Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,700
- 试验地点
- 1
- 主要终点
- Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
研究概览
简要总结
The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of adult participants diagnosed by their physician with fibromyalgia (FM) and who are starting any "new pharmacologic agent" for FM.
The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize management of FM. This study will address current gaps in a rapidly growing body of literature on FM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Meet criteria for fibromyalgia (FM) in the opinion of the investigator
- •Must be prescribed a 'new' treatment for FM
- •Male and female participants at least 18 years of age
- •Willing to complete the Informed Consent Document (ICD) and any other required forms to be eligible for study participation
- •Currently under the care of the participating physician
- •Cognitively able to understand and complete participant self-rated scales in English or Spanish via computer-assisted telephone interview (CATI)
- •Available for 12 months to participate in the study
排除标准
- •Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- •Are Lilly employees
- •Are Terminally ill
- •Currently participating in other research studies or if beginning a research study while participating in this study
- •Unable to respond via telephone for CATI
- •Incompetent for interview as deemed by the participating physician
- •Unwilling to provide written ICD or other required forms to participate in the study
研究组 & 干预措施
Fibromyalgia (FM) Participants
FM participants starting any new pharmacologic FM agent.
干预措施: Treatment for Fibromyalgia (Drug)
结局指标
主要结局
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
时间窗: Baseline through 12 months
Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication
时间窗: Baseline through 12 months
Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.
Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use
时间窗: Baseline through 12 months
Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity \[not at all severe, severe for several days, severe for more than half the days, severe nearly every day\]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.
次要结局
- Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study(Baseline through 12 months)
- Percentage of Participants Who Discontinued Opioids(Baseline through 12 months)
- Hazard Ratios for Factors Associated With Discontinued Opioid Use(Baseline through 12 months)
- Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months(Baseline, 12 months)
- Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months(Baseline, 12 months)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months(Baseline, 12 months)
- Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months(Baseline, 12 months)
- Number of Outpatient Visits Due to Fibromyalgia (FM)(Baseline through 12 months)
- Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)(Baseline through 12 months)
- Number of Days of Partial Care for Fibromyalgia (FM) Participants(Baseline through 12 months)
- Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)(Baseline through 12 months)
- Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)(Baseline through 12 months)
- Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)(Baseline through 12 months)
- Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)(Baseline through 12 months)