This study compared direct and indirect costs associated with chronic widespread pain (CWP) and fibromyalgia (FM) in the US. Participants ≥18 years old from the general population (N=8,382; females were oversampled), completed an online screener including the London Fibromyalgia Epidemiology Study Screening Questionnaire. Subjects who screened positive (bilateral pain, above/below waist over ≥3 months, lasting ≥1 week; CWP+), and a control group (CWP-) were invited for physician evaluation of FM including a tender point exam. Of 1,331 CWP+ and 502 CWP- subjects who consented to schedule a visit, mutually exclusive groups of CWP- (n=125), CWP+ (n=176) and confirmed FM subjects (n=171) completed a visit and questionnaire including the Work Productivity and Impairment Index (WPAI) and questions on healthcare resource utilization and costs. Statistical significance was tested (0.05 significance level) across the 3 groups using ANOVA (continuous variables) and chi-square or Fisher's exact test (categorical variables). Age and race were similar across groups (46.1-47.2 years, 76.7%-86.4% white), but proportion of females was higher with FM (90.6%) and CWP+ (80.7%) relative to CWP- (64.8%) (P<0.0001). Fewer FM subjects were employed (38.0%) relative to CWP+ (53.4%) and CWP- (51.2%) (P=0.0092). Among those employed, the WPAI showed increases from CWP- to CWP+ to FM in absenteeism (P=0.0076), presenteeism (P<0.0001), and overall work impairment (P<0.0001). In the past 3 months relative to the other two groups, more FM subjects consulted primary care physicians (PCP) for pain (P<0.0001), had more pain-related PCP visits (P<0.05), and had highest prescription pain medication use (P<0.0001). Total direct costs/subject in prior 3 months were $1,394 for FM, $831 for CWP+, and $556 for CWP- (P<0.0001); indirect costs were $6,354, $2,951, and $1,185, respectively (P<0.0001). Subjects with CWP+ and FM were characterized by greater economic burden relative to CWP-, which was highest with FM. This research was supported by Pfizer Inc.

We sought to identify and summarize the incidence and prevalence of neuropathy among HIV patients and subgroups. A systematic search of the literature was performed using MEDLINE and EMBASE. The relevant literature was identified based on predefined criteria. Prevalence data were collected from cross-sectional and cohort studies. Incidence data were collected from cohort and case-control studies. Thirty-seven studies were included of which there were 23 cohort studies, 13 cross-sectional studies, and one case-control study. The prevalence of neuropathy among HIV patients derived from 25 studies varied from 1.2% to 69.4%. Regarding the development of neuropathy among HIV-positive patients, standardized by study duration, the rates per 100 person-years ranged from 0.7 to 39.7. Among older patients there is a greater risk of neuropathy. The same seems to be the case for patients with more severe disease. Currently available studies providing information on the incidence and prevalence of neuropathy among HIV patients suggest a significant burden, but there is a great variation in results across studies. There is no definitive explanation for the variation. However, it underscores the fact that complexity of the disease, along with absence of standardized diagnostic criteria, has considerably influenced the methodologies and outcomes of the studies.

Assessments composed of patient-reported outcome (PRO) measures can be used in health care settings as screeners for various conditions. The objective of developing and using a PRO screening measure may be to quickly identify patients who are likely to benefit from a formal diagnostic evaluation. Alternatively, the development objective may be to avoid unnecessary diagnostic procedures, particularly when these are time or resource-intensive or invasive in nature. The PRO screener may also be administered to simply rule out the existence of a particular condition. The evaluation of a PRO screening assessment ideally occurs through analyses using a “gold standard” diagnosis of the condition of interest. A number of existing statistical and psychometric methods may be used in such an evaluation, including sensitivity and specificity, positive and negative predictive value, kappa, accuracy, odds ratio, and likelihood ratio. The evaluation method selected depends on the objective of the screener itself. If the formal diagnostic procedures are particularly invasive or time- or resource-intensive, then screeners should minimize false positives; in contrast, diseases with exceptional risks when left undiagnosed call for screeners that minimize false negatives. In this research, we explore these methods using data from a study comparing various fibromyalgia screening instruments with the currently accepted gold standard diagnosis for fibromyalgia, namely the American College of Rheumatology 1990 diagnostic criteria (Wolfe et al., 1990). Using the example application, we illustrate the pros and cons of a battery of statistical methods and how they can be used to select the “best” candidate screener.

OBJECTIVE:To evaluate health care resource utilization and costs 1 year before and 3 years after a fibromyalgia (FM) diagnosis. METHODS:This retrospective cohort analysis used claims from Humana to identify newly diagnosed FM patients ≥18 years of age based on ≥2 medical claims for ICD-9 CM code 729.1 and 729.0 between June 1, 2002 and March 1, 2005. Prevalence of comorbidities, as well as utilization and costs of pharmacotherapy and health care services were examined for 12 months preceding (pre-diagnosis) and 36 months following (post-diagnosis) the date of first FM diagnosis. These periods were subdivided into 6-month blocks to better observe patterns of change. RESULTS:We identified 2613 FM patients who had a mean age at diagnosis of 58.5 ± 15.3 years and a mean Charlson Comorbidity Index of 0.48 ± 1.05. Of those, 73% were female. The use and costs of pain-related medications rose from pre-diagnosis and remained stable after the 6-month post-diagnosis period, while the use of non-pain-related medications steadily rose from pre-diagnosis to 3 years post-diagnosis. This increase was concomitant with an increase in the presence of conditions that may account for higher resource utilization. The use of recommended FM therapies (i.e., antidepressants and anticonvulsants) increased post-diagnosis but remained less common than other pain-related therapies. Total resource utilization and costs increased during the period up to 6 months after diagnosis. This increase was followed by a decline (7-12 months post-diagnosis), and plateau, with an increase during the final 6 months of the study period. Total mean per patient costs were $3481 for the 6-month post-diagnosis period, and $3588 for the final 6 months. Limitations include potential errors in coding and recording, and an inability of claims analyses to determine causality between resource utilization and the specific diagnosis of interest. CONCLUSIONS:An FM diagnosis was associated with increased utilization and pain-related medication cost up to the first 6 months post-diagnosis followed by stabilization over 3 years post-diagnosis. Less use of recommended therapies relative to other therapies suggests that further dissemination of treatment guidelines is needed. An increase in non-pain medications over the observation period accounted for the majority of pharmacy costs. These pharmacy costs may be related to an increasing prevalence of comorbid conditions.

Fibromyalgia (FM) is a chronic condition characterized by widespread pain and can impose substantial economic burden. This study estimates the annualized differences in healthcare costs associated with improvement in FM severity among pregabalin-treated patients. Data from 3 similarly designed, 3-month placebo-controlled, clinical trials of pregabalin in FM patients were modeled. Extrapolation of efficacy results was based on a 1-year open-label study. Mean annual costs (direct and indirect) were assigned based on FM severity levels (mild: $10,219; moderate: $26,217; severe: $42,456) and were derived from the US Fibromyalgia Burden of Illness Study. FM severity levels were defined using established cutpoints on the Fibromyalgia Impact Questionnaire. Mean annualized costs at endpoint were estimated for all patients within each cohort and the mean differences in costs were compared between cohorts using a regression model. Relative to placebo, the proportion of mild subjects at endpoint was significantly higher with pregabalin 450mg and significantly lower for severe subjects. Mean total costs were lower with pregabalin (300mg, $25,721; 450mg, $24,103) than placebo ($26,162). Relative to placebo, the difference in mean annual costs was $2059 lower for pregabalin 450mg (P=0.003) and $441 lower for pregabalin 300mg (P=0.52). Mean direct costs were higher with pregabalin (300mg, $4,962; 450mg, $4820) than placebo ($4,364). Relative to placebo, the difference in mean annual direct costs was significantly higher for pregabalin 450mg by $456 (P<0.0001) and by $599 for pregabalin 300mg (P<0.0001). Mean indirect costs for pregabalin (300mg, $20,783; 450mg, $19,306) were lower than placebo ($21,735). Relative to placebo, the difference in mean annual direct costs for pregabalin 450mg was significantly lower by $2,429 (P<0.0001), and for pregabalin 300mg was lower by $951 (P=0.12). Improvements in FM severity are associated with overall reductions in costs that may offset the costs of treatment with pregabalin.

Fibromyalgia (FM) is a complex, multifaceted disorder characterized by widespread pain. Office time required for primary care physicians (PCPs) to diagnose, treat, and manage 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 (QoL), as reported by the physician. 14 semi-structured focus groups were conducted among 94 U.S., private-practice PCPs who diagnose, manage, and treat FM patients. Structured instruments were used to capture the number of office visits and time spent with FM patients. Post-hoc, PCPs were allocated into 2 groups: FM-Efficient (FME) (n=40) and FM-Usual Care (FMUC) (n=54), based on their reported ability to achieve an acceptable QoL for ≥50% of their FM patients in ≤4 office visits post diagnosis. An economic model monetized the value of each PCP cohorts' time spent with a newly diagnosed FM patient over a 2 year timeframe. Projecting the finding across a two-year period, the research found significant office time cost differences between FME-PCPs and FMUC-PCPs ($840 vs $1,117 P=0.018). FME-PCPs incurred a significantly lower cost burden with respect to scheduled time required to confirm the diagnosis ($243 vs $339, P=0.016) and time required to find the right treatment ($264 vs $365, P=0.016) than FMUC-PCPs. Both groups incurred costs related to longer than average visit time for FM patients, but costs were lower for FME-PCPs ($119, 29 minutes) than FMUC-PCPs ($182, 44 minutes, P<0.001, P<0.001), driven by faster confirmation of the diagnosis and quicker treatment initiation. Research suggests that "efficient" FM practitioners can improve practice economics and deliver effective FM care. This research is sponsored by Pfizer, Inc. Fibromyalgia (FM) is a complex, multifaceted disorder characterized by widespread pain. Office time required for primary care physicians (PCPs) to diagnose, treat, and manage 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 (QoL), as reported by the physician. 14 semi-structured focus groups were conducted among 94 U.S., private-practice PCPs who diagnose, manage, and treat FM patients. Structured instruments were used to capture the number of office visits and time spent with FM patients. Post-hoc, PCPs were allocated into 2 groups: FM-Efficient (FME) (n=40) and FM-Usual Care (FMUC) (n=54), based on their reported ability to achieve an acceptable QoL for ≥50% of their FM patients in ≤4 office visits post diagnosis. An economic model monetized the value of each PCP cohorts' time spent with a newly diagnosed FM patient over a 2 year timeframe. Projecting the finding across a two-year period, the research found significant office time cost differences between FME-PCPs and FMUC-PCPs ($840 vs $1,117 P=0.018). FME-PCPs incurred a significantly lower cost burden with respect to scheduled time required to confirm the diagnosis ($243 vs $339, P=0.016) and time required to find the right treatment ($264 vs $365, P=0.016) than FMUC-PCPs. Both groups incurred costs related to longer than average visit time for FM patients, but costs were lower for FME-PCPs ($119, 29 minutes) than FMUC-PCPs ($182, 44 minutes, P<0.001, P<0.001), driven by faster confirmation of the diagnosis and quicker treatment initiation. Research suggests that "efficient" FM practitioners can improve practice economics and deliver effective FM care. This research is sponsored by Pfizer, Inc.

The health status of patients with fibromyalgia is worse than healthy controls and patients with other chronic diseases as indicated by significantly lower scores on the EuroQol (EQ-5D) index (United States [U.S.] version range -0.109 to 1.0, where 0.0=death and 1.0=perfect health). The objective of this analysis was to identify clinical predictors of the EQ-5D that may be modified in order to improve the health status of patients with fibromyalgia. With adjustment for age and gender, a mean EQ-5D index score of 0.56 was estimated among patients in the U.S. Fibromyalgia Burden of Illness Survey (n=203; 94.6% female; mean [SD] age of 47.9 [16.0] years) using U.S. preference weights. Demographic and clinical factors identified as contributing to the EQ-5D score in simple regression analysis (P<0.05) were then included in a multiple regression analysis. Among clinical variables, the number of tender points was not predictive in the multiple regression model, nor was duration of fibromyalgia. Patient self-reported fibromyalgia symptom severity was a significant predictor of EQ-5D score in the multiple regression model. Compared with those reporting "very severe," patients with "moderate," " mild," and "very mild" symptoms had significantly (p < 0.05) higher (better) mean EQ-5D scores with adjusted differences of 0.19, 0.27, and 0.44 respectively, all of which exceed the clinically important difference of 0.07 that has been estimated for the EQ-5D. In the multiple regression model, major depressive disorder was a significant predictor; the presence of anxiety, cognitive dysfunction, and chronic fatigue syndrome were not. In addition to the clinical predictors, employment status was a significant predictor in the multiple regression model. Based on these results, self-reported symptom severity was identified as a significant predictor of EQ-5D-assessed health status in fibromyalgia patients. Effective management of symptoms will help improve the health status of these individuals. Funded by Pfizer, Inc.

A cross-disciplinary approach to treating fibromyalgia (FM) is often warranted. A number of physician specialties manage FM patients and numerous prescription medications are used. The study objectives are to assess differences in prescribing patterns and prescription medication costs and subject-reported satisfaction and efficacy of treatment across physician specialties. This cross-sectional, observational study recruited 203 FM subjects from 20 US community-based, physician offices (90 from primary care, 69 from neurology, 19 psychiatry and 25 rheumatology). Subjects completed questions about health burden, productivity, and expenses related to FM; site-staff recorded subjects' clinical characteristics and treatment based on medical records. Annual costs were calculated in 2009 US dollars. The mean (SD) annual prescription medication costs per FM subject were $3,822 (3,921) for primary care; $3,505 3,790) for rheumatology; $2,804 (3,244) for neurology; and $2,198 (2,266) for psychiatry. The mean number of FM medications prescribed per subject was highest for primary care (mean (SD): 2.9 (1.7) for primary care; 2.6 (1.6) for rheumatology, 1.7 (1.2) for neurology, and 2.0 (1.2) for psychiatry; p=0.024). The proportions of patients receiving muscle relaxants, anxiolytics, hypnotics, and anti-epileptics for FM differed significantly across specialties (p<0.05). Primary care had the highest percentage of opioid use for FM management (59% of subjects) compared to rheumatology (39%), neurology (37%), and psychiatry (44%) (p=0.056). There were no significant differences among specialties for subject-reported outcomes of efficacy and satisfaction of current FM prescriptions. Subjects in each group had similar duration of symptoms (p=0.257). The direct medical costs for FM prescriptions are substantial. Although prescribing patterns differed among physician specialties, FM subjects did not report significant differences in their satisfaction with FM treatment. (This study was funded by Pfizer, Inc.) A cross-disciplinary approach to treating fibromyalgia (FM) is often warranted. A number of physician specialties manage FM patients and numerous prescription medications are used. The study objectives are to assess differences in prescribing patterns and prescription medication costs and subject-reported satisfaction and efficacy of treatment across physician specialties. This cross-sectional, observational study recruited 203 FM subjects from 20 US community-based, physician offices (90 from primary care, 69 from neurology, 19 psychiatry and 25 rheumatology). Subjects completed questions about health burden, productivity, and expenses related to FM; site-staff recorded subjects' clinical characteristics and treatment based on medical records. Annual costs were calculated in 2009 US dollars. The mean (SD) annual prescription medication costs per FM subject were $3,822 (3,921) for primary care; $3,505 3,790) for rheumatology; $2,804 (3,244) for neurology; and $2,198 (2,266) for psychiatry. The mean number of FM medications prescribed per subject was highest for primary care (mean (SD): 2.9 (1.7) for primary care; 2.6 (1.6) for rheumatology, 1.7 (1.2) for neurology, and 2.0 (1.2) for psychiatry; p=0.024). The proportions of patients receiving muscle relaxants, anxiolytics, hypnotics, and anti-epileptics for FM differed significantly across specialties (p<0.05). Primary care had the highest percentage of opioid use for FM management (59% of subjects) compared to rheumatology (39%), neurology (37%), and psychiatry (44%) (p=0.056). There were no significant differences among specialties for subject-reported outcomes of efficacy and satisfaction of current FM prescriptions. Subjects in each group had similar duration of symptoms (p=0.257). The direct medical costs for FM prescriptions are substantial. Although prescribing patterns differed among physician specialties, FM subjects did not report significant differences in their satisfaction with FM treatment. (This study was funded by Pfizer, Inc.)

Fibromyalgia (FM) patients present with heterogeneous symptoms including pain, fatigue, depression, and sleep disturbance. Symptom severity often drives treatment prioritization. This study sought to characterize FM severity based on clinical assessment and standardized patient self-report of FM impact on pain, sleep, and mood. 203 FM patients were recruited from 20 US physician offices during routine visits. Patients completed questions about their average pain over the past 24 hours, the Medical Outcomes Study (MOS)Sleep Scale, and the Hospital Anxiety and Depression Scale (HADS). FM severity was defined using patients' Fibromyalgia Impact Questionnaire (FIQ)total scores:0-<39, 39-<59, and 59-100 representing mild, moderate, and severe, respectively. Patients and physicians ranked FM severity in stand-alone questions. Site staff completed case report forms using patients' medical records. The mean (SD) age was 47.9 (10.9) and 95% of the patients were female. Most patients were classified as having moderate (24%) or severe (66%) FM. FIQ-based FM severity was significantly correlated with both patient self-assessed and physician-reported FM severity (p<0.0001). Severe FM was associated with more tender points compared to moderate and mild FM (15.1 vs. 13.8 vs. 13.7 respectively, p<0.05). As FM severity worsened, more patients were diagnosed with depressive symptoms (p<0.0001), major depressive disorder (p=0.02), anxiety (p=0.002), and chronic fatigue syndrome (p=0.003). The mean (SD) average pain score increased significantly (p<0.0001) as FM severity worsened. Patients also reported significantly worse HADS Depression, HADS Anxiety, and MOS Sleep scores (p<0.0001) as FM severity worsened. There were no significant differences in age, gender, time since first experiencing FM, or time since diagnosis across FM severity levels. FM presents a substantial burden to patients. Severe FM was more likely to be accompanied by comorbid depression, anxiety, or chronic fatigue syndrome than mild or moderate FM. (Funded by Pfizer.)

Fibromyalgia (FM) patients report persistent, widespread pain, fatigue, and substantial functional limitations. FM is associated with a number of co-morbities; thus, FM patients seek care from various physician specialties. The objective of this study is to assess differences between office visit costs among physician specialties in routine clinical practice in the US. This cross-sectional, observational study recruited 203 FM subjects from 20 community-based physician offices. Subjects completed questions about pain, health-related quality-of-life, productivity, and expenses related to FM; site staff recorded subjects' treatment and medical resource use based on a review of medical records. Annual costs were calculated in 2009 US dollars. Psychiatry subjects had more FM-related physician visits over the past 3 months with a mean (SD) of 5.7 (6.1) than neurology [3.8 (3.0)], rheumatology [3.8 (4.8)], and primary care subjects [4.2 (3.9)]. Psychiatry subjects also had the highest mean (SD) annual payer costs per subject for FM-related physician visits (p=0.001). The mean number of FM-related visits for massage therapy and physical therapy did not differ across physician specialties. Incorporating the costs of physician, physical therapy and massage therapy offices visits, mean (SD) annual costs for FM-related office visits were highest for psychiatry and lowest for rheumatology subjects (p=0.004; Mean (SD): $1,835 (2,633) for psychiatry, $1,682 (2,017) for neurology, $1,673 (1,878) for primary care, and $1,186 (1,734) for rheumatology). Additionally, there is a significant difference (p < 0.001) between physician specialties and number of comorbid conditions per subject. FM imposes a substantial economic burden on society. There are significant differences between physician specialties regarding the number of FM-related physician visits and the associated costs, and the number of comorbid conditions per subject. (This study was funded by Pfizer, Inc.)

P>Introduction:Few studies have comprehensively assessed the burden associated with fibromyalgia (FM). This cross-sectional, observational study evaluates the impact of FM on patients in France and Germany.Methods:A total of 299 FM patients were recruited from 33 physician offices in France and Germany during routine visits. Patients completed a survey that included the Brief Pain Inventory-Short Form (BPI-sf), Fibromyalgia Impact Questionnaire (FIQ), EuroQol 5D (EQ-5D) and the Hospital Anxiety and Depression Scale (HADS) to describe their pain, FM and health-related quality of life (HRQOL). FM severity was defined using patients' FIQ total scores with 0 to < 39, 39 to < 59 and 59-100, representing mild, moderate and severe FM, respectively. Site staff completed case report forms using patients' medical records.Results:Mean (standard deviation, SD) age was 54.2 (12.6); 81% of patients were women. The mean (SD) FIQ total score was 53.3 (19.6); 33% and 44% of patients reported moderate and severe FM, respectively. Most patients (91%) were receiving prescription medications for FM during the study. Patients reported a mean (SD) EQ-5D health state valuation of 0.44 (0.33) and a mean (SD) BPI-sf Pain Severity Index score of 4.9 (1.8). Forty-one percent of patients reported some level of disruption in their employment because of FM; employed patients missed a mean (SD) of 2.2 (4.6) workdays during the past 4 weeks. An increase in FM severity was significantly associated with increased pain severity, productivity loss, sleep disturbance and higher anxiety and depression (p < 0.0001).Conclusions:There is a substantial burden of illness including treatment limitations for FM patients in France and Germany.