Search

This work is the third in a series of articles dedicated to the EASY-NET network programme. The first article described the rationale, structure, and methodologies; while the second evaluated the adherence of individual audit&feedback A&F interventions tested in EASY-NET to literature recommendations. This contribution provides a concise summary of the effectiveness results of A&ented by clinical and organizational areas: chronic disease management, emergency territorial and hospital care for acute conditions, post-acute rehabilitation, hospital oncology care, childbirth, and caesarean sections. In alignment with existing literature, the results on the effectiveness of A&F, in terms of measurable improvement, were observed across all settings, although to varying degrees and more significantly in processes than in outcomes. Key elements that proved to be fundamental to the implementation of A&F interventions include the importance of institutions in making A&F systematic, continuous, and a priority for healthcare professionals; the central role of the required and available data for preparing feedback; the involvement of A&F recipients in the whole path, from the design of the interventions to the discussion of results and improvement actions. A final consideration, in light of the activities conducted and the results achieved, suggests that integrating research into practice and practice into research is essential to ensure, on one hand, the transferability of evidence into operations and, on the other hand, the design of studies that are feasible and integrable into daily activities - a necessary aspect to optimize resources.

Italy is a destination country for a growing international migration, accounting for 8.4% of the total population. The COVID-19 pandemic has increased the difficulties in accessing healthcare services among immigrants, and barriers due to linguistic and cultural differences had a significant impact during the pandemic. This paper presents the methodology used in the project 'Epidemiological surveillance and control of COVID-19 in metropolitan urban areas for the containment of SARS-CoV-2 circulation in the immigrant population in Italy', carried out with the technical and financial support of the Italian Ministry of Health. This methodology is aimed to identify and select statements available in the literature, transferable to the Italian context, on the topic of interventions deemed useful in reducing the impact of the COVID-19 pandemic on the foreign population in urban/metropolitan settings.In February 2022, a systematic search was conducted in databases such as Medline, Embase, and Web of Science, as well as on national and international websites (WHO, Italian Institute of Health, and CDC), and on 'RecMap' (included in the 'COVID19 Recommendations' website) to identify guidelines containing recommendations on the management and prevention of COVID-19 among immigrants. The selected recommendations were divided into intervention areas (infection control, vaccination, screening, planning and monitoring, healthcare systems). In the first phase, a group of researchers independently assessed the inclusion of recommendations through three rounds of consensus. The Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool was used to assess the quality of the included guidelines. In the second phase, an external group of experts independently evaluated the relevance of the included recommendations using a Likert scale. The document is the result of a collaborative work based on evidence from the literature available until that time. The adaptation and adoption of recommendations already formulated by other international organizations on the topic of preparedness and response to the COVID-19 pandemic, evaluated through a consensus process with experts, can be a valid method aimed at producing documents to inform and guide those involved in the care of immigrants in Italy, as well as promoting inclusive forms of prevention in emergency contexts.

This is the second of a series of papers dedicated to the EASY-NET research programme (NET-2016-02364191). The rationale, structure and methodologies are described in the previous contribution. Scientific literature demonstrated that Audit & Feedback (A&F) is an effective strategy for continuous quality improvement and its effectiveness varies considerably according to factors that are currently little known. Some recent publication pointed out, with the contribution of an international group of experts, 15 suggestions to optimize A&F and developed a tool to evaluate their application. This tool, called REFLECT-52, includes 52 items related to the 15 suggestions and organized into four categories relating to the "Nature of the desired action", to the "Nature of the data available for feedback", to the "Feedback Display" and to the "Intervention delivery". Then, the aim of this work was to evaluate the level of adherence of A&F interventions tested in EASY-NET to suggestions from the literature by using a slightly adapted version of the REFLECT-52 tool, in its original language. In EASY-NET, 14 A&F interventions with different characteristics and in different clinical and organizational contexts were tested in seven Italian regions, each of these was evaluated by the respective research groups. Overall, the level of adherence was high in three of the four categories analysed, with some difficulties reported regarding the nature of the data available for feedback. In fact, contrary to what the literature suggests, it was not possible to send repeated feedback for some interventions and, in some cases, the data available for feedback presented a delay longer than one year. In summary, this analysis has confirmed a high level of compliance of the interventions tested with the suggestions from the literature, but it has also allowed researchers to identify critical aspects that need to be addressed for the future development of these strategies.

Objectives: to evaluate the impact of school closures, as a measure to contain the transmission of SARS-CoV-2 infection, on the psychological well-being of students of all levels starting from the 2020-2021 school year., Design: a systematic literature review was conducted according to the PRISMA 2020 Guidelines. The literature search was conducted on 4 different databases: MedLine, Embase, PsycINFO, and L.OVE Platform. Quantitative observational studies published until 10.01.2022 were included. Studies conducted during the first pandemic wave, i.e., during the 2019-2020 school year and/or during the mandatory lockdown or confinement period, were excluded. The methodological quality of the studies was assessed with validated scales. Study selection, data extraction, and quality assessment were carried out independently by two authors., Setting and Participants: children, adolescents, and young people attending all levels of education (including universities) and, for reasons related to COVID-19, having a suspension of "in presence" school or attending classes remotely., Main Outcome Measures: a. outcomes directly related to mental health: suicides, emergency department visits, and hospitalizations for psychiatric problems; anxiety and depression, emotional difficulties, feelings of loneliness and isolation; b. well-being outcomes: sleep quality, perceived well-being (by child/adolescent/youth or referred by parents); c. health-related behaviours: tobacco smoking, alcohol, drug use. Outcomes related to school/academic performance, physical health, and those related to parents were not considered., Results: after having removed duplicate articles, 2,830 records were retrieved with the bibliographic search. Twelve studies (2 uncontrolled before-after studies and 10 cross sectional surveys) were included, involving a total of 27,787 participants. Three studies involved university students, 2 involved high school students, and the remaining involved a mixed population of students attending primary and middle schools. The studies were conducted between September 2020 and April 2021. The methodological quality was rated as high in five studies and intermediate in the remaining studies. Due to the high heterogeneity of outcome measures and statistical analyses performed among the included studies, it was not possible to conduct a meta-analysis of the results of the considered publications. Nevertheless, the present review showed a clear signal of increase in mental health problems in relation to school closure or virtual instruction. In particular, results suggest evidence of association between school closure and risk of suicidal attempts or thoughts, mental health symptoms such as anxiety, depression, emotional disorders, psychological stress. Sleeping problems, drug and alcohol addiction were poorly studied., Conclusions: despite the limitations of the included studies and possible residual confounding and contamination due to restrictive measures and social isolation implemented during the pandemic, the available evidence confirms the negative impact on students' mental health associated with school closures and distance learning. Given the availability of vaccination also for young children, a long period of school closure should be avoided also in the case of the emergence of new pandemic waves.

Objectives: to describe trends of overall and intensive care hospitalization for COVID-19 since the beginning of the pandemic in Italy until June 2021, and to compare the results between foreign and Italian population., Design: retrospective observational study., Setting and Participants: hospital discharges of 28 million people living in Lombardy, Piedmont, Emilia-Romagna (Northern Italy), Toscana and Lazio (Central Italy) occurred between 22.02.2020 and 02.07.2021 in the hospitals located in each considered Region., Main Outcome Measures: two weekly outcomes were examined: 1. the overall number of COVID-19 hospitalizations; 2. the number of COVID-19 hospitalizations in intensive care units., Results: a higher COVID-19 overall and intensive care unit hospitalization was found among the foreign population compared to Italians. The association emerged only after the adjustment for age, and it was consistent among all Regions, though less marked in Lombardy. The association varied across epidemic phases., Conclusions: the issue of vulnerability of migrants to the risk of severe COVID-19 calls for a diversity-sensitive approach in prevention. The specific country of origin and the prevalence of preventable co-morbidities that are often underestimated in the migrant populations, and related to COVID-19 complications, should be taken into consideration in future analyses.

Objectives: to geocode all residence addresses from Lazio Health Information System in order to obtain a geographical regional database., Design: a semiautomatic and multistep geocoding procedure using several tools and software., Setting and Participants: all residence addresses of resident population of Lazio Region (Central Italy) in 2020., Main Outcome Measures: geographic coordinates at residence addresses and accuracy level of geocoding procedure for more than 1 million of addresses., Results: the 99% of residence addresses in the Lazio Region have been geocoded thanks to the purposed procedure; almost 94% of the addresses have been geocoded with a good level of accuracy (more than 56% at civic number level). In the province of Rome, the percentage of addresses geocoded with a good level of accuracy is higher (97.1%), while in the province of Rieti and Frosinone is lower (82.7% and 84.2%, respectively)., Conclusions: this method is useful to obtain accurate geographic coordinates of residences of the entire regional population. This database will be useful for several epidemiological studies in the Region.

Objectives: to investigate, for the first time, the incidence of cancer (years 2009-2015) and geographical distribution among children and adolescents with cancer diagnosis in Lazio Region (Central Italy)., Design: to compute incidence rates of childhood cancers from Lazio Region Childhood Cancer Registry (LRCCR) database, established in 2015, and to compare results with national figures for 2012 provided by the Italian cancer registries network (AIRTUM)., Setting and Participants: all new cases of malignant tumours (behaviour: /3 of ICD-O-3 classification) and all central nervous system tumours were selected, regardless of behaviour (/0, /1, /3) in children and adolescents (0-19 years) registered in the LRCCR data base., Main Outcome Measures: it was computed: • the raw and the direct standardised rates for the 0-14-year and the 15-19-year age groups for total malignant tumours of the ICCC-3 classification by area (province level and municipality of Rome); • Relative Risks (RR) for area-specific rate compared with that of the Lazio Region and 95% Confidence Intervals (95%CI)., Results: a total of 1,782 incident cases were recorded in 2009-2015; of these, 91.4% were confirmed by a pathology report. Standardized Incidence Rate for all malignant tumours is 207.2×1,000,000 (95%CI 195.5-219.5) in children and 335.1×1,000,000 (95%CI 308.9-361.2) in adolescents. Compared to the Lazio Region, a higher incidence of tumours is observed in Rome municipality (RR 1.09; 95%CI 0.98-1.20) and in the Frosinone province (RR 1.07; 95%CI 0.91-1.25) for the whole 0-19-year age group., Conclusions: compared to the pooled AIRTUM figures for 2003-2008, Lazio Region showed a higher incidence for all cancers, both in children and adolescents, and for specific tumours, such as leukaemia in children and thyroid carcinoma in adolescents. Apart from the diverse observation period, these differences may be due to a higher registry sensitivity of the childhood specialized registry compared to general population registries. The observed incidence excesses for specific geographical areas and tumours deserve further investigations. Overall, in its first seven years of activity, the Lazio childhood cancer registry was able to provide reliable epidemiological figures of cancer incidence in children and adolescents in the Italian context.

Objectives: to estimate the impact of the COVID-19 epidemic on total and cause-specific mortality in people residing and dead in the Municipality of Rome (Italy) in 2020, and to describe the causes of death of subjects with SARS-CoV-2 infection confirmed by molecular test., Design: descriptive analysis of total and cause-specific mortality in 2020 in Rome and comparison with a reference period (2015-2018 for total mortality and 2018 for cause-specific mortality); descriptive analysis of cause-specific mortality in the cohort of SARS-CoV-2 infected subjects., Setting and Participants: 27,471 deaths registered in the Lazio mortality-cause Registry, relating to people residing and died in the municipality of Rome in 2020, 2,374 of which died from COVID-19.MAIN OUCOME MEASURES: all-cause mortality by month, gender, age group and place of death, cause-specific mortality (ICD-10 codes)., Results: in the municipality of Rome in 2020, an excess of mortality from all causes equal to +10% was observed, with a greater increase in the months of October-December (+27%, +56%, and +26%, respectively) in people aged 50+, with the greatest contribution from the oldest age groups (80+) who died in the nursing homes or at home. Lower mortality was observed in the age groups 0-29 years (-30%) and 40-49 years (-13%). In 2020, COVID-19 represents the fourth cause of death in Rome after malignant tumours, diseases of the circulatory system, and respiratory diseases. Excess mortality was observed from stroke and pneumonia (both in men and women), from respiratory diseases (in men), from diabetes, mental disorders, dementia and Parkinson's disease (in women). On the contrary, mortality is lower for all cancers, for diseases of the blood and haematopoietic organs and for the causes of the circulatory system. The follow-up analysis of SARS-CoV-2 positive subjects residing in Rome shows that a share of deaths (about 20%) reports other causes of death such as cardiovascular diseases, malignant tumours, and diseases of the respiratory system on the certificate collected by the Italian National Statistics Institute., Conclusions: the 2020 mortality study highlighted excesses for acute and chronic pathologies, indicative of possible delays in the diagnosis or treatment of conditions indirectly caused by the pandemic, but also a share of misclassification of the cause of death that is recognized as COVID-19 death.

Objectives: to assess the temporal variation in excess total mortality and the portion of excess explained by COVID-19 deaths by geographical area, gender, and age during the COVID-19 epidemic., Design: descriptive analysis of temporal variations of total excess deaths and COVID-19 deaths in the phase 1 and phase 2 of the epidemic in Italy., Setting and Participants: 12 Northern cities and 20 Central-Southern cities from December 2019 to June 2020: daily mortality from the National Surveillance System of Daily Mortality (SiSMG) and COVID-19 deaths from the integrated COVID-19 surveillance system., Main Outcome Measures: total mortality excess and COVID-19 deaths, defined as deaths in microbiologically confirmed cases of SARS-CoV-2, by gender and age groups., Results: the largest excess mortality was observed in the North and during the first phase of the epidemic. The portion of excess mortality explained by COVID-19 decreases with age, decreasing to 51% among the very old (>=85 years). In phase 2 (until June 2020), the impact was more contained and totally attributable to COVID-19 deaths and this suggests an effectiveness of social distancing measures., Conclusions: mortality surveillance is a sensible information basis for the monitoring of health impact of the different phases of the epidemic and supporting decision making at the local and national level on containment measures to put in place in coming months.

Background: the Covid-19 pandemic has provoked a huge of clinical and epidemiological research initiatives, especially in the most involved countries. However, this very large effort was characterized by several methodological weaknesses, both in the field of discovering effective treatments (with too many small and uncontrolled trials) and in the field of identifying preventable risks and prognostic factors (with too few large, representative and well-designed cohorts or case-control studies)., Objectives: in response to the fragmented and uncoordinated research production on Covid-19, the   italian Association of Epidemiology (AIE) stimulated the formation of a working group (WG) with the aims of identifying the most important gaps in knowledge and to propose a structured research agenda of clinical and epidemiological studies considered at high priority on Covid-19, including recommendations on the preferable methodology., Methods: the WG was composed by 25 subjects, mainly epidemiologists, statisticians, and other experts in specific fields, who have voluntarily agreed to the proposal. The agreement on a list of main research questions and on the structure of the specific documents to be produced were defined through few meetings and cycles of document exchanges., Results: twelve main research questions on Covid-19 were identified, covering aetiology, prognosis, interventions, follow-up and impact on general and specific populations (children, pregnant women). For each of them, a two-page form was developed, structured in: background, main topics, methods (with recommendations on preferred study design and warnings for bias prevention) and an essential bibliography., Conclusions: this research agenda represents an initial contribution to direct clinical and epidemiological research efforts on high priority topics with a focus on methodological aspects. Further development and refinements of this agenda by Public Health Authorities are encouraged.

Background: one of the most affected European countries by the COVID-19 epidemic is Italy; data show the strong geographical heterogeneity of the epidemic., Objectives: to propose an analysis strategy to ascertain the non-random nature of the spatial spread of COVID-19 cases infection and identify any territorial aggregations, in order to enhance contact tracing activities in specific areas of the Lazio Region (Central Italy) and a large urban area as Rome., Methods: all cases of COVID-19 of the Lazio Region notified to the Regional Service for Epidemiology, Surveillance, and Control of Infectious Diseases (Seresmi) with daily updates from the beginning of the epidemic to April 27, 2020 were considered. The analyses were carried out considering two periods (the first from the beginning of the epidemic to April 6 and the second from the beginning of the epidemic to April 27) and two different levels of spatial aggregation: the entire Lazio region excluding the Municipality of Rome, where the 377 municipalities represent the area units, and the Municipality of Rome, where the area units under study are the 155 urban areas (ZUR). The Scan statistic of Kulldorff was used to ascertain the non-random nature of the spatial spread of infected cases and to identify any territorial aggregations of cases of COVID-19 infection, using a retrospective spatial analysis in two overlapping periods., Results: analysis was conducted at regional level in the two survey periods and revealed the presence of 7 localized clusters. In the Municipality of Rome, a single cluster (Historic Centre) was identified in the first period which includes 7 urban areas, while in the second period two distinct clusters (Omo and Farnesina) were observed., Conclusions: Scan statistics are an important surveillance tool for monitoring disease outbreaks during the active phase of the epidemic and a useful contribution to epidemiological surveillance during the COVID-19 epidemic in a specific territory.

Objectives: to describe hospitalisation, access to emergency care, and mortality of people living in marginalized urban areas which include public housing buildings in the North-West suburb of Rome, and to compare the results with those observed among people living in the neighbouring area., Design: cross sectional study., Setting and Participants: resident population in the XIII and XIV Municipality of Rome, subdivided into five urban areas, in 2011-2018., Main Outcome Measures: hospitalisation, access to emergency care, and mortality rates and rates ratios based on hospital discharges and emergency department visits derived from the Health Information Systems and from the Mortality Registry of Lazio Region (Central Italy), stratified by urban areas., Results: the results show a higher use of hospital assistance and emergency care services as well a higher mortality among residents of urban areas characterized by marginalization and social disadvantage in the North-West suburb in Rome, compared to the surrounding area. The association is stronger for the residents of ex-Bastogi, a compound particularly marginalised and socially disadvantaged, where excesses in hospitalisation, emergency care admission, and mortality of +60%, +150%, and +140%, respectively, occurred., Conclusions: the excesses of hospital use, emergency care visits, and mortality observed among the residents of marginalized urban areas suggest the need to reorganize the preventive and primary care services considering the socioeconomic disadvantage in such housing contexts. The use of both qualitative and quantitative approaches allows to understand the complexity of such contexts.

Objectives: to evaluate the impact of the SARS-CoV-2 epidemic on the access to the emergency services of the Lazio Region (Central Italy) for time-dependent pathologies, for suspected SARS-CoV-2 symptoms, and for potentially inappropriate conditions., Design: observational study., Setting and Participants: accesses to the emergency departments (EDs) of Lazio Region hospitals in the first three months of 2017, 2018, 2019, and 2020., Main Outcome Measures: total number of accesses to the emergency room and number of specific accesses for cardio and cerebrovascular diseases, for severe trauma, for symptoms, signs, and ill-defined conditions, and for symptoms related to pneumonia., Results: in the first 3 months of 2019, there were 429,972 accesses to the EDs of Lazio Region; in the same period of 2020, accesses arise to 353,806, (reduction of 21.5%), with a 73% reduction in the last three weeks of march 2020 as compared with the corresponding period of 2019. Comparing the first 3 months of the 2017-2019 with 2020, the accesses for acute coronary syndrome and acute cerebrovascular disease decreased since the 10th week up to more than 57% and 50%, respectively. The accesses due to symptoms, signs, and ill-defined conditions, proxy of potentially inappropriate conditions, decreased since the 8th week, with a maximum reduction of 70%. Access to severe trauma decreased by up to 70% in the 11th week. The accesses for pneumonia increased up to a 70% increment in the 12th week., Conclusions: the evaluation of accesses to emergency services during the SARS-CoV-2 epidemic can provide useful elements for the promotion and improvement of the planning, for the management of critical situations, and for the reprogramming of the healthcare offer based on clinical and organizational appropriateness.

Objectives: to evaluate the gap in life expectancy on the municipality of Rome, through the spatio-temporal changes in life expectancy at the birth and at 65 years old of residents in between 2006 and 2017, by gender, socioeconomic position, and health district., Design: epidemiological study based on the construction of mortality tables describing age-specific mortality rates and life expectancy at birth and at 65 years old., Setting and Participants: from the Register of the Causes of Death (ReNCaM), between 2006 to 2017, 329,426 deaths of residents in Rome were selected., Main Outcome Measures: the variation in life expectancy at birth was estimated by gender, by socioeconomic position, and by health district for four triennial observation periods from 2006 to 2017. Temporal and socioeconomic position changes, through an indicator of deprivation of a small area specific for the city of Rome, and possible geographical patterns, by observing the variation in the 15 health districts, between 2006 and 2017 were observed., Results: in Rome, between the first three-year period (2006-2008) and the last one (2015-2017), the life expectancy at birth increases, whit a gain of about 1.5 years among males (from 78.7 to 80.4 years) and just under 1 year among females (from 83.6 to 84.4 years). The increase in life expectancy, however, is not uniform in the population and the results show differences in socioeconomic position that increase in the most recent three years to 4 years for males and 2.2 years for females. The geographical analysis shows important differences in the life expectancy among health districts with differences up to about 3 years for males and 2.2 years for females at the beginning of the study period among districts in the historical centre and districts on the outskirts of the City of Rome, which are reduced to 2.7 years for males and 2.1 years for females in the most recent period., Conclusions: the analysis of geographical and socioeconomic differences of the life expectancy provides important information to identify the areas of the Municipality of Rome on which to strengthen prevention interventions and the actions to be taken for Objective 10 ("Reducing inequalities") of Agenda 2030 for sustainable development.

Objectives: to investigate the association between real estate prices, education, and mortality., Design: cohort study., Setting and Participants: residents in Rome at the 2011 Italian Census, not living in institutions, and living in the address reported in the Census survey. People aged 18-99 years were followed from 2011 to 2016 using anonymous record linkage procedures with administrative databases. The Census includes several individual information, such as gender, age, education, residential neighbourhood. Data and cause of death were collected from mortality register. Real estate prices (euros/m2) were available for each neighbourhood., Main Outcome Measures: adjusted Cox regression models (hazard ratios - HRs and 95%CIs) were used to estimate the association among individual education, real estate price in the neighbourhood, and mortality., Results: the subjects selected were 2,051,376 (54% women, 22.5% with high education level). During the follow-up, 127,352 subjects died. Taking into account gender, age, marital status, and real estate prices, education level was strongly associated with all-cause mortality; compared to highly educated the higher mortality, risk was 35% (95%CI 32%-37%) for low education level and 16% (95%CI 14%-19%) for medium education level. Taking into account the same factors and education level, each increase of 1,000 euros in price/m2 was inversely associated with mortality (HR 0.96, 95%CI 0.96-0.97)., Conclusions: there is an independent association between the two indicators and mortality in Rome. A simple indicator such as real estate prices can be used to tackle inequalities.

We are presenting here the findings of the reaction to the COVID-19 epidemic during the period March to June 2020 of those centres participating in the research EASY-NET which is on-going in Italy, funded by the Ministry of Health and co-founded by the Regional Health Authorities. The objective of EASY-NET is to evaluate the effectiveness of the audit and feedback (A&F) strategies in different clinical and organizational settings in seven regions. As a negative consequence of the COVID-19 epidemic, the activities of the project have suddenly slowed down; nevertheless, the COVID-19 epidemic represented an opportunity to apply the A&F methodology and support the healthcare within the regional authorities in order to manage and monitor the impact of this new disease. The reaction to the crisis on behalf of EASY-NET was inconsistent across the participating regions for various reasons. Factors which influenced the reaction levels in relation to the rapidity and efficiency of the implementation of the A&F strategies were as follows: the varying epidemiological impact of the COVID-19 epidemic in the various territories, the different clinical and organizational context and availability of expert research teams together with A&F procedures which had already been tested before the start of the epidemic.

Objectives: 1. to describe temporal trend (2008-2017) in kidney transplant (KT) provision in the Lazio Region; 2. to measure KT outcomes by comparing three different time periods; 3. to estimate the prevalence of individuals with functioning kidney transplant., Design: cross sectional (objective 1); cohort study (objectives 2 and 3)., Setting and Participants: the study population included people residing in Lazio Region who received a kidney transplant between 2008 and 2017. Participants were selected through the integration of data from different sources: the Hospital Information System, the Regional Register of Dialysis and Transplantation, and the Regional Waiting List for Kidney Transplantation., Main Outcome Measures: standardised KT incidence rates x100,000 by year and age-specific rates were calculated separately for men and women. Mortality and failure of KT were considered as outcomes at one year; for both outcomes, the cumulative incidence x100 and raw and adjusted (by gender and age) incidence rates x100,000 person-day were calculated using a Poisson model. Raw and standardised prevalence rates x100,000 of people residing in Lazio Region with functioning KT at 31.12.2016 were calculated., Results: in the study period, 1,646 KTs were performed. The KT rate increased significantly overtime, ranging between 2.9 in 2008 and 3.6 in 2017. Rates were higher for men compared to women. For men aged 65+ incidence KT rate increased significantly: 3.5 in 2008 and 7.1 in 2017. Among women, there was an increasing trend in the age groups 0-18 and 35-49 years. The one-year mortality rate decreased from 11.9 in 2008-2010 to 4.2 in 2014-2016. The failure rate was stable: 21.4 in 2008-2010 and 19.2 in 2014-2016. The number of individuals with functioning kidney transplant was 1,148. The standardised prevalence rate was 25.8 in men and 14.6 in women., Conclusions: increased offer of renal transplantation and better outcomes were observed in Lazio region. The proposed methodology is useful for the construction of indicators to monitor over time both KT provision and outcomes.

Objectives: to evaluate equity in the Lazio regional Health System, both in terms of unequal access to health care among individuals with different educational levels and of heterogeneity in hospital performance, between 2012 and 2017., Design: retrospective cohort study., Setting and Participants: all patients living in Lazio region and discharged from a regional facility between 2012 and 2017 were enrolled. Three cohorts of hospitalizations were selected: acute myocardial infarctions with ST segment elevation (STEMI), hip fractures, and deliveries., Main Outcome Measures: the proportions of STEMIs with PCI within 90 minutes, of patients with a hip fracture who underwent surgery within 2 days, and of deliveries with primary caesarean section were evaluated, accounting for patient demographic characteristics and comorbidities that could affect the outcome under study. These proportions were calculated by education and by hospital of admission. The heterogeneity among facilities was assessed through the median odds ratio (MOR)., Results: in Lazio region, between 2012 and 2017, an improvement of the quality of care was observed: in 2017, 50.4% of STEMI patients underwent to a PCI within 90 minutes, 54.4% of patients with a hip fracture underwent surgery within 2 days, and 26.2% of women had a C-section. In 2012, when comparing the adjusted proportions of outcomes by educational level, the probability of being treated with a PCI within 90 minutes for STEMIs and with surgery within 2 days for hip fractures was higher for graduated patients than for those with the lowest education. In contrast, graduated women had the highest risk of having a C-section. In 2017, there was no difference anymore between classes of education in STEMIs and C-sections, while in patients with hip fracture the difference was decreased, but still present. For hip fractures, a reduction of heterogeneity of hospital performances was also detected., Conclusion: in Lazio region, a reduction in inequalities in access to health care was observed for different clinical areas. The "public disclosure" of the PReValE results and the management strategy applied in mid-2013 could have driven the overall improvement of the health system for the conditions under study, helping to achieve a fairer access to health.

Introduction: Describing and monitoring socioeconomic inequalities in health are the prerequisite for planning equity policies. In Italy, some cities have integrated personal information from the municipal registries with Census data and with data from healthcare information systems to set up Longitudinal Metropolitan Studies (LMS). Under the coordination of the Italian National Institute for Health, Migration, and Poverty (NIHMP), six cities in the LMS network have contributed to the present monograph: Turin, Venice, Reggio Emilia, Modena, Bologna, and Rome. MORTALITY RESULTS. Significant socioeconomic differences by level of education were seen in all the participating centres. People who live alone or in single-parent households are more likely to die, as are those living in a substandard dwelling. Immigrants resident in the six cities included in the study showed lower all-cause mortality than Italians (males: MRR 0.83; 95%CI 0.78-0.90 - females: MRR 0.70; 95%CI 0.64-0.77). Sub-Saharan Africans experienced a significant higher mortality than Italians (males: MRR 1.33; 95%CI 1.12-1.59 - females: MMR 1.69; 95%CI 1.31-2.17). Immigrants had a neonatal and post-neonatal mortality risk about 1.5 times higher than Italians (neonatal: OR 1.71; 95%CI 1.22-2.39 - post-neonatal: OR 1.63; 95%CI 1.03-2.57). A difference between Italians and immigrants was also observed for mortality in children aged 1-4 years, though less marked (OR 1.24; 95%CI 0.73-2.11). Excesses concerned particularly immigrants from North Africa and from sub-Saharan Africa as well as those residing in Italy for >5 years. HOSPITALISATION RESULTS. Hospitalisation rates are lower for immigrants than for Italians, except when due to infectious diseases, blood disorders, and, among women, for reasons linked to pregnancy and childbirth. Avoidable hospitalisation rates of adults from low migratory pressure Countries are lower than or equal to those of Italians. On the contrary, adults from low migratory pressure Countries show higher avoidable hospitalisation rates compared to Italians in every cohort, with the exception of Rome (RR 0.81; 95%CI 0.78-0.85), with RR ranging from 1.08 (95%CI 0.96-1.22) in Venice to 1.64 (95%CI 1.47-1.83) in Modena., Conclusions: Maternal and child health is the most critical area of health for immigrant population. Considering the importance that the issue of health equity has taken on in the political agenda, the data presented in this volume are a great asset, particularly in light of the long recession and the social crisis that have impacted the Country.

Background: there has been a long-standing, consistent use worldwide of Healthcare Administrative Databases (HADs) for epidemiological purposes, especially to identify acute and chronic health conditions. These databases are able to reflect health-related conditions at a population level through disease-specific case-identification algorithms that combine information coded in multiple HADs. In Italy, in the past 10 years, HAD-based case-identification algorithms have experienced a constant increase, with a significant extension of the spectrum of identifiable diseases. Besides estimating incidence and/or prevalence of diseases, these algorithms have been used to enroll cohorts, monitor quality of care, assess the effect of environmental exposure, and identify health outcomes in analytic studies. Despite the rapid increase in the use of case-identification algorithms, information on their accuracy and misclassification rate is currently unavailable for most conditions., Objectives: to define a protocol to systematically review algorithms used in Italy in the past 10 years for the identification of several chronic and acute diseases, providing an accessible overview to future users in the Italian and international context., Methods: PubMed will be searched for original research articles, published between 2007 and 2017, in Italian or English. The search string consists of a combination of free text and MeSH terms with a common part on HADs and a disease-specific part. All identified papers will be screened for eligibility by two independent reviewers. All articles that used/defined an algorithm for the identification of each disease of interest using Italian HADs will be included. Algorithms with exclusive use of death certificates, pathology register, general practitioner or pediatrician data will be excluded. Pertinent papers will be classified according to the objective for which the algorithm was used, and only articles that used algorithms with "primary objectives" (I disease occurrence; II population/cohort selection; III outcome identification) will be considered for algorithm extraction. The HADs used (hospital discharge records, drug prescriptions, etc.), ICD-9 and ICD-10 codes, ATC classification of drugs, follow-back periods, and age ranges applied by the algorithms will be collected. Further information on specific accuracy measures from external validations, sensitivity analyses, and the contribution of each source will be recorded. This protocol will be applied for 16 different systematic reviews concerning eighteen diseases (Hypothyroidism, Hyperthyroidism, Diabetes mellitus, Type 1 diabetes mellitus, Acute myocardial infarction, Ischemic heart disease, Stroke, Hypertension, Heart failure, Congenital heart anomalies, Parkinson's disease, Multiple sclerosis, Epilepsy, Chronic obstructive pulmonary disease, Asthma, Inflammatory bowel disease, Celiac disease, Chronic kidney failure)., Conclusion: this protocol defines a standardized approach to extensively examine and compare all experiences of case identification algorithms in Italy, on the 18 abovementioned diseases. The methodology proposed may be applied to other systematic reviews concerning diseases not included in this project, as well as other settings, including international ones. Considering the increasing availability of healthcare data, developing standard criteria to describe and update characteristics of published algorithms would be of great use to enhance awareness in the choice of algorithms and provide a greater comparability of results.

Background: the assessment of individual exposure to toxicants in industrially contaminated areas is difficult when multiple productions are actively close to residential areas. Two thermoelectric power plants (one recently converted to coal) and a large harbour have been operating since the Sixties in the area of Civitavecchia (North of Rome, Lazio Region, Central Italy). Detailed exposure assessment of pollutants from industrial sources, heating (biomass combustion), and urban traffic were not available., Objectives: to assess the individual exposure of residents by using both dispersion models and human biomonitoring., Design: cross-sectional study., Setting and Participants: residents in the area of Civitavecchia since 2001 aged 35-69 years were enrolled and their addresses were geocoded. Exposure assessment to power plants emissions (PM10), traffic (NOx), harbour (PM10), and biomass burning (PM10) was performed at individual residential address using Lagrangian dispersion models. The "Ambiente e Biomarcatori a Civitavecchia" study (Environment and biomarkers in Civitavecchia - ABC study) made available urinary concentrations of metals (i.e., Cd, Pt, W, Pd, Hg, Tl, Cr, Pd, Ni, As) in a sample of residents, while information on personal characteristics, lifestyles, work history, clinical history, and use of drugs was collected by interview., Main Outcome Measures: for each metal, a linear regression analysis was implemented to study the association between its log-transformed values (adjusted for urinary creatinine) and the linear terms of the estimated pollutants concentrations, adjusted for age, gender, period, and other risk factors (i.e., educational level, smoking habit, alcohol, BMI). Geometric Mean Ratios (GMR) and the corresponding confidence intervals (95%CI) were computed., Results: in the ABC sample of 1,141 residents (42% male, mean age 53.5 years, SD 9.7), there was a positive association between PM10 from power plants and urinary cadmium (Cd) (GMR: 1.12; 95%CI 1.00-1.25), traffic pollution (NOx) and platinum (Pt) (GMR: 1.17; 95%CI 1.00-1.38), PM10 from biomass burning and Cd (GMR: 1.14; 95%CI 1.05-1.24), and tungsten (W) (GMR: 1.19; 95%CI 1.03-1.37) and palladium (Pd) (GMR: 1.11; 95%CI 1.00-1.23). Other associations observed did not reach statistical significance., Conclusions: although it may not be said that dispersion models can replace biomonitoring studies, they certainly represent an excellent tool for exposure assessment and, therefore, they may be used for the estimation of the individual exposure of populations living in industrially contaminated areas.

Objectives: to evaluate the association between short term maternal exposure to high temperature and air pollution on preterm births (PBs), which represent the first cause of perinatal mortality and morbidity in developed Countries, and to identify maternal risk factors enhancing individual susceptibility., Design: time series. SETTING E PARTICIPANTS: all singleton live-births occurred in six Italian cities between 1st April and 31st October of each year in the period 2001-2010 were identified through the Certificate of Delivery Care Registry (CedAP)., Main Outcome Measures: births occurred between 22nd and 36th week of gestation were defined as preterm births. Daily values were obtained for maximum apparent temperature (MAT), PM10, NO2, and O3. Exposures-preterm births association was estimated using a generalized additive model (GAM) with a Poisson distribution. Exposure and city-specific lag structure were computed using a non-linear distributed lag model (DLNM)., Results: 121,797 newborns were enrolled, 6,135 (5.0%) of which were PBs. For MAT, a linear relationship was observed for Turin (Piedmont Region, Northern Italy), Trieste (Friuli Venezia Giulia Region, Northern Italy), Rome (Lazio Region, Central Italy), and Palermo (Sicily Region, Southern Italy), while non-linear relationship was found for Bologna (Emilia-Romagna Region, Northern Italy) and Venice (Veneto Region, Northern Italy). The relative risks (RR) for MAT, computed comparing the 90th vs. the 75th percentile, vary from 1.02 (95%CI 0.95-1.09; lag 0-2) in Palermo to 1.94 (95%CI 1.32-2.85; lag 0-3) in Venice. For pollutants, a significant effect for 10 µg/m3 (IQR) increase of PM10 in Rome (RR: 1.07; 95%CI 1.02-1.12; lag 12-22) and for 16 µg/m3 (IQR) increase of O3 in Palermo (RR: 1.29; 95%CI 1.03-1.62; lag 2-9) was detected. In Rome, a significant effect modification by age and education level of the MAT-PB relationship and by education level and clinical conditions of PM10-PB was found., Conclusions: results showed a clear positive association between MAT and the risk of NP and a lower and variable effect of pollutants. It is important and necessary to limit the impact of these risk factors on the probability of NP with appropriate prevention programmes.

Objectives: to test the validity of algorithms to identify diabetes, chronic obstructive pulmonary disease (COPD), hypertension, and hypothyroidism from routinely collected health data using information from self-reported diagnosis and laboratory or functional test., Setting and Participants: clinical or self-reported diagnosis from three surveys conducted in Lazio Region (Central Italy) between year 2010 and 2014 were assumed as gold standard and compared to the results of the algorithms application to administrative data., Main Outcome Measures: prevalence resulted from administrative data and from information available in the surveys were compared. Sensitivity, specificity, positive predictive value, and positive likelihood ratio of algorithms with respect to self-reported diagnosis, laboratory or functional test, assumed as gold standards, were calculated., Results: we analyzed data of 7,318 subjects (1,545 for diabetes, 1,783 for COPD, 2,448 for hypertension, and 1,542 for hypothyroidism). For hypertension and hypothyroidism, we observed a higher prevalence from laboratory or functional test compared to self-reported diagnosis (54.5% vs. 44.9% and 7.5% vs. 1.5%). Sensitivity of administrative data with respect to self-reported diagnosis resulted 90.9%, 38.5%, 88.3%, and 47.8%, respectively, for diabetes, COPD, hypertension, and hypothyroidism. Respectively, specificity was 97.4%, 91.7%, 84.8% and 91.8%; positive predictive value was 70,9%, 38.1%, 82.6% and 8.1%. All values of positive likelihood ratio resulted moderate (about 5), with exception of the diabetes algorithm and the disease-specific payment exemptions register for hypertension (respectively 35.5 and 17.4)., Conclusion: hypertension and hypothyroidism resulted markedly underdiagnosed from self-reported data. Case identification algorithms are highly specific, allowing their utilization for selection of cohort of subject affected by chronic diseases. The sub-optimal sensitivity observed for COPD and hypothyroidism could limit the utilization of the algorithms for prevalence estimation.

Objectives: to define a national geographic domain, with high spatial (1 km²) and temporal (daily) resolution, and to build a list of georeferenced environmental and temporal indicators useful for environmental epidemiology applications at national level., Design: geographic study., Setting and Participants: study domain: Italian territory divided into 307,635 1-km² grid cells; study period: 2006-2012, divided into 2,557 daily time windows., Main Outcome Measures: for each grid cell and day, an extensive number of indicators has been computed. These indicators include spatial (administrative layers, resident population, presence of water bodies, climatic zones, land use variables, impervious surfaces, orography, viability, point and areal emissions of air pollutants) and spatio-temporal predictors (particulate matter data from monitoring stations, meteorological parameters, desert dust advection episodes, aerosol optical depth, normalized difference vegetation index, planetary boundary layer) potentially useful to characterize population environmental exposures and to estimate their health effects, at national level., Results and Conclusions: this study represents the first example of relational big data in environmental epidemiology at national level, where multiple sources of data (satellite, environmental, meteorology, land use, population) have been linked on a common spatial and temporal domain, aimed at promoting environmental epidemiology applications at national and local level.

BACKGROUND Improving quality and effectiveness of healthcare is one of the priorities of health policies. Hospital or physician volume represents a measurable variable with an impact on effectiveness of healthcare. An Italian law calls for the definition of «qualitative, structural, technological, and quantitative standards of hospital care». There is a need for an evaluation of the available scientific evidence in order to identify qualitative, structural, technological, and quantitative standards of hospital care, including the volume of care above or below which the public and private hospitals may be accredited (or not) to provide specific healthcare interventions. OBJECTIVES To identify conditions/interventions for which an association between volume and outcome has been investigated. To identify conditions/interventions for which an association between volume and outcome has been proved. To analyze the distribution of Italian health providers by volume of activity. To measure the association between volume of care and outcomes of the health providers of the Italian National Health Service (NHS). METHODS Systematic review An overview of systematic reviews was performed searching PubMed, EMBASE, and The Cochrane Library up to November 2016. Studies were evaluated by 2 researchers independently; quality assessment was performed using the AMSTAR checklist. For each health condition and outcome, if available, total number of studies, participants, high volume cut-off values, and metanalysis have been reported. According to the considered outcomes, health topics were classified into 3 groups: positive association: a positive association was demonstrated in the majority of studies/participants and/or a pooled measure (metanalysis) with positive results was reported; lack of association: both studies and/or metanalysis showed no association; no sufficient evidence of association: both results of single studies and metanalysis do not allow to draw firm conclusions on the association between volume and outcome. Analysis of the distribution of Italian hospitals by volume of activity and the association between volume of activity and outcomes: the Italian National Outcome evaluation Programme 2016 The analyses were performed using the Hospital Information System and the National Tax Register (year 2015). For each condition, the number of hospitals by volume of activity was calculated. Hospitals with a volume lower than 3-5 cases/year were excluded. For conditions with more than 1,500 cases/year and frequency of outcome ≥1%, the association between volume of care and outcome was analyzed estimating risk-adjusted outcomes. RESULTS Bibliographic searches identified 80 reviews, evaluating 48 different clinical areas. The main outcome considered was intrahospital/30-day mortality. The other outcomes vary depending on the type of condition or intervention in study. The relationship between hospital volume and outcomes was considered in 47 out of 48 conditions: 34 conditions showed evidence of a positive association; • 14 conditions consider cancer surgery for bladder, breast, colon, rectum, colon rectum, oesophagus, kidney, liver, lung, ovaries, pancreas, prostate, stomach, head and neck; • 11 conditions consider cardiocerebrovascular area: nonruptured and ruptured abdominal aortic aneurysm, acute myocardial infarction, brain aneurysm, carotid endarterectomy, coronary angioplasty, coronary artery bypass, paediatric heart surgery, revascularization of lower limbs, stroke, subarachnoid haemorrhage; • 2 conditions consider orthopaedic area: knee arthroplasty, hip fracture; • 7 conditions consider other areas: AIDS, bariatric surgery, cholecystectomy, intensive care unit, neonatal intensive care unit, sepsis, and traumas; for 3 conditions, no association was demonstrated: hip arthroplasty, dialysis, and thyroidectomy. for the remaining 10 conditions, the available evidence does not allow to draw firm conclusions about the association between hospital volume and considered outcomes: surgery for testicular cancer and intracranial tumours, paediatric oncology, aortofemoral bypass, cardiac catheterization, appendectomy, colectomy, inguinal hernia, respiratory failure, and hysterectomy. The relationship between volume of clinician/surgeon and outcomes was assessed only through the literature re view; to date, it is not possible to analyze this association for Italian health provider hospitals, since information on the clinician/surgeon on the hospital discharge chart is missing. The literature found a positive association for 21 conditions: 9 consider surgery for cancer: bladder, breast, colon, colon rectum, pancreas, prostate, rectum, stomach, and head and neck; 5 consider the cardiocerebrovascular area: ruptured and nonruptured abdominal aortic aneurysm, carotid endarterectomy, paediatric heart surgery, and revascularization of the lower limbs; 2 consider the orthopaedic area: knee and hip arthroplasty; 5 consider other areas: AIDS, bariatric surgery, hysterectomy, intensive care unit, and thyroidectomy. The analysis of the distribution of Italian hospitals concerned the 34 conditions for which the systematic review has shown a positive volume-outcome association. For the following, it was possible to conduct the analysis of the association using national data: unruptured abdominal aortic aneurysm, coronary angioplasty, hip arthroplasty, knee arthroplasty, coronary artery bypass, cancer surgery (colon, liver, breast, pancreas, lung, prostate, kidney, and stomach), laparoscopic cholecystectomy, hip fracture, stroke, acute myocardial infarction. For these conditions, the association between volume and outcome of care was observed. For laparoscopic cholecystectomy and surgery of the breast and stomach cancer, the association between the volume of the discharge (o dismissal) operating unit and the outcome was analyzed. The outcomes differ depending on the condition studied. The shape of the relationship is variable among different conditions, with heterogeneous slope of the curves. DISCUSSION For many conditions, the overview of systematic reviews has shown a strong evidence of association between higher volumes and better outcomes. The quality of the available reviews can be considered good for the consistency of the results between the studies and for the strength of the association; however, this does not mean that the included studies are of good quality. Analyzing national data, potential confounders, including age and comorbidities, have been considered. The systematic review of the literature does not permit to identify predefined volume thresholds. The analysis of national data shows a strong improvement in outcomes in the first part of the curve (from very low to higher volumes) for most conditions. In some cases, the improvement in outcomes remains gradual or constant with the increasing volume of care; in other, the analysis could allow the identification of threshold values beyond which the outcome does not further improve. However, a good knowledge of the relationship between effectiveness of treatments and costs, the geographical distribution and the accessibility to healthcare services are necessary to choose the minimum volumes of care, under which specific health procedures could not been provided in the NHS. Some potential biases due to the use of information systems data should also be considered. The different way of coding among hospitals could lead to a different selection of cases for some conditions. Regarding the definition of the exposure (volume of care), a possible bias could result from misclassification of health providers with high volume of activity. Performing the intervention in different departments/ units of the same hospital would result in an overestimation of the volume of care measured for hospital rather than for department/unit. For the conditions with a further fragmentation within the same structure, the association between volumes of discharge department and outcomes has also been evaluated. In this case, the two curves were different. The limit is to attribute the outcome to the discharge unit, which in case of surgery may not be the intervention unit. A similar bias could occur if the main determinant of the outcome of treatment was the caseload of each surgeon. The results of the analysis may be biased when different operators in the same hospital/unit carried out the same procedure. In any case, the observed association between volumes and outcome is very strong, and it is unlikely to be attributable to biases of the study design. Another aspect on which there is still little evidence is the interaction between volume of the hospital and of the surgeon. A MEDICARE study suggests that in some conditions, especially for specialized surgery, the effect of the surgeon's volume of activity is different depending on the structure volume, whereas it would not differ for some less specialized surgery conditions. The data here presented still show extremely fragmented volumes of both clinical and surgical areas, with a predominance of very low volume structures. Health systems operate, by definition, in a context of limited resources, especially when the amount of resources to allocate to the health system is reduced. In such conditions, the rationalization of the organization of health services based on the volume of care may make resources available to improve the effectiveness of interventions. The identification and certification of services and providers with high volume of activity can help to reduce differences in the access to non-effective procedures. To produce additional evidence to guide the reorganization of the national healthcare system, it will be necessary to design further primary studies to evaluate the effectiveness and safety of policies aimed at concentrating interventions in structures with high volumes of activity.

Background: medical cannabis refers to the use of cannabis or cannabinoids as medical therapy to treat disease or alleviate symptoms. In the United States, 23 states and Washington DC (May 2015) have introduced laws to permit the medical use of cannabis. Within the European Union, medicinal cannabis laws and praxis vary wildly between Countries., Objectives: to provide evidence for benefits and harms of cannabis (including extracts and tinctures) treatment for adults in the following indications: control of spasticity and pain in patients with multiple sclerosis; control of pain in patients with chronic neuropathic pain; control of nausea and vomiting in adults with cancer receiving chemotherapy., Methods: we searched the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE from inception to September 2016. We also searched for on-going studies via ClinicalTrials.gov and the World Health Organization and International Clinical Trials Registry Platform (ICTRP) search portal. All searches included also non-English language literature. All relevant randomized controlled trials (RCTs) evaluating the safety and efficacy of cannabis (including extracts and tinctures) compared with placebo or other pharmacological agents were included. Three authors independently evaluated the titles and abstracts of studies identified in the literature searches for their eligibility. For studies considered eligible, we retrieved full texts. Three investigators independently extracted data. For the assessment of the quality of evidence, we used the standard methodological procedures recommended by Cochrane and GRADE working Group., Results: 41 trials (4,550 participants) were included; 15 studies considered efficacy and safety of cannabis for patients with multiple sclerosis, 12 for patients with chronic pain, and 14 for patients with cancer receiving chemotherapy. The included studies were published between 1975 and 2015, and the majority of them were conducted in Europe. We judged almost 50% of these studies to be at low risk of bias. The large majority (80%) of the comparisons were with placebo; only 8 studies included patients with cancer receiving chemotherapy comparing cannabis with other antiemetic drugs. Concerning the efficacy of cannabis (compared with placebo) in patients with multiple sclerosis, confidence in the estimate was high in favour of cannabis for spasticity (numerical rating scale and visual analogue scale, but not the Ashworth scale) and pain. For chronic and neuropathic pain (compared with placebo), there was evidence of a small effect; however, confidence in the estimate is low and these results could not be considered conclusive. There is uncertainty whether cannabis, including extracts and tinctures, compared with placebo or other antiemetic drugs reduces nausea and vomiting in patients with cancer requiring chemotherapy, although the confidence in the estimate of the effect was low or very low. In the included studies, many adverse events were reported and none of the studies assessed the development of abuse or dependence., Conclusions: there is incomplete evidence of the efficacy and safety of medical use of cannabis in the clinical contexts considered in this review. Furthermore, for many of the outcomes considered, the confidence in the estimate of the effect was again low or very low. To give conclusive answers to the efficacy and safety of cannabis used for medical purposes in the clinical contexts considered, further studies are needed, with higher quality, larger sample sizes, and possibly using the same diagnostic tools for evaluating outcomes of interest.

Objectives: we analysed evidence on effective interventions to improve the quality of care and management in patients with diabetes type 2. This review focuses particularly on audit and feedback intervention, targeted to healthcare providers, and continuous quality improvement (CQI) involving health professionals and health care systems, respectively., Methods: we searched The Cochrane Library, PubMed, and EMBASE (search period: January 2005-December 2015) to identify systematic reviews (SR) and randomized controlled trials (RCTs) considering patients' outcomes and process measures as quality indicators in diabetes care. Selection of studies and data extraction were carried out independently by two reviewers. Methodological quality of individual studies was assessed using the checklist «Assessment of methodological quality of systematic review» (AMSTAR) and the Cochrane's tool, respectively. We produced summaries of results for each study design., Results: the search process resulted in 810 citations. One SR and 7 RCTs that compared any intervention in which audit and feedback and CQI was a component vs. other interventions were selected. The SR found that audit and feedback activity was associated with improvements of glycaemic (mean difference: 0.26; 95%CI 0.08;0.44) and cholesterol control (mean difference: 0.03; 95%CI -0.04;0.10). CQI interventions were not associated with an improvement of quality of diabetes care. The RCTs considered in this review compared a broad range of interventions including feedback as unique activity or as part of more complex strategies. The methodological quality was generally poor in all the included trials., Conclusions: the available evidence suggests that audit and feedback and CQI improve quality of care in diabetic patients, although the effect is small and heterogeneous among process and outcomes indicators.

Introduction: the Italian National Institute of Statistics (Istat) estimated an increase in mortality in Italy of 11.3% between January and August 2015 compared to the previous year. During summer 2015, an excess in mortality, attributed to heat waves, was observed., Objectives: to estimate the excess mortality in 2015 using data from the rapid mortality surveillance system (SiSMG) operational in 32 Italian cities., Design: time series models were used to estimate the excess in mortality among the elderly (65+ years) in 2015 by season (winter and summer). Excess mortality was defined as the difference between observed daily and expected (baseline) mortality for the five previous years (2009- 2013); seasonal mortality in 2015 was compared with mortality observed in 2012, 2013, and 2014. An analysis by cause of death (cardiovascular and respiratory), gender, and age group was carried out in Rome., Results: data confirm an overall estimated excess in mortality of +11% in 2015. Seasonal analysis shows a greater excess in winter (+13%) compared to the summer period (+10%). The excess in winter deaths seems to be attributable to the peak in influenza rather than to low temperatures. Summer excess mortality was attributed to the heat waves of July and August 2015. The lower mortality registered in Italy during summer 2014 (-5.9%) may have contributed to the greater excess registered in 2015. In Rome, cause-specific analysis showed a higher excess among the very old (85+ years) mainly for cardiovascular and respiratory causes in winter. In summer, the excess was observed among both the elderly and in the adult population (35-64 years)., Conclusion: results suggest the need for a more timely use of mortality data to evaluate the impact of different risk factors. Public health measures targeted to susceptible subgroups should be enhanced (e.g., Heat Prevention Plans, flu vaccination campaigns).

Objectives: to evaluate the effect of the 2010 legal decree (DCA) in the Lazio Region (Central Italy), promoting appropriateness on use of agents acting on the renin-angiotensin system, and limiting use of angiotensin II receptor blockers (ARBs) within this drug group to levels below 30%., Setting and Participants: two cohorts of incident patients with diagnosis of cardiovascular disease (CVD) were enrolled from the regional hospital information system: the first cohort included patients discharged during the 12 months before DCA (35,917 patients), and the second one patients discharged during the 12 months after DCA (35,491 patients)., Design: the first prescriptions of angiotensin- converting enzyme inhibitors (ACEIs) and ARBs in the 30 days after discharge were collected from the drug claims registry. The trends of monthly prescription proportions for the two drug groups were compared through a segmented regression analysis., Main Outcomes Measures: comparison between the pre- and post-DCA periods, distinguishing between prescription made by hospital physicians and by general practitioners, and between naïve and prevalent users., Results: proportion of patients with CVD treated with ACEIs/ARBs after discharge was 50% in both pre-DCA (35,917 patients) and post-DCA (35,491 patients) cohorts, with the same share of ACEIs (60%) and ARBs (40%). ARB proportions met the threshold only for hospital prescriptions. Among naïve users, the target was met for both hospital physicians and general practitioners., Conclusions: the specific DCA has not led to an overall improvement in the appropriateness of prescribing of ACEIs/ARBs in secondary cardiovascular prevention. However, there is a suitable prescription choice for naïve patients and when the drug is dispensed in hospital pharmacies.

Background: the body of evidence on health effects of residential exposure to urban waste incinerators suggests association with reproductive outcomes and some cancers, but the overall evidence is still limited., Objectives: we evaluated the impact of two incinerators on hospital admissions for respiratory and cardiovascular diseases in a cohort of people living nearby two incineration plants in Lazio Region (Central Italy) using a before-and-after design., Methods: the study area was defined as the 7-km radius around the incinerators. People who were resident in the area from 1996 to 2008 were enrolled in a retrospective longitudinal study. All addresses were geocoded. A Lagrangian dispersion model (SPRAY) for PM₁₀ (ng/m³) was used for incinerators exposure assessment. Average annual concentration of background PM₁₀ (μg/m³) was estimated on a regional basis by means of RAMS and FARM models. Both PM₁₀ exposures were estimated at the residential address. All subjects were followed for hospital admissions in the period before (1996-2002) and after (2003-2008) the activation of the plants. The association between exposure to emissions from incinerators and hospitalizations in the two periods was estimated using the multivariate Cox model (for repeated events), adjusting for age, area-level socioeconomic status, distance from industries, traffic roads and highways. An interaction term between the period of follow-up (before or after the activation of the plants) and the exposure levels was used to test the effect of the incinerators., Results: 47,192 subjects resident in the study area were enrolled. No clear association between pollution exposure from incinerators and cause-specific morbidity of residents in highest concentration areas was found when compared to the reference group. However, an effect of PM₁₀ on respiratory diseases and chronic obstructive pulmonary disease was suggested. The effect was due to excesses of hospitalizations for the same causes among men living in highest exposure areas in respect to the reference group (hazard ratio - HR: 1.26; 95%CI 0.99-1.60, and HR: 1.86; 95%CI 1.04-3.33, respectively). There were associations between exposure to background pollution from other sources and hospitalizations for diseases of the circulatory system (HR: 1.08; 95%CI 1.03-1.13) and respiratory diseases (HR: 1.07; 95%CI 1.02-1.11) (for a unitary increment of PM₁₀, μg/m³)., Conclusions: living in areas with high PM₁₀ levels due to incinerators was associated with increased morbidity levels for respiratory disorders among men. The study area is critical from an environmental point of view, hence an epidemiological surveillance is recommended.

Background: aircraft noise has been associated with several health effects. Because of the great success of low-cost flights, small airports have been turned into international airports thus exposing nearby residents to an increase in noise levels and potential disturbances and health disorders., Objective: to estimate the exposure levels and evaluate the health impact of aircraft noise on residents nearby six airports in Italy (Rome: Ciampino; Milan: Linate and Malpensa; Pisa; Turin; Venice) focusing on hypertension, acute myocardial infarction (AMI), annoyance and sleep disturbances., Methods: residents in the local Municipalities considered at 31.12.2010 were included in the study and their addresses were geocoded. Aircraft noise exposure in 2011 was defined using the Integrated Noise Model linked to each participant's address. Lden (<55, 55-60, 61-65, 65-70 dB), Lnight, Leq (day and night) were calculated. Available exposure-response relationships were used to estimate the number of additional cases of hypertension, AMI, annoyance and sleep disturbances in the local population., Results: 73,272 persons exposed to aircraft noise levels >55dB were considered: 55,915 (76.3%) were exposed to 55-60 dB; 16,562 (22.6%) to 60-65 dB; 795 (1.2%) to 65-70 dB. Exposure to aircraft noise levels above 55 dB was estimated to be responsible each year of 4,607 (95%CI 0-9,923) additional cases of hypertension; 3.4 (95%CI 0-10.7) cases of AMI; 9,789 (95%CI 6,895-11,962) cases of annoyance; 5,084 (95%CI 1,894-10,509) cases of sleep disturbances., Conclusions: a significant impact of airport noise on the health of residents nearby six Italian airports was estimated. Epidemiological evaluation and noise mitigation measures should be introduced to protect the health of residents.

Objectives: to evaluate the association between socioeconomic position (SEP) and adherence to appropriate antiplatelet therapy (AAT) after percutaneous coronary intervention (PCI) in the year following the discharge., Design: according to scientific guidelines, AAT for PCI patients consists of Clopidogrel for a minimum of 1 month and ideally up to 12 months after discharge, and with Acetylsalicylic Acid (ASA) indefinitely. For each patient, drug claims over a 1-year period after discharge were retrieved from Regional Drug Dispense Registry. Drug use was measured with Proportion of Days Covered (PDC). PDC was computed dividing the total number of dispensed Defined Daily Dose by each patient's follow-up time. Dual antiplatelet therapy with PDC ≥75% and single therapy based on Clopidogrel with PDC ≥75% were considered as AAT. We used a composite area-based index of socioeconomic position by census block of residence built using the 2001 census of Rome, assuming 5 levels (from 1 =High SEP to 5 =Low SEP)., Setting and Participants: study population of 5,901 patients resident in Rome, who underwent their first PCI during 2006-2007 were selected from the Hospital Information System., Main Outcome Measures: proportions of patients treated with AAT by SEP was measured for the overall year and by semester. The association between SEP and adherence to AAT was estimated through logistic regression models adjusting for factors selected by a stepwise procedure (gender, age, comorbidities, discharged from cardiology or coronary care unit, new user of antiplatelet drugs)., Results: 76% of the study population were men, 96% were aged more than 44 years, and 63% belonged to medium-low SEP. In the 1-year follow-up, the proportion of patients adherent to appropriate antiplatelet therapy was 65%; SEP was associated with AAT (OR high vs. low SEP 1.26; 95%CI 1.05-1.51; p trend =0.002)., Conclusions: during the year after discharge, adherence to AAT of PCI patients was unsatisfactory and it decreased overtime more in medium-low SEP patients than in high SEP patients. Strategies to improve adherence to AAT among patients who underwent PCI need to be identified taking into account the multifactorial nature of poor medication adherence, and in particular patients' socioeconomic position.

The population-based cohort study is the best design for assessing the possible health effects resulting fromliving in contaminated sites. The ERAS (Epidemiology,Waste disposal, Environment and Health) Project was established to study the health of people living in close proximity to urban solid waste treatment (RU) plants in Lazio. It was conducted using an integrated approach, which consisted in studying mortality and hospital discharges of residential cohorts surrounding urban waste treatment plants. The level of exposure of each address was assigned using pollution dispersion models and studying the effects on mortality and hospital discharges. Further studies were conducted on residents of areas adjacent to waste disposal sites (includingMalagrotta in Rome), incinerators andmechanical biological treatment plants. The final version of the ERAS Report is available at www.eraslazio.it. The residential cohort approach and the combination of environmental and health-related information proved invaluable in the assessment of the health impact of solid waste treatment in Lazio.

Objective: to analyze the validity of information on educational level from Hospital discharge register, by comparison with the 2001 Census; to develop a hierarchical algorithm which allows to maximize its validity., Methods: Hospital Information System (HIS) of Lazio Region and 2001 Census were used to select all the hospital admissions between 2000 and 2009 of at least 35-year-old people living in Rome and registered at 2001 Census. For each hospitalisation, the information on education stated on Census was associated. Agreement with Census was measured using Cohen's kappa. A hierarchical algorithm based on the results of agreement analysis was developed. For each patient, it selects the most valid admission in order to find the most accurate information on education. The application of the algorithm was tested on four cohorts of 2008-2009 hospital admissions., Results: a good agreement on education from HIS and Census (k between 0.5 and 0.6) was found. The information on education was better for planned hospitalisations placed in hospitals with a volume of care within the 12,000 admissions per year. The agreement between HIS and Census in hip fractures and acute myocardial infarction cohorts was considered sufficient (k=0.3), while it was found a good/excellent agreement in cholecystectomy and coronary artery bypass (k=0.6 for both conditions) cohorts. The application of the algorithm to the cohorts of acute care hospitalisations allowed moving to a level of good agreement (increase: 19%). The gain was much lower in the elective admission cohorts (4%)., Conclusions: the overall agreement is good, but it depends on the characteristics of the hospital admission. However, these differences may be reduced by using hierarchical algorithm.

Background: Improving quality and effectiveness of health care is one of the priorities of health policies. Hospital or physician volume represents a measurable variable with a relevant impact on effectiveness of health care. A recent Italian law, the "spending review", calls for the definition of "qualitative, structural, technological and quantitative standards of hospital care". There is a need for an accurate evaluation of the available scientific evidence in order to identify these standards, including the volume of care above or below which the public and private hospitals may be accredited (or not) to provide specific health care interventions. Since 2009, the National Outcomes Programme evaluates outcomes of care of the Italian hospitals; nowadays it represents an official tool to assess the National Health System (NHS). In addition to outcome indicators, the last edition of the Programme (2013) includes a set of volume indicators for the conditions with available evidence of an association between volume and outcome. The assessment of factors, such as volume, that may affect the outcomes of care is one of its objectives., Objectives: To identify clinical conditions or interventions for which an association between volume and outcome has been investigated. To identify clinical conditions or interventions for which an association between volume and outcome has been proved. To analyse the distribution of Italian health providers by volume of activity. To measure the association between volume of care and outcomes of the health providers of the Italian NHS., Methods: Systematic review. An overview of systematic reviews and Health Technology Assessment (HTA) reports performed searching electronic databases (PubMed, EMBASE, Cochrane Library), websites of HTA Agencies, National Guideline Clearinghouse up to February 2012. Studies were evaluated for inclusion by two researchers independently; the quality assessment of included reviews was performed using the AMSTAR checklist. For each health condition and for each outcome considered, total number of studies, participants, high volume cut-off values (range, average and median) have been reported, where presented. Number of studies (and participants) with statistically significant positive association and metanalysis performed were also reported, if available. Analysis of the distribution of Italian hospitals by volume of activity and the association between volume of activity and outcomes. Outcomes National Programme 2011 The analyses were performed using the Hospital Information System and the National Tax Register pertaining the year 2011. For each condition, the number of hospitals by volume of activity was calculated. Hospitals with a volume of activity lower than 3-5 cases/year for the condition under study were excluded from the analysis. For conditions with more than 1,500 cases per year and frequency of outcome ≥ 3%, the association between volume of care and outcome was analysed. For these conditions, risk-adjusted outcomes were estimated according to the selection criteria and the statistical methodology of the National Outcome Programme., Results: The systematic reviews identified were 107, of which 47, evaluating 38 clinical areas, were included. Many outcomes were assessed according to the clinical condition/procedure considered. The main outcome common to all clinical condition/procedures was intrahospital/30-day mortality. Health topics were classified in the following groups according to this outcome: Positive association: a statistically significant positive association was demonstrated in the majority of studies/participants and/or a pooled measure (metanalysis) with positive results was reported. Lack of association: no association was demonstrated in the majority of studies/participants and/or no metanalysis with positive results was reported. No sufficient evidence of association: both results of single studies and metanalysis do not allow to draw firm conclusions on the association between volume and outcome. Evidence of a positive association between volumes and intrahospital/ 30-day mortality was demonstrated for 26 clinical areas: AIDS, abdominal aortic aneurysm (ruptured and unruptured), coronary angioplasty, myocardial infarction, knee arthroplasty, coronary artery bypass, cancer surgery (breast, lung, colon, colon rectum, kidney, liver, stomach, bladder, oesophagus, pancreas, prostate); cholecystectomy, brain aneurysm, carotid endarterectomy, hip fracture, lower extremity bypass surgery, subarachnoid haemorrhage, neonatal intensive care, paediatric heart surgery. For 2 clinical conditions (hip arthroplasty and rectal cancer surgery) no association has been reported. Due to a lack of evidence, it was not possible to draw firm conclusion for 10 clinical areas (appendectomy, colectomy, aortofemoral bypass, testicle cancer surgery, cardiac catheterization, trauma, hysterectomy, inguinal hernia, paediatric oncology). The relationship between volume of clinician and outcomes has been assessed only through the literature review; to date, it is not possible to analyse this association for Italian health providers hospitals, since information on the clinician/surgeon on the hospital discharge chart is missing. The literature found a positive association for: AIDS, coronary angioplasty, unruptured abdominal aortic aneurysm, hip arthroplasty, coronary artery bypass, cancer surgery (colon, stomach, bladder, breast, oesophagus), lower extremity bypass surgery. The analysis of the distribution of Italian hospitals per volume of activity concerned the 26 conditions for which the systematic review has shown a positive association between volume of activity and intrahospital/30-day mortality. For the following conditions it was possible to conduct the analysis of the association between volume and outcome of treatment using national data: unruptured abdominal aortic aneurysm, coronary angioplasty, knee arthroplasty, coronary artery bypass, cancer surgery (colon, pancreas, lung, prostate, stomach, bladder), laparoscopic cholecystectomy, endarterectomy, hip fracture and acute myocardial infarction. For them, the association between volume and outcome of care has been observed. The shape of the relationship is variable among different conditions, with heterogeneous "slope" of the curves. DISCUSSION For many conditions, the systematic review of the literature has shown a strong evidence of association between higher volumes and better outcomes. Due to the difficulty to test such an association in randomized controlled studies, the studies included in the reviews were mainly observational studies: however, the quality of the available evidence can be considered good both for the consistency of the results between the studies and for the strength of the association. Where national data had sufficient statistical power, this association has been observed by the empirical analysis conducted on the health providers of the NHS in 2011. Analysing national data, potential confounders, including age and the presence of comorbidities in the admission under study and in the admissions of the two previous years, have been considered. The systematic review of the literature does not permit to identify predefined volume thresholds. The analysis of national data shows a strong improvement in outcomes in the first part of the curve (from very low volumes to higher volumes) for the majority of the studied conditions. In some cases the improvement in outcomes remains gradual or constant with the increasing volume of care, in other the analysis could allow the identification of threshold values beyond which the outcome does not improve further. However, a good knowledge of the relationship between effectiveness of treatments and their costs, the geographical distribution and the accessibility to health care services are necessary to choose the minimum volumes of care, under which specific health procedures in the NHS should not be provided. Some potential biases due to the use of information systems data should also be taken into account. In particular, it is necessary to consider possible selection bias due to the different way of coding among hospitals that could lead to a different selection of cases for some conditions (e.g. acute myocardial infarction), less likely to occur in the selection of cases for oncologic, orthopaedic, vascular, abdominal, and cardiac surgery. Regarding the definition of the exposure (volume of care), a possible bias could result from misclassification of health providers with high volume of activity. In fact, performing the intervention in different departments/units of the same hospital would result in an overestimation of the volume of care measured for hospital rather than for department/unit. A similar bias could occur if the main determinant of the outcome of treatment was the case load of each surgeon: the results of the analysis may be biased when the same procedure was carried out by different operators in the same hospital/unit. In any case, the observed association between volumes of care and outcome is very strong, and it is unlikely to be attributable to biases of the study design. However, the foreseen bias is likely to be non-differential, and, therefore, it would eventually lead to an underestimation of the true association between volume of care and outcome. Health systems operate, by definition, in a context of limited resources, especially when societies and governments choose to reduce the amount of resources to allocate to the health system. In such conditions, the rationalisation of the organization of health services based on the volume of care may make resources available to improve the effectiveness of interventions. The identification and certification of services and provider with high volume of activity can help to reduce differences in the access to no effective procedures.

Introduction: the potential health impacts due to the decommissioned Nuclear power plants (NPP) located in Borgo Sabotino and Garigliano in Central Italy (active from the early 1960s to the late 1980s) have raised several concerns. Brain, thyroid, breast and lung cancer and leukaemia have been associated with exposure to ionizing radiations, but the health effects of nuclear plants on the resident populations are controversial., Objective: to evaluate whether living close to NPPs is associated with an increased risk of cancer incidence and mortality., Methods: we defined a cohort of residents within 7 km from the NPPs during the period 1996-2002. Individual follow-up for vital status at 01.01.2007 was conducted using municipality data. Gender specific Standardized Incidence and Mortality Ratios, adjusted for age, were calculated (SIR and SMR) using the regional population as reference. Each participant's address was assigned to a distance from the NPP on the basis of a GIS. A relative risk (RR, CI95%), adjusted for age and socioeconomic status, was calculated in 3 bands of increasing radius from the plants: 0-2, 2-4, and 4-7 km (reference group), using a Poisson regression model., Results: the cohort was of 39,775 people, 32%of whom lived near (0-4 km) the NPP. No differences in mortality was found when comparing the cohort with the regional population; among women living within 7 km from the NPP, we found thyroid cancer incidence higher than expected (SIR 1.53 CI95% 1.18-1.95). However, when the analysis was conducted on the basis of the distance from the NPP, we found a statistically significant increase in male mortality only for causes unrelated to radiation exposure (all causes, stomach cancer, and cardiovascular diseases). No mortality excess was observed among women living close to the NPPs. No statistically significant distance-related gradient was observed for cancer incidence both in men and women., Conclusions: living close to the NPP was not associated with mortality for causes related to radiation exposure. However, the results suggest to continue the epidemiological surveillance of the population.

Objective: To develop and validate a predictive model for the identification of patients with Chronic Obstructive Pulmonary Disease (COPD) among the resident population of the Lazio region, using information available in the regional administrative systems (SIS) as well as clinical data of a panel of COPD patients., Setting and Participants: All residents in the Lazio region over 40 years of age in 2007 (2,625,102 inhabitants), Main Outcome Measures: The predictive model was developed through record linkage of health care related consumption patterns among 428 panel patients with confirmed COPD diagnosis in 2006 and a control group of patients without COPD (selection from outpatients specialized health care registry, 1:4). Hospital admission for COPD was defined a priori to be sufficient to identify a COPD patient. For all other panel patients and controls, specific drug use (minimum 2 prescriptions during 12 months) and hospitalization for respiratory causes during the past 9 years were retrieved and compared between panel and control patients. COPD associated factors were selected through a Bootstrap- Stepwise (BS) procedure. The predictive model was validated through internal (cross-validation-bootstrap) and external validation (comparison with external COPD patients with confirmed diagnosis), and through comparison with other COPD identification approaches., Results: The BS procedure identified the following predictors of COPD: consumption of beta 2 agonists, anticholinergics, corticosteroids, oxygen, and previous hospitalization for respiratory failure. For each patient, the expected probability of being affected by COPD was estimated. Depending on the cut-point of expected probability, sensibility ranged from 74.5% to 99.6% and specificity from 37.8% to 86.2%. Using the 0.30 cut-point, the model succeeded in identifying 67% of patients with diagnosis of COPD confirmed with spirometry. The predictive performance increased with increasing COPD severity. Prevalence of COPD turned out to be 7.8 %. The age-specific estimation was similar to results from other approaches., Conclusion: The predictive model shows good performance to identify COPD patients, even if it does not allow to identify those patients who have not been registered in the regional health care service or do not request any public health care service.