The Comparative Burden of Chronic Widespread Pain and Fibromyalgia in the United States.

BACKGROUND/PURPOSE: Little information exists on the comparative patient and economic burden of chronic widespread pain (CWP) and fibromyalgia (FM) in the United States. METHODS: This multistage, observational study included an online screening survey of a large geographically diverse US sample to assess CWP status, a physician/site visit to determine FM diagnosis, and an online subject questionnaire to capture clinical characteristics, pain, health status, functioning, sleep, healthcare resource use (HRU), productivity, and costs. Based on the screener and physician evaluation, mutually exclusive groups of subjects without CWP (CWP-), with CWP but without FM (CWP+), and with confirmed FM were identified. RESULTS: Disease burden was examined in 472 subjects (125 CWP-, 176 CWP+, 171 FM). Age, race, and ethnicity were similar across groups. Mean body mass index and number of comorbidities increased from CWP- to CWP+ to FM (P = 0.0044, P < 0.0001, respectively). From CWP- to CWP+ to FM, there were reductions in health status (EQ-5D, SF-12) and sleep outcomes (MOS-SS, SSQ) (all P < 0.05). Pain severity, interference with function (BPI-SF), and overall work impairment (WPAI:SHP) increased from CWP- to CWP+ to FM (all P < 0.0001). Higher proportions of CWP+ (52.8%) and FM subjects (62.6%) were taking pain-related prescription medications relative to CWP- subjects (32.8%; P < 0.0001). Significant differences in total direct and indirect costs across the three groups (both P < 0.0001) were observed, with highest costs among FM subjects. CONCLUSION: Fibromyalgia subjects were characterized by the greatest disease burden with more comorbidities and pain-related medications, poorer health status, function, sleep, lower productivity, and higher costs.

The comparative economic burden of mild, moderate, and severe fibromyalgia: results from a retrospective chart review and cross-sectional survey of working-age U.S. adults.

BACKGROUND: Patients with fibromyalgia report persistent widespread pain, fatigue, and substantial functional limitations, which may lead to high health resource use (HRU) and lost productivity. Previous analyses of the U.S. population have not examined the direct and indirect costs of fibromyalgia by severity level. OBJECTIVES: To assess (a) HRU, direct and indirect costs associated with fibromyalgia in routine clinical practice in the United States using a patient-centric approach, and (b) the relationship of fibromyalgia severity level to HRU and costs. METHODS: This study recruited a nonprobability convenience sample of 203 subjects aged 18 through 65 years between August 2008 and February 2009 from 20 U.S. community-based physician offices. Subjects had a prior diagnosis of fibromyalgia by a rheumatologist, neurologist, or pain specialist; received treatment at the enrolling physician's practice for at least 3 months; experienced widespread pain for at least 3 months; and experienced pain in the previous 24 hours. Subjects completed a 106-item patient questionnaire that included 5 validated health-related quality-of-life instruments and study-specific questions about demographics; clinical history; overall health; treatment satisfaction; and impact of fibromyalgia on cognitive function, daily activities, and employment status. Subjects also self-reported hours of unpaid informal caregiver time because of inability to perform daily activities (e.g., housework, child care), out-of-pocket expenses for medical and nonmedical services, and lost productivity related to fibromyalgia for the previous 4 weeks. The 20-item Fibromyalgia Impact Questionnaire total score was used to stratify subjects into fibromyalgia severity groups (0 to less than 39 = mild, 39 to less than 59 = moderate, 59 to 100 = severe). Staff at each site recorded clinical characteristics, HRU, and medication use attributable to fibromyalgia on a paper clinical case report form (CRF) based on a 3-month retrospective medical chart review. Unit costs for 2009 were assigned to the 3-month HRU data reported on the CRF and 4-week subject-reported lost productivity. Costs were then annualized and reported in the following categories: direct medical, direct nonmedical, and indirect. Differences across severity levels were evaluated using the Kruskal-Wallis test (continuous measures) and Pearson chi-square or Fisher's exact tests (categorical measures) at the 0.05 alpha level. RESULTS: Of the 203 subjects, 21 (10.3%) had mild, 49 (24.1%) had moderate, and 133 (65.5%) had severe fibromyalgia. For subjects with mild, moderate, and severe fibromyalgia, respectively, the number of fibromyalgia-related medications (3-month means: 1.8, 2.3, and 2.8, P = 0.011) and office visits to health care providers (3-month means: 2.7, 5.2, and 6.9, P < 0.001) significantly differed across severity levels. Across severity levels, total medical and nonmedical out-of-pocket costs also differed (P = 0.025). Mean [median] 3-month total direct costs (including payer costs for HRU and out-of-pocket costs for medical and nonmedical services) were $1,213 [$1,150], $1,415 [$1,215], and $2,329 [$1,760] for subjects with mild, moderate, and severe fibromyalgia, respectively (P = 0.002); and mean [median] 3-month indirect costs (including subject-reported absenteeism, unemployment, disability, and the estimated value of unpaid informal care) were $1,341 [$0], $5,139 [$1,680], and $8,285 [$7,030] (P < 0.001). Mean total indirect costs accounted for 52.5%, 78.4%, and 78.1% of mean total costs for subjects with mild, moderate, and severe fibromyalgia, respectively. CONCLUSIONS: Direct and indirect costs related to fibromyalgia are higher among subjects with worse fibromyalgia severity. Indirect costs account for a majority of fibromyalgia-related costs at all fibromyalgia severity levels.

The impact of 'best-practice' patient care in fibromyalgia on practice economics.

OBJECTIVE: The office time required for primary care physicians (PCPs) to diagnose, treat and manage fibromyalgia (FM) patients can be extensive. The study objective was to determine if PCPs can positively impact practice economics by requiring fewer patient visits and less office time, while still achieving an acceptable quality of life, as reported by the physician. STUDY DESIGN: Survey of PCPs who diagnose, manage and treat FM patients. METHODS: Surveys were administered to US private practice PCPs, obtaining information on the number of office visits, and time spent with FM patients. PCPs were allotted into two groups: FM-efficient (FME; n = 40) and FM usual care (FMUC; n = 54), based on their reported ability to achieve an acceptable quality of life for ≥50% of their FM patients in less than four office visits post FM diagnosis. An economic model estimated the monetary value of each PCP cohorts' time spent with a newly diagnosed FM patient over a 2-year timeframe. RESULTS: Significant office time cost differences across 2 years exist between FME PCPs and FMUC PCPs ($840 vs. $1117, P < 0.05). FME PCPs had a significantly lower cost of scheduled time to confirm diagnosis ($243 vs. $339, P < 0.05) and time to find right treatment ($264 vs. $365, P < 0.05) than FMUC PCPs. Both groups incurred costs related to excess visit time, but it was less for FME PCPs ($119, 29 minutes) than FMUC PCPs ($182, 44 minutes, P < 0.01), driven by quicker diagnosis confirmation (P < 0.01) and treatment initiation (P < 0.01). CONCLUSIONS: Research suggests that efficient FM care delivery during diagnosis and treatment can be associated with improved practice economics.

Efficient practices associated with diagnosis, treatment and management of fibromyalgia among primary care physicians.

OBJECTIVES: To describe beliefs and practice patterns of primary care physicians (PCPs) providing fibromyalgia (FM) care, and to characterize differences between PCPs who report being able to provide timely and beneficial care versus the remaining PCPs. METHODS: A mixed-methods approach including surveys followed by semi-structured focus groups among United States-based PCPs in seven cities was used. Post hoc, a composite threshold of timely and beneficial care, defined as PCPs reports of at least one-half of their patients achieving an 'acceptable' quality of life within one to four office visits after diagnosis, was created to compare subgroups. RESULTS: Forty-six per cent of PCPs reported some uncertainty when diagnosing FM. PCPs reported personally treating approximately two-thirds of their patients (63%), and reported an average of three dosage titrations. In a post hoc exploratory analysis, 42.5% of PCPs met a composite threshold of self-reported timely and beneficial FM care. These PCPs reported fewer office visits to confirm an FM diagnosis (2.7 versus 4.0 visits [P<0.01]) and more patients with 'significant improvement' (38% versus 23% [P<0.01]) after six months of treatment compared with the remaining PCPs. CONCLUSIONS: Physicians self-reported an inadequacy in diagnosing, treating and managing patients with FM in current practice. A subset of PCPs, however, perceived an ability to reach a definitive diagnosis and initiate treatment plans relatively sooner than the other respondents. If the perception of this subset can be confirmed with objective clinical outcomes, and these behaviours modelled, steps could be taken to improve FM care within the broader PCP setting.

The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States.

BACKGROUND: Fibromyalgia (FM) is characterized by chronic, widespread pain, fatigue, and other symptoms; yet few studies have comprehensively assessed its humanistic burden. This observational study evaluates the impact of FM severity on patients' symptoms, health-related quality of life (HRQoL), and productivity in the United States. METHODS: 203 FM subjects were recruited from 20 physician offices. Subjects completed a questionnaire including the EuroQol 5D (EQ-5D), Fibromyalgia Impact Questionnaire (FIQ), Multidimensional Assessment of Fatigue (MAF), Medical Outcomes Study Sleep Scale (MOS-SS), and Hospital Anxiety and Depression Scale (HADS) and questions about demographics, pain and other symptoms, HRQoL and productivity. FIQ total scores were used to define FM severity, with 0- < 39, 39- < 59, and 59-100, representing mild, moderate, and severe FM, respectively. Sites recorded subjects' clinical characteristics and FM treatment on case report forms using medical records. Summary statistics were calculated for continuous variables and frequency distributions for categorical variables. Differences across FM severity groups were evaluated using the Kruskal-Wallis or Chi-square tests. Statistical significance was evaluated at the 0.05 level. RESULTS: Mean (SD) age was 47.9 (10.9); 95% were female. Most (92%) were prescribed medication for FM; 24% and 66% reported moderate and severe FM, respectively. Mean (SD) scores were: 6.3 (2.1) for pain intensity; 0.35 (0.35) for EQ-5D; 30.7 (14.2) for MAF; 57.5 (18.4) for MOS-SS Sleep Problems Index; 10.2 (4.8) for HADS anxiety and 9.4 (4.4) for HADS depression. Subjects with worse FM severity reported significantly increased pain severity, HRQoL, fatigue, sleep disturbance, anxiety and depression (p < 0.001). Overall, 50% of subjects reported some disruption in their employment due to FM; this differed across severity levels (p < 0.001). Employed subjects missed a mean (SD) of 1.8 (3.9) workdays during the past 4 weeks; this also differed across severity levels (p = 0.03). CONCLUSIONS: FM imposes a substantial humanistic burden on patients in the United States, and leads to substantial productivity loss, despite treatment. This burden is higher among subjects with worse FM severity.

Treatment patterns among physician specialties in the management of fibromyalgia: results of a cross-sectional study in the United States.

BACKGROUND: Fibromyalgia (FM) is characterized by persistent and widespread pain and often associated with other symptoms and comorbidities. Thus, FM patients seek care from multiple physician specialties. This study compared prescribing patterns, patient-reported outcomes (PROs), healthcare resource use (HRU), and direct costs related to FM in routine clinical practice across physician specialties. METHODS: This cross-sectional, observational study recruited 203 FM subjects from 20 community-based physician offices (eight primary care, six rheumatology, three neurology, three psychiatry). Subjects completed questions about pain, other symptoms, quality of life, productivity, treatment effectiveness and satisfaction, and out-of-pocket expenses related to FM; site staff recorded subjects' treatment and HRU based on medical chart review. Results were compared across specialties. Statistical significance was evaluated at the 0.05 level. Annual direct costs associated with FM were calculated in 2009 US dollars. RESULTS: Subject demographic and clinical characteristics were not significantly different across physician specialties, except psychiatry subjects had the highest mean number of co-morbid conditions; p < 0.001. PROs were similar across physician specialties except fatigue; neurology subjects reported the highest levels. There were no significant differences in subject-reported outcomes of medication effectiveness (p = 0.782) and medication satisfaction (p = 0.338) for FM. Psychiatry subjects had more FM-related physician visits compared to other specialties (p = 0.013) and a higher proportion received diagnostic tests related to FM (p = 0.013). The mean (SD) number of FM prescription medications prescribed per subject was highest in the primary care and lowest in the neurology group; p = 0.024. The proportion of hypnotic (p = 0.001), muscle relaxant (p = 0.005), anxiolytic (p = 0.005), anti-epileptic (p = 0.007), and other medications (p = 0.044) prescribed for FM were significantly different across specialties. Overall direct medical costs did not differ significantly (p = 0.284) across specialties. CONCLUSIONS: Patient characteristics were similar across specialties, except with regards to comorbidity burden. This study noted significant differences among physician specialties in HRU and treatment patterns among medications, diagnostics, and outpatient visits. Consistent with other studies, this study did not identify a dominant strategy for FM management across physician specialties as overall per patient medical costs and subject-reported treatment satisfaction were similar. Future research to better characterize differences among physician specialties in FM management, as well as the reasons for these differences, would be useful.