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Objective: To evaluate healthcare resource utilization (HCRU) by osteoarthritis (OA) pain severity., Methods: 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., Results: 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; p < 0.0001). Pain severity was associated with an increased number of physician-reported and patient-reported overall healthcare provider visits (HCPs; both p < 0.001). As pain increased, patients reported an increased need for mobility aids, accessibility modifications to homes, and help with daily activities due to functional disability. The number of imaging tests used to diagnose OA was similar across pain severity but varied when used for monitoring (X-rays: p < 0.0001; computerized tomography scans: p < 0.0447). Hospitalization rates for OA were low but were significantly associated with pain severity (mild: 4.9%; severe: 11.5%). Emergency department visits were infrequent but increasing pain severity was associated with more prior and planned surgeries., Conclusion: 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.

Background: Anticipating and controlling drug-drug interactions (DDIs) in older patients with painful diabetic peripheral neuropaty (pDPN) presents a significant challenge to providers. The purpose of this study was to examine the impact of newly initiated pregabalin or duloxetine treatment on Medicare Advantage Prescription Drug (MAPD) plan pDPN patients' encounters with potential drug-drug interactions, the healthcare cost and utilization consequences of those interactions, and opioid utilization., Methods: Study subjects required a pregabalin or duloxetine pharmacy claim between 07/01/2008-06/30/2012 (index event), ≥1 inpatient or ≥2 outpatient medical claims with pDPN diagnosis between 01/01/2008-12/31/2012, and ≥12 months pre- and ≥6 post-index enrollment. Propensity score matching was used to balance the pregabalin and duloxetine cohorts on pre-index demographics and comorbidities. Potential DDIs were defined by Micromedex 2.0 and identified by prescription claims. Six-month post-index healthcare utilization (HCU) and costs were calculated using pharmacy and medical claims., Results: No significant differences in pre-index demographics or comorbidities were found between pregabalin subjects (n = 446) and duloxetine subjects (n = 446). Potential DDI prevalence was significantly greater (p < 0.0001) among duoxetine subjects (56.7%) than among pregabalin subjects (2.9%). There were no significant differences in HCU or costs between pregablin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($13,908 vs. $9,830; p = 0.001), more subjects with ≥1 inpatient visits (35.6% vs 25.4%; p = 0.02), and more subjects with ≥1 emergency room visits (32.8% vs. 20.7%; p = 0.005) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a difference between pregabalin and duloxetine subjects in their respective pre-versus-post differences in milligrams (mg) of morphine equivalents/30 days used (60.2 mg and 176.9 mg, respectively; p = 0.058)., Conclusion: The significantly higher prevalence of potential DDIs and potential cost impact found in pDPN duloxetine users, relative to pregabalin users, underscore the importance of considering DDIs when selecting a treatment.

Background: Managed healthcare organizations often utilize formulary management strategies such as prior authorization and step therapy to guide appropriate medication use and to control medication expenditures. The objective of this study was to examine clinical and economic outcomes associated with implementation of a pregabalin step therapy (ST) policy among Medicare Advantage Prescription Drug (MAPD) members., Methods: Pharmacy and medical claims data from Humana (restricted cohort; ST policy implemented 01/01/2009) and Thomson Reuters MarketScan(®) (unrestricted cohort) were analyzed for MAPD members aged 65 to 89 years receiving treatment for painful diabetic peripheral neuropathy (pDPN), postherpetic neuralgia (PHN) or fibromyalgia (FM). Difference-in-differences (DID) was used to examine year-over-year changes in disease-related and all-cause utilization and costs. Regression analyses examined medication utilization and healthcare expenditures after controlling for between-group compositional differences., Results: We identified 13,911 members in the restricted cohort and matched to members from unrestricted health plans. FM (51.0%) and pDPN (41.8%) were the most common diagnoses. Members in the unrestricted cohort were older and had a greater level of comorbidity than members in the restricted cohort. The restricted cohort demonstrated greater year-over-year decrease in pregabalin utilization and increase in year-over-year gabapentin utilization compared with the unrestricted cohort. ST restriction was associated with an increase in disease-related pharmacy costs and a decrease in total medical costs for the restricted cohort compared with the unrestricted cohort. There was no difference between cohorts in total healthcare cost., Conclusion: After controlling for differences in age and comorbidity burden between the groups, implementation of a pregabalin ST restriction was associated with increased disease-related pharmacy costs and decreased total medical costs; however, there was no net difference in total healthcare cost or total pharmacy cost., (© 2013 Pfizer Inc and Humana, Inc. Pain Practice © 2013 World Institute of Pain.)

Objective: Research has shown that painful diabetic peripheral neuropathy (pDPN) is associated with worse health outcomes. However, among pDPN patients, few studies have examined the relationship between the severity of pain and health outcomes., Design: The current project included pDPN patients (N=1506) from the 2006, 2007, and 2008 waves of the National Health and Wellness Survey., Outcome Measures: Health status (Short Form [SF]-12), work productivity (Work Productivity and Activity Impairment questionnaire), and health care resource use in the past 6 months were compared among pDPN patients with mild, moderate, and severe pain, adjusting for demographics and clinical characteristics., Results: More than half (51.2%) of the patients reported their pain as severe, 45.2% reported moderate pain, and 3.7% reported mild pain. Those with severe pain reported significantly lower levels of health status, higher levels of work and activity impairment, and higher levels of resource use relative to the other groups. Annual per-patient costs for those with severe pain were $12,856, $3927, and $16,783 for direct, indirect, and total costs, respectively. Both direct and total costs were significantly higher in this group relative to both mild and moderate pain patients., Conclusions: These results suggest that pain severity contributes substantially to the health outcomes of pDPN patients and that greater resources should be allocated to the management of patients with severe pain., (Wiley Periodicals, Inc.)

Introduction: Understanding the relationship between patient-reported osteoarthritis (OA) severity and other patient-reported outcomes in the real-world clinical setting can provide a basis for appropriate patient management. The objective of this study was to determine how patient-reported OA severity correlates with patient-reported outcomes including pain, function and productivity., Methods: We used the Adelphi Disease Specific Programme (DSP) for OA, a database aggregated from large, multinational, observational studies for specific chronic diseases. Data were obtained based on a 0 to 100 mm pain visual analogue scale (VAS) and a series of questions including functioning (that is, activities of daily living) and work productivity. OA severity was rated by the patients based on the question "How bad would you say your arthritis is now?" with potential responses of "mild," "moderate," and "severe." Regression models and chi-square analyses were used to evaluate the relationships between self-reported OA severity and other outcomes., Results: Of 998 subjects in the OA DSP U.S. database, 714 (72.5%) agreed to participate. This sample was predominantly female (61.7%) with a mean age of 63.8 ± 12.9 years. Increased OA severity was associated with an older population (P < 0.05). With increasing OA severity (mild, moderate, severe), statistically significant differences (P < 0.05) were observed in increased pain VAS scores (23.5, 50.2, 70.8, respectively), lower functioning outcomes, and a higher percent of overall work impairment due to OA (17%, 37%, 48%, respectively). The increased work impairment at greater severity levels also resulted in higher costs related to lost work productivity, with annual costs due to lost productivity estimated at $6,096, $13,2510, and $17,214 per patient for self-reported mild, moderate, and severe OA, respectively (P < 0.05 for pairwise comparisons)., Conclusions: In the clinical practice setting, patient-reported OA severity was associated with other key patient-reported outcomes and thus may provide an accurate and tangible assessment of patients' perceptions of their disease. Identifying OA patients by their perceived severity level may be of benefit to patients and health-care providers when choosing treatment options aimed at reducing pain, and improving function and productivity.

Interpretation of results on patient-reported pain outcomes from clinical trials should be meaningful to patients and healthcare providers. This study applied an area-under-the-curve (AUC) analysis to responder profiles in a clinical trial of pregabalin for the treatment of fibromyalgia (FM). Data were from a 14-week, randomized, placebo-controlled trial of pregabalin (300, 450, or 600 mg/day) for the treatment of FM in patients meeting American College of Rheumatology criteria for FM and with a baseline pain score of at least 40 mm on the 100-mm pain visual analogue scale. Pain was evaluated in a daily diary by patients using an 11-point numeric rating scale (0 = no pain, 10 = worst possible pain). Response profiles on pain improvement scores and their differences between pregabalin and placebo were assessed using the AUC (derived using the trapezoidal rule) from the responder curve (vertical axis, proportion of subjects; horizontal axis, minimum percent improvement in pain). The AUC can be interpreted as if all responders were improved by the same percentage equal to the AUC divided by 100. The AUCs (2,100 for placebo, and 2,944, 3,170, and 3,349 for pregabalin 300, 450, and 600 mg, respectively) can be considered as if every responder improved by 21, 29, 31, and 33.5% in the responder's respective treatment group. Pain improvement was significantly better with pregabalin (P < 0.05), with pregabalin responders improving by 8.4% (300 mg/day), 10.7% (450 mg/day), and 12.5% (600 mg/day) more than placebo responders. This novel approach demonstrates that responder profiles can provide an enhanced interpretation of pain outcomes for patient care and symptom management.

Objective: To define meaningful within-patient change (MWPC) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Methods: Data were analyzed separately from 3 phase III clinical trials (ClinicalTrials.gov: NCT02697773, NCT02709486, NCT02528188) of tanezumab, a novel treatment intended for the relief of signs and symptoms of moderate-to-severe osteoarthritis (OA), administered subcutaneously every 8 weeks. Patients with moderate-to-severe OA of the hip or knee completed the WOMAC and patient global assessment of OA (PGA-OA) at regular timepoints. A repeated measures longitudinal model with change in WOMAC Pain, Physical Function, or Stiffness domain score as the outcome and change in PGA-OA as the anchor was used to establish MWPC for WOMAC domains.Results: In the 3 studies, there were 688, 844, and 2948 subjects available for analyses, respectively. Analysis showed that a linear relationship between changes in WOMAC domains and changes in PGA-OA was supported and justified. Moreover, the relationships between these changes were very similar for 2 trials and close for the third. The estimated MWPC for the 3 WOMAC domains were from 0.84-1.16 (0-10 numerical rating scale) and from 12.50-16.23%, depending on study and domain, that corresponded to a 1-category change on PGA-OA. For a 2-category change those values were from 1.68-2.31 and from 25.01-32.46%, respectively.Conclusion: These results establish MWPCs for WOMAC domains, at the individual patient level, for patients with moderate-to-severe OA of the hip or knee. [ClinicalTrials.gov: NCT02697773, NCT02709486, and NCT02528188]. [ABSTRACT FROM AUTHOR]

Abstract Background Difficulty sleeping is common among patients with fibromyalgia (FM); however, its impact on health-related quality of life (HRQoL) is not well understood. The aim of the current study was to assess the burden of sleep difficulty symptoms on HRQoL among patients with FM. Methods The current study included data from the 2009 National Health and Wellness Survey (N=75,000), which is a cross-sectional, Internet-based survey representative of the adult US population. The prevalence of sleep difficulty symptoms among patients with FM (n=2,196) were compared with matched controls (n=2,194), identified using propensity-score matching. Additionally, the relationship between the number of sleep difficulty symptoms (none, one, or two or more) and HRQoL (using the SF-12v2) was assessed using regression modeling, controlling for demographic and health history variables. Results Of the 2,196 patients with FM, 11.2% reported no sleep difficulty symptoms, 25.7% reported one sleep difficulty symptom, and 63.05% reported two or more sleep difficulty symptoms. The prevalence of sleep difficulty symptoms was significantly higher than matched controls. Patients with one and two sleep difficulty symptoms both reported significantly worse HRQoL summary and domain scores relative to those with no sleep difficulty symptoms (all p Conclusions Among the FM population, sleep difficulty symptoms were independently associated with clinically-meaningful decrements in mental and physical HRQoL. These results suggest that greater emphasis in the treatment of sleep difficulty symptoms among the FM population may be warranted.

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 NaP-related symptoms with varying levels of dysfunction across subtypes. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To evaluate the effectiveness of opioids and/or pregabalin on patient‐reported outcomes among fibromyalgia (FM) patients based on levels of improvement. Methods: A total of 1,421 FM patients were identified, with 3,082 observational periods of opioids with or without pregabalin use between April 2008 and February 2015. Patients were categorized by opioids, and pregabalin with and without opioids; opioids were designated by morphine equivalent dose (MED) of ≤ 20 (low MED), > 20 to < 100 (moderate MED), ≥ 100 (high MED), and pregabalin doses of ≤ 150 mg, 151 to 300 mg, and 301 to 450 mg. Proportions of patients meeting clinically relevant thresholds of ≥ 30% and ≥ 50% improvement for pain interference (ability to enjoy life; activity; mood; relationships; sleep), pain severity, and fatigue were compared among treatments, and area under the curve (AUC) for improvement and worsening of effects was determined, enabling ranking of treatments. Further analysis compared pregabalin doses. Results: Pregabalin without opioids resulted in the highest proportions of patients with ≥ 30% improvement on all pain items and pain interference with “ability to enjoy life,” “activity” “mood,” and “sleep.” For the ≥ 50% threshold, pregabalin alone was highest for all pain interference items and for “average pain” and “worst pain.” Pregabalin was consistently lowest across thresholds for fatigue, but showed better results combined with moderate MED opioids. Pregabalin doses recommended for treatment of FM (151 to 450 mg) generally resulted in the highest proportion of patients achieving thresholds relative to opioids. The AUC results were consistent with thresholds; pregabalin without opioids resulted in the greatest benefits with regard to improvement, with the highest ranking for overall improvement and overall effects. Conclusion: Pregabalin without opioids provided the most favorable outcomes overall based on ≥ 30% and ≥ 50% improvement thresholds and AUC, with support for moderate MED opioids + pregabalin in patients suffering from fatigue. While most patients took less than recommended pregabalin doses, higher doses may lead to improved outcomes. [ABSTRACT FROM AUTHOR]

Objective To compare fibromyalgia ( FM) characteristics among patients identified in a community-based chronic pain cohort based on traditional International Classification of Diagnoses 9th revision ( ICD-9) diagnostic coding, with that of patients identified using a novel predictive model. Methods This retrospective study used data collected from July 1999 to February 17, 2015, in multiple chronic pain clinics in the United States. Patients were assigned to the FM case group based on specific inclusion criteria using ICD-9 codes or, separately, from results of a novel FM predictive model that was developed using random forest and logistic regression techniques. Propensity scoring (1:1) matched FM patients (cases) to nonmalignant chronic pain patients without FM (controls). Patient-reported measures (eg, pain, fatigue, quality of sleep) and clinical characteristics (ie, comorbidities, procedures, and regions of pain) were outcomes for analysis. Results Nine ICD-9 clinical modification diagnoses had odds ratios with large effect sizes (Cohen's d > 0.8), demonstrating the magnitude of the difference between the FM and matched non- FM cohorts: chronic pain syndrome, latex allergy, muscle spasm, fasciitis, cervicalgia, thoracic pain, shoulder pain, arthritis, and cervical disorders (all P < 0.0001). Six diagnoses were found to have a moderate effect size (Cohen's 0.5 < d > 0.8): cystitis, cervical degeneration, anxiety, joint pain, lumbago, and cervical radiculitis. Conclusions The identification of multiple comorbidities, diagnoses, and musculoskeletal procedures that were significantly associated with FM may facilitate differentiation of FM patients from other conditions characterized by chronic widespread pain. Predictive modeling may enhance identification of FM patients who may otherwise go undiagnosed. [ABSTRACT FROM AUTHOR]

Background: painDETECT (PD-Q) is a self-reported assessment of pain qualities developed as a screening tool for pain of neuropathic origin. Rasch analysis is a strategy for examining the measurement characteristics of a scale using a form of item response theory. We conducted a Rasch analysis to consider if the scoring and measurement properties of PD-Q would support its use as an outcome measure.Methods: Rasch analysis was conducted on PD-Q scores drawn from a cross-sectional study of the burden and costs of NeP. The analysis followed an iterative process based on recommendations in the literature, including examination of sequential scoring categories, unidimensionality, reliability and differential item function. Data from 624 persons with a diagnosis of painful diabetic polyneuropathy, small fibre neuropathy, and neuropathic pain associated with chronic low back pain, spinal cord injury, HIV-related pain, or chronic post-surgical pain was used for this analysis.Results: PD-Q demonstrated fit to the Rasch model after adjustments of scoring categories for four items, and omission of the time course and radiating questions. The resulting seven-item scale of pain qualities demonstrated good reliability with a person-separation index of 0.79. No scoring bias (differential item functioning) was found for this version.Conclusions: Rasch modelling suggests the seven pain-qualities items from PD-Q may be used as an outcome measure. Further research is required to confirm validity and responsiveness in a clinical setting. [ABSTRACT FROM AUTHOR]

Objective: Collecting data that helps evaluate different types of pain may improve physicians' decision-making with regard to treatment selection and on-going monitoring of patients. To date, no chronic pain assessments have been widely implemented in primary care. The aim of this study was to psychometrically validate the electronic Chronic Pain Questions (eCPQ) in a primary care setting.Research Design and Methods: All men and women ≥18 years arriving at two similar primary care clinics in southeastern Michigan were invited to participate. Clinic staff verbally administered the eCPQ to patients and recorded their answers into the electronic medical record (EMR) prior to physician consultation with results available for physician review. Concurrent validity was assessed using Spearman correlations between eCPQ and patient-completed ancillary measures. Known-group validity was assessed by stratifying patients on self-reported chronic pain as well as by pain diagnosis (i.e. ICD-9 codes). To compare patients with chronic pain versus no chronic pain t-tests and chi-square tests were performed. Reproducibility was assessed between interviewer- and self-administration over time.Results: A total of 534 patients were invited to participate and 455 patients consented to take part in the study (85.2% response rate); 395 patients had analyzable eCPQ data; 70.1% were Caucasian; 68.1% female; mean age was 43.4; 52.7% (n = 208) self-reported chronic pain. Correlations between eCPQ and ancillary measures supported concurrent validity. Excellent discrimination between groups was evidenced based on self-reported chronic pain and ICD-9 diagnosis. Patients with self-reported chronic pain reported significantly (p < .0001) higher pain ratings and greater interference with usual activities, sleep, and mood than those without chronic pain. Test-retest reliability between modes (interviewer- vs. self-administration) was excellent as was reproducibility based on self-administration of the eCPQ at two separate time points. Key limitations: Discriminant validity was determined by comparing participants based on ICD codes. Utilizing ICD codes to identify individuals with chronic pain may not be a reliable approach as it is dependent upon providers accurately and consistently entering chronic pain diagnoses in the EMR.Conclusions: The eCPQ has sound psychometric measurement properties, including concurrent validity, discriminant validity, and reproducibility. The eCPQ appears to be useful to identify patients with chronic pain and to assess and monitor symptoms over time. [ABSTRACT FROM AUTHOR]

Objectives To compare pain medication treatment changes across cohorts of newly diagnosed patients with fibromyalgia ( FM) treated with guideline-recommended medications or opioids. Methods and Design Retrospective claims data analysis examined adult commercial health plan members newly diagnosed with FM (initial diagnosis = index date) from January 2008 to February 2012. Patients had 6-month pre-index and 12-month postindex periods and received pain medication within 6 months postindex; cohorts were based on the first postindex medication. Guideline-recommended medication cohorts were anti-epileptic drug ( AED), serotonin-norepinephrine reuptake inhibitor ( SNRI), selective serotonin reuptake inhibitor ( SSRI), and tricyclic antidepressant ( TCA). Short-acting and long-acting opioid ( SAO, LAO) cohorts were also identified. Pairwise comparisons with the SAO cohort were conducted. Cox proportional hazards regressions modeled the likelihood of receiving guideline-recommended therapy. Results The final sample was 96,175 patients (mean age 47.3 years; 72.5% female), distributed into SAO (57%), SSRI (22%), AED (10%), SNRI (6%), TCA (3%), and LAO (2%) cohorts. The SAO cohort had the most discontinuation (49% vs. 6% to 22%, P < 0.01) and the least augmentation (29% vs. 35% to 50%, P < 0.01). Regression analyses indicated that patients with (vs. without) pre-index guideline-recommended medications were 2 to 4 times more likely to receive them postindex. Patients in the opioid cohorts were about half as likely to receive subsequent guideline-recommended medications. Conclusions Opioid use was widespread among patients with FM. Once patients received opioids postdiagnosis, the likelihood of receiving guideline-recommended medications was small. These real-world results indicate an opportunity may exist for improved FM management using recommended therapies in clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: This study investigated the effect of pain severity on health status, work productivity, health care resource use, and costs among respondents with lower back pain (LBP), in Japan. Materials and methods: Data from the 2013 Japan National Health and Wellness Survey, a survey of Japanese adults, were analyzed (N=30,000). All respondents provided informed consent, and the protocol was institutional review board-approved. Respondents who reported experiencing LBP were propensity score–matched to those without LBP, based on demographics and health history. Using regression modeling, patients with mild, moderate, and severe pain were compared against matched controls, with respect to health status (Mental and Physical Component Summary scores, and health utilities from the Short Form®-36 Health Survey version 2), work productivity (Work Productivity and Activity Impairment – General Health version), health care resource use, and annual per-patient costs (estimated using published annual wages and resource use event costs). Results: A total 1,897 patients reported experiencing LBP in the past month (6.32%); 52.45% reported their pain as mild, 32.79% as moderate, and 14.76% as severe. Increasing pain severity was associated with significantly lower levels of mental component scores (46.99 [mild], 42.93 [moderate], and 40.58 [severe] vs 48.10 [matched controls]), physical component scores (50.29 [mild], 46.74 [moderate], and 43.94 [severe] vs 52.93 [matched controls]), and health utilities (0.72 [mild], 0.66 [moderate], and 0.62 [severe] vs 0.76 [matched controls]) (all P,0.05). Indirect costs were significantly higher (P,0.05) among those with moderate (¥1.69 million [MM] [equivalent to $17,000, based on United States dollar exchange rates on September 1, 2014]) and severe (¥1.88 MM [$19,000]) pain, relative to matched controls (¥0.95 MM [$9,500]). Direct costs were only marginally different (P=0.05) between those with severe pain and matched controls (¥1.33 MM [$13,000] vs ¥0.54 MM [$5,000]). Conclusion: Increasing pain severity among respondents with LBP was associated with significantly worse health status, to a clinically-relevant degree, along with greater indirect and direct costs, in Japan. [ABSTRACT FROM AUTHOR]

Purpose To determine prior authorization (PA) impact on healthcare utilization, costs, and pharmacologic treatment patterns for painful diabetic peripheral neuropathy ( pDPN) and fibromyalgia (FM). Methods This retrospective, observational, longitudinal cohort study used medical and pharmacy claims data. Newly diagnosed patients treated for FM or pDPN between 7/1/2007 and 12/31/2011 were included. PA and no PA groups were matched by propensity score 4:1. Medical resource utilization, direct medical and pharmacy costs, and treatment pattern differences were compared. Pre and postindex differences between PA and no PA cohorts were determined by difference in difference analysis. Results Analysis of 2,315 FM patients (1,852 PA; 463 no PA) demonstrated greater increases in postindex all-cause costs ($197; P = 0.6673) and disease-related costs ($72; P = 0.4186) in the PA cohort. Analysis of 1,300 pDPN patients (1,040 PA; 260 no PA) demonstrated postindex all-cause cost increases of $1,155 more in the no PA cohort ( P = 0.6248); disease-related costs decreased $2,809 more in the no PA cohort ( P = 0.4312). Treatment patterns were similar between cohorts; opioid usage was higher in the FM PA cohort ( P = 0.0082). Conclusions There was no evidence of statistically significant differences between PA and no PA cohorts in either FM or pDPN populations for total all-cause or disease-related costs. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Sleep disturbances are common in patients with fibromyalgia (FM). The objective of this analysis was to evaluate the effects of pregabalin on sleep in patients with FM. Methods: Analyses were based on two randomized, double-blind, placebo-controlled trials of pregabalin (300mg, 450mg, and 600mg daily) in adult FM patients. Sleep outcomes included the Medical Outcomes Study (MOS) Sleep Scale and a daily diary assessment of sleep quality. Treatment effects were evaluated using analysis of covariance. Clinically important differences (CID) in the Sleep Quality Diary and MOS Sleep Disturbance scores were estimated using mixed-effects models of changes in scores as a function of patients’ global impressions of change. Mediation modeling was used to quantify the direct treatment effects on sleep in contrast to indirect influence of the treatment on sleep via pain. Results: A total of 748 and 745 patients were randomized in the respective studies. Patients were predominantly Caucasian females, average age 48–50 years, on average had FM for 9–10 years, and experienced moderate to severe baseline pain. Pregabalin significantly improved the Sleep Quality Diary (P <0.001), MOS Sleep Disturbance (P <0.01), MOS Quantity of Sleep (P <0.003), and MOS Sleep Problems Index scores (P <0.02) relative to placebo. Treatment effects for the 450mg and 600mg groups exceeded the estimated CID thresholds of 0.83 and 7.9 for the Sleep Quality Diary and MOS Sleep Disturbance scores, respectively. Mediation models indicated that 43–80% of the benefits on sleep (versus placebo) were direct effects of pregabalin, with the remainder resulting from an indirect effect of treatment via pain relief. Conclusions: These data demonstrate improvement in FM-related sleep dysfunction with pregabalin therapy. The majority of this benefit was a direct effect of pregabalin on the patients’ insomnia, while the remainder occurred through the drug’s analgesic activity. [Copyright &y& Elsevier]