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

Background: Vitiligo is an autoimmune disorder that causes patchy loss of skin pigmentation. Up to 2.16% of pediatric patients may have vitiligo. This study estimated vitiligo point prevalence in children and adolescents (ages: 4-11 and 12-17 years) in the United States (US)., Methods: An online, population-based survey of a nationally representative sample of individuals based on 2017 US Census Bureau estimates for age, race, Hispanic origin, income, and geographic region was conducted from December 2019 to March 2020. Parent/legal guardian proxies responded on behalf of their children or adolescents to vitiligo screening questions. Proxy-reported vitiligo status was adjudicated by expert dermatologists who reviewed photographs of vitiligo lesions uploaded by proxies using a teledermatology application. Estimated point prevalence (including diagnosed and undiagnosed vitiligo and its subtypes) was calculated for proxy-reported and clinician-adjudicated vitiligo., Results: There were 9,118 eligible proxy responses (5,209 children, mean age 7.7 years; 3,909 adolescents, mean age 14.4 years). The proxy-reported vitiligo prevalence (95% confidence interval) for children and adolescents was 1.52% (1.11-1.93) and 2.16% (1.66-2.65), respectively. The clinician-adjudicated prevalence (sensitivity analysis bounds) was 0.84% (0.83-1.23) and 1.19% (1.18-1.74), respectively. Approximately 69% of children and 65% of adolescents had nonsegmental vitiligo (clinician adjudicated) and up to 50% may be undiagnosed., Conclusion: Based on the clinician-adjudicated prevalence estimates, there were more than 591,000 cases of vitiligo in children and adolescents in the US in 2020. More than two-thirds had nonsegmental vitiligo and nearly half may be undiagnosed. Future studies should confirm these findings., (© 2023 S. Karger AG, Basel.)

Purpose: This study sought to describe patient characteristics and treatment patterns among patients with insomnia prescribed trazodone in the United States., Methods: This real-world, retrospective, descriptive cohort study used US commercial insurance claims from July 1, 2009, through June 30, 2019. The index date was the first prescription for trazodone between January 1, 2010, and December 31, 2018, with 6 months for the preindex period and ≥6 months for the postindex period., Findings: Among 5.8 million patients with insomnia, 17.7% were prescribed trazodone, and 357,380 adults (6.2%) and 7564 children (0.1%) met the study eligibility criteria. The mean (SD) age was 48.8 (15.8) years for adults and 14.8 (2.7) years for pediatrics. Most patients were female (229,280 adults [64.2%] and 4481 children [59.2%]). Insomnia due to mental disorder was the most common specific diagnosis. The most common (>25%) comorbid conditions were anxiety, depression, and hypertensive disease, and 1 of 10 had a history of substance abuse. Zolpidem was previously prescribed (73,342 adults [20.5%] and 233 children [3.1%]) and continued to be prescribed. Concomitant antidepressants were most common (216,893 adults [60.7%] and 5414 children [71.6%]), but benzodiazepines (132,740 adults [37.1%] and 1188 children [15.7%]), antiepileptics (115,064 adults [32.2%] and 2103 children [27.8%]), nonbenzodiazepines (90,946 adults [25.4%] and 542 children [7.2%]), and antipsychotics (40,490 adults [11.3%] and 2063 children [27.3%]) were also prescribed., Implications: This study provides current evidence that trazodone use is widespread among patients with insomnia and is often associated with other specific comorbidities, such as psychiatric conditions. A deeper knowledge of the real-world management of patients with insomnia may facilitate steps toward improving sleep quality, daytime functioning, and clinical outcomes for patients., Competing Interests: Declaration of Competing Interest All authors have seen and approved the manuscript. This study was sponsored by Angelini Pharma S.p.A., of which I. Pochiero, M. Gorini, A. Comandini, F. Calisti, G. Di Loreto, and A. Cattaneo are employees. The study was conducted by Labcorp Drug Development, of which T. Knight, K.P. Anastassopoulos, R. Patel, and R. Baik are employees. O. Bruni is a consultant for Fidia Pharma., (Copyright © 2022. Published by Elsevier Inc.)

Importance: Vitiligo can have profound effects on patients and is often associated with other autoimmune comorbid conditions. It is important to understand the current prevalence of vitiligo, including diagnosed, undiagnosed, and subtypes (nonsegmental and segmental)., Objective: To estimate the point prevalence of vitiligo in the US., Design, Setting, and Participants: For this population-based study of adults in the US, a cross-sectional online survey was administered between December 2019 and March 2020 to obtain participant self-reported vitiligo status. A representative sample of the US adult general population, aged 18 to 85 years, was recruited using a stratified proportional, sampling design from general population research panels. Additionally, 3 expert dermatologists adjudicated participants' self-reported vitiligo diagnosis by reviewing photographs uploaded by the participants using a teledermatology app designed and tested specifically for this study., Main Outcomes and Measures: The main outcomes were the point prevalence estimates of overall vitiligo, as well as diagnosed, undiagnosed, nonsegmental, and segmental vitiligo., Results: Among the 40 888 eligible adult participants, the mean (SD) age was 44.9 (17.4) years, 23 170 (56.7%) were female, 30 428 (74.4%) were White, and 4225 (10.3%) were of Hispanic, Latino, or Spanish origin. Self-reported vitiligo prevalence was 1.38% (95% CI, 1.26%-1.49%), with 0.77% (95% CI, 0.68%-0.85%) for diagnosed and 0.61% (95% CI, 0.54%-0.69%) for undiagnosed. Based on expert dermatologist review of 113 photographs of participants with self-reported vitiligo, clinician-adjudicated vitiligo prevalence (sensitivity bounds) was 0.76% (0.76%-1.11%), with 0.46% (0.46%-0.61%) for diagnosed and 0.29% (0.29%-0.50%) for undiagnosed. Self-reported nonsegmental vitiligo prevalence was 0.77% (95% CI, 0.68%-0.85%), with 0.48% (95% CI, 0.41%-0.55%) for diagnosed and 0.29% (95% CI, 0.23%-0.34%) for undiagnosed. Clinician-adjudicated nonsegmental vitiligo prevalence (sensitivity bounds) was 0.58% (0.57%-0.84%), with 0.37% (0.37%-0.49%) for diagnosed and 0.21% (0.20%-0.36%) for undiagnosed. Self-reported segmental vitiligo prevalence was 0.61% (95% CI, 0.53%-0.69%), with 0.28% (95% CI, 0.23%-0.33%) for diagnosed and 0.33% (95% CI, 0.27%-0.38%) for undiagnosed. Clinician-adjudicated segmental vitiligo prevalence (sensitivity bounds) was 0.18% (0.18%-0.27%), with 0.09% (0.09%-0.12%) for diagnosed and 0.08% (0.08%-0.15%) for undiagnosed., Conclusions and Relevance: Results of this survey study demonstrated that the current US population-based prevalence estimate of overall (diagnosed and undiagnosed combined) vitiligo in adults is between 0.76% (1.9 million cases in 2020) and 1.11% (2.8 million cases in 2020). Additionally, this study suggests that approximately 40% of adult vitiligo in the US may be undiagnosed. Future studies should be performed to confirm these findings.

Background: HIV-related neuropathic pain (HIV-NeP) is common; however, the burden of HIV-NeP is not well-understood., Methods: The cross-sectional study aimed to characterize the HIV-NeP burden. A total of 103 patients with HIV-NeP recruited during routine office visits completed a questionnaire to assess patient-reported outcomes, including pain severity, health status, sleep, mood, and lost productivity. Physicians completed a 6-month retrospective chart review., Results: The sample was predominantly male and not employed for pay. A majority (75.7%) of patients experienced moderate or severe pain. Pain interference, general health, physical health, and depression were worse among patients with more severe pain (all Ps < .006). Most (87.4%) patients were prescribed at least 1 medication for NeP. HIV-related neuropathic pain was associated with 36.1% work impairment. Adjusted annualized costs increased with increasing pain severity (P < .0001)., Conclusion: The impact of HIV-NeP on health status, physical function, and depression increases with severity, resulting in substantial clinical and economic burden., (© The Author(s) 2015.)

Objective: Pain is a prevalent condition that often involves a neuropathic component. Hydrocodone is one of the most widely used opioids for pain but is often associated with side effects (SEs). This study sought to characterize the experience of patients taking hydrocodone for non-cancer pain., Methods: A nationwide survey of adults in the United States taking hydrocodone for non-cancer pain was conducted. The survey included questions to characterize these patients and their experience with hydrocodone-related SEs. A neuropathic pain subgroup also was examined., Results: Among 630 respondents, the average age was 50.1 years (14.25). Most (90.6 percent) were Caucasian and 72.5 percent were female. Back pain or low back pain was the most common (42.1 percent) type of pain. Almost three-fourths (73.3 percent) experienced at least one SE, and 67.3 percent reported being bothered. More than three-fourths (78.3 percent) reported being satisfied with hydrocodone relieving pain; however, less (74.8 percent) reported being satisfied with it overall. More than one-fourth (27.6 percent) reported taking hydrocodone less than instructed with 41.4 percent of them reporting that SEs were bothersome as a reason. A greater percent of the neuropathic pain subgroup (266 respondents) experienced at least one SE (80.8 percent) and were bothered by them (75.6 percent). Overall satisfaction was slightly lower (71.1 percent) among these respondents, and among the 24.8 percent taking less than instructed, more than half (54.5 percent) reported that SEs were bothersome as a reason., Conclusions: This study demonstrates an unmet need for better therapeutic options to manage pain, including neuropathic pain. Therapies that offer improved tolerability also may increase adherence, which could affect overall satisfaction and response to pain management.

Background: Chronic pain is a prevalent condition in the United States. Musculoskeletal pain, including joint and back pain, is the most common type of chronic pain, and many patients with back pain have a neuropathic component. Pain has direct economic consequences. While oxycodone controlled-release (CR) is one of the most widely used oral long-acting opioids for pain, including pain with a neuropathic component, it is often associated with bothersome side effects, resulting in additional medical resource use (MRU) and costs., Objective: To examine the impact on MRU and costs to payers of side effects in patients taking oxycodone CR alone or in combination with other pain medications for noncancer pain (including those with neuropathic pain symptoms)., Methods: A nationwide convenience sample of adults in the United States, who participated in a survey research panel and reported current use of oxycodone CR for noncancer pain, completed an online survey between November 2, 2010, and December 13, 2010. Respondents were excluded if they reported current use of other extended-release or long-acting opioid prescription medications. The survey consisted of questions on demographics, clinical characteristics, pain characteristics, experience with pain medication, and MRU associated with side effects. Payer costs were calculated based on the MRU reported by the respondents multiplied by Medicare reimbursement rates for hospitalizations and outpatient visits and average wholesale price (AWP) minus 20% for medications. A subgroup of patients who reported neuropathic pain symptoms also was examined., Results: After applying the exclusion criteria, 432 respondents completed the survey. Approximately half of the respondents (n = 219; 50.7%) reported neuropathic pain symptoms. The majority of respondents were Caucasian (88.4%) and female (63.7%) with an average age of 41.8 years (14.89). Respondents most frequently reported low back pain (41.2%), followed by osteoarthritis/rheumatoid arthritis (20.4%), neuropathic pain (10.6%), and fibromyalgia (9.0%). Respondents reported having their pain condition for an average of 5.4 (7.42) years. On days when taken, respondents reported a mean oxycodone CR daily dose of 83.3 mg (126.93) taken in an average of 2 doses. Most respondents (82.4%) reported experiencing at least 1 side effect with 77.5% being bothered by at least 1 side effect. The most frequently reported side effects ( greater than 25%) were drowsiness (41.4%), constipation (37.0%), fatigue or daytime sleepiness (36.6%), and dizziness (27.1%). Among respondents who reported being bothered by one or more side effects in the previous month, MRU associated with side effects was reported by 39.1% of respondents and significantly increased as the level of side-effect bother increased from 19.8% among those "A little bit bothered" to 38.4% among those "Bothered" to 61.0% among those "Extremely bothered" (P less than 0.001). Additionally, total average payer costs (in 2010 dollars) per respondent in the previous month associated with side effects were $238 ($1,159) and also significantly increased as the level of side-effect bother increased from $61 ($512) among those "A little bit bothered" to $238 ($1,160) among those "Bothered" to $425 ($1,561) among those "Extremely bothered" (P less than 0.001). Results reported in the neuropathic pain subgroup were similar to results reported in the total study sample., Conclusions: Among adults taking oxycodone CR for chronic noncancer pain (with or without a neuropathic pain component), over three-fourths reported being bothered by side effects. Respondents who reported higher levels of side-effect bother also reported greater MRU, resulting in increased payer costs. The results of this study provide further support of the econo-mic burden to payers associated with opioid-related side effects in patients with chronic noncancer pain, with and without neuropathic pain.

Background: Patients with fibromyalgia report persistent widespread pain, fatigue, and substantial functional limitations, which may lead to high health resource use (HRU) and lost productivity. Previous analyses of the U.S. population have not examined the direct and indirect costs of fibromyalgia by severity level., Objectives: To assess (a) HRU, direct and indirect costs associated with fibromyalgia in routine clinical practice in the United States using a patient-centric approach, and (b) the relationship of fibromyalgia severity level to HRU and costs., Methods: This study recruited a nonprobability convenience sample of 203 subjects aged 18 through 65 years between August 2008 and February 2009 from 20 U.S. community-based physician offices. Subjects had a prior diagnosis of fibromyalgia by a rheumatologist, neurologist, or pain specialist; received treatment at the enrolling physician's practice for at least 3 months; experienced widespread pain for at least 3 months; and experienced pain in the previous 24 hours. Subjects completed a 106-item patient questionnaire that included 5 validated health-related quality-of-life instruments and study-specific questions about demographics; clinical history; overall health; treatment satisfaction; and impact of fibromyalgia on cognitive function, daily activities, and employment status. Subjects also self-reported hours of unpaid informal caregiver time because of inability to perform daily activities (e.g., housework, child care), out-of-pocket expenses for medical and nonmedical services, and lost productivity related to fibromyalgia for the previous 4 weeks. The 20-item Fibromyalgia Impact Questionnaire total score was used to stratify subjects into fibromyalgia severity groups (0 to less than 39 = mild, 39 to less than 59 = moderate, 59 to 100 = severe). Staff at each site recorded clinical characteristics, HRU, and medication use attributable to fibromyalgia on a paper clinical case report form (CRF) based on a 3-month retrospective medical chart review. Unit costs for 2009 were assigned to the 3-month HRU data reported on the CRF and 4-week subject-reported lost productivity. Costs were then annualized and reported in the following categories: direct medical, direct nonmedical, and indirect. Differences across severity levels were evaluated using the Kruskal-Wallis test (continuous measures) and Pearson chi-square or Fisher's exact tests (categorical measures) at the 0.05 alpha level., Results: Of the 203 subjects, 21 (10.3%) had mild, 49 (24.1%) had moderate, and 133 (65.5%) had severe fibromyalgia. For subjects with mild, moderate, and severe fibromyalgia, respectively, the number of fibromyalgia-related medications (3-month means: 1.8, 2.3, and 2.8, P = 0.011) and office visits to health care providers (3-month means: 2.7, 5.2, and 6.9, P < 0.001) significantly differed across severity levels. Across severity levels, total medical and nonmedical out-of-pocket costs also differed (P = 0.025). Mean [median] 3-month total direct costs (including payer costs for HRU and out-of-pocket costs for medical and nonmedical services) were $1,213 [$1,150], $1,415 [$1,215], and $2,329 [$1,760] for subjects with mild, moderate, and severe fibromyalgia, respectively (P = 0.002); and mean [median] 3-month indirect costs (including subject-reported absenteeism, unemployment, disability, and the estimated value of unpaid informal care) were $1,341 [$0], $5,139 [$1,680], and $8,285 [$7,030] (P < 0.001). Mean total indirect costs accounted for 52.5%, 78.4%, and 78.1% of mean total costs for subjects with mild, moderate, and severe fibromyalgia, respectively., Conclusions: Direct and indirect costs related to fibromyalgia are higher among subjects with worse fibromyalgia severity. Indirect costs account for a majority of fibromyalgia-related costs at all fibromyalgia severity levels.

Background: Fibromyalgia (FM) is characterized by chronic, widespread pain, fatigue, and other symptoms; yet few studies have comprehensively assessed its humanistic burden. This observational study evaluates the impact of FM severity on patients' symptoms, health-related quality of life (HRQoL), and productivity in the United States., Methods: 203 FM subjects were recruited from 20 physician offices. Subjects completed a questionnaire including the EuroQol 5D (EQ-5D), Fibromyalgia Impact Questionnaire (FIQ), Multidimensional Assessment of Fatigue (MAF), Medical Outcomes Study Sleep Scale (MOS-SS), and Hospital Anxiety and Depression Scale (HADS) and questions about demographics, pain and other symptoms, HRQoL and productivity. FIQ total scores were used to define FM severity, with 0- < 39, 39- < 59, and 59-100, representing mild, moderate, and severe FM, respectively. Sites recorded subjects' clinical characteristics and FM treatment on case report forms using medical records. Summary statistics were calculated for continuous variables and frequency distributions for categorical variables. Differences across FM severity groups were evaluated using the Kruskal-Wallis or Chi-square tests. Statistical significance was evaluated at the 0.05 level., Results: Mean (SD) age was 47.9 (10.9); 95% were female. Most (92%) were prescribed medication for FM; 24% and 66% reported moderate and severe FM, respectively. Mean (SD) scores were: 6.3 (2.1) for pain intensity; 0.35 (0.35) for EQ-5D; 30.7 (14.2) for MAF; 57.5 (18.4) for MOS-SS Sleep Problems Index; 10.2 (4.8) for HADS anxiety and 9.4 (4.4) for HADS depression. Subjects with worse FM severity reported significantly increased pain severity, HRQoL, fatigue, sleep disturbance, anxiety and depression (p < 0.001). Overall, 50% of subjects reported some disruption in their employment due to FM; this differed across severity levels (p < 0.001). Employed subjects missed a mean (SD) of 1.8 (3.9) workdays during the past 4 weeks; this also differed across severity levels (p = 0.03)., Conclusions: FM imposes a substantial humanistic burden on patients in the United States, and leads to substantial productivity loss, despite treatment. This burden is higher among subjects with worse FM severity.

Background: Fibromyalgia (FM) is characterized by persistent and widespread pain and often associated with other symptoms and comorbidities. Thus, FM patients seek care from multiple physician specialties. This study compared prescribing patterns, patient-reported outcomes (PROs), healthcare resource use (HRU), and direct costs related to FM in routine clinical practice across physician specialties., Methods: This cross-sectional, observational study recruited 203 FM subjects from 20 community-based physician offices (eight primary care, six rheumatology, three neurology, three psychiatry). Subjects completed questions about pain, other symptoms, quality of life, productivity, treatment effectiveness and satisfaction, and out-of-pocket expenses related to FM; site staff recorded subjects' treatment and HRU based on medical chart review. Results were compared across specialties. Statistical significance was evaluated at the 0.05 level. Annual direct costs associated with FM were calculated in 2009 US dollars., Results: Subject demographic and clinical characteristics were not significantly different across physician specialties, except psychiatry subjects had the highest mean number of co-morbid conditions; p < 0.001. PROs were similar across physician specialties except fatigue; neurology subjects reported the highest levels. There were no significant differences in subject-reported outcomes of medication effectiveness (p = 0.782) and medication satisfaction (p = 0.338) for FM. Psychiatry subjects had more FM-related physician visits compared to other specialties (p = 0.013) and a higher proportion received diagnostic tests related to FM (p = 0.013). The mean (SD) number of FM prescription medications prescribed per subject was highest in the primary care and lowest in the neurology group; p = 0.024. The proportion of hypnotic (p = 0.001), muscle relaxant (p = 0.005), anxiolytic (p = 0.005), anti-epileptic (p = 0.007), and other medications (p = 0.044) prescribed for FM were significantly different across specialties. Overall direct medical costs did not differ significantly (p = 0.284) across specialties., Conclusions: Patient characteristics were similar across specialties, except with regards to comorbidity burden. This study noted significant differences among physician specialties in HRU and treatment patterns among medications, diagnostics, and outpatient visits. Consistent with other studies, this study did not identify a dominant strategy for FM management across physician specialties as overall per patient medical costs and subject-reported treatment satisfaction were similar. Future research to better characterize differences among physician specialties in FM management, as well as the reasons for these differences, would be useful.