Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)

Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Treatment for Fibromyalgia

• Study Type: Observational
• Enrollment (Actual): 1700

Contacts and Locations

Study Locations

• Puerto Rico
  • Cidra, Puerto Rico, 00739
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  • Hato Rey, Puerto Rico, 00920
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  • Humacao, Puerto Rico, 00791
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  • Levittown, Puerto Rico, 00949
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  • Manati, Puerto Rico, 00674
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  • Mayaguez, Puerto Rico, 00680
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  • Rio Piedras, Puerto Rico, 00921
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  • San German, Puerto Rico, 00683
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  • Santa Isabel, Puerto Rico, 00757
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• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
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  • California
    • Santa Barbara, California, United States, 93108
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  • Connecticut
    • Danbury, Connecticut, United States, 06810
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    • Waterbury, Connecticut, United States, 06708
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  • District of Columbia
    • Washington, District of Columbia, United States, 20006
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  • Florida
    • Jupiter, Florida, United States, 33458
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    • Tampa, Florida, United States, 33609
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    • Winter Park, Florida, United States, 32792
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  • Georgia
    • Blue Ridge, Georgia, United States, 30513
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    • Snellville, Georgia, United States, 30078
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  • Idaho
    • Meridian, Idaho, United States, 83646
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    • Nampa, Idaho, United States, 83686
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  • Illinois
    • Peoria, Illinois, United States, 61614
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    • Springfield, Illinois, United States, 62702
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  • Indiana
    • Evansville, Indiana, United States, 47710
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    • Fishers, Indiana, United States, 46038
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    • Indianapolis, Indiana, United States, 46260
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  • Kentucky
    • Louisville, Kentucky, United States, 40223
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
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  • Maryland
    • Baltimore, Maryland, United States, 21222
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    • Towson, Maryland, United States, 21286
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    • Wheaton, Maryland, United States, 20902
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  • Michigan
    • Lansing, Michigan, United States, 48910
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Missouri
    • West Plains, Missouri, United States, 65775
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Nevada
    • Reno, Nevada, United States, 89502
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • New Jersey
    • Dover, New Jersey, United States, 07801
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • East Brunswick, New Jersey, United States, 08816
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Medford, New Jersey, United States, 08055
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • New York
    • Schenectady, New York, United States, 12308
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Charlotte, North Carolina, United States, 28210
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  • North Dakota
    • Minot, North Dakota, United States, 58701
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Cleveland, Ohio, United States, 44195
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Findlay, Ohio, United States, 45840
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • West Reading, Pennsylvania, United States, 19611
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  • Texas
    • Arlington, Texas, United States, 76011
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Dallas, Texas, United States, 75278
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    • Flower Mound, Texas, United States, 75028
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Garland, Texas, United States, 75042
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Grand Prairie, Texas, United States, 75050
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    • Houston, Texas, United States, 77034
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  • Utah
    • Salt Lake City, Utah, United States, 84102
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Washington
    • Kirkland, Washington, United States, 98034
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Seattle, Washington, United States, 98104
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Multiple care centers

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibromyalgia (FM) Participants; FM participants starting any new pharmacologic FM agent.	Drug: Treatment for Fibromyalgia; FM participants starting any new pharmacologic FM agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months		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	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.	Baseline through 12 months
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	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.	Baseline through 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study	Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.	Baseline through 12 months
Percentage of Participants Who Discontinued Opioids		Baseline through 12 months
Hazard Ratios for Factors Associated With Discontinued Opioid Use	Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.	Baseline through 12 months
Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months	Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.	Baseline, 12 months
Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months	BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.	Baseline, 12 months
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months	FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.	Baseline, 12 months
Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months	The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.	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	Partial (day or night) care included day care, day nursing home, and partial hospitalization.	Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)	Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.	Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)	Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.	Baseline through 12 months
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)	Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.	Baseline through 12 months
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)	Participant productivity was described as the number of days a participant missed work due to FM.	Baseline through 12 months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 28, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 11540; F1J-MC-B020 (Other Identifier: Eli Lilly and Company)