A Qualitative Evidence Synthesis of Patient Perspectives on Migraine Treatment Features and Outcomes

Abbreviation: CERQual, Confidence in the Evidence from Reviews of Qualitative Research.

Abbreviation: CERQual, Confidence in the Evidence from Reviews of Qualitative Research.

Abbreviation: CERQual, Confidence in the Evidence from Reviews of Qualitative Research.

Authors and Disclosures

Meritxell Urtecho MD^1,2, Brittin Wagner PhD³, Zhen Wang PhD^1,2,4, Juliana H. VanderPluym MD^1,5, Rashmi B. Halker Singh MD^1,5, Jane Noyes MSc, DPhil⁶, Mary E. Butler PhD, MBA³ and Mohammad Hassan Murad MD, MPH<sup>1,2

1</sup>Mayo Clinic Evidence-Based Practice Center, Rochester, Minnesota, USA
²Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA
³Minnesota Evidence-Based Practice Center, University of Minnesota School of Public Health, Minneapolis, Minnesota, USA
⁴Division of Health Care Delivery Research, Mayo Clinic, Rochester, Minnesota, USA
⁵Department of Neurology, Mayo Clinic, Scottsdale, Arizona, USA
⁶School of Medical and Health Sciences, Bangor University, Bangor, UK

Correspondence
Mohammad Hassan Murad, Mayo Clinic Evidence-Based Practice Center, Rochester, MN, USA. Email: murad.mohammad@mayo.edu

Author Contributions
Study concept and design: Mary E. Butler, Mohammad Hassan Murad, Meritxell Urtecho, Brittin Wagner, Zhen Wang. Acquisition of data: Brittin Wagner, Mohammad Hassan Murad, Meritxell Urtecho, Mary E. Butler, Zhen Wang. Analysis and interpretation of data: Mohammad Hassan Murad, Brittin Wagner, Meritxell Urtecho, Zhen Wang, Mary E. Butler. Drafting of the manuscript: Brittin Wagner, Meritxell Urtecho, Mohammad Hassan Murad, Mary E. Butler, Zhen Wang, Juliana H. VanderPluym, Rashmi B. Halker Singh, Jane Noyes. Revising it for intellectual content: Meritxell Urtecho, Mohammad Hassan Murad, Jane Noyes, Brittin Wagner, Mary E. Butler, Zhen Wang, Juliana H. VanderPluym, Rashmi B. Halker Singh. Final approval of the completed manuscript: Meritxell Urtecho, Mohammad Hassan Murad, Jane Noyes, Brittin Wagner, Mary E. Butler, Zhen Wang, Juliana H. VanderPluym, Rashmi B. Halker Singh.

Conflicts of Interest
Dr. VanderPluym reports receiving a research grant from Amgen. Dr. Halker Singh reports consulting for Teva and Impel, and receiving a research grant from Amgen. All other authors report no conflicts of interest.

Appendix 1

Details of Themes Identified Regarding Preferences About the Treatment Process

1. Shared decision-making

Patients preferred treatment processes that allowed them to receive explanations of their health and treatment options, be active participants in their care, and practice SDM with the health-care professional.^[26,44–46] It is important to note that most participants were women.

Patients in three studies described how important it was for them to be engaged in a participatory conversation or talk with clinicians about migraine.^[26,47,48] Patients in one study appreciated a treatment process that allowed their physical therapist's care to shift in its approach based on what the patient was saying to the physical therapist (quote 1.1).^[49] Patients in another study experienced a shift from perceiving the health-care professional as "the one in charge" to perceiving themselves as having full involvement in the treatment decisions (quote 1.2).^[50] Patients in one study who shared and discussed with their clinician described being "heard" (quote 1.3).^[51]

Description of SDM across four studies is conceptualized as follows: in one of these studies, patients described preference for fully sharing their migraine-related experiences and concerns with the clinician, then receiving information or strategies from the clinician, followed by being able to ask questions of and receive helpful answers to their questions (quote 1.4).^[52]

These descriptions of SDM overlap to some extent with other themes, such as Trust in the Health-Care Professional and Ease of Communication, but the latter themes do not represent the full process or sequence of SDM, and hence are presented as separate themes. Similarly, patients in one study^[53] reported that SDM was absent where patients feel dismissed or not taken seriously by health-care professionals, which was separate theme that we present later (Undermining Patient Preferences).

2. Tailored approach

Across four studies, patients preferred treatment processes that were or could be tailored to them as an individual manner (quotes 1.5 and 1.6).^[54–56] Tailored approach was also mentioned for different situations and circumstances (e.g., commuting or in the workplace) (quote 1.7),^[57] to condition and treatment changes over time or due to information exchange.^[58] Patients also preferred treatments that were tailored or appropriate to the interpersonal style of the clinician.^[59,70]

3. Trust in the health-care professional

Patients preferred treatment processes in which they felt they could trust the health-care professional. Trust is found coherently present across studies where patients felt secure despite their own awareness of their vulnerabilities. One manifestation of trust was when the clinician was aware that the patient felt or was in a vulnerable position (quote 1.8),^[60] patients may be afraid of not being taken seriously by the clinician (quote 1.9), or that the clinician may be unwilling or unable to be helpful to the patient (quote 1.10).^[61–63]

In one study, trust in the health-care professional was demonstrated through a process in which providers listened to what the patient was saying and adapted the treatment approach.^[29] Trust in the health-care professional featured treatment processes that naturally produced knowledge about migraine and treatment options for patients and clinicians.^[28] Trust in the health-care professional was an important missing feature in one study among patients who reported previous experiences with providers who seemed to lack sympathy^[62] (see Undermining Patient Preferences) and where patients may feel overburdened with a sense that they cannot "prove" their condition (see Lack of Reciprocity).^[33]

4. Process provides knowledge and options

Patients preferred treatment processes that confer knowledge and advance treatment options for their condition.^{[2,20,25–29,31]} These processes often allow the possibility of surprise: they allow the patient to try various treatments, to notice the impacts of various treatments,^[30] and overlap with the features of SDM and Trust in the Health-Care Professional. For example, participants in one study reported that they continued in the study because the process of SDM and building trust in their clinician made them notice the positive impacts of treatment and the clinician–patient relationship, both of which were unexpected from their perspective (quote 1.11).^[29] Patients in one study described an active gathering or learning process in which they gained alternatives to treatment options that may not work for them, as well as knowledge about how treatment processes may relate to migraine experiences and outcomes (quote 1.12).^[20] Taken together, this treatment process feature is likely foundational to a Tailored Approach.

Patients in two studies noted development of a sense of ownership over migraine^[26] and observing a surprising response to treatment (quote 1.13)^[30] as well as the resulting ability to make good decisions for themselves. Patient self-monitoring is also impactful for revealing treatment preferences. In one study, migraine education helped patients monitor and control their migraine attacks and understand the likely impact of different treatments on their migraine outcomes (quote 1.14).^[66] Patients in a different study found processes that provide knowledge and options as a positive experience for patients engaged in migraine self-management, where patients reported migraine management as a matter of "doing the work" themselves (quote 1.15).^[29] In a study of pharmaceutical prophylaxis for migraine, patients described becoming aware of appropriate use versus overuse of acute treatments as part of a process wherein health-care professionals monitored patients' use of treatments and made recommendations for changes accordingly.^[28] This study reported a shift from patients having limited awareness about the risks of overusing acute treatments before a migraine occurred, reporting that some patients who used excessive acute treatment mistakenly called it "prevention," and dread of clinician phone calls (due to fear of prescription nonrenewal due to too frequent use of medications) to patients reporting feeling appreciation for their clinician's concern and change in treatment approach based on a learning process shared by the patient and their clinician.

Finally, patients reported preference for processes in which they feel they are continuously learning from their clinician and receiving guidance in doing the right things while being ultimately responsible for their own actions.^[25] These themes coincide with features of SDM and Tailored Approach and Trust in the Health-Care Professional.

5. Holistic approach to treatment

Patients preferred treatment processes that engage them in a learning conversation about holistic approaches to headache and non-headache aspects of migraine. Patients preferred processes that engage them as "whole persons," rather than processes that merely attend to symptoms (quote 1.16).^[67] Where this feature is present, the patient feels they are in a participatory conversation, that they "now have options" (quote 1.17).^[68] Related to processes that provide migraine knowledge and treatment options, patients in a focus group study explained their preference for a holistic approach because it helps them learn how non-headache areas are connected to migraine and/or that such areas can improve (e.g., posture, jaw, and migraine attacks).^[69]

6. Ease of communication

Patients preferred treatment processes that ease the communication between the patients and the health-care team, especially for complex treatments such as behavioral intervention and self-administered techniques. In one study about chiropractic care, a patient reported that chiropractors provided more knowledge of this technique with exercises and homework for the patients (quote 1.18).^[29]

Patients noted that some therapeutic interventions were challenging to handle on their own; therefore, having a health-care professional to adequately guide them through this process was beneficial (quote 1.19).^[31]

7. Undermining patient preferences

This process features undermining patient experience, preferences, and abilities (impacting almost all of the process features highlighted above), including where information about migraine appeared, not only from health-care professionals but also from outside of health-care settings (e.g., advertisements).^[30,32]

In both studies that report on finding preferences for SDM, patients reported a need for information from clinicians about migraine as a condition as well as about treatment options.^[26,30] In one of these studies, patients reported the absence of SDM where insurance or health system changes excluded them from clinicians or treatments they may have worked to find (quote 1.20).^[31] In other study, patients reported absence of SDM where they perceived low or lack of provider knowledge about migraine (quote 1.21).^[30]

In a study of prophylaxis for migraine, trust in the health-care professional occurs when clinicians take patients and their conditions seriously, as indicated by listening, demonstrating awareness and consideration of patients' fears of not being taken seriously, and helping ensure that patients "have a say" in their own treatments.^[28] In a study of patient access to triptans, patients' previous experiences when clinicians seemed unsympathetic about migraine was followed by lack of trust (quote 1.22).^[32] In a different study, patients discovered information about their condition and treatment options from sources other than health-care professionals (quote 1.23).^[28] In this and another study, mistrust of the clinician's knowledge followed after patients experienced lack of sympathy and relative lack of knowledge about migraine and treatment options.^[32]

8. Lack of reciprocity

Patients preferred reciprocal treatment processes in which mutual respect can be exercised between patient and clinician in the forms of patient inclusion, as well as information-gathering and explanation-sharing on the parts of both the clinician as well as the patient. When patients were excluded from treatment options (e.g., due to change in insurance) and were not consulted about treatment approaches, they experienced their exclusion as intentional "like you do not count" and as a one-sided dismissal by bureaucracy (quote 1.24).^[34] Patients described not being given an explanation for being excluded from access to treatment options in conjunction with their experience of health-care professionals attempting to control treatment without consulting them (quote 1.25). Patients also described feeling as though they had done more research about treatment options than clinicians had (quote 1.26).^[30]

Other studies found cases in which patients felt not taken seriously or dismissed in processes involving individual health-care professionals. For example, a patient in a focus group study described a verbal communication from a health-care professional where they felt they were being dismissed, explaining that the clinician told them to "live with it" (quote 1.27).^[34] Whether patients experience lack of reciprocity as a lack of access due to not being paid attention to or not being taken seriously,^[33] a loss of access to preferred treatments without being consulted by bureaucracy, or as intentional exclusion from exploring or learning about migraine treatments with their clinicians, this feature of treatment processes stands in contrast to patient preference for mutual respect and undermines foundations for trust in the health-care professional and SDM (quote 1.28).^[33] In one study, patients felt the inability to initiate contact or request follow-up with their clinician was a lack of reciprocity (quote 1.29).^[33] Patients in one study of a physical therapy intervention described the structure of their treatment with their provider as unequal (quote 1.30). This study identified Trust in the Health-Care Professional as a feature ameliorating the unequal structure of migraine treatment (quote 1.31).^[20]

Appendix 2

Details of Themes Identified Regarding Preferences About the Treatment Itself

1. Non-pharmacologic treatment

Availability and knowledge of non-pharmacological treatment options is important, even when these treatment options are not selected. When non-pharmacologic options were selected, patients described feeling relief about no longer needing to fill prescriptions for medication and reported newly obtained satisfaction with over-the-counter medications. Some patients described their selection of non-pharmacologic treatment as following a period of heavy or overuse of medications (quotes 2.1 and 2.2).^[35] In another study, non-pharmacologic treatments motivated patients to learn more about their condition and become more aware of their body (quote 2.3).^[29]

In some studies of medications, where non-pharmacologic treatment options were not selected, patients acknowledged their need for medication along with expressing a desire to use less medication or find non-drug treatment options.^[26] In one study of non-pharmacologic treatment for migraine, all study participants took some sort of medication for migraine. They acknowledged the need for this, but repeatedly expressed a desire to use non-pharmacological approaches for prevention, long-term migraine reduction, and contributions to overall health (quote 2.4).^[26]

Another study found that some patients, especially women considering pregnancy, were dissatisfied with a perceived emphasis on drug therapy (quotes 2.5, 2.6, and 2.7).^[34]

Patients in a study exploring the opinions, motives, and expectations of patients regarding prophylactic therapy described how using daily preventive pills would make them feel emotionally unhealthy (quote 2.8).^[28]

2. Highly effective

Interviews of patients who received migraine treatment in the ED showed the overwhelming majority (76%) emphasizing the importance of treatment effectiveness to them.^[37] Many quotes from respondents were consistent in stating that this was their number one priority (quotes 2.9 and 2.10). Similar findings were stated in a study of experiences of acupuncture among women with migraine (quote 2.11).^[23] There was also one study that reported patients not convinced that their medications were effective (quotes 2.12 and 2.13).^[26]

3. Rapidity of action

Only one study of intravenous (IV) medication in the ED, touched on rapidity of action. Rapidity of action was reported as a theme in response to the question, "What was good about the IV medication you have received for headache in the ED?" and provided a representative quote from among patients preferring or appreciating rapidity of action (quote 2.14).^[37]

4. Long-lasting effect

Only one study of IV medication in the ED touched on long-lasting treatment effect. This study reported a theme in response to the question, "What was good about the IV medication you have received for headache in the ED?" and provided a representative quote from among patients preferring or appreciating prolonged duration of efficacy (quote 2.15).^[37]

5. Less costly and more accessible treatment

Treatment cost as a barrier to specific treatments and the cost of access interruptions were addressed in five studies. Participants with low socioeconomic status frequently mentioned financial constraints (quote 2.16).^[34] A study reports patient selection of pharmacologic treatments is based on cost preferences, describing how a patient used Imigran only for her severe migraine attacks, otherwise she relied on over-the-counter drugs. This patient also limited her use of Imigran because of the personal cost, but this cost preference was balanced with effectiveness (quote 2.17).^[33]

The patients were frustrated by "the bureaucrats" in managed care companies who mandated their choices of physicians and medications (quote 2.18). This study also reports related additional costs to access interruptions, describing lack of affordability as particularly infuriating for those who had spent significant time and effort finding a physician with whom they felt comfortable or a medication that worked for them, only to be told that because of a change in insurance coverage, they had to change physicians, medications, or both.^[34]

Lack of access was also identified as costly for financial, mental, and emotional well-being. A study of access to triptans for episodic migraine attacks reports that many private insurers impose quantity limits on triptans, with physician and patient participants reporting patient anxiety regarding exceeding monthly coverage limits (quote 2.19).^[32]

One study noted that frequently it was cost that prevented patients from trying alternative therapies.^[34] The study participants, who had consulted alternative therapists, compared these consultations to the traditional medical consultations. They gave little descriptions on how effective they found alternative therapy, but they expressed satisfaction with the time and advice offered by alternative therapists. Although not all the participants had consulted an alternative therapist, they generally expressed an interest in what alternative therapies had to offer.

6. Abortive versus prophylactic treatments

Dekker et al. interviewed 20 patients with migraine (9 had experience with prophylactic medications).^[28] The interviews provided heterogeneous views in which some patients preferred abortive treatments and some did not (quotes 2.20, 2.21, and 2.22).

7. Self-management and self-delivery option

Matthews and Kneipp reported on self-management strategies used by patients including those during an attack (medication, meditation, caffeine) or between attacks (diet, exercise, hydration, hot showers, etc.). Of note, these self-management strategies were learned from one trusted individual who also had migraine, labeled as the "trusted migraineur."^[38] In Morgan et al., cognitive behavioral therapy was the self-management tool used (quote 2.23).^[31]

Various aspects of self-management were also described in Peters et al. (quote 2.24).^[20] Another patient assessed the type of headache and accordingly selected treatment to achieve the best outcome (quote 2.25). Decision was an active stage that described the patients' choices for management. Decision, the outcome of evaluation, was often a compromise between their options and perceptions (quote 2.26).^[35]

Appendix 3

Details of Themes Identified Regarding Outcomes Valued by Patients

1. Side effects

Many studies reported on the importance of side effects to patients (quote 4.1).^[21] In interview data collected by Friedman et al. of patients in the ED, 27% emphasized different concerns (quotes 4.2, 4.3, 4.4, and 4.5).^[37] In Meyer's study, patients were concerned about having a stroke (quote 4.6).^[36]

2. Addiction to medication

A negative outcome reported by two studies was addiction to medication, especially in long-term treatment, such as prophylaxis. In one study, the authors reported that more than half of the patients stated that daily use of tablets for migraine would make them feel emotionally unhealthy.^[28] Other negative factors included the fear of drug dependency, a low assessment of their own capacity for compliance, and the negative reactions of persons in their direct surroundings (quote 4.7). Rutberg and Ohrling reported that the use of medication made patients worry about the risk of becoming addicted (quote 4.8).^[24]

3. Function

Restoring, maintaining, or improving function as an outcome of migraine treatment was reported in seven studies. In one study patients mentioned that they would consider taking treatment for their migraines depending on their daily workload (quote 4.9).^[36]

Patients expressed their preference for treatment that keeps them completely functional (quotes 4.10 and 4.11).^[26,29] Another patient described their concern about being functional and taking long-term treatment (quote 4.12).^[21]

4. Pain reoccurrence

In one study patients emphasized the importance of avoiding pain reoccurrence (quote 4.13). Of note, this theme as a treatment outcome overlaps with the theme of long-lasting treatment effect, which is a treatment feature.^[37]

5. Non-headache symptoms

Migraine-associated symptoms such as nausea, vomiting, and sensitivity to light and sound were outcomes of importance for patients (quotes 4.14, 4.15, and 4.16).^[22,24] Numerous quotes from Speck et al. highlighted how patients were distressed by light sensitivity, nausea, and visual concerns.^[39] Another study mentioned how patients prioritize the non-headache symptoms over pain itself, despite high costs (quote 4.17).^[34]