Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial.

BACKGROUND: The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women's reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. METHODS: At inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants' acceptability and comprehension of the trial, and their experience of risk assessment. DISCUSSION: Beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. TRIAL REGISTRATION: Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). CLINICALTRIALS: gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

The role of PET/CT in disease activity assessment in patients with large vessel vasculitis.

OBJECTIVES: To evaluate the accuracy of PET/CT and of PET vascular activity score (PETVAS) in assessing disease activity and the ability of PETVAS in predicting relapses in a large single-centre cohort of patients with large vessel vasculitis (LVV). METHODS: We conducted a retrospective cohort study of prospectively collected data of consecutive patients diagnosed with LVV who underwent at least one PET/CT scan between 2007 and 2020. The nuclear medicine physician's interpretation of each PET/CT scan (active/inactive vasculitis) was compared with disease activity clinical judgement (active disease/remission). For each PET/CT scan, the PETVAS score was calculated and its accuracy in assessing disease activity was evaluated. The ability of PETVAS in predicting subsequent relapses was evaluated. RESULTS: A total of 100 consecutive LVV patients (51 large vessel GCA, 49 Takayasu arteritis) underwent a total of 476 PET/CT scans over a mean follow-up period of 97.5 months. Physician-determined PET/CT grading was able to distinguish between clinically active and inactive LVV with a sensitivity of 60% (95% CI 50.9, 68.7) and specificity of 80.1% (95% CI 75.5, 84.1); the area under the curve (AUC )was 0.70 (95% CI 0.65, 0.75). PETVAS was associated with disease activity, with an age and sex-adjusted odds ratio for active disease of 1.15 (95% CI 1.11, 1.19). A PETVAS ≥10 provided 60.8% sensitivity and 80.6% specificity in differentiating between clinically active and inactive LVV; the AUC was 0.73 (95% CI 0.68, 0.79). PETVAS was not associated with subsequent relapses, with an age and sex-adjusted hazard ratio of 1.04 (95% CI 0.97, 1.11). CONCLUSIONS: The visual PET/CT grading scale and PETVAS had moderate accuracy to distinguish active LVV from remission. PETVAS did not predict disease relapses.

Barriers to Accessing Primary Care and Appropriateness of Healthcare Among Immigrants in Italy.

INTRODUCTION: The health status and health care needs of immigrant populations must be assessed. The aim of this study was to evaluate barriers to accessing primary care and the appropriateness of health care among resident immigrants in Italy, using indicators regarding maternal health, avoidable hospitalization, and emergency care. METHODS: Cross-sectional study using some indicators of the National Monitoring System of Health Status and Healthcare of the Immigrant Population (MSHIP), coordinated by the National Institute for Health, Migration and Poverty (INMP), calculated on perinatal care, hospital discharge, and emergency department databases for the years 2016-2017 in nine Italian regions (Piedmont, Trento, Bolzano, Emilia-Romagna, Tuscany, Umbria, Latium, Basilicata, Sicily). The analyses were conducted comparing immigrant and Italian residents. RESULTS: Compared to Italian women, immigrant women had fewer than five gynecological examinations (8.5 vs. 16.3%), fewer first examinations after the 12th week of gestational age (3.8 vs. 12.5%), and fewer than two ultrasounds (1.0 vs. 3.8%). Compared to Italians, immigrants had higher standardized rates (× 1,000 residents) of avoidable hospitalizations (males: 2.1 vs. 1.4; females: 0.9 vs. 0.7) and of access to emergency departments for non-urgent conditions (males: 62.0 vs. 32.7; females: 52.9 vs. 31.4). CONCLUSIONS: In Italy, there appear to be major issues regarding accessing services and care for the immigrant population. Policies aimed at improving socioeconomic conditions and promoting integration can promote healthy lifestyles and appropriate access to health care, counteracting the emergence of health inequities in the immigrant population.

Feasibility and efficiency of European guidelines for NAFLD assessment in patients with type 2 diabetes: A prospective study.

AIM: We aimed to evaluate the feasibility and efficiency of a guidelines-compliant NAFLD assessment algorithm in patients with newly diagnosed type 2 diabetes (T2D). METHODS: Consecutive patients aged < 75 newly diagnosed with T2D without coexisting liver disease or excessive alcohol consumption were enrolled. Patients were stratified based on liver enzymes, fatty liver index, ultrasound, fibrosis scores and liver stiffness measurement. Referral rates and positive predictive values (PPVs) for histological non-alcoholic steatohepatitis (NASH) and significant fibrosis were evaluated. RESULTS: Of the 171 enrolled patients (age 59 ± 10.2 years, 42.1% females), 115 (67.3%) were referred to a hepatologist due to abnormal liver enzymes (n = 60) or steatosis plus indeterminate (n = 37) or high NAFLD fibrosis score (n = 18). Liver biopsy was proposed to 30 patients (17.5%), but only 14 accepted, resulting in 12 NASH, one with significant fibrosis. The PPV of hepatological referral was 12/76 (15.8%) for NASH and 1/76 (1.3%) for NASH with significant fibrosis. The PPV of liver biopsy referral was 12/14 (85.7%) for NASH and 1/14 (7.1%) for NASH with significant fibrosis. CONCLUSIONS: By applying a guidelines-compliant algorithm, many patients with T2D were referred for hepatological assessment and liver biopsy. Further studies are necessary to refine non-invasive algorithms.

Accuracy and Reproducibility of Contrast-Enhanced Mammography in the Assessment of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients with Calcifications in the Tumor Bed.

This study aimed to evaluate contrast-enhanced mammography (CEM) accuracy and reproducibility in the detection and measurement of residual tumor after neoadjuvant chemotherapy (NAC) in breast cancer (BC) patients with calcifications, using surgical specimen pathology as the reference. Pre- and post-NAC CEM images of 36 consecutive BC patients receiving NAC in 2012-2020, with calcifications in the tumor bed at diagnosis, were retrospectively reviewed by two radiologists; described were absence/presence and size of residual disease based on contrast enhancement (CE) only and CE plus calcifications. Twenty-eight patients (77.8%) had invasive and 5 (13.9%) in situ-only residual disease at surgical specimen pathology. Considering CE plus calcifications instead of CE only, CEM sensitivity for invasive residual tumor increased from 85.7% (95% CI = 67.3-96%) to 96.4% (95% CI = 81.7-99.9%) and specificity decreased from 5/8 (62.5%; 95% CI = 24.5-91.5%) to 1/8 (14.3%; 95% CI = 0.4-57.9%). For in situ-only residual disease, false negatives decreased from 3 to 0 and false positives increased from 1 to 2. CEM pathology concordance in residual disease measurement increased (R squared from 0.38 to 0.45); inter-reader concordance decreased (R squared from 0.79 to 0.66). Considering CE plus calcifications to evaluate NAC response in BC patients increases sensitivity in detection and accuracy in measurement of residual disease but increases false positives.

Geographic Inequalities in Breast Cancer in Italy: Trend Analysis of Mortality and Risk Factors.

We calculated time trends of standardised mortality rates and risk factors for breast cancer (BC) from 1990 to 2016 for all women resident in Italy. The age-standardised mortality rate in Italy decreased from 4.2 in 1990 to 3.2 (×100,000) in 2016. While participation in organised screening programmes and age-standardised fertility rates decreased in Italy, screening invitation coverage and mammography uptake, the prevalence of women who breastfed and mean age at birth increased. Although southern regions had favourable prevalence of protective risk factors in the 1990s, fertility rates decreased in southern regions and increased in northern regions, which in 2016 had a higher rate (1.28 vs. 1.32 child per woman) and a smaller increase in women who breastfed (+4% vs. +30%). In 2000, mammography screening uptake was lower in southern than in northern and central regions (28% vs. 52%). However, the increase in mammography uptake was higher in southern (203%) than in northern and central Italy (80%), reducing the gap. Participation in mammographic screening programmes decreased in southern Italy (-10%) but increased in the North (6.6%). Geographic differences in mortality and risk factor prevalence is diminishing, with the South losing all of its historical advantage in breast cancer mortality.

[Trends in educational inequalities in premature mortality between 2001 and 2016: results from the Emilian Longitudinal Study]. / Andamento delle disuguaglianze per livello di istruzione nella mortalità prematura tra il 2001 e il 2016 nello Studio longitudinale emiliano.

OBJECTIVES: to describe changes in relative and absolute inequalities in mortality by education level between 2001 and 2016 in the Emilian longitudinal study (SLEm) and to estimate the impact of these inequalities at population level. DESIGN: closed cohort study based on record-linkage between municipal population registries, Census archives of 2001 and 2011, and the mortality register. SETTING AND PARTICIPANTS: 2001- and 2011-Census respondents >=30 years old residing in Bologna, Modena, or Reggio Emilia followed up to the age of 75 years, death, emigration, or end of follow-up (December 2006 or December 2016). MAIN OUTCOME MEASURES: premature mortality for all causes and for 16 groups of causes known to be associated with socioeconomic position. In order to capture various aspects of the inequalities, the association with the education level is assessed through summary regression-based indexes (Relative and Slope Index of Inequality) and the Attributable Population Fraction. RESULTS: premature mortality declined across all educational level between 2001-2006 and 2011-2016; declines were greater among men than women. Among men, relative inequalities in mortality slightly increased (RII from 1.86 in 2001 to 2.13 in 2011), while absolute inequalities declined (SII from 382.3 to 360.6). Among women, both relative and absolute inequalities increased (RII from 1.23 to 1.65, SII from 73.7 to 137.4). Educational inequalities in lung cancer, respiratory and cerebrovascular diseases mortality decreased among men and increased among women. The proportion of the low educated shrank over time (men: from 40% to 36%; women: from 43% to 35%); nonetheless, the fraction of the deaths attributable to educational inequalities showed an upward tendency (from 18.5% to 21.9% in men and from 9.7% to 15.6% in women); the groups of causes that contribute most to this increase were malignant cancers, especially lung cancer, diseases of the circulatory and respiratory systems, and accidents. CONCLUSIONS: relative inequalities slightly increased in both genders, while absolute inequalities only in women. A reduction in the population impact could be achieved by tackling educational inequalities in mortality due to lung cancer, diseases of the circulatory and respiratory systems, and accidents.

A cluster randomized trial to measure the impact on nonsteroidal anti-inflammatory drug and proton pump inhibitor prescribing in Italy of distributing cost-free paracetamol to osteoarthritic patients.

BACKGROUND: Paracetamol is recommended as first-line treatment for pain control in osteoarthritis because it has fewer side effects than do other therapeutic options, including nonsteroidal anti-inflammatory drugs (NSAIDs). Prescribing proton pump inhibitors (PPIs) as gastric bleeding prophylaxis in chronic NSAID users is also common, although not recommended. In Italy, paracetamol is not reimbursed by the National Health System. The aim of this trial was to test whether the availability to osteoarthritis patients of free paracetamol would decrease their use of NSAIDs and, as a secondary objective, whether opioid and PPI consumption would also decrease. METHODS: Eight general practitioners (GPs) (59 patients) were randomized to usual care and 8 (58 patients) to the experimental arm, where prescribed paracetamol was directly distributed for free by the local hospital. After 6 months, paracetamol was also available for free in the control arm. The main outcome was the pre/post difference in average NSAID and PPI consumption. Differences between experimental and control arms in pre/post differences are reported, as registered by the drug prescription information system. RESULTS: Average NSAID consumption decreased non-significantly, from 6.79 to 2.16 defined daily dose (DDD) in the experimental arm and from 3.19 to 2.97 DDD in the control group (p = 0.067). No changes were observed for PPIs (from 11.27 to 14.65 DDD and from 9.74 to 12.58 DDD in experimental and control arms, respectively, p = 0.788) or opioids (from 1.61 to 1.14 DDD and from 1.41 to 1.56 DDD in experimental and control arms, respectively, p = 0.419). When the intervention was extended to the control arm, no decrease in NSAID consumption was observed (from 2.46 to 2.43 DDD, p = 0.521). CONCLUSIONS: Removing small economic barriers had small or no effect on the appropriateness of opioid or PPI prescribing to patients with osteoarthritis; a reduction in NSAID consumption cannot be ruled out. TRIAL REGISTRATION NUMBER: NCT02691754 (Approved February 24, 2016).

[Immigrants' health and socioeconomic inequalities of overall population residing in Italy evaluated through the Italian network of Longitudinal Metropolitan Studies]. / Salute degli immigrati e disuguaglianze socioeconomiche nella popolazione residente in Italia valutate attraverso la rete degli Studi Longitudinali Metropolitani.

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.

The effect of Public Health/Pediatric Obesity interventions on socioeconomic inequalities in childhood obesity: A scoping review.

Childhood obesity has a strong social gradient. This scoping review aims to synthesize the evidence on the impact on inequalities of non-targeted interventions to reduce the prevalence of childhood and adolescent obesity in high-income countries. We updated a review by Hillier-Brown, searching up to 31 December 2017 on MEDLINE, Embase, The Cochrane Library, CINAHL, and PsycINFO, with no limitations on study design. Fifty-eight studies describing 51 interventions were included: 31 randomized clinical trials and 27 non-randomized trials, with sample sizes from 67 to 2,700,880 subjects. The majority were implemented in the school setting at a community level; the others were in health services or general population setting and targeting individuals or the system. Twenty-nine interventions proved to be effective overall; seven others had an effect only in a subgroup, while 15 proved not to be effective. All types of included interventions can increase inequalities. Moreover, some interventions had opposite effects based on the socioeconomic characteristics. Any kind of intervention can reduce equity. Consequences are difficult to predict based on intervention construct. Complex interventions acting on multiple targets, settings, and risk factors are more effective and have a lower risk of increasing inequalities.

Quantitative assessment of the anticoagulant in plasma units collected by plasmapheresis.

BACKGROUND: To date, the quantification of the anticoagulant (ACD-A) in plasma units has been based on theoretical calculations. An accurate quantification could help minimize the risks associated with plasmapheresis, given that the total ACD-A used during the procedure is distributed between the donor and the plasma unit. Our aim was to experimentally quantify the volume of ACD-A in units collected by plasmapheresis. STUDY DESIGN AND METHODS: We used proton nuclear magnetic resonance spectroscopy to measure the ACD-A volume in 295 plasma units collected by the Azienda USL-IRCCS of Reggio Emilia, Italy. We analyzed the determinants of the differences between estimated and measured ACD-A through multivariate regression models. RESULTS: The experimentally measured ACD-A in plasma units was variable, with 45% of the samples showing a discrepancy of more than 15 mL compared to the manufacturer's estimate. ACD-A was underestimated for higher density of the units (p < 0.0005); a weak association was also observed with triglycerides (underestimated for higher levels, p = 0.015) and sex (overestimated in females, p = 0.008), but our model explained only 35% of the individual variability. CONCLUSION: The manufacturer's algorithms do not accurately estimate the ACD-A in units collected by plasmapheresis. Donor-related characteristics may affect ACD-A distribution between donor and plasma unit, thereby explaining the discrepancies between estimate and measurement. Errors in the estimate of the ACD-A actually received by donors could hamper studies on dose-response relationship between anticoagulant and adverse reactions. Our work should stimulate research on tailored procedures aimed at minimizing the anticoagulant received by donors and increasing plasmapheresis safety.

Italian Atlas of mortality inequalities by education level. / Atlante italiano delle disuguaglianze di mortalità per livello di istruzione.

OBJECTIVES: To evaluate the geographical and socioeconomic differences in mortality and in life expectancy in Italy; to evaluate the proportion of mortality in the population attributable to a medium-low education level through the use of maps and indicators. DESIGN: Longitudinal design of the population enrolled in the 2011 Italian Census, following the population over time and registering any exit due to death or emigration. SETTING AND PARTICIPANTS: The study used the database of the Italian National Institute of Statistics (Istat) developed by linking the 2011 Census with the Italian National Register of Causes of Death (2012-2014) for 35 groups of causes of death. Age, sex, residence, and education level information were collected from the Census. MAIN OUTCOME MEASURES: Life expectancy at birth was calculated by sex, Italian region, and education level. For the population aged 30-89 years, the following items were developed by sex: 1. provincial maps showing, for each cause of death, the distribution in quintiles of smoothed standardized mortality ratio (SMR), adjusted for age and education level and estimated with Bayesian models for small areas (spatial conditional autoregressive model); 2. regional maps of population attributable fraction (PAF) for low and medium education levels, calculated starting from age-standardized mortality ratios; 3. tables illustrating for each region standardized mortality rates and standardized years of life lost rate by age (standardized YLL rate), and mortality rate ratios standardized by age (MMRs). RESULTS: Males with a lower education level throughout Italy show a life expectancy at birth that is 3 years less than those with higher education; residents in Southern Italy lose an additional year in life expectancy, regardless of education level. Social inequalities in mortality are present in all regions, but are more marked in the poorer regions of Southern Italy. Geographical differences, taking into account the different population distributions in terms of age and education level, produce mortality differences for all causes: from -15% to +30% in women and from -13% to +26% in men, compared to the national average. Among the main groups of causes, the geographical differences are greater for cardiovascular diseases, respiratory diseases, and accidents, and lower for many tumour sites. A clear mortality gradient with an excess in Southern Italy can be seen for cardiovascular diseases: there are some areas where mortality for people with higher education level is higher than that for residents in Northern Italy with low education level. The gradient for "All tumours", instead, is from South to North, as it is for most single tumour sites. Population attributable fraction for low education level in Italy, taking into account the population distribution by age, is 13.4% in women and 18.3% in men. CONCLUSIONS: The study highlighted important geographical differences in mortality, regardless of age and socioeconomic level, with a more significant impact in the poorer Southern regions, revealing a never-before-seen health advantage in the regions along the Adriatic coast. A lower education level explains a considerable proportion of mortality risk, although with differing effects by geographical area and cause of death. There are still mortality inequalities in Italy, therefore, representing a possible missed gain in health in our Country; these inequalities suggest a reassessment of priorities and definition of health targets. Forty years after the Italian National Health Service was instituted, the goal of health equity has not yet been fully achieved.

[Differences in mortality by educational level in Italy (2012-2014)]. / Differenze nella mortalità per livello di istruzione in Italia (2012-2014).

OBJECTIVES: to evaluate socioeconomic inequalities in mortality by educational level in Italy. DESIGN: cohort study based on the record linkage between the 2012-2014 archives of mortality and the 2011 Italian population Census. SETTING AND PARTICIPANTS: Italian population registered in the 2011 Census. MAIN OUTCOME MEASURES: life expectancy by educational level, age-standardized mortality rates, mortality rate ratios (MRRs) for overall mortality, and 12 groups of causes of death. RESULTS: life expectancy at birth was 80.3 years among men and 84.9 among women. High-educated men were expected to live 3 years longer than lower educated men, while the gap was narrower in women (1.5 years). Lower educated men had a higher mortality from any cause (MRR: 1.34; 95%CI 1.33-1.35) with larger differentials for lung, upper aerodigestive, and liver cancers, respiratory system diseases, AIDS and accidents. Socioeconomic inequalities were larger in the North-West of the Country for lung and liver cancer. Educational inequalities were smaller among women for all-cause mortality, but remarkably larger for circulatory system diseases (MRR: 1.40; 95%CI 1.38-1.42), particularly in the South (MRR: 1.46; 95%CI 1.42-1.50). CONCLUSIONS: this study documented socioeconomic inequalities in mortality in Italy for many causes of death; some of them resulted heterogeneous by area of residence. Most of the inequalities can be counteracted with specific measures aimed to improve behavioural risk factors among less educated people.

Cohort profile: the Italian Network of Longitudinal Metropolitan Studies (IN-LiMeS), a multicentre cohort for socioeconomic inequalities in health monitoring.

PURPOSE: The Italian Network of Longitudinal Metropolitan Studies (IN-LiMeS) is a system of integrated data on health outcomes, demographic and socioeconomic information, and represents a powerful tool to study health inequalities. PARTICIPANTS: IN-LiMeS is a multicentre and multipurpose pool of metropolitan population cohorts enrolled in nine Italian cities: Turin, Venice, Reggio Emilia, Modena, Bologna, Florence, Leghorn, Prato and Rome. Data come from record linkage of municipal population registries, the 2001 population census, mortality registers and hospital discharge archives. Depending on the source of enrolment, cohorts can be closed or open. The census-based closed cohort design includes subjects resident in any of the nine cities at the 2001 census day; 4 466 655 individuals were enrolled in 2001 in the nine closed cohorts. The open cohort design includes subjects resident in 2001 or subsequently registered by birth or immigration until the latest available follow-up (currently 31 December 2013). The open cohort design is available for Turin, Venice, Reggio Emilia, Modena, Bologna, Prato and Rome. Detailed socioeconomic data are available for subjects enrolled in the census-based cohorts; information on demographic characteristics, education and citizenship is available from population registries. FINDINGS TO DATE: The first IN-LiMeS application was the study of differentials in mortality between immigrants and Italians. Either using a closed cohort design (nine cities) or an open one (Turin and Reggio Emilia), individuals from high migration pressure countries generally showed a lower mortality risk. However, a certain heterogeneity between the nine cities was noted, especially among men, and an excess mortality risk was reported for some macroareas of origin and specific causes of death. FUTURE PLANS: We are currently working on the linkage of the 2011 population census data, the expansion of geographical coverage and the implementation of the open design in all the participating cohorts.

The effects of improving the mesothelioma surveillance network on sensitivity, timeliness in reporting and asbestos exposure assessment.

BACKGROUND: In Italy, Mesothelioma Registries (MRs) have been established by law for the epidemiological surveillance of occupational cancers. MRs collect information about asbestos exposure of incident cases, through interviews. In the Emilia-Romagna region, MR was implemented in 1996 and extended its network of health professionals who report suspected mesothelioma in 2001 and 2007. OBJECTIVES: This study evaluated the impact of the extension of the network on MR sensitivity and timeliness. METHODS: Mesothelioma cases were analysed in three subsequent periods: 1996-2001 (before any network extension), 2002-2007 (after first extension) and 2008-2014 (after second extension). Sensitivity was evaluated by the proportion of cases directly reported by the network out of the total number of incident cases; reporting and interview timeliness were assessed by median times between diagnosis and, respectively, reporting and interview. Pleural mesothelioma reporting timeliness was also evaluated by use of quantile regression models, stratified by diagnostic certainty and adjusted by sex and age. RESULTS: Sensitivity increased from 79.4% (1996-2001), to 89.0% (2002-2007) and to 91.4% (2008-2013). For mesothelioma with diagnostic certainty, we recorded considerably reduced reporting times from the 50th percentile on, whereas for uncertain mesothelioma relevant reductions were observed also in the lower percentiles. A reduced time to interview was observed too, which was more significant for uncertain cases. The proportion of patients directly interviewed increased from 33.5% (1996-2001), to 39.1% (2002-2007), to 49.5% (2008-2014). CONCLUSIONS: The extended network improved the MR sensitivity and allowed shorter reporting and interview times and more frequent patient interviews, thus improving accuracy of exposure definition.

Factors Influencing the Accuracy of Infectious Disease Reporting in Migrants: A Scoping Review.

We conducted a scoping review of literature to improve our understanding of the accuracy of infectious disease monitoring in migrants in the Europe. We searched PubMed for papers relevant to the topic including: case reports, observational and experimental studies, reviews, guidelines or policy documents; published after 1994. We identified 532 papers, 27 of which were included in the review. Legislation and right to access health care influence both the accuracy of rates and risk measures under estimating the at risk population, i.e., the denominator. Furthermore, the number of reported cases, i.e., the numerator, may also include cases not accounted for in the denominator. Both biases lead to an overestimated disease occurrence. Restriction to healthcare access and low responsiveness may cause under-detection of cases, however a quantification of this phenomenon has not been produced. On the contrary, screening for asymptomatic diseases increases ascertainment leading to increased detection of cases. Incompleteness of denominator data underestimates the at-risk population. In conclusion, most studies show a lower probability of under-reporting infectious diseases in migrants compared with native populations.

Health care costs and functional outcomes of road traffic injuries in the Lazio region of Italy.

The economic consequences of road traffic injuries (RTIs) are very important in terms of health care costs. The aim of this study is to provide estimates of health care costs of non-fatal RTIs and to estimate functional outcomes using in-hospital rehabilitation data. We identified all emergency department (ED) visits related to RTI during 2008 and then linked them with hospital discharges and rehabilitation admissions, health care costs following RTI were estimated from the integrated database. We performed an epidemiological evaluation of RTI with a comprehensive description of functional outcomes at 6 months. Health care costs have been estimated at about €80 million with a per person cost of €522. About 18% of the total cost was due to rehabilitation treatments. In multivariate analysis the variables that correlated better with higher total health care costs were: older age, injury severity, presence of spinal lesion. Patients requiring rehabilitation were: the elderly, patients suffering from a spinal cord injury and leg injuries. This study provides consistent health care cost estimates of RTI using administrative databases and it shows a picture of functional outcomes after RTI. Further research is needed for the estimation of other components of the total cost of RTI.

[Evaluation of the cancer co-pay fee exemption data source (048 code) to estimate cancer incidence]. / Valutazione del flusso delle esenzioni ticket per neoplasia (codice 048) per stimare l'incidenza dei tumori.

OBJECTIVES: to assess whether the data source of cancer exemption ticket (code 048) correctly estimate the cancer incidence produced by Cancer registries (CR). DESIGN: comparison between incidence estimates produced by cancer exemptions ticket and cases registered by CR. SETTING AND PARTICIPANTS: six CRs provided incidence data for one year in the five-year period from 2007 to 2011 and for the previous five years, the exemptions provided for the same year and for the previous five years. MAIN OUTCOME MEASURES: incidence distribution by gender, age and tumour site, exemptions 048/incident cancers ratio, and trend estimates. RESULTS: out of 14,586 patients with 048 exemption, a first group was present in the CR database in the same reference year (No. 8,015) and a second group in the previous 6 months (No. 1,696). Of the remaining 4,875, only 2,771 were prevalent cases and 2,104 were manually re-valued: 514 non-cancer; 710 non-malignant/noninfiltrating tumours, 250 non-residents, 532 unknown, and 98 lost at CR. The exemption/ tumours ratio was 32%in males and 37% in females. Out of 27,632 cancer patients in CR, only 29% had a 048 exemption. Among linked cases, there is a case-mix problem: the exemptions overestimated the weight of some cancer sites (breast, prostate), but underestimate the weight of other sites (stomach, liver, lung) and the burden of tumours in the elderly.The trend estimated from the exemptions underestimates the true incidence of tumours and presents fluctuations, because of local administrative and organisational issues. CONCLUSIONS: the 048 codes are an accessory source for CRs, but when used as single flow they are not able to estimate the true incidence of tumours and, therefore, do not provide useful information on cancer trends.

Differences in diabetes prevalence and inequalities in disease management and glycaemic control by immigrant status: a population-based study (Italy).

BACKGROUND: The diabetes prevalence increases at an alarming rate around the world and understanding disparities in occurrence, care management, and health outcomes may be a starting point towards achieving more effective strategies to prevent and manage it. The aims of this study are to compare immigrants and Italians in terms of the differences in diabetes prevalence and to evaluate inequalities in disease management and glycaemic control by using information included in Reggio Emilia diabetes register. METHODS: We retrieved from the diabetes register subjects aged 20-74 on December 31(st), 2009. Using citizenship, we created three main groups: Italy, High Developed Countries (HDC), and High Migration Pressure Countries (HMPC). These were split into sub-regions of origin. We calculated age-adjusted prevalence by gender and sub-region. Using logistic regression model, we analyzed the association between area of origin and following indicators: 1) not being in care of diabetes clinics; 2) not having glycated haemoglobin (HbA1c) test in 2010; 3) among those tested, having a HbA1c value > = 9% (75 mmol/mol). RESULTS: We found 15,889 Italian and 1,295 HMPC citizens with diabetes. HMPC citizens had higher age-adjusted prevalence of diabetes than Italians (females 5.0% vs 3.6%; males 6.5% vs 5.5%). The excess was mostly due to a strong excess in immigrants from Southern Asia (females 9.7%, males 10.2%) and Northern Africa (females 9.3%, males 5.9%). HMPC citizens were cared for by diabetes clinics in a similar proportion than Italians (OR: 1.08; 95% CI: 0.93-1.25), but had a greater odds of not being tested for HbA1c (OR: 1.51; 95% CI: 1.34-1.71), as well as of having HbA1c values equal to or over 9% (OR: 2.06; 95% CI: 1.80-3.14). The outcomes were poorer in HMPC females for the first two outcomes, while there was no difference for the HbA1c values (Wald test for heterogeneity p = 0.0850; p = 0.0156; p = 0.6635, respectively). CONCLUSIONS: Our findings highlight the need for gender-oriented actions for prevention and early diagnosis of the diabetes to contrast the higher risk in Northern Africans and Southern Asians. Further studies are required to determine whether the protocols in use are adequate for different immigrant groups.