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Patients often take opioids to relieve osteoarthritis (OA) pain despite limited benefits and potential harms. This study aimed to compare cross-sectional perspectives of patients that were taking prescription opioid (N = 471) or nonopioid medications (N = 185) for OA in terms of satisfaction, expectations of effectiveness, and concerns. Patients prescribed opioids (>7 days) reported more prior treatments (2.47 vs. 1.74), greater mean pain intensity (5.47 vs. 4.11), and worse quality of life (EQ-5D-5L index value mean 0.45 vs. 0.71) than patients prescribed nonopioid medications (all p < 0.0001). Based on linear regression models adjusting for demographics and pain intensity, patients prescribed opioids were less satisfied with overall regimen (3.40 vs. 3.67, p = 0.0322), had less belief that medications were meeting effectiveness expectations (2.72 vs. 3.13, p < 0.0001), and had more concerns about treatments being “not very good” (3.66 vs. 3.22, p = 0.0026) and addiction (3.30 vs. 2.65, p < 0.0001) than patients prescribed nonopioid regimens. When the models were replicated for subgroups with ≥30 days’ medication regimen duration, the findings were consistent with the main analyses. Patients have concerns about the risk of opioid addiction, but those with greater disease burden and more prior treatments continue taking opioid regimens.

BackgroundOsteoarthritis (OA) is a complex disease, and prior studies have documented the health and economic burdens of patients with OA compared to those without OA. Our goal was to use two strategies to further stratify OA patients based on both pain and treatment intensity to examine healthcare utilization and costs using electronic records from 2001-2018 at a large integrated health system. Methods Adult patients with ≥1 pain numerical rating score (NRS) and diagnosis of OA were included. Pain episodes of ≥90 days were defined as mild (0-3), moderate (4-6) or severe (7-10) based on initial NRS. Patients were initially classified as mild and moved to moderate-severe OA if any of eight treatment-based criteria were met. Outpatient visits (OP), emergency department visits (ED), inpatient days, and healthcare costs (both all-cause and OA-specific) were compared among pain levels and OA severity levels as frequencies and per-member-per-year rates, using generalized linear regression models adjusting for age, sex and body mass index, with contrasts of pResultsWe identified 127,656 patients, 92,576 with pain scores. Moderate and severe pain were associated with significantly higher rates of OA-related utilization and costs, and all-cause ED visits and pharmacy costs. Moderate-severe OA patients had significantly higher OA-related utilization and costs, and all-cause OP, ED and pharmacy costs. ConclusionsPain and treatment intensity were both strongly associated with OA-related resource utilization but not consistently with all-cause utilization. With better understanding of how OA patients intensify services, thus increasing costs, we can deploy targeted preventative strategies aimed at halting progression into more costly phases of the disease.

Opioids are often prescribed for osteoarthritis (OA) pain, despite recommendations to limit use due to minimal benefits and associated harms. This study aimed to assess physicians’ practice patterns and perceptions regarding opioids by specialty one year following the Centers for Disease Control and Prevention (CDC) published guidance on opioid prescribing. The 139/153 (90.8%) physicians who reported prescribing opioids in the previous year reported decreased prescribing for mild OA (51.3%, 26.5% and 33.3% of primary care physicians, rheumatologists, and orthopaedic surgeons, respectively), moderate OA (50.0%, 47.1% and 48.1%) and severe OA (43.6%, 41.2% and 44.4%). Prescribing changes were attributed to the CDC guidelines for 58.9% of primary care physicians, 59.1% of rheumatologists, and 73.3% of orthopaedic surgeons. Strong opioids were mostly reserved as third-line treatment. Although treatment effectiveness post-CDC guidelines was not assessed, perceptions of efficacy and quality of life with opioids significantly differed across specialties, whereas perceptions of safety, convenience/acceptability and costs did not. Physicians generally agreed on the barriers to opioid prescribing, with fear of addiction and drug abuse being the most important. Across specialties, physicians reported decreased opioid prescribing for OA, irrespective of OA severity, and in most cases attributed changes in prescribing to the CDC guideline.

Objectives: Examine short-term disability (STD) and workers’ compensation (WC) associated leave and wage replacements, and overall direct healthcare payments, among employees with osteoarthritis (OA) versus other chronically painful conditions; quantifying the impact of opioid use. Methods: Analysis of employees with more than or equal to two STD or WC claims for OA or pre-specified chronically painful conditions (control) in the IBM MarketScan Research Databases (2014 to 2017). Results: The OA cohort (n = 144,355) had an estimated +1.2 STD days, +$152 STD payments, and +$1410 healthcare payments relative to the control cohort (n = 392,639; P

This study estimated all-cause health care resource utilization (HRU) and costs and work loss outcomes associated with pain management of employed patients with osteoarthritis of the hip and/or knee.Optum Health Care Solutions data were analyzed for employed patients prescribed nonsteroidal anti-inflammatory drugs, tramadol, or nontramadol opioids following diagnoses of osteoarthritis of the hip and/or knee. A pre-post design was used to evaluate changes in all-cause HRU and costs, and work loss days and associated costs.Costs rose for patients in all three cohorts (up to 198.3% for health care costs [tramadol] and up to 178.7% for work loss costs [tramadol]). Greatest increases in all-cause HRU included inpatient visits (237.9% [nonsteroidal anti-inflammatory drugs]; 600% [tramadol]).Study results provide evidence of increases in all-cause HRU and costs and work loss days and associated costs.

ObjectivesAs understanding of the pathogenesis and treatment strategies for osteoarthritis (OA) evolves, it is important to understand how patient factors are also changing. Our goal was to examine demographics and known risk factors of patients with OA over time.DesignOpen-cohort retrospective study using electronic health records.SettingLarge US integrated health system with 7 hospitals, 2.6 million outpatient clinic visits and 97 300 hospital admissions annually in a mostly rural geographic region.ParticipantsAdult patients with at least two encounters and a diagnosis of OA or OA-relevant surgery between 2001 and 2018. Because of geographic region, over 96% of participants were white/Caucasian.InterventionsNone.Primary and secondary outcome measuresDescriptive statistics were used to examine age, sex, body mass index (BMI), Charlson Comorbidity Index, major comorbidities and OA-relevant prescribing over time.ResultsWe identified 290 897 patients with OA. Prevalence of OA increased significantly from 6.7% to 33.5% and incidence increased 37% (from 3772 to 5142 new cases per 100 000 patients per year) (pConclusionsWe observe increasing OA prevalence and a greater proportion of younger patients over time. With better understanding of how characteristics of patients with OA are changing over time, we can develop better approaches for managing disease burden in the future.

To evaluate healthcare resource utilization (HCRU) by osteoarthritis (OA) pain severity.Cross-sectional surveys of US physicians and their patients were conducted between February and May 2017. Using the Numeric Rating Scale, patients were classified by self-reported pain intensity in the last week into mild (0-3), moderate (4-6), and severe (7-10) cohorts. Parameters assessed included clinical characteristics, HCRU, and current caregiver support. Descriptive statistics were obtained, and analysis of variance and chi-square tests were performed.Patients (n = 841) were mostly female (60.9%) and white (77.8%), with mean age of 64.6 years. Patients reported mild (45.4%), moderate (35.9%), and severe (18.7%) OA pain. Mean number of affected joints varied by pain severity (range mild: 2.7 to severe: 3.6;Greater current pain was associated with more prior HCRU including imaging for monitoring progression, HCP visits including more specialty care, hospitalizations, surgery/planned surgery, and loss of independence due to functional disability. Yet rates of hospitalizations and X-ray use were still sizable even among patients with mild pain. These cross-sectional findings warrant longitudinal assessment to further elucidate the impact of pain on HCRU.

Srinivas R Nalamachu,1 Rebecca L Robinson,2 Lars Viktrup,3 Joseph C Cappelleri,4 Andrew G Bushmakin,4 Leslie Tive,5 Jennifer Mellor,6 Niall Hatchell,6 James Jackson6 1Mid America PolyClinic, Overland Park, KS, USA; 2Patient Outcomes and Real-World Evidence, Eli Lilly and Company, Indianapolis, IN, USA; 3Lilly Bio-Medicines Core Team, Eli Lilly and Company, Indianapolis, IN, USA; 4Statistics, Pfizer Inc, Groton, CT, USA; 5Medical Affairs, Pfizer Inc, New York, NY, USA; 6Real World Research, Adelphi Real World, Bollington, Cheshire, UKCorrespondence: Rebecca L RobinsonEli Lilly and Company, Lilly Research Labs, Lilly Corporate Center, Indianapolis, IN 46285, USATel +1 317-224-5833Fax +1 317-277-0490Email rlrobinson@lilly.comPurpose: The purpose of this study was to assess how patient-reported pain is related to osteoarthritis (OA) treatment patterns in routine clinical practice.Patients and Methods: Data were collected between February and May 2017 from 153 United States (US) primary care physicians, rheumatologists, and orthopedic surgeons. Each invited up to nine consecutive patients to rate their OA pain in the last week. Physicians provided demographic, clinical, and treatment information for patients, including nonpharmacologic therapies ever recommended, currently recommended over-the-counter (OTC) medications, and currently and ever prescribed medications for the management of OA. Findings for patients with mild (0─3), moderate (4─6), and severe current pain (7─10) were compared using appropriate statistics.Results: Among the 841 patients (61% female; mean 65 years; 57% knee OA), 45% reported mild, 36% moderate, and 19% severe current OA pain. Current treatment modalities differed by pain severity (P< 0.05). Most patients (70%) had been recommended nonpharmacologic therapy and 40% were currently recommended OTC medications. More patients with moderate (81%) or severe pain (78%) currently received prescription medications, with or without nonpharmacologic therapy, versus those with mild pain (67%). Overall, 47% of patients currently received just one prescription drug, while 49% had received one prescription drug ever. Nonsteroidal anti-inflammatory drugs (NSAIDs) were the most common current (58%) and ever received (88%) prescriptions. Current NSAID prescriptions were not associated with pain severity. Acetaminophen recommendations, opioid prescriptions (current and ever), and multiple prescription medications tried were numerically highest in the severe pain group (all P< 0.05 by pain severity). In all groups, > 80% of treatment switches were due to lack of efficacy.Conclusion: Real-life treatment patterns for OA in the US are significantly associated with current patient-reported pain. Combining nonpharmacologic and pharmacologic treatments is common but higher pain ratings are associated with multiple failed prescription treatments. Current use of acetaminophen and opioids, but not NSAIDs, increases alongside pain severity.Keywords: nonprescription drugs, prescription drugs, therapeutics, pain management, practice patterns, physicians

To describe and compare baseline characteristics, healthcare and drug utilization, and negative clinical outcomes of commercially-insured patients diagnosed with OA of the hip and/or knee who initiated treatment on traditional oral NSAIDs (tNSAIDs), topical NSAIDs, or cyclooxygenase-2 inhibitors (COX-2s).A commercial claims database (1/2012-3/2017) was used to identify patients ≥18 years old, with ≥2 diagnoses of hip and/or knee OA, and ≥90 days supply of NSAIDs. Patients were assigned to cohorts based on the type of NSAID initially prescribed and observed in the 6 months before (baseline) and 36 months after (follow-up) the date of their first NSAID prescription after the first OA diagnosis. Analyses estimated baseline demographic and clinical characteristics and follow-up period drug utilization. Logistic regressions assessed the risk of gastrointestinal (GI) and acute renal failure (ARF) events.tNSAIDs were the most frequently prescribed treatment. During the follow-up period, less than 15% of patients prescribed tNSAIDs switched to either COX-2s or topical NSAIDs and 37% of patients prescribed a COX-2 and 56% of patients prescribed a topical NSAID switched to tNSAIDs. GI and ARF events during the follow-up period ranged from 7.3-8.1% and 8.0-11.0%, respectively, across cohorts. The tNSAIDs and COX-2s cohorts had increased risk of both types of events relative to patients prescribed topical NSAIDs, controlling for other characteristics.Analyses characterize the long-term real-world utilization of NSAIDs and associated outcomes for patients with OA of the hip and/or knee. Study results highlight the likelihood of switching and the risk of negative clinical outcomes associated with long-term use.

Bone pain is one of the most common forms of pain reported by cancer patients with metastatic disease. We conducted a review of oncology literature to further understand the epidemiology of and treatment approaches for metastatic cancer-induced bone pain and the effect of treatment of painful bone metastases on the patient's quality of life. Two-thirds of patients with advanced, metastatic, or terminal cancer worldwide experience pain. Cancer pain due to bone metastases is the most common form of pain in patients with advanced disease and has been shown to significantly reduce patients' quality of life. Treatment options for cancer pain due to bone metastases include nonsteroidal anti-inflammatory drugs, palliative radiation, bisphosphonates, denosumab, and opioids. Therapies including palliative radiation and opioids have strong evidence supporting their efficacy treating cancer pain due to bone metastases; other therapies, like bisphosphonates and denosumab, do not. There is sufficient evidence that patients who experience pain relief after radiation therapy have improved quality of life; however, a substantial proportion are nonresponders. For those still requiring pain management, even with available analgesics, many patients are undertreated for cancer pain due to bone metastases, indicating an unmet need. The studies in this review were not designed to determine why cancer pain due to bone metastases was undertreated. Studies specifically addressing cancer pain due to bone metastases, rather than general cancer pain, are limited. Additional research is needed to determine patient preferences and physician attitudes regarding choice of analgesic for moderate to severe cancer pain due to bone metastases.

Satisfaction with medications prescribed for osteoarthritis (OA) varies; this study aimed to determine the factors associated with satisfaction in US patients and their physicians.This point-in-time study used the Adelphi OA Disease Specific Programme (physicians identified from public lists reported on nine consecutive patients diagnosed with OA [any joint]: physicians and patients completed questionnaires). Patient's demographic, clinical, and treatment characteristics associated with patient-reported and physician-rated overall satisfaction with, and expectations of effectiveness of, medication for OA were assessed using multivariate linear regression.Responses from 572 patients (mean age 64.9 years, 60.5% female) currently prescribed medication for OA and 153 physicians (81 primary care, 35 rheumatologists, 37 orthopedic surgeons) were analyzed. Pain intensity was moderate or severe for 59.4% of patients. Greater patient-reported overall satisfaction with medication was significantly associated with (standardized beta, 95% confidence interval) exercise (0.12, 0.03-0.20), comorbid other musculoskeletal or painful conditions (vs none) (0.15, 0.06-0.24), and physicians' report that the best control had been achieved (0.12, 0.03-0.20); lack of efficacy was among factors associated with worse satisfaction. Greater patient-reported expectation of effectiveness was significantly associated with exercise (0.12, 0.03-0.21) and the most troublesome joint not being a knee, hip, or their back (0.08, 0.01-0.14). Greater physician-rated overall satisfaction with medication was significantly associated with their report that the best control had been achieved (0.18, 0.11-0.26), the most troublesome joint being a knee (0.08, 0.01-0.14), comorbid other musculoskeletal or painful conditions (0.07, 0.01-0.12), obesity (0.06, 0.00-0.11), and female patients (0.06, 0.00-0.11); lack of efficacy and adverse events/tolerability issues were among factors associated with worse satisfaction. For physicians, their report that the best control had been achieved (0.19, 0.11-0.27), the most troublesome joint being a knee (0.08, 0.00-0.15), improving (vs stable) OA (0.15, 0.07-0.24), and uncertain duration of OA (0.11, 0.02-0.21) were associated with greater perception that the medication was meeting patients' efficacy expectations.Although efficacy was strongly associated with both patients' and physicians' satisfaction with medication, other factors were also important, including exercise (for patients), tolerability (for physicians), and knee OA (for physicians).

Patricia Schepman,1 Sheena Thakkar,1 Rebecca Robinson,2 Deepa Malhotra,1 Birol Emir,1 Craig Beck1 1Pfizer Inc., New York, NY, USA; 2Eli Lilly and Company, New York, NY, USACorrespondence: Sheena ThakkarPfizer Inc., 235 East 42nd Street, New York, NY, 10017, USATel +1 347 961-9174Email sheena.thakkar@pfizer.comPurpose: Osteoarthritis (OA) is one of the most common causes of chronic pain and a leading cause of disability in the US. The objective of this study was to examine the clinical and economic burden of OA by pain severity.Patients and Methods: We used nationally representative survey data. Adults ≥ 18 years with self-reported physician-diagnosed OA and experiencing OA pain were included in the study. OA pain severity was measured using the Short Form McGill Pain Questionnaire Visual Analog Scale (SF-MPQ-VAS). Data were collected for demographics, clinical characteristics, health-related quality of life (HRQoL), productivity, OA treatment, adherence to pain medication, and healthcare resource utilization. Univariate analysis was performed to examine differences between respondents with moderate-to-severe OA pain vs those with mild OA pain.Results: Higher proportions of respondents with moderate-to-severe OA pain (n=3798) compared with mild OA pain (n=2038) were female (69.4% vs 57.3%), < 65 years of age (54.8% vs 43.4%), and not employed (70.6% vs 64.5%). Respondents with moderate-to-severe OA pain experienced OA pain daily (80.8% vs 48.8%), were obese (53.0% vs 40.5%), had more comorbidities (sleep disturbance, insomnia, depression, and anxiety), and reported significantly poorer health status and HRQoL, and greater productivity and activity impairment (all P< 0.05). Moderate-to-severe OA pain respondents were prescribed significantly more pain medications than mild OA pain respondents (41.0% vs 17.0%) and had higher adherence (75.9% vs 64.1%) yet were less satisfied with their pain medications (all P< 0.001). Outpatient and emergency room visits, and hospitalizations in the 6 months prior to the survey were significantly higher in moderate-to-severe OA pain respondents vs those with mild OA pain (all P< 0.05).Conclusion: Patient and clinical burden was significantly greater in moderate-to-severe OA pain respondents vs mild OA pain respondents and may inform decision-making for appropriate resource allocation and effective management strategies that target specific subgroups.Keywords: osteoarthritis, moderate-to-severe pain, pain severity, health-related quality of life, HRQoL, healthcare resource utilization, HCRU, medication adherence, treatment satisfaction

Purpose To evaluate the relationship between self-reported concerns about becoming addicted to a medication and health-related quality of life (HRQoL) in patients with osteoarthritis (OA). Methods This real-world study used patient-level cross-sectional survey data collected from the US Adelphi Disease Specific Programme (DSP). The DSP for OA selected 153 physicians who collected de-identified data on their next nine adult patients with OA. Each patient completed a disease-relevant survey, which included the Likert-scale question, “I am concerned about becoming addicted to my medicine,” (CAA) with responses ranging from “completely disagree” [1] to “completely agree” [5]. HRQoL was measured by the EQ-5D-5L index value and the EQ Visual Analogue Scale (VAS). A set of ordinary least squares regressions using HRQoL measures as outcomes and CAA as a continuous predictor were estimated. Standardized effect size (ES) was used to gauge the magnitude of effects. Results A total of 866 patients with OA completed the survey (female, 61.2%; White, 77.7%; mean age, 64.2 years). Of the 775 patients who completed the CAA question, almost one-third responded that they “agree” (18%) or “completely agree” (11%), while 27% responded “completely disagree” and 20% “disagree.” Regression analyses found that patients who have concerns about medication addiction have significantly different EQ-5D-5L index values and EQ VAS scores compared with patients who do not have this concern (p Conclusion Our findings suggest that concern about medication addiction in patients with OA may have an impact on patient HRQoL, with more concerned patients reporting poorer HRQoL outcomes.

Use of tramadol and nontramadol opioids among patients with osteoarthritis is associated with increased rates of negative clinical outcomes, resource use, and costs., In 2019, the American College of Rheumatology conditionally recommended tramadol and conditionally recommended against nontramadol opioids for patients with hip and knee osteoarthritis. Although tramadol is known to be less prone to opioid use disorders, little is known about the differing magnitude of negative clinical outcomes, health care resource utilization, and costs of tramadol relative to nontramadol opioids. Administrative claims records for commercially insured patients with osteoarthritis who were prescribed opioids were used to compare clinical and cost outcomes during a 3-year follow-up period by conducting a pre–post analysis and a matched case–cohort analysis. Data for 14,491 patients were analyzed: 4048 (28%) were initiated on tramadol, and 10,443 (72%) were initiated on nontramadol opioids. After matching, 4048 patients per cohort were analyzed. In each empirical analysis, tramadol patients did develop opioid use disorders; however, opioid use disorder rates were 3.5-fold higher in the nontramadol cohort (1.2% vs 4.2%). In addition, rates of other opioid-related clinical outcomes (falls, fractures, nausea, fatigue, and constipation) were also directionally lower among the tramadol cohort, although quantitatively similar (

Background: Costs associated with early stages of Alzheimer’s disease (AD; mild cognitive impairment [MCI] and mild dementia [MILD]) are understudied. Objective: To compare costs associated with MCI and MILD due to AD in the United States. Methods: Data included baseline patient/study partner medical history, healthcare resource utilization, and outcome assessments as part of a prospective cohort study. Direct, indirect, and total societal costs were derived by applying standardized unit costs to resources for the 1-month pre-baseline period (USD2017). Costs/month for MCI and MILD cohorts were compared using analysis of variance models. To strengthen the confidence of diagnosis, amyloid-β (Aβ) tests were included and analyses were replicated stratifying within each cohort by amyloid status [+ /−]. Results: Patients (N = 1327) with MILD versus MCI had higher total societal costs/month ($4243 versus $2816; p

Cluster headache (CH) is a rare trigeminal cephalalgia that is associated with extremely painful unilateral headache attacks and autonomic symptoms. Attacks may be episodic or chronic and associated with substantial suffering due to excruciating pain and limited treatment options. Frequent cluster headaches cause substantial burden for patients, resulting in reduced productivity caused by disability, as well as direct costs in some European countries. Less is known, however, about direct costs of recurring health care resource utilization (HCRU) in the United States.To characterize HCRU and direct costs associated with CH in the United States from a third-party payer perspective.This retrospective observational study analyzed claims data from the Truven Health Analytics MarketScan Research Databases from 2009-2014. Two cohorts were compared: CH (2 diagnostic CH claims) and controls (nonheadache patients). All patients were enrolled continuously for ± 12 months from date of first CH claim. HCRU and direct costs were examined during 12 months post-index as all-cause and CH-specific. Cost and HCRU differences were compared using propensity score-adjusted bin bootstrapping.CH and control cohorts comprised 6,562 and 143,761 patients (aged ≥ 18 years), respectively. Post-index, 36.9% of CH patients versus 16.2% of controls were admitted to the emergency department (ED), and 14.8% versus 6.1% were hospitalized for any reason, respectively (each P0.001). CH patients had a 2- to 3-fold significantly greater number of all-cause mean claims for outpatient visits (26.5 vs. 12.4 visits), hospital visits (0.2 vs. 0.1 visits), and ED visits (1.0 vs. 0.3 visits) versus controls (all P0.001). The mean number of all-cause visits with reported radiology and laboratory claims was 1.5- to 2.0-fold greater in CH patients versus controls (each P0.001). Mean total direct costs for all-cause claims were more than 2-fold greater in post-index ($16,530) for CH patients versus controls ($7,197, P0.0001). Similarly, mean direct all-cause costs attributable to outpatient, inpatient, and pharmacy claims were significantly (2-fold) greater; radiology and ED claims were 3- to 4-fold greater among CH patients versus controls (all P0.001). However, CH was cited infrequently as a reason for HCRU, indicating that comorbid conditions may substantially increase HCRU in CH patients. The most common reasons for ED admission in CH patients were gastric ulcer with hemorrhage, sub-arachnoid hemorrhage, and headache symptoms. The most common hospital discharge diagnoses for CH patients not observed in top 10 reasons in controls included cerebral artery occlusion/unspecified with cerebral infarction, headache symptoms, syncope/collapse, and diverticulitis.These findings suggest that, from a payer perspective, CH patients incur significantly higher health care costs versus controls. However, these high costs were not exclusively headache-related. Extrapolating our cost findings to estimated U.S. prevalence rates, approximate total direct cost for CH is greater than $2.8 billion/year.Eli Lilly and Company was the sole sponsor and funder for this study and was responsible for the study design, data collection, data analysis, interpretation of data, and decision to publish the findings. All authors are employees and minor stockholders of Eli Lilly and Company.

Objective To characterize demographics, clinical characteristics, and treatment patterns of patients with cluster headache (CH). Background CH is an uncommon trigeminal autonomic cephalalgia with limited evidence‐based treatment options. Patients suffer from extremely painful unilateral headache attacks and autonomic symptoms with episodic and chronic cycles. Design/Methods This retrospective analysis used insurance claims from Truven Health Analytics MarketScan® research databases from 2009 to 2014. Two cohorts were compared: CH patients (with ≥2 CH claims) were propensity score matched with 4 non‐headache controls, all with continuous enrollment for 12 months before and after the date of first CH claim or matched period among controls. Results CH patients (N = 7589) were mainly male (57.4%) and 35‐64 years old (73.2%), with significantly more claims for comorbid conditions vs controls (N = 30,341), including depressive disorders (19.8% vs 10.0%), sleep disturbances (19.7% vs 9.1%), anxiety disorders (19.2% vs 8.7%), and tobacco use disorders (12.8% vs 5.3%), with 2.5 times greater odds of suicidal ideation (all P 12 unique prescription drug claims. Most commonly prescribed drug classes for CH patients included: opiate agonists (41%), corticosteroids (34%), 5HT‐1 agonists (32%), antidepressants (31%), NSAIDs (29%), anticonvulsants (28%), calcium antagonists (27%), and benzodiazepines (22%). Only 30.4% of CH patients received recognized CH treatments without opioids during the 12‐month post‐index period. These patients were less likely to visit emergency departments or need hospitalizations (26.8%) as compared to CH patients with no pharmacy claims for recognized CH treatments or opioids (33.6%; P

Summary Background Alcohol dependence is often untreated. Although abstinence is often the aim of treatment, many drinkers prefer drinking reduction goals. Therefore, if supported by evidence of benefit, drinking reduction goals could broaden the appeal of treatment. Regulatory agencies are considering non-abstinent outcomes as efficacy indicators in clinical trials, including reduction in WHO drinking risk levels—very high, high, moderate, and low—defined in terms of mean ethanol consumption (in grams) per day. We aimed to study the relationship between reductions in WHO drinking risk levels and subsequent reduction in the risk of alcohol dependence. Methods In this population-based cohort study, we included data from 22 005 drinkers who were interviewed in 2001–02 (Wave 1) and re-interviewed 3 years later (2004–05; Wave 2) in the US National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol consumption (WHO drinking risk levels) and alcohol dependence (at least three of seven DSM-IV criteria in the previous 12 months) were assessed at both waves. We used logistic regression to test the relationship between change in WHO drinking risk levels between Waves 1 and 2, and alcohol dependence at Wave 2. Findings At Wave 1, 2·5% (weighted proportion) of the respondents were very-high-risk drinkers, 2·5% were high-risk drinkers, 4·8% were moderate-risk drinkers, and most (90·2%) were low-risk drinkers. Reduction in WHO drinking risk level predicted significantly lower odds of alcohol dependence at Wave 2, particularly among very-high-risk drinkers (adjusted odds ratios 0·27 [95% CI 0·18–0·41] for reduction by one level, 0·17 [0·10–0·27] for two levels, and 0·07 [0·05–0·10] for three levels) and high-risk drinkers (0·64 [0·54–0·75] for one level and 0·12 [0·09–0·15] for two levels), and among those with alcohol dependence at Wave 1 (0·29 [0·15–0·57] for one level, 0·06 [0·04–0·10] for two levels, and 0·04 [0·03–0·06] for three levels in very-high-risk drinkers). Interpretation Our results support the use of reductions in WHO drinking risk levels as an efficacy outcome in clinical trials. Because these risk levels can be readily translated into standard drink equivalents per day of different countries, the WHO risk levels could also be used internationally to guide treatment goals and clinical recommendations on drinking reduction. Funding US National Institute on Alcohol Abuse and Alcoholism, New York State Psychiatric Institute, the Alcohol Clinical Trials Initiative.

Background: Alzheimer’s disease (AD) is one of the costliest diseases in the United States. Objective: To describe aspects of real-world patient and caregiver burden in patients with clinician-diagnosed early AD, including mild cognitive impairment (MCI) and mild dementia (MILD) due to AD. Methods: Cross-sectional assessment of GERAS-US, a 36-month cohort study of patients seeking care for early AD. Eligible patients were categorized based on study-defined categories of MCI and MILD and by amyloid positivity [+] or negativity [–] within each severity cohort. Demographic characteristics, health-related outcomes, medical history, and caregiver burden by amyloid status are described. Results: Of 1,198 patients with clinician-diagnosed early AD, 52% were amyloid[+]. For patients in both cohorts, amyloid[–] was more likely to occur in those with: delayed time to an AD-related diagnosis, higher rates of depression, poorer Bath Assessment of Subjective Quality of Life in Dementia scores, and Hispanic/Latino ethnicity (all p

Background:Osteoarthritis (OA) is a common disease that varies in severity among patients. A standardized definition to classify patients into different severity levels is lacking, however, due to the disease’s complex pathogenesis and presentation. Prior studies have shown associations between pain severity and higher healthcare resource utilization (HRU) and costs. We investigated an association between pain severity and higher healthcare resource utilization by examining the use of specific OA-related treatments across pain intensity levels in a large, integrated health system’s OA population over an 18-year period.Objectives:Our aim was to compare use of medications and other treatments among OA patients experiencing mild, moderate, or severe pain.Methods:This was a retrospective study of electronic health records from 2001 to 2018 at Geisinger, an integrated health system in Pennsylvania. Patients were included with a diagnosis code for OA (ICD-9: 715.*, ICD-10 M15-19) on a problem list or encounter or an OA-specific procedure (hip or knee replacement, arthroscopy or injection). We examined pain scores (0-10 scale, with 10 being worst pain) taken after the first OA diagnosis date and defined pain episodes starting on the pain score’s date and lasting for 90 days. If a new pain score was measured before 90 days elapsed, the episode was extended for an additional 90 days, with this process repeated as necessary. Each episode was categorized as mild (pain score 0-3), moderate (4-6), or severe (7-10) based on initial score, and patients could contribute multiple episodes to the analysis. Descriptive statistics were used to quantify treatment utilization during each patients’ mild, moderate and severe episodes. Percentages of patients who had any use of 10 medication types (tramadol, non-tramadol opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), injectable corticosteroids, acetaminophen, salicylates, duloxetine, homeopathic medications, other topical medications, and other over-the-counter (OTC) medications were compared across pain episode types. Percentages of patients with knee or hip surgeries, spine or joint imaging procedures (x-ray, computed tomography or magnetic resonance) and consults to OA-related care (pain management, orthopedics or physical medicine and rehabilitation) were also compared. All analyses used logistic regression with p-values Results:We identified 290,897 patients with OA, representing 34% of the health system population in 2018; 58% were female with mean age of 49 years and mean BMI of 30.5 kg/m2. A total of 801,144 pain episodes were defined, with 75% of patients having at least one pain score. The two most frequently occurring pain scores were 0 (17%) and 5 (13%), and pain episodes were classified as 43% mild, 32% moderate and 25% severe. Significantly higher percentages of patients used certain medication types (NSAIDs, injectable corticosteroids, non-tramadol opioid, duloxetine) in both moderate and severe pain episodes as compared to mild episodes, but other medication types were less likely to be used as pain severity increased (acetaminophen, salicylates, homeopathic medications, other OTC medications). Knee or hip surgeries, imaging, and consults to OA-related specialists were all consistently significantly more likely to occur in patients during moderate or severe pain episodes versus mild episodes (relative risk ratios of 1.76, 1.25 and 1.35 for moderate vs mild, respectively, and 2.00, 1.44 and 1.46 for severe vs mild, all p-values Conclusion:While pain is generally recognized to be a subjective measure that could be influenced by other unmeasured factors and can be confounded with treatment effectiveness, it is nevertheless the primary symptom of OA. It is important to understand the relationship between pain intensity and treatment utilization, and our results support an overall association between pain and utilization but provide new details on the extent to which it depends on specific utilization type.Acknowledgements:Pfizer and Eli Lilly and Company for sponsoring this study.Disclosure of Interests:Jove Graham Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Tonia Novosat Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Haiyan Sun Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Brian Piper Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Joseph Boscarino Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Vanessa Duboski Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Melissa Kern Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Eric Wright Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Rebecca Robinson Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., Edward Casey Shareholder of: Pfizer, Inc., Paid instructor for: As an employee of Pfizer, Inc. this is part of my role., Employee of: Pfizer, Inc., Craig Beck Shareholder of: Pfizer, Inc., Employee of: Pfizer, Inc., Jerry Hall Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., Patricia Schepman Shareholder of: Pfizer, Inc., Employee of: Pfizer, Inc.

Background:The 2019 American College of Rheumatology (ACR) guidelines strongly recommend oral nonsteroidal anti-inflammatory drugs (NSAIDs) for management of hip and knee osteoarthritis (OA) and strongly recommend topical NSAIDs for knee OA. There are, however, important safety considerations with NSAIDs in terms of increased rates of gastrointestinal, cardiovascular, and renal events. Given these risks, it is important to understand the characteristics and drug utilization of the patients who start treatment on these different treatments (i.e., traditional NSAIDs [tNSAIDs] and cyclooxygenase-2 inhibitors [COX-2s]).Objectives:The goal of this research was to describe and compare baseline characteristics of commercially-insured patients diagnosed with OA of the hip and/or knee who started treatment on different types of NSAIDs (i.e., oral tNSAIDs, topical tNSAIDs, and COX-2s).Methods:The Optum Healthcare Solutions, Inc. claims database (1/2012-3/2017) was used to identify patients ≥18 years old, with ≥2 diagnoses of hip and/or knee OA, and ≥90 days supply of oral tNSAIDs, topical tNSAIDs, or COX-2s during the one-year follow up period. The index date was defined as the first prescription after the first OA diagnosis. Patients were assigned to cohorts based on the type of NSAID prescribed on index date. Patients were required to be continuously-enrolled six months before (baseline period) and 36 months after (follow-up period) the index date. Demographic and clinical characteristics including age, sex, comorbidities, and healthcare resource use (HRU) were summarized during baseline. Drug utilization characteristics including days supply and number of prescriptions for the different NSAIDs types were summarized during follow-up period.Results:Data for 23,796 patients were analyzed: 18,100 patients received oral tNSAIDs, 4,825 received COX-2s, and 871 topical tNSAIDs. Patients who initiated treatment on oral tNSAIDs were the youngest (mean age of 60.6 vs. 64.6 for COX-2s and 65.0 for topical tNSAIDs) and topical tNSAIDs had the highest proportion of female patients (71% vs. 62% for oral tNSAIDs and 63% for COX-2s). The topical tNSAIDs cohort had the highest presence of chronic kidney disease (2.6% vs. 1.0% and 1.5% for oral tNSAIDs and COX-2s, respectively) and congestive heart failure (2.5% vs. 0.8% and 1.7% for oral tNSAIDs and COX-2s, respectively) at baseline. In terms of HRU during baseline, topical tNSAIDs had the most patients with emergency department visits (20.8% vs. 16.7% in both COX-2s and oral tNSAIDs), and COX-2 had the most patients with inpatient visits (18.1% vs. 15.4% for topical tNSAIDs and 11.8% for oral tNSAIDs). Oral tNSAIDs had the lowest total all-cause cost ($6,504), and the topical tNSAIDs cohort had the highest costs ($8,455), but fairly comparable with COX-2s ($8,289). During follow-up, oral tNSAIDs patients stayed mostly on oral tNSAIDs as less than 15% of oral tNSAIDs patients later had a prescription for COX-2s or topical tNSAIDs. 37% of COX-2 patients and 56% of topical tNSAIDs patients later took oral tNSAIDs. Topical tNSAIDs patients had an average of 184.4 days of supply for topical tNSAIDs yet also extensively used oral NSAIDs during follow-up (average days of supply for oral tNSAIDs was 315.5 days and for COX-2s was 383.5 days).Conclusion:This study suggests that patients with more complex comorbidity profiles, including higher rates of adverse effects, often start pharmacological treatment with topical tNSAIDs. However, patients who start treatment with topical tNSAIDs switch to other types of NSAIDs; oral tNSAIDs were the most frequently prescribed treatment across the cohorts. Thus, despite the safety concerns with oral tNSAIDs and COX-2s, patients are still placed on these treatments to manage their OA pain. There is a need for new innovative treatments as there is currently a lack of other options.Disclosure of Interests:Stuart Silverman Consultant of: Stuart Silverman is a paid consultant to Pfizer and Eli Lilly and Company in connection with this study, Patricia Schepman Shareholder of: Patricia Schepman is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, James B Rice Consultant of: Brad Rice is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Craig Beck Shareholder of: Craig Beck is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, Alan White Consultant of: Alan White is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Sheena Thakkar Shareholder of: Sheena Thakkar is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, Michaela Johnson Consultant of: Michaela Johnson is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Rebecca Robinson Shareholder of: Rebecca Robinson is an employee and minor stockholder of Eli Lilly and Company, Employee of: Eli Lilly and Company, Birol Emir Shareholder of: Birol Emir is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer

SummaryAim To compare atomoxetine (ATX) length of therapy (LoT) among adults with ADHD who reached the recommended dose of 80 mg/day (ATX ≥ 80) versus those who did not (ATX

ObjectiveTo characterize healthcare costs, resource use, and treatment patterns of survey respondents with a history of depression who are high utilizers (HUds) of healthcare and to identify factors associated with high utilization.MethodsAdults with two or more depression diagnoses identified from the HealthCore Integrated Research Database were invited to participate in the CODE study, which links survey data with 12-month retrospective claims data. Patient surveys provided data on demographics, general health, and symptoms and/or comorbidities associated with depression. Similar clinical conditions also were identified from the medical claims. Factors associated with high utilization were identified using logistic regression models.ResultsOf 3132 survey respondents, 1921 were included, 193 of whom were HUds (defined as those who incurred the top 10% of total all-cause costs in the preceding 12months). Mean total annual healthcare costs were eightfold greater for HUds than for non-HUds ($US56,145 vs. $US6,954; p

Background:Prescription NSAIDs/Cox-2s (“NSAIDs”) are commonly prescribed by physicians to treat patients with chronic pain, and much is known about the potential negative outcomes associated with their use1. Such negative outcomes include gastrointestinal (“GI”) issues and hepatorenal toxicity.1In addition, CV risk of Cox-2s has not been completely clarified.1,2However, less is known about the extent to which these outcomes are pervasive and problematic in specific patient populations such as those diagnosed with osteoarthritis (“OA”).Objectives:The goal of this research is to assess the clinical burden of commercially-insured patients diagnosed with OA of the hip and/or knee before and after treatment with prescription NSAIDs, in a large, national database in recent years.Methods:The Optum Healthcare Solutions, Inc. data (1/2012-3/2017) were used to identify patients ≥18 years old with ≥2 diagnoses of hip and/or knee OA, and ≥90 days supply of NSAIDs during the three-year period from first prescription (index date) after their first OA diagnosis. Patients were required to be continuously-enrolled during the six months before (baseline period) and 36 months after (follow-up period) the index date. Selected clinical outcomes such as GI issues, CV events, and renal toxicity were compared between the baseline and follow-up periods. Costs and resource use were normalized to account for differential duration in analytic time periods.Results:Data for 22,435 patients (60.8% as female, with an average age of 62) with hip and/or knee OA were analyzed. On average, patients were prescribed NSAIDs for 489 days during the follow-up period. From the baseline period to follow-up period, negative clinical outcomes associated with GI issues increased by 393% (1.5% v 7.5%), driven by a 667% (0.3% v 2.3%) increase in acute GI hemorrhages. Additionally, negative clinical outcomes associated with CV events increased by 73% (40.7% v 70.6%), largely due to a 600% (0.3% v 2.1%) increase in acute myocardial infarction. Lastly, negative clinical outcomes associated with renal toxicity increased by 433% (1.5% v 8.0%), with a 740% (0.5% v 4.2%) increase in acute renal failure being the most substantial.Conclusion:These findings suggest that prescribing of NSAIDs among OA patients is associated with an increase in negative clinical outcomes. This suggests that new treatment options other than NSAIDs should be evaluated.References:[1]van Laar M, et al. Pain treatment in arthritis-related pain: beyond NSAIDs.Open Rheumatol J. 2012;6:320–330.[2]Nissen SE, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.NEJM2016;2519-2529.Disclosure of Interests:Stuart Silverman Consultant of: Pfizer and Eli Lilly for this project., Speakers bureau: Amgen, Radius, James Rice Consultant of: Pfizer and Eli Lilly have funded this project., Alan White Consultant of: Pfizer and Eli Lilly have funded this project., Nguyen Le Consultant of: Pfizer and Eli Lilly have funded this project., Michael Somma Consultant of: Eli Lilly and Pfizer have funded this project., Craig Beck Shareholder of: Pfizer, Employee of: Pfizer, Rebecca Robinson Shareholder of: Eli Lilly, Employee of: Eli Lilly, Patricia Schepman Shareholder of: Pfizer, Employee of: Pfizer

This study tested implications of the context switching perspective proposed by Hamby, Ickes, and Babcock ( 2016 ). Using trained raters to assess the amount of reframing required to interpret the meaning of the subsequent (second) item within all adjacent item pairs, we first established that this process variable could be measured reliably. Then, in the data for 18 personality measures drawn from 3 individual-difference domains, we found that the amount of reframing (i.e., context switching) needed to interpret successive items predicted both lower interitem correlations and a greater percentage of misresponders. Similarly, item pairs that were mismatched in "directional" wording also predicted both lower interitem correlations and more misresponders. Finally, item pairs representing different factors predicted lower interitem correlations. Although the effects of direction switching and factor switching were partially mediated by the amount of reframing required, they remained significant even when the mediating effect of reframing was statistically controlled. These results indicate that interpreting the meaning of test items is a task for which the level of difficulty can vary with each successive item, as a function of how the current item compares to the previous item in aspects such as its context generality or specificity, directional wording, and content domain.

Purpose– The purpose of this research is to (1) to identify personality variables that reliably predict verbal rudeness ( i.e by replicating previous findings) and (2) to investigate what personality variables predict more general ugly confrontational behaviors.Design/methodology/approach– In Study 1, the authors used an online survey to collect information regarding individual differences in social desirability, self-esteem, narcissism, blirtatiousness, behavioral inhibition, behavioral activation, conventional morality (CM), thin-skinned ego defensiveness (TSED), affect intensity for anger and frustration (AIAF), and verbal rudeness. In Study 2, the authors used a similar online survey to collect the same information, but extended the survey questionnaire to include measures of entitlement, psychopathology, Machiavellianism, and a retrospective checklist of ugly confrontational behaviors.Findings– In Study 1, regression analyses revealed that CM, behavioral inhibition, and behavioral activation reward responsiveness were significant negative predictors of rudeness. AIAF, TSED and behavioral activation drive were significant positive predictors of rudeness. In Study 2, regression analyses revealed that CM was again a significant negative predictor of rudeness. AIAF, and narcissism were significant positive predictors of rudeness. CM also negatively predicted ugly confrontational behaviors, whereas AIAF, blirtatiousness, and Machiavellianism were positive predictors.Originality/value– Although several measures of aggression exist, the current studies of rudeness and ugly confrontational behavior specifically assess tendencies to abuse strangers. These studies begin to establish a personality profile of the type of person that might abuse strangers.

Osteoarthritis (OA) is the leading cause of disability in older adults. Total healthcare costs tend to rise as pain severity associated with OA increases. To understand treatment and healthcare resource utilization (HCRU) by OA pain severity, data were collected from Feb-May 2017 using US Adelphi Disease Specific Programme, a cross-sectional survey of primary care physicians, rheumatologists, orthopedists and their patients. Descriptive statistics were used and all data were analysed using SPSS v6 and Stata v14.1. A total of 841 patients seeking care for OA were included. Patient-reported pain severity (Numeric Rating Scale; 0-10) over the last week was categorized as none/mild (45.4%; 0-3), moderate (35.9%, 4-6) and severe (18.7%; 7-10) pain. The majority of patients were female (61%) and white (78%) and the average age was 64.6 years. Increased pain severity was associated with a higher Body Mass Index and increased reliance on walking aids (21%, 38%, 47%), modifications to home (9%, 19%, 31%), and need for caregivers (5%, 14%, 31%) (all p

Objective To describe 12-month treatment patterns and outcomes for patients starting a new medication for fibromyalgia in routine clinical practice. Design and Outcome Measures Data from 1,700 patients were collected at baseline and 1, 3, 6, and 12 months. Repeated measures and Poisson regression models controlling for demographic, clinical, and baseline outcomes were used to assess changes in health outcomes (Brief Pain Inventory severity and interference, Sheehan Disability Scale, Fibromyalgia Impact Questionnaire), satisfaction, and economic factors for patients who initiated on pregabalin (214, 12.6%), duloxetine (264, 15.5%), milnacipran (134, 7.9%), or tricyclic antidepressants (66, 3.9%). Sensitivity analyses were run using propensity-matched cohorts. Results Patients started on 145 unique drugs for fibromyalgia, and over 75% of patients took two or more medications concurrently for fibromyalgia at each time point assessed. Overall, patients showed improvement on the four health outcomes, with few differences across medication cohorts. At baseline, patients reported annual averages of 20.3 visits for outpatient care, 27.7 missed days of work, and 32.6 days of care by an unpaid caregiver. The duloxetine and milnacipran (vs pregabalin or tricyclic antidepressant) cohorts had fewer outpatient visits during the 12-month study. Patients reported satisfaction with overall treatment and their fibromyalgia medication (46.0% and 42.8%, respectively). Conclusions In this real-world setting, patients with fibromyalgia reported modest improvements, high resource, and medication use, and were satisfied with the care they received. Cohort differences were difficult to discern because of the high rates of drug discontinuation and concomitant medication use over the 12-month study period.

Using a sample of 363 participants, we tested whether differences in the use of linguistic categories in written self-introductions at the start of the semester predicted final course performance at the end of the semester. The results supported this possibility: Course performance could indeed be predicted by relative word usage in particular linguistic categories—predominantly by the use of punctuation (commas and quotes), word simplicity, first-person singular pronouns, present tense, details concerning home and social life, and words pertaining to eating, drinking, and sex. Our interpretation of the findings emphasizes the egocentric “narrowed focus” of low-performing students and therefore stands in contrast to a previous interpretation that characterized these students as being “dynamic thinkers.”

Stephen L Able,1 Rebecca L Robinson,2 Kurt Kroenke,3,4 Philip Mease,5,6 David A Williams,7 Yi Chen,8 Madelaine Wohlreich,9 Bill H McCarberg10 1US Health Outcomes and Technology Assessment, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 2Lilly Research Labs, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 3Department of Medicine, Indiana University, 4VA Health Services Research and Development Center for Health Information and Communication, Regenstrief Institute, Indianapolis, IN, USA; 5Rheumatology Associates, Division of Rheumatology Clinical Research, Swedish Medical Center, 6University of Washington School of Medicine, Seattle, WA, USA; 7Chronic Pain and Fatigue Research Center, Michigan Institute for Clinical and Health Research, University of Michigan School of Medicine, Ann Arbor, MI, USA; 8inVentiv Health Clinical, Indianapolis, IN, USA; 9USMD Neuroscience, Lilly USA LLC, Eli Lilly and Company, Indianapolis, IN, USA; 10Department of Family Medicine, University of California at San Diego School of Medicine, San Diego, CA, USA Purpose: To evaluate the effect of physician specialty regarding diagnosis and treatment of fibromyalgia (FM) and assess the clinical status of patients initiating new treatment for FM using data from Real-World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments. Patients and methods: Outpatients from 58 sites in the United States were enrolled. Data were collected via in-office surveys and telephone interviews. Pairwise comparisons by specialty were made using chi-square, Fisher’s exact tests, and Student’s t-tests. Results: Physician specialist cohorts included rheumatologists (n=54), primary care physicians (n=25), and a heterogeneous group of physicians practicing pain or physical medicine, psychiatry, neurology, obstetrics and gynecology, osteopathy, or an unspecified specialty (n=12). The rheumatologists expressed higher confidence diagnosing FM (4.5 on a five-point scale) than primary care physicians (4.1) (P=0.037). All cohorts strongly agreed that recognizing FM is their responsibility. They agreed that psychological aspects of FM are important, but disagreed that symptoms are psychosomatic. All physician cohorts agreed with a multidisciplinary approach including nonpharmacological and pharmacological treatments, although physicians were more confident prescribing medications than alternative therapies. Most patients reported moderate to severe pain, multiple comorbidities, and treatment with several medications and nonpharmacologic therapies. Conclusion: Physician practice characteristics, physician attitudes, and FM patient profiles were broadly similar across specialties. The small but significant differences reported by physicians and patients across physician cohorts suggest that despite published guidelines, treatment of FM still contains important variance across specialties. Keywords: medical specialty, treatment, prospective observational study

Objective. This study was designed to describe burden of illness and treatment patterns, and to examine the patient, physician, and care factors associated with the treatment choices of individuals receiving new prescriptions for fibromyalgia (FM). Design. This is a baseline assessment of the Real-World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS), a prospective observational study. Baseline data (including a physician survey, a patient visit form, and computer-assisted telephone interviews) were collected from July 2008 through May 2010 in 58 care settings in the United States, including Puerto Rico. Results. Patients (N = 1,700) were mostly female (94.6%) and white (82.9%). Mean age was 50.4 years and mean duration of illness was 5.6 years. Mean Fibromyalgia Impact Questionnaire total score was 54.4 (range 0–80), and Brief Pain Inventory average pain severity level was 5.5 (range 0–10). Patients reported high annual health care use and numerous work limitations related to FM. Patients were taking 182 unique types of medications prescribed for FM, including duloxetine (26.8%), nonsteroidal anti-inflammatory drugs (26.6%), pregabalin (24.5%), opioids (24.2%), tramadol (15.3%), benzodiazepines (15.2%), cyclobenzaprine (12.9%), milnacipran (8.9%), and others. Most patients took more than one medication concurrently (77.8%). Type of current medications used was most strongly associated with medication history and physician specialty. Conclusions. Burden of illness was high for patients with FM, and treatment patterns were highly variable. Importantly, the treatments with the most evidence to support their use were not always the most frequently chosen.