title: Fibromyalgia Outcomes Over Time: Results from a Prospective Observational Study in the United States.
abstract: BACKGROUND
  Longitudinal research on outcomes of patients with fibromyalgia is limited.
  
  
  OBJECTIVE
  To assess clinician and patient-reported outcomes over time among fibromyalgia patients.
  
  
  METHODS
  At enrollment (Baseline) and follow-up (approximately 2 years later), consented patients were screened for chronic widespread pain (CWP), attended a physician site visit to determine fibromyalgia status, and completed an online questionnaire assessing pain, sleep, function, health status, productivity, medications, and healthcare resource use.
  
  
  RESULTS
  Seventy-six fibromyalgia patients participated at both time points (at Baseline: 86.8% white, 89.5% female, mean age 50.9 years, and mean duration of fibromyalgia 4.1 years). Mean number of tender points at each physician visit was 14.1 and 13.5, respectively; 11 patients no longer screened positive for CWP at follow-up. A majority reported medication use for pain (59.2% at Baseline, 62.0% at Follow-up). The most common medication classes were opioids (32.4%), SSRIs (16.9%), and tramadol (14.1%) at Follow-up. Significant mean changes over time were observed for fibromyalgia symptoms (modified American College of Rheumatology 2010 criteria: 18.4 to 16.9;P=0.004), pain interference with function (Brief Pain Inventory-Short Form: 5.9 to 5.3;P=0.013), and sleep (Medical Outcomes Study-Sleep Scale: 58.3 to 52.7;P=0.004). Patients achieving ≥2 point improvement in pain (14.5%) experienced greater changes in pain interference with function (6.8 to 3.4;P=0.001) and sleep (62.4 to 51.0;P=0.061).
  
  
  CONCLUSIONS
  Fibromyalgia patients reported high levels of burden at both time points, with few significant changes observed over time. Outcomes were variable among patients over time and were better among those with greater pain improvement.
authors.affiliation: Covance Market Access Services Inc., Gaithersburg, MD, USA.
authors.forename: Caroline P
authors.initials: CP
authors.lastname: Schaefer
authors.affiliation: Covance Market Access Services Inc., Gaithersburg, MD, USA.
authors.forename: Edgar H
authors.initials: EH
authors.lastname: Adams
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Margarita
authors.initials: M
authors.lastname: Udall
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Elizabeth T
authors.initials: ET
authors.lastname: Masters
authors.affiliation: Covance Market Access Services Inc., San Diego, CA, USA.
authors.forename: Rachael M
authors.initials: RM
authors.lastname: Mann
authors.affiliation: Covance Market Access Services Inc., Conshohocken, PA, USA.
authors.forename: Shoshana R
authors.initials: SR
authors.lastname: Daniel
authors.affiliation: Covance (Asia) Pte Ltd., Singapore.
authors.forename: Heather J
authors.initials: HJ
authors.lastname: McElroy
authors.affiliation: Pfizer Inc., Groton, CT, USA.
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cappelleri
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Clair
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Markay
authors.initials: M
authors.lastname: Hopps
authors.affiliation: University of Florida, Gainesville, FL, USA.
authors.forename: Roland
authors.initials: R
authors.lastname: Staud
authors.affiliation: Swedish Medical Center and University of Washington, Seattle, WA, USA.
authors.forename: Philip
authors.initials: P
authors.lastname: Mease
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Stuart L
authors.initials: SL
authors.lastname: Silverman
keywords: Burden of illness; Chronic widespread pain; Clinician-reported outcomes; Fibromyalgia; Health resource use; Outcome assessment; Patient-reported outcomes; Quality of life; Treatment patterns