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Zorzi M.,Registro Tumori del Veneto | Senore C.,AOU Citta della Salute e della Science | Turrin A.,Settore promozione e sviluppo igiene e sanita pubblica | Mantellini P.,Instituto per lo Studio e la Prevenzione Oncologica | And 24 more authors.
Gut | Year: 2015

Objectives To assess the appropriateness of recommendations for endoscopic surveillance in organised colorectal cancer (CRC) screening programmes based on the faecal immunochemical test (FIT). Design 74 Italian CRC screening programmes provided aggregated data on the recommendations given after FIT-positive colonoscopies in 2011 and 2013. Index colonoscopies were divided into negative/no adenoma and low- risk, intermediate-risk and high-risk adenomas. Postcolonoscopy recommendations included a return to screening (FIT after 2 years or 5 years), an endoscopic surveillance after 6 months or after 1 year, 3 years or 5 years, surgery or other. We assessed the deviation from the postcolonoscopy recommendations of the European Guidelines in 2011 and 2013 and the correlation between overuse of endoscopic surveillance in 2011 and the process indicators associated with the endoscopic workload in 2013. Results 49 704 postcolonoscopy recommendations were analysed. High-risk, intermediate-risk and low-risk adenomas, and no adenomas were reported in 5.9%, 19.3%, 15.3% and 51.5% of the cases, respectively. Endoscopic surveillance was inappropriately recommended in 67.4% and 7%, respectively, of cases with low-risk and no adenoma. Overall, 37% of all endoscopic surveillance recommendations were inappropriate (6696/17 860). Overuse of endoscopic surveillance was positively correlated with the extension of invitations (correlation coefficient (cc) 0.29; p value 0.03) and with compliance with post-FIT+ colonoscopy (cc 0.25; p value 0.05), while it was negatively correlated with total colonoscopy waiting times longer than 60 days (cc -0.26; p value 0.05). Conclusions In organised screening programmes, a high rate of inappropriate recommendations for patients with low risk or no adenomas occurs, affecting the demand for endoscopic surveillance by a third. © 2015 BMJ Publishing Group Ltd & British Society of Gastroenterology.


Gonzalez-Lorenzo M.,University of Milan | Piatti A.,Direzione Generale Salute | Coppola L.,Direzione Generale Salute | Gramegna M.,Direzione Generale Salute | And 9 more authors.
Vaccine | Year: 2015

Health policy makers often have to face decisions on whether and how to incorporate new vaccines into immunisation plans. This study aims to review and catalogue the relevant current frameworks and taxonomies on vaccines and connect these to the DECIDE Evidence to Decision framework (EtD), a general framework based on evidence-based criteria to guide decision-making on intervention adoption. Methods: We systematically searched MEDLINE, EMBASE, Cochrane Library and funding agency websites from 1990 to 2013. We included systematic reviews and primary studies presenting decision-making tools for community vaccine adoption. We qualitatively summarised the reports by purpose, targeted country, principal results, and decisional models. We then extracted and compared the dimensions adopted by vaccine frameworks across studies. Results: Fourteen studies (five systematic reviews and nine primary studies) were included. Several factors frequently influenced decision-makers' views on vaccines: the most frequent political-context factors considered were Importance of illness or problem, Vaccine characteristics, Resource use, and Feasibility. Others such as Values and preferences and Acceptability were less consistently reported. We did not find evidence on the reasons why a framework for vaccine adoption differs from that for decisions on the adoption of an intervention in general, such as the EtD. There are limited data on how dimensions are explained in practical factors and directly linked to coverage decisions. Conclusions: This review summarises conceptual models and taxonomy of a heterogeneous and evolving area in health policy decisions. A shared and comprehensive framework on vaccine coverage remains to be achieved with its single dimensions (epidemiologic, effectiveness, economic, and social) valued differently across studies. A generic tool such as the EtD conceptualises all relevant dimensions, and might reduce inconsistencies. © 2014 The Authors.


PubMed | Ss Epidemiologia, Servizio di Epidemiologia e Registri di Popolazione, University of Bergamo, University of Milan Bicocca and 5 more.
Type: Journal Article | Journal: Journal of evaluation in clinical practice | Year: 2015

Assuring the best standards of care - in a sustainable way - in chronic diseases as breast cancer is nowadays an important challenge for any health system. The aim of this study was to present the methodology used to define a set of quality indicators, computable from administrative data for the pathway of care of breast cancer, and its application at a population level.The cohort of 2007-2009 incident cases of breast cancer was identified through a network of six cancer registers in Northern Italy. Cases of sarcoma and lymphoma, patients with multiple primary cancers and those metastatic at diagnosis were excluded; 9614 women were retained for the analysis. For each indicator, the sub-cohort of women eligible for the diagnostic/therapeutic procedures was identified and calculations were performed through record linkage between the cohort and sources of health information. Data on potential available confounders or prognostic factors were also collected.For a few indicators, such as cyto-histological assessment before surgery (62%) and intensive follow-up (79%), deviation from recommendations was evident. Younger patients (50 years) more frequently needed a short term re-intervention, while older patients less frequently underwent reconstructive surgery and received palliative care. Several indicators had a great variability across hospitals. In some cases, this heterogeneity appeared to be related to the hospital size, with high-volume hospitals being more compliant to guidelines.It is possible to evaluate the quality of cancer care delivered in clinical practice in recent years, in order to implement interventions aimed to improve adherence to international standards of care.


Arioli F.,University of Milan | Pasquale E.,University of Milan | Panseri S.,University of Milan | Bonizzi L.,University of Milan | And 4 more authors.
Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment | Year: 2015

The debate about the origin of prednisolone in animal organisms has lasted for 5 years. Bovine species have been the most studied, but studies on humans and horses are also present in the literature. Even if prednisolone in pigs does not yet represent a problem for control agencies, interest has recently increased with regard to this species. To date, there has been just a single study in the literature about this topic, performed on 10 sows treated with prednisolone or a synthetic analogue of adrenocorticotropic hormone. We therefore initiated a study on 80 pigs, a number considered representative in relation to the expected frequency (prevalence) of prednisolone detection in urine collected at slaughter. Prednisolone was detected in urine both at the farm and at the slaughterhouse, with a concentration and frequency higher at slaughter. The presence of prednisolone was also studied in the adrenal glands, where the corticosteroids are produced in response to stress, and it was detected in 89% of the samples. These results, together with the similar behaviours of prednisolone and cortisol, i.e. a mutual rise in the two corticosteroids in urine collected at the slaughterhouse and the correlation between the concentrations of the two corticosteroids in the adrenal glands, seem to indicate an endogenous origin of prednisolone in pigs. © 2015, © 2015 Taylor & Francis.


Corrao G.,University of Milan Bicocca | Ghirardi A.,University of Milan Bicocca | Ibrahim B.,University of Milan Bicocca | Merlino L.,Direzione Generale Salute | Maggioni A.P.,Associazione Nazionale Medici Cardiologi Ospedalieri Research Center
International Journal of Cardiology | Year: 2015

Objective Predictors of mortality and readmission among patients hospitalized for the first time for heart failure (HF) were investigated for a large, unselected population. Methods The cohort of 13,171 patients in the Lombardy Region (Italy), all of whom were aged 50 years or older and survived their first hospitalization for HF during 2011, were followed after discharge. Mortality and readmission within 30 days and one year of index discharge were investigated. Kaplan-Meier estimator and Cox model were respectively used to estimate the cumulative proportions of patients experiencing the outcomes and the hazard ratio (HR) for the association between selected covariates and time of outcome onset. Results Within 30 days of index discharge, 4.7% and 4.3% of the cohort members died or were readmitted for HF, respectively, while 22.6% and 57.2% of them died or were readmitted for any cause within one year of index discharge. Older age was an independent predictor of mortality at both 30 days and one year. One-year mortality was affected by the use of diuretics, mineralocorticoid receptor antagonists and antigout preparations and by previous hospitalization for respiratory and cerebrovascular diseases. Younger age, use of antidiabetics, diuretics, other antihypertensives, NSAIDs and antigout preparations and previous hospitalization for renal, respiratory, coronary heart and cerebrovascular disease, were independent predictors of hospital readmission. Conclusion Short-and long-term mortality and readmissions after first hospitalization for HF are high and heterogeneous across different patient subgroups. Characterization of hospitalized HF is very important in assisting clinicians in decision-making and targeting treatment of high-risk patients.


Corrao G.,University of Milan Bicocca | Ghirardi A.,University of Milan Bicocca | Ibrahim B.,University of Milan Bicocca | Merlino L.,Direzione Generale Salute | Maggioni A.P.,Associazione Nazionale Medici Cardiologi Ospedalieri Research Center
European Journal of Heart Failure | Year: 2014

Aims Heart failure has been described as one of the emerging pandemics of the 21st century. This report aims to measure the burden of new hospitalization for heart failure in the population of an Italian region of nearly 10 million inhabitants. Methods and results Data were retrieved from healthcare utilization databases covering the population of the Italian region of Lombardy. We identified patients who were hospitalized for the first time with a primary diagnosis of heart failure (hospitalized heart failure, HHF) during 2011. Incident HHF cases were used for measuring incidence rates and exploring mortality, re-hospitalizations, and healthcare costs on the 1-year time horizon after the index hospitalization. Out-of-hospital mortality, hospitalizations, and healthcare costs were also measured in a referent cohort free from heart failure hospitalization and matched 1:1 by gender and age with the HHF cohort. The overall HHF incidence rate was 32 and 20 events per 10 000 person-years in men and women, respectively. The incidence increased steeply with age in both genders. Among newly hospitalized patients, 7% died during hospitalization. Among survivors, cumulative out-of-hospital mortality and hospital readmission were 24% and 59%, respectively. The average per capita cost was €11 000, the main cost being hospitalizations. Mortality, readmissions, and costs experienced by HHF patients of 88, 75, and 79%, respectively, exceeded those of the referent cohort. Conclusions The main burden associated with HHF is related to hospitalizations. Effective treatment options that decrease hospitalization rates could reduce patients' suffering and offer considerable cost savings. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.


Gonzalez-Lorenzo M.,Instituto Ortopedico Galeazzi | Gonzalez-Lorenzo M.,University of Milan | Tirani M.,Vita-Salute San Raffaele University | Piatti A.,Direzione Generale Salute | And 7 more authors.
Recenti Progressi in Medicina | Year: 2016

Introduction: Decision makers adopt interventions, including vaccines, which are most beneficial to populations. A transparent, unbiased, and comprehensive framework based on evidence-based criteria is a promising tool to guide decision-making on vaccine adoption: we developed a multi-dimensional framework conceived from the DECIDE - Evidence to decision Framework (EtD framework). We validated the framework by conducting a real data and evidence set collection on varicella vaccination and tested it with a multidisciplinary group. Methods. The EtD framework presented evidence concerning the varicella vaccination organized in six dimensions: Burden of disease, Vaccine characteristics and impact of immunization program, Values and preferences, Resource use, Equity and Feasibility. Two reviewers completed each dimension with information about varicella vaccine. A multidisciplinary group of 42 participants were asked to evaluate the information in the framework, decide whether to introduce varicella vaccine in the national immunization program, assess the usefulness, and propose some impovements of the decision-making tool. Results. From 33 responders (79%) out of 42, 61% supported the adoption of the varicella vaccine as part of the national immunization program. A half (50%) favored the monovalent vaccine while the other half chose the tetravalent vaccine. About 90% of responders found information in the EtD framework comprehensive, easy to understand, and presented in a way that helped make decisions. Conclusions. Complete and transparent information are welcome. The EtD identified a situation of important divergences between policy makers regarding the introduction and the choice of vaccine. In our case study, for example, a third of the multidisciplinary group did not recommend the adoption of varicella vaccine.


Perfetti V.,Science Oncologia Fondazione IRCCS Policlinico San Matteo | Dalle Carbonare S.,ASL Pavia | Vecchio S.,ASL Pavia | Paglino C.,Science Oncologia Fondazione IRCCS Policlinico San Matteo | And 4 more authors.
PharmacoEconomics - Italian Research Articles | Year: 2015

Background: Biosimilars of hemopoietic growth factors present an important saving opportunity in oncology. However, while pharmacologists are aware of their potential benefits, biosimilars are still under-used in Italy. Improved information and guided clinical experience may help to increase the clinical acceptance of these drugs. To this aim, a collaborative educational project was set between an Hospital Oncology Unit and the Local Health Care Authority in Pavia, Italy. Methods: The project lasted 12 months. The strategy included an education-information seminar at startup, a reporting meeting at +6$+6$ months, electronic prescription monitoring and implementation of pharmacovigilance. The target was set to reach 90% of all naïve patients treated with biosimilars. Results: At the end of the study (2013), a dramatic relative increase in the prescription of biosimilar drugs was noted, with virtually 100% of new patients receiving biosimilar drugs during the last 4 months, with a positive impact on average per capita drug expenses. Active pharmacovigilance did not report any serious adverse drug reactions. An anonymous questionnaire showed that oncologists judged the experience quite positively, acquired a positive attitude toward these drugs and considered biosimilars a relevant saving opportunity, while adherence to prescription guidelines was maintained. Analysis of the year following the end of the project, 2014, showed a persistent prescription change. Conclusions: Results from this local experience suggests that specifically designed pragmatic interventions focused on information-education and monitoring may help in promoting the use and acceptance of biosimilar drugs in the real clinical setting. © 2015, Springer International Publishing Switzerland.


PubMed | Direzione Generale Salute, Vita-Salute San Raffaele University and University of Milan
Type: Journal Article | Journal: Recenti progressi in medicina | Year: 2016

Decision makers adopt interventions, including vaccines, which are most beneficial to populations. A transparent, unbiased, and comprehensive framework based on evidence-based criteria is a promising tool to guide decision-making on vaccine adoption: we developed a multi-dimensional framework conceived from the DECIDE - Evidence to decision Framework (EtD framework). We validated the framework by conducting a real data and evidence set collection on varicella vaccination and tested it with a multidisciplinary group.The EtD framework presented evidence concerning the varicella vaccination organized in six dimensions: Burden of disease, Vaccine characteristics and impact of immunization program, Values and preferences, Resource use, Equity and Feasibility. Two reviewers completed each dimension with information about varicella vaccine. A multidisciplinary group of 42 participants were asked to evaluate the information in the framework, decide whether to introduce varicella vaccine in the national immunization program, assess the usefulness, and propose some impovements of the decision-making tool.From 33 responders (79%) out of 42, 61% supported the adoption of the varicella vaccine as part of the national immunization program. A half (50%) favored the monovalent vaccine while the other half chose the tetravalent vaccine. About 90% of responders found information in the EtD framework comprehensive, easy to understand, and presented in a way that helped make decisions.Complete and transparent information are welcome. The EtD identified a situation of important divergences between policy makers regarding the introduction and the choice of vaccine. In our case study, for example, a third of the multidisciplinary group did not recommend the adoption of varicella vaccine.


PubMed | Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Direzione Generale Salute and University of Milan Bicocca
Type: | Journal: International journal of cardiology | Year: 2015

Predictors of mortality and readmission among patients hospitalized for the first time for heart failure (HF) were investigated for a large, unselected population.The cohort of 13,171 patients in the Lombardy Region (Italy), all of whom were aged 50years or older and survived their first hospitalization for HF during 2011, were followed after discharge. Mortality and readmission within 30days and one year of index discharge were investigated. Kaplan-Meier estimator and Cox model were respectively used to estimate the cumulative proportions of patients experiencing the outcomes and the hazard ratio (HR) for the association between selected covariates and time of outcome onset.Within 30days of index discharge, 4.7% and 4.3% of the cohort members died or were readmitted for HF, respectively, while 22.6% and 57.2% of them died or were readmitted for any cause within one year of index discharge. Older age was an independent predictor of mortality at both 30days and one year. One-year mortality was affected by the use of diuretics, mineralocorticoid receptor antagonists and antigout preparations and by previous hospitalization for respiratory and cerebrovascular diseases. Younger age, use of antidiabetics, diuretics, other antihypertensives, NSAIDs and antigout preparations and previous hospitalization for renal, respiratory, coronary heart and cerebrovascular disease, were independent predictors of hospital readmission.Short- and long-term mortality and readmissions after first hospitalization for HF are high and heterogeneous across different patient subgroups. Characterization of hospitalized HF is very important in assisting clinicians in decision-making and targeting treatment of high-risk patients.

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