key: cord-0683486-ava04oh1
authors: Buse, Dawn C.; Gerstein, Maya T.; Houts, Carrie R.; McGinley, James S.; Uzumcu, Alyssa A.; McCarrier, Kelly P.; Cooke, Alexis; Touba, Nancy M.; Nishida, Tracy K.; Wirth, R. J.; Lipton, Richard B.
title: Impact of the COVID‐19 pandemic on people living with migraine: Results of the MiCOAS qualitative study
date: 2022-03-16
journal: Headache
DOI: 10.1111/head.14274
sha: 02f27cae53f9ccbd415d02be6d48d0a0a167bcd7
doc_id: 683486
cord_uid: ava04oh1

BACKGROUND: The coronavirus disease 2019 (COVID‐19) pandemic is an ongoing global health crisis that has had a range of impacts on people living with migraine. METHODS: Qualitative interviews performed as part of the Migraine Clinical Outcome Assessment System project, a multi‐stage Food and Drug Administration–grant funded program to develop a patient‐centered core set of outcome measures for use in migraine clinical trials, offered an opportunity to explore the experience of living with migraine during the pandemic as well as to examine whether migraine treatment priorities, symptoms, and associated disability changed due to the pandemic. Semi‐structured interviews were conducted in the United States between the summer and fall of 2020 with 40 individuals with self‐reported, medically diagnosed migraine who self‐reported that they had not tested positive for or been diagnosed with COVID‐19. RESULTS: Seventy percent (n = 28) of the sample reported ≥1 pandemic‐related impact on their life with migraine. Fourteen participants reported both positive and negative impacts, twelve reported negative impacts only, and two reported positive impacts only. Among those reporting ≥1 pandemic‐related impact, nine participants (32%) reported more frequent and five (17%) reported less frequent migraine attacks. Other negative impacts included interrupted medical care (n = 9; 32%), and greater stress (n = 13; 46%). The most frequent positive impact reported was greater access to health care (n = 8; 29%). Ictal and interictal symptoms were not noted to change due to the pandemic, but some respondents reported less disability due to increased flexibility of schedules and reduced expectations. Treatment priorities did not change due to the pandemic. CONCLUSION: The global COVID‐19 pandemic has resulted in both negative and positive impacts for people living with migraine. Lessons to be considered when moving into a post‐pandemic world include benefits of and satisfaction with telehealth and the benefits and importance of healthy lifestyle habits and flexibility such as improved sleep, reduced stress, and fewer social expectations.

The coronavirus disease 2019 (COVID-19) global pandemic has had significant global impact, including on people living with migraine. Severe acute respiratory syndrome coronavirus 2 emerged in December 2019 and COVID-19 was declared a global pandemic in March 2020. 1 The pandemic impacted people both directly (e.g., contracting the virus) and indirectly, particularly as mitigation and containment strategies resulted in dramatic changes in daily work and social habits, and alterations in health-care delivery. [2] [3] [4] Migraine is ideally managed with a combination of tailored pharmacologic, non-pharmacologic, and lifestyle interventions. 5, 6 Access to most of these types of therapies has been impacted at various times during the pandemic. Data collected via clinician interviews, chart reviews, and web-based surveys of people living with migraine during the pandemic have documented cancellation of face-to-face medical visits and in-clinic procedures, heightened levels of psychosocial stress, social isolation, disruption of sleep and dietary habits, and financial concerns, as well as other issues thought to contribute to increased attack frequency. [4] [5] [6] [7] [8] [9] [10] Some studies have also reported perceived benefits to people with migraine including reduced frequency of migraine attacks, improved health-care access primarily via telehealth, the ability to work and attend school from home, increased and improved sleep, and reduced social pressures and expectations for some individuals. 11, 12 To our knowledge, none of the published studies used patientcentered qualitative approaches to characterize the impact of the COVID-19 pandemic on migraine. Our study addresses this gap by capturing the impact of the pandemic on people living with migraine disease through in-depth, individual, semi-structured interviews and qualitative analysis techniques. Qualitative interviews, like those conducted in this study, offer a dynamic approach to data collection, generating valuable conversation and depth of understanding that is difficult to gain from a survey or chart review. 

Individuals were recruited through a study announcement disseminated by the Coalition for Headache and Migraine Patients (CHAMP), a patient advocacy organization. Eligible participants were US residents self-reporting a medical diagnosis (SR-MD) of migraine who screened positive for migraine based on the ID Migraine screener (with at least two of the following: disability due to headache ≥1 day in the past 3 months, phonophobia, and/or nausea with headache), were able to complete an interview in English, aged 18-75, and were willing to participate in a 90-minute recorded interview. 13 Exclusion criteria included: (1) patient SR-MD of multiple sclerosis, schizophrenia, bipolar disorder, cognitive impairment, Alzheimer's disease or dementia, or epilepsy; (2) screening positive for alcohol or drug abuse over the past 3 months using the CAGE questionnaire; 14 (3) self-reported diagnosis, symptoms, or hospitalization related to COVID-19.

In total, 428 individuals completed the screener and were eligible for participation. Of these, 40 participants were selected through iterative purposeful sampling including participant demographics and salient headache features designed to ensure participant diversity. The study sample size was selected to ensure concept saturation (i.e., the point during data collection when no new relevant information is identified and additional interviews are unlikely to yield novel concepts). Based on the research team's substantial experience conducting qualitative research and recent methodological research in this area, the research team determined that a sample of N = 40 carried a strong likelihood of achieving concept saturation. 15 Participants completed an online informed consent process during which they read information then checked a box either agreeing or declining to participate. The study was approved by an independent institutional review board (WCG).

A screener, sociodemographic and migraine questionnaire, and semi-structured interview guide were developed by the MiCOAS research team. Respondents were not allowed to skip any screener or sociodemographic questions but could select "prefer not to answer" as a response option for several questionnaire items.

Following consent, in the online sociodemographic and migraine questionnaire participants were asked to provide socio- Participants were informed during the semi-structured interview of the option to decline answering any question and that they could stop the interview at any time. None of the study participants declined answers or stopped the interview before completion. Therefore, there were no missing data attributed to this study.

November 2020 by trained interviewers using a semi-structured 

Audio recordings of the interviews were transcribed verbatim for analysis and coded using a hybrid deductive/inductive approach informed by both a preliminary codebook constructed a priori and open codes, developed iteratively at each interview wave.

Four researchers (AC, AU, MTG, NT) participated in data coding of the primary qualitative data collected. Ten percent of interviews were coded independently by two members of the research team. The passages of text tagged for coding were compared across team members. For transcripts where agreement among coders regarding code attribution (i.e., which codes to attribute to which passages of text) was less than 85%, discrepancies were reviewed and addressed through research team consensus. The research team met no less than bi-weekly throughout the study to discuss coding and address any questions or issues that may have arisen during the coding process. All coded passages were reviewed by a senior member of the research team with significant experience in coding and analysis of qualitative data (MTG, KM). All interview data were managed using Atlas.ti (v8.0) software.

Where appropriate, frequency counts were utilized to offer a high-level overview of coded content. Concept frequencies and case counts alone do not provide a full picture of the experience of individuals living with migraine as was reflected through their thoughtful insights and observations. Thus, thematic content analysis was undertaken to identify patterns within the data and to categorize coded information into recurrent themes. Concept counts, average treatment priority rankings, and thematic content analysis were used to identify key concepts and themes within multiple domains of interest. An examination of concept saturation was conducted.

The characteristics of our study sample were rendered using descriptive statistics (e.g., frequency). All statistical analysis was conducted in R software (v4.1.1). Table 1 provides a demographic and descriptive summary of the participants. Participants ranged from 21 to 70 years of age (mean = 44). The sample was 78% female, 68% White, and 53% did not have a college degree. Slightly more than half of participants (55%) were employed. Participants had ≥2 monthly headache days on average. Half of participants (N = 20) had ≥15 and half (N = 20)

had <15 headache days per month on average. All participants currently used acute treatment(s) and 88% currently used preventive therapy for migraine.

Concepts endorsed in each interview wave were measured against previous interview waves to identify the appearance of novel concepts. This process continued for a total of eight interview waves, with each wave containing four to six interviews. Saturation grids were constructed to allow for an examination of first coding appearance by transcript and interview group and to demonstrate increasingly fewer newly cited codes in later stages of interview con-

duct. An examination of saturation grids demonstrated that 95% of codes related to COVID-19 impacts were identified within the first 55% (n = 22) of conducted interviews, suggesting that concept saturation was reached. $100,000 and over 8 (20) Prefer not to answer 4 (10)

Migraine subtype by frequency, n (%) Total percent exceeds 100 because participants were able to select more than one race and/or employment status category. b Respondent reported races of "White, South American, and North

African" and chose the label "other." c Chronic migraine was defined as an average monthly headache day frequency of ≥15 per month among people who meet criteria for migraine as per Silberstein-Lipton criteria and episodic migraine was the corollary. 25 It was not possible to assess the ICHD-3 CM criterion of ≥8 migraine days per month in this single visit study, which did not include a diary. Percentages ending in ≥0.5 were rounded up to the next whole number. And that was scheduled to be in March, and then got transitioned to telehealth, and then that provider left the practice. So I'm now between the provider that I saw for telehealth in March and seeing the next provider, which I actually see this week"

Delayed and/or backordered prescriptions "But during the heat of the pandemic, my medications were delayed. Sometimes the pharmacy couldn't get their shipments in or whatever else, and so I would be delayed getting my preventative or any of my migraine-related prescriptions, which was not the best thing"

Desire to avoid visiting urgent care centers and emergency departments "I am not going to the hospital as much, because it's riskier than normal. So that's some of the only like big changes is that I refuse the majority-unless it's like super, superbad, I'm not going to the hospital. I'll just tough it out and be with it or something"

Perceived reasons for increased migraine attack frequency and severity

Disrupted access to preventive treatments (e.g., onabotulinumtoxinA injections) and therapies (e.g., physical therapy)

"When it first started, we had went down to XXXX to visit our family, and then it had broke out, and we were stuck there for a little bit because they were not allowing people through certain places. And I missed my Botox by about-I think it was three weeks late, by the time I was able to come back and get in and get it done. And it, of course, was worse. I was getting them every-back to every other day again, the way I was before"

Increased stress and anxiety "I think going out is more anxiety provoking to me than before COVID. And as my anxiety levels come up or stay up for extended periods of time, usually I will see an increase in migraine or headache symptoms as well, so I'm trying to stay calm"

Less opportunity to engage in preventive behaviors and therapies and challenges with telemedicine "So I rely on massages a lot to help control the migraines, because a lot of the migraines come from the muscle knots in my neck. And during the beginning of the pandemic, physical therapy and massage therapy was out of the question.

And I tried to see my neurologist via telemedicine, but the connection from his office wasn't very strong. And it didn't really work out, so I was forced to go back in … So yeah, it was really disruptive" Note: Generally it is the practice of the authors and the journal to use generic medication names rather than trade names; however, in this case participants quotes are presented verbatim including medication trade names as they are primary data.

Abbreviation: COVID-19, coronavirus disease 2019.

Seventy percent (n = 28) of the sample reported ≥1 pandemicrelated impact on their experience with migraine, compared to 30%

(n = 12) who did not. Perceived COVID-19 pandemic-related impacts included both negative (Table 2 ) and positive impacts (Table 3) . (Table 3) .

Generally, respondents did not note changes to ictal and interictal migraine symptoms due to the pandemic. However, n = 8 (20%)

reported perceived reduction in associated disability and distress, both ictally and interictally, due to the pandemic. This reduction was attributed to more flexibility in work, school, and social expectations, and more control over their schedule and environment. When asked if the current pandemic caused any changes in their ranking of acute or preventive treatment priorities, all responses were negative.

Respiratory Syndrome (SARS) in China and Canada, as well as the 2014 Ebola outbreak in Africa, found that quarantine was associated with a range of negative physical and psychological effects, such as post-traumatic stress symptoms and a potential increase in suicide risk. [16] [17] [18] Therefore, it was hypothesized that lockdown and stay-at-home orders implemented to mitigate the COVID-19

pandemic could dramatically increase the burden of migraine and could lead to adverse medical and psychological outcomes. [19] [20] [21] However, results from our qualitative interviews revealed both No participants reported that the current pandemic changed their perspective on their priorities for acute or preventive treatments.

To our knowledge, this is the first time these concepts have been assessed and reported. Respondents also did not report changes in ictal or interictal migraine attack symptoms, but they shared narratives suggesting a reduction in disability of attacks, often related to greater control over one's schedule, fewer expectations, and the ability to work and/or attend school from home. 

Fewer concerns about the need to engage in activities outside the home (e.g., remote work and school, errands, appointments)

"Just that the world kind of has to live the way I have now. Has to stay inside, and things are more accessible to me"

Reduced guilt over cancelling social events with friends or family "Because I can't really do much, because I can't go out with friends or go do anything at a theater or like a festival or a concert or something. I guess I am able to just stay home in between and not have to worry about breaking plans as much. But in a way, it's kind of a relief, I suppose"

Greater access to online services (e.g., delivery services, telehealth)

"There's a lot more online that I couldn't access and I'm afraid will be gone again. But actually, the world's like a better place for me…"

The ability to work from home and feeling more in control

"You know what, I feel really bad saying this, but in any way, I think the silver lining of pandemic is getting to do everything from home. So I can, to the best of my abilities, control my own environment. So in an office or in a classroom, I can't do my work sprawled on the bed in the dark with an ice hat, but I can do that. So now-so it-again, it sounds so terrible to take something good out of this, but that part has been a little bit easier"

Benefits of telehealth Improved access to care "Before coronavirus, I had to go to an emergency room every time that I needed care_that I needed medications to break it. So now that I have it at home, I don't have to do that and I don't have to coordinate with somebody else to drive me and hang out with me for a couple hours and then drive me later. Now I can just be at home, and I don't have to do anything. And I know I'm going to feel better in 15 minutes. And I can just go back to living my life."

Reduced need for travel to work, medical appointments, etc "Now, benefits of COVID is (a) I don't have to get in my car in the sun and drive to my doctor"

Reduced exposure to potential migraine triggers "I'm like now, I won't have people up on my back with their nasty-smelling perfume. And you know, I-they limit the number of people in the stores. See, this was all perfect for people with migraines, because we_these are things-we're like, I wish people would just stay off my back. I can't-back up, you know? So this helps us greatly. And then they're only allowing a certain amount of people in an area, and this is perfect for people like us"

Coordination of at-home treatments leading to quicker pain and symptom relief "So now-so coronavirus actually helped me be able to get the treatment to be-to do it at home, because my doctors didn't want me to be going to emergency rooms" 

Migraine Buddy studies, a review of data from a headache clinic in Genova, Italy found primarily positive outcomes during quarantine.

and were asked about their migraine experience from March 10 to One of the most frequently reported benefits in our study re- 

The MiCOAS qualitative interviews found that the COVID-19

pandemic has had both perceived negative and positive impacts for people living with migraine. Our findings align with some previously collected data and differ from others. There were reports of increased migraine attack frequency, often attributed to stress and interruption to medical care. There were also reported positive impacts including expanded availability and use of telehealth as well as improvements in healthy lifestyle routines and the ben- 

National Headache Foundation, and the Marx Foundation

He receives personal fees as a consultant or advisor from Allergan/Abbvie, Amgen, Biohaven Holdings, Dr. Reddy's, GlaxoSmithKline, Grifols

Analysis and interpretation of data

Drafting of the manuscript

Revising it for intellectual content: Dawn C

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