Clopidogrel versus Aspirin in Patients with Atherothrombosis

Background: Atherothrombosis represents a leading cause of morbidity and mortality worldwide. Given the prominent role of platelet aggregation in atherothrombosis, antiplatelet therapy forms the cornerstone of treatment, with proven efficacy in the secondary prevention of atherothrombotic events. Although clopidogrel seems to be superior to aspirin in terms of risk reduction for an atherothrombotic event, whether this clinical advantage is cost effective in Greece is unknown. Objective: The aim of this study was to conduct a cost-effectiveness analysis comparing clopidogrel with aspirin in the secondary prevention of atherothrombotic events in patients with peripheral artery disease, a recent stroke or a recent myocardial infarction, from the third-party-payer perspective in Greece. Methods: A Markov model with a 6-month cycle length was developed. Transition probabilities used in the model were obtained from the event rates reported in the CAPRIE trial. The effect of clopidogrel was applied only during the first 2 years of the model. Utility data were used to estimate quality-adjusted life-years (QALYs). Costs (for the year 2012) assigned to each health state included antiplatelet treatment cost, cost for the management of adverse events related to antiplatelet therapy and the direct healthcare cost of patients (i.e. concomitant medication, hospitalization, outpatient visits, rehabilitation, laboratory and imaging diagnostic examinations as well as interventions) in the acute and follow-up phase, separately. The incremental cost-effectiveness ratio (ICER) was calculated for life-years (LYs) and QALYs, separately. A probabilistic sensitivity analysis was conducted in order to evaluate the impact of the variation that characterizes the majority of model parameters to the cost-effectiveness results. Results: The Markov analysis revealed that the discounted survival was 11.83 (95% CI 11.40, 12.22) years and 12.17 (95% CI 11.75, 12.55) years in the aspirin and clopidogrel treatment groups, respectively, a difference of 0.34 (95% CI 0.09, 0.618) LYs. The corresponding discounted QALYs were 8.63 (95% CI 8.34, 8.90) and 8.84 (95% CI 8.54, 9.10), respectively, a difference of 0.21 (95% CI 0.05, 0.37) QALYs. The cumulated lifetime costs per patient were €20 678 (95% CI 19 675, 21 724) and €21 688 (95% CI 20 649, 22 773), for aspirin and clopidogrel treatment arm, respectively. The ICER for clopidogrel was calculated to be €4038 (95% CI 2743, 7837) for each LY saved and €5518 (95% CI 3358, 12921) for each QALY saved. Conclusion: The analysis indicates that clopidogrel is cost effective for the secondary prevention of atherothrombotic events in the Greek setting. These findings are in line with those reported in other European countries.     

Cost effectiveness of implantable cardioverter-defibrillators for primary prevention in a belgian context

Background

Implantable cardioverter-defibrillator (ICD) therapy was traditionally applied in patients who survived a cardiac arrest or who experienced a symptomatic ventricular tachyarrhythmia. Its use in primary prevention (i.e. in patients who have yet to experience a serious arrhythmic event, but who are considered at high risk for sudden cardiac death) has become more common, and policy makers question whether ICD therapy should be reimbursed in these instances.

Objective

To assess the cost effectiveness of primary prevention ICD therapy versus conventional therapy from the perspective of the Belgian health insurance system.

Method

A lifetime 1-month cycle Markov model was constructed and populated with clinical and effectiveness data from the SCD-HeFT study and real-world Belgian cost data expressed in year 2005 values. Probabilistic modelling and sensitivity analyses were performed.

Results

ICD therapy results in 1.22 life-years gained (LYG) or 1.03 QALYs gained. The lifetime cost-effectiveness and cost-utility ratios were €59 989 (95% CI 35 873, 113 518) per LYG and €71 428 (95% CI 40 225, 134 623) per QALY gained, respectively. A cost-effectiveness ratio <€50 000 per QALY gained was obtained in 15.5% of 1000 simulations. Increasing the service life of the device from 5 to 7 years would improve the cost effectiveness to €57 229 (95% CI 32 568, 106 410) per QALY gained.

Conclusions

ICD therapy may not be judged cost effective for the primary prevention of death in patients with a SCD-HeFT profile in the Belgian context using current technology and patient selection. A combination of price reductions and increased service life of the device may alter this conclusion.     

Economic Evaluation of Clopidogrel in Acute Coronary Syndrome Patients without ST-Segment Elevation in Greece

Background: Current guidelines recommend treatment with antiplatelet and anticoagulant therapy for the secondary prevention of atherothrombotic events among patients with non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (UA). The CURE (Clopidogrel in Unstable angina to prevent Recurrent Events) trial has shown that clopidogrel alone or in combination with aspirin is more effective in reducing the risk of atherothrombotic events than aspirin alone in NSTEMI or UA patients. However, in the current climate of financial constraints, the effectiveness of a treatment should be considered in conjunction with its long-term economic costs to determine the best possible care. Objective: To evaluate the cost effectiveness of 1 year of treatment with clopidogrel in addition to aspirin in NSTEMI or UA patients from the third-party-payer perspective in Greece. Methods: An existing Markov model consisting of six states (NSTEMI/UA/no event, first year with stroke, history of stroke, first year with myocardial infarction [MI], history of MI and death) was adapted and extended to the Greek healthcare setting for year 2012. Utility values obtained from a Greek national study were assigned to each health state in order to estimate the quality-adjusted life-years (QALYs). Costs assigned to each health state included antiplatelet treatment cost, cost for the management of adverse events and the costs for concomitant medication, hospitalization, outpatient visits, rehabilitation and nursing. Cost effectiveness and cost utility was expressed as the cost per life-year (LY) gained and QALY gained, respectively. A probabilistic sensitivity analysis was conducted. Results: The Markov analysis predicts a discounted survival of 8.27 years in the aspirin treatment group and 8.41 years in the aspirin plus clopidogrel treatment group. The corresponding discounted QALYs were 6.88 and 7.00, respectively. The cumulated lifetime costs per patient were €18 779 and €19191, for the aspirin and aspirin plus clopidogrel treatment arms, respectively. The incremental cost-effectiveness ratio (ICER) with the addition of clopidogrel was €2951 for each LY saved and €3541 for each QALY saved. Finally, clopidogrel plus aspirin was found to be cost effective in more than 95% of simulated samples at a threshold of €7000 per discounted QALY gained. Conclusion: One-year treatment with clopidogrel in addition to aspirin is a cost-effective treatment option for secondary prevention in patients with acute coronary syndrome without ST-segment elevation in Greece.     

Increases in physical activity may affect quality of life differently in men and women: the PACE project

Purpose

Obesity is associated with impaired quality of life (QoL), but less is known about physical activity. We investigated how decreases in body mass index (BMI) and increases in activity affect obesity-specific QoL and potential gender differences in associations.

Methods

In a large worksite randomized trial of a multilevel intervention on diet and physical activity behaviors, we conducted a cohort analysis at two years of follow-up. Self-reported activity and Obesity and Weight Loss Quality of Life (OWLQOL) were analyzed for individual-level associations using linear mixed models accounting for random worksite effects.

Results

Gender modified the BMI–OWLQOL relationship, so analyses were conducted for males and females separately. Adjusting for demographic confounders, baseline OWLQOL, and several worksite-level variables including intervention arm, a 1.9 unit decrease in BMI (the interquartile range) was associated with an OWLQOL increase of 1.7 (95 % CI: 1.2, 2.2) in males and 3.6 (95 % CI: 3.2, 4.0) in females. Similarly, a 23 unit increase in physical activity score was associated with an OWLQOL increase of 0.9 (95 % CI: 0.5, 1.4) in males and 1.6 (95 % CI: 1.0, 2.3) in females. Physical activity associations were attenuated when adjusting for change in BMI, but remained significant for women (mean BMI 27.8 kg/m²).

Conclusions

This is the first study to demonstrate that increasing physical activity may improve obesity-specific QoL to a greater extent in women, particularly among overweight women, independent of BMI. Results may inform the design of interventions tailored to women targeting well-being through messages of increasing physical activity.     

Pregnancy Intention and Contraceptive Use among Women by Class of Obesity: Results from the 2006–2010 and 2011–2013 National Survey of Family Growth

Objective

Conflicting research findings on the association of obesity and pregnancy intention may be due to their collective definition of obesity at a body mass index of 30 kg/m² or greater. However, obese women with a BMI of 40 kg/m² or greater may be both behaviorally and clinically different from obese women with a lower BMI. This study reexamines this relationship, stratifying by class of obesity; the study also explores variations in contraceptive use by class of obesity given their potential contribution to the incidence of unintended or unwanted pregnancy.

Pediatric adiposity stabilized in Switzerland between 1999 and 2012

Purpose

Several countries have recently reported stabilization and/or a decrease in the prevalence of pediatric obesity. However, systematic, repeated national monitoring studies are scarce, and it is unclear whether this trend would be sustained. The objective was to present the latest overweight and obesity prevalence in Swiss children and to investigate trends in prevalence from 1999 to 2012.

Methods

Using probability-proportionate-to-size cluster sampling, nationally representative samples of children aged 6–12 years were recruited in 1999 (n = 594), 2002 (n = 2,493), 2004 (n = 328), 2007 (n = 2,218), 2009 (n = 907), and 2012 (n = 2,963). Height and weight were measured to calculate BMI (kg/m²). BMI cutoffs proposed by the Centers for Disease Control and Prevention (CDC) and by the International Obesity Task Force were used to determine the prevalence of overweight (excluding obesity) and obesity. Waist circumference was measured in 2007 and 2012, and multiple skinfold thicknesses assessed in 2002 and 2012.

Results

Using the CDC criteria, prevalences of overweight and obesity in 2012 were 11.9 % (95 % CI 10.7–13.1) and 7.1 % (95 % CI 6.2–8.0), respectively, and did not change between 1999 and 2012 (β = ?0.144, p = 0.293 and β = ?0.063, p = 0.552, respectively). Boys had significantly higher obesity prevalence than girls in 2007 (5.6 vs. 3.4 %) and 2012 (8.1 vs. 5.9 %). Percentage of children with excess waist circumference and body fat percentage did not differ between 2007 and 2012, and 2002 and 2012, respectively.

Conclusion

Our data indicate the prevalence of childhood adiposity in Switzerland stabilized between 1999 and 2012, but ≈1 in 5 children remain overweight or obese and further efforts are needed to control the epidemic.     

Genetic determinants of serum vitamin B12 and their relation to body mass index

Lower serum vitamin B12 levels have been related to adverse metabolic health profiles, including adiposity. We used a Mendelian randomization design to test whether this relation might be causal. We included two Danish population-based studies (n_total = 9311). Linear regression was used to test for associations between (1) serum vitamin B12 levels and body mass index (BMI), (2) genetic variants and serum vitamin B12 levels, and (3) genetic variants and BMI. The effect of a genetically determined decrease in serum vitamin B12 on BMI was estimated by instrumental variable regression. Decreased serum vitamin B12 associated with increased BMI (P < 1 × 10^?4). A genetic risk score based on eight vitamin B12 associated variants associated strongly with serum vitamin B12 (P < 2 × 10^?43), but not with BMI (P = 0.91). Instrumental variable regression showed that a 20% decrease in serum vitamin B12 was associated with a 0.09 kg/m² (95% CI 0.05; 0.13) increase in BMI (P = 3 × 10^?5), whereas a genetically induced 20% decrease in serum vitamin B12 had no effect on BMI [?0.03 (95% CI ?0.22; 0.16) kg/m²] (P = 0.74). Nevertheless, the strongest serum vitamin B12 variant, FUT2 rs602662, which was excluded from the B12 genetic risk score due to potential pleiotropic effects, showed a per allele effect of 0.15 kg/m² (95% CI 0.01; 0.32) on BMI (P = 0.03). This association was accentuated including two German cohorts (n_total = 5050), with a combined effect of 0.19 kg/m² (95% CI 0.08; 0.30) (P = 4 × 10^?4). We found no support for a causal role of decreased serum vitamin B12 levels in obesity. However, our study suggests that FUT2, through its regulation of the cross-talk between gut microbes and the human host, might explain a part of the observational association between serum vitamin B12 and BMI.     

Association between body mass index and mortality among institutionalized elderly adults in Japan

Background

The purpose of this study is to assess the association between body mass index (BMI) and mortality among nursing home residents in Japan.

Methods

A one-year prospective cohort study was conducted with 8,510 elderly individuals across 140 nursing homes. Baseline measurements included age, sex, height, weight, BMI, activities of daily living (ADL) (Barthel Index), and degree of dementia. Information regarding dates of discharge and mortality were also obtained to calculate person-years. Cox’s proportional hazards model was used to estimate hazard ratios.

Results

Mean age and BMI were 84.3 [standard deviation (SD) 8.1] years and 20.6 (SD 3.8) kg/m², respectively. Hazard ratios of mortality adjusted for sex, age, ADL, degree of dementia, and type of home were 2.4 [95 % confidence interval (CI): 1.9–3.1] for the 1st quintile of BMI (<17.3 kg/m²), 1.7 (95 % CI: 1.3–2.3) for the 2nd quintile (17.3–19.2 kg/m²), 1.5 (95 % CI: 1.2–2.0) for the 3rd quintile (19.3–21.1 kg/m²), and 1.2 (95 % CI: 0.9–1.6) for the 4th quintile (21.2–23.5 kg/m²) (P for trend <0.001), compared with the reference 5th quintile (23.6≤ kg/m²).

Conclusions

There was a clear inverse dose-dependent relationship between BMI and mortality. Future studies should be conducted to determine the effects of nutritional intervention on mortality in institutionalized elderly adults.     

Excess weight and abdominal obesity in postmenopausal Brazilian women: a population-based study

Background

The menopause is associated with a tendency to gain weight. Several alterations in fat deposits occur, leading to changes in the distribution of body fat. There are strong indications that, in middle age, obesity is associated with increased mortality. This study set out to determine the factors associated with the prevalence of overweight and abdominal obesity in postmenopausal women in a population-based study in Brazil.

Methods

The sample included 456 women, aged 45–69 years, residing in the urban area of Maringa, Parana. Systematic sampling, with a probability proportional to the size of the census sector, was performed. Behavioral, economic, and sociodemographic data were collected, and body mass index (BMI) and waist circumference (WC) were determined.

Results

According to BMI criteria (≥25.0 kg/m²), 72.6% of the women were overweight, and according to WC (≥88 cm), 63.6% had abdominal obesity. Based on logistic regression analysis, the factors that were most closely associated with overweight were: having three or more children (odds ratio (OR): 1.78; 95% confidence interval (CI): 1.06–3.00); and not taking hormone replacement therapy (OR: 1.69; 95% CI: 1.06–2.63). The prevalence of abdominal obesity was positively associated with greater parity (OR: 1.34, 95% CI: 1.05–1.72) and age older than 65 years (OR: 1.50; 95% CI: 1.03–2.19).

Conclusions

This study found that the prevalences of overweight and abdominal obesity were higher for postmenopausal women who had three or more children. Age over 65 years was also a risk factor for abdominal obesity and no use of hormonal replacement therapy was a risk factor for overweight.

     

The role of lifestyle, health, and work in educational inequalities in sick leave and productivity loss at work

Purpose

To investigate the influence of lifestyle, health, and work conditions in the association between education and productivity loss at work and sick leave.

Methods

Employees of six companies filled out a questionnaire on demographics, lifestyle-related, health, and work-related factors, and productivity loss at work and sick leave at baseline (n = 915) and after 1-year (n = 647).

Results

Employees with a low education were more likely to report productivity loss at work (OR = 1.49, 95 % CI 0.98–2.26) and sick leave (OR = 1.81, 95 % CI 1.15–2.85). After adjustment for lifestyle, health, and work conditions, the association between education and productivity loss at work did not attenuate. Work conditions attenuated the association between low education and sick leave (OR = 1.62, 95 % CI 1.01–2.61), and additional adjustment for health and lifestyle-related factors further reduced the strength of the association (OR = 1.42, 95 % CI 0.86–2.34).

Conclusion

Work conditions and lifestyle-related factors partly explained the association between education and sick leave, but did not influence the association between education and productivity loss at work. The educational differences in sick leave prompt for interventions that address behavioral aspects as well as work-related and lifestyle-related factors.     

Accuracy of commercial geocoding: assessment and implications

Background

Published studies of geocoding accuracy often focus on a single geographic area, address source or vendor, do not adjust accuracy measures for address characteristics, and do not examine effects of inaccuracy on exposure measures. We addressed these issues in a Women's Health Initiative ancillary study, the Environmental Epidemiology of Arrhythmogenesis in WHI.

Results

Addresses in 49 U.S. states (n = 3,615) with established coordinates were geocoded by four vendors (A-D). There were important differences among vendors in address match rate (98%; 82%; 81%; 30%), concordance between established and vendor-assigned census tracts (85%; 88%; 87%; 98%) and distance between established and vendor-assigned coordinates (mean ρ [meters]: 1809; 748; 704; 228). Mean ρ was lowest among street-matched, complete, zip-coded, unedited and urban addresses, and addresses with North American Datum of 1983 or World Geodetic System of 1984 coordinates. In mixed models restricted to vendors with minimally acceptable match rates (A-C) and adjusted for address characteristics, within-address correlation, and among-vendor heteroscedasticity of ρ, differences in mean ρ were small for street-type matches (280; 268; 275), i.e. likely to bias results relying on them about equally for most applications. In contrast, differences between centroid-type matches were substantial in some vendor contrasts, but not others (5497; 4303; 4210) p_interaction < 10^-4, i.e. more likely to bias results differently in many applications. The adjusted odds of an address match was higher for vendor A versus C (odds ratio = 66, 95% confidence interval: 47, 93), but not B versus C (OR = 1.1, 95% CI: 0.9, 1.3). That of census tract concordance was no higher for vendor A versus C (OR = 1.0, 95% CI: 0.9, 1.2) or B versus C (OR = 1.1, 95% CI: 0.9, 1.3). Misclassification of a related exposure measure – distance to the nearest highway – increased with mean ρ and in the absence of confounding, non-differential misclassification of this distance biased its hypothetical association with coronary heart disease mortality toward the null.

Conclusion

Geocoding error depends on measures used to evaluate it, address characteristics and vendor. Vendor selection presents a trade-off between potential for missing data and error in estimating spatially defined attributes. Informed selection is needed to control the trade-off and adjust analyses for its effects.     

Potential local and regional impacts of particulate matter emitted from one of the world’s largest open-pit coal mines

This study was designed to evaluate the atmospheric total suspended particle (TSP) and particulate matter (PM₁₀) concentrations and temporal variability in one of the world’s largest open-pit coal mines (El Cerrejon) located in northeast Colombia, during 2012–2016. The results showed overall average TSP and PM₁₀ concentrations of 86 μg m^?3 (CI_95% 84–88 μg m^?3) and 34 μg m^?3 (CI_95% 33–35 μg m^?3), respectively, with the highest concentrations between March and August each year. A time trend analysis of the results revealed that PM₁₀ concentrations in particular have significantly increased between 6.2 and 7.7% per year (CI_95% 1.2–12.8% year^?1) in several of the monitoring stations. Meteorological parameters were also evaluated. It was observed that NE winds with speeds above 2 m s^?1 were significantly correlated with an increase in the concentration of PM₁₀ for selected downwind sites, which suggested that coal mining operations are an important source of atmospheric PM in the area. Regional long-range atmospheric transport scenarios showed potential effects on neighboring municipalities and countries within 72-h transportation events. These highlighted the need to develop new strategies to control the emissions of PM from the local mining industry to comply with local and international guidelines and regulations, particularly when industrial expansion is planned for the near future and relatively large population centers are in the area, of which a high proportion belong to indigenous populations.     

Ursachen von Übergewicht

Background

Obesity is an increasing problem in Germany. This underlines the importance of preventive activities as part of primary health care. In this study we analysed patients’ beliefs about the causes of obesity, which were identified in behaviour-change counselling interviews with general practitioners.

Methods

Twelve physicians audiotaped check-up dialogues with 52 overweight patients (BMI≥25 kg/m^²). After the interviews were transcribed, a content analysis was performed using the method of Mayring.

Results

Patients attributed their overweight to both behavioural and non-behaviour-related causes during counselling interviews with physicians. Among the behavioural causes, we found different statements of self-responsibility. Patients identified metabolic factors or other predispositions as non-behaviour-related causes.

Conclusions

Patients have complex concepts about their beliefs about overweight; these offer physicians valuable access to patients’ perspectives. In terms of counselling about overweight, physicians should use this knowledge to strengthen their prevention activities.     

Palliative treatment of colorectal cancer in Germany: cost of care and quality of life

Introduction

To estimate the costs of palliative care for colorectal cancer (CRC) from the perspective of German statutory health insurance and to measure the patients’ quality of life (QoL) for a 2-year time period.

Methods

A prospective observational multicentre study was carried out to estimate the direct costs of care over a 2-year period. Case report forms, medical records, and claims data were all applied to document medical and resource usage data in real-world settings. QoL was measured by using the Short Form-12 Health Survey.

Results

In total 101 patients (mean age 67.09 ± 11.13 years, 68 % male) from 12 different settings were included. The mean costs per patient during the 1st and 2nd years were calculated to be 42,361€ and 32,023€, respectively. Highest mean costs were calculated for the second quarter, which reached an amount of 12,900€ (95 % CI: 11,127€–14,673€). Mean physical summary scores and mean mental summary scores were 41.8 and 49.7, respectively.

Discussion

This is the first study assessing the costs of palliative care and the quality of life of patients with CRC in real-world health-care delivery in Germany. It could be shown that CRC treatment represents an enormous economic burden to the German health-care system. Increased efforts in promoting effective and efficient treatment options, or performance-based medication reimbursement schemes, might be helpful in reducing the costs.     

Assessing surrogacy of data sources for institutional comparisons

Can administrative claims data, Z, serve as a surrogate for better clinical data, X, when assessing institutional performance? We consider an analysis of I hospitals, each of which involves an adjusted outcome. In the i ^th hospital, we denote the true association between the outcome and the risk factors using one data source by θ _i (X), the true association between the outcome and the risk factors using the other data source by γ _i (Z), and assume we have estimates of each available. Within hospital i, the estimated association parameters are jointly normally distributed such that conditional on γ _i (Z), a simple linear relationship exists between θ _i (X) and γ _i (Z). Methods are illustrated using mortality rates for 181,032 elderly US heart attack patients treated at 4322 hospitals. We find a strong linear relationship between the hospital standardized mortality rates adjusted by risk factors found in administrative claims data and rates adjusted by risk factors found in medical charts (posterior mean [95% interval] for slope: 0.997 [0.965,1.028]). However, the absolute and relative differences between the two sets of rates increase as hospital volume increases. For typically-sized standard deviations of claims-based rates, there is reasonable certainty of quality problems when the hospital’s claims-based rate is 0.72 times or smaller than the national mean or 1.45 times or greater than the national mean. Fewer hospitals are classified as either low-mortality or high-mortality hospitals when using claims-based estimates compared to chart-based estimates.     

Time Costs Associated with Informal Care for Colorectal Cancer: An Investigation of the Impact of Alternative Valuation Methods

Background

A societal perspective in economic evaluation necessitates that all resources associated with a disease or intervention should be valued; however, informal care time costs are rarely considered.

Objective

We estimated time allocated to care by informal carers of colorectal cancer survivors; and investigated the impact of applying alternative valuation methods to this time.

Methods

Colorectal cancer cases (ICD10 C18-C20) diagnosed 6–30 months previously and identified from the National Cancer Registry Ireland were invited to provide details of informal carers. Carers completed a postal questionnaire. Time estimates per week associated with hospital-related and domestic-related care activities were collected for two phases: diagnosis and initial treatment (initial 3 months) and ongoing care (previous 30 days). Seven valuation scenarios, based on variants of the opportunity cost approach (OCA), and the proxy good approach (PGA), were considered. The base-case was OCA with all carer time valued at the average national wage.

Results

We received 154 completed questionnaires (response rate = 68 %). Average weekly time allocated to caring was 42.5 h in the diagnosis and initial treatment phase and 16.9 h in the ongoing care phase. Under the base-case, average weekly time costs were €295 (95 % CI 255–344) for hospital-related activities and €630 (95 % CI 543–739) for domestic-related activities in the diagnosis and initial treatment phase and €359 (95 % CI 293–434) in the ongoing care phase. PGA estimates were 23 % below the base-case. Only one alternative scenario (occupation and gender-specific wages for carers in paid work and replacement wages for non-working carers) surpassed base-case costs, and the difference was modest.

Conclusions

Overall, significant time is associated with informal caring in colorectal cancer. Different time valuation methods can produce quite different cost estimates. A standardised methodology for estimating informal care costs would facilitate better integration of these into economic evaluations.     

Social/economic costs and health-related quality of life in patients with epidermolysis bullosa in Europe

Background

The aim of this study was to determine the social/economic costs and health-related quality of life (HRQOL) of patients with epidermolysis bullosa (EB) in eight EU member states.

Methods

We conducted a cross-sectional study of patients with EB from Bulgaria, France, Germany, Hungary, Italy, Spain, Sweden and the United Kingdom. Data on demographic characteristics, health resource utilisation, informal care, labour productivity losses, and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire.

Results

A total of 204 patients completed the questionnaire. Average annual costs varied from country to country, and ranged from €9509 to €49,233 (reference year 2012). Estimated direct healthcare costs ranged from €419 to €10,688; direct non-healthcare costs ranged from €7449 to €37,451 and labour productivity losses ranged from €0 to €7259. The average annual cost per patient across all countries was estimated at €31,390, out of which €5646 accounted for direct health costs (18.0 %), €23,483 accounted for direct non-healthcare costs (74.8 %), and €2261 accounted for indirect costs (7.2 %). Costs were shown to vary across patients with different disability but also between children and adults. The mean EQ-5D score for adult EB patients was estimated at between 0.49 and 0.71 and the mean EQ-5D visual analogue scale score was estimated at between 62 and 77.

Conclusion

In addition to its negative impact on patient HRQOL, our study indicates the substantial social/economic burden of EB in Europe, attributable mostly to high direct non-healthcare costs.

     

The direct and indirect cost of diabetes in Italy: a prevalence probabilistic approach

Introduction

Diabetes mellitus is a chronic degenerative disease associated with a high risk of chronic complications and comorbidities. However, very few data are available on the associated cost. The objective of this study is to identify the available information on the epidemiology of the disease and estimate the average annual cost incurred by the National Health Service and Society for the Treatment of Diabetes in Italy.

Methods

A probabilistic prevalence cost of illness model was developed to calculate an aggregate measure of the economic burden associated with the disease, in terms of direct medical costs (drugs, hospitalizations, monitoring and adverse events) and indirect costs (absenteeism and early retirement). A systematic review of the literature was conducted to determine both the epidemiological and economic data. Furthermore, a one-way and probabilistic sensitivity analysis with 5,000 Monte Carlo simulations was performed to test the robustness of the results and define a 95 % CI.

Results

The model estimated a prevalence of 2.6 million patients under drug therapies in Italy. The total economic burden of diabetic patients in Italy amounted to €20.3 billion/year (95 % CI €18.61 to €22.29 billion), 54 % of which are associated with indirect costs (95 % CI €10.10 to €11.62 billion) and 46 % with direct costs only (95 % CI €8.11 to €11.06 billion).

Conclusions

This is the first study conducted in Italy aimed at estimating the direct and indirect cost of diabetes with a probabilistic prevalence approach. As might be expected, the lack of information means that the real burden of diabetes is partly underestimated, especially with regard to indirect costs. However, this is a useful approach for policy makers to understand the economic implications of diabetes treatment in Italy.

     

Economic evaluation of URMEL-ICE, a school-based overweight prevention programme comprising metabolism, exercise and lifestyle intervention in children

Objective

Measuring the impact of the URMEL-ICE school-based overweight prevention programme on anthropometric measures in primary-school children, computing incremental cost-effectiveness relation (ICER) and net monetary benefit (NMB).

Methods

This is an intervention study with historical control. Propensity score method is applied to account for group differences. One-year teacher-driven classroom implementation is used, which is based on especially developed teaching material including health education, physical activity breaks and parent involvement. 354 children in the control and 365 children in the intervention group at baseline and follow-up were analysed. Effectiveness is measured as cm waist circumference (WC) and unit (0.01) waist-to-height ratio (WHtR) increase prevented in intervention vs. control group using an adjusted two-level model. Standard cost-effectiveness analysis methods, net benefit regression and a societal perspective for a 1-year time horizon are applied.

Results

WC gain was 1.61 cm and WHtR gain was 0.014 significantly less in intervention vs. control group. Intervention costs were €24.09 per child. ICER was €11.11 (95% confidence interval (CI) [8.78; 15.02]) per cm WC and €18.55 (95% CI [14.04; 26.86]) per unit WHtR gain prevented. At a maximum willingness to pay (MWTP) of €35, both values of the CIs for NMB regarding WC and WHtR are located in the positive range.

Conclusions

The study gives new information about the cost-effectiveness of structured health promotion embedded in daily routine at primary schools. Assuming a MWTP of €35 the intervention is cost-effective with a positive NMB. This result may help decision makers in implementing programmes to prevent childhood overweight in school settings.