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Sheng-Yuan Yu,1 Bi-Fa Fan,2 Fei Yang,1 Marco DiBonaventura,3 Yu-Xuan Chen,4 Ruo-Yu Li,5 Kristen King-Concialdi,6 Ian Kudel,6 Patrick Hlavacek,3 Markay Hopps,3 Margarita Udall,3 Alesia Sadosky,3 Joseph C Cappelleri7 1Department of Neurology, Chinese PLA General Hospital, Beijing, People’s Republic of China; 2Department of Pain Medicine, Pain Management Centre, China-Japan Friendship Hospital, Beijing, People’s Republic of China; 3Pfizer, New York, NY, USA; 4Pfizer China, Beijing, People’s Republic of China; 5Department of Dermatology, Peking University First Hospital, Beijing, People’s Republic of China; 6Kantar Health, New York, NY, USA; 7Pfizer Inc, Groton, CT, USACorrespondence: Sheng-Yuan YuDepartment of Neurology, Chinese PLA General Hospital, Hai Dian District, Beijing 100853, People’s Republic of ChinaTel +86 105 549 9118Fax +86 108 862 6299Email yusy1963@126.comBackground: Little is known about the patient-reported and economic burdens of postherpetic neuralgia (PHN) among China’s urban population.Methods: This noninterventional study was conducted among adults ≥40 years with PHN who were seeking medical care at eight urban hospitals in China. At one study site, patients completed a questionnaire evaluating the patient-reported disease burden (N=185). The questionnaire consisted of validated patient-reported outcomes including the Brief Pain Inventory (BPI), 5-dimension, 3-level EuroQol (EQ-5D-3L), Medical Outcomes Study Sleep Scale, and Work Productivity and Activity Impairment Questionnaire for Specific Health Problems. Questions on non-pharmacologic therapy and out-of-pocket (OOP) expenses were also included. At all study sites, physicians (N=100) completed a structured review of patient charts (N=828), which was used to derive health care resource utilization and associated costs from the societal perspective. Annual costs in Chinese Yuan Renminbi (RMB) for the year 2016 were converted to US dollars (US$).Results: Patients (N=185, mean age 63.0 years, 53.5% female) reported pain of moderate severity (mean BPI score 4.6); poor sleep quantity (average of 5.3 hrs per night) and quality; and poorer health status on the EQ-5D-3L relative to the general Chinese population. Respondents also reported average annual OOP costs of RMB 16,873 (US$2541) per patient, mainly for prescription PHN medications (RMB 8990 [US$1354]). Substantial work impairment among employed individuals resulted in annual indirect costs of RMB 28,025 (US$4221). In the chart review, physicians reported that patients (N=828) had substantial health resource utilization, especially office visits; 98% had all-cause and 95% had PHN-related office visits. Total annual direct medical costs were RMB 10,002 (US$1507), mostly driven by hospitalizations (RMB 8781 [US$1323]).Conclusion: In urban China, PHN is associated with a patient-reported burden, affecting sleep, quality-of-life, and daily activities including work impairment, and an economic burden resulting from direct medical costs and indirect costs due to lost productivity. These burdens suggest the need for appropriate prevention and management of PHN.Keywords: postherpetic neuralgia, disease burden, health-related quality-of-life, EQ-5D, China, health care costs, productivity

Ian Kudel,1 Markay Hopps,2 Joseph C Cappelleri,3 Alesia Sadosky,2 Kristen King-Concialdi,1 Ryan Liebert,1 Bruce Parsons,2 Patrick Hlavacek,2 Andrea H Alexander,2 Marco D DiBonaventura,4 John D Markman,5 John T Farrar,6 Brett R Stacey7 1Health Outcomes Practice, Kantar Health, New York, NY, USA; 2Pfizer Inc, New York, NY, USA; 3Pfizer Inc, Groton, CT, USA; 4Pfizer Inc, New York, NY, USA; 5University of Rochester Medical Center School of Medicine and Dentistry, Rochester, NY, USA; 6Department of Biostatistics and Epidemiology University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA; 7UW Center for Pain Relief, University of Washington, Seattle, WA, USA Background: The aim of this study was to identify the clinical characteristics, treatment usage, and health outcomes of US adults diagnosed with neuropathic pain (NeP) by experienced physicians. Methods: Adults with scores exceeding the threshold for probable NeP (painDETECT ≥19) and diagnosed with NeP by a qualified physician completed a questionnaire that included comorbid conditions, pain symptoms and experiences, medication use, health status (3-level EuroQol 5 Dimensions (EQ-5D-3L]: health utilities index and visual analog scale), pain severity and interference with functioning (Brief Pain Inventory), and work and activity impairment (Work Productivity and Activity Impairment questionnaire). Descriptive analyses were performed for each NeP subtype. Results: Participants (n=295) were predominantly female (64.4%), middle-aged (53.9%), and white (51.5%). Chronic low back pain was the most frequently diagnosed major NeP syndrome (n=166), followed by diabetic peripheral neuropathy (n=58), post-trauma neuropathy (n=47), post-surgical neuropathy (n=28), and central NeP (n=23). An additional 45 participants were diagnosed, but did not meet the criteria for the aforementioned subtypes. Participants could be diagnosed with multiple subtypes. Across each NeP subtype, patients reported high rates of comorbid disease, including arthritis (range: 39.1%–64.3%) and high blood pressure (range: 26.1%–69.0%), as well as symptomology that included numbness (range: 68.1%–91.4%) and changes in muscular strength (range: 24.1%–65.2%). The majority of patients reported back pain (range: 77.8%–95.7%) and arthritis/joint pain (range: 68.1%–78.6%). The most commonly reported types of NeP pain medication were non-steroidal anti-inflammatory drugs (range: 43.1%–70.2%), weak opioids (range: 22.2%–39.3%), and strong opioids (range: 8.7%–28.6%). All six NeP groups generally reported similar levels of dysfunction on all self-report measures. The most notable finding was that the EuroQol-5D-3L health utilities index scores for each of the six groups were lower than the US norms by a clinically important amount. Conclusion: These exploratory findings indicate that patients with NeP across different etiologies are medically complex and experience impaired function across multiple domains. Keywords: activity impairment, functional status, health-related quality of life, neuropathic pain, pain medication use, physician diagnosis, work impairment

Margarita Udall,1 Ian Kudel,2 Joseph C Cappelleri,3 Alesia Sadosky,1 Kristen King-Concialdi,2 Bruce Parsons,1 Patrick Hlavacek,1 Markay Hopps,1 P Arline Salomon,4 Marco D DiBonventura,2 Patricia Clark,5,6 João Batista Santos Garcia7 1Pfizer Inc, New York, NY, USA; 2Health Outcomes Practice, Kantar Health, New York, NY, USA; 3Pfizer Inc, Groton, CT, USA; 4Pfizer Inc, Bosques de las Lomas, Mexico; 5Clinical Epidemiology Unit, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; 6Faculty of Medicine UNAM, Mexico City, Mexico; 7Pain and Palliative Care Department, Federal University of Maranhão, Maranhão, Brazil Objectives: Estimate the prevalence of neuropathic pain (NeP) among chronic pain patients attending Brazilian hospitals and pain clinics in São Paulo, Ceara, and Bahia and explore clinical characteristics by subtypes: painful diabetic peripheral neuropathy (pDPN), central neuropathic pain (CNP), chronic low back pain with a neuropathic component (CLBP-NeP), postherpetic neuralgia (PHN), post-traumatic neuropathic pain (PTN), and post-surgical neuropathic pain (PSN).Methods: Physicians screened patients reporting chronic pain for ≥3 months (n=2,118) for probable NeP, using the Douleur Neuropathique 4 questionnaire and physician assessment, and reported their NeP subtype(s), symptoms, and medications. Identified NeP patients completed a questionnaire including treatment experiences, quality of life EuroQol 5 Dimensions [EQ-5D]), pain severity and interference (Brief Pain Inventory [BPI]), and Work Productivity and Activity Impairment scales. Descriptive analyses were performed by NeP subtype.Results: The prevalence of probable NeP was 14.5% (n=307). NeP patients were mostly female (80.5%), middle-aged (mean [M]=52.5, SD=13.9), and Pardo (44.3%). Of those diagnosed with an NeP subtype (n=209), the largest proportions were CLBP-NeP (36.8%), followed by pDPN (18.7%), CNP (17.7%), PTN (17.2%), PSN (13.4%), and PHN (3.3%). Across subtypes, the most widely reported symptoms were numbness (range: 62.2%–89.7%) and hyperalgesia (range: 32.1%–76.9%) and the most commonly prescribed pain analgesics were NSAID (range: 18.2%–57.1%), opioids (range: 0.0%–39.3%), and antiepileptics (range: 18.2%–57.1%). PTN and PSN patients reported the least favorable EQ-5D index scores (M=0.42, SD=0.19) and BPI-Pain Severity scores (M=7.0, SD=1.9), respectively. Those diagnosed with CNP had the least favorable BPI-Pain Interference scores (M=6.0, SD=2.7). Patients with PHN reported the least impairment based on EQ-5D index scores (M=0.60, SD=0.04). Those with pDPN had the most favorable BPI scores (BPI-Pain Severity: M=4.6, SD=2.3; BPI-Pain Interference: M=4.7, SD=2.7).Conclusion: Evaluation of chronic pain patients in Brazil yielded a 14.5% probable NeP prevalence. NSAIDs and opioids were commonly used, and there was a high incidence of NeP-related symptoms with varying levels of dysfunction across subtypes. Keywords: neuropathic pain, Brazil, quality of life, pain, work productivity and activity impairment

Markay Hopps, Laura Iadeluca, Margaret McDonald, Geoffrey T MakinsonPfizer Inc., New York, NY, USA Background: Family caregiving is an increasingly important component of care for patients and the elderly. Objective: The aim of this study is to characterize the burden of family caregiving among employed adults. Methods: Employed adults (≥18 years) from the 2013 US National Health and Wellness Survey (NHWS) were classified as family caregivers if they reported currently caring for at least one adult relative. Chi-square tests and one-way analyses of variance assessed whether employed caregivers, weighted to the US population, differed from employed non-caregivers on behavioral characteristics, workplace productivity, and health care resource utilization. Results: Eight million workers were family caregivers in the United States, more often female than male (51% vs. 49%, P < 0.05), and 53% were between 40 and 64 years of age. Eighteen percent of caregivers were Hispanic compared with 15% of non-caregivers (P < 0.05). Similar behavioral characteristics between caregivers and non-caregivers included daily alcohol consumption (6% vs. 5%) and lack of vigorous exercise (25% vs. 29%), but caregivers had a higher prevalence of smoking (26% vs. 19%, P < 0.05). Caregivers reported a higher mean percentage of work time missed (8% vs. 4%, P < 0.05) and greater productivity impairment (24% vs. 14%, P < 0.05). Some form of depression was reported by 53% of caregivers compared with 32% of non-caregivers (P < 0.05), and more caregivers had self-reported insomnia than non-caregivers (46% vs. 37%, P < 0.05). The number of self-reported diagnosed comorbidities was higher among caregivers compared with that of non-caregivers (5.0 vs. 3.1, P < 0.05), as was the mean number of outpatient visits in the previous 6 months (4.1 vs. 2.7, P < 0.05). Conclusion: Family caregiving is associated with a multidimensional burden that impacts caregivers and has implications for employers and the health care system. Clinicians and employers need to recognize and understand this burden. Characterization of caregivers as reported in this study can inform development of targeted programs to help mitigate the burden. Keywords: caregiver burden, productivity, mental health, health care resource use, workforce, employed, family caregivers

Marco D DiBonaventura,1 Alesia Sadosky,2 Kristen Concialdi,1 Markay Hopps,2 Ian Kudel,1 Bruce Parsons,2 Joseph C Cappelleri,3 Patrick Hlavacek,2 Andrea H Alexander,2 Brett R Stacey,4 John D Markman,5 John T Farrar6 1Health Outcomes Practice, Kantar Health, 2Pfizer Inc, New York, NY, 3Pfizer Inc, Groton, CT, 4University of Washington, Seattle, WA, 5University of Rochester School of Medicine and Dentistry, Rochester, NY, 6University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, US Background: The prevalence of neuropathic pain (NeP) has been estimated within specific health conditions; however, there are no published data on its broad prevalence in the US. The current exploratory study addresses this gap using the validated PainDetect questionnaire as a screener for probable NeP in a general-population health survey conducted with a multimodal recruitment strategy to maximize demographic representativeness. Materials and methods: Adult respondents were recruited from a combination of Internet panels, telephone lists, address lists, mall-based interviews, and store-receipt invitations using a random stratified-sampling framework, with strata defined by age, sex, and race/ethnicity. Older persons and minorities were oversampled to improve prevalence estimates. Results were weighted to match the total adult US population using US Census data. Demographic information was collected, and respondents who experienced physical pain in the past 12 months completed the PainDetect and provided additional pain history. A cutoff score of 19 or greater on the PainDetect was used to define probable NeP. Results: A total of 24,925 respondents (average response rate 2.5%) provided demographic data (52.2% female, mean age 51.5 years); 15,751 respondents reported pain (63.7%), of which 2,548 (15.7%, 95% confidence interval 14.9%–16.5%) had probable NeP based on the PainDetect, which was 10% (95% confidence interval 9.5%–10.5%) of all respondents. Among those reporting pain, the prevalence of probable NeP among Blacks and Hispanics was consistently higher than Whites in each age- and sex group. The highest prevalence among those with pain was among male Hispanics 35–44 years (32.4%) and 45–54 years (24.2%) old. The most commonly used medications reported by those with probable NeP were nonsteroidal anti-inflammatory drugs (44.2%), followed by weak opioids (31.7%), antiepileptics (10.9%), and strong opioids (10.9%). Conclusion: This is the first study to provide an estimate of the prevalence of probable NeP in the US, showing significant variation by age and ethnicity. Keywords: neuropathic pain, prevalence, pain types, epidemiology

Laura Iadeluca,1 Jack Mardekian,1 Pratibha Chander,2 Markay Hopps,1 Geoffrey T Makinson1 1Pfizer Inc., 2Atrium Staffing, New York, NY, USA Objective: To characterize the disease burden among survivors of those cancers having the highest incidence in the US.Methods: Adult (≥18 years) survivors of the 11 most frequently diagnosed cancers were identified from publically available data sources, including the Surveillance Epidemiology and End Results 9 1973–2012, National Health Interview Survey 2013, and the Medical Expenditure Panel Survey 2011. Chi-square tests and one-way analyses of variance were utilized to assess differences between cancer survivors and non-cancer controls in behavioral characteristics, symptoms and functions, preventative screenings, and health care costs.Results: Hematologic malignancies, melanoma, and breast, prostate, lung, colon/rectal, bladder, kidney/renal, uterine, thyroid, and pancreatic cancers had the highest incidence rates. Breast cancer had the highest incidence among women (156.4 per 100,000) and prostate cancer among men (167.2 per 100,000). The presence of pain (P=0.0003), fatigue (P=0.0005), and sadness (P=0.0012) was consistently higher in cancer survivors 40–64 years old vs. non-cancer controls. Cancer survivors ≥65 years old had higher rates of any functional limitations (P=0.0039) and reported a lack of exercise (P

Edgar H Adams,1 Heather J McElroy,2 Margarita Udall,3 Elizabeth T Masters,3 Rachael M Mann,4 Caroline P Schaefer,1 Joseph C Cappelleri,5 Andrew G Clair,3 Markay Hopps,3 Shoshana R Daniel,6 Philip Mease,7,8 Stuart L Silverman,9,10 Roland Staud11 1Covance Market Access Services Inc, Gaithersburg, MD, USA; 2Covance (Asia) Pte Ltd, Singapore, Singapore; 3Pfizer Inc, New York, NY, 4Covance Market Access Services Inc, San Diego, CA, 5Pfizer Inc, Groton, CT, 6Covance Market Access Services Inc, Conshohocken, PA, 7Division of Rheumatology Research, Swedish Medical Center, Seattle, WA, 8Department of Rheumatology, University of Washington, Seattle, WA, 9Department of Medicine, Division of Rheumatology, Cedars-Sinai Medical Center, Los Angeles, CA, 10Department of Medicine, University of California, Los Angeles, CA,11Department of Medicine, University of Florida, Gainesville, FL, USA Background: A previous fibromyalgia (FM) research reports that 20%–47% of diagnosed patients may not meet the study definition of FM 1–2 years after diagnosis. The aim of this study was to gain a better understanding of the progression of FM in a geographically diverse cohort over a 2-year time period. Methods: This cohort study followed 226 subjects recruited online to assess FM and chronic widespread pain (CWP) diagnosis stability over time. At enrollment (baseline), subjects provided informed consent, completed an online questionnaire consisting of the London Fibromyalgia Epidemiology Study Screening Questionnaire to screen for CWP (bilateral pain above/below waist lasting ≥1 week in the past 3 months), visited a site for physician evaluation for FM, and completed a questionnaire with validated patient-reported outcome instruments. Subjects were classified into mutually exclusive groups: FM+CWP+ (screened positive for CWP and received physician diagnosis of FM), FM-CWP+ (screened positive for CWP but did not receive physician diagnosis of FM), and FM-CWP- (screened negative for CWP). Approximately 2 years later (follow-up), subjects were reassessed at the same study site and completed a questionnaire with the same patient-reported outcomes. Results: Seventy-six FM+CWP+ subjects completed assessments at both time points; 56 (73.7%) met the FM study definition at follow-up. Twenty subjects no longer met the FM study definition (eleven became FM-CWP- and nine became FM-CWP+). Ten subjects (two from FM-CWP- and eight from FM-CWP+) transitioned into the FM+CWP+ group at follow-up; they reported more tender points and pain interference with sleep and worse physical function at baseline compared with subjects who did not transition to FM+CWP+. Most (76.7%) of the subjects who transitioned into/out of FM+CWP+ experienced changes in CWP, number of positive tender points, or both. Conclusion: The results suggest that some FM+CWP+ patients experience fluctuation in symptoms over time, which may reflect the waxing and waning nature of FM and affect diagnosis and treatment. Keywords: fibromyalgia, chronic widespread pain, physician assessment

Background: ROS1 rearrangements ( ROS1 +) define a distinct molecular subset of lung adenocarcinomas. ROS1 + tumors are known to occur more in never-smokers, but the frequency and outcome of ROS1 positivity by sex and smoking intensity are not clearly documented., Patients and Methods: This patient cohort study included all never- (<100 cigarettes lifetime) and light- (100 cigarettes-20 pack-years) smokers, and a sample of heavy-smokers. ROS1 + rates by sex and smoking intensity were compared within and beyond our study. Survival outcomes were analyzed using Kaplan-Meier curves and Cox proportional hazards models., Results: Of the 571 total patients, ROS1 + was detected in 24 (4.2%): 6.4% in men and 3.0% in women; 5.1% in never-, 5.7% in light-, and 1.8% in heavy-smokers ( P =0.05). Among the 209 stage IIIB-IV patients, men had much higher ROS1 + rate (11.1%) not only than women (1.7%, P =0.004) in our study, but also than men (0.4%-1.8%) in 8 published studies ( Ps  = 0.0019-0.0001). ROS1 + rates were similar between never- (9.3%) and light-smokers (8.1%) and significantly lower in heavy-smokers (1.2%, P =0.017), a finding confirmed by 6 published studies ( Ps  = 0.041-0.0001). Overall survival of ROS1 + patients were significantly better than the ROS1- ( P =0.023) mainly due to targeted therapy. Among patients who exhibited resistance to crizotinib, follow-up treatment of entrectinib and lorlatinib showed remarkable survival benefits., Conclusions: The ROS1 + rates were higher in men than in women, and similar in never- and light-smokers, more pronounced in stage IIIB-IV patients. Newer-generation ALK / ROS1 -targeted drugs showed efficacy in a cohort of crizotinib resistant ROS1 + patients. These results, when validated, could assist efficiently accruing ROS1 + patients., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 Published by Elsevier Ltd.)

Introduction: Few studies have examined the epidemiology of herpes zoster (HZ) and postherpetic neuralgia (PHN) in China. The aim of this study was to estimate the prevalence of HZ and PHN in China, and to examine the clinical characteristics of patients identified with PHN., Methods: This was a cross-sectional study conducted in 24 hospitals in seven cities in China. Prevalence of HZ and PHN was determined by physician (n = 100) chart review of patients (n = 36,170) aged ≥ 40 years seeking medical care over a 30- to 60-day period. The health history of patients identified with PHN was obtained and included time since diagnosis of HZ or PHN, time since onset of PHN-related pain, and the methods used for diagnosing HZ and PHN., Results: The prevalence rates of HZ and PHN were 7.7% [95% confidence interval (CI) 7.5-8.0] and 2.3% (95% CI 2.2-2.5), respectively. Of patients with HZ, 29.8% developed PHN. Rates of HZ and PHN increased with age and were highest in patients aged ≥ 70 years (10.6% and 4.1%, respectively). The majority of patients with PHN were diagnosed with HZ (80.9%) and PHN (83.8%) for < 1 year, and had experienced PHN-related pain for < 1 year (80.5%). Patient description and clinical examination were most commonly used to diagnose HZ and PHN., Conclusion: These results provide current estimates of the prevalence of HZ and PHN in the general adult population in urban China. These rates are similar to previously reported rates in China and worldwide, and highlight the global nature of HZ and PHN., Funding: Pfizer Inc.

We describe 542 cases of symptomatic hereditary transthyretin amyloid polyneuropathy (ATTR-PN) identified through a review of the literature published between 2005 and 2016. Approximately 18% of the cases were from countries where ATTR-PN is traditionally considered to be endemic (i.e., Portugal, Japan, and Sweden). East Asia (Japan, China, Taiwan, and South Korea) contributed a sizeable combined proportion (37.0%, n = 200) with Japan (n = 92) and China (n = 71) being the primary contributors. The most common genotypes among the 65 genotypes represented in the sample were Val30Met (47.6%), Ser77Tyr (10%), Ala97Ser (6.5%), and Phe64Leu (4.4%). Cases with genotypes other than the aforementioned four had the lowest ages at onset (mean 49.2 [standard deviation {SD} 21.0; inter-quartile range {IQR}14.7]) and diagnosis (mean 53.4 [SD 21.0; IQR 14.7]). Conversely, Phe64Leu mean age of onset was 67.5 (SD 8.8; IQR 5.2) and mean age of diagnosis was 71.3 (SD 8.8; IQR 5.4). The prevalence of upper and lower limb involvement at the time of diagnosis (67 and 41%) observed across all cases is consistent with the typical presentation of ATTR-PN. Other notable findings at the time of diagnosis included a high rate of impotence among the Ala97Ser cases versus all others (67% vs. 21%) and a high rate of non-motor visual symptoms (i.e., visual opacities and glaucoma) in the Ser77Tyr cases versus all others (93% vs. 16%). Though comparisons were made descriptively and were hindered by inconsistency of reporting across the cases, these findings support the notion that ATTR-PN is a more phenotypically and geographically variable disease than is typically considered.

Objective: To identify variables correlated with a diagnosis of diabetic peripheral neuropathy (DPN) using random forest modeling applied to electronic health records., Design: Retrospective analysis., Setting: Humedica de-identified electronic health records database., Subjects: Subjects ≥ 18 years old with type 2 diabetes from January 1, 2008-September 30, 2013 having continuous data for 1 year pre- and postindex with DPN (n = 35,050) and without DPN (n = 288,328) were identified., Methods: Demographic, clinical, and health care resource utilization variables (e.g., inpatient and outpatient encounters, medications, and procedures) were input into a random forest model to identify the most important correlates of a DPN diagnosis. Random forest modeling is a computationally extensive, robust data mining technique that accommodates large sets of variables to identify associated factors using an ensemble of classifications trees. Accuracy of the model was evaluated using receiver operating characteristic curves (ROC)., Results: The final random forest model consisted of the following variables (importance) associated with a DPN diagnosis: Charlson Comorbidity Index score (100%), age (37.1%), number of pre-index procedures and services (29.7%), number of pre-index outpatient prescriptions (24.2%), number of pre-index outpatient visits (18.3%), number of pre-index laboratory visits (16.9%), number of pre-index outpatient office visits (12.1%), number of inpatient prescriptions (5.9%), and number of pain-related medication prescriptions (4.4%). ROC analysis confirmed model performance, with an area under the curve of 0.824 and accuracy of 89.6% (95% confidence interval 89.4%, 89.8%)., Conclusions: Random forest modeling can determine likelihood of a DPN diagnosis. Further validation of the random forest model may help facilitate earlier diagnosis and enhance management strategies., (© 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

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)., Conclusion: 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.