Comparing Patient-Reported Outcomes Between Rimegepant and Triptan Users With Migraine in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,395
- 试验地点
- 1
- 主要终点
- Treatment satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Currently on both rimegepant and triptans at the time of the survey
结局指标
主要结局
Treatment satisfaction
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 12 months
Measured in NHWS by asking respondents about: Number of traditional healthcare provider visits (within the last six months; any cause)
次要结局
未报告次要终点