FormalPara Key Summary Points

Why carry out this study?

It is widely recognized that people with migraine experience a substantial disease-related burden, but “burden” is often poorly defined or described.

Most reports on the burden of migraine address symptoms (e.g., headache frequency and severity) and work productivity, and a thorough evaluation of the impact of migraine on non-work activities and fundamental health indicators (sleep and mental health) has been lacking.

We used patient-reported outcome scales to describe the impact of migraine on sleep, mental health, and daily activities, including housework, family/social/leisure activities, and driving.

What was learned from the study?

People with migraine reported problems with sleep and mental health impacts, including depression and anxiety.

Migraine reduced the amount of housework performed by people with migraine and resulted in people missing family, leisure, and social activities, and not driving due to migraine.

The burden of migraine on sleep, mental health, and daily activities is substantial for people with migraine in Japan.

Introduction

Migraine is a chronic neurological disease characterized by moderate-to-severe pulsating headaches, which are associated with other symptoms such as nausea, phonophobia, photophobia, and/or visual disturbances [1]. Migraine is the second most common cause of disability worldwide [2]. Pain and migraine symptoms have been studied extensively [3, 4], and the additional impacts of migraine beyond pain have become a recent focus of research. People with migraine experience significant burden from the disease, including disability, impairment at work and in the home, and disruptions to family and leisure activities [3, 5,6,7,8]. People with migraine also experience impairment between migraine attacks (interictal burden) [5, 9, 10]. Migraine is associated with mental health comorbidities, including depression and anxiety disorder [6, 7, 11], and with sleep disorders such as insomnia [11].

Migraine disease severity is often evaluated in terms of pain levels and frequency of headaches. However, given that migraine affects many aspects of daily life, it is also important to evaluate migraine burden across a range of regular daily activities, including during interictal periods. Evaluating the effect of migraine on the interrelated fundamental health indicators of sleep and mental health also provides insight into the impact of migraine on daily life. The ObserVational survey of the Epidemiology, tReatment, and Care Of MigrainE (OVERCOME [Japan]) study is a cross-sectional survey that provides an observational “snapshot” of people with migraine in Japan. Previous analyses of OVERCOME (Japan) data have described symptomatology, diagnosis, and treatment [12]; disability, quality of life, and work impairment [5]; potential unmet treatment needs [13]; and factors associated with insufficient effectiveness of acute treatment [14]. However, the impacts of migraine on daily, non-work activities and fundamental health indicators have not previously been described in detail for people with migraine in Japan.

The objective of the current analysis of the OVERCOME (Japan) data was to evaluate in detail the impact of migraine on daily life among people with migraine in Japan. “Daily life” in this analysis encompassed daily activities (housework, family/social/leisure activities, and driving) and fundamental health indicators (sleep and mental health). Where possible, existing validated, migraine-specific, patient-reported outcome (PRO) scales were used.

Methods

Study Design and Study Population

OVERCOME (Japan) was a cross-sectional, population-based web survey conducted from July to September 2020. The study was granted ethical approval by the Research Institute of Healthcare Data Science Ethical Review Board (ID: RI2020003), and electronic informed consent was obtained from all respondents. All data were anonymized before analysis. The study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments.

As described previously [5, 12,13,14], eligible participants were adults, resident in Japan, able to understand Japanese, able to access the internet, able to provide electronic informed consent, and were members of the Kantar profiles (Lightspeed) online global survey panel (or its panel partners) led by Cerner Enviza, an Oracle company (formerly Kantar Health).

The OVERCOME (Japan) survey was completed by a sample population selected to match preset quotas for sex, age, and geographic region, based on Japanese population data [12]. The migraine group consisted of people with migraine and severe headache who self-reported a physician diagnosis of migraine or met modified International Classification of Headache Disorders, third edition (ICHD-3) criteria [1] as assessed by a validated American Migraine Study/American Migraine Prevalence and Prevention Study migraine diagnostic questionnaire [3, 15].

Outcome Measures

Impact of Migraine on Daily Activities

In this analysis of data from OVERCOME (Japan), we present results from several PRO scales that relate to daily activities (housework and family, social, and leisure activities). Individual questions (items) relating to daily activities were selected from the Migraine Disability Assessment (MIDAS) [16, 17], Migraine-Specific Quality-of-Life Questionnaire (MSQ version 2.1) [18, 19], and Impact of Migraine on Partners and Adolescent Children (IMPAC) [20] scales. Overall MIDAS and MSQ scores for the OVERCOME (Japan) migraine population have been previously published [5, 12].

The MIDAS questionnaire measures headache-related disability and impairment in the previous 3 months [16], and it has been validated in Japanese [17]. The MIDAS items included in the current analysis related to housework (two items) and family, social, and leisure activities (one item) (Table S1 in the electronic supplementary material [ESM]).

The MSQ version 2.1 assesses health-related quality of life specific to migraine in the previous 1 month (4 weeks) [18], and the Japanese version has been validated [19]. MSQ items included in the present analysis covered housework (one item) and family, social, and leisure activities (three items) (Table S1 in the ESM).

The IMPAC scale was developed to assess the family impact of migraine [20]; a Japanese version was used in this study (the Japanese version has been linguistically validated, and correlation with other instruments, e.g., MIDAS, was confirmed [21]. The IMPAC questionnaire was answered by subpopulations of the migraine group. Those living with any family member(s) completed Part A; those living with a spouse or partner completed Part B; and those living with adolescent children (aged 13–18 years) completed Part C. The IMPAC questions included in the present analysis covered housework (IMPAC Part A—one item, IMPAC Part B—one item), and family, social, and leisure time (IMPAC Part A—three items, IMPAC Part B—one item, IMPAC Part C—one item) (Table S1 in the ESM). For IMPAC questions that address the frequency of events, the recall period is the previous 1 month (30 days) [20].

The impact of migraine on the daily activities of exercise and driving was assessed using questions developed for the OVERCOME (Japan) survey (Table S2 in the ESM).

Impact of Migraine on Fundamental Health Indicators

The impact of migraine on sleep and overall mood was assessed using questions developed for the OVERCOME (Japan) survey (Table S2 in the ESM). Depression symptoms were measured using the validated Japanese version of the eight-item Patient Health Questionnaire depression scale (PHQ-8) [22, 23]. Each item is scored from 0 to 3, resulting in a total score between 0 and 24. PHQ-8 severity categories were defined as none to minimal (score of 0–4), mild (5–9), moderate (10–14), moderate-to-severe (15–19), and severe (20–24). A PHQ-8 cutoff score of ≥ 10 was considered indicative of current depression [22]. Anxiety symptoms were measured using a validated Japanese version of the seven-item Generalized Anxiety Disorder scale (GAD-7) [24, 25]. Each item is scored from 0 to 3, resulting in a total score between 0 and 21. GAD-7 severity categories were defined as none to minimal (score of 0–4), mild (5–9), moderate (10–14), and severe (15–21). A GAD-7 cutoff score of ≥ 10 was considered indicative of current generalized anxiety [24].

The Interictal Burden of Migraine

Interictal burden was assessed using the four-item Migraine Interictal Burden Scale (MIBS-4) [9, 10]. The scale measures burden in four domains: impairment at work or school, impairment in family and social life, difficulty in making plans or commitments, and emotional and cognitive distress [10]. Overall MIBS-4 burden categories for the OVERCOME (Japan) migraine population have been previously published [5].

Statistical Analysis

Results are presented using descriptive statistics. Means and standard deviations (SDs) are reported for continuous variables, and frequencies and percentages are reported for categorical variables.

Subgroup analyses were performed to describe differences across sex, diagnostic status (no migraine diagnosis and with migraine diagnosis), number of migraine headache days per month (0–3, 4–7, 8–14, and ≥ 15), MIDAS pain severity category (no pain, mild pain, moderate pain, and severe pain), headache duration (< 4 h and ≥ 4 h), MIDAS categories (little or no disability, mild disability, moderate disability, and severe disability), and MIBS-4 categories (no burden, mild burden, moderate burden, and severe burden).

Statistical analyses were performed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA).

Results

Demographic and Baseline Clinical Characteristics

As previously reported [12], the migraine group was predominantly female (66.5%), with a mean age of 40.7 years (Table 1). Most people with migraine were living with any family members (79.4%), more than half were married or living with a partner (57.4%), and 13.8% were living with children aged 13–18 years. Overall, 56.6% of respondents reported that they had received a diagnosis of migraine from a physician; when stratified by sex, 56.0% of female respondents and 57.8% of male respondents had received a migraine diagnosis. More male respondents were in full-time employment than female respondents (80.3% and 43.8%, respectively). As reported previously [5, 13], there was evidence of substantial disability, with 20.7% of respondents being in the moderate-to-severe MIDAS categories and 37.4% reporting severe impairment or requiring bed rest. There was also evidence of substantial interictal burden, with 41.5% of respondents in the moderate-to-severe MIBS-4 categories.

Table 1 Demographic and clinical characteristics
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Impact of Migraine on Daily Activities

Housework

Migraine had both direct and indirect impacts on housework (Fig. 1). In the whole migraine group (N = 17,071), respondents reported not doing housework, or their housework productivity being reduced by half or more, on a mean (SD) of 2.2 (5.5) and 2.7 (5.8) days in the previous 3 months, respectively (Fig. 1a). In the same period, 43.4% of respondents reported doing no housework on ≥ 1 day; 49.2% had reduced housework productivity on ≥ 1 day. Among respondents living with any family (N = 13,548), half (49.7%) reported that they let their share of housework go undone at least once in the past 30 days (Fig. 1b). Indirect impacts included people with migraine needing help in handling routine household chores, with 24.8% of the whole migraine group reporting they required assistance at least some of the time (Fig. 1c). Furthermore, 15.2% of respondents living with a spouse or partner (N = 9807) agreed with the statement “my partner resents having to do everything when I have a headache” (Fig. 1d).

Fig. 1
figure 1

Impact of migraine on housework. Direct impacts (impact on the respondents’ ability to do housework): a MIDAS responses (N = 17,071); b IMPAC Part A response for respondents living with any family members (N = 13,548; respondents who selected “not applicable” are not shown: n = 1800 [13.3%]). Indirect impacts (impact on other household members): c MSQ response for respondents living with any family members (N = 13,548); d IMPAC Part B response for respondents living with a partner/spouse (N = 9807; respondents who selected “not applicable” are not shown: n = 1842 [18.8%]). All combined percentages were calculated from source data, rounded to one decimal place. IMPAC Impact of Migraine on Partners and Adolescent Children; MIDAS Migraine Disability Assessment; MSQ Migraine-Specific Quality-of-Life Questionnaire; SD standard deviation

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Family, Social, and Leisure Activities

There were diverse impacts of migraine on family, social, and leisure activities (Fig. 2).

Fig. 2
figure 2

Impact of migraine on family, social, and leisure activities. a MIDAS response (N = 17,071); b impact on exercise (N = 17,071; respondents who selected “not applicable” are not shown, n = 1609 [9.4%]); c MSQ responses (N = 17,071); d IMPAC responses for respondents living with any family members (Part A, N = 13,548; respondents who selected “not applicable” are not showna), living with a partner/spouse (Part B, N = 9807; respondents who selected “not applicable” are not shown: n = 1844 [18.8%]), and living with children aged 13–18 years (Part C, N = 2358; respondents who selected “not applicable” are not shown: n = 464 [19.7%]). All combined percentages were calculated from source data, rounded to one decimal place. an = 2232 (16.5%) for “not participate in family activity at home,” n = 3262 (24.1%) for “not do anything physical with family,” and n = 2812 (20.8%) for “involvement in/enjoyment of family activities significantly reduced.” IMPAC Impact of Migraine on Partners and Adolescent Children; MIDAS Migraine Disability Assessment; MSQ Migraine-Specific Quality-of-Life Questionnaire; SD standard deviation

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In the whole migraine group (N = 17,071), respondents reported missing family, social, or leisure activities on average 1.3 (4.5) days in the past 3 months (Fig. 2a). In the same period, 32.1% of respondents reported missing family/social/leisure activities on ≥ 1 day. About half (51.8%) of the whole migraine group reported that migraine pain and symptoms interfered with their ability to exercise or play sports at least some of the time (Fig. 2b).

There were three MSQ questions relating to family, social, and leisure activities (Fig. 2c). Nearly one third (31.8%) of respondents reported that migraines interfered with how well they dealt with family and friends at least some of the time. Migraine interfered with leisure time activities (e.g., reading, exercising) at least some of the time for 41.6% of respondents. Migraine interfered with participation in social activities (e.g., parties, dinner with friends) at least some of the time for 18.0% of respondents.

Among respondents living with any family (N = 13,548), 41.7% reported not participating in family activity at home at least once, 30.6% had not done anything physical with family at least once, and 31.6% reported that their involvement or enjoyment of family activities was significantly reduced at least once, in the past 30 days (Fig. 2d). For respondents living with a spouse or partner (N = 9807), 38.8% reported their enjoyment of time spent with their partner was significantly reduced at least once in the past 30 days. Among those living with children aged 13–18 years (N = 2358), 40.5% reported that their involvement in or enjoyment of their child(ren)’s activities was significantly reduced in the past 30 days.

Driving

There was a substantial impact of migraine on driving (Fig. 3). Among the respondents who had a driver’s license and drove ≥ 1 day per week during the past month (N = 10,921), 43.9% reported that pain and migraine symptoms interfered with their ability to drive a car at least some of the time (Fig. 3a). When migraine attack pain severity (mild, moderate, or severe) was taken into account, the highest frequency of not driving was seen in respondents during a severe pain migraine attack (44.9% vs. 21.5% and 15.8% of N = 10,921 during moderate and mild pain, respectively; Fig. 3b). However, 20.1% of respondents reported that they drove while experiencing severe pain at least some of the time.

Fig. 3
figure 3

Impact of migraine on driving. a Impact of pain and symptoms on respondents’ ability to drive a car (N = 10,921; respondents who selected “not applicable” are not shown, n = 419 [3.8%]); b frequency of driving while having a migraine attack in the past 12 months, stratified by pain level of migraine attack (N = 10,921); c frequency of not driving due to migraine or severe headache in the past 12 months (N = 10,921); d reasons for not driving due to migraine or headache in the past 12 monthsa (respondents who answered “yes” in part c, N = 3566). All combined percentages were calculated from source data, rounded to one decimal place. aRespondents could provide more than one reason for not driving

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Almost one third (32.7%) of people who drove reported at least one occasion in the past 12 months in which they had not driven due to migraine or severe headache (Fig. 3c). The most frequently reported reasons for not driving due to migraine or severe headache in the past 12 months were concerns about safety, pain preventing respondents from driving, and driving making headache pain worse (Fig. 3d).

Impact of Migraine on Fundamental Health Indicators

Sleep

Migraine also had impacts on respondents’ sleep (Fig. 4). More than half (52.7%) of respondents reported that migraine pain and symptoms interfered with their ability to sleep at least some of the time (Fig. 4a). Approximately 27% of respondents reported that their migraine attacks typically started between 6 PM and midnight (20.2%) or between midnight and 5:59 AM (7.5%) (Table 1), and 39.2% reported needing to take medication for migraine between midnight and 5:59 AM at a frequency of “less than half of the time” or more (Fig. 4b).

Fig. 4
figure 4

Impact of migraine on sleep. a Impact of pain and symptoms on respondents’ ability to sleep (N = 17,071; respondents who selected “not applicable” are not shown, n = 524 [3.1%]); b how often respondents needed to take medication at night (from midnight to 5:59 AM) (N = 17,071). All combined percentages were calculated from source data, rounded to one decimal place

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Mental Health

Many respondents reported that migraine affected their mental health (Fig. 5). A large majority (70.7%) reported that migraine pain and symptoms interfered with their mood at least some of the time (Fig. 5a).

Fig. 5
figure 5

Impact of migraine on mental health. a Impact of pain and symptoms on respondents’ mood (N = 17,071; respondents who selected “not applicable” are not shown, n = 360 [2.1%]); b depression, measured using the PHQ-8 (N = 17,071); c anxiety, measured using the GAD-7 (N = 17,071). All combined percentages were calculated from source data, rounded to one decimal place. GAD-7 seven-item Generalized Anxiety Disorder questionnaire; PHQ-8 eight-item Patient Health Questionnaire

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The mean (SD) PHQ-8 score of the migraine group was 7.1 (5.6). Overall, 28.6% of respondents had a PHQ-8 score in the moderate (10–14), moderate-to-severe (15–19), or severe (20–24) categories (Fig. 5b). However, only 20.5% reported depression symptoms in the last 12 months, and even fewer (15.4%) reported that they had ever received a depression diagnosis.

The mean (SD) GAD-7 score of the migraine group was 5.7 (5.5). Overall, 22.0% of respondents had a GAD-7 score in the moderate (10–14) or severe (15–21) categories (Fig. 5c). A similar proportion (23.1%) reported anxiety symptoms in the last 12 months, although only 7.8% of respondents reported that they had ever received an anxiety diagnosis.

The Interictal Burden of Migraine

Responses to the four MIBS-4 individual items indicated that migraine had an impact on people in between migraine attacks (Fig. 6). Headaches affected work/school at times when respondents did not have a headache at least some of the time for 19.0% of respondents. At least some of the time, 26.8% of respondents worried about planning social or leisure activities. At least some of the time, 22.7% and 22.5% of respondents reported that headaches impacted their lives and made them feel helpless, respectively, at times when they did not have a headache.

Fig. 6
figure 6

Interictal burden of migraine, assessed using the MIBS-4. Responses to each of the MIBS-4 items are shown. Percentages shown are proportions of the full migraine group (N = 17,071). Not shown are the percentages of respondents who selected “not applicable”; this was n = 2643 (15.5%), n = 2105 (12.3%), n = 1968 (11.5%), and n = 1961 (11.5%) for each of the four items, respectively. All combined percentages were calculated from source data, rounded to one decimal place. MIBS Migraine Interictal Burden Scale

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Subgroup Analyses

The burden of migraine on daily life tended to be slightly greater in female compared with male respondents, except for the impact on participation in social activities (Fig. S1 in the ESM). The burden of migraine on daily life was generally greater for respondents with a physician diagnosis of migraine than for those without (Fig. S2 in the ESM). Burden on daily life also increased with increasing number of headache days per month (Fig. S3 in the ESM), increasing pain severity (Fig. S4 in the ESM), longer headache duration (Fig. S5 in the ESM), increasing severity of disability (MIDAS category; Fig. S6 in the ESM), and increasing interictal burden (MIBS-4 category; Fig. S7 in the ESM). For example, migraine interfered with respondents’ relationships with family and friends at least some of the time for 50.7%, 49.0%, 37.7%, 63.0%, and 53.1% of the most affected subgroups of monthly headache days, pain severity, headache duration, MIDAS category, and MIBS-4 category, respectively. However, burden was also reported by many people even in the least affected subgroup in each analysis. For example, the percentages of respondents whose relationships were interfered with by migraine at least some of the time were 26.0%, 12.7%, 23.9%, 22.0%, and 19.5% in the least affected subgroups of headache days (Fig. S3 in the ESM), pain severity (mild pain, Fig. S4 in the ESM), headache duration (Fig. S5 in the ESM), MIDAS category (Fig. S6 in the ESM), and MIBS-4 category (Fig. S7 in the ESM), respectively.

Discussion

In this analysis of data from OVERCOME (Japan), there were multiple impacts of migraine on aspects of daily life, including housework, sleep, driving, and family, leisure, and social activities. Moreover, people with migraine also reported mental health impacts, including depression and anxiety, and these mental health impacts appeared to be underdiagnosed.

Migraine not only directly impacts execution of housework by people with migraine, but also results in the need for help from their family, which may cause physical and/or mental stress on family members. Among OVERCOME (Japan) respondents, nearly half (43.4–49.2%) reported interrupted or reduced housework on ≥ 1 day over 3 months (MIDAS), and half of respondents (49.7%) living with family reported leaving household chores undone at least once in the previous 30 days (IMPAC). The fact that migraine has a negative impact on housework is consistent with the small amount of data previously available for people with migraine in Japan [6, 7, 26, 27]. The stress on family/partner relationships implied by the partner resentment reported in the current analysis has not previously been reported for Japanese people with migraine. However, our results are consistent with results from the US-based Chronic Migraine Epidemiology and Outcomes (CaMEO) study, in which 17.0% of respondents with migraine reported partner resentment [28].

Migraine affects leisure, social, and family activities. These impacts have not previously been reported in detail for Japanese people with migraine. Migraine interfered with leisure time activities, such as reading, exercise, and sports, at least some of the time, for 41.6–51.8% of respondents. In a recent survey of 691 Japanese people with migraine, of whom 24.2% had a formal diagnosis of migraine, 18.7% of respondents reported that they actually refrained from or reduced exercise due to migraine symptoms [27]. Family activities, including physical activities, were missed at least once by 30.6–41.7% of respondents with migraine, consistent with the results of the US CaMEO study and American Migraine Study II [3, 28]. In OVERCOME (Japan), enjoyment of activities was significantly reduced for family activities, activities with spouse/partner, and children’s activities for 31.6%, 38.8%, and 40.5% of respondents, respectively. Again, this is consistent with the CaMEO study [28].

In the OVERCOME (Japan) study, among respondents who had a driver’s license and drove ≥ 1 day per week, 32.7% reported not driving at least once due to migraine. This was somewhat consistent with the previously reported small survey of Japanese people with migraine, presumably including those who do not drive in their daily life, in which 13.3% of respondents refrained from or reduced driving due to migraine symptoms [27]. Reasons given by people with migraine in the OVERCOME (Japan) study for not driving included safety concerns (47.7%) or because driving worsened their symptoms (15.2–29.7%). However, many respondents (73.4%) reported driving at least once per week in the past month, and approximately 20% of respondents drove at least sometimes even while experiencing severe pain, presumably because of the necessity of driving in their life. This is concerning because both migraine symptoms and migraine medications may potentially impair driving performance [29]. Improved prevention of migraine via preventive medications may be one way to reduce the frequency of driving with severe pain in people who need to drive. Societal supports such as safe and accessible public transportation would also benefit this group.

Migraine is known to be comorbid with several sleep disorders, including insomnia [11].

Just over half (52.7%) of the OVERCOME (Japan) respondents reported that their sleep is affected by migraine at least some of the time, consistent with a previous study of Japanese people with migraine [26]. In addition, many respondents (39.2%) reported needing to take medication for migraine during the night, suggesting additional disruption to sleep. The impact of migraine on sleep is concerning because sleep is a fundamental aspect of people’s overall health, and the relationship between sleep and migraine burden is bidirectional [11]. Thus, in addition to migraine disrupting sleep, sleep disturbance may worsen migraine symptoms and burden. For example, in Chinese people with migraine, poor sleep quality was shown to be significantly and independently associated with pain burden, headache severity, quality of life, anxiety, and depression [30].

More than 70% of respondents reported that their mood is affected by migraine at least some of the time, a much larger proportion of respondents than those who reported migraine affecting exercise, driving, or sleep. Mental health was also a component of interictal burden, with 22.5% and 26.8% of respondents reporting feeling helpless and worrying about planning social or leisure activities, respectively. These results are consistent with existing evidence that migraine is highly comorbid with psychiatric disorders, including depression and anxiety [11, 31, 32]. In OVERCOME (Japan), 28.6% and 22.0% of respondents exceeded PHQ-8 and GAD-7 thresholds for depression and anxiety disorder, respectively. Depression and anxiety were more common in people with migraine than in the general Japanese population [33], consistent with a previous report that Japanese people with migraine experience poorer mental health than those with no headache, in an evaluation using the SF-12v2 mental health subscale [34]. However, most OVERCOME (Japan) respondents experienced an impact on their mood without evidence of a clinical mood disorder. Furthermore, the proportion of patients with a medical diagnosis of depression or anxiety was lower (15.4% and 7.8%, respectively) than the proportions meeting PHQ-8 and GAD-7 criteria for clinical depression and anxiety. This low proportion of respondents with medical diagnoses of depression or anxiety may be partly owing to the tendency of Japanese people to suppress emotions [35]. People with undiagnosed depression and anxiety can experience a higher burden of their mental illness than those who are diagnosed [36], and therefore these people may be experiencing effects of their undiagnosed mental illness in addition to the burden of migraine. From our results, it appears that pain and the impacts of migraine on daily life directly affect mood, and it is possible that effective migraine treatment may help reduce the chance of people with migraine developing clinical mood disorders, but this is yet to be determined. In addition, mental health issues in people with migraine in Japan may be underdiagnosed and hence undertreated. Thus, improved education for patients, physicians, and the general public may be helpful to improve identification and management of comorbid migraine, depression, and anxiety, and reduce the burden from these diseases.

From the subgroup analyses, people with migraine reported considerable burden of migraine on their daily life regardless of symptom frequency, severity, headache duration, disability, sex, or diagnosis, with even the least affected subgroup in each analysis reporting substantial burden on daily activities. The observation that a higher proportion of female respondents reported an impact on daily activities in general may be partly influenced by female patients’ experience of menstrual and perimenopausal migraine, which tends to be severe, includes symptoms such as nausea and vomiting, and is often resistant to treatment [37]. On the other hand, male respondents reported more burden on their social activities. This may be related to the fact that a higher proportion of male respondents were employed full-time, which in Japanese society is associated with social opportunities, such as attending dinners, parties with colleagues, but this warrants further investigation to confirm. As expected for the well-established MIDAS instrument, the impact on daily activities increased according to MIDAS category. This relationship between MIDAS category and burden on daily life (particularly leisure, mood, and sleep) highlights that migraine disability affects more than just the work and household duties that are the chief focus of many migraine assessment instruments. The subgroup analyses also show that the burden of migraine on daily life is influenced by both migraine attacks and the interictal period between attacks, as impacts across MIBS-4 categories were consistent with those across MIDAS categories. People in the “severe disability” MIDAS and “severe burden” MIBS-4 categories generally reported greater impact on daily activities than those with ≥ 15 headache days per month, whereas those in the “little or no burden” MIDAS and “no burden” MIBS-4 categories reported smaller impact on daily activities than those with 0–3 headache days per month. This suggests that in clinical practice it may be beneficial to evaluate migraine burden with instruments like MIDAS and MIBS-4 in addition to evaluating pain, symptoms, and headache frequency, in order to better understand the impact of migraine on the daily life of people with migraine.

In the subgroup analyses, the degree of the impact observed in the response to the family/social/leisure question, “How often were you not able to go to social activities such as parties, dinner with friends, because you had a migraine?”, changed most steeply with decreasing severity of MIDAS and MIBS categories, compared with responses to other questions. This may mean that people with migraine, despite having considerable migraine burden even in the lowest MIDAS/MIBS-4 category, try to endure and participate in such social activities when their migraine burden is relatively small. However, the capacity to participate in such social activities, which are not “necessary” but are important for personal happiness, is much reduced when patients have severe migraine burden both during (MIDAS) and between (MIBS) migraine attacks.

Strengths of this analysis of OVERCOME (Japan) study data include the large sample size and the use of a sample population demographically matched to the general Japanese population. The study also included participants with migraine without formal diagnosis and those who may not have been receiving appropriate treatment [13]. Furthermore, the assessments used were existing, validated, PRO measures specific to migraine and validated mental health assessment tools (PHQ-8, GAD-7).

Limitations of the OVERCOME (Japan) study and this analysis include limitations common to online survey studies, including the use of self-reported data, which may be subject to recall bias, and potential participation bias, due to a low participation rate and self-selection of survey participants. There are limitations specific to the OVERCOME (Japan) study; for example, during data collection for this study, IMPAC Part C was asked only for the respondents living with children aged 13–18 years, so the impact of migraine on families with cohabiting children aged < 13 years cannot be analyzed from this dataset. Finally, the OVERCOME (Japan) survey was conducted during the COVID-19 pandemic, which may have affected the results, particularly assessments of mental health.

Conclusions

The burden, including interictal burden, of migraine on daily life is substantial for people with migraine in Japan. These impacts on daily activities and fundamental health indicators (sleep and mental health) have not been captured well in the total scores of existing scales for migraine; daily life impacts in our analysis were elucidated from individual items from several scales. Medical and social support systems for people with migraine need to recognize the broad range of impacts of migraine on daily life, and it is important to evaluate these impacts in clinical practice. Management of migraine beyond its pain and symptoms should be a key focus of people with migraine, their families and friends, and healthcare professionals.