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In this article the various descriptions and interpretations of professional autonomy, as have been given in the articles from Belgium, Italy and the UK are subjected to a further analysis. The implicit claim that professional autonomy of physicians is beneficial for the health of patients is scrutinized and is proven to be untrue and invalid. The conclusion is that professional autonomy is more directed at the interests of physicians than of those of patients and deserves no special place in health care. [ABSTRACT FROM AUTHOR]

Hospital Length of Stay (LoS) is a valid proxy to estimate the consumption of hospital resources. Average LoS, however, albeit easy to quantify and calculate, can be misleading if the underlying distribution is not symmetric. Therefore the average does not reflect the nature of such underlying distribution and may mask different effects. This paper uses routinely collected data of an Italian hospital patients from different departments over a period of 5 years. This will be the basis for a running example illustrating the alternative models of patients length of stay. The models includes a new density model called Hypergamma. The paper concludes by summarizing these various modelling techniques and highlighting the use of a risk measure in bed planning. [ABSTRACT FROM AUTHOR]

Background: The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients.Main Body: This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources.Conclusion: Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level. [ABSTRACT FROM AUTHOR]

Background: Accounting for patients' perspective has become increasingly important. Based on the Consumer Quality Index method (founded on Consumer Assessment of Healthcare Providers and Systems) a questionnaire was recently developed for Dutch cancer patients. As a next step, this study aimed to adapt and pilot this questionnaire for international comparison of cancer patients experience and satisfaction with care in six European countries.Method: The Consumer Quality Index was translated into the local language at the participating pilot sites using cross-translation. A minimum of 100 patients per site were surveyed through convenience sampling. Data from seven pilot sites in six countries was collected through an online and paper-based survey. Internal consistency was tested by calculating Cronbach's alpha and validity by means of cognitive interviews. Demographic factors were compared as possible influencing factors.Results: A total of 698 patients from six European countries filled the questionnaire. Cronbach's alpha was good or satisfactory in 8 out of 10 categories. Patient satisfaction significantly differed between the countries. We observed no difference in patient satisfaction for age, gender, education, and tumor type, but satisfaction was significantly higher in patients with a higher level of activation.Conclusion: This European Cancer Consumer Quality Index(ECCQI) showed promising scores on internal consistency (reliability) and a good internal validity. The ECCQI is to our knowledge the first to measure and compare experiences and satisfaction of cancer patients on an international level, it may enable healthcare providers to improve the quality of cancer care. [ABSTRACT FROM AUTHOR]

Background: Pancreatic enucleation (PE) is a viable option for the removal of non-malignant pancreatic masses leading to complete preservation of organ function. Nevertheless, PE is associated with substantial rates of post-operative pancreatic fistula (POPF), particularly when the mass is close to the main pancreatic duct (MPD). Preoperative stenting of the MPD may prevent its injury when performing PE. This paper describes a novel technique of "deep" PE preceded by endoscopic stenting of the MPD.Methods: From January 2017 to May 2019, patients with small pancreatic neuroendocrine tumors proximal to the MPD were candidates for PE with previous stenting of the MPD at the University of Verona, Italy, and at the UCLA Medical Center, Los Angeles, California. The endoscopic stenting was scheduled either the day before or 3 weeks before surgery, depending on the participating institute.Results: Ten patients were included in this pilot study. The endoscopic procedure was successful and well tolerated in all cases. Open, laparoscopic and robotic PE were performed. Seven patients had surgical complications. Among these, six developed a post-operative pancreatic fistula (POPF), but neither grade C fistulas nor disruptions of the MPD were detected. At pathology, a low grade pancreatic neuroendocrine tumor was confirmed in all cases.Conclusion: In the setting of high-volume centers, this procedure is safe, and it is associated with acceptable short-term surgical morbidity. The preoperative stenting of the MPD might extend the surgical indications for PE. [ABSTRACT FROM AUTHOR]

Oral sucrose is included in almost all recommendations for treatment of pain in newborns, but evidence if multiple doses might be more effective than a single standard dose is lacking. We designed a single-centre, double-blind, randomised, controlled trial. We enrolled preterm infants needing the heel prick procedure. Each enrolled infant was randomised to receive a single standard dose of sucrose 2 min before or a double dose of sucrose 2 min before, and 30 s after heel prick. Primary outcome was the efficacy of the two interventions tested by the premature infant pain profile-PIPP scale obtained at 30 s, 60 s, and 120 s after heel prick. Secondary outcome was the evaluation of the concordance between the PIPP scale and other pain scores more feasible in clinical practice. Seventy-two infants were randomised. No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline; 6.0(IQR 5.0-10.0) vs 6.0(IQR 4.0-8.5) at 30 s; 6.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-8.5) at 60 s and 5.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-7.5) at 2 min, in the experimental and standard treatment groups, respectively (p = 0.9020). There was no correlation between PIPP scores and other pain scales.Conclusion: We do not recommend doubling the dose during heel prick.What is Known:• Oral sucrose is included in almost all international position papers and recommendations for the treatment of mild to moderate pain in newborns, associated with non-nutritive sucking and facilitated tucking• Premature infant pain profile (PIPP) scale is the gold standard for evaluation of pain in preterms but it is difficult to use in clinical practiceWhat is New:• Repeating a dose of 24% sucrose is not effective in reducing pain during the recovery phase of a skin breaking procedure• Other pain scales, easier to use in clinical practice, are not comparable with PIPP for the evaluation of procedural pain in preterms. [ABSTRACT FROM AUTHOR]

Many countries produce data on the prevalence and duration of breastfeeding, but are they reliable? We reviewed 16 studies on breastfeeding in Italy published after 1990. They report a prevalence of breastfeeding at and around birth ranging from 66% to 91%, decreasing to 17-52% at 4 mo and 28-36% at 6 mo. Most studies refer to a non-representative sample of the Italian population. Two studies used standard definitions of breastfeeding, but their results are difficult to interpret or cannot be generalized. Five other studies used non-standard definitions that undermine the interpretation of results. The remaining nine studies used no definition at all. All studies used a recall period different from 24 h, or from the whole hospital stay for breastfeeding at discharge, making the interpretation of results even more difficult. We conclude that the published information gives an inaccurate picture of the prevalence and duration of breastfeeding in Italy, leading to unjustified optimism and inaction. The actual figures may be lower, as shown by preliminary data from a small Italian region: using standard definitions and methods during a 9-mo monitoring period, exclusive breastfeeding averaged 35% at discharge and 23% at about 4 mo of age. [ABSTRACT FROM AUTHOR]

Background: GENetics of mOyaMoyA (GEN-O-MA) project is a multicenter observational study implemented in Italy aimed at creating a network of centers involved in moyamoya angiopathy (MA) care and research and at collecting a large series and bio-repository of MA patients, finally aimed at describing the disease phenotype and clinical course as well as at identifying biological or cellular markers for disease progression. The present paper resumes the most important study methodological issues and preliminary results.Methods: Nineteen centers are participating to the study. Patients with both bilateral and unilateral radiologically defined MA are included in the study. For each patient, detailed demographic and clinical as well as neuroimaging data are being collected. When available, biological samples (blood, DNA, CSF, middle cerebral artery samples) are being also collected for biological and cellular studies.Results: Ninety-eight patients (age of onset mean ± SD 35.5 ± 19.6 years; 68.4% females) have been collected so far. 65.3% of patients presented ischemic (50%) and haemorrhagic (15.3%) stroke. A higher female predominance concomitantly with a similar age of onset and clinical features to what was reported in previous studies on Western patients has been confirmed.Conclusion: An accurate and detailed clinical and neuroimaging classification represents the best strategy to provide the characterization of the disease phenotype and clinical course. The collection of a large number of biological samples will permit the identification of biological markers and genetic factors associated with the disease susceptibility in Italy. [ABSTRACT FROM AUTHOR]

Objectives: MEETINGDEM investigated whether the Dutch Meeting Centres Support Programme (MCSP) could be implemented in Italy, Poland, and the UK with comparable benefits. This paper reports on the impact on people living with dementia attending pilot Meeting Centres in the 3 countries.Methods: Nine pilot Meeting Centres (MCs) participated (Italy-5, Poland-2, UK-2). Effectiveness of MCSP was compared with Usual Care (UC) on outcomes measuring behavioural and psychological symptoms (NPI), depression (CSDD), and quality of life (DQoL, QOL-AD), analysed by ANCOVAs in a 6-month pre-test/post-test controlled trial.Results: Pre/post data were collected for 85 people with dementia and 93 carers (MCSP) and 74 people with dementia /carer dyads' receiving UC. MCSP showed significant positive effects for DQoL [Self-esteem (F = 4.8, P = 0.03); Positive Affect (F = 14.93, P < 0.00); Feelings of Belonging (F = 7.77, P = 0.01)] with medium and large effect sizes. Higher attendance levels correlated with greater neuropsychiatric symptom reduction (rho = 0.24, P = 0.03) and a greater increase in feelings of support (rho = 0.36, P = 0.001).Conclusions: MCSPs showed significant wellbeing and health benefits compared with UC, building on the evidence of effectiveness from the Netherlands. In addition to the previously reported successful implementation of MCSP in Italy, Poland, and the UK, these findings suggest that further international dissemination of MCSP is recommended. [ABSTRACT FROM AUTHOR]

Studies of health system responsiveness mostly focus on the demand side by investigating the association between sociodemographic characteristics of patients and their reported level of responsiveness. However, little is known about the influence of supply-side factors. This paper addresses that research gap by analysing the role of hospital-specialty characteristics in explaining variations in patients' evaluation of responsiveness from a sample of about 38,700 in-patients treated in public hospitals within the Italian Region of Emilia-Romagna. The analysis is carried out by adopting a 2-step procedure. First, we use patients' self-reported data to derive 5 measures of responsiveness at the hospital-specialty level. By estimating a generalised ordered probit model, we are able to correct for variations in individual reporting behaviour due to the health status of patients and their experience of being in pain. Second, we run cross-sectional regressions to investigate the association between patients' responsiveness and potential supply-side drivers, including waiting times, staff workload, the level of spending on non-clinical facilities, the level of spending on staff education and training, and the proportion of staff expenditure between nursing and administrative staff. Results suggest that responsiveness is to some extent influenced by the supply-side drivers considered. [ABSTRACT FROM AUTHOR]

In this paper, we propose a location model for the optimal organization of transplant system. Instead of simulation approach, which is typical when facing many health care applications, our approach is distinctively based on a mathematical programming formulation of the relevant problem. In particular, we focus on the critical role of time in transplantation process as well as on a spatial distribution of transplant centers. The allocation of transplantable organs across regions with the objective of attaining regional equity in health care, is the aim of this paper. Our model differs from previous modeling approaches in that it considers the nationwide reorganization of the transplant system, identifying system barriers that may impair equity and efficiency. The demolition of these barriers may leads on a reduction of waiting lists and of wasted organs. We provide the basic structure and the properties of the model, and validate it on a real case study. The experimental validation of the model demonstrates the effectiveness and robustness of our proposal. [ABSTRACT FROM AUTHOR]

In Italy, educational programs for cancer patients are currently provided by the national government, scientific societies, and patient advocate organizations. Several gaps limit their effectiveness, including the lack of coordinated efforts, poor involvement of patient feedback in the planning of programs, as well as a lack of resources on innovative cancer-related topics. This process is parallel to a strong shift in the attitude of patients towards health in general and taking charge of their own health conditions in particular. The National Cancer Institute in the USA and the Organization of European Cancer Institutes encourage comprehensive cancer centers in providing educational programs conceived to overcome these gaps. The goal of this paper is to identify and describe the key elements necessary to develop a global patient education program and provide recommendations for strategies with practical examples for implementation in the daily activities of cancer institutes. A multidisciplinary committee was established for patient education, including patient representatives as equal partners, to define, implement, verify, and evaluate the fundamental steps for establishing a comprehensive education program. Six essential topics were identified for the program: appropriate communication of cancer epidemiology, clinical trial information, new therapeutic technologies, support in the use of medicines, psycho-oncological interventions, age-personalized approaches, and training programs for healthcare providers. Integration of these topics along with patient feedback is the key to a successful model for educational programs. An integrated educational program can transform a comprehensive cancer center to an institution that provides research and care for and with patients. [ABSTRACT FROM AUTHOR]

In this paper, a brief summary is given about marble quarries in Carrara (Italy) and Iscehisar (Turkey), the Elmeri method is introduced, work accidents that can happen in marble quarries and their causes besides work safety behaviours in fields are explained, and the Elmeri monitoring method is applied and analysed. For this reason, marble quarries are divided into seven in terms of working conditions and active six quarries both in Carrara and Iscehisar areas, and work safety behaviours are analysed. Analysis process is based on True–False method; there are 18 items in total under six main topics; three items on each topic. The safety index for each section and the main topics are also calculated. According to the calculated safety indexes, Carrara area marble quarries (65.08%) are safer than Iscehisar area marble quarries (46.01%). [ABSTRACT FROM PUBLISHER]

Background: As the novel SARS-CoV-2 pandemic occurred, no specific treatment was yet available. Inflammatory response secondary to viral infection might be the driver of severe diseases. We report the safety and efficacy (in terms of overall survival and hospital discharge) of the anti-IL6 tocilizumab (TCZ) in subjects with COVID-19.Methods: This retrospective, single-center analysis included all the patients consecutively admitted to our Hospital with severe or critical COVID-19 who started TCZ treatment from March 13th to April 03rd, 2020. A 1:2 matching to patients not treated with TCZ was performed according to age, sex, severity of disease, P/F, Charlson Comorbidity Index and length of time between symptoms onset and hospital admittance. Descriptive statistics and non-parametric tests to compare the groups were applied. Kaplan Meier probability curves and Cox regression models for survival, hospital discharge and orotracheal intubation were used.Results: Seventy-four patients treated with TCZ were matched with 148 matched controls. They were mainly males (81.5%), Caucasian (82.0%) and with a median age of 59 years. The majority (69.8%) showed critical stage COVID-19 disease. TCZ use was associated with a better overall survival (HR 0.499 [95% CI 0.262-0.952], p = 0.035) compared to controls but with a longer hospital stay (HR 1.658 [95% CI 1.088-2.524], p = 0.019) mainly due to biochemical, respiratory and infectious adverse events.Discussion: TCZ use resulted potentially effective on COVID-19 in terms of overall survival. Caution is warranted given the potential occurrence of adverse events.Financial Support: Some of the tocilizumab doses used in the subjects included in this analysis were provided by the "Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia" (EudraCT Number: 2020-001110-38) supported by the Italian National Agency for Drugs (AIFA). No specific funding support was planned for study design, data collection and analysis and manuscript writing of this paper. [ABSTRACT FROM AUTHOR]

The issue of whether, how and how much to tell cancer patients about their diagnosis and prognosis is confronted in different ways in different countries. This paper reflects my direct experience as a medical oncologist both in the US and in Italy. It is an attempt to describe two different ways of dealing with truth-telling in oncology and to explore their reasons and consequences. [ABSTRACT FROM AUTHOR]

The current paper describes the natural history and management of mucopolysaccharidosis VI (MPS VI) in all patients currently diagnosed with the disease in Italy. Nine patients (5.5-14.4 years) were included in the data review in March 2008. Gestational and perinatal data were normal for all patients. Median age at diagnosis was 1.9 years. During the course of the disease, all patients developed coarsened facial features, short stature, heart valve disease, eye problems, musculoskeletal problems, hepatosplenomegaly and neurological abnormalities. All patients received rhASB enzyme replacement therapy (ERT) and showed improvement or stabilisation in clinical manifestations after onset of therapy. The most frequently reported improvements were increased joint mobility and reduced hepatosplenomegaly. No relevant safety issues of ERT were reported. In conclusion, patients in Italy with MPS VI are diagnosed early in life. All patients have access to ERT and appear to benefit from this therapy. [ABSTRACT FROM AUTHOR]

Teratoma is the most common germ cell tumour in childhood; mature (MT) and immature teratomas (IT) are benign tumours, but if they recur, they can be in some cases malignant. The aim of this paper is to evaluate Italian patients with MT and IT enrolled from 1991 to 2001, in a prospective multicentric study. One hundred and eighty-three patients, observed in 15 Italian Centers of Paediatric Oncology and three Paediatric Surgical Units were enrolled. Clinical data, treatment and results were all analysed. Initial evaluation and subsequent follow up included clinical examination, tumour markers and imaging procedures. Surgical resection was recommended for all the tumours. Histology was centrally reviewed and IT was classified as grading 1–3. Chemotherapy (CT) with Vinblastine, D-actinomycin and cyclophosphamide was indicated for extra-testicular IT grade 2 or 3. MT was diagnosed in 127 patients (93 F and 34 M, age 1–192 months, median 24): 58 patients had gonadic tumour (23 testicular, 35 ovaric), 69 extragonadic (45 sacrococcygeal, 11 mediastinic, 7 retroperitoneal, 6 in other sites). A complete resection was performed in 117 patients, a partial resection in eight patients and biopsy in one. IT was diagnosed in 56 patients (34 F, 22 M, age 1–168 months, median 7). The T grading was 1 in 14 cases, 2 in 26, 3 in 16; 28 had gonadic T (17 ovary, 11 testis), 28 extragonadic (sacrococcygeal 19, mediastinic 3, retroperitoneal 2, other sites 4). CT was administered in eight patients; 15/182 patients relapsed (1 in a metastatic site) and in 5/15 the relapse showed malignant histology. Seven MT (5.5%) relapsed (five sacrococcygeal, one retroperitoneal, one mediastinic): surgery at diagnosis had been complete in five and with residual in two; the relapse was malignant in two patients with sacrococcygeal (sc) tumours, who had a complete resection and a partial resection respectively. Eight IT (14.2%) relapsed (four ovary, three sc, one retroperitoneal). The initial surgical resection had been complete in one, with residual in six, and a biopsy had been performed in one. A malignant recurrence occurred in two patients with sc tumours (after partial resection in one and after biopsy + CT in one) and in one patient with ovarian IT after a partial resection. All the patients underwent surgical excision of the recurred mass; CT according to Protocol for Malignant GCT was administered to those who had malignant recurrence; 122/126 patients with MT and 53/56 with IT are alive without disease with a follow up of 8–144 months (median 56). Two patients with malignant relapse (one with sc MT, one with sc IT) died because of the progression of the disease. Another two died due to severe malformations (one MT, one IT) and three were lost to follow up (two MT, one IT). The overall survival (OS) at 10 years is 98% (95% CI 93.9–99.4); the event free survival (EFS) is 90.4% (95 CI 84.8–94.0). At Cox analysis no significant difference in EFS was found regarding age and site of the primary tumour, while females ( P = 0.011), patients with grade 1–3 histology ( P = 0.025) and patients with incomplete resection appeared at higher risk of death or relapse ( P < 0.001), with a seven, three and eightfold increase in risk, respectively. Our data showed that incomplete resection and female gender are important risk factors for relapse or death, more so than IT histology. The number of patients treated with CT is not sufficient to evaluate the efficacy of CT in avoiding malignant relapse. [ABSTRACT FROM AUTHOR]

Sutton (1991, Sunk costs and market structure. Cambridge: MIT Press; 1998, Technology and market structure. Cambridge: MIT Press) theorised that industries evolve into distinct market configurations in terms of concentration, depending upon product homogeneity and whether R&D or advertising are relevant relative to set-up costs. This paper tests the existence of such a relationship between technological profiles and market structure empirically, using the health care services provided by the Italian National Health Service as the specific economic framework. Our results support the empirical predictions made by Sutton. In particular, in markets where the technological intensity is low the lower bound to concentration converges monotonically to zero when the market size increases, for any level of product homogeneity. Conversely, in markets where the technological intensity is high the lower bound of concentration converges to some positive (non-zero) value when market size increases, while the lower bound increases (from zero) when the level of product homogeneity increases. [ABSTRACT FROM AUTHOR]

Cancer prevalence is the proportion of people in a population diagnosed with cancer in the past and still alive. One way to estimate prevalence is via population-based registries, where data on diagnosis and life status of all incidence cases occurring in the covered population are collected. In this paper, a method to estimate the complete prevalence and its variance from population-based registries is presented. In order to obtain unbiased estimates of the complete prevalence, its calculation can be thought as made by three steps. Step 1 counts the incidence cases diagnosed during the period of registration and still alive. Step 2 estimates the expected number of survivors among cases lost to follow-up. Step 3 estimates the complete prevalence by taking into account cases diagnosed before the start of registration. The combination of steps 1+2 is defined as the counting method, to estimate the limited duration prevalence; step 3 is the completeness index method, to estimate the complete prevalence. For early established registries, steps 1+2 are more important than step 3, because observation time is long enough to include all past diagnosed cases still alive in the prevalence data. For more recently established registries, step 3 is by far the most critical because a large part of prevalence might have been diagnosed before the period of registration (Corazziari I, Mariotto A, Capocaccia R. Correcting the completeness bias of observed prevalence. Tumori 1999; 85: 370–81). The work by Clegg LX, Gail MH, Feuer EJ. Estimating the variance of disease-prevalence estimates from population-based registries. Biometrics 2002; 55: 1137–44. considers the problem of the variability of the estimated prevalence up to step 2. To our knowledge, no other work has considered the variability induced by correcting for the unobserved cases diagnosed before the period of registration, crucial to estimate the prevalence in recent registries. An analytic approach is considered to calculate the variance of step 3. A unified expression for the variance of the prevalence allowing for steps 1 through 3 is obtained. Some applications to cancer data are presented. [ABSTRACT FROM AUTHOR]

Objective: To design a Health-related Quality of Life (HRQoL) instrument for HIV-infected people in the era of highly active antiretroviral therapy (HAART).Methods: The self-administered questionnaire was developed by an Italian network including researchers, physicians, people living with HIV, national institutions and community-based organizations (CBO) through several steps: (1) review of existing HRQoL literature and questionnaires for HIV-infected people; (2) selection of relevant domains measuring HRQoL in HIV-infected people, and identification of new domains related to new aspects of HRQoL concerning HAART-treated individuals; (3) conduction of two pre-test analyses in independent groups of Italian HIV-positive people (n approximately =100) distributed throughout the country. The objectives of the first pre-test were to verify the usefulness of the questionnaire, to construct a form easily understandable by everyone, to define the domains and their significance; the second pre-test aimed at evaluating and reshaping the questionnaire based on a statistical analysis of the outcomes of first pre-test; (4) validation analysis. A large cohort of people with HIV infection was recruited for the last step.Results: The internal consistence reliability (Cronbach's alpha) was >or=0.70 for all domains. Most domains had Cronbach's coefficient >0.80. All domains demonstrated convergent and discriminant validity. The final version of ISSQoL includes two sections: HRQoL Core Evaluation Form (9 domains) and Additional Important Areas for HRQoL (6 domains). The ISSQoL was administered together with two additional forms: a Daily Impact of Symptoms Form and a Demographic Information Form. The Additional Important Areas for HRQoL include social support, interaction with medical staff, treatment impact, body changes, life planning, and motherhood/fatherhood.Conclusion: The data reported in the present paper provide preliminary evidence of the reliability and validity of the ISSQoL questionnaire for the measurement of HRQoL in HIV-infected people. The direct involvement of HIV-positive people in all the phases of the project was a key aspect of our work. [ABSTRACT FROM AUTHOR]

Survival after childhood cancer has been improving since the late 1970s in most developed countries. The Childhood Cancer Registry of Piedmont has been recording malignant tumors in children (0-14 years) throughout Piedmont since 1967. The present paper is based on the records of the 2,970 children diagnosed during the period 1970-2001; survival rates are estimated up to June 30, 2004. Based on records from the Registrar Offices of the relevant towns of residence, 1,698 children were reported to be alive, 1,252 deceased, and 20 were of unknown vital status. Over the period 1970-2001, 5-year survival rates for all tumor types combined showed a statistically significant increasing trend (p<0.0001). For acute lymphocytic leukemia, the survival rate increased steadily from 24.7% (95% CI 15.0-34.3) in 1970-1974 to 87.8% (82.1-93.6) in 1995-1999. Five-year survival rates for central nervous system tumors increased from 32.8% (21.0-44.6) in 1970-1974 to 80.3% (72.6-88.0) in 1990-1994 and decreased thereafter. Age of less than 1 year at time of diagnosis was a favorable prognostic factor for neuroblastoma and ganglioneuroblastoma. The extent of disease at diagnosis was related to prognosis for neuroblastoma and ganglioneuroblastoma and other selected solid tumors. A white blood cell count greater than 50,000 x 10(6) cells/l was associated with decreased survival in children with acute lymphocytic leukemia and acute non-lymphocytic leukemia. We have found positive trends in survival for all tumor types in Piedmont, similar to those reported by other population-based cancer registries. Age, extent of disease, and white blood cell count at diagnosis are prognostic factors for selected cancer sites. [ABSTRACT FROM AUTHOR]

Objectives: This paper presents a multi-access service for the management of diabetes mellitus patients and the results of its assessment in two Italian clinical sites.Methods: The service was evaluated for one year in order to prove the advantages of these kind of systems from different points of view. In this paper the clinical, usability and technical outcomes are presented.Results: The evaluation results show that, thanks to the high flexibility of the implemented service, the telemedicine management of diabetes patients is feasible, well accepted by patients and clinically effective. However, in Italy the problem of quantifying the reimbursement rate of telematic services and the impact they have on the organization are factors that may hamper their introduction in routine clinical practice.Conclusions: The evaluation study showed that the telemedicine intervention has been satisfactory both for physicians because it allows to constantly monitor the patients' blood glucose level and for patients because it strengthens their motivation to self-monitor the metabolic situation. [ABSTRACT FROM AUTHOR]

The purpose of this paper is twofold: on the one hand, to confirm the positive results on n-3 PUFA from the overall results Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GlSSI)-Prevenzione trial; on the other, to summarize and describe how the results of an important trial can help generate hypotheses either on mechanisms of action or on differential results in particular subgroups of patients, as well as test the pathophysiological hypotheses that have accompanied in the years the story of the hypothesized mechanisms of action of a drug. GISSI-Prevenzione was conceived as a pragmatic population trial on patients with recent myocardial infarction and it was conducted in the framework of the Italian public health system. In GISSI-Prevenzione, 11,323 patients were enrolled in a clinical trial aimed at testing the effectiveness of n-3 polyunsaturated fatty acids (PUFA) and vitamin E. Patients were invited to follow Mediterranean dietary habits, and were treated with up-to-date preventive pharmacological interventions. Long-term n-3 PUFA at 1 g daily, but not vitamin E at 300 mg daily, was beneficial for death and for combined death, non-fatal myocardial infarction, and stroke. All the benefit, however, was attributable to the decrease in risk for overall (-20%), cardiovascular (-30%), and sudden death (-45%). At variance from the orientation of a scientific scenario largely dominated by the "cholesterol-heart hypothesis", GISSI-Prevenzione results indicate n-3 PUFA (virtually devoid of any cholesterol-lowering effect) as a relevant pharmacological treatment for secondary prevention after myocardial infarction. [ABSTRACT FROM AUTHOR]

Objectives: Biomedical applications, such as analysis and management of mass spectrometry proteomics experiments, involve heterogeneous platforms and knowledge, massive data sets, and complex algorithms. Main requirements of such applications are semantic modeling of the experiments and data analysis, as well as high performance computational platforms. In this paper we propose a software platform allowing to model and execute biomedical applications on the Grid.Methods: Computational Grids offer the required computational power, whereas ontologies and workflow help to face the heterogeneity of biomedical applications. In this paper we propose the use of domain ontologies and workflow techniques for modeling biomedical applications, whereas Grid middleware is responsible for high performance execution. As a case study, the modeling of a proteomics experiment is discussed.Results: The main result is the design and first use of PROTEUS, a Grid-based problem-solving environment for biomedical and bioinformatics applications.Conclusion: To manage the complexity of biomedical experiments, ontologies help to model applications and to identify appropriate data and algorithms, workflow techniques allow to combine the elements of such applications in a systematic way. Finally, translation of workflow into execution plans allows the exploitation of the computational power of Grids. Along this direction, in this paper we present PROTEUS discussing a real case study in the proteomics domain. [ABSTRACT FROM AUTHOR]

Background: Recent data support the hypothesis that genetic damage occurring early in life during childhood can play an important role in the development of chronic diseases in adulthood, including cancer.Objectives: The objective of this paper, part of the MAPEC_LIFE project, is to describe the frequency of micronuclei and meta-nuclear alterations in exfoliated buccal cells of 6-8year-old Italian children recruited in five Italian towns (i.e., Brescia, Torino, Pisa, Perugia and Lecce) with different air pollution levels.Methods: About 200 children per town were recruited from primary schools. Biological samples were collected twice from the same children, in two different seasons (winter 2014-15 and late spring 2015). Cytogenetic damage was evaluated by the buccal micronucleus cytome assay.Results: Overall,n = 1046 children represent the final cohort of the MAPEC_LIFE study. On the whole, the results showed a higher mean MN frequency in winter (0.42 ± 0.54‰) than late-spring (0.22 ± 0.34‰). MN frequency observed among the five Italian towns showed a trend that follows broadly the levels of air pollution in Italy: the highest MN frequency was observed in Brescia during both seasons, the lowest in Lecce (winter) and Perugia (late-spring).Conclusions: To the best of our knowledge, the number of recruited children included in the analysis (n = 1046) is the highest compared to previous studies evaluating the frequency of MN in exfoliated buccal cells so far. MN frequency was associated with winter season and living in towns at various levels of air pollution, suggesting an important role of this exposure in determining early cytogenetic effects. [ABSTRACT FROM AUTHOR]

Background: We present the detailed protocol set up to investigate how agonistic sport affects the self-perceived psychological and emotional well-being of disabled young people.Methods: The study will be carried out on a number of subjects as large as 800-1200, using well-established indices that give a quantitative measure of such well-being, namely SF-12 and PGWBI. The related questionnaires will be administered to the participants to a forthcoming international event, the European Para-Youth Games, 9-15 October 2017, Liguria, Italy, as well as to a reference population of a similar number of subjects, made up of young disabled people that do not practice agonistic sport.Discussion: We expect that the outcomes of the study may strongly impact not only the socio-sanitary field but also society in general, as disabled people can be considered an extreme situation in the issue of balancing individual needs and environment to pursue psychological well-being.Trial Registration: ISRCTN14389453 (29 June 2017). [ABSTRACT FROM AUTHOR]

For planning or co-ordinating health services it is necessary to have reference points for evaluating similar departments in which homogeneous or equivalent activities are carried out. It is also necessary to consider the cost/benefit of the services. The paper presents several new indices of performance which may be applied to this problem and which enable quantitative comparisons to be made between hospitals and between departments. These indices include assessment of electrical hazards and service ability of equipment as well as the ratio of technical support staff to inpatient stay. The indices have been evaluated in a few large hospitals and found to be an effective management tool. [ABSTRACT FROM AUTHOR]

Background: COVID-19 is the most widely discussed topic worldwide in 2020, and at the beginning of the Italian epidemic, scientists tried to understand the virus diffusion and the epidemic curve of positive cases with controversial findings and numbers.Objective: In this paper, a data analytics study on the diffusion of COVID-19 in Italy and the Lombardy Region is developed to define a predictive model tailored to forecast the evolution of the diffusion over time.Methods: Starting with all available official data collected worldwide about the diffusion of COVID-19, we defined a predictive model at the beginning of March 2020 for the Italian country.Results: This paper aims at showing how this predictive model was able to forecast the behavior of the COVID-19 diffusion and how it predicted the total number of positive cases in Italy over time. The predictive model forecasted, for the Italian country, the end of the COVID-19 first wave by the beginning of June.Conclusions: This paper shows that big data and data analytics can help medical experts and epidemiologists in promptly designing accurate and generalized models to predict the different COVID-19 evolutionary phases in other countries and regions, and for second and third possible epidemic waves. [ABSTRACT FROM AUTHOR]

Objective: Although a concern exists that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) might increase the risk of intracerebral haemorrhage (ICH), the contribution of these agents to the relationship between serum cholesterol and disease occurrence has been poorly investigated.Methods: We compared consecutive patients having ICH with age and sex-matched stroke-free control subjects in a case-control analysis, as part of the Multicenter Study on Cerebral Haemorrhage in Italy (MUCH-Italy), and tested the presence of interaction effects between total serum cholesterol levels and statins on the risk of ICH.Results: A total of 3492 cases (mean age, 73.0±12.7 years; males, 56.6%) and 3492 control subjects were enrolled. Increasing total serum cholesterol levels were confirmed to be inversely associated with ICH. We observed a statistical interaction between total serum cholesterol levels and statin use for the risk of haemorrhage (Interaction OR (IOR), 1.09; 95% CI 1.05 to 1.12). Increasing levels of total serum cholesterol were associated with a decreased risk of ICH within statin strata (average OR, 0.87; 95% CI 0.86 to 0.88 for every increase of 0.26 mmol/l of total serum cholesterol concentrations), while statin use was associated with an increased risk (OR, 1.54; 95% CI 1.31 to 1.81 of the average level of total serum cholesterol). The protective effect of serum cholesterol against ICH was reduced by statins in strictly lobar brain regions more than in non-lobar ones.Conclusions: Statin therapy and total serum cholesterol levels exhibit interaction effects towards the risk of ICH. The magnitude of such effects appears higher in lobar brain regions. [ABSTRACT FROM AUTHOR]

Objective: To examine knowledge displays (KDs), a practice by which Therapeutic Community (TC) professionals exhibit previous knowledge about their clients' circumstances and experiences.Methods: Conversation analysis is used to examine 12 staff-led meetings recorded in Italy (8 in a drug addiction TC; 4 in a mental health TC).Results: The TC professionals use KDs within broader sequences of talk where they solicit their clients to share personal information and where the clients provide insufficient or inconsistent responses. In these circumstances, the staff members employ KDs to pursue responses that redress emerging knowledge gaps and discrepancies regarding the clients' experiences or circumstances.Conclusion: KDs allow the staff members to achieve a balance between respecting their clients' right to report their own experiences and influencing the ways in which they report them. KDs help to reinforce the culture of openness that is central to many forms of therapeutic interaction, to forward the therapeutic agenda and to expand the staff members' knowledge of the clients' experiences and circumstances.Practice Implications: KDs can be used to solicit clients to share personal information. This paper illustrates core features that underlie the function of KDs (where they are used and how they are constructed). [ABSTRACT FROM AUTHOR]

Multiple layers of dealers connect international drug traffickers to users. The fundamental activity of these dealers is buying from higher-level dealers and re-selling in smaller quantities at the next lower market level. Each instance of this can be viewed as completing a drug dealing "cycle". This paper introduces an approach for combining isolated accounts of such cycles into a coherent model of the structure, span, and profitability of the various layers of the domestic supply chain for illegal drugs. The approach is illustrated by synthesizing data from interviews with 116 incarcerated dealers to elucidate the structure and operation of distribution networks for cocaine and heroin in Italy and Slovenia. Inmates' descriptions of cycles in the Italian cocaine market suggest fairly orderly networks, with reasonably well-defined market levels. The Italian heroin market appears to have more "level-jumpers" who skip a market level by making a larger number of sales per cycle, with each sale being of a considerably smaller weight. Slovenian data are sparser, but broadly consistent. Incorporating prices allows calculation of how much of the revenue from retail sales is retained by dealers at each market level. In the Italian cocaine market, both retail sellers and the international supply chain outside of Italy each appear to receive about 30-40% of what users spend, with the remaining 30% going to higher-level dealers operating in Italy (roughly 10% to those at the multi-kilo level and 20% to lower level wholesale dealers). Factoring in cycle frequencies permits rough estimation of the number of organizations at each market level per billion euros in retail sales, and of annual net revenues for organizations at each level. These analyses provide an approach to gaining insight into the structure and operation of the supply chain for illegal drugs. They also illustrate the value of two new graphical tools for describing illicit drug supply chains and hint at possible biases in how respondents describe their drug dealing activities. [ABSTRACT FROM AUTHOR]

Background: A growing body of literature aims to improve understanding of the operations of drug trafficking markets through conducting interviews with dealers and traffickers. Insight into how these individuals conduct business can provide evidence to inform the efforts by policy makers, law enforcement and practitioners to disrupt illicit markets. This paper aims to make a contribution to this evidence base by extending the number of European countries in which interviews have been conducted with incarcerated drug dealers and traffickers.Methods: It draws on interviews with 135 men convicted of offences related to the distribution or sale of heroin or cocaine and imprisoned in Italy, Slovenia and Germany. The research was conducted as part of the Reframing Addictions Project (ALICE-RAP) funded by the European Commission. The sample was diverse. It included a range of nationalities and some individuals who were members of organised crime groups. The majority of the interviewees were dealers who sold at the retail and street level, but there were some who were importers and wholesalers.Findings: Most dealers in each of the three countries reported having more than one regular supplier, and were able to respond to periods of over and under supply without losing customers. Supply arrangements varied in terms of frequency and quantities bought. Dealers engaged in repeated transactions and their relationships with customers were based on trust and reputation. Dealers aimed to sell to regular customers and to provide drugs of good quality. While dealers sought to maximise their profits by cutting drugs with cutting agents, the quality of drugs that they sold could affect their reputation and thus their profits and position in the market. Lastly, while there are some significant differences in the approach between those involved in organised crime groups and those who are not, and between street dealers and those operating at higher levels of the market, there were striking similarities in terms of the day-to-day operational concerns and modes of relationship management.Conclusions: Interviewees' arrangements for securing supplies of drugs provide support to the notion that drug markets are resilient and flexible. Our findings correspond with other empirical research in relation to the centrality of trust in the practical operation of supply and sale of drugs. The research highlights some differences, but important similarities between dealers who were part of organised crime groups and those who were not; dealers all faced some common challenges and adopted some common responses to these. [ABSTRACT FROM AUTHOR]

Objective: To simulate the impact - effectiveness and safety - of water fortification with different concentrations of Ca using the Intake Modelling, Assessment and Planning Program.Design: This is a secondary analysis of national or sub-national dietary intake databases.Setting and Participants: Uganda, Lao People's Democratic Republic (PDR), Bangladesh, Zambia, Argentina, USA and Italy.Results: We found that for dietary databases assessed from low- and middle-income countries (LMIC), the strategy of fortifying water with 500 mg of Ca/l would decrease the prevalence of low Ca intake in all age groups. We also found that this strategy would be safe as no group would present a percentage of individuals exceeding the upper limit in >2 %, except women aged 19-31 years in Lao PDR, where 6·6 % of women in this group would exceed the upper limit of Ca intake. The same strategy would lead to some groups exceeding the upper limit in USA and Italy.Conclusions: We found that for most LMIC countries, water fortified with Ca could decrease the prevalence of Ca intake inadequacy without exceeding the upper levels of Ca intake. [ABSTRACT FROM AUTHOR]

Background: Behavioral and psychological symptoms of dementia (BPSD) have a large impact on the quality of life of patients with Alzheimer's disease (AD). Few studies have compared BPSD between early-onset (EOAD) and late-onset (LOAD) patients, finding conflicting results.Objective: The aims of this study were to: 1) characterize the presence, overall prevalence, and time of occurrence of BPSD in EOAD versus LOAD; 2) estimate the prevalence over time and severity of each BPSD in EOAD versus LOAD in three stages: pre-T0 (before the onset of the disease), T0 (from onset to 5 years), and T1 (from 5 years onwards); 3) track the manifestation of BPSD sub-syndromes (i.e., hyperactivity, psychosis, affective, and apathy) in EOAD versus LOAD at T0 and T1.Methods: The sample includes 1,538 LOAD and 387 EOAD diagnosed from 1996 to 2018. Comprehensive assessment batteries, including the Neuropsychiatric Inventory (NPI), were administered at the first medical assessment and at different follow-up period.Results: The overall prevalence for the most of BPSD was significantly higher in EOAD compared to LOAD whereas most BPSD appeared significantly later in EOAD patients. Between the two groups, from pre-T0 to T1 we recorded a different pattern of BPSD prevalence over time as well as for BPSD sub-syndromes at T0 and T1. Results on severity of BPSD did not show significant differences.Conclusion: EOAD and LOAD represent two different forms of a single entity not only from a neuropathological, cognitive, and functional level but also from a psychiatric point of view. [ABSTRACT FROM AUTHOR]

Background: Duodenal fistula (DF) after gastrectomy continues to be a life-threatening problem. We performed a retrospective multicenter study analyzing the characteristics of DF after elective gastrectomy for malignant disease.Methods: Three thousand seven hundred eighty-five patients who had undergone gastrectomy with duodenal stump in 11 Italian surgical units were analyzed.Results: Sixty-eight DFs occurred, with a median frequency of 1.6% and a mortality rate of 16%. Complications were mainly septic but fistulas or bleeding of surrounding organs accounted for about 30%. Reoperation was performed in 40% of patients. We observed a correlation between mortality and age (hazard ratio 1.09; 95% CI 1.00-1.20) and serum albumin (hazard ratio 0.90; 95% CI 0.83-0.99). The appearance of further complications was associated with reoperation (P < 0.001) and death (P = 0.054), while the preservation of oral feeding was related to DF healing (P < 0.001).Conclusions: This paper represents the largest series ever published on DF and shows that its features have changed in the last 20 years. DF alone no longer leads to death and some complications observed in the past have disappeared, while new ones are emerging. Nowadays, medical therapy is preferred and surgery is indicated only in cases of abdominal sepsis or bleeding. [ABSTRACT FROM AUTHOR]

Background: In health applications, and elsewhere, 3D data sets are increasingly accessed through the Internet. To reduce the transfer time while maintaining an unaltered 3D model, adequate compression and decompression techniques are needed. Recently, Grid technologies have been integrated with Web Services technologies to provide a framework for interoperable application-to-application interaction.Objectives: The paper describes an implementation of the Edgebreaker compression technique exploiting web services technology and presents a novel approach for using such services in a Grid Portal. The Grid portal, developed at the CACT/ISUFI of the University of Lecce, allows the processing and delivery of biomedical images (CT--computerized tomography--and MRI--magnetic resonance images) in a distributed environment, using the power and security of computational Grids.Methods: The Edgebreaker Compression Web Service has been deployed on a Grid portal and allows compressing and decompressing 3D data sets using the Globus toolkit GSI (Globus Security Infrastructure) protocol. Moreover, the classical algorithm has been modified extending the compression to files containing more than one object.Results and Conclusions: An implementation of the Edgebreaker compression technique and related experimental results are presented. A novel approach for using the compression web service in a Grid portal allowing storing and preprocessing of huge 3D data sets, and subsequent efficient transmission of results for remote visualization is also described. [ABSTRACT FROM AUTHOR]

This study calculated the resource utilization and direct medical costs related to age-related macular degeneration (AMD). We conducted a multicenter observational study in 1999 in seven hospital ophthalmology departments in northern and central Italy. A total of 476 patients aged over 50 years with the diagnoses were classified into three prognostic groups: (a) drusen (23.7%), (b) geographic atrophy (16.4%), and (c) retinal changes associated with choroidal neovascularization (CNV) (59.9%). In addition to the costs reimbursed by the Italian National Health Service, we estimated also patients' out of pocket expenses. The mean cost per patient per year was 383.2 euro; patients with CNV were by far the most costly (540.1 euro, vs. 158.1 euro for drusen and 147.9 euro for geographic atrophy). Hospital costs and diagnostics were the main cost determinants. Services directly paid for by patients (private consultations and OTCs) amounted to 46.5 euro for patients with CNV, 50.3 euro for drusen, and 68.8 euro for geographic atrophy. The major finding of the study was that the presence of CNV involved higher expenditure than drusen or geographic atrophy. This suggests that the costs of AMD rise significantly with the severity of the illness. [ABSTRACT FROM AUTHOR]

Background: Leigh syndrome (LS) is a progressive neurodegenerative disorder associated with primary or secondary dysfunction of mitochondrial oxidative phosphorylation and is the most common mitochondrial disease in childhood. Numerous reports on the biochemical and molecular profiles of LS have been published, but there are limited studies on genetically confirmed large series. We reviewed the clinical, imaging, biochemical and molecular data of 122 patients with a diagnosis of LS collected in the Italian Collaborative Network of Mitochondrial Diseases database.Results: Clinical picture was characterized by early onset of several neurological signs dominated by central nervous system involvement associated with both supra- and sub-tentorial grey matter at MRI in the majority of cases. Extraneurological organ involvement is less frequent in LS than expected for a mitochondrial disorder. Complex I and IV deficiencies were the most common biochemical diagnoses, mostly associated with mutations in SURF1 or mitochondrial-DNA genes encoding complex I subunits. Our data showed SURF1 as the genotype with the most unfavorable prognosis, differently from other cohorts reported to date.Conclusion: We report on a large genetically defined LS cohort, adding new data on phenotype-genotype correlation, prognostic factors and possible suggestions to diagnostic workup. [ABSTRACT FROM AUTHOR]

Background: There are few data comparing the relative effectiveness of the individual β-lactams.Objectives: To quantify the reduced effectiveness, defined as switching to a different antibiotic being prescribed for the same indication, among new users of β-lactam antibiotics in primary care.Methods: A retrospective cohort study was conducted using the Health Search Database, an Italian primary care data source. Patients newly prescribed with β-lactams for a specific indication between 1 January 2013 and 31 December 2017 were identified. A switch to a different antibiotic for the same indication occurring during a 30day follow-up was the study outcome. Cox regression was adopted to assess the risk of switching between the different β-lactams.Results: Among 178 256 patients newly treated with β-lactam antibiotics, 1172 (0.65%) switched to a different antibiotic. Amoxicillin/clavulanate (co-amoxiclav: n = 104 891) and amoxicillin (n = 21 699) were the most frequently prescribed β-lactams. The other antibiotics showed significantly higher risk of switching when compared with co-amoxiclav for lower respiratory tract [e.g. ceftriaxone, hazard ratio (HR): 1.6, 95% CI: 1.2-2.0], dental [e.g. amoxicillin, HR: 4.2, 95% CI: 2.9-5.9], and middle ear infections [e.g. amoxicillin, HR: 1.8, 95% CI: 1.1-2.7]. The same results were gathered when parenteral formulations were excluded.Conclusions: The prevalence of reduced effectiveness of newly prescribed β-lactam antibiotics was lower than 1%. Specifically, the rate of switch to another antibiotic, when it was prescribed to treat low respiratory tract, dental, and middle ear infections, was lower among users of co-amoxiclav than those prescribed with other β-lactams. [ABSTRACT FROM AUTHOR]

The experience of third-generation tyrosine kinase inhibitor ponatinib treatment in Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph'+ ALL) patients post-allogeneic transplantation is limited. We retrospectively collected data on 25 Ph'+ ALL patients who were started on ponatinib after allogeneic transplantation between July 2015 and July 2019 from nine transplantation centers in Italy. Ponatinib was given in prophylaxis in five (20%), as pre-emptive treatment in seven (28%), and as salvage therapy in thirteen (52%) patients. It was combined with donor leukocyte infusions in ten patients. Half of the patients (12/25) harbored T315I mutation of BCR/ABL1, while in the remaining mutational analysis was negative or not performed. Among the 20 patients who received ponatinib as pre-emptive/salvage treatment, complete molecular response was achieved in 15 (75%) patients. Estimated overall survival at 2-year post-initiation of treatment in the whole cohort was 65% (respectively 60%, 60%, and 78% for the prophylaxis, pre-emptive, and salvage therapy groups). In patients with T315I-positive mutational status, the estimated 2-year survival was 40%. Fourteen patients (56%) experienced toxicity, requiring temporary or definitive suspension of treatment. In conclusion, treatment of Ph'+ ALL patients with ponatinib after transplantation is effective, although the question of adequate drug dose and treatment duration remains unanswered. [ABSTRACT FROM AUTHOR]

The international PRECONNECT Phase IIIb study demonstrated safety and efficacy of trifluridine/tipiracil in the management of patients with metastatic colorectal cancer. Post-hoc analyses in a national context are important because of the differences in disease management across countries. Post-hoc safety and efficacy analyses in the PRECONNECT Italian patient subset were conducted. Patients' quality of life was assessed from baseline to end of treatment. In Italy, 161 patients were enrolled. The median age was 64 years, with a performance status of 0-1. The most common hematological drug-related adverse events ≥grade 3 were neutropenia (41.0%) and anemia (13.7%). The median progression-free survival was reached at 3.0 months, with a disease control rate of 28.6%. The Quality of Life Questionnaire Core 30 score improved in 25.4% of the patients. Safety, efficacy and quality of life results confirmed trifluridine/tipiracil as a feasible and favorable treatment option for metastatic colorectal cancer patients. [ABSTRACT FROM AUTHOR]

Background: This study estimated the economic and organisational impact of using subcutaneous injection (SC) formulations of two monoclonal antibodies (rituximab and trastuzumab) in patients with non-Hodgkin's lymphoma (NHL) and HER2 + breast cancer (BC).Methods: The database of the Unit of Oncology and Haematology of the IRST of Meldola was used. The analysis was structured as follows: i) measurement of the volume of Day-Hospital activity; ii) identification of activities and time to complete the administration; iii) estimate the mean cost of an SC or IV (intravenous infusion); iv) estimate the impact of SC formulations on the volumes of activities provided; v) estimate the social impact of SC or IV formulations.Results: The use of an SC formulation was associated a significant reduction in the time that the patient takes to complete the administration (trastuzumab -1 hr 18 min; rituximab -2 hr 24 min) and in consumption of healthcare resources and related costs for trastuzumab (IV: € 1781; SC: € 1701) and rituximab (IV: € 2116; SC: € 1941).Conclusion: The adoption of the SC formulation for rituximab and trastuzumab can generate a greater value for both the national healthcare system and the patient compared to an IV formulation. [ABSTRACT FROM AUTHOR]

Klebsiella pneumoniae carbapenemase-producing K. pneumoniae (KPC-Kp) has been endemic in Italy since 2013. In a multicenter cohort study, we investigated various aspects of KPC-Kp among patients, including 15-day mortality rates and delays in adequate therapy. Most (77%) KPC-Kp strains were sequence types ST512 or ST307. During 2017, KPC-Kp prevalence was 3.26 cases/1,000 hospitalized patients. Cumulative incidence of KPC-Kp acquired >48 hours after hospital admission was 0.68% but varied widely between centers. Among patients with mild infections and noninfected colonized patients, 15-day mortality rates were comparable, but rates were much higher among patients with severe infections. Delays of >4 days in receiving adequate therapy more frequently occurred among patients with mild infections than those with severe infections, and delays were less common for patients with known previous KPC-Kp colonization. Italy urgently needs a concerted surveillance system to control the spread of KPC-Kp. [ABSTRACT FROM AUTHOR]

This paper examines the right to health care. Various expressions of this right may be distinguished. These include both individual rights and social rights which could be based upon international treaties and constitutional rights. They may be found in national health legislation and, in some cases, in jurisprudence. To analyze the consequences of limiting the right to health care, a framework for judicial review has been developed which encompasses these expressions of the right to health care. The framework was used to examine legal and health policy developments in three Western and two Eastern European countries. In Italy and the Netherlands the right to health care is protected constitutionally (but on differing legal bases) while the United Kingdom does not have a written constitution. In contrast, Hungary and Poland have for many years seen the state take responsible for the provision, administration and allocation of health care services and the right to health care was guaranteed theoretically but not in practice because of the lack of (financial) means. However, the Polish Constitution explicitly anticipates possible limitations of the right to health care. What all these countries have in common is a cost containment perspective where the future will bring even tighter limits on what resources patients may consume. Despite differences in legal structure between these countries, where they seem to converge is on the consequences of putting limitations on the right to health care. The courts in Italy, the Netherlands and the UK have formulated conditions drawn from the acceptance that this right has to be judged within the context of limited resources. It may be concluded that finding a compromise between the right to health care and cost containment policies could also be an issue, Eastern European countries will have to face in the future. [ABSTRACT FROM AUTHOR]

Objective: To construct international ultrasound-based standards for fetal cerebellar growth and Sylvian fissure maturation.Methods: Healthy, well nourished pregnant women, enrolled at < 14 weeks' gestation in the Fetal Growth Longitudinal Study (FGLS) of INTERGROWTH-21st , an international multicenter, population-based project, underwent serial three-dimensional (3D) fetal ultrasound scans every 5 ± 1 weeks until delivery in study sites located in Brazil, India, Italy, Kenya and the UK. In the present analysis, only those fetuses that underwent developmental assessment at 2 years of age were included. We measured the transcerebellar diameter and assessed Sylvian fissure maturation using two-dimensional ultrasound images extracted from available 3D fetal head volumes. The appropriateness of pooling data from the five sites was assessed using variance component analysis and standardized site differences. For each Sylvian fissure maturation score (left or right side), mean gestational age and 95% CI were calculated. Transcerebellar diameter was modeled using fractional polynomial regression, and goodness of fit was assessed.Results: Of those children in the original FGLS cohort who had developmental assessment at 2 years of age, 1130 also had an available 3D ultrasound fetal head volume. The sociodemographic characteristics and pregnancy/perinatal outcomes of the study sample confirmed the health and low-risk status of the population studied. In addition, the fetuses had low morbidity and adequate growth and development at 2 years of age. In total, 3016 and 2359 individual volumes were available for transcerebellar-diameter and Sylvian-fissure analysis, respectively. Variance component analysis and standardized site differences showed that the five study populations were sufficiently similar on the basis of predefined criteria for the data to be pooled to produce international standards. A second-degree fractional polynomial provided the best fit for modeling transcerebellar diameter; we then estimated gestational-age-specific 3rd , 50th and 97th smoothed centiles. Goodness-of-fit analysis comparing empirical centiles with smoothed centile curves showed good agreement. The Sylvian fissure increased in maturation with advancing gestation, with complete overlap of the mean gestational age and 95% CIs between the sexes for each development score. No differences in Sylvian fissure maturation between the right and left hemispheres were observed.Conclusion: We present, for the first time, international standards for fetal cerebellar growth and Sylvian fissure maturation throughout pregnancy based on a healthy fetal population that exhibited adequate growth and development at 2 years of age. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

The special circumstances surrounding a terminally ill patient require that a classification system for case-mix and staging take quality of life as its main endpoint. From all possible variables relevant to the case-mix description, a small group of variables relating to the functional status, physical symptoms, psychocognitive problems, and financial status have been isolated in order to identify a limited number of groups of patient who differ in terms of quality of life and/or survival throughout the entire period of treatment in a palliative care unit (PCU). The study is still in progress and involves an estimated sample of about 900 terminal cancer patients being cared for in 61 PCUs in Italy. This paper provides information about the rationale and objectives of the study and the methods used. [ABSTRACT FROM AUTHOR]

Objectives: A population based case-control study was conducted in a highly agricultural area in the north east of Italy to evaluate the association between farming and animal breeding and the risk of developing non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukaemia (CLL).Methods: Occupational histories and other data were collected by personal interview on 164 NHLs, 23 CLLs, diagnosed in 1988-90, and on 977 controls. This paper only reports the results of the analysis relative to the coding of job titles through the modified International Labour Office (ILO) classification. Estimates of odds ratios (ORs) for occupational variables were calculated, after adjustment for sex, age, altitude of municipality, first degree familiarity, and previous Herpes zoster infection.Results: From the analysis of the most frequent occupational categories, no occupation showed a significantly high risk. When the two job titles farmers only and farmer-breeders who are also involved in animal breeding are classified within the extremely varied occupation of agriculture or animal-breeding or fishing, a high risk for NHLs and CLLs is seen in the farmer-breeders (OR 1.79, 95% CI 1.22 - 2.63). Analyses according to histological type show that the risks are concentrated in CLLs and in low grade NHLs. No effect or trend by period at work or duration of employment in farming and animal breeding was found.Conclusion: Subjects working in agriculture associated with animal breeding are at high risk of NHL/CLLs, particularly CLLs and low grade NHLs. This finding could be related to the use of chemicals in agriculture or to exposure to animal transmitted diseases or specific chemicals used in animal breeding. [ABSTRACT FROM AUTHOR]

This paper investigates the price variability of standardized medical devices purchased by Italian Public Buyers (PBs). A semiparametric approach is used to recover the marginal cost of each device. Average prices vary substantially between PBs; we show that most of the difference between the purchase prices and estimated costs is associated with a PB fixed effect, which, in turn, is related to the institutional characteristics and size of the PB. Repeating the main estimation using device fixed effects yields similar results. Finally, an exogenous policy change, i.e. the termination of the mandatory reference price regime, is used to assess how discretion affects medical device procurement given the skills of each PB. Our results show that less PB discretion - i.e. when mandatory reference prices apply - determines efficiency gains and losses for low- and high-skilled PBs, respectively. [ABSTRACT FROM AUTHOR]

Background: MEN1 is a complex, rare, syndrome inherited in an autosomal dominant tract and characterized by the development of multiple neuroendocrine tumors, requiring lifelong surveillance and multiple medical and surgical therapies throughout the patient's life. For all these reasons, a diagnosis of MEN1 can be a psychological shock for the patient, as well as his/her relatives, more so than the diagnosis of a single tumor. In the last two decades, clinicians have started to consider the emotional, psychological, relational, and social aspects of their patients' lives. The data collected in the present analyses highlight the unique features of MEN1 syndrome, and aim to evaluate the Quality of Life in the patients and their relatives. In this study, a comprehensive survey of various aspects of Health-Related Quality of Life was performed in a large series of Italian MEN1 patients, by administering five of the most common targeted questionnaires.Results: The results of the study showed that our patients, despite having a complex multi-tumor syndrome, were moderately optimistic (50%), and this corresponds with a normal Quality of Life. This positive response is strictly correlated with the fact that the patients are cared for at a dedicated Referral Center, receiving personalized care and constant follow-up, which gives them reassurance regarding the high quality of management of the disorder.Conclusions: The possibility of having access to a clinical Referral Center for their complex rare disease, together with the support of a dedicated patient association, has been demonstrated to be the ideal model for the management of post-diagnosis shock, and contributes to the preservation of a good Health-Related Quality of Life for MEN1 patients. [ABSTRACT FROM AUTHOR]

Context: Analysis of a 2-screen program for congenital hypothyroidism (CH) was performed using differential dried-blood spot thyrotropin (bTSH) cutoffs of 10 mU/L at first screening (all infants) and 5 mU/L at second screening (selected infants).Objectives: This work aimed to characterize CH infants identified by the second screening and compare infants with bTSH of 5.0 to 9.9 and 10 mU/L or greater on second screening.Design and Patients: Maternal and neonatal clinical features were retrospectively analyzed for 119 CH babies detected on the second screen in the Lombardy region of Italy, 2007 to 2014.Results: Fifty-two (43.7%) of the 119 CH neonates showed bTSH values ranging from 5.0 to 9.9 mU/L at the second screening (low bTSH group) and 67 (56.3%) bTSH of 10.0 mU/L or greater (high bTSH group). The frequency of thyroid dysgenesis and eutopic gland was similar in both groups, as was the frequency of permanent and transient CH. Moreover, a high frequency of extrathyroidal malformations was found in both groups. The percentage of preterm infants (57.7% vs 23.9%, P < .001) and infants admitted to the neonatal intensive care unit (50.0% vs 17.9%, P < .001) was significantly higher in the low vs the high bTSH group. In addition, maternal treatment with glucocorticoids in pregnancy was significantly more frequent in the low bTSH group than in the high bTSH group (11.5% vs 1.5%, P = .042), as well as maternal hypothyroidism and/or goiter (26.9% vs 10.4%, P = .036).Conclusions: This study has demonstrated that a lower TSH cutoff at the second screening can detect additional cases of CH and that a second bTSH cutoff of 5.0 mU/L is appropriate for identifying preterm newborns and babies with associated risk factors. [ABSTRACT FROM AUTHOR]