Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study.

BACKGROUND: Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104-183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available. METHODS: ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial. CONCLUSIONS: ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02943993.

Correction to: Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study.

[This corrects the article DOI: 10.1186/s12959-018-0163-7.].

Cost-utility analysis of an intervention designed to reduce the critical handling error of insufficient inspiratory effort.

OBJECTIVES: Up to 70-80% of patients use inhalers incorrectly. Dry-powder inhalers (DPIs) require forceful inhalation for optimal delivery, and approximately 40% of Global Initiative for Asthma (GINA)-defined Step-3+ patients inhale corticosteroid and long-acting beta-agonist through DPIs. The CRITIKAL study (Price et al. in J Allergy Clin Immunol Pract 5:1071-e9-1081-e9, 2017) found a statistically significant association between 'insufficient inspiratory effort' error and increased risk of uncontrolled asthma and hospitalisation-requiring exacerbations. This paper explores the cost-effectiveness of an error-targeted intervention. METHODS: A probabilistic Markov cost-utility model simulated patients transitioning between controlled and uncontrolled health states over one year. Odds ratios (ORs, from the CRITIKAL study) of a patient having uncontrolled asthma conditional on making the error were applied to baseline transition probabilities sourced from the literature, both indirectly via an adjustment formula (Zhang et al. in JAMA 280:1690-1691, 1998) and directly by assuming OR approximates relative risk (RR). The analysis explored complete/partial eradication of the error when the intervention was priced to match comparators, as well as impact of indirect costs based on lost/reduced productivity. RESULTS: The intervention dominated both DPI comparators over one year, with direct cost savings of £45/£86 with 0.0053/0.0102 additional quality-adjusted life years (QALYs), and had the highest probability of being cost-effective at a £20,000/QALY threshold. Key factors driving variance were weekly utilities per state and RR of moving to an uncontrolled state. CONCLUSION: The analysis demonstrated the economic and societal costs of 'insufficient inspiratory effort' and potential economic benefits of introducing an effective intervention to reduce/eradicate this error. Further research should assess the economic impact of other handling errors.

Cost-utility analysis applied to the treatment of burn patients in a specialized center.

OBJECTIVE: To discover the total costs and quality of life of burn patients in a specialist center classified by diagnosis-related groups (DRGs). DESIGN: Prospective study of 5-year follow-up from January 1, 1997, through December 31, 2001. SETTING: Burn Center of Valencia. PATIENTS: A total of 898 patients treated at the Burn Center of Valencia. MAIN OUTCOME MEASURES: Hospital, extrahospital, caregiving, labor, and social costs of the burn patients grouped by DRG (code 457: extensive burns without operating room procedure; code 458: nonextensive burns with skin graft; code 459: nonextensive burns with wound debridement or other operating room procedure; code 460: nonextensive burns without operating room procedure; or code 472: extensive burns with operating room procedure) were studied. The costs were compared with those that the DRG system assigns. The quality of life of the patients at the end of the follow-up period was also studied. To measure quality of life, the EuroQol 5-Dimensions survey was used. Utility calculations and cost-utility analysis were undertaken according to life expectancy. RESULTS: The number of quality-adjusted life-years produced by the center was 13 577, with a mean quality-of-life level on release from the study of 0.87. The mean cost per patient, including the social and labor costs, was $95 551, with health care costs amounting to only 10%. The mean cost per quality-adjusted life-year was $686. CONCLUSIONS: The labor costs were the most important and amounted to 56%; together with the social costs, these constituted 85% of the total costs. The DRG code 456 was an option dominated by the remaining DRG codes 458 through 460 and 472. Given the high costs of treating burn patients, a clear health care policy is urgently needed.

Socio-economic cost and health-related quality of life of burn victims in Spain.

OBJECTIVES: The aim of the study was to determine the economic burden (direct and indirect costs) of burn victims and the impact of burn on health-related quality of life in Spain. METHODS: In 2003, a cross-sectional study was carried out with 898 burned people. Data regarding demographic features, health resource use, informal care, indirect costs and quality of life were prospectively collected through hospital admission databases and questionnaires filled out by burn victims and caregivers. RESULTS: The mean annual cost (direct and indirect) per burn patient was US$ 99,773. The most important categories of costs were those of in-patient care and temporary and permanent disability. Direct healthcare costs of burn patients represented 19.6% of the total. Total annual cost for burn patients in Spain was US$ 313 million. The mean health-related quality of life measured by European Quality of Life 5-Dimension score was 0.84 and the mean visual analogue score was 67. CONCLUSIONS: The costs of burn are higher than those of many other conditions, and a cost-effectiveness assessment of the different interventions for burn should become a priority in health policy.

The economic costs of traffic accidents in Spain.

BACKGROUND: This study aimed to evaluate the economic impact of traffic accidents in Spain during 1997. METHODS: The cost-of-illness method was used. Direct costs were divided into health services costs, insurance administration costs, and the costs of the material damages to the vehicles. Indirect costs were obtained through transformation of physical units into monetary units using the approach based on the human capital theory. RESULTS: The total cost of traffic accidents was 6,280.36 million euros, which amounts to 157.59 euros for each inhabitant in Spain and represents 1.35% of the gross national product. The total direct cost was 3,397.00 million euros, representing 54.1% of the total cost. The total indirect cost was 2,883.36 million euros, accounting for 45.9% of the total cost. CONCLUSIONS: The high socioeconomic cost of traffic accidents clearly indicates the need for the different administrations in Spain to collaborate in implementing preventive measures.