Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology

The aim of the present study was to assess the estimated "per patient" total cost for a single Oncologic Italian Cancer Center participating in a multicenter clinical trial with new anticancer biological agents using the activity-based costing (ABC) methodology

Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry

Background: Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and to investigate the role of BRS postdilatation. Methods: Consecutive ACS patients undergoing BRS implantation in 8 centers were com­pared with those with EES before and after propensity score matching. Major adverse cardiac event (MACE), myocardial infarction, and target lesion revascularization (TLR) were the primary endpoint. Sensitivity analysis was performed according to postdilatation after BRS implantation. We enrolled 303 BRS and 748 EES patients; 215 from each group were com­pared after matching, and 117 (55.2%) BRS patients were treated with postdilatation. Results: After a median follow-up of 24.0 months, MACE rates were higher in BRS patients than in EES patients (9.3% vs. 4.7%, p < 0.001), mainly driven by TLR (6.1% vs. 1.9%, p < 0.001). Stent thrombosis increased in the BRS group (2.8% vs. 0.9%, p = 0.01). How­ever, after sensitivity analysis, MACE rates in BRS patients with postdilatation were signifi­cantly lower than in those without, comparable to EES patients (6.0% vs. 12.6% vs. 4.7%, p < 0.001). The same trend was observed for TLR (3.4% vs. 8.4% vs. 1.9%, p < 0.001). Stent thrombosis rates were higher in both the BRS groups than in EES patients (2.6% vs. 3.2% vs. 0.9%, p = 0.045). Conclusions: Postdilatation appears effective when using BRS in ACS patients. MACE rates are comparable to those of EES, although scaffold thrombosis is not negligible. Randomized prospective studies are required for further investigation

Micromechanical Properties of Injection-Molded Starch–Wood Particle Composites

The micromechanical properties of injection molded starch–wood particle composites were investigated as a function of particle content and humidity conditions. The composite materials were characterized by scanning electron microscopy and X-ray diffraction methods. The microhardness of the composites was shown to increase notably with the concentration of the wood particles. In addition,creep behavior under the indenter and temperature dependence were evaluated in terms of the independent contribution of the starch matrix and the wood microparticles to the hardness value. The influence of drying time on the density and weight uptake of the injection-molded composites was highlighted. The results revealed the role of the mechanism of water evaporation, showing that the dependence of water uptake and temperature was greater for the starch–wood composites than for the pure starch sample. Experiments performed during the drying process at 70°C indicated that the wood in the starch composites did not prevent water loss from the samples.Peer reviewe

Mycobacterium xenopi pulmonary infection resulting in self-limited immune reconstitution inflammatory syndrome in an HIV-1 infected patient

Highly active antiretroviral therapy (HAART) has been shown to induce a major and durable viral load reduction accompanied by a stable CD4 increase. This process may evolve with adverse clinical phenomena, known as the immune reconstitution inflammatory syndrome (IRIS). In the HIV population, non-tuberculous mycobacteria are a common cause of IRIS. However, only a few cases of Mycobacterium xenopi associated IRIS have been described. This paper concerns a case of M. xenopi pulmonary infection resulting in self-limited immune reconstitution inflammatory syndrome in an HIV-1 infected patient

Sicurezza dei pazienti e gestione del rischio clinico: la qualit\ue0 dell'assistenza farmaceutica

La Sicurezza dei pazienti \ue8 una priorit\ue0 che il nostro Servizio sanitario si pone a garanzia della qualit\ue0 ed equit\ue0 delle cure prestate su tutto il territorio nazionale. Il miglioramento della qualit\ue0 dipende da molteplici fattori che agiscono sul sistema e pu\uf2 essere raggiunto attraverso pratiche di Governo clinico che pongono al centro della programmazione e gestione dei servizi sanitari i bisogni dei cittadini e valorizzano nel contempo il ruolo e la responsabilit\ue0 di tutte le figure professionali che operano in sanit\ue0. Rafforzare le competenze dei professionisti \ue8 infatti un valore essenziale, cos\uec come la formazione costituisce uno strumento indispensabile per assi- curare l\u2019erogazione di cure efficaci e sicure. L\u2019obiettivo, infatti, \ue8 quello di offrire, nello specifico ambito della Sicurezza dei pazienti, un\u2019opportunit\ue0 di formazione ad operatori sanitari e suggerire a Regioni e Province Autonome, Aziende sanitarie, Universit\ue0 nonch\ue9 Ordini professionali, strumenti formativi per sviluppare ulteriori programmi nella logica del miglioramento della qualit\ue0 e della Sicurezza delle cure

Bioresorbable Scaffold vs. Second Generation Drug Eluting Stent in Long Coronary Lesions requiring Overlap: A Propensity-Matched Comparison (the UNDERDOGS study)

Background Randomized clinical trials on bioresorbable scaffolds (BRS) enrolled patients with simple coronary lesions. The present study was sought to give preliminary findings about safety of BRS implantation in overlap in long coronary lesions. Methods From June 2012 to January 2015, we prospectively collected data from 162 consecutive patients receiving overlapping BRS implantation in the 16 participating institutions. We applied a propensity-score to match BRS-treated patients with 162 patients receiving second generation drug eluting stents (DES) in overlap. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization. Results DOCE rate did not significantly differ between the two groups (5.6% in BRS group vs. 7.4% in DES group, HR 0.79, 95%CI 0.37-3.55, p = 0.6). Also stent/scaffold thrombosis did not differ between groups (1.2% in BRS group vs. 1.9% in DES group, p = 0.6). Occurrence of procedural-related myocardial injury was significantly higher in the BRS group (25% vs. 12%, p = 0.001), although it was not related to DOCE (HR 1.1, 95%CI 0.97-1.2, p = 0.2). Imaging techniques and enhanced stent visualization systems were significantly more employed in the BRS group (p = 0.0001 for both). Procedure length, fluoroscopy time and contrast dye amount were significantly higher in the BRS group (p = 0.001, p = 0.001 and p = 0.01, respectively). Conclusions Overlapping BRS utilization in long coronary lesions showed a comparable DOCE rate at 1 year if compared to second generation DES. Further and larger studies are on demand to confirm our findings

Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter "real-world" registry

BACKGROUND: Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and to investigate the role of BRS postdilatation. METHODS: Consecutive ACS patients undergoing BRS implantation in 8 centers were com-pared with those with EES before and after propensity score matching. Major adverse cardiac event (MACE), myocardial infarction, and target lesion revascularization (TLR) were the primary endpoint. Sensitivity analysis was performed according to postdilatation after BRS implantation. We enrolled 303 BRS and 748 EES patients; 215 from each group were com-pared after matching, and 117 (55.2%) BRS patients were treated with postdilatation. RESULTS: After a median follow-up of 24.0 months, MACE rates were higher in BRS patients than in EES patients (9.3% vs. 4.7%, p < 0.001), mainly driven by TLR (6.1% vs. 1.9%, p < 0.001). Stent thrombosis increased in the BRS group (2.8% vs. 0.9%, p = 0.01). How-ever, after sensitivity analysis, MACE rates in BRS patients with postdilatation were signifi-cantly lower than in those without, comparable to EES patients (6.0% vs. 12.6% vs. 4.7%, p < 0.001). The same trend was observed for TLR (3.4% vs. 8.4% vs. 1.9%, p < 0.001). Stent thrombosis rates were higher in both the BRS groups than in EES patients (2.6% vs. 3.2% vs. 0.9%, p = 0.045). CONCLUSIONS: Postdilatation appears effective when using BRS in ACS patients. MACE rates are comparable to those of EES, although scaffold thrombosis is not negligible. Randomized prospective studies are required for further investigation