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Understanding how organisms adapt to complex environments lies at the very heart of evolutionary biology and ecology, and is of particular concern in the current era of anthropogenic global change. Variation in ecologically important traits associated with environmental gradients is considered to be strong evidence for adaptive responses. Here, we study phenotypic variation along a latitudinal and an altitudinal cline in 968 field-collected males of the widespread European butterfly Pieris napi. In contrast to our expectations, body size decreased with increasing latitude and altitude, suggesting that warmer rather than cooler conditions may be more beneficial for individual development in this species. Higher altitudes but not latitudes seemed to be associated with increased flight performance, suggesting stronger challenges for flight activity in high-altitude environments (e.g. due to strong wind). Moreover, wing melanization increased while yellow reflectance decreased towards colder environments in both clines. Thus, increased melanization under thermally challenging conditions seems to compromise investment into a sexually selected trait, resulting in a trade-off. Our study, although exclusively based on field-collected males, revealed indications of adaptive patterns along geographical clines. It documents the usefulness of field-collected specimens, and the strength of comparing latitudinal and altitudinal clines to identify traits being potentially under thermal selection.

Double three-phase winding is one of the best solutions to improve the fault tolerance of an electric motor which is required to work continuously even under partial fault conditions. Actually, this type of machines is often preferred to custom and expensive multiphase drives, since it can be obtained by dividing the stator winding into two subsets connected to two standard, independent inverters of half the same total power. In the event of a fault, one of the two subsets is simply disconnected and the motor can continue to operate at a reduced power or with some overload of the remaining three-phase system.

Rotary transformers are adopted to transfer energy from primary to secondary in situations in which the two sides are in relative rotation. These devices are cylindrical transformers with two cores and the corresponding winding separated by an air gap. Their employment became quite convenient with the availability of power electronics, allowing the operation of electrical systems at relatively high frequencies. In particular, this paper proposes the design of a light and efficient transformer which can be used in applications involving large shafts. Moreover, a sliced arrangement for the magnetic core is proposed together with the experimental validation of this solution on a reduced-size prototype.

BACKGROUND: After two strong earthquakes in the Emilia region in Italy, many HCWs had to deal with the psychological consequences of the aftershocks. OBJECTIVE: The aims of this case study were a) to describe the psychosocial condition of the HCWs affected by the earthquake; b) to present an intervention immediately after the earthquake on HCWs in a post-disaster situation using a mixed-method approach. METHODS: A mixed-method study was conducted collecting qualitative data (during Group Counselling sessions) and quantitative data (through questionnaires). RESULTS: The results suggested that the impact of the earthquake was very strong, as more than 80% perceived at least a severe impact event capable of altering their ability to function; most of the thoughts and feelings were related to death and fear. CONCLUSIONS: This study adds knowledge about how to plan interventions aiming to help those workers at both individual and organisational level.

BACKGROUND The aim of this study was to assess clinical and contemporary costs associated with elective endovascular repair of intact descending thoracic aortic aneurysms (DTAA) into the mid-term follow-up. METHODS A retrospective review of a prospectively maintained clinical database including 29 consecutive patients from July 2005 to December 2009 treated with elective endovascular repair (TEVAR) or TEVAR and surgical infrarenal repair (hybrid) of intact DTAA was performed. Mean age was 74.5 years old (±7.1). Primary clinical endpoints include mortality and major morbidity. Additionally a comprehensive economic appraisal of individual in-hospital and follow-up costs was executed. Economic endpoints include in-hospital and follow-up costs and patient discharge status. Elective endovascular and open repairs' clinical and economical outcomes in contemporary literature were assessed for comparison according to PRISMA standards. RESULTS Immediate mortality was 6.9% (1/24 TEVAR and 1/5 hybrid). Three respiratory complications were recorded (11%; 2 TEVAR, 1 hybrid). Renal and cardiac complication rates were 7.4% (1 TEVAR, 1 hybrid) and 3.7% (1 TEVAR) respectively. Routine discharge home was achieved for 85% of patients (95.7% TEVAR, 25% hybrid). Three endoleaks were treated throughout the follow-up (2 TEVAR, 1 hybrid; mean 30.4 mo, ±19.9) rendering an 11% (3/27) reintervention rate. Average immediate cost was €21,976.87 for elective endovascular repair and €33,783.21 for elective endovascular hybrid repair. Additional reintervention and routine follow-up costs augmented immediate costs by 12.4%. CONCLUSIONS This study supports satisfying immediate clinical outcomes for TEVAR and TEVAR+surgical infrarenal procedures. Although limited by a small population size and difficulties in economic comparisons, this study presents the real world social and economic cost scenario for both elective TEVAR and TEVAR hybrid treatment of DTAA of both the in-hospital and at mid term follow-up periods.

Objectives: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones.Methods: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework.Results: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions.Conclusions: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.

Laboratory data play a pivotal role in the clinical decision-making process. Major transformations have occurred in laboratory medicine in recent decades. To face the economic pressures, hospital laboratories are forced to enhance efficiency. Decisions on policy and practice take place at many levels. However, decision-making often does not follow Evidence Based Laboratory Medicine principles. Also, the literature shows limited influence of economic evaluations on health care decisions and diagnostic processes. Several barriers to the use of economic evaluation in decision-making process have been identified, and guidelines tend to focus on issues of effectiveness and have not explicitly considered broader issues, particularly cost. As an example, we analyzed recommendations on the use of brain natriuretic peptide (BNP) or N-terminal fragment of the prohormone BNP (NT-proBNP) in patients with chronic heart failure. All guidelines recommend the use of BNP if available. Nevertheless, none included economic data explicitly, even if economic information exists in the literature. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group, propose using a balance sheet approach, one way of helping decision makers to explicitly consider resource use along with other outcomes when making recommendations. Key aspects of GRADE, such as the explicit presentation of information and the quality evaluation of the economic data can help overcome barriers in the use of economic evaluations in the decision-making in process. This approach can help to give health decision makers, clinical guideline panels and patients, a better appreciation of the overall health benefits, harms and costs of laboratory tests.

To describe the characteristics of a diabetic population in a primary care setting, and to evaluate changes in glycaemic control at varying body weight categories.We collected 4,610 valid baseline and three years follow-up paired data sheets sent from 77% of the general practitioners adhering to our shared-care program (257 GPs out of 521) for people with type 2 diabetes. Three conventional body weight categories were defined: "normal" (BMI,or = 25 kg/m2), "overweight" (BMI 25.0-29.9), "obesity" (BMIor = 30). According to weight status we calculated descriptive statistics and follow-up paired changes.A fifth of the diabetic patients had a "normal" BMI, about 45% was "overweight" and 34% was "obese". At follow-up, the glycaemic control significantly improved both in "normal" and "overweight" people, while it significantly worsened in "obese" ones.Our data confirm the crucial role played by body weight and its changes in diabetic patients.

Country profiles from the watchdog Transparency International show a high level of citizen reported corruption in Italy.1 The problem is associated with the activity of criminal organisations, such as the Mafia, N’drangheta, and Camorra, which originated in the south of the country but are now active across the whole nation. As in other countries, healthcare is particularly …

Objective To estimate the cost-effectiveness of treatment with n-3 polyunsaturated fatty acids (PUFA) for secondary prevention after myocardial infarction (MI).

Background: In the Ramipril Efficacy In Nephropathy (REIN) trial, ramipril significantly lowered the rate of reaching the combined end-point of doubling of baseline serum creatinine levels or end-stage renal failure (ESRF). Objective: To determine the additional cost per patient-year of chronic (long term) dialysis avoided (PYCDA) when the ACE inhibitor, ramipril, was added to conventional treatment of patients with non-diabetic nephropathy and hypertension. Study perspective: Statutory Health Insurance (SHI) provider in Germany. Design and setting: Data from the REIN Study were used in a cost-effectiveness analysis (CEA). A modelling approach was used, which was based on secondary analysis of published data, and costs were those incurred by the SHI provider (i.e. SHI expenses). In the base-case analysis, average case-related SHI expenses were applied and PYCDA were quantified using the cumulative incidence of ESRF as observed in the REIN trial. Main outcome measures and results: The incremental cost-effectiveness ratios (ICERs) of ramipril varied between about − 76 700 deutschmarks (DM) and -DM81 900 per PYCDA(DM1 ≈ 0.55 US dollars; 1999 values), according to the treatment periods of 1 year and 3 years, respectively. In the sensitivity analysis, the robustness of the model and its results were shown when the extent of influence of different model variables on the base-case results was investigated. First, probabilities of ESRF and PYCDA were estimated according to the Weibull method. Second, the influence of the model variables on the target variable was quantified using a deterministic model. Third, the dependency of the target variable (ICER) on random variables was described in a simulation. The cost for chronic dialysis had by far the greatest impact on the target variable, which was 28 times greater than the impact of clinical effectiveness of ramipril, i.e. the number of PYCDA. There were net savings per PYCDA with ramipril treatment after 1, 2 and 3 years: 95% of the 10 000 simulation steps resulted in savings of between DM69 500 and DM94 600 per PYCDA after 3 years. Conclusions: Results from this evaluation show that ramipril offers enormous savings from the perspective of the SHI provider (third-party payer) in Germany when added to the conventional treatment of patients with non-diabetic nephropathy and hypertension.

To review studies on the costs of diabetes and its complications through a scheme designed specifically for assessing the quality of cost-of-illness (COI) studies.The methodology of COI studies in diabetes was analysed in order to assess the significance of quantitative results. The scheme adopted 7 items identified as the main points for discussing the methodological choices governing the results. We also used a checklist based on questions related to the 7 items.The answers showed that many studies appear not to give technical details, so it is hard to understand the method. Methodological choices varied widely between the studies. This is probably due to the lack of consensus on the methodology of COI studies. Based on the findings of this review, we suggest also some specific points that could help produce more reliable results on the costs of diabetes.Clearly, a general consensus on COI studies is still remote, making the value of any comparison of results questionable.

Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. The retina at the macula thickens and this can cause gradual loss of central vision. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual loss in DMO or clinically significant macular oedema (CSMO), vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities has recently been proposed for improving vision in people with DMO. Anti-VEGF drugs are delivered by an injection in the vitreous cavity of the eye.This review aims to assess the effectiveness of anti-VEGF therapy for preserving or improving vision in people with DMO.

Objectives In this article, we describe how to include considerations about resource utilization when making recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Study Design and Settings We focus on challenges with rating the confidence in effect estimates (quality of evidence) and incorporating resource use into evidence profiles and Summary of Findings (SoF) tables. Results GRADE recommends that important differences in resource use between alternative management strategies should be included along with other important outcomes in the evidence profile and SoF table. Key steps in considering resources in making recommendations with GRADE are the identification of items of resource use that may differ between alternative management strategies and that are potentially important to decision makers, finding evidence for the differences in resource use, making judgments regarding confidence in effect estimates using the same criteria used for health outcomes, and valuing the resource use in terms of costs for the specific setting for which recommendations are being made. Conclusions With our framework, decision makers will have access to concise summaries of recommendations, including ratings of the quality of economic evidence, and better understand the implications for clinical decision making.

On the basis of a local household survey carried out in 2006, this paper examines health inequalities of people living in the province of Modena, one of the richest areas in Italy. Health were considered using different point of view: lifestyle habits (obesity, smoking, physical exercise), use of private and public health services and quality of life. The paper finds evidence of inequalities measured using different indicators, such as income, education, gender. Family environment was found to be a clear key drivers for healthy lifestyle habits.

Background Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important determinants of this gap and may influence an excessive variability in physicians' prescriptions. This is quite noticeable in Italy, where the philosophy and methods of Evidence-Based Medicine still enjoy limited diffusion among practitioners. Academic detailing and pharmacist outreach visits are interventions of proven efficacy to make independent and evidence-based information available to physicians; this approach and its feasibility have not yet been tested on a large scale and, moreover, they have never been formally tested in Italy. Methods/Design Two RCTs are planned: 1) a two-arm cluster RCT, carried out in Emilia-Romagna and Friuli Venezia Giulia, will evaluate the effectiveness of small group meetings, randomising about 150 Primary Care Groups (corresponding to about 2000 GPs) to pharmacist outreach visits on two different topics. Physicians' prescriptions (expressed as DDD per 1000 inhabitants/day), knowledge and attitudes (evaluated through the answers to a specific questionnaire) will be compared for target drugs in the two groups (receiving/not receiving each topic). 2) A three-arm RCT, carried out in Sardinia, will evaluate both the effectiveness of one-to-one meetings (one pharmacist visiting one physician per time) and of a 'new' information format (compared to information already available) on changing physicians' prescription of specific drugs. About 900 single GPs will be randomised into three groups: physicians receiving a visit supported by "traditional" information material, those receiving a visit with "new" information material on the same topic and those not receiving any visit/material. Discussion The two proposed RCTs aim to evaluate the organisational feasibility and barriers to the implementation of independent information programs led by NHS pharmacists. The objective to assess a 10 or 15% decreases in the prescription of the targeted drugs is quite ambitious in such 'natural' settings, which will be minimally altered by the interventions themselves; this in spite of the quite large sample sizes used comparing to other studies of these kind. Complex interventions like these are not easy to evaluate, given the many different variables into play. Anyway, the pragmatic nature of the two RCTs appears to be also one of their major strengths, helping to provide a deeper insight on what is possible to achieve – in terms of independent information – in a National Health System, with special reference to Italy. Trial registration ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT)

Diabetic macular oedema (DMO) is a major cause of visual loss among diabetics, occurring in 14% to 25% of patients depending on age and insulin treatment status.1 In 2006, the International Diabetes Federation showed that diabetes affects 246 million people worldwide—a figure that will rise to 552 million by 2030 (http://www.idf.org/diabetesatlas/5e/theglobal-burden); therefore the burden of care for DMO will be massive worldwide. Antiangiogenic therapy is an established treatment option in patients with macular oedema due to diabetic retinopathy. A recently published Cochrane review2 has summarised the evidence, showing that intravitreal injections of vascular endothelial growth factor inhibitors can achieve better visual outcomes at 1 year than conventional focal or grid laser photocoagulation. The cost–effectiveness of this treatment, however, has been questioned in the last few years, particularly in the UK where the National Institute for Health and Care Excellence (NICE) has been using sophisticated methods informing cost utility assessment (see http://www.nicedsu.org.uk/). The Cochrane review found that at 1 year, antiangiogenic therapy can at least double the chance of gaining three or more lines of vision, as well as halve the risk of losing them. This evidence was collected by meta-analysis of 2 studies on bevacizumab (167 participants), 2 on ranibizumab (300 participants) and 1 on aflibercept (221 participants, of whom 89 were used in the analysis). The evidence was judged to be of moderate quality, mainly because there were not enough trials to investigate heterogeneity and the overall sample size did not meet optimal criteria for sample size requirements.2 Better evidence was available for ranibizumab, but there was little power to investigate the difference in drug efficacy. Safety of the drug and the intravitreal injection procedure was good in the trials, but further long-term data are believed to be needed to exclude …

Objective: To estimate the cost effectiveness of treatment with n-3 polyunsaturated fatty acids (PUFA) for secondary prevention after myocardial infarction (MI). Design and setting: The cost-effectiveness analysis of n-3 PUFA treatment after MI was based on morbidity and mortality data and the use of resources obtained prospectively during the 3.5 year follow-up period of the Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto (GISSI)-Prevenzione study. The cost-effectiveness analysis took into account the incremental number of life-years gained and the incremental costs for hospital admissions, diagnostic tests and drugs, applying a 5% discount rate. The value for money of n-3 PUFA treatment was assessed using the cost-effectiveness ratio and the number needed to treat (NNT) approach. Perspective: Third-party payer. Main outcome measures and results: The incremental cost-effectiveness ratio for n-3 PUFA in the base case scenario was 24 603 euro (EUR, 1999 values) per life-year gained (95% confidence interval: 22 646 to 26 930). Sensitivity analysis included the analysis of extremes, producing estimates varying from EUR15 721 to EUR52 524 per life-year gained. 172 patients would need to be treated per year with n-3 PUFA, at an annual cost of EUR68 000, in order to save 1 patient. This is comparable with the NNT value, and associated annual cost for simvastatin, but less costly than that for pravastatin. Conclusions: The cost effectiveness of long term treatment with n-3 PUFA is comparable with other drugs recently introduced in the routine care of secondary prevention after MI. Since the clinical benefit provided by n-3 PUFA is additive, this therapy should be added to the established routine practice, with additive costs.

Diabetic nephropathy is one of the major complications of insulin-dependent diabetes mellitus (IDDM), with proteinuria being the main clinical manifestation of diabetic nephropathy. Most patients who develop overt proteinuria progress to end-stage renal disease (ESRD), usually within 5 to 7 years; ESRD necessitates dialysis or renal transplantation. Although a relationship between blood pressure reduction and delaying of ESRD has been assumed for a long time, only recently has a controlled randomised clinical trial shown that the treatment of diabetic nephropathy with an ACE inhibitor can significantly delay the loss of renal function and, therefore, ESRD. Consistent with the clinical trial on which this economic evaluation was based, the costs and consequences of 2 alternatives were considered: (i) patients subject to blood pressure control with only antihypertensive medication, but without an ACE inhibitor (placebo group) and (ii) patients given ACE inhibitor therapy (captopril group) with similar blood pressure control to the placebo group. This cost-effectiveness analysis was performed from the perspective of the Italian National Health Service [Servizio Sanitario Nazionale (SSN)]. Accordingly, only direct costs related to publicly funded healthcare services were included. The number of dialysis-years avoided (DYA) was the clinical end-point. A 10-year time horizon was considered for the economic evaluation. Captopril therapy was dominant, being at the same time more effective and less costly. The total cost for the captopril alternative during the 10-year period was 21,901,625 Italian lire (L; 1993 values) per patient, while total cost for the placebo alternative was L30,352,590 per patient. Compared with placebo, 20.01 DYA per 100 patients treated were estimated with captopril therapy during the trial period, equivalent to 2.4 months per patient. The robustness of this result was confirmed by sensitivity analysis: for both extremes, captopril remained dominant. This economic evaluation, requested by the Italian Ministry of Health, demonstrated savings in healthcare expenditure with the use of an ACE inhibitor in patients with proteinuria.

Interest in measuring qualitative aspects of life that are most closely related to health and healthcare has increased in recent years. Methods of describing patients' subjective health status now incorporate standardised measures, and several psychometric measures are available. Despite the thousands of empirical and conceptual papers in the medical and pharmacological literature on health-related quality of life (HR-QOL), the value of such measures in the regulatory process is still being debated. We conducted an assessment to understand and document the position of the European Agency for the Evaluation of Medicinal Products (EMEA) on the use of HR-QOL measures in studies conducted for regulatory purposes. Official documents produced and circulated by the EMEA containing recommendations on trial design, conduct and analysis for sponsors and scientific experts were independently reviewed by authors to document the position of the Agency on the specific topic of HR-QOL. All documents found in the Agency website on 30 September 1999 were identified and then assessed to: (i) identify diseases or drugs for which formal HR-QOL assessment is recommended; (ii) identify measures and methods recommended; and (iii) evaluate the reliability of recommendations across documents. Of the 189 documents retrieved, none focused directly on health-related quality of life. A few explicit recommendations were identified for 13 specific drugs or conditions. These recommendations were mostly general and vague, and used nonstandard terminology. In addition, terminology and recommendations were not consistent across documents and, in at least one case, were in contrast with the US Food and Drug Administration (FDA) guidelines. EMEA guidelines incorporating quality-of-life outcomes are welcomed but it is obvious that more detailed guidance is required. Closer collaboration between the EMEA and the FDA is also recommended. Experts from different disciplines should be involved in the preparation of such documents to assure the necessary technical expertise and the representativeness of the various counterparts.