Background: Ipilimumab, a fully human monoclonal antibody that blocks CTLA-4 to promote anti-tumour immunity, was the first treatment in metastatic melanoma to show a significant survival benefit. Methods: A three-health-state partitioned survival model was developed to assess ipilimumab 3 mg/kg compared to dacarbazine and vemurafenib in first line therapy of advanced melanoma treatment-naive patients in Italy. The outcomes considered were costs, life years (LYs) and quality-adjusted life years (QALYs). Given the lack of trials assessing ipilimumab 3 mg/kg in this subgroup of patients, the efficacy was derived from a dataset of chemo-naive patients. Patient's management costs were estimated based on a micro-costing approach and the cost of adverse events based on both outpatient and inpatient care. Utilities considered were elicited from ipilimumab's clinical trials. Results: Basecase results showed that ipilimumab was both more costly and more effective than dacarbazine, with ratios of €38,345/LYs and €49,466/QALYs. By contrast, results vs. vemurafenib showed a marginal increase in health outcomes accompanied by a saving of €32,999, thus making ipilimumab the dominant strategy over vemurafenib in the base-case analysis. Sensitivity analysis showed overall robustness of the model. Conclusions: Treatment with ipilimumab showed better results in terms of LYs and QALYs against both comparators. Moreover, ipilimumab was the dominant strategy compared to vemurafenib, thus highly likely to bring both health benefits and cost savings in the Italian setting.
Background Limited data are available on the epidemiology and clinical management of anaemia in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). Methods This retrospective observational study was based on records from databases of five Local Health Units across Italy. Adults with reported NDD-CKD stage 3a–5 between 1 January 2014 and 31 December 2016 were identified. Annual prevalence and incidence of anaemia (age- and sex-standardised) and clinical management (erythropoiesis-stimulating agents [ESAs], intravenous [IV] iron, and blood transfusions) were evaluated. Eligibility for ESAs was defined by ≥ 2 records of Hb < 10 g/dL, or < 11 g/dL over 6 months. Results Overall, 101,143 individuals with NDD-CKD (3a–5) recorded between 2014 and 2016 were identified, of whom 40,020 (39.6%) were anaemic. Prevalence of anaemia was 33.8% in 2016 and incidence of anaemia was stable (11.4–12.4%) from 2014 to 2016. Prevalence and incidence of anaemia increased with CKD stage. Among eligible patients, 12.8% with Hb < 11 g/dL and 15.5% with Hb < 10 g/dL received ESAs, and the proportion treated increased with CKD stage. Among ESA-treated patients with at least 2 years of follow up, 18.4% and 19.3% received IV iron in the Hb < 11 and < 10 g/dL groups, respectively, and 16.5% and 19.4% received blood transfusions. Corresponding proportions for the overall anaemic cohort were 9.0% and 11.3%, respectively. Conclusions Anaemia is a significant issue in patients with NDD-CKD. Low rates of ESA treatment indicate a potential treatment gap and suggest that anaemia may not be adequately controlled in many patients. Graphical abstract
This paper is a reflection, on the basis of empirical research conducted in Italy, on theoretical, methodological and systemic-organisational aspects linked to the recognition and validation of the prior learning acquired by adult learners or workers who decide to enrol at university at a later stage in their lives. The interest in this research theme derives from the continuously growing number of adults who enrol on graduate degree programmes. The growing national and European debate on the reform of educational systems which ensued from the Bologna Process is focused on the development of a bridging system between the formal systems of education and the non formal and informal learning contexts, in view of developing validation procedures for prior learning. The research method, which combined both qualitative and quantitative approaches, consisted in a national survey on the basis of a questionnaire submitted to all the Italian universities and used methods of qualitative orientation, such as Bilan de Competénces and Biographic Laboratory. The survey helped to identify instruments and organisational procedures for the validation of prior vocational learning. Moreover, on the basis of the research conducted and keeping in mind the international setting, it can be stated that it is only from the perspective of lifelong learning that universities can approach the object at issue.
Background and Aims Anaemia is a common complication in patients with NDD-CKD, and its prevalence increases with advancing CKD stage.1,2 It is a risk factor for both CKD progression and other adverse outcomes, including major adverse cardiac events, hospitalisation and all-cause mortality.1 We aim to report the prevalence of NDD-CKD stage 3a–5 in Italy, and to evaluate the prevalence and incidence of anaemia among patients with NDD-CKD. Of those patients with anaemia, we seek to establish the size of the patient pool eligible for ESAs, and consequently, the proportion of patients treated with ESAs. Method Patients ≥18 years of age with a record of NDD-CKD stage 3a–5 between 1 January 2014 and 31 December 2016 were identified from databases of five Local Health Units (LHUs) across Italy. NDD-CKD stage 3a–5 in our study was defined as either ≥1 hospitalisation record with discharge diagnosis of CKD (ICD-9-CM 585.x, where x = 3, 4, or 5) or ≥1 record of estimated glomerular filtration rate (eGFR) <60 mL/min. eGFR values were estimated using the Modification of Diet in Renal Disease method and were as reported by LHUs. Patient classification into CKD stage 3a–5 based on eGFR was done according to KDIGO guidelines.3 Anaemia was defined as Hb <13 g/dL (males) or <12 g/dL (females). Prevalence was defined as the presence of ≥1 record of NDD-CKD stage 3a–5 or anaemia in the entire period preceding the timepoint of interest, or as incident NDD-CKD/anaemia; incidence was defined as a first record of the condition in the year of interest (no record of the condition in the patient’s history). Point prevalence (at 31 December of each reported year) and annual incidence were age- and sex-standardised using census data from 1 January of the following year. Among patients with anaemia of NDD-CKD stage 3a–5, eligibility for ESA was defined as at least one record of Hb <10 g/dL,4 and patients with a record of ESA prescription were categorised as ESA treated. Results For 2016, the prevalence of NDD-CKD stage 3a–5 in the population aged ≥18 years was 5.6% (83,625/1,507,391): CKD stage 3a was the most common (4.2%; 62,683/1,507,391), while the prevalence of each of the stages 3b–5 was ≤1.0% (Table). The prevalence and incidence of anaemia among patients with NDD-CKD stage 3a–5 in 2016 was 33.8% and 11.4%, respectively. The prevalence of anaemia increased with CKD stage: from 28.2% among patients with stage 3a to 78.9% among those with stage 5. A similar trend was observed for incidence, which increased from 9.3% for stage 3a to 32.8% for stage 5. The proportion of patients with NDD-CKD stage 3a–5 and anaemia who were eligible for ESA treatment from 2014–2016 ranged from 51.9% to 75.6% across the CKD stages. In 2016, the proportion of patients with incident NDD-CKD anaemia who were eligible for ESAs but not treated was 42.3%. This proportion was similar across the CKD stages, except for stage 5, for which the proportion of patients who were eligible but not ESA treated was 51.1%. Conclusion In Italy, we found that higher CKD stages are associated with increased prevalence and incidence of anaemia in NDD-CKD, a finding which is supported by previous research in other countries worldwide.1,2 Despite this, almost half of patients with anaemia of NDD-CKD stage 3a–5 were eligible for ESA treatment but did not receive ESAs. This suggests that anaemia may not be adequately controlled in patients with NDD-CKD stage 3a–5, and may need further attention and treatment.
The third sector represents a vast and heterogeneous universe that has a key role in society from both the social and civil points of view. It also represents an informal learning context where competence and knowledge are acquired, often in a tacit and indirect way. This research focuses on the key competences of the third sector professionals and on the pedagogical methods to make them visible and to encourage their recognition. The quantitative and qualitative data sources include: questionnaires, focus groups, and diaries. The results show that the informal learning of key competences by professionals is a primary result of their activities that should be given greater visibility. Six areas of expertise have been identified in order to classify the range of knowledge and competence. The pedagogical approach has highlighted the importance of the tutor who applies narrative tutoring methods to facilitate the recognition of competences and their enhancement for personal and professional development. The full enhancement of competences, considered as the strengthening of people’s reflection and planning potential, requires policies that can be effectively applied to the national competences certification system.
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