Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities Based on Occupational Health Care Registry in Finland: an Observational Retrospective Mirror-image Study (REFI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Number of sick leave days (headache)
研究概览
简要总结
This was a retrospective registry-based study utilizing data collected in association with clinical care of patients. All data was stored in electronic health records at Terveystalo data base, and no patients were contacted for the study.
详细描述
Patients initiating erenumab treatment between 20.9.2018 - 15.10. 2019, and data on sick leave days, diagnoses and health care visits as well as medications based on prescriptions were assessed.
Following time frames for analyses of sick leaves and health care utilization in patients on erenumab treatment and in controls were reported:
Follow-up analyses: For cases (erenumab) with occupational healthcare, a minimum of 12 months on erenumab treatment was required for the analysis of sick leaves and visits
Pre erenumab: Follow-up data before index (defined as the first reimbursement decision/prescription for erenumab, or initiation of erenumab injections (before reimbursement approval)) from the Terveystalo database of those with consent
Post erenumab: Follow-up data after index, from the Terveystalo database of those with consent
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients on erenumab treatment ATC: N02CX07
- •Diagnosis of migraine (ICD G43)
- •Consented
- •Occupational healthcare
排除标准
- 未提供
结局指标
主要结局
Number of sick leave days (headache)
时间窗: throughout the study, approximately 2 years
Sick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.
次要结局
- Change in number of healthcare visits (all cause)(throughout the study, approximately 2 years)
- Change in number of healthcare visits (head-ache related)(throughout the study, approximately 2 years)
- Change in number of sick leave days (all cause)(throughout the study, approximately 2 years)
- Medication patterns: Number of patients receiving medications of interest(throughout the study, approximately 2 years)