Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey
- Conditions
- Migraine
- Registration Number
- NCT06680206
- Lead Sponsor
- Pfizer
- Brief Summary
This is a cross-sectional study using the cross-sectional 2023 National Health and Wellness Survey (NHWS) data from the US, with a large and nationally representative population (N=75,007).
All data from the NHWS are reported by respondents, who are recruited through an existing, general-purpose, web-based, consumer panel via opt-in e-mails, co-registration with panel partners, e-newsletter campaigns, banner placements, and affiliate networks. All respondents explicitly agree to be a panel member, register with the panel through a unique e-mail address, and complete an in-depth demographic registration profile.
This analysis will focus on respondents who self-report having migraine diagnosed by a physician. Individuals who use rimegepant for acute treatment of migraine will be compared with those who use triptans for acute treatment of migraine. Outcomes of interest include treatment satisfaction, healthcare resource utilization (HCRU), quality of life (QoL), work productivity loss, and migraine-specific disability outcomes.
Inverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.
- Detailed Description
This is a cross-sectional study using the cross-sectional 2023 National Health and Wellness Survey (NHWS) data from the US, with a large and nationally representative population (N=75,007).
All data from the NHWS are reported by respondents, who are recruited through an existing, general-purpose, web-based, consumer panel via opt-in e-mails, co-registration with panel partners, e-newsletter campaigns, banner placements, and affiliate networks. All respondents explicitly agree to be a panel member, register with the panel through a unique e-mail address, and complete an in-depth demographic registration profile.
This analysis will focus on respondents who self-report having migraine diagnosed by a physician. Individuals who use rimegepant for acute treatment of migraine will be compared with those who use triptans for acute treatment of migraine. Outcomes of interest include treatment satisfaction, healthcare resource utilization (HCRU), quality of life (QoL), work productivity loss, and migraine-specific disability outcomes.
Inverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.
Additional information is provided in the study protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1363
- Participated in 2023 NHWS in the US
- Consented to the anonymous use of their data for research purpose
- Aged 18 or older
- Self-reported a diagnosis of migraine by physician
- Currently on rimegepant or triptan (via oral route) at the time of the survey
- Currently on both rimegepant and triptans at the time of the survey
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment satisfaction 12 months Measured in NHWS by asking respondents to rate their satisfaction with treatment on a 7-point Likert scale (from 1=extremely dissatisfied to 7=extremely satisfied).
Respondents will be stratified into 3 groups based on their answer:
1. Dissatisfied (1=extremely dissatisfied to 2=very dissatisfied)
2. Neutral (3=somewhat dissatisfied, 4=neither dissatisfied nor satisfied, 5=somewhat satisfied)
3. Satisfied (6=very satisfied to 7=extremely satisfied)Quality of Life (QoL) 12 months Measured in NHWS by asking respondents to complete the validated questionnaire that report on general health-related QoL:
EuroQoL5 dimension (EQ-5D) - Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.Qulaity of Life (QoL) 12 months Measured in NHWS by asking respondents to complete the validated questionnaire that report on general health-related QoL:
Short form 36 (SF-36) - The higher the score, the less disability i.e., a score of zero (minimum) is equivalent to maximum disability and a score of 100 (maximum) is equivalent to no disability.Work productivity loss 12 months Measured in NHWS by asking respondents about:
1. Employment status 2. Absenteeism 3. Presenteeism 4. Work productivity loss 5. Activity impairment.
Work productivity loss: WPAI (Work productivity and activity impairment) scores are based on 1-item (presenteeism, activity impairment), 2-items (absenteeism) and multiple items (overall work productivity). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.Migraine-specific disability 12 months Measured in NHWS by asking respondents to complete the Migraine Disability Assessment Scale (MIDAS), a validated instrument that assesses disability related to migraine for:
1. School work or work for pay
2. Household work or chores
3. Family, social, and leisure activities
Respondents are stratified by MIDAS scores (from Grade 1 indicating little or no disability to grade 4 indicating severe disability)Healthcare Resource Utilization (HCRU) 12 months Measured in NHWS by asking respondents about:
Number of traditional healthcare provider visits (within the last six months; any cause)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer
🇺🇸New York, New York, United States