Elranatamab efficacy in MagnetisMM-3 compared with real-world control arms in triple-class refractory multiple myeloma.

Elranatamab efficacy in the single-arm, registrational MagnetisMM-3 trial (NCT04649359) was compared with that of physician's choice of treatment (PCT) for triple-class refractory multiple myeloma. MagnestisMM-3 eligibility criteria were applied to two USA-based oncology electronic health record databases, COTA and Flatiron Health (FH), to identify cohorts for this study (NCT05932290). Applied statistical techniques accounted for cohort imbalances. MagnetisMM-3 (BCMA-naive; n = 123) outcomes were compared with those from COTA (n = 239) and FH (n = 152). Elranatamab was associated with a significantly higher objective response rate (risk ratios, 1.88-2.25), significantly longer progression-free survival (hazard ratios [HRs], 0.37-0.57), and, across most analyses, significantly longer overall survival (HRs, 0.46-0.66) versus PCT. BCMA-naive patients who were treated with elranatamab exhibited significantly better outcomes than patients treated in real-world clinical practice.

Elranatamab is a new medicine for the treatment of people with multiple myeloma. In the ongoing clinical trial MagnetisMM-3, most people had fewer myeloma cells when treated with elranatamab. However, MagnetisMM-3 only looks at the effects of elranatamab without comparing it to other myeloma treatments. Therefore, a new study was designed to compare the effectiveness of elranatamab in the MagnetisMM-3 study with other treatments used in real-world clinical practice (not in a clinical trial). Data from people in MagnetisMM-3 was compared with data from two US databases (COTA and Flatiron Health) containing health records of patients treated for multiple myeloma in real-life clinical practice. The same criteria used to select patients for the MagnetisMM-3 trial (123 people) were used to identify people with similar characteristics in COTA (239 people) and Flatiron Health (152 people). More people treated with elranatamab had fewer myeloma cells in their bodies after treatment than people who received their doctor's choice of treatment in clinical practice. In fact, six out of ten people treated with elranatamab had fewer myeloma cells versus about three in ten people from each real-world database. People treated with elranatamab versus physician's choice of treatment lived longer without their disease getting worse and lived longer overall. In conclusion, this study found that more people treated with elranatamab responded to treatment and lived longer than similar people from the COTA and Flatiron Health databases who were given treatments available in a real-world clinical setting.Clinical Trial Registration: NCT05932290 (ClinicalTrials.gov).

The societal burden of chronic pain in Japan: an internet survey.

OBJECTIVES: Chronic pain affects between 10-20 % of the population of Japan and several specific types of chronic pain have been found to be associated with worse health outcomes. The aim of the current study was to investigate the economic burden of chronic pain as well as the health status among Japanese patients. METHODS: Data from the Japan National Health and Wellness Survey (NHWS), a cross-sectional health survey of adults, were used (N = 30,000). Respondents with chronic pain (N = 785) were compared with respondents without chronic pain (N = 29,215) with respect to health status (using the SF-12v2), work productivity and activity impairment (WPAI questionnaire), and healthcare resource use using regression modeling, controlling for demographic and health history covariates. Indirect costs were calculated using wage rates and the human capital method. RESULTS: Back pain (72.10 %) and shoulder pain/stiffness (54.90 %) were the most prevalent pain types. Adjusting for demographic and health history differences, respondents with chronic pain reported lower health status [mental component summary (MCS): 44.26 vs. 51.14; physical component summary (PCS): 44.23 vs. 47.48; both p < 0.05], greater absenteeism (4.74 vs. 2.74 %), presenteeism (30.19 vs. 15.19 %), overall work impairment (31.70 vs. 16.82 %), indirect costs (¥ 1488,385 vs. ¥ 804,634), activity impairment (33.45 vs. 17.25 %), physician visits (9.31 vs. 4.08), emergency room (ER) visits (0.19 vs. 0.08), and hospitalizations (0.71 vs. 0.34) (all p < 0.05). Nearly 60 % of respondents with chronic pain were untreated. The mean level of pain severity in the last week was 5.26 (using a 0-11 scale); being female, being elderly, having low income, and having multiple pain types were significantly associated with greater pain severity (all p < 0.05). Regular exercise was associated with lower pain severity (p < 0.05). CONCLUSIONS: The results suggest that chronic pain has a significant association in an individual's health status, work productivity, daily activity impairment, healthcare resource use, and economic burden in Japan. Along with low treatment rates, a multidisciplinary approach may lead to an improved quality of life and reduce the economic burden among patients with chronic pain in Japan.

Burden of gastrointestinal disease in the United States: 2012 update.

BACKGROUND & AIMS: Gastrointestinal (GI) diseases account for substantial morbidity, mortality, and cost. Statistical analyses of the most recent data are necessary to guide GI research, education, and clinical practice. We estimate the burden of GI disease in the United States. METHODS: We collected information on the epidemiology of GI diseases (including cancers) and symptoms, along with data on resource utilization, quality of life, impairments to work and activity, morbidity, and mortality. These data were obtained from the National Ambulatory Medical Care Survey; National Health and Wellness Survey; Nationwide Inpatient Sample; Surveillance, Epidemiology, and End Results Program; National Vital Statistics System; Thompson Reuters MarketScan; Medicare; Medicaid; and the Clinical Outcomes Research Initiative's National Endoscopic Database. We estimated endoscopic use and costs and examined trends in endoscopic procedure. RESULTS: Abdominal pain was the most common GI symptom that prompted a clinic visit (15.9 million visits). Gastroesophageal reflux was the most common GI diagnosis (8.9 million visits). Hospitalizations and mortality from Clostridium difficile infection have doubled in the last 10 years. Acute pancreatitis was the most common reason for hospitalization (274,119 discharges). Colorectal cancer accounted for more than half of all GI cancers and was the leading cause of GI-related mortality (52,394 deaths). There were 6.9 million upper, 11.5 million lower, and 228,000 biliary endoscopies performed in 2009. The total cost for outpatient GI endoscopy examinations was $32.4 billion. CONCLUSIONS: GI diseases are a source of substantial morbidity, mortality, and cost in the United States.

Burden of peripheral arterial disease in Europe and the United States: a patient survey.

BACKGROUND: The aim of the current study was to quantify the burden of peripheral arterial disease (PAD) with respect to health-related quality of life, work productivity and activity impairment, and healthcare resource utilization. METHODS: Data were obtained from the 2010 EU National Health and Wellness Survey (NHWS), which included participants from France, Germany, Italy, Spain, and the UK (5 EU, N = 57,805) as well as the 2010 US NHWS (N = 75,000). The NHWS is an annual, cross-sectional, self-administered Internet survey which employs a stratified random sampling frame to match the age and gender characteristics of the NHWS sample with known population statistics. Participants who self-reported a diagnosis of PAD were compared with participants who did not self-report a diagnosis of PAD on health-related quality of life (mental and physical component summary scores and health utilities from the Short Form-12v2), work productivity and activity impairment (Work Productivity and Activity Impairment questionnaire), and healthcare resource use in terms of the number of physician visits, emergency room visits, and hospitalizations in the past six months through regression modeling adjusting for demographics and health characteristics. RESULTS: A total of 743 (1.29%) and 777 (1.04%) participants self-reported a diagnosis of PAD in the 5 EU and US, respectively. After adjusting for demographics and health characteristics, patients with PAD reported worse health-related quality of life, as measured by health utilities (5 EU: 0.66 vs. 0.70; US: 0.66 vs. 0.72; all p < .05), greater overall work impairment percentage (5 EU: 38.27% vs. 27.48%; US: 23.89% vs. 14.26%) and greater healthcare resource use compared to participants without PAD (all p < .05). CONCLUSIONS: These results suggest a significant burden for patients with PAD in both the 5 EU countries and the US with respect to both quality of life and economic outcomes. Improved management of these patients may have profound effects from both patient and societal perspectives.

Incorporating indirect costs into a cost-benefit analysis of laparoscopic adjustable gastric banding.

OBJECTIVES: The objective of this study was to estimate the time to breakeven and 5-year net costs of laparoscopic adjustable gastric banding (LAGB) taking both direct and indirect costs and cost savings into account. METHODS: Estimates of direct cost savings from LAGB were available from the literature. Although longitudinal data on indirect cost savings were not available, these estimates were generated by quantifying the relationship between medical expenditures and absenteeism and between medical expenditures and presenteeism (reduced on-the-job productivity) and combining these elasticity estimates with estimates of the direct cost savings to generate total savings. These savings were then combined with the direct and indirect costs of the procedure to quantify net savings. RESULTS: By including indirect costs, the time to breakeven was reduced by half a year, from 16 to 14 quarters. After 5 years, net savings in medical expenditures from a gastric banding procedure were estimated to be $4970 (±$3090). Including absenteeism increased savings to $6180 (±$3550). Savings were further increased to $10,960 (±$5864) when both absenteeism and presenteeism estimates were included. CONCLUSIONS: This study presented a novel approach for including absenteeism and presenteeism estimates in cost-benefit analyses. Application of the approach to gastric banding among surgery-eligible obese employees revealed that the inclusion of indirect costs and cost savings improves the business case for the procedure. This approach can easily be extended to other populations and treatments.

The burden of illness for patients with viral hepatitis C: evidence from a national survey in Japan.

OBJECTIVE: Viral hepatitis C (HCV) affects 170 million patients worldwide and 2 million patients in Japan. The objective of the current study was to examine the burden of HCV in Japan from a patient's perspective. METHODS: Using data from the 2008 and 2009 Japan National Health and Wellness Surveys, patients who reported an HCV diagnosis (n = 306) were compared with a propensity-score-matched control group (n = 306) on measures of quality of life (using the Medical Outcomes Study 12-Item Short Form Survey Instrument version 2), work productivity (using the Work Productivity and Activity Impairment questionnaire), and health-care resource use. All analyses applied sampling weights to project to the population. RESULTS: Prior to matching, patients with HCV had higher rates of hepatocellular carcinoma (4.88% vs. 0.02%) and cirrhosis (12.20% vs. 0.11%) than did subjects without HCV. The propensity-matching process eliminated differences between the two groups on demographics and patient characteristics. The postmatching analysis found significantly lower levels of quality of life for patients with HCV as measured by bodily pain (72.07 vs. 76.28), general health (44.64 vs. 48.61), and mental health (66.50 vs. 70.32) (all Ps < 0.05). Furthermore, compared with the matched group, the HCV group had significantly higher workplace absenteeism (8.59% vs. 4.12%), overall work impairment (26.08% vs. 17.32%), and health-care provider visits in the past 6 months (14.80 vs. 9.74). CONCLUSIONS: The results of this study suggest that HCV can be a substantial burden on patients in terms of quality of life in both physical and mental health measures. In addition, HCV can be a significant cost driver in terms of health-care use and lost productivity.

Impact of self-rated osteoarthritis severity in an employed population: cross-sectional analysis of data from the national health and wellness survey.

BACKGROUND: Although osteoarthritis (OA) often affects older persons, it has a profound effect on individuals actively employed. Despite reports of reduced productivity among workers with OA, data are limited regarding the impact of OA among workers. The objective of this study was to evaluate the impact of self-rated OA severity on quality of life, healthcare resource utilization, productivity and costs in an employed population relative to employed individuals without OA. METHODS: This cross-sectional analysis used data derived from the 2009 National Health and Wellness Survey (NHWS). Multivariable analyses characterized outcomes and costs (direct medical costs and indirect) among workers (full-time, part-time, or self-employed) ≥ 20 years of age who were diagnosed with OA and who self-rated their OA severity as mild, moderate, or severe relative to workers without OA. Evaluated outcomes included productivity, assessed using the Work Productivity and Impairment (WPAI) scale; health-related quality of life, using the SF-12v2 Health Survey; and healthcare resource utilization. RESULTS: 4,876 workers reported being diagnosed with OA (45.0% mild, 45.9% moderate, and 9.1% severe); 34,896 workers comprised the non-OA comparator cohort. There was a greater proportion of females in the OA cohort (55.5% vs 45.6%; P < 0.0001) and more individuals in the 40-64 year and ≥ 65 year age ranges (P < 0.0001). As OA severity increased, workers reported more frequent pain, poorer quality of life, greater use of specific healthcare resources (hospitalizations) and reduced productivity. All outcomes indicated a significantly greater burden among workers with OA relative to those without OA (P < 0.0001). Estimated total annual costs per worker were $9,801 for mild OA, $14,761 for moderate OA, $22,111 for severe OA compared with $7,901 for workers without OA (P < 0.0001). CONCLUSIONS: Workers with OA were characterized by significant disease and economic burdens relative to workers without OA that substantially increased with greater self-rated OA severity. Greater levels of OA severity were associated with reductions in quality of life and productivity, and increases in healthcare resource utilization and costs.

The impact of COPD on quality of life, productivity loss, and resource use among the elderly United States workforce.

Abstract To address the gap in knowledge about the impact of chronic obstructive pulmonary disease (COPD) on older working adults, this study examined quality of life, worker productivity, and healthcare resource utilization among employed adults aged 65 and older with and without COPD. Among 2009 National Health and Wellness Survey (a cross-sectional, internet-based survey representative of the US adult population) respondents, employed adults aged 65 years and older, with COPD (n = 297) and without COPD (n = 3061), were included in analyses. Impact of self-reported COPD diagnosis on mean quality of life (using health utilities and mental, MCS, and physical, PCS, component summary scores from SF-12v2), work productivity and activity impairment (using the WPAI questionnaire), and resource use were examined. Adjusting for demographic and health characteristics such as co-morbidities (weighted to project to the US population) in regression models (linear, negative binomial, or logistic, as appropriate given the outcome measure), older workers with COPD reported significantly lower MCS (52.1 vs. 53.4, p < .05), PCS (40.3 vs. 47.2, p < .05), and health utilities (0.72 vs. 0.79, p < .05) than those without COPD, and significantly greater percentages of impairment while at work (presenteeism) (12.6% vs. 8.7%, p < .0001), overall work impairment (absenteeism and presenteeism combined) (19.3% vs. 10.0%, p < .05), and impairment in daily activities (23.9% vs. 13.7%, p < .05). There were no significant differences in absenteeism or healthcare use. Quality of life and work productivity suffered among employed adults aged 65 years and older with COPD, emphasizing the need for disease management in this population.

Association between pain severity and health care resource use, health status, productivity and related costs in painful diabetic peripheral neuropathy patients.

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.

Evaluating the health and economic impact of osteoarthritis pain in the workforce: results from the National Health and Wellness Survey.

BACKGROUND: There has been increasing recognition that osteoarthritis (OA) affects younger individuals who are still participants in the workforce, but there are only limited data on the contribution of OA pain to work productivity and other outcomes in an employed population. This study evaluated the impact of OA pain on healthcare resource utilization, productivity and costs in employed individuals. METHODS: Data were derived from the 2009 National Health and Wellness Survey. Univariable and multivariable analyses were used to characterize employed individuals (full-time, part-time, or self-employed) ≥ 20 years of age who were diagnosed with OA and had arthritis pain in the past month relative to employed individuals not diagnosed with OA or not experiencing arthritis pain in the past month. Work productivity was assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire; health status was assessed using the physical (PCS) and mental component summary (MCS) scores from the SF-12v2 Health Survey and SF-6D health utilities; and healthcare utilization was evaluated by type and number of resources within the past 6 months. Direct and indirect costs were estimated and compared between the two cohorts. RESULTS: Individuals with OA pain were less likely to be employed. Relative to workers without OA pain (n = 37,599), the OA pain cohort (n = 2,173) was significantly older (mean age 52.1 ± 11.5 years vs 41.4 ± 13.2 years; P < 0.0001) and with a greater proportion of females (58.2% vs 45.9%; P < 0.0001). OA pain resulted in greater work impairment than among workers without OA pain (34.4% versus 17.8%; P < 0.0001), and was primarily due to presenteeism (impaired activity while at work). Health status, assessed both by the SF-12v2 and the SF-6D was significantly poorer among workers with OA pain (P < 0.0001), and healthcare resource utilization was significantly higher (P < 0.0001) than workers without OA pain. Total costs were higher in the OA pain cohort ($15,047 versus $8,175; P < 0.0001), driven by indirect costs that accounted for approximately 75% of total costs. CONCLUSIONS: A substantial proportion of workers suffer from OA pain. After controlling for confounders, the impact of OA pain was significant, resulting in lower productivity and higher costs.

Treatment patterns and perceptions of treatment attributes, satisfaction and effectiveness among patients with psoriasis.

Psoriasis is a chronic autoimmune condition that affects over 7 million Americans, approximately 1-3 percent of the population. Although there are a number of treatment options currently available, little is known about the treatment patterns of patients. Using data from 1,006 psoriasis sufferers, the aim of the present study was to analyze patients' treatment timeline, as well as their perceptions about these treatments. Most respondents were white, female and had health insurance. The results suggested that over-the-counter (OTC) and prescription topicals were the most common initial treatments, but systemic orals and biologics were the most common treatments for patients who required a third-line or fourth-line treatment (and for patients with greater severity). Treatment dissatisfaction was relatively high, with very few positive attributes associated with the current treatment options. Overall, this study suggests that treatment options vary (at a statistically significant level) as a function of severity, and many patients, despite the choices in the number and quality of treatment options, are generally dissatisfied.

A computerized Stroop task to assess cancer-related cognitive biases.

Biases in processing information related to sources of stress have widely been demonstrated with the use of Stroop emotional color word tasks. One study reported such biases among women with histories of breast cancer in a first-degree relative (FH+) who were given a Stroop cancer word task. This study aimed to replicate and extend these findings with a computerized version of the task. Response latencies and errors were recorded during administration of the task to FH+ and FH- women. A cancer list and 5 comparison lists were administered. Results indicated that FH+ women exhibited longer response latencies for cancer words than did FH- women (p < 0.04), providing further support for cognitive biases in FH+ women. Confirming the psychometric properties of the task, lists exhibited high reliability for both latency (alphas 0.96-0.98) and error rate (alphas 0.61-0.79). In sum, results support the favorable psychometrics and predictive validity of the Stroop cancer word task.

Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe.

OBJECTIVE: The aim of the present study is to examine how moderate-to-severe ulcerative colitis (UC) is currently managed in real-world clinical practice across the United States (US) and European Union Five (EU5; France, Germany, Italy, Spain, and the United Kingdom). METHODS: Data from the 2017 Adelphi Inflammatory Bowel-Disease Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of patient chart information abstracted by selected gastroenterologists across the US and EU5. Eligible gastroenterologists who agreed to participate were asked to complete patient record forms for the next seven consecutive eligible adult patients with UC. Only charts from patients with moderate-to-severe UC were included in the analysis (defined as those with documented administration of either an immunosuppressant [IM] or a biologic). Treatment patterns were reported descriptively. RESULTS: 411 and 1191 patient charts were included in the US and EU5 (mean ages 44.2 and 39.6 years; 53.0% and 43.5% female), respectively. For those with complete treatment history, 40.7% and 52.9% used either an IM or biologic as their first treatment (with or without steroids). Usage of these therapies increased in subsequent lines. The percentage of patients treated with combination therapy (i.e., biologic therapy with a concomitant IM) in first line generally varied between 10-20% (e.g., US: adalimumab (ADA), 10.8%; infliximab (IFX), 18.2%; EU5: ADA, 12.5%; IFX, 19.9%), though increased in later lines in the EU5. Among patients currently using a biologic therapy, between 10-40% of patients used a higher than indicated dose or greater than indicated dosing frequency during maintenance (e.g., US: IFX, 37.1%; ADA, 13.4%; EU5: IFX, 39.1%; ADA, 36.1%). In both the US and EU5, the primary reason for switching therapy was efficacy-related. CONCLUSIONS: In this analysis, many patients with moderate-to-severe UC use an IM or biologic as their first therapy after diagnosis. Combination therapy and dose escalation are also common, and underscore the challenges with managing this patient population.

An economic evaluation of tofacitinib for the treatment of moderately-to-severely active ulcerative colitis: modeling the cost of treatment strategies in the United States.

Aims: To evaluate the cost differences between a treatment strategy including tofacitinib (TOFA) vs treatment strategies including adalimumab (ADA), golimumab (GOL), infliximab (IFX), and vedolizumab (VEDO) among all patients with moderate-to-severe ulcerative colitis (UC) (further stratified by patients naïve/exposed to tumor necrosis factor inhibitors [TNFis]). Materials and methods: An Excel-based decision-analytic model was developed to evaluate costs from the perspective of a third-party US payer over 2 years. Efficacy and safety parameters were taken from prescribing information and published trials. All patients started induction therapy on the first treatment in the strategy and continued if efficacy criteria were met and no major adverse event occurred (in which cases they proceeded to the next treatment in the strategy). Results: The cost per member per month (PMPM) of the TOFA->IFX->VEDO->GOL strategy ($1.11) was lower than that of the ADA->IFX->VEDO->GOL strategy ($1.34; Δ = $-0.23) among the TNFi-naïve population (n = 204 patients out of a plan of one million members). Similarly, the use of TOFA before ADA (i.e. TOFA->ADA->IFX-> VEDO) was also associated with lower PMPM costs than the use of ADA before TOFA (i.e. ADA->TOFA->IFX->VEDO): $1.15 vs $1.25 (Δ = $-0.10). Similar, and often larger, differences were observed in both the overall moderate-to-severe population and the TNFi-exposed population. Sensitivity analyses resulted in the same conclusions. Limitations: Our model relied on efficacy data from prescribing information and published trials, which were not head-to-head and slightly differed with respect to methods. Additionally, our model used representative minor and major ADRs (and the associated costs) to represent toxicity management, which was a simplifying assumption. Conclusions: This analysis, the first of its kind to evaluate TOFA vis-à-vis other advanced therapies in the US, suggests the early use of TOFA among both TNFi-naïve and TNFi-failure patients results in lower PMPM costs compared with other treatment alternatives.

Do decision biases predict bad decisions? Omission bias, naturalness bias, and influenza vaccination.

PURPOSE: Numerous studies using hypothetical vignettes have demonstrated decision biases or deviations from utility theory. Do people who commit biases in questionnaire studies make worse real-world decisions than do less biased people? METHODS: Two hundred seventy university faculty and staff participated in a questionnaire study in which they reported whether they accepted a free influenza vaccine offered at their work place. Influenza vaccine acceptance was the measure of real-world decision making. Participants responded to 3 hypothetical scenarios. Two scenarios measured the omission bias and described a vaccine (scenario 1) and a medication (scenario 2) that prevented a negative health outcome but that itself could cause the negative health outcome. The omission bias is a preference for not vaccinating or medicating even when the vaccine/medication lowers the total risk of the negative outcome. A 3rd scenario measured the naturalness bias by presenting a choice between 2 chemically identical medications, one extracted from a natural herb and the other synthesized in a laboratory. Preference for the natural medication indicated the naturalness bias. RESULTS: The results indicated that a substantial proportion of participants exhibited these biases and that participants who exhibited these biases were less likely to accept the flu vaccine. CONCLUSIONS: To the extent that declining a free flu vaccine is a worse real-world decision, people who demonstrate the naturalness and omission biases in hypothetical scenarios make worse real-world decisions.

The burden of insomnia in Japan.

OBJECTIVES: Several studies have suggested that patients who experience insomnia report a number of significant impairments. However, despite this literature, fewer studies have focused on the burden of insomnia among patients in Japan. The objective of the current study is to extend this work in Japan to further understand the effect of insomnia on health-related quality of life (hrQOL). Further, another objective is to understand general predictors of hrQOL among patients with insomnia. METHODS: Data from the 2012 Japan National Health and Wellness Survey, an annual, cross-sectional study of adults aged 18 years or older, were used (N=30,000). All National Health and Wellness Survey respondents were categorized based on the incidence of self-reported insomnia diagnosis and prescription medication usage (clinical insomniacs under treatment versus [vs] good sleepers without insomnia or insomnia symptoms). Comparisons among different groups were made using multiple regression models controlling for demographics and health history. RESULTS: Clinical insomniacs (n=1,018; 3.4%) reported significantly worse hrQOL compared with good sleepers (n=20,542) (mental component summary: 34.2 vs 48.0; physical component summary: 48.0 vs 52.8; health utilities: 0.61 vs 0.76; all P<0.05). Health behaviors (smoking, exercise, alcohol use) and comorbidities were the strongest predictors of health utilities for clinical insomniacs. For all three clinical insomniac subgroups of interest, those with a physical comorbidity but not a psychiatric one, those with a psychiatric comorbidity but not a physical one, and those without either a physical or psychiatric comorbidity, large decrements in health utilities were observed for respondents who did not engage in any positive health behaviors (0.61, 0.57, 0.64, respectively) relative to good sleepers (0.78). However, the gap in health utility scores between these subgroups and good sleepers diminishes with an increasing number of positive health behaviors (eg, clinical insomniacs with a physical comorbidity but not a psychiatric comorbidity performing all three positive health behaviors =0.67 vs good sleepers =0.78). DISCUSSION: A significant burden remains for those with insomnia who are treated. Given the particularly low levels of hrQOL among treated insomnia patients who have poor health behavior profiles and have psychiatric comorbidities, physicians should place particular emphasis on these patients who are most in need of intervention. Improved treatments may help to address the unmet needs of these patient populations.

Impact of middle-of-the-night awakenings on health status, activity impairment, and costs.

STUDY OBJECTIVES: Middle-of-the-night (MOTN) awakenings with difficulty returning to sleep are among the most common symptoms of insomnia. Despite the epidemiological studies that have been conducted, there is a lack of data on the impact of MOTN awakenings on health status and socioeconomic indicators in comparison with other insomnia symptoms. METHODS: Data were analyzed from the 2011 US National Health and Wellness Survey (adults ≥18 years old; N=60,783), which asked respondents whether they had experienced specific symptoms of insomnia (ie, MOTN awakenings, difficulty falling asleep, waking several times, waking up too early, or poor quality of sleep). Respondents who reported only one insomnia symptom were compared among insomnia subgroups and with no insomnia symptom controls with respect to demographics, health history, and health outcomes (Short Form-12v2, Work Productivity and Activity Impairment questionnaire, and costs). Additional analyses compared respondents with only MOTN awakenings and matched controls on health outcomes. RESULTS: MOTN awakenings without other insomnia symptoms were reported by 3.5% of respondents. Poor quality of sleep was associated with the strongest effects on health status compared with other insomnia symptoms even after adjusting for demographic and health characteristics differences. Differences across insomnia symptoms with respect to cost-related outcomes were generally modest, though all were higher (if not significantly so) than respondents without insomnia. Respondents who experienced only waking several times and only MOTN awakenings had the highest direct costs, while respondents who experienced only poor quality of sleep and only difficulty falling asleep had the highest indirect costs. Respondents with only MOTN awakenings reported significantly worse mental and physical health status and worse health utilities relative to insomnia-free matched controls (all P<0.05). Annual per-employee indirect costs were also significantly higher ($4,328 vs $3,000; P<0.05). Among only MOTN awakenings respondents, 74.6% were considered only symptomatic (ie, they did not report having insomnia or having been diagnosed with insomnia). CONCLUSION: These findings collectively highlight the prevalence and socioeconomic impact of specific types of insomnia symptoms, including MOTN awakenings, experienced by adults in the US.

Multicountry burden of chronic hepatitis C viral infection among those aware of their diagnosis: a patient survey.

BACKGROUND: The World Health Organization has called for global and regional assessments of the burden of hepatitis C (HCV) along with country-specific patient profiles to better inform healthcare policy. The present investigated the characteristics and burden of patients reporting a diagnosis of HCV infection in the US, France, Germany, Italy, Spain, the UK, urban China, and Japan using a consistent methodology of patient-reported surveys. METHODS: The 2010 5EU (N = 57,805), 2009 US (N = 75,000), 2008/2009 Japan (N = 37,683), and 2009/2010 urban China (N = 33,261) waves of the National Health and Wellness Survey were used as the data source. Within each country, patients with a self-reported diagnosis of HCV were compared with those who did not report a diagnosis of HCV on sociodemographics, health behaviors, comorbidities, and health outcomes (e.g., Short Form-12v2). The effect of HCV was examined using regression analysis applying sampling weights. RESULTS: The prevalence of HCV ranged from 0.26% (China) to 1.42% (Italy). Patients in Japan and Italy (61.60 and 61.02 years, respectively) were the oldest, while patients in the US were the most likely to be obese (39.31%) and have concomitant anxiety (38.43%) and depression (46.05%) compared with other countries. Pooling countries and adjusting for sociodemographics, health behaviors, and comorbidities, HCV was associated with significantly lower physical component summary scores (b = -2.51) and health utilities (b = -0.04) and greater overall work impairment (b = 8.79), physician visits (b = 2.91), and emergency department visits (b = 0.30) (all p<.05). The effects on health status were strongest in the US and UK while the effects on healthcare resource use were strongest in Japan. CONCLUSIONS: HCV was associated with a significant humanistic and economic burden. These results suggest that the manifestation of the HCV burden, and the profile of the patients themselves, varied dramatically by country. Successful disease management should be cognizant of region-specific unmet needs.

Burden of vasomotor symptoms in France, Germany, Italy, Spain, and the United Kingdom.

BACKGROUND: Several studies have documented a significant association between vasomotor symptoms (VMS) and a decrement in health outcomes among postmenopausal women, but these studies have mostly focused on the US. The aim of the current study was to broaden this investigation by examining the burden of VMS symptoms in the European Union with respect to both humanistic and economic outcomes. METHODS: All women aged 40-75 years who completed the 2010 5EU (France, Germany, Italy, Spain, and the UK) National Health and Wellness Survey were identified as potential respondents and invited to participate in an additional cross-sectional, Internet-based survey. Only postmenopausal women from 5EU were included in the current analyses (n = 3801). VMS was assessed using the Menopausal Rating Scale, and was used in multiple regression models as the primary predictor of health status (EQ-5D-3L), work productivity loss, and the number of physician visits due to menopause. RESULTS: Over half (50.3%) of postmenopausal women experienced either mild (24.6%), moderate (17.6%), or severe (8.1%) VMS. Controlling for confounding variables, mild (b = -0.03, P < 0.05), moderate (b = -0.07, P < 0.05), and severe VMS (b = -0.17, P < 0.05) were each associated with worse health utilities relative to women without VMS. Similarly, increased resource use (b = 1.04-2.39, all P < 0.05), overall work impairment (b = 8.71-19.69, all P < 0.05), and activity impairment (b = 11.22-24.54, all P < 0.05) were also observed as VMS severity increased (with each b representing the difference between each level of severity and the reference category). CONCLUSION: These results suggest a high prevalence of VMS in Western Europe. These symptoms are also associated with both humanistic and economic outcomes. Improved management of VMS may be able to increase the health status and ability to work productively as well as reduce societal direct costs.

The impact of menopausal symptoms on quality of life, productivity, and economic outcomes.

BACKGROUND: The aim of this study was to investigate the impact of menopausal symptoms and menopausal symptom severity on health-related quality of life (HRQoL), work impairment, healthcare utilization, and costs. METHODS: Data from the 2005 United States National Health and Wellness Survey were used, with only women 40-64 years without a history of cancer included in the analyses (N=8,811). Women who reported experiencing menopausal symptoms (n=4,116) were compared with women not experiencing menopausal symptoms (n=4,695) on HRQoL, work impairment, and healthcare utilization using regression modeling (and controlling for demographics and health characteristic differences). Additionally, individual menopausal symptoms were used as predictors of outcomes in a separate set of regression models. RESULTS: The mean age of women in the analysis was 49.8 years (standard deviation,±5.9). Women experiencing menopausal symptoms reported significantly lower levels of HRQoL and significantly higher work impairment, and healthcare utilization than women without menopausal symptoms. Depression, anxiety, and joint stiffness were symptoms with the strongest associations with health outcomes. CONCLUSIONS: Menopausal symptoms can be a significant humanistic and economic burden on women in middle age.