controls with no history of severe headaches, identified by a telephone survey, were interviewed in person, using a standardized psychiatric interview. Cox proportional hazards models with time-dependent covariates were used to examine the relationship of headaches with first-onset panic disorder and vice versa.
Lifetime prevalence of panic disorder was significantly higher in persons with migraine and in persons with other severe headaches, compared with controls. Migraine and other severe headaches were associated with an increased risk for first onset of panic disorder (hazards ratios = 3.55 and 5.75). Panic disorder was associated with an increased risk for first onset of migraine and for first onset of other severe headaches, although the influences in this direction were lower (hazards ratios = 2.10 and 1.85).
Comorbidity of panic disorder is not specific to migraine and applies also to other severe headaches. The influence is primarily from headaches to panic disorders, with a weaker influence in the reverse direction. The bidirectional associations, despite the difference in the strength of the associations, suggest that shared environmental or genetic factors might be involved in the comorbidity of panic disorder with migraine and other severe headaches.
To determine the prevalence and distribution of migraine in the United States as well as current patterns of health care use.
A random-digit-dial, computer-assisted telephone interview (CATI) survey was conducted in Philadelphia County, PA, in 1998. The CATI identifies individuals with migraine (categories 1.1 and 1.2) as defined by the diagnostic criteria of the International Headache Society with high sensitivity (85%) and specificity (96%). Interviews were completed in 4,376 subjects to identify 568 with migraine. Those with 6 or more attacks per year (n = 410) were invited to participate in a follow-up interview about health care utilization and family impact of migraine; 246 (60.0%) participated.
The 1-year prevalence of migraine was 17.2% in females and 6.0% in males. Prevalence was highest between the ages of 30 and 49. Whereas 48% of migraine sufferers had seen a doctor for headache within the last year (current consulters), 31% had never done so in their lifetimes and 21% had not seen a doctor for headache for at least 1 year (lapsed consulters). Of current or lapsed consulters, 73% reported a physician-made diagnosis of migraine; treatments varied. Of all migraine sufferers, 49% were treated with over-the-counter medications only, 23% with prescription medication only, 23% with both, and 5% with no medications at all.
Relative to prior cross-sectional surveys, epidemiologic profiles for migraine have remained stable in the United States over the last decade. Self-reported rates of current medical consultation have more than doubled. Moderate increases were seen in the percentage of migraine sufferers who use prescription medications and in the likelihood of receiving a physician diagnosis of migraine.
Health related quality of life (HRQOL) is increasingly recognised as an important outcome in epilepsy. However, interpretation of HRQOL data is difficult because there is no agreement on what constitutes a clinically important change in the scores of the various instruments.
To determine the minimum clinically important change, and small, medium, and large changes, in broadly used epilepsy specific and generic HRQOL instruments.
Patients with difficult to control focal epilepsy (n = 136) completed the QOLIE-89, QOLIE-31, SF-36, and HUI-III questionnaires twice, six months apart. Patient centred estimates of minimum important change, and of small, medium, and large change, were assessed on self administered 15 point global rating scales. Using regression analysis, the change in each HRQOL instrument that corresponded to the various categories of change determined by patients was obtained. The results were validated in a subgroup of patients tested at baseline and at nine months.
The minimum important change was 10.1 for QOLIE-89, 11.8 for QOLIE-31, 4.6 for SF-36 MCS, 3.0 for SF-36 physical composite score, and 0.15 for HUI-III. All instruments differentiated between no change and minimum important change with precision, and QOLIE-89 and QOLIE-31 also distinguished accurately between minimum important change and medium or large change. Baseline HRQOL scores and the type of treatment (surgical or medical) had no impact on any of the estimates, and the results were replicated in the validation sample.
These estimates of minimum important change, and small, medium, and large changes, in four HRQOL instruments in patients with epilepsy are robust and can distinguish accurately among different levels of change. The estimates allow for categorisation of patients into various levels of change in HRQOL, and will be of use in assessing the effect of interventions in individual patients.
The aims of this study were: (i) to compare health-related quality of life (HRQoL) as measured by the Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) in a population sample of migraine headache sufferers and controls without migraine; (ii) to assess the relationship of HRQoL and work-related disability attributed to headache in a population sample. The study was conducted in two phases. First, a population-based, telephone interview survey of 5769 residents of greater London, England was conducted to identify individuals with migraine headache (cases) and controls without migraine. In the second stage, in-person interviews were conducted in a matched sample of 200 migraine cases and 200 controls selected from survey respondents. At the beginning of the in-person interview, participants were asked to complete the SF-36. In addition, a work-related disability score based on the telephone interview was defined as the number of lost work days or days when usual activity was reduced by 50% or more over the previous year. The disability score was trichotomized as mild (n = 98), moderate (n = 49), and severe disability (n = 49). Compared with controls, individuals with migraine headache scored significantly lower in eight of the nine domains of the SF-36 as well as in the overall Physical Component Summary (PCS) score and Mental Component Summary (MCS) score. Further, among migraine sufferers, each of the disability groups scored significantly lower in seven of the nine domains and in the summary scales. Scores showed greater reductions in HRQoL for the moderate and severe disability groups vs. the mild disability group in five of nine scales and in the Total Physical Summary score. We conclude that, in a population-based sample of migraine headache sufferers, individuals with migraine headache have lower HRQoL scores compared with controls. Moreover, among individuals with migraine headache, work-related disability is associated with lower HRQoL scores. Specifically, individuals classified with moderate to severe work-related disability had lower HRQoL scores than those classified with low disability.
This is a review of the Health Utilities Index (HUI) multi-attribute health-status classification systems, and single- and multi-attribute utility scoring systems. HUI refers to both HUI Mark 2 (HUI2) and HUI Mark 3 (HUI3) instruments. The classification systems provide compact but comprehensive frameworks within which to describe health status. The multi-attribute utility functions provide all the information required to calculate single-summary scores of health-related quality of life (HRQL) for each health state defined by the classification systems. The use of HUI in clinical studies for a wide variety of conditions in a large number of countries is illustrated. HUI provides comprehensive, reliable, responsive and valid measures of health status and HRQL for subjects in clinical studies. Utility scores of overall HRQL for patients are also used in cost-utility and cost-effectiveness analyses. Population norm data are available from numerous large general population surveys. The widespread use of HUI facilitates the interpretation of results and permits comparisons of disease and treatment outcomes, and comparisons of long-term sequelae at the local, national and international levels.
Small open-label and controlled trials suggest that the antiepileptic drug topiramate is effective for migraine prevention.
To assess the efficacy and safety of topiramate for migraine prevention in a large controlled trial.
A 26-week, randomized, double-blind, placebo-controlled study was conducted during outpatient treatment at 52 North American clinical centers. Patients were aged 12 to 65 years and had a 6-month history of migraine (International Headache Society criteria) and 3 to 12 migraines a month but no more than 15 headache days a month during a 28-day prospective baseline phase.
After a washout period, patients meeting entry criteria were randomized to topiramate (50, 100, or 200 mg/d) or placebo. Topiramate was titrated by 25 mg/wk for 8 weeks to the assigned or maximum tolerated dose, whichever was less. Patients continued receiving that dose for 18 weeks.
The primary efficacy measure was change from baseline in mean monthly migraine frequency. Secondary efficacy measures included responder rate (proportion of patients with > or =50% reduction in monthly migraine frequency), reductions in mean number of monthly migraine days, severity, duration, and days a month requiring rescue medication, and adverse events. The month of onset of preventive treatment action was assessed.
Of 483 patients randomized, 468 provided at least 1 postbaseline efficacy assessment and comprised the intent-to-treat population. Mean monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg/d (-2.1, P =.008) and topiramate at 200 mg/d (-2.4, P<.001) vs placebo (-1.1). Statistically significant reductions (P<.05) occurred within the first month with topiramate at 100 and 200 mg/d. The responder rate was significantly greater with topiramate at 50 mg/d (39%, P =.01), 100 mg/d (49%, P<.001), and 200 mg/d (47%, P<.001) vs placebo (23%). Reductions in migraine days were significant for the 100-mg/d (P =.003) and 200-mg/d (P<.001) topiramate groups. Rescue medication use was reduced in the 100-mg/d (P =.01) and 200-mg/d (P =.005) topiramate groups. Adverse events resulting in discontinuation in the topiramate groups included paresthesia, fatigue, and nausea.
Topiramate showed significant efficacy in migraine prevention within the first month of treatment, an effect maintained for the duration of the double-blind phase.
Topiramate (TPM) has shown efficacy in migraine prophylaxis in two large placebo-controlled, dose-ranging trials. We conducted a randomised, double-blind, multicentre trial to evaluate the efficacy and safety of two doses of topiramate vs placebo for migraine prophylaxis, with propranolol (PROP) as an active control. Subjects with episodic migraine with and without aura were randomised to TPM 100 mg/d, TPM 200 mg/d, PROP 160 mg/d (active control), or placebo. The primary efficacy measure was the change in mean monthly migraine frequency from the baseline phase relative to the double-blind treatment phase. Five hundred and seventy-five subjects were enrolled from 61 centres in 13 countries. TPM 100 mg/d was superior to placebo as measured by reduction in monthly migraine frequency, overall 50% responder rate, reduction in monthly migraine days, and reduction in the rate of daily rescue medication use. The TPM 100 mg/d and PROP groups were similar with respect to reductions in migraine frequency, responder rate, migraine days, and daily rescue medication usage. TPM 100 mg/d was better tolerated than TPM 200 mg/d, and was generally comparable to PROP. No unusual or unexpected safety risks emerged. These findings demonstrate that TPM 100 mg/d is effective in migraine prophylaxis. TPM 100 mg/d and PROP 160 mg/d exhibited similar efficacy profiles.
Migraine is a common disorder characterised by recurrent episodes of disability. Despite the high prevalence of migraine, data have been lacking on its impact in a working population. The advent of new therapies has stimulated interest in this area, and evidence is now available that documents the substantial impact of migraine on workplace productivity and the likelihood of untreated migraine leading to unemployment or underemployment for the patient.
This paper reviews current findings of both observational and interventional studies about the impact of migraine on productivity and employment. When considered in the light of migraine demographics, the high prevalence of migraine, and its low consultation and treatment rates, this evidence indicates that improved screening and treatment for this common condition could have a substantial impact on worker productivity and on patient well-being.
Synopsis
Migraine is a common illness characterised by severe, often throbbing and/or unilateral headache, which may be accompanied by sensitivity to light or noise. A minority of migraine attacks are preceded by transient visual or sensory disturbances. Migraine is associated with reductions in health-related quality of life, both during and between attacks.
Despite methodological limitations in cost-of-illness studies, it is clear that the cost of migraine to society is substantial. Indirect costs (primarily workplace productivity losses) make up 75 to 90% of total costs. Direct costs, such as the cost of drug treatment, physician consultation, hospitalisation and emergency room treatment, make up most of the remainder.
Sumatriptan is an effective and well tolerated agent in the treatment of migraine. Its main advantage over other agents used in the acute management of migraine appears to be its rapid onset of action. Sumatriptan reduces headache severity within 2 hours of oral administration in 50 to 67% of patients and within 1 hour of subcutaneous administration in 70 to 80% of patients. Headache recurs in approximately 40% of patients who initially respond to oral or subcutaneous sumatriptan; however, a second dose of the drug is effective against the symptoms of recurrence in a majority of patients. Some patients experience relief of non-headache migraine symptoms, including nausea, vomiting, photophobia and phonophobia. Adverse events reported after sumatriptan are generally mild and transient.
Data from studies of patients who used their usual therapies and sumatriptan in nonblinded, sequential phases indicate that both workplace and nonworkplace productivity losses were reduced during sumatriptan therapy. A cost-benefit analysis applied to some of these workplace productivity data indicated that, including direct costs and productivity savings, sumatriptan was associated with a net reduction in total cost of migraine. In retrospective cost analyses, sumatriptan was associated with increased prescription costs; the effect of the drug on other direct treatment costs was less clear. A retrospective pharmacoeconomic model suggested that the cost-effectiveness of subcutaneous sumatriptan versus subcutaneous dihydroergotamine depended on which outcome measure was of greatest interest. For measures of rapid relief of migraine, sumatriptan was superior, but the cost of achieving rapid relief was substantial.
Sumatriptan improved global quality-of-life scores compared with patients’ usual therapy in a randomised crossover trial and appeared to do the same when the drugs were administered in nonblinded, sequential phases in trials which used general and migraine-specific quality-of-life instruments.
Thus, sumatriptan is associated with a fast onset of action and improvements in health-related quality of life in patients with migraine. However, the cost of achieving rapid relief of migraine symptoms may be substantial. Compared with patients’ usual treatments, sumatriptan appeared to reduce workplace and non-workplace productivity losses. However, few economic data from well controlled prospective comparisons of sumatriptan with other available agents are available to quantify the effect of sumatriptan on the overall cost of migraine.
Overview of Migraine
Migraine headache affects 8 to 12% of the general adult population, but is more prevalent in women. Attacks of migraine, which may occur with or without aura, are characterised by severe, often unilateral and/or throbbing, head pain accompanied by nausea and/or sensitivity to light or noise. Transient visual or sensory disturbances (auras) precede a minority of attacks. Migraine is associated with reductions in health-related quality of life, particularly in the dimensions of bodily pain and role-physical (ability to function limited by physical health), both during and between attacks. More than half all of persons with migraine surveyed in the US reported at least 1 severe attack per month. More than 80% of patients report some disability with their attacks. Despite low rates of physician consultation, most persons with migraine use prescription or nonprescription medication for acute migraine headache.
Cost-of-illness estimates are associated with theoretical and methodological limitations; however, it is clear that the cost of migraine to society is substantial. Indirect costs, primarily those resulting from lost workplace productivity, make up the largest portion of total costs (75 to 90%). Estimates of the annual indirect cost of migraine range from $US1.4 to $US17.2 billion in the US (calculated using earnings data published in 1989) and £250 to £741 million in the UK (1990 and 1992 costs, respectively). Estimates of direct costs (e.g. the costs of medication, physician consultation, hospitalisation and emergency room treatment) are about 10 to 25% of the total cost of illness.
Clinical Profile of Sumatriptan
Sumatriptan is an effective and well tolerated agent in the treatment of migraine. Its main advantage over other available antimigraine drugs appears to be its rapid onset of action. Sumatriptan reduces headache severity in 50 to 67% of patients within 2 hours of oral administration and 70 to 80% of patients 1 hour after subcutaneous administration. Headache recurred within 48 hours in approximately 40% of patients who initially responded to the drug. A second dose of medication administered for symptom recurrence was effective in the majority of patients.
In randomised studies, headache relief after oral sumatriptan was as good as, or better than, that provided by other oral agents, including aspirin plus metoclopramide, ergotamine plus caffeine, and lysine acetylsalicylate plus metoclopramide. Subcutaneous sumatriptan provided more rapid relief of headache pain than subcutaneous dihydroergotamine mesylate (DHE), but was not superior 4 and 24 hours after administration. Fewer patients required rescue medication after oral sumatriptan than after aspirin plus metoclopramide or ergotamine plus caffeine.
Adverse events associated with sumatriptan are generally transient and of mild to moderate severity and would not be expected to substantially increase the cost of migraine treatment. After sumatriptan, some patients experience relief of non-headache migrainous symptoms, including nausea, vomiting, photophobia and phonophobia.
Pharmacoeconomic and Quality-of-Life Considerations
Limitations of available pharmacoeconomic analyses of sumatriptan include the absence of blinding and parallel control groups in most studies. Compared with patients’ usual treatments, oral and subcutaneous sumatriptan are associated with reductions in workplace productivity losses: estimated productivity gains with sumatriptan ranged from 12.1 to 89.8 hours per patient per year. Although of less measurable economic impact, nonworkplace productivity gains — generally less than an hour per treated migraine day — have also been documented with sumatriptan therapy.
A cost-benefit analysis of sumatriptan therapy suggested that the cost of oral sumatriptan 50mg (£220 per patient per year) was more than offset by reductions in workplace productivity losses, resulting in a net annual economic benefit of sumatriptan therapy to society of £125 per patient (1996 costs). In retrospective cost analyses, the introduction of sumatriptan was associated with increased prescription costs, but its effect on other direct costs associated with migraine treatment was unclear.
A pharmacoeconomic model applied retrospectively to a comparison of subcutaneous sumatriptan with subcutaneous DHE suggested that cost effectiveness of the 2 therapies was dependent upon which outcome measure was of greatest interest. For 4 outcome measures associated with rapid relief of migraine symptoms (requirement for no more than 1 dose of medication, ability to carry on as normal 1 hour after first dose and complete relief of symptoms or nausea 1 hour after first dose), the extra cost per patient successfully treated with sumatriptan ranged from $US4131 to $US6697 (1993 dollars). For other measures, DHE was both more efficacious and less expensive; therefore, cost-effectiveness ratios were not calculated. The additional cost of treating 100 patients with sumatriptan instead of DHE was estimated at $US88 395 per year (i.e. $US 884 per patient per year) [1993 dollars].
Health-related quality of life in patients with migraine is improved during treatment with sumatriptan, as demonstrated in a randomised crossover trial. Improvements in global health-related quality-of-life scores and scores for the domains of functional, physical and social impairments and iatrogenic disturbance were significantly greater during sumatriptan therapy than when patients used their usual medications. Health-related quality of life, measured by general and migraine-specific quality-of-life instruments, improved after sumatriptan therapy compared with baseline or scores after patients’ usual therapies, but the lack of parallel control groups and blinding in these studies limits the conclusions that can be drawn.
OBJECTIVE: Compare adult migraineurs' health related quality of life to adults in the general U.S. population reporting no chronic conditions, and to samples of patients with other chronic conditions.
METHODS: Subjects (n = 845) were surveyed 2-6 months after participation in a placebo-controlled clinical trial and asked to complete a questionnaire including the SF-36 Health Survey, a migraine severity measurement scale and demographics. Results were adjusted for severity of illness and comorbidities. Scores were compared with responses to the same survey by the U.S. sample and by patients with other chronic conditions.
RESULTS: Response rate was 67%. After adjustment for comorbid conditions, SF-36 scale scores were significantly (P 0.001) lower in migraineurs, relative to age and sex-adjusted norms for the U.S. sample with no chronic conditions. Some health dimensions were more affected by migraine than other chronic conditions, while other dimensions were less affected by migraine. Measures of bodily pain, role disability due to physical health and social functioning discriminated best between migraineurs, the U.S. sample, and patients with other chronic conditions. Patients reporting moderate, severe and very severe migraines scored significantly (P < or = 0.001) lower on five of the eight SF-36 scales than the U.S. sample.
CONCLUSIONS: Migraine has a unique, significant quality of life burden.
A random sample survey was conducted to determine the prevalence of migraine in nurses and to study its effect on quality of life and productivity. Of the 10 000 nurses sampled, 2949 returned the questionnaire for a response rate of 29.5%. The majority (99%) of respondents were employed and worked in hospitals (60%). According to the International Headache Society (IHS) criteria, 17% of the sample (n=495) were classified as having migraine. An additional 25% (n=750) suffered severe headaches but did not meet IHS criteria for migraine, and the remaining 58% (n=1704) were classified as not having either migraine or severe headaches. The migraineurs had significantly reduced work productivity and quality of life compared to both the severe headache and the nonmigraine nonsevere headache groups. This study will increase awareness and sensitivity of the profession to its colleagues who are migraine sufferers.
Objective.—A population-based survey was conducted in 1999 to describe the patterns of migraine diagnosis and medication use in a representative sample of the US population and to compare results with a methodologically identical study conducted 10 years earlier.
Methods.—A survey mailed to a panel of 20 000 US households identified 3577 individuals with severe headache meeting a case definition for migraine based on the International Headache Society (IHS) criteria. Those with severe headache answered questions regarding physician diagnosis and use of medications for headache as well as headache-related disability.
Results.—A physician diagnosis of migraine was reported by 48% of survey participants who met IHS criteria for migraine in 1999, compared with 38% in 1989. A total of 41% of IHS-defined migraineurs used prescription drugs for headaches in 1999, compared with 37% in 1989. The proportion of IHS-defined migraineurs using only over-the-counter medications to treat their headaches was 57% in 1999, compared with 59% in 1989. In 1999, 37% of diagnosed and 21% of undiagnosed migraineurs reported 1 to 2 days of activity restriction per episode (P<.001); 38% of diagnosed and 24% of undiagnosed migraineurs missed at least 1 day of work or school in the previous 3 months (P<.001); 57% of diagnosed and 45% of undiagnosed migraineurs experienced at least a 50% reduction in work/school productivity (P<.001).
Conclusions.— Diagnosis of migraine has increased over the past decade. Nonetheless, approximately half of migraineurs remain undiagnosed, and the increased rates of diagnosis of migraine have been accompanied by only a modest increase in the proportion using prescription medicines. Migraine continues to cause significant disability whether or not there has been a physician diagnosis. Given the availability of effective treatments, public health initiatives to improve patterns of care are warranted.
SYNOPSIS
Objective: To assess the reliability and validity of the Medical Outcomes Study (MOS) Short Form Health Survey as an indicator for quality of life in patients with chronic headaches.
Design: Patient interview survey.
Setting: A headache clinic within a multi-specialty group practice. Patients: 208 consecutive patients seeking evaluation of headache at the above site. Measurements: All six health components of the MOS Short Form Health Survey were included in the study.
Main results: The MOS Short Form Health Survey was both reliable and valid in the group of patients with headache. Patients with headache had significantly worse physical, social, and role functioning, and worse mental health than did patients with chronic diseases (P<0.0001). The functioning associated with chronic headaches was worse than that associated with major chronic medical conditions such as arthritis and diabetes, and was comparable to the level of functioning associated with recent myocardial infarction or congestive heart failure.
Conclusions: The MOS survey is a reliable measure of quality of life for patients with chronic headaches Chronic headache disorders cause significantly more morbidity and impairment of function than has previously been appreciated.
The aim of the present study was to compare the general well-being of migraine patients between attacks with that of an age- and sex-matched control group. One hundred and forty-five consecutive and eligible patients at the Gothenburg Migraine Clinic were asked about their well-being and their complaints. Using three self-administered standardized questionnaires, the Minor Symptoms Evaluation Profile (MSEP), Subjective Symptoms Assessment Profile (SSAP) and the Psychological General Well-Being (PGWB) Index, evaluable responses were obtained from 138 migraine patients. Compared with control subjects, migraineurs perceived more symptoms and greater emotional distress as well as disturbed contentment, vitality and sleep. It is concluded that the general well-being of the migraine patient is impaired, even between the attacks.
What is the effect of migraine on health status, defined as the patient's physical, psychological, and social functioning? And, suppose that the health status of migraine sufferers appears to be impaired, to what extent is this a consequence of migraine-associated comorbidity rather than of migraine itself?
A group of 846 migraineurs, selected from the general population following IHS criteria, and a control group were surveyed with the Medical Outcomes Study 36-item Short-Form Health Survey, Nottingham Health Profile, EuroQol instrument, and the COOP/WONCA charts. Questions on demographic characteristics and comorbidity were included.
The health status of migraineurs appeared to be significantly impaired in comparison to the control group. Because statistical significance is distinct from relevance, effect size estimators were employed. Although the direction of the differences indicated consistently a worse health status of the migraineurs, regardless of the instrument used, the sizes of the differences were small to medium. Self-reported comorbidity, especially depression, was more prevalent in the migraine group. However, this offered only a partial explanation for the impaired health status of the migraine group.
Migraine has an independent moderately deteriorating effect on the daily functioning of individuals.
SYNOPSIS
To explore the social and personal impact of headache, we contributed questions on serious headache to a population-based telephone survey on health in Kentucky. A total of 647 persons aged 20 and older was assessed for serious headache. Migraine without aura was distinguished from non-migraine headache using a modification of the 1988 IHS criteria. The 12-month period prevalence for all serious headaches was 13.4%; for migraine, it was 8.5%. Demographically, there was a higher proportion of headache sufferers in the low income bracket (<$10,000/year) and a higher proportion of women reporting migraines. Of those with serious headaches, 73.6% stated that headaches adversely affected their lifestyle in at least one way. Migraineurs reported significantly more interference in family relations, work attendance, and work efficiency than non-migraineurs. Women said their family relationships and work productivity were impacted significantly more often than men. Of those reporting disability, 46.8% said they take only non-prescription medications. We conclude there is a significant number of serious headache sufferers in Kentucky who experience social as well as vocational impairment as a result of their illness. Further research is recommended to evaluate the extent of interpersonal and personal disability and to identify barriers to adequate health care for headache sufferers.
Compare adult migraineurs' health related quality of life to adults in the general U.S. population reporting no chronic conditions, and to samples of patients with other chronic conditions.
Subjects (n = 845) were surveyed 2-6 months after participation in a placebo-controlled clinical trial and asked to complete a questionnaire including the SF-36 Health Survey, a migraine severity measurement scale and demographics. Results were adjusted for severity of illness and comorbidities. Scores were compared with responses to the same survey by the U.S. sample and by patients with other chronic conditions.
Response rate was 67%. After adjustment for comorbid conditions, SF-36 scale scores were significantly (P 0.001) lower in migraineurs, relative to age and sex-adjusted norms for the U.S. sample with no chronic conditions. Some health dimensions were more affected by migraine than other chronic conditions, while other dimensions were less affected by migraine. Measures of bodily pain, role disability due to physical health and social functioning discriminated best between migraineurs, the U.S. sample, and patients with other chronic conditions. Patients reporting moderate, severe and very severe migraines scored significantly (P < or = 0.001) lower on five of the eight SF-36 scales than the U.S. sample.
Migraine has a unique, significant quality of life burden.
OBJECTIVE
To compare healthcare use and associated costs in patients with migraine and patients without migraine headache.
DESIGN
Retrospective review of a managed care organization's medical and pharmacy claims databases for claims filed between January 1, 1989 and June 30, 1990.
PATIENTS
Patients between 18 and 64 years old with a 12-month minimum enrollment in the health plan, including enrollment for the prescription drug benefit. Migraine group (n=1336) inclusion required a medical claim with the diagnosis of migraine headache and a pharmacy claim for a medication potentially used for migraine treatment. Comparison group (n=1336) inclusion required at least one medical claim with no diagnosis of migraine; a pharmacy claim was not required. Comparison group patients were matched to migraine group patients by age, gender, enrollment status, and subscriber or dependent enrollment status.
OUTCOME MEASURES
Total health services use, diagnosis-specific use of services, diagnostic procedures performed, comorbid conditions, medication use, and associated costs were tallied.
RESULTS
Migraineurs generated nearly twice as many medical claims as comparison group patients, and nearly 2.5 times as many pharmacy claims. Number of claims generated and numbers of patients who generated claims within each of 19 diagnostic categories indicated greater comorbidity in the migraine group. Migraineurs used emergency services more than did patients in the comparison group. Total medical and pharmacy claims costs were $3.4 million for the migraine group and $2.1 million for the comparison group. The average amount paid per member-month of enrollment was significantly greater in the migraine group than in the comparison group. Comorbid conditions were responsible for a significant portion of costs in the migraine group. The migraine group incurred $83 537 for diagnostic procedures compared with $13 140 incurred by the comparison group.
To develop consensus-based recommendations guiding the conduct of cost-effectiveness analysis (CEA) to improve the comparability and quality of studies. The recommendations apply to analyses intended to inform the allocation of health care resources across a broad range of conditions and interventions. This article, first in a 3-part series, discusses how this goal affects the conduct and use of analyses. The remaining articles will outline methodological and reporting recommendations, respectively.
The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, was convened by the US Public Health Service (PHS).
The panel reviewed the theoretical foundations of CEA, current practices, and alternative procedures for measuring and assigning values to resource use and health outcomes.
The panel met 11 times during 2 1/2 years with PHS staff and methodologists from federal agencies. Working groups brought issues and preliminary recommendations to the full panel for discussion. Draft recommendations were circulated to outside experts and the federal agencies prior to finalization.
The panel's recommendations define a "reference case" cost-effectiveness analysis, a standard set of methods to serve as a point of comparison across studies. The reference case analysis is conducted from the societal perspective and accounts for benefits, harms, and costs to all parties. Although CEA does not reflect every element of importance in health care decisions, the information it provides is critical to informing decisions about the allocation of health care resources.
A random sample survey was conducted to determine the prevalence of migraine in nurses and to study its effect on quality of life and productivity. Of the 10,000 nurses sampled, 2949 returned the questionnaire for a response rate of 29.5% The majority (99%) of respondents were employed and worked in hospitals (60%). According to the International Headache Society (IHS) criteria, 17% of the sample (n=495) were classified as having migraine. An additional 25% (n = 750) suffered severe headaches but did not meet IHS criteria for migraine, and the remaining 58% (n = 1704) were classified as not having either migraine or severe headaches. The migraineurs had significantly reduced work productivity and quality of life compared to both the severe headache and the nonmigraine nonsevere headache groups. This study will increase awareness and sensitivity of the profession to its colleagues who are migraine sufferers.
The extensive literature on pain and the family contains little on migraine and the family.
A national sample of migraine sufferers, interviewed by telephone, was questioned on how they perceived migraine affected their family life.
Sixty percent believed that their families were significantly affected. Most stated that their families were understanding, but a considerable number reported that family members took a negative attitude. This was particularly so with younger children deprived of parental care during migraine attacks. Spousal relationships also suffered. Frequency and quality of sexual relationships were affected; and in a small number of cases, divorce was the outcome. The significance of these findings in migraine management is discussed.
According to population-based epidemiological studies using International Headache Society diagnostic criteria, the prevalence of migraine in developed countries ranges from 8 to 14%. These prevalence figures confirm the widespread nature of the disorder. Moreover, as migraine is a chronic episodic disorder that predominantly affects people during their working lives (between the ages of 25 and 55 years), indirect costs associated with reduced productivity represent a substantial proportion of the total cost of migraine. The results of health-related quality-of-life studies demonstrate that migraine has a considerable impact on functional capacity, resulting in disrupted work and social activities. Many migraineurs, however, do not seek medical attention, have not been accurately diagnosed by a physician or do not use prescription medication. Therefore, the direct costs of treatment for migraine are relatively small compared with the indirect costs. Migraine is an important chronic illness that has a major impact on the working sector of a population. The overall cost attributable to migraine is unknown, but it is now established that the indirect costs of migraine outweigh the direct costs and therefore represent an obvious target for healthcare intervention aimed at reducing the impact of this chronic condition.
Migraine is a common illness characterised by severe, often throbbing and/or unilateral headache, which may be accompanied by sensitivity to light or noise. A minority of migraine attacks are preceded by transient visual or sensory disturbances. Migraine is associated with reductions in health-related quality of life both during and between attacks. Despite methodological limitations in cost-of-illness studies, it is clear that the cost of migraine to society is substantial. Indirect costs (primarily workplace productivity losses) make up 75 to 90% of total costs. Direct costs, such as the cost of drug treatment, physician consultation, hospitalisation and emergency room treatment, make up most of the remainder. Sumatriptan is an effective and well tolerated agent in the treatment of migraine. Its main advantage over other agents used in the acute management of migraine appears to be its rapid onset of action. Sumatriptan reduces headache severity within 2 hours of oral administration in 50 to 67% of patients and within 1 hour of subcutaneous administration in 70 to 80% of patients. Headache recurs in approximately 40% of patients who initially respond to oral or subcutaneous sumatriptan; however, a second dose of the drug is effective against the symptoms of recurrence in a majority of patients. Some patients experience relief of non-headache migraine symptoms, including nausea, vomiting, photophobia and phonophobia. Adverse events reported after sumatriptan are generally mild and transient. Data from studies of patients who used their usual therapies and sumatriptan in nonblinded, sequential phases indicate that both workplace and nonworkplace productivity losses were reduced during sumatriptan therapy. A cost-benefit analysis applied to some of these workplace productivity data indicated that, including direct costs and productivity savings, sumatriptan was associated with a net reduction in total cost of migraine. In retrospective cost analyses, sumatriptan was associated with increased prescription costs: the effect of the drug on other direct treatment costs was less clear. A retrospective pharmacoeconomic model suggested that the cost-effectiveness of subcutaneous sumatriptan versus subcutaneous dihydroergotamine depended on which outcome measure was of greatest interest. For measures of rapid relief of migraine, sumatriptan was superior, but the cost of achieving rapid relief was substantial. Sumatriptan improved global quality-of-life scores compared with patients' usual therapy in a randomised crossover trial and appeared to do the same when the drugs were administered in nonblinded, sequential phases in trials which used general and migraine-specific quality-of-life instruments. Thus, sumatriptan is associated with a fast onset of action and improvements in health-related quality of life in patients with migraine. However, the cost of achieving rapid relief of migraine symptoms may be substantial. Compared with patients' usual treatments, sumatriptan appeared to reduce workplace and non-workplace productivity losses. However, few economic data from well controlled prospective comparisons of sumatriptan with other available agents are available to quantify the effect of sumatriptan on the overall cost of migraine.
This study reports on the influence of migraine and comorbid depression on health-related quality of life (HRQoL) in a population-based sample of subjects with migraine and nonmigraine controls.
Two population-based studies of similar design were conducted in the United States and United Kingdom. A clinically validated, computer-assisted telephone interview was used to identify individuals with migraine, as defined by the International Headache Society, and a nonmigraine control group. During follow-up interviews, 389 migraine cases (246 US, 143 UK) and 379 nonmigraine controls (242 US, 137 UK) completed the Short Form (SF)-12, a generic HRQoL measure, and the Primary Care Evaluation of Mental Disorders, a mental health screening tool. The SF-12 measures HRQoL in two domains: a mental health component score (MCS-12) and a physical health component score (PCS-12).
In the United States and United Kingdom, subjects with migraine had lower scores (p < 0.001) on both the MCS-12 and PCS-12 than their nonmigraine counterparts. Significant differences were maintained after controlling for gender, age, and education. Migraine and depression were highly comorbid (adjusted prevalence ratio 2.7, 95% CI 2.1 to 3. 5). After adjusting for gender, age, and education, both depression and migraine remained significantly and independently associated with decreased MCS-12 and PCS-12 scores. HRQoL was significantly associated with attack frequency (for MCS-12 and PCS-12) and disability (MCS-12).
Subjects with migraine selected from the general population have lower HRQoL as measured by the SF-12 compared with nonmigraine controls. Further, migraine and depression are highly comorbid and each exerts a significant and independent influence on HRQoL.
To assess health-related quality of life (HRQOL) in migraineurs in the general population.
Cross-sectional study within the context of a population-based study monitoring health characteristics of the Dutch adult population in two municipalities representative of the general population in the Netherlands. Migraine was assessed in a multistaged procedure that included a semistructured clinical interview by telephone. Final diagnosis met 1988 International Headache Society criteria. HRQOL was measured with the self-administered RAND 36-item Health Survey (RAND-36), including physical functioning, social functioning, role limitations, and physical perception. HRQOL of migraineurs was compared with that of nonmigraineurs. To compare and study the effect of comorbidity, the authors also identified subjects with asthma or chronic musculoskeletal pain. There were 5998 people with complete data, 620 of whom had migraine in the last year.
Compared with nonmigraineurs, significantly more migraineurs had asthma (OR = 1.6; 95% CI 1.1, 2.4) or chronic musculoskeletal pain (OR = 1.7; 95% CI 1.5, 2.1). Migraineurs reported diminished functioning and well-being on all eight domains as compared with nonmigraineurs. HRQOL was inversely related to attack frequency (p < 0.0002). Migraineurs had a poorer HRQOL than did those reporting asthma, except for dimensions concerning physical functioning and general health perception, but they had a better HRQOL than did subjects with chronic musculoskeletal pain. Comorbidity of asthma or chronic musculoskeletal pain in migraine further reduced HRQOL.
Migraineurs report more asthma and chronic musculoskeletal pain. Compared with nonmigraineurs and to others with chronic conditions, migraineurs report compromised physical, mental, and social functioning, particularly those with a high frequency of attack.
The Health Utilities Index (HUI) is a generic, multiattribute, preference-based health-status classification system. The HUI Mark 3 (HUI3) differs from the earlier HUI2 by modifying attributes and allowing more flexibility for capturing high levels of impairment. The authors compared HUI2 and HUI3 scores of patients with Alzheimer's disease (AD) and caregivers, and contrasted results of a cost-effectiveness analysis of new drugs for AD using the two systems.
In a cross-sectional study of 679 AD patient/caregiver pairs, stratified by patient's disease stage (questionable/mild/moderate/severe/profound/terminal) and setting (community/assisted living/nursing home), caregivers completed the combined HUI2/HUI3 questionnaire as proxy respondents for patients and for themselves.
Mean (SD) global utility scores for patients were lower on the HUI3 (0.22[0.26]) than on the HUI2 (0.53 [0.21]). Patient HUI3 utility scores ranged from 0.47(0.24) for questionable AD to -0.23 (0.08) for terminal AD, compared with a range of 0.73 (0.15) to 0.14 (0.07) for the HUI2. Among the 203 patients in the severe, profound, and terminal stages, 96 (48%) had negative global HUI3 utility scores, while none had a negative HUI2 score. The utility scores for caregivers were similar on the HUI3 (0.87 [0.14]) and HUI2 (0.87 [0.11]). Cost-effectiveness analysis of a new medication to treat AD showed somewhat more favorable results using the HUI3.
The HUI2 and HUI3 discriminate well across AD stages. Compared with the HUI2, the HUI3 yields lower global utility scores for patients with AD, and more scores for states judged worse than dead. The HUI3 may yield substantially different results from the HUI2, particularly for persons who have serious cognitive impairments such as AD.
Migraine is a common disorder characterised by recurrent episodes of disability. Despite the high prevalence of migraine, data have been lacking on its impact in a working population. The advent of new therapies has stimulated interest in this area, and evidence is now available that documents the substantial impact of migraine on workplace productivity and the likelihood of untreated migraine leading to unemployment or underemployment for the patient. This paper reviews current findings of both observational and interventional studies about the impact of migraine on productivity and employment. When considered in the light of migraine demographics, the high prevalence of migraine, and its low consultation and treatment rates, this evidence indicates that improved screening and treatment for this common condition could have a substantial impact on worker productivity and on patient well-being.
We evaluated the agreement between Migraine Disability Assessment (MIDAS) scores and independent physician judgments about pain, disability, and treatment needs based on patient medical histories.
The MIDAS questionnaire measures headache-related disability as lost time due to headache from paid work or school, household work, and nonwork activities.
Twelve histories from patients with migraine were presented to 49 primary and specialty care physicians unaware of the MIDAS scores. Physicians graded each patient for pain level (mild, moderate, or severe), level of disability (none, mild, moderate, or severe), and need for medical care (from 0 [lowest] to 100 [highest]). Physicians also identified MIDAS scores they associated with different degrees of disability and with the urgency to prescribe an effective treatment during the first consultation.
The physicians' perceptions of the need for medical care based on medical histories correlated with the MIDAS score (r =.69). Estimates of pain and disability by physicians were directly correlated with increasing MIDAS scores. Using the physicians' clinical judgments, the overall MIDAS score was categorized into four grades of increasing severity.
Scores on the MIDAS are highly correlated with physician judgments regarding patients' pain, disability, and need for medical care. These findings support the potential utility of the MIDAS questionnaire in clinical practice.
The Health Utilities Index Mark 3 (HUI3) is a generic multiattribute preference-based measure of health status and health-related quality of life that is widely used as an outcome measure in clinical studies, in population health surveys, in the estimation of quality-adjusted life years, and in economic evaluations. HUI3 consists of eight attributes (or dimensions) of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain with 5 or 6 levels per attribute, varying from highly impaired to normal.
The objectives are to present a multiattribute utility function and eight single-attribute utility functions for the HUI3 system based on community preferences.
Two preference surveys were conducted. One, the modeling survey, collected preference scores for the estimation of the utility functions. The other, the direct survey, provided independent scores to assess the predictive validity of the utility functions.
Preference measures included value scores obtained on the Feeling Thermometer and standard gamble utility scores obtained using the Chance Board.
A random sample of the general population (> or =16 years of age) in Hamilton, Ontario, Canada.
Estimates were obtained for eight single-attribute utility functions and an overall multiattribute utility function. The intraclass correlation coefficient between directly measured utility scores and scores generated by the multiattribute function for 73 health states was 0.88.
The HUI3 scoring function has strong theoretical and empirical foundations. It performs well in predicting directly measured scores. The HUI3 system provides a practical way to obtain utility scores based on community preferences.
The authors compared SF-36 utilities with Health Utilities Index (HUI) utilities (HUI2 and HUI3) assessed in patients with intermittent claudication. A total of 87 patients with intermittent claudication completed the SF-36 and HUI before and 1, 3, and 12 months after revascularization. Utilities were estimated using SF-36 and HUI published algorithms (i.e., both algorithms were based on standard-gamble utilities assessed in random samples of the general population). The utilities were compared using repeated-measures multivariate analysis of variance, paired t tests, and univariate linear regression analyses. Before treatment, the mean SF-36 and HUI3 utilities were the same (0.66 vs. 0.66, P = 0.92) and less than the mean HUI2 utility (0.70, P = 0.02). After treatment, all utilities showed improvement from before treatment (P < 0.05); the gain in utilities from treatment was lowest when using the SF-36 (e.g., 0.74, 0.80, 0.77 at 3 months for the SF-36, HUI2, and HUI3, respectively). The correlations of changes over time of the SF-36 with HUI2 utilities and of the SF-36 with HUI3 utilities were 0.39 and 0.49, respectively. The relationships between the SF-36 and HUI2 or HUI3 utilities were moderate to good (i.e., range-adjusted R2 = 31% to 72%). The results suggest that SF-36 data can be transformed to preference-based utilities and be used for economic evaluation in health care. The gain in utilities from treatment, however, was less for SF-36 utilities than for HUI utilities.
igraine headache is a common disorder seen in pri- mary care. It affects 18% of women and 6.5% of men in the United States, almost half of whom are un- diagnosed or undertreated (1, 2). These guidelines, devel- oped by the American Academy of Family Physicians and the American College of Physicians-American Society of Internal Medicine, with assistance from the American Headache Society, are based on two previously published papers (3, 4). The papers, titled "Evidence-Based Guide- lines for Migraine Headache in the Primary Care Setting: Pharmacological Management of Acute Attacks," by Mat- char and colleagues (3), and "Evidence-Based Guidelines for Migraine Headache in the Primary Care Setting: Phar- macological Management for Prevention of Migraine," by Ramadan and coworkers (4), can be found at www.aan- .com/professionals/practice/guidelines.cfm.1 The target audience for this guideline is primary care physicians. The guideline applies to patients with acute migraine attacks, with or without aura, and patients with migraine who are candidates for preventive drug therapy. Although these guidelines are all based on the articles by Matchar and Ramadan and colleagues, the recommenda- tions may differ because different thresholds of evidence were needed for making a positive recommendation. Table 1 compares the AAFP/ACP-ASIM guideline and the U.S. Headache Consortium Guideline. Throughout the text, asterisks indicate drugs that are currently not available in the United States.
To assess the interchangeability of preference-based health-related quality of life tools and compare the potential gains in quality-adjusted life years (QALYs) in patients with musculoskeletal disease.
Consecutive patients visiting a rheumatology clinic completed health-related quality of life assessments at baseline and 3, 6, and 12 months with the EuroQol (EQ-5D), Health Utilities Index (HUI3), and Short-Form 6D (SF-6D). Patients rated their health changes retrospectively and responses were categorized into three groups: better, same, and worse. Correlations and repeated measures analysis of variance with post hoc contrasts and a Bonferroni correction were used to assess interchangeability of tools.
Results were based on 161 cases with complete baseline data and 98 cases with data at baseline and 12 months. Correlations ranged from 0.66 to 0.79. An interaction effect showed that for the better group, the EQ-5D showed a significantly greater mean improvement (0.15) than the HUI3 (0.07) or the SF-6D (0.05). For the worse group, the EQ-5D showed a significantly greater mean decrease (0.19) than either the HUI3 (0.05) or the SF-6D (0.03). QALYs differences between the better and worse groups were significantly greater (0.23) with the EQ-5D than with the HUI3 (0.11) or the SF-6D (0.09).
Although results moderately support the idea that the three tools are measuring a similar underlying construct, the tools are not interchangeable because they are scaled differently and produce varying results. These findings have potential implications for the interpretation and comparability of health outcome studies and economic analyses. Possible approaches are sensitivity analysis or standardization of scores before calculation of QALYs.
Open-label trials and small controlled studies report topiramate's efficacy in migraine prevention.
To assess the efficacy and safety of topiramate as a migraine-preventive therapy.
A 26-week, randomized, double-blind, placebo-controlled study.
Outpatient treatment at 49 US clinical centers. Patients Patients were aged 12 to 65 years, had a 6-month International Headache Society migraine history, and experienced 3 to 12 migraines per month, but had 15 or fewer headache days per month during the 28-day baseline period.
Participants were randomized to placebo or topiramate, 50, 100, or 200 mg/d, titrated by 25 mg/wk to the assigned dose or as tolerated in 8 weeks; maintenance therapy continued for 18 weeks.
The primary efficacy assessment was a reduction in mean monthly migraine frequency across the 6-month treatment phase. Secondary end points were responder rate, time to onset of action, mean change in migraine days per month, and mean change in rescue medication days per month.
Four hundred eighty-seven patients were randomized, and 469 composed the intent-to-treat population. The mean +/- SD monthly migraine frequency decreased significantly for the 100-mg/d group (from 5.4 +/- 2.2 to 3.3 +/- 2.9; P <.001) and the 200-mg/d group (from 5.6 +/- 2.6 to 3.3 +/- 2.9; P <.001) vs the placebo group (from 5.6 +/- 2.3 to 4.6 +/- 3.0); improvements occurred within the first treatment month. Significantly more topiramate-treated patients (50 mg/d, 35.9% [P =.04]; 100 mg/d, 54.0% [P <.001]; and 200 mg/d, 52.3% [P <.001]) exhibited a 50% or more reduction in monthly migraine frequency than placebo-treated patients (22.6%). Adverse events included paresthesia, fatigue, nausea, anorexia, and taste per version.
Topiramate, 100 or 200 mg/d, was effective as a preventive therapy for patients with migraine.
The International Classification of Headache Disorders, second edition (ICHD-II) was the result of 4 years' work by a large number of headache experts from different parts of the world. This article summarizes the main new features of ICHD-II, compared with the original International Headache Society classification: better definition of migraine with aura, inclusion of chronic migraine, inclusion of a number of new primary headaches (SUNCT, hypnic headache, benign thunderclap headache, new daily-persistent headache, hemicrania continua), better definition of the secondary headaches, introduction of medication-overuse headache and of headache attributed to psychiatric disorder. An appendix defines a number of entities for research purposes. The new classification has already been translated into many of the world's major languages and many more are in the pipeline. It is enormously important that headache experts support and encourage the use of the new classification in order to develop a common knowledge base, and that they research ways of further improving it.
To assess the current level of headache burden and the headache management needs at three diverse clinical sites.
Headache is a common disabling disorder that is costly for the patient and a management challenge for physicians. The determination of whether and how to intervene to improve headache management depends on both the burden of disease and the characteristics of patients that would likely be targeted.
Patients from three healthcare organizations were identified by administrative records as having either migraine or tension-type headache and then mailed a survey that addressed demographics, headache type, headache-related disability, depression and anxiety, satisfaction with care, general health, worry about headache, problems with headache management, and healthcare utilization. Comparisons were made across sites and between patients with more and less severe headache-related impairments.
Of the 789 patients contacted, 385 (50%) returned a survey. While the socio-demographic characteristics of the patients were diverse, headache-related characteristics were similar. These patients have significant problems with headache management, disability, pain, worry, and dissatisfaction with care. Patients who described higher headache-related impairment experienced significantly greater problems in these areas, perceived themselves to be in worse general health, and had significantly greater use of medical services than those with lower headache severity.
Despite various elements of heterogeneity, we observed across the sites a consistent need for improvement in headache management. Future efforts should be directed at developing and evaluating methods for effectively improving headache management.
Patients whose migraines are frequent, cause disruptions of daily routines, or are unresponsive to acute treatment are primary candidates for preventive migraine therapy. This cost-effectiveness model assesses the clinical and economic impact of topiramate (TPM) therapy versus no preventive treatment for migraine headache in the United States.
Despite significant progress in treatment options, the economic burden of migraine to patients, employers, health systems, and society is substantial. Treatment strategies for migraine are directed toward managing acute episodes. However, preventive therapy should be used for patients with frequent migraine attacks (>2 per month) or those experiencing attacks that disrupt daily routines.
Data for the model were obtained from the published literature and pooled results of two randomized, double-blinded, placebo-controlled trials of TPM in migraine prevention. Model inputs included baseline migraine frequency (the base case assumed 6 per month, consistent with the average rate in the TPM trials), treatment discontinuation (including discontinuation due to adverse events), treatment response (ie, > or = 75%, 50% to 75%, and <50% reduction in migraine frequency), cost of preventive therapy (TPM plus physician visits for medication titration), cost of acute treatment per attack (including pharmacy and medical service costs), hours of disability per attack, hourly wage, and quality-of-life (utility) weights. Model outcomes included the number of migraines averted, disability hours, total cost of acute and preventive treatment, and lost wages. Results were expressed as cost per migraine averted and cost per quality-adjusted life years (QALY). All costs were stated as 2002 U.S. dollars. We also conducted sensitivity analyses to assess the robustness of model findings with respect to variation in key parameters.
We estimated that the use of TPM would prevent 1.85 migraines per patient and almost 5 hours of disability per month versus no preventive treatment. Resulting savings in cost of acute treatment (dollar 27) and work loss (dollar 51) offset 68% of the expected monthly cost of TPM (dollar 113). The incremental cost per migraine averted was dollar 19, while the incremental cost per QALY was estimated to be dollar 10,888 (dollar 26,191 when indirect costs were excluded from the analysis). Model results were sensitive to baseline migraine rate and gain in health utility from migraine prevention.
Economic savings associated with reduced migraine frequency offset approximately two thirds of the cost of preventive TPM therapy. The cost-effectiveness of TPM depends on utility gains associated with a reduced frequency of migraine headaches, which is the subject of ongoing research. However, results from our model suggest that the use of TPM in prevention of migraine may offer reasonable value for money relative to many well-accepted medical interventions.
This study aimed to describe the self-reported health status of the general adult U.S. population using 3 multi-attribute preference-based measures: the EQ-5D, Health Utilities Index Mark 2 (HUI2), and Mark 3 (HUI3).
We surveyed the general adult U.S. population using a probability sample with oversampling of Hispanics and non-Hispanic blacks. Respondents to this home-visit survey self-completed the EQ-5D and HUI2/3 questionnaires. Overall health index scores of the target population and selected subgroups were estimated and construct validity of these measures was assessed by testing a priori hypotheses.
Completed questionnaires were collected from 4048 respondents (response rate: 59.4%). The majority of the respondents were women (52.0%); the mean age of the sample was 45 years, with 14.8% being 65 or older. Index scores (standard errors) for the general adult U.S. population as assessed by the EQ-5D, HUI2, and HUI3 were 0.87 (0.01), 0.86 (0.01), and 0.81 (0.01), respectively. Generally, younger, male and Hispanic or non-Hispanic black adults had higher (better) index scores than older, female and other racial/ethnic adults; index scores were higher with higher educational attainment and household income. The 3 overall preference indices were strongly correlated (Pearson's r: 0.67-0.87), but systematically different, with intraclass correlation coefficients between these indices ranging from 0.59 to 0.77.
This study provides U.S. population norms for self-reported health status on the EQ-5D, HUI2, and HUI3. Although these measures appeared to be valid and demonstrated similarities, health status assessed by these measures is not exactly the same.
We examine the relationship between Visual Analogue Scale (VAS) and Standard Gamble (SG) assumed in the development of the multiplicative multi-attribute utility functions (M-MAUFs) for the Health Utilities Index (HUI) Mark 2 and Mark 3, using data from a UK valuation study of the HUI2. A range of functional forms are considered, and are compared on the basis of their explanatory power and predictive ability.
A restricted cubic function fits the data better than a power curve with a mean absolute error (MAE) of 0.025 and root mean square error (RMSE) of 0.029 compared to a MAE of 0.135 and RMSE of 0.135 for the power curve. The use of a cubic mapping function instead of a power function leads to different predicted health state values.
We question the reliance on the assumption of a power curve relationship between VAS and SG data, in the Health Utilities Index valuation framework. Our results demonstrate that further work is required to examine the appropriateness of the published M-MAUFs for the Health Utilities Indices. Copyright
The aim of this study was to assess the cost-effectiveness of topiramate vs. no preventive treatment in the UK. Model inputs included baseline migraine frequency, treatment discontinuation and response, preventive and acute medical cost per attack [2005 GBP ( pound)] and gain in health utility. Outcomes included monthly migraines averted, acute and preventive treatment costs and cost per quality-adjusted life year (QALY). Topiramate was associated with 1.8 fewer monthly migraines and a QALY gain of 0.0384. The incremental cost of topiramate vs. no preventive treatment was about 10 UK pounds per migraine averted and 5700 UK pounds per QALY. Results are sensitive to baseline monthly migraine frequency, triptan use rate and the gain in utility. Incorporating savings from reduced work loss (about 36 UK pounds per month) suggests that topiramate would be cost saving compared with no preventive treatment. This analysis suggests that topiramate is a cost-effective treatment for migraine prevention compared with no preventive treatment.
1) To reassess the prevalence of migraine in the United States; 2) to assess patterns of migraine treatment in the population; and 3) to contrast current patterns of preventive treatment use with recommendations for use from an expert headache panel.
A validated self-administered headache questionnaire was mailed to 120,000 US households, representative of the US population. Migraineurs were identified according to the criteria of the second edition of the International Classification of Headache Disorders. Guidelines for preventive medication use were developed by a panel of headache experts. Criteria for consider or offer prevention were based on headache frequency and impairment.
We assessed 162,576 individuals aged 12 years or older. The 1-year period prevalence for migraine was 11.7% (17.1% in women and 5.6% in men). Prevalence peaked in middle life and was lower in adolescents and those older than age 60 years. Of all migraineurs, 31.3% had an attack frequency of three or more per month, and 53.7% reported severe impairment or the need for bed rest. In total, 25.7% met criteria for "offer prevention," and in an additional 13.1%, prevention should be considered. Just 13.0% reported current use of daily preventive migraine medication.
Compared with previous studies, the epidemiologic profile of migraine has remained stable in the United States during the past 15 years. More than one in four migraineurs are candidates for preventive therapy, and a substantial proportion of those who might benefit from prevention do not receive it.