Objective-The objective of this study was to elicit and assess important symptom domains and the impact of fibromyalgia on patients' quality of life and functioning from a patient's perspective. The intention was to collect this information as part of an overall effort to overcome shortcomings of existing outcome measures in fibromyalgia.Methods-This was a qualitative study in which six focus group sessions with 48 women diagnosed with fibromyalgia were conducted to elicit concepts and ideas to assess the impact of fibromyalgia on their lives.Results-The focus groups conducted with fibromyalgia patients identified symptom domains that had the greatest impact on their quality of life including pain, sleep disturbance, fatigue depression, anxiety, and cognitive impairment. Fibromyalgia had a substantial negative impact on social and occupational function. Patients reported disrupted relationships with family and friends, social isolation, reduced activities of daily living and leisure activities, avoidance of physical activity, and loss of career or inability to advance in careers or education. Conclusion-The findings from the focus groups revealed that fibromyalgia has a substantial negative impact on patients' lives.Practice Implications-A comprehensive assessment of the multiple symptoms domains associated with fibromyalgia and the impact of fibromyalgia on multidimensional aspects of function should be a routine part of the care of fibromyalgia patients.

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Results. Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo (؊0.93 on a 0-10 scale) (P < 0.001), and significantly more patients in this group had >50% improvement in pain at the end point (29%, versus 13% in the placebo group; P ‫؍‬ 0.003). Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality, fatigue, and global measures of change. Pregabalin at 450 mg/day improved several domains of health-related quality of life. Dizziness and somnolence were the most frequent adverse events. Rates of discontinuation due to adverse events were similar across all 4 treatment groups.Conclusion. Pregabalin at 450 mg/day was efficacious for the treatment of FMS, reducing symptoms of pain, disturbed sleep, and fatigue compared with placebo. Pregabalin was well tolerated and improved global measures and health-related quality of life.Fibromyalgia syndrome (FMS) affects ϳ3-6 million people in the US, with a prevalence in the general population estimated at 2% and an increased frequency among women (1). A characteristic symptom complex of chronic widespread musculoskeletal pain, disordered sleep, and fatigue associated with a lowered pain threshold is shared among those patients meeting the American College of Rheumatology (ACR) classification criteria for FMS (2). The etiology and pathogenesis of FMS are not well understood, but they are probably

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Summary Purpose:  To examine the characteristics and healthcare costs of fibromyalgia syndrome (FMS) patients in clinical practice. Materials and methods:  Using a US health‐insurance database, we identified all patients, aged ≥ 18 years, with any healthcare encounters for FMS (ICD‐9‐CM diagnosis code 729.1) in each year of the 3‐year period, 1 July 2002 to 30 June 2005. A comparison group was then constituted, consisting of randomly selected patients without any healthcare encounters for FMS during this 3‐year period. Comparison group patients were matched to FMS patients based on age and sex. Characteristics and healthcare costs of FMS patients and comparison group patients were then examined over the 1‐year period, 1 July 2004 to 30 June 2005 (the most recent year for which data were available at the time of the study). Results:  The study sample consisted of 33,176 FMS patients and an identical number in the comparison group. Mean age was 46 years, and 75% were women. FMS patients were more likely to have various comorbidities, including painful neuropathies (23% vs. 3% for comparison group), anxiety (5% vs. 1%), and depression (12% vs. 3%) (all p < 0.001); they also were more likely to have used pain‐related pharmacotherapy (65% vs. 34% for comparison group; p < 0.001). Mean (SD) total healthcare costs over 12 months were about three times higher among FMS patients [$9573 ($20,135) vs. $3291 ($13,643); p < 0.001]; median costs were fivefold higher ($4247 vs. $822; p < 0.001). Conclusions:  Patients with FMS have comparatively high levels of comorbidities and high levels of healthcare utilization and cost.