Background
Methods
Results and Discussion
Concept identification (stage 1)
Concept identification methods
Concept identification results
Concept elicitation (stage 2)
Concept elicitation methods
Themes to be explored | Examples of questions |
---|---|
1. History of migraine | Diagnosis, medications, treatments |
2. Migraine symptoms | How often? How much intensity/severity)? When? |
3. Exploration of symptom impact/impact on functioning migraine has on subject’s life | How is your life impacted by your migraines? |
4. Impact migraine symptoms have on subject’s physical function | How is your physical function affected by your migraines? |
5. Impact migraine symptoms have on subject’s ability to do day-to-day activities | How is your everyday activity affected by your migraines? |
6. Impact migraine symptoms have on subject’s social or recreational activities | How are your social or recreational activities affected by your migraines? |
7. Impact migraine symptoms have on subject’s relationships | How is your personal or family life affected by your migraines? |
8. Impact migraine symptoms have on subject’s emotions | How are your emotions affected by your migraines? |
9. Exploring cognitive impact migraine symptoms have on subject’s life | What cognitive impact from migraines have you noticed in your life? |
10. Overall ranking | What aspect of having a migraine has the MOST IMPACT on your life? |
Qualitative analyses
Concept elicitation results
Overall
N = 32 | Episodic migraine
N = 21 | Chronic migraine
N = 11 | |
---|---|---|---|
Age (years), mean (SD) | 40.3 (11.3) | 39.7 (11.1) | 41.5 (12.1) |
Sex (female), n (%) | 27 (84.4) | 17 (81.0) | 10 (90.1) |
Ethnicity (not Hispanic or Latino), n (%) | 28 (87.5) | 17 (81.0) | 11 (100) |
Race, n (%)a
| |||
White | 26 (81.3) | 17 (81.0) | 9 (81.8) |
Black or African American | 6 (18.8) | 3 (14.3) | 3 (27.3) |
American Indian or Alaska Native | 2 (6.3) | 1 (4.8) | 1 (9.1) |
Other | 1 (3.1) | 0 (0) | 1 (9.1) |
Employment status, n (%)a
| |||
Employed, full-time | 19 (59.4) | 15 (71.4) | 4 (36.4) |
Employed, part-time | 10 (31.3) | 5 (23.8) | 5 (45.5) |
Student | 2 (6.3) | 2 (9.5) | 0 (0) |
Unemployed | 1 (3.1) | 0 (0) | 1 (9.1) |
Other | 1 (3.1) | 0 (0) | 1 (9.1) |
Highest level of education, n (%) | |||
Secondary/high school | 3 (9.4) | 0 (0.0) | 3 (27.3) |
Some college | 14 (43.8) | 10 (47.6) | 4 (36.4) |
College degree | 13 (40.6) | 10 (47.6) | 3 (27.3) |
Postgraduate degree | 2 (6.3) | 1 (4.8) | 1 (9.1) |
Migraine diagnosis duration (years), mean (SD) | 14.3 (9.7) | 12.2 (8.4) | 18.5 (11.0) |
Migraine interference with daily activities in past week, n (%) | |||
Not at all (0) | 1 (3.1) | 1 (4.8) | 0 (0) |
Mildly (1–3) | 5 (15.6) | 2 (9.5) | 3 (27.3) |
Moderately (4–6) | 14 (43.8) | 10 (47.6) | 4 (36.4) |
Markedly (7–9) | 9 (28.1) | 6 (28.6) | 3 (27.3) |
Extremely (10) | 3 (9.4) | 2 (9.5) | 1 (9.1) |
Did you miss work or school due to migraine related symptoms in the past week? n (%) | |||
Yes | 9 (28.1) | 7 (33.3) | 2 (18.2) |
No | 20 (62.5) | 14 (66.7) | 6 (54.6) |
I do not attend work or school | 3 (9.4) | 0 (0) | 3 (27.3) |
Treatments taken to treat migraines when they occur, n (%)a
| |||
Over the counter/non-prescription medication | 24 (75) | 19 (90.5) | 5 (45.6) |
Prescription drug | 18 (56.3) | 10 (47.6) | 8 (72.7) |
Domain | Episodic migraine quote | Chronic migraine quote |
---|---|---|
Physical functioning |
You just don’t move around as much…and you don’t move real fast, you don’t want to dance, you don’t want to do anything like that that will kind of jolt your body. (EM no aura) |
I don’t like to do anything when I’m in the middle of a migraine. I mean, even just any slight movement hurts. I don’t want to get up and go to the bathroom, I don’t. (CM no aura)
|
Social and leisure functioning |
Okay. So I’ve had to skip weddings, I’ve had to skip school events, I’ve had to skip my, uh, grandchild’s, um, baptism I had to skip because I had a migraine. Um, just activities, you know, just normal everyday life things that you look forward to. You know, I haven’t been to gone—do because, you know, migraine and, um, you know, and I push myself to try to go to this stuff and, you know, and there’s—then I start throwing up and it’s like, no, I can’t, you know, so. (EM no aura)
|
Well, whether it be visiting, uh, parents to, uh, to recreational sports; whether it be fishing, boating, uh, going to the beach, or the playground…swimming at a neighbor’s house, or going out to eat, any, you know, anything like that. I just wouldn’t do it. (001–006 – CM no aura)
|
Emotional functioning |
[Migraines]…just add a lot of stress because of, um, having to worry about like working around it or working through it or making arrangements to be able to not have to do things. (EM aura)
|
I feel like I’m a burden to people when I have migraines, you know, because I have to rely on them and my whole independence is taken away, you know, but, um, when I don’t have a migraine I’m, you know, I’m happy go lucky. (CM no aura)
|
Development conceptual disease model (stage 3)
Selection of concept of interest (stage 4)
Item level review of content of PRO instruments to evaluate measurement of the COI (stage 5)
Concepts covered | ||||||
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Number of items | Recall period | Everyday activity | Impact on movement | Impact on social interactions | Emotional response | |
Migraine Disability Assessment questionnaire (MIDAS) | 5 | 3 months | On how many days did you miss work or school because of your headaches? | |||
How many days was your productivity at work or school reduced by half or more because of your headaches? | ||||||
On how many days did you not do household work because of your headaches? | ||||||
How many days was your productivity in household work reduced by half or more because of your headaches? | ||||||
Headache Impact Test (HIT-6) | 6 | 4 weeks | How often does your headache limit your ability to do usual daily activities (household, work, school, social)? | When you have a headache how often do you wish you could lie down? | ||
How often have you felt too tired to do work or daily activities because of your headache? | How often have you felt too tired to do work or daily activities because of your headache? | |||||
How often did your headaches limit your ability to concentrate on work or daily activities? | ||||||
Migraine Specific Quality of Life Questionnaire (MSQ; version 2.1) | 14 | 4 weeks | How often does your headache limit your ability to do usual daily activities (household, work, school, social)? | How often have migraines left you too tired to do work or daily activities? | ||
How often have you felt too tired to do work or daily activities because of your headache? | How often have migraines limited the number of days you have felt energetic? | |||||
How often did your headaches limit your ability to concentrate on work or daily activities? | ||||||
How often does your headache limit your ability to do usual daily activities (household, work, school, social)? |