Fibromyalgia (FM) is characterized by chronic widespread pain (CWP), fatigue, and functional limitations. Previous research suggests remission from FM and its symptoms is rare, though some studies report 20%-47% of diagnosed patients may no longer meet the study definition of FM at 1-2 years after diagnosis.1 This study followed a cohort of 226 subjects recruited online to assess transitions into and out of FM over 2 years. At enrollment (Year 1) subjects completed a brief online questionnaire to screen for CWP (bilateral pain, above/below waist lasting ≥1 week) based on the 4 pain questions of the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ), site visit for physician evaluation of FM, and another online questionnaire with several validated patient-reported outcome instruments. Subjects were classified into mutually-exclusive groups: FM (study definition required CWP-positive screen and physician diagnosis of FM), CWP+ (CWP-positive screen without physician diagnosis of FM), and CWP- (CWP-negative screen). At the follow-up visit (approximately 2 years later), subjects completed the same questionnaires and were reassessed by the physician. Among FM subjects who completed assessments at both time points (n=76), 56 (73.7%) met the study definition of FM at follow-up. Twenty subjects no longer met the FM study definition (11 switched to CWP-, 9 to CWP+). Ten subjects (2 from CWP-, 8 from CWP+) transitioned into the FM group; they reported greater number of tender points, lower physical function, and more sleep disturbance in Year 1 compared with subjects who did not transition to FM. Most subjects (23/30, 76.7%) who transitioned into/out of FM experienced corresponding changes in CWP, number of positive tender points (≥11), or both. Results suggest some patients may experience fluctuation in symptoms over time, which may reflect the waxing and waning nature of FM and further complicate diagnosis. (1. White, Curr Pain Headache Rep, 2001) Research supported by Pfizer Inc.

Background Published findings on natural history of fibromyalgia (FM) are limited. Objectives The multisite US prospective observational cohort study followed FM subjects to assess disease burden and natural history. Methods At enrollment, consented subjects completed an online questionnaire to screen for chronic widespread pain (CWP, pain on both sides and above and below waist for ≥1 week); a physician site visit to determine FM diagnosis; and another online questionnaire to capture demographics, clinical characteristics, medications, healthcare resource use (HRU), pain (Brief Pain Inventory-Short Form [BPI-SF]), FM (modified [self-report] American College of Rheumatology [ACR] 2010 criteria, Revised Fibromyalgia Impact Questionnaire [FIQ-R]), sleep (Medical Outcomes Study-Sleep Scale [MOS-SS]), and health status (Short Form 12-item Health Survey [SF-12]). At follow-up, approximately 2 years later, subjects and physicians completed the same assessments. Statistical significance of changes was tested (p<0.05) using analysis of covariance and generalized McNemar9s test. Results A total of 76 FM subjects participated at both time points (at enrollment: 89.5% female, mean age 50.9 years, mean duration of FM 4.1 years, 86.8% white). Mean number of tender points at each physician visit was 14.1 and 13.5, respectively. Distribution of FM severity based on physician evaluation at enrollment was 19.7% mild/very mild, 48.7% moderate, 31.6% severe/very severe, and at follow-up was 15.6% mild/very mild, 43.8% moderate, 40.6% severe/very severe. At follow-up, 20.3% of subjects reported their overall health status had improved since enrollment, while 47.5% reported a decline. Comorbidities reported by ≥20% of subjects at follow-up: arthritis, lower back pain, depression, high cholesterol, hypertension, headache/migraine, anxiety, and sleep apnea. Medication use for pain was reported by 59.2% and 62.0% of subjects at each time point, respectively. Most common medication classes were opioids (32.4%), SSRIs (16.9%), and tramadol (14.1%) at follow-up. Mean number of healthcare provider visits for pain over the past 3 months (among those with ≥1) was 5.4 and 4.9 at each time point, respectively. There were no statistically significant changes in pain-related HRU. Significant mean changes (p-value <0.05) over time were observed for mean modified ACR 2010 criteria score (18.4 to 16.9, p=0.004), BPI-SF pain interference index (5.9 to 5.3, p=0.013), and MOS-SS overall sleep problems index (58.3 to 52.7, p=0.004). No statistically significant differences were observed for BPI-SF pain severity index (5.2 to 5.1), FIQ-R overall score (53.2 to 53.2), SF-12 physical (32.8 to 34.1) and mental (41.9 to 42.4) component summary scores. Conclusions FM patients continued to report high levels of disease burden at follow-up. There was variability among patients in outcomes, with few significant differences over time. Data suggest improvement in symptoms, sleep and pain interference with function due potentially to active management (pharmacologic, nonpharmacologic) of the condition. Disclosure of Interest C. Schaefer Consultant for: Pfizer Inc (paid consulting services provided by Covance Market Access Services), E. Adams Consultant for: Pfizer Inc (paid consulting services provided by Covance Market Access Services), M. Udall Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., E. Masters Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., R. Mann Consultant for: Pfizer Inc (paid consulting services provided by Covance Market Access Services), S. Daniel Consultant for: Pfizer Inc (paid consulting services provided by Covance Market Access Services), H. McElroy Consultant for: Pfizer Inc (paid consulting services provided by Covance Market Access Services), J. Cappelleri Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., A. Clair Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., M. Hopps Employee of: Pfizer Inc., R. Staud Grant/research support from: Investigator initiated grant from Pfizer Inc., P. Mease Grant/research support from: Pfizer Inc., Consultant for: Pfizer Inc., Speakers bureau: Pfizer Inc., S. Silverman Grant/research support from: Pfizer Inc., Consultant for: Pfizer Inc. and Lilly, Speakers bureau: Pfizer Inc. and Lilly

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.

Study design: Cross-sectional, observational study. Objectives: Characterize demographic and clinical characteristics, health status, pain, function, productivity and economic burden in spinal cord injury-related neuropathic pain (SCI-NeP) subjects, by pain severity. Setting: United States. Methods: One hundred and three subjects diagnosed with SCI-NeP recruited during routine primary care or specialty physician office visits completed a questionnaire to assess patient-reported outcomes. Physicians completed a case report form on inclusion/exclusion criteria, subject clinical characteristics and health-care resource use (HRU) based on 6-month retrospective chart review. Results: Subjects’ mean age was 48.7, 69.9% were male and 48.5% were unable to walk. The most frequently reported comorbidities were sleep disturbance/insomnia (28.2%), depressive symptoms (25.2%) and anxiety (23.3%). Subjects’ mean pain severity score was 5.3 (0–10 scale), and 77.7% reported moderate or severe pain. On a 0–10 scale, subjects’ reported moderate pain interference with function: mean 5.4. Subjects’ health status, as measured by the EuroQol 5-dimensions health-state utility, was 0.49 (−0.11 to 1.00 scale). Pain interference with function and health status were significantly worse among subjects with more severe pain ( P <0.0005). Among employed subjects (13.6%), overall work impairment was 38.0%. The proportion of subjects who were prescribed ⩾1 medication was 94.2%, and the mean number of physician office visits in past 6 months due to SCI-NeP was 2.2. Total annualized cost per subject was $26 270 (direct: $8636, indirect: $17 634). Conclusion: SCI-NeP subjects exhibited high pain levels, despite active management. Pain levels were associated with poor function, low health status and lost productivity. HRU was prevalent, and costs, particularly indirect, were substantial, highlighting unmet need. Sponsorship: This study was supported by Pfizer, Inc.

Neuropathic pain (NeP) may result from physical injury/trauma, systemic disease, infections and autoimmune disorders, and has been shown in painful diabetic neuropathy (pDPN) to be associated with reduced quality of life and functioning. This observational study sought to comprehensively characterize the humanistic burden of NeP, by pain severity. A total of 624 subjects recruited during routine physician office visits had a diagnosis of one of the following: human immunodeficiency virus (HIV)-related NeP, post-trauma/post-surgical (PTPS) NeP, spinal cord injury (SCI)-related NeP, chronic low back pain (CLBP) with NeP, pDPN, and painful peripheral neuropathy with small fiber involvement (PPN-SF). Subjects completed a one-time questionnaire containing validated measures of pain severity and pain interference, health status, sleep, and anxiety and depression. Subjects' mean age was 55.5 years; 55.4% were male. Mean number of comorbidities was 3.2. Mean scores overall were 5.5 and 5.6 for pain severity and pain interference (0-10 scale); 31.1 and 42.5 for physical and mental health status (0-100 scale); 0.55 for health utility (-0.1-1.0 scale); 50.5 for sleep problems (0-100 scale); and 8.8 and 8.2 for anxiety and depression (0-21 scale). For each patient-reported outcome, scores were significantly worse among subjects with greater pain severity (all p<0.0001). Mean scores for each NeP condition ranged from 5.2-6.0 for pain severity, 5.0-6.6 for pain interference, and 27.2-34.4 and 39.0-45.8 for physical and mental health status, respectively. For each patient-reported outcome, CLBP-NeP subjects reported the worst scores followed by PTPS subjects, except for mental health status, utility, and anxiety, where HIV-NeP or SCI-NeP subjects reported one of the two worst mean scores. Subjects across NeP conditions exhibited high pain levels, which were statistically significantly associated with poor function, compromised health status and sleep, and increased anxiety and depression, indicating substantial humanistic burden. Study supported by Pfizer, Inc.

Opioids, generally recommended as second- or third-line agents for neuropathic pain (NeP), are commonly used. This study characterized opioid and antiepileptic drug (AED) utilization among patients with NeP associated with diabetic peripheral neuropathy (DPN), HIV, spinal cord injury (SCI), chronic low-back pain (CLBP), post-trauma/post-surgery (PTPS), and small-fiber involvement (SF) stratified by pain severity (mild, moderate, severe). Data were from an observational study of NeP patients recruited during routine visits with primary-care or specialty physicians. Subjects completed a one-time questionnaire, and investigators completed a case report form based on a 6-month retrospective chart review. Pain severity was based on the Brief Pain Inventory average pain score. A total of 624 subjects were enrolled: 71.8% were white; 55.4% were male; mean age was 55.5±13.7 years; with a mean of 7.8±6.8 years since NeP diagnosis. The proportion of patients with each NeP indication was similar (16.0%-17.9%). Pain severity was mild, moderate, and severe in 17.6%, 47.6%, and 33.2%, respectively. The most frequently used NeP medications over the past 6 months were opioids (53.0%) and AEDs (49.0%), ranging from 33.0% (DPN) to 81.1% (CLBP) for opioids, and 28.3% (CLBP) to 64.1% (SCI) for AEDs. Overall, AED use remained unchanged across pain severity categories (46.4%-50.5%), while opioid use increased significantly with greater pain severity: 28.2% mild, 53.2% moderate, 65.2% severe (p<0.0001). Opioids were used by substantial proportions of patients across all pain severity levels including 33.3% in SCI, 50.0% in CLBP, and 71.4% in PTPS. Except for DPN, strong short-acting opioids were the most frequently used opioid class, ranging from 14.3% in DPN to 55.7% in CLBP. Patterns of opioid use observed in this study were not fully consistent with published guidelines; opioid use was common across six different chronic NeP conditions and did not appear to be reserved for more severe pain patients.

The American Recovery and Reinvestment Act of 2009 includes an estimated $27 billion over 10 years to support adoption of electronic health records (EHRs). This includes the Health Information Technology (HIT) for Economic and Clinical Health Act of 2009, which promotes meaningful use of HIT through Medicare and Medicaid EHR Incentive Programs. In November 2011, the United States (US) Department of Health and Human Services released a report showing adoption of HIT doubled in two years. The objective of this review was to examine the impact of EHR and computerized physician order entry (CPOE) on health care efficiency. A review of published original research in the United States was conducted in PubMed for years 2007 through 2011. The number of studies reporting efficiencies and inefficiencies, setting of care, and areas of efficiency and inefficiency were examined. A total of 18 studies were reviewed: 13 EHR or EHR/CPOE and 5 CPOE only. Settings of care included the hospital inpatient (n=6), outpatient clinic/practice (n=6), emergency department (n=3), surgical center (n=2), and assisted-living facility (n=1). All but one study reported efficiencies in at least one area. Efficiencies from EHR or EHR/CPOE were reported in decreased physician/staff time (n=6), increased patient volume (n=3), decreased length of stay (n=3), increased provider productivity (n=2), decreased tests/procedures ordered (n=1), and decreased time to diagnosis (n=1). Efficiencies from CPOE were observed in decreased order processing/verification time (n=3), decreased physician/staff time (n=1), and decreased time to medication administration (n=1). Inefficiencies from one CPOE study were reported in increased prescribing time. Three of the EHR or EHR/CPOE studies also reported inefficiencies. Some factors that contributed to inefficiencies included complex/acute cases and the level of EHR implementation. EHR implementation has the potential to improve efficiencies in various practice settings. Further investigation is warranted to examine factors contributing to inefficiencies.

Recent developments in the United States (US) health care reform and funding for comparative effectiveness research suggest that use of electronic medical records (EMR) in outcomes research may increase over time. EMR can be particularly useful when outcomes are not well-defined with diagnosis or procedures codes or when clinical data are needed. The objective of this study was to review trends in the use of EMR during the past decade. A review of published literature was conducted in PubMed for years 2001 through 2010 to identify outcomes studies in the US that used EMR. Internal quality assurance studies and validation studies that used EMR were excluded. The number of studies, setting of care, patient population, whether the study was comparative, and any noted limitations were examined. A total of 58 EMR-based, outcomes studies in the US were identified over the past decade; increasing from 3 in 2001 to 12 in 2010. The majority of studies included outpatient EMR. Studies included a variety of patient populations with over one-third in cardiovascular disease, psychiatric disease, and diabetes combined. The percent of studies that were comparative ranged from 0% in 2001 to 45% in 2010. Measures of effectiveness varied widely and included lab values, clinical measures, and health-related quality-of-life outcomes. Some noted limitations on the use of EMR data in outcomes research included lack of representativeness of all care delivered across practice settings, lack of generalizability and standardization, and reliance on health care provider reporting. Although the use of EMR in outcomes research has increased slowly in the past decade, the proportion of comparative studies using EMR has increased over time. As the industry works to standardize EMR and more advanced outcomes are collected in EMR systems, EMR data may play a larger role in comparative effectiveness research.