The REFLECTIONS Study is a 12-month, prospective observational study that will be utilized in approximately 100 care settings in the United States (US) and Puerto Rico.
It is designed to examine treatment patterns and health outcomes of 2,500 adult patients diagnosed by their physician with fibromyalgia (FM) and who are starting any "new pharmacologic agent" for FM. (REFLECTIONS stands for “Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments” – ClinicalTrials.gov ID NCT00725101)
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 the management of FM. This study will address current gaps in a rapidly growing body of literature for FM.
Primary Outcome Measures will be:
• To describe how FM is treated in patients from naturalistic outpatient care settings who are "newly prescribed" pharmacologic treatments for FM and who are followed for 12 months.
• To examine patient characteristics, FM profile, and physician characteristics that influence baseline and longitudinal treatment.
Secondary Outcome Measures will be:
• To describe reasons for 'new' pharmacologic treatment in FM patients at baseline and changes post-baseline
• To examine patient and physician characteristics that are associated with a reduction in opioid use
• To examine treatment, patient and physician characteristics associated with changes in patient clinical characteristics, burden and economic measures.
For more information, including the locations of participating care centers, and to contact the study coordinators with any questions (9 AM to 5 PM Eastern Time), go to the ClinicalTrials.gov listing at http://clinicaltrials.gov/ct2/show/NCT00725101