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Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 â SB2) were 98% (95% confidence interval [CI] 94%-100%) and 90% (95% CI 81%-99%), respectively. Four patients experienced a total of five AEs, all graded 1-3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.
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Anticuerpos Monoclonales/farmacología , Anticuerpos Monoclonales/uso terapéutico , Biosimilares Farmacéuticos/farmacología , Biosimilares Farmacéuticos/uso terapéutico , Sustitución de Medicamentos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Infliximab/farmacología , Infliximab/uso terapéutico , Resultado del Tratamiento , Adolescente , Adulto , Estudios de Cohortes , Femenino , Humanos , Masculino , Adulto JovenRESUMEN
During the past 50 years, the aim to reduce the eddy current losses in magnetic cores to a minimum led to the formulation of new materials starting from electrically insulated iron powders, today called Soft Magnetic Composites (SMC). Nowadays, this promising branch of materials is still held back by the mandatory tradeoff between energetic, electrical, magnetic, and mechanical performances. In most cases, the research activity focuses on the deposition of an insulating/binding layer, being one of the critical points in optimizing the final composite. This insulation usually is achieved by either inorganic or organic layer constituents. The main difference is the temperature limit since most inorganic materials typically withstand higher treatment temperatures. As a result, the literature shows many materials and process approaches, each one designed to meet a specific application. The present work summarizes the recent advances in state of the art, analyzing the relationship among material compositions and magnetic and mechanical properties. Each coating shows its own processing sets, which vary from simple mechanical mixing to advanced chemical methods to metallurgical treatments. From state of the art, Aluminum coatings are characterized by higher current losses and low mechanical properties. In contrast, higher mechanical properties are obtained by adopting Silicon coatings. The phosphates coatings show the best-balanced overall properties. Each coating type was thoroughly investigated and then compared with the literature background highlighting. The present paper thus represents a critical overview of the topic that could serve as a starting point for the design and development of new and high-performing coating solutions for SMCs. However, global research activity continuously refines the recipes, introducing new layer materials. The following steps and advances will determine whetherthese materials breakthrough in the market.
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BACKGROUND & AIM: Although acute lower GI bleeding (LGIB) represents a significant healthcare burden, prospective real-life data on management and outcomes are scanty. Present multicentre, prospective cohort study was aimed at evaluating mortality and associated risk factors and at describing patient management. METHODS: Adult outpatients acutely admitted for or developing LGIB during hospitalization were consecutively enrolled in 15 high-volume referral centers. Demographics, comorbidities, medications, interventions and outcomes were recorded. RESULTS: Overall 1,198 patients (1060 new admissions;138 inpatients) were included. Most patients were elderly (mean-age 74±15 years), 31% had a Charlson-Comorbidity-Index ≥3, 58% were on antithrombotic therapy. In-hospital mortality (primary outcome) was 3.4% (95%CI 2.5-4.6). At logistic regression analysis, independent predictors of mortality were increasing age, comorbidity, inpatient status, hemodynamic instability at presentation, and ICU-admission. Colonoscopy had a 78.8% diagnostic yield, with significantly higher hemostasis rate when performed within 24-hours than later (21.3% vs.10.8%, pâ¯=â¯0.027). Endoscopic hemostasis was associated with neither in-hospital mortality nor rebleeding. A definite or presumptive source of bleeding was disclosed in 90.4% of investigated patients. CONCLUSION: Mortality in LGIB patients is mainly related to age and comorbidities. Although early colonoscopy has a relevant diagnostic yield and is associated with higher therapeutic intervention rate, endoscopic hemostasis is not associated with improved clinical outcomes [ClinicalTrial.gov number: NCT04364412].
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Hemorragia Gastrointestinal/mortalidad , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Femenino , Hemorragia Gastrointestinal/etiología , Mortalidad Hospitalaria , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: Prospective studies about endoscopic retrograde cholangio-pancreatography (ERCP) in a community setting are rare. AIM: To assess success and complication rates of routinely-performed ERCP in a regional setting, and the priority quality indicators for ERCP practice. METHODS: Prospective region wide observational study on consecutive patients undergoing ERCP during a 6-month period. A centralized online ERCP questionnaire was built and used for data storage. Primary quality indicators provided by the American Society of Gastrointestinal Endoscopy (ASGE) were considered. RESULTS: 38 endoscopists from 18 centers performed a total of 2388 ERCP. The most common indication for ERCP was choledocholitiasis (54.8%) followed by malignant jaundice (22.6%). Cannulation of the desired duct was obtained in 2293 cases (96%) and ERCP was successful in 2176 cases (91.1%). Success and ERCP difficulty were significantly related to the experience of the operator (pâ¯=â¯0.001 and pâ¯<â¯0.001, respectively). ERCP difficulty was also significantly related to volume centers (pâ¯<â¯0.01). The overall complication rate was 8.4%: post-ERCP pancreatitis (PEP) occurred in 4.1% of procedures, bleeding in 2.9%, infection in 0.8%, perforation in 0.4%. Mortality rate was 0.4%. All the ASGE priority quality indicators for ERCP were confirmed. CONCLUSIONS: The procedural questionnaire proved to be an important tool to assess and verify the quality of routinely-performed ERCP performance in a community setting.
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Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Colangiopancreatografia Retrógrada Endoscópica/estadística & datos numéricos , Hemorragia/epidemiología , Pancreatitis/epidemiología , Indicadores de Calidad de la Atención de Salud , Cateterismo/estadística & datos numéricos , Coledocolitiasis/diagnóstico por imagen , Coledocolitiasis/cirugía , Bases de Datos Factuales , Hemorragia/etiología , Humanos , Italia/epidemiología , Ictericia/diagnóstico por imagen , Modelos Logísticos , Pancreatitis/etiología , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
Flood risk mitigation usually requires a significant investment of public resources and cost-effectiveness should be ensured. The assessment of the benefits of hydraulic works requires the quantification of (i) flood risk in absence of measures, (ii) risk in presence of mitigation works, (iii) investments to achieve acceptable residual risk. In this work a building-scale is adopted to estimate direct tangible flood losses to several building classes (e.g. residential, industrial, commercial, etc.) and respective contents, exploiting various sources of public open data in a GIS environment. The impact simulations for assigned flood hazard scenarios are computed through the RASOR platform which allows for an extensive characterization of the properties and their vulnerability through libraries of stage-damage curves. Recovery and replacement costs are estimated based on insurance data, market values and socio-economic proxies. The methodology is applied to the case study of Florence (Italy) where a system of retention basins upstream of the city is under construction to reduce flood risk. Current flood risk in the study area (70 km2) is about 170 Mio euros per year without accounting for people, infrastructures, cultural heritage and vehicles at risk. The monetary investment in the retention basins is paid off in about 5 years. However, the results show that although hydraulic works are cost-effective, a significant residual risk has to be managed and the achievement of the desired level of acceptable risk would require about 1 billion euros of investments.
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Inundaciones , Medición de Riesgo , Ciudades , Vivienda , ItaliaRESUMEN
BACKGROUND AND AIMS: Perception of quality of care is important in the management of patients with chronic diseases, particularly inflammatory bowel disease. AIMS AND METHODS: This longitudinal study aimed to investigate variations of the Quality of Care through the Patients' Eyes (QUOTE-IBD) questionnaire scores one year after the basal evaluation in the Studio Osservazionale quaLità cUre malatTIe crOniche intestiNali (SOLUTION-1) study. RESULTS: Of the cohort of 992 patients, 936 were evaluable. The QUOTE-IBD score overcame satisfactory levels of more than the 80%, overall and in all subdomains except for the "Continuity of Care" sub-dimension (mean, 8.3; standard deviation, 1.49), scored satisfactory only by 34% of the patients. No significant changes in satisfaction were recorded overall, or considering patients subgroups. Significant differences were found at the end of the follow-up between physicians' and patients' perceptions of quality of care, with the former over-rating their performance in "Continuity of Cares" and under-rating "Costs", "Competence", and "Accessibility" sub-domains of the score (p<0.05 for all). CONCLUSION: Perceived quality of care in a large cohort of Italian patients with inflammatory bowel disease remains unchanged after one-year follow-up and was not significantly affected by disease activity or therapeutic interventions. Differences between physicians' and patients' perceptions of quality of care should be taken into account.
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Enfermedades Inflamatorias del Intestino/psicología , Enfermedades Inflamatorias del Intestino/terapia , Satisfacción del Paciente/estadística & datos numéricos , Médicos/psicología , Calidad de la Atención de Salud/normas , Adolescente , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Italia , Modelos Logísticos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Distribución por Sexo , Encuestas y Cuestionarios , Adulto JovenRESUMEN
BACKGROUND: Not much is known about errors and near misses in digestive endoscopy. AIMS: To verify whether an incident report, with certain facilitating features, gives useful information about unintended events, only excluding errors in medical diagnosis. METHOD: Nine endoscopy units took part in this cross sectional, prospective, multicentre study which lasted for two weeks. Members of the staff were required to report any unintended, potentially dangerous event observed during the daily work. A form was provided with a list of "reminders" and facilitators were appointed to help. The main outcome measurements were type of event, causes, corrective interventions, stage of occurrence in the workflow and qualification of the reporters. RESULTS: A total of 232 errors were reported (two were not related to endoscopy). The remaining 230 amount to 10.3% of 2239 procedures; 66 (29%) were considered errors with consequences, 164 (71%) "near misses". There were 150 pre-operative errors (65%), 22 operative (10%) and 58 post-operative (25%). Corrective interventions were provided for 60 cases of errors and 119 near misses. Most of the events were reported by the nurses (106 out of 232, 46%). CONCLUSIONS: Short-term incident reporting focusing on near misses, using forms with lists of "reminders", and the help of a facilitator, can give useful information on errors and near misses in digestive endoscopy.
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Endoscopía del Sistema Digestivo/estadística & datos numéricos , Errores Médicos/estadística & datos numéricos , Estudios Transversales , Humanos , Periodo Perioperatorio/estadística & datos numéricos , Estudios Prospectivos , Gestión de Riesgos/estadística & datos numéricos , Flujo de TrabajoRESUMEN
OBJECTIVES: Nonvariceal upper gastrointestinal hemorrhage is a frequent reason for ordinary hospital admission. In Italy the use of prognostic scores to stratify the risk has not been adequately validated: the impact on clinical management of a rating system like the Rockall score remains to be established. RING is a 'register' that has been collecting hospital discharge files from hospital gastroenterology units, giving a broad picture of the patients admitted for this pathology. METHODS: We analyzed the hospital discharge files collected between 2001 and 2005 from 12 gastroenterology units, which issued more than 26,000 hospital discharge files for ordinary hospital admission and have been using the Rockall score for defining nonvariceal upper gastrointestinal hemorrhage since 2003. RESULTS: There were 2832 hospital discharge files with a main diagnosis of nonvariceal upper gastrointestinal hemorrhage: 1335 'before' the Rockall score was introduced, 1497 'after' the introduction. Patients' mean age was 67.7+/-16.7 years, with a male/female ratio of 1.7 and no significant changes over the years. There were no differences in the distribution of diagnoses in nonvariceal upper gastrointestinal hemorrhage patients before/after the introduction of the Rockall score, though the mean hospital stay became shorter (7.1+/-5.0 vs. 6.3+/-4.5 days), and mortality declined (2.8 vs. 2.3%), in parallel with the caselist as a whole. For 1102 ordinary hospital admission Rockall score was calculated. Diagnoses were more accurate: significantly fewer undefined causes and an increase in peptic ulcer. The mean Rockall score was 4.6+/-2.2: 17.8% low (0-2), 48.7% intermediate (3-5), and 33.5% high (>or=6). Mean hospital stay, rebleeding, and mortality were correlated with the severity of the score. CONCLUSION: The Rockall score enables the clinician to formulate a more precise diagnosis and substantially shortens the time in hospital, especially for patients at low-risk of rebleeding and death, so more resources can be dedicated to critically ill patients.
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Hemorragia Gastrointestinal/etiología , Índice de Severidad de la Enfermedad , Adulto , Anciano , Anciano de 80 o más Años , Úlcera Duodenal/complicaciones , Úlcera Duodenal/diagnóstico , Endoscopía Gastrointestinal , Femenino , Hemorragia Gastrointestinal/mortalidad , Hospitalización/estadística & datos numéricos , Humanos , Italia/epidemiología , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Pronóstico , Recurrencia , Úlcera Gástrica/complicaciones , Úlcera Gástrica/diagnósticoRESUMEN
Endoscopic palliation is the most suitable approach to improve quality of life in patients with esophageal cancer since diagnosis is often made at an advanced stage, when radical treatment is unfeasible. Endoscopy offers several techniques to palliate dysphagia either by stenting the stenosis or by reducing the tumor mass with thermoablation. A small number of randomized controlled trials is available to compare the efficacy of different techniques and the ideal palliation has not been defined as yet. Recently, the development of self-expandable covered metal stents has rapidly gained ground in the endoscopy units throughout the world as a simple, single step procedure for palliation of dysphagia.
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Neoplasias Esofágicas/terapia , Esofagoscopía , Cuidados Paliativos/métodos , Cateterismo , Trastornos de Deglución/terapia , Electrocoagulación , Humanos , Terapia por Láser , Fotoquimioterapia , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , StentsRESUMEN
BACKGROUND/AIMS: Measurement of health related quality of life (HRQoL) is a new tool to evaluate patients with inflammatory bowel disease (IBD). The aims of this study were to verify reliability and responsiveness of a disease-specific questionnaire [Italian Questionnaire on Quality of Life (IQQoL)], and to assess the relationship between clinical and demographic variables and HRQoL in IBD patients. METHODOLOGY: The IQQoL was submitted to all IBD patients consecutively seen at eight participating Hospitals, and re-administered at follow-up visits. The IQQoL covers intestinal and systemic symptoms, emotional and social function. The higher the score, the worse the HRQoL. RESULTS: 249 patients were enrolled, 106 with Crohn's disease (CD) and 143 with ulcerative colitis (UC). IQQoL was re-administered to 134 patients: 98 with unchanged, 17 with worsened and 19 with improved disease activity. The IQQoL was stable over time in patients with stable clinical conditions, and very responsive to change both in patients with improved and worsened disease activity. HRQoL was inversely correlated with disease activity, both in CD and UC. Perception of HRQoL was significantly worse in women than in men. CONCLUSIONS: The IQQoL is a reliable and responsive instrument to assess HRQoL in IBD patients. Active disease is related to poor HRQoL perception. In CD, women, mainly if young, have a worse HRQoL perception than men.