Noise exposure among staff in intensive care units and the effects of unit-based noise management: a monocentric prospective longitudinal study.

Background: Intensive care units (ICUs) are often too noisy, exceeding 70-80 dBA, which can have negative effects on staff. The corresponding recommendation of the World Health Organization (average sound pressure level below 35 dBA) is often not achieved. To date there is a lack of intervention studies examining the extent to which unit-based noise management in ICUs contributes to a reduction in noise exposure for the staff.

Nutritional support during the hospital stay is cost-effective for preventing adverse outcomes in patients with cancer.

Objective: Among patients with cancer, malnutrition remains common and is a key challenge in oncology practice today. A prior study from our group revealed that malnourished cancer inpatients who got nutritional treatment (intervention group) had lower mortality and improved functional and quality of life outcomes compared to inpatients without nutritional support (control group). Our present analysis aimed to determine whether the improved patient recovery by nutritional support was paralleled by cost-effectiveness of this nutritional care.

Economic Evaluation of Individualized Nutritional Support for Hospitalized Patients with Chronic Heart Failure.

Background Malnutrition is a highly prevalent risk factor in hospitalized patients with chronic heart failure (CHF). A recent randomized trial found lower mortality and improved health outcomes when CHF patients with nutritional risk received individualized nutritional treatment. Objective To estimate the cost-effectiveness of individualized nutritional support in hospitalized patients with CHF.

A Cost Impact Analysis of clonoSEQ as a Valid and CE-Certified Minimal Residual Disease (MRD) Diagnostic Compared to No MRD Testing in Multiple Myeloma in Germany.

Introduction: The measurement of minimal residual disease (MRD) with clonoSEQ can be used in the assessment of B-cell lymphoid tumor burden throughout treatment with accuracy, sensitivity and standardization when compared to traditional cytomorphology. With the approval of novel treatments, standardized MRD assessment with improved performance is increasingly important. The aim of this analysis is to estimate the cost-effectiveness of MRD testing with clonoSEQ compared to no MRD testing for patients with multiple myeloma (MM) on maintenance therapy in Germany.

Cost savings associated with nutritional support in medical inpatients: an economic model based on data from a systematic review of randomised trials.

Background And Aims: Nutritional support improves clinical outcomes during hospitalisation as well as after discharge. Recently, a systematic review of 27 randomised, controlled trials showed that nutritional support was associated with lower rates of hospital readmissions and improved survival. In the present economic modelling study, we sought to determine whether in-hospital nutritional support would also return economic benefits.

Economic evaluation of individualized nutritional support in medical inpatients: Secondary analysis of the EFFORT trial.

Background & Aims: Existing guidelines support the importance of nutritional interventions for medical inpatients at malnutrition risk to alleviate the impact of malnutrition on outcomes. While recent studies have reported positive effects of nutritional support on health outcomes, limited evidence exists on whether in-hospital nutritional support also results in economic advantages. We report the results of the economic evaluation of EFFORT-a pragmatic, investigator-initiated, open-label, multicenter trial.

Incidence of acquired thrombotic thrombocytopenic purpura in Germany: a hospital level study.

Background: Acquired thrombotic thrombocytopenic Purpura (aTTP) is a life-threatening ultra-orphan disease with a reported annual incidence between 1.5 and 6.0 cases per million in Europe and mainly affecting otherwise young and healthy adults aged 40 years on average.

A cost-effectiveness analysis of a hydration response technology dressing in the treatment of venous leg ulcers in the UK.

Objective: Venous leg ulcers (VLUs) cause significant pain and suffering for patients. Additionally, they place considerable financial and service burden on the National Health Service (NHS). A large proportion of VLUs do not heal within the standard time frame of 16-24 weeks, resulting in static wounds which commonly have issues with increasing exudate production.

Administrative risk quantification of subcutaneous and intravenous therapies in Italian centers utilizing the Failure Mode and Effects Analysis approach.

Background: In oncology, an important parameter of safety is the potential treatment error in hospitals. The analyzed hypothesis is that of subcutaneous therapies would provide a superior safety benefit over intravenous therapies through fixed-dose administrations, when analyzed with trastuzumab and rituximab.

Methods: For the calculation of risk levels, the Failure Mode and Effect Analysis approach was applied.

Potential resource and cost saving analysis of subcutaneous versus intravenous administration for rituximab in non-Hodgkin's lymphoma and for trastuzumab in breast cancer in 17 Italian hospitals based on a systematic survey.

Introduction: Subcutaneous versions of different oncology therapies have been available for patients for a few years, yet patient-relevant and hospital benefits have not been assessed in real life.

Methods: In order to analyze the impact of subcutaneous administrations for rituximab or trastuzumab in comparison to the respective intravenous mode a primary research in Italy was executed. The study's primary objectives were to analyze the resource and cost implications from different perspectives (patient, medical staff) in the real world.

Simulation and comparison of progression-free survival among patients with non-squamous non-small-cell lung cancer receiving sequential therapy.

Objectives: In recent years, the treatment landscape in advanced non-squamous non-small-cell lung cancer (nsNSCLC) has changed. New therapies (e.g.

Evaluation of a possible predictor for Federal Joint Committee decisions on early benefit assessments according to the German act on the reform of the market for medicinal products.

Objectives: As of 1st January 2011 the German drug market is regulated by the act on the reform of the market for medicinal products (AMNOG). Since then the normal procedure for reimbursement of a new pharmaceutical is a benefit assessment by the joint federal committee (G-BA) which determines one of six additional benefit levels.

Methods: In order to evaluate a possible predictor of G-BA decisions, the 'evaluation of pharmaceutical innovations (EVITA)' score was calculated for 40 out of 63 dossiers and compared with published G-BA appraisals.

Health economics evidence for medical nutrition: are these interventions value for money in integrated care?

Background: Health care decision-makers have begun to realize that medical nutrition plays an important role in the delivery of care, and it needs to be seen as a sole category within the overall health care reimbursement system to establish the value for money. Indeed, improving health through improving patients' nutrition may contribute to the cost-effectiveness and financial sustainability of health care systems. Medical nutrition is regulated by a specific bill either in Europe or in the United States, which offers specific legislations and guidelines (as provided to patients with special nutritional needs) and indications for nutritional support.

Health economic analyses in medical nutrition: a systematic literature review.

Background: Medical nutrition is a specific nutrition category either covering specific dietary needs and/or nutrient deficiency in patients or feeding patients unable to eat normally. Medical nutrition is regulated by a specific bill in Europe and in the US, with specific legislation and guidelines, and is provided to patients with special nutritional needs and indications for nutrition support. Therefore, medical nutrition products are delivered by medical prescription and supervised by health care professionals.

Free drugs in clinical trials and their potential cost saving impact on the National Health Service: a retrospective cost analysis in Italy.

Background: The cost of new anti-cancer drugs has dramatically increased in recent years, and countermeasures are required in order to limit pharmaceutical expenses. Sponsored clinical trials that provide drugs free of charge may be a useful tool in order to reduce drug costs. The aim of this analysis is to evaluate the effect of clinical trials on pharmaceutical expenditure savings.

Effects of erlotinib first-line maintenance therapy versus placebo on the health-related quality of life of patients with metastatic non-small-cell lung cancer.

Introduction: Maintenance therapy can delay progression and prolong survival in metastatic non-small-cell lung cancer (mNSCLC). As treatment for mNSCLC is non-curative, its impact on patient health-related quality of life (HRQoL) is an important consideration. SATURN (Sequential Tarceva in Unresectable NSCLC) was a randomised, double-blind, placebo-controlled, multicentre study investigating the impact of erlotinib maintenance therapy on HRQoL in patients with locally advanced or recurrent NSCLC.

Societal savings in patients with advanced non-squamous non-small-cell lung cancer receiving bevacizumab-based versus non-bevacizumab-based treatments in France, Germany, Italy, and Spain.

Background: The purpose of this study was to investigate the savings accrued using bevacizumab-based treatment for non-small-cell lung cancer from the societal perspective, taking only public costs into account, in France, Germany, Italy, and Spain.

Methods: Societal costs were estimated by collecting and analyzing labor costs, carer costs, sickness benefits, disability benefits, and home care benefits. Cost inputs were derived from publicly available databases or from the published literature.

Maintenance erlotinib in advanced nonsmall cell lung cancer: cost-effectiveness in EGFR wild-type across Europe.

Background: First-line maintenance erlotinib in patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) has demonstrated significant overall survival and progression-free survival benefits compared with best supportive care plus placebo, irrespective of epidermal growth factor receptor (EGFR) status (SATURN trial). The cost-effectiveness of first-line maintenance erlotinib in the overall SATURN population has been assessed and published recently, but analyses according to EGFR mutation status have not been performed yet, which was the rationale for assessing the cost-effectiveness of first-line maintenance erlotinib specifically in EGFR wild-type metastatic NSCLC.

Methods: The incremental cost per life-year gained of first-line maintenance erlotinib compared with best supportive care in patients with EGFR wild-type stable metastatic NSCLC was assessed for five European countries (the United Kingdom, Germany, France, Spain, and Italy) with an area-under-the-curve model consisting of three health states (progression-free survival, progressive disease, death).

Cost comparison of second-line treatment options for late stage non-small-cell lung cancer: cost analysis for Italy.

Background: Lung cancer is the leading cause of cancer deaths worldwide (1.38 million cancer deaths, 18.2% of the total) and of cancer morbidity (1.

Cross-market cost-effectiveness analysis of erlotinib as first-line maintenance treatment for patients with stable non-small cell lung cancer.

Background: Platinum-doublet, first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) is limited to 4-6 cycles. An alternative strategy used to prolong the duration of first-line treatment and extend survival in metastatic NSCLC is first-line maintenance therapy. Erlotinib was approved for first-line maintenance in a stable disease population following results from a randomized, controlled Phase III trial comparing erlotinib with best supportive care.

A cross-market cost comparison of erlotinib versus pemetrexed for first-line maintenance treatment of patients with locally advanced or metastatic non-small-cell lung cancer.

Erlotinib and pemetrexed were approved by the European Medicines Agency for first-line maintenance treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) to prolong overall survival after first-line therapy. An adjusted, matched, indirect comparison of erlotinib and pemetrexed suggested that survival benefits were not statistically significantly different between treatments. We conducted a cost-comparison analysis of erlotinib versus pemetrexed in first-line maintenance treatment of locally advanced or metastatic, non-squamous NSCLC in France, Germany, Italy and Spain, performed from the perspective of national health-care decision-makers or purchasers.

An indirect comparison of the efficacy of bevacizumab plus carboplatin and paclitaxel versus pemetrexed with cisplatin in patients with advanced or recurrent non-squamous adenocarcinoma non-small cell lung cancer.

Objective: There are two new treatment options available for the treatment of adenocarcinoma histology non-small cell lung cancer (NSCLC) which offer improved benefit in terms of progression-free (PFS) and overall survival (OS) over chemotherapy. Both bevacizumab and pemetrexed when combined with chemotherapy significantly increase PFS and OS in patients with advanced NSCLC versus chemotherapy alone. The aim of this analysis was to compare the efficacy for patients with non-squamous adenocarcinoma NSCLC treated with bevacizumab, carboplatin and paclitaxel (BCP) to pemetrexed and cisplatin (PC) by using indirect comparison (ITC) methodology.

Indirect treatment comparison of bevacizumab + interferon-α-2a vs tyrosine kinase inhibitors in first-line metastatic renal cell carcinoma therapy.

Background: The vascular endothelial growth factor inhibitor bevacizumab (BEV) given in combination with interferon-α-2a (IFN), and the tyrosine kinase inhibitors (TKIs) sunitinib (SUN) and pazopanib (PAZ), have all shown significant increase in progression-free survival (PFS) in first-line metastatic renal-cell carcinoma (mRCC) therapy. These targeted therapies are currently competing to be primary choice; hence, in the absence of direct head-to-head comparison, there is a need for valid indirect comparison assessment.

Methods: Standard indirect comparison methods were applied to independent review PFS data of the pivotal Phase III trials, to determine indirect treatment comparison hazard-ratios (HR) with 95% confidence intervals (95% CI).

Comparative effectiveness of bevacizumab plus cisplatin-based chemotherapy versus pemetrexed plus cisplatin treatment in East Asian non-squamous non-small cell lung cancer patients applying real-life outcomes.

Aim: To indirectly compare real-life clinical effectiveness of bevacizumab + cisplatin-based therapy from the Safety of Avastin in Lung (SAiL) phase IV clinical trial with published evidence from the phase III clinical trial for pemetrexed + cisplatin among East Asian patients with non-squamous metastatic or recurrent non-small cell lung cancer (NSCLC).

Methods: Survival outcomes were compared between subgroups of East Asian patients receiving treatments of either bevacizumab + cisplatin-based chemotherapy or pemetrexed + cisplatin using a matching-adjusted indirect comparison approach. Patient-level data were used to derive a new group with similar characteristics compared to those reported in a phase III clinical trial evaluating pemetrexed + cisplatin therapy.

Cost-effectiveness of bevacizumab-based therapy versus cisplatin plus pemetrexed for the first-line treatment of advanced non-squamous NSCLC in Korea and Taiwan.

Aims: The aim of this analysis is to investigate the mean incremental costs and life expectancy associated with two first-line treatments for advanced non-squamous non-small cell lung cancer (NSCLC) in Korea and Taiwan; bevacizumab plus cisplatin and gemcitabine (BevCG) and cisplatin plus pemetrexed (CP).

Methods: A health economic (area under curve) model with three health states was developed to assess health outcomes (life-years gained [LYG]), direct costs, and incremental cost-effectiveness ratio (ICER). Progression-free survival (PFS) and overall survival (OS) were derived from randomized clinical trials and used in an indirect comparison in order to estimate their cost effectiveness.