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Marco Finocchietti,1,* Maria Lucia Marino,1,* Alessandro C Rosa,1 Arianna Bellini,1 Lucia Masiero,2 Massimo Cardillo,2 Marco Massari,3 Stefania Spila Alegiani,3 Silvia Pierobon,4 Eliana Ferroni,4 Martina Zanforlini,5 Olivia Leoni,6 Stefano Ledda,7 Donatella Garau,7 Marina Davoli,1 Antonio Addis,1 Valeria Belleudi1 On behalf of CESIT Study Group1Department of Epidemiology, Lazio Regional Health Service-ASL Roma 1, Rome, Italy; 2Italian National Transplant Center, Istituto Superiore di Sanità, Rome, Italy; 3National Center for Drug Research and Evaluation, Istituto Superiore Di Sanità, Rome, Italy; 4Azienda Zero, Veneto Region, Padua, Italy; 5The innovation and procurement regional company, A.R.I.A. S.p.A.-Lombardy Region, Milan, Italy; 6Regional Epidemiological Observatory, Lombardy Region, Milan, Italy; 7General Directorate for Health, Sardinia Region, Cagliari, Italy*These authors contributed equally to this workCorrespondence: Valeria Belleudi, Department of Epidemiology, ASL Roma 1, Lazio Region, Via Cristoforo Colombo, 112, Roma, 00147, Italy, Tel +39.06.99722133, Fax +39.06.99722111, Email v.belleudi@deplazio.itPurpose: This study evaluates the use, benefit-risk profile, and economic impact of generic immunosuppressants (tacrolimus-TAC, cyclosporine-CsA, and mycophenolate-MYC) in kidney and liver transplant recipients compared to brand-name drugs.Patients and Methods: A retrospective multicentre observational study, involving four Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data. The analysis focused on incident patients who received kidney and liver transplants between 2013 and 2019 and evaluated the use of generic of CsA, TAC, and MYC during the 30-day period following discharge. For each type of transplant and immunosuppressive agent, the benefit-risk profile of generic vs branded drugs in a two-year window was estimated by multivariate Cox models (HR; 95% CI). Furthermore, the potential cost savings per person associated with one year of treatment using generics were calculated.Results: The utilization of generic drugs showed a significant increase; over the study years, the proportion of users among kidney recipients ranged from 14.2% to 40.5% for TAC, from 36.9% to 56.7% for MYC, and from 18.2% to 94.7% for CsA. A great variability in generic uptake for region was found. A comparable risk-benefit profile between generic and branded formulations was shown for all immunosuppressors considered. Choosing generic immunosuppressants during maintenance could result in yearly savings of around 2000 euros per person for each therapy ingredient.Conclusion: The study shows an increasing proportion of patients using generic immunosuppressive drugs over time suggesting a growing acceptance of generics within the transplant community and reveals comparable risk-benefit profiles between the generic and branded formulations of TAC, CsA, and MYC. A significant variability in the use of generics immunosuppressive agents was found both at the regional level and among transplant centers and future research should delve into regional prescribing variations.Keywords: transplant, maintenance therapy, tacrolimus, cyclosporine, mycophenolate, uptake generics, risk-benefit profile, sustainability

Anna Maria Bargagli, Silvia Cascini, Nera Agabiti, Ursula Kirchmayer, Claudia Marino, Marina Davoli Department of Epidemiology, Regional Health Service Lazio Region, Rome, ItalyCorrespondence: Silvia CasciniDepartment of Epidemiology, Regional Health Service Lazio Region, Via Cristoforo Colombo, Rome 112 - 00147, ItalyTel +39 06 9972 2130Fax +39 06 9972 2111Email s.cascini@deplazio.itIntroduction: Despite recommendations from associations of geriatric and psychiatry societies and warnings from drug agencies, antipsychotic (AP) drugs are frequently used to control behavioral and psychological symptoms of dementia. APs are associated with a range of potential adverse events, including increased risk of cerebrovascular events and mortality. Evidence suggests limited efficacy of APs for aggression and psychosis. Our objectives were to investigate patterns and predictors for prescription of APs among older adults with dementia residing in a large region of central Italy, and to identify patient characteristics related to typical or atypical APs prescribing.Methods: This is a retrospective population-based cohort study using data from regional health information systems (HIS). We included dementia patients aged ≥65 years residing in the Lazio region. The exposure was defined as new use vs non-use of APs. Dementia patients with incident use of APs during 2015 were followed-up from the date of first prescription to the earliest among discontinuation of use, death, or end of study (December 31, 2016).Results: We enrolled 24,735 dementia patients, 1727 (6.7%) new users and 23,008 non-users of APs. Forty-four percent of AP users were treated for more than 3 months, and among these about 60% received APs continuously for at least 12 months. Individuals using antidepressant or anti-dementia drugs had higher odds of being prescribed with APs (OR: 1.67 and OR: 1.86, respectively). Patients exposed to polypharmacy were less likely to receive APs (OR: 0.82). Cardiovascular risk factors and comorbidities were not associated with APs use. Low socio-economic position was associated with lower odds of atypical AP prescribing (OR: 0.57).Conclusion: The study showed that a not negligible proportion of patients had a period of AP use longer than recommended by guidelines. We identified socio-demographic and clinical factors associated with first use of APs, providing insight into prescribing practices in a community setting and useful information to address areas of potential inappropriateness.Keywords: dementia, antipsychotics, health information systems, older adults

Riccardo Di Domenicantonio,1 Francesco Trotta,1 Silvia Cascini,1 Nera Agabiti,1 Anna Kohn,2 Antonio Gasbarrini,3 Marina Davoli,1 Antonio Addis1 1Department of Epidemiology, Lazio Regional Health Service, Rome, Italy; 2IBD Unit, AO San Camillo Forlanini, Rome, Italy; 3Department of Internal Medicine, Agostino Gemelli University Hospital, Catholic University of Sacred Heart, Rome, Italy Background: The comparison of effectiveness and safety of anti-tumor necrosis factor-alpha agents for the treatment of inflammatory bowel disease (IBD) is relevant for clinical practice and stakeholders. Objective: The objective of this study was to compare the risk of abdominal surgery, steroid utilization, and hospitalization for infection in Crohn’s disease (CD) or ulcerative colitis (UC) patients newly treated with infliximab (IFX) or adalimumab (ADA). Methods: A retrospective population-based cohort study was performed using health information systems data from Lazio region, Italy. Patients with CD or UC diagnosis were enrolled at first prescription of IFX or ADA during 2008–2014 (index date). Only new drug users were followed for 2 years from the index date. IFX versus ADA adjusted hazard ratios were calculated applying “intention-to-treat” approach, controlling for several characteristics and stratifying the analysis on steroid use according to previous drug utilization. Sensitivity analyses were performed according to “as-treated” approach, adjusting for propensity score, censoring at switching or discontinuation, and evaluating different lengths of follow-up periods. Results: We enrolled 1,432 IBD patients (42% and 83% exposed to IFX for CD and UC, respectively). In both diseases, treatment effects did not differ in any outcome considered, and sensitivity analyses confirmed the results from the main analysis. Conclusion: In our population-based cohort study, effectiveness and safety data in new users of ADA or IFX with CD or UC were comparable for the outcomes we tested. Keywords: biologics, real-world effectiveness, inflammatory bowel disease

Female density and distribution are dependent on resource phenology and female availability strongly influences male mating behaviour and success. When a male adopts a 'resource defence' tactic, his reproductive success depends on the location and attractiveness of his territory. Environmental factors associated with territory quality are expected to influence mating success, for example, through territory features or male–male competition. In a protected population of a mountain‐dwelling polygynous herbivore, the Alpine chamois Rupicapra r. rupicapra, we investigated the relationships among mating opportunities, some environmental variables (snow depth, topographic features and size of territories) and male intra‐sexual competition for mating. We recorded the mating behaviour and territory size of 15 GPS‐GSM radio‐tagged territorial males, during five rutting seasons (early November to early December: N = 8 individuals in 2011, N = 9 in 2012, N = 8 in 2015, N = 11 in 2016, N = 7 in 2017; 80% of them were observed for more than one mating season) and related them to snow depth and topography of territories. In ruts with deep snow cover, territorial males had smaller territories and higher number of mating opportunities than in ruts with lower snow cover. Smaller territories showed the highest values of terrain roughness, in turn with little or no snow cover in the mating season, and were visited by a greater number of females, than larger territories. Number of wins was positively influenced by snow depth and negatively related to the frequency of aggressions. The frequency of male–male aggressive interactions was greater during ruts with deep snow cover and for males with territories at higher elevations; additionally, it was negatively related to interactions won. Thus, snow depth, which influences resource distribution and female movements, is confirmed as a strong determinant of male mating opportunities and mating behaviour. [ABSTRACT FROM AUTHOR]

Background: Although sex differences in cardiovascular diseases are recognised, including differences in incidence, clinical presentation, response to treatments, and outcomes, most of the practice guidelines are not sex-specific. Heart failure (HF) is a major public health challenge, with high health care expenditures, high prevalence, and poor clinical outcomes. The objective was to analyse the sex-specific association of socio-demographics, life-style factors and health characteristics with the prevalence of HF and diastolic left ventricular dysfunction (DLVD) in a cross-sectional population-based study.Methods: A random sample of 2001 65-84 year-olds underwent physical examination, laboratory measurements, including N-terminal pro-B-type natriuretic peptide (NT-proBNP), electrocardiography, and echocardiography. We selected the subjects with no missing values in covariates and echocardiographic parameters and performed a complete case analysis. Sex-specific multivariable logistic regression models were used to identify the factors associated with the prevalence of the diseases, multinomial logistic regression was used to investigate the factors associated to asymptomatic and symptomatic LVD, and spline curves to display the relationship between the conditions and both age and NT-proBNP.Results: In 857 men included, there were 66 cases of HF and 408 cases of DLVD (77% not reporting symptoms). In 819 women, there were 51 cases of HF and 382 of DLVD (79% not reporting symptoms). In men, the factors associated with prevalence of HF were age, ischemic heart disease (IHD), and suffering from three or more comorbid conditions. In women, the factors associated with HF were age, lifestyles (smoking and alcohol), BMI, hypertension, and atrial fibrillation. Age and diabetes were associated to asymptomatic DLVD in both genders. NT-proBNP levels were more strongly associated with HF in men than in women.Conclusions: There were sex differences in the factors associated with HF. The results suggest that prevention policies should consider the sex-specific impact on cardiac function of modifiable cardiovascular risk factors. [ABSTRACT FROM AUTHOR]

Objectives. To explore the interaction between surgeon volumes (SVs) and hospital volumes (HVs) on health outcomes. Materials and Methods. We searched MEDLINE, Embase, CINAHL, Web of Science as of May 2017. We included studies investigating the interaction between high or low SVs operating in high or low HVs. Review process follows the PRISMA guidelines. We assessed the methodological quality of the included studies using validated critical appraisal checklists. Results. Sixteen studies were included. Due to the heterogeneity of studies, it was not possible to perform a quantitative analysis. Heath outcome are worse when high SV operating in low HV vs high HV, for the majority of the conditions (colorectal cancer, cystectomy, liver resection, mitral valve surgery, pancreatico-duodenectomy). Results for low SV are better when operating in high HV vs low HV for patients undergoing pancreatic-duodenectomy for mortality, 30 days complications and length of stay. Results for low SV are worse vs high SV when operating in high HV for most considered conditions. Results were in favour of higher SV vs low SV when operating in low HV for digital replantation success after injuries, 30 days mortality and complications after pancreatic-duodenectomy. Conclusion. The available evidence is limited. It is necessary to increase the monitoring of the association between surgeons volumes and hospitals volumes in which they operate, to ensure fairness and accuracy of care for better health outcomes. [ABSTRACT FROM AUTHOR]

Background Polypharmacy in the elderly is a matter of concern, especially regarding adverse events and drug–drug interactions. Little is known about real world drug use in the elderly in Italy. The present study aimed at describing drug use in the elderly with respect to individual characteristics, performing a cross-sectional population study in Lazio, Italy. Methods From the regional health care assistance file, residents aged 65 years and older (mean age = 75.9 years, SD = 7.4) and alive at the end of 2010 were enrolled. Drug consumption was linked from the drug claims registry for 2010, and hospital admissions were retrieved from the hospital admission registry during 2009–2010. Enrolees were characterised for socio-demographic variables, presence of chronic diseases, and drug consumption, considering large groups, and specific sub-groups. Polypharmacy was defined as use of 6+ drugs (ATC 4th level). Results Of the 1,122,864 elderly residents, 57.9% were women, and 48.8% aged 75+. In the previous two years, 28.3% had been admitted to hospital; most common causes were cerebro- and cardiovascular diseases, diabetes and tumours; 78.9% of the elderly population of the city of Rome lived in low-level socio-economic areas. Only 6.8% had not been prescribed drugs in the 12-months observation period, and 58.8% were exposed to polypharmacy. With respect to the overall population, polypharmacy users were more often females (59.7%), older (54.5% aged 75 + ), had poorer health conditions (37.2% hospitalised), and more often lived in poorer areas (19.9%). Conclusion In Lazio, polypharmacy is an important phenomenon in the elderly population. Female gender, older ages and presence of chronic diseases are related to multiple drug use. The present results offer a useful tool for future initiatives aiming at reducing inappropriate polypharmacy and target interventions to subpopulations at higher risk of being exposed to polypharmacy. [ABSTRACT FROM AUTHOR]

AIM: To evaluate the efficacy of naltrexone maintenance treatment in preventing relapse in opioid addicts after detoxification. DESIGN: A systematic review according to the methodology developed by the Cochrane Collaboration based on either randomized controlled trials (RCTs) or controlled clinical trials (CCTs). PARTICIPANTS: Seven hundred and seven heroin dependent in- and out-patients, or former heroin addicts dependent on methadone and participating in a naltrexone treatment programme; 89% were male. INTERVENTION: Maintenance treatments on opiate dependent people after detoxification, comparing naltrexone with placebo, pharmacological or behavioural treatments. MEASUREMENTS: The outcomes considered were successfully completed treatment, opioid use under treatment (re)-incarcerations during the study period, mean duration of treatment. FINDINGS: The outcomes tended to be slightly although not significantly in favour of the naltrexone groups. Use of naltrexone in addition to behavioural treatment significantly decreased the probability of (re-)incarceration (OR=0.30; 95% CI 0.12, 0.76). The difficulties in producing a quantitative analysis were due mainly to the heterogeneity of the included studies. CONCLUSIONS: From the available clinical trials performed up to this time, there is insufficient evidence to justify the use of naltrexone in maintenance treatment of opioid addicts. [ABSTRACT FROM AUTHOR]

A cross-sectional survey was carried out between April 1997 and February 1998 among street prostitutes in Rome. The study population (n = 142) consisted of 102 women and 40 transsexuals: 20% from Western Europe, 38% Eastern Europe, 23% Latin America and 17% Africa. Two-thirds of the population had more than 20 clients during the last week and most respondents (95%) reported always using condoms with clients. Eight per cent of the women and 2% of the transsexuals report a history of injecting drug use. Only 38% of the women with a stable partner reported use of contraceptives and 33% of them had undergone a voluntary abortion during the last year. Only 38% of the women had been checked for STDs during the last year, compared with 80% of the transsexuals. The HIV-prevalence was 6% among the women and 20% among the transsexuals. Four out of the six positive women and one of the positive transsexuals had a history of injecting drug use. Five out of the six HIV-positive women were Italian. Transsexual prostitutes seem to pay more attention to their medical wellbeing compared with females who rarely go for medical check-ups and only a minority uses efficient contraceptive methods. [ABSTRACT FROM AUTHOR]

Background: Multiple Sclerosis (MS) patients might represent a vulnerable population to SARS-CoV-2 infection due to several factors, including the immunosuppressive or immunomodulating disease-modifying therapies (DMT) they use and the young age that expose them to a high number of contacts. This study aimed to estimate incidence of SARS-Cov-2 infection in a cohort of MS patients living in the Lazio region and to identify the risk factors for the infection. Methods: A retrospective cohort study was performed based on regional health administrative databases linked to the new integrated surveillance system of SARS-CoV-2 infection. MS patients residing in Lazio region and aged 18 years on 31 December 2019 were enrolled and followed-up to 31 March 2021. Ageand gender-standardised incidence ratios (SIR) was calculated to compare the infection rate of MS cases with that of the regional general population. A large number of sociodemographic and clinical variables were explored as potential risk factors using a multivariable logistic regression model. Results: In the Lazio region lived 10,248 individuals affected by MS (mean age 49.2]12.9; 32.2% males; 67.8% females). During the follow-up period the overall incidence of SARS-CoV-2 infection was 5.0% (n = 510), 5.2% and 4.8% among males and females, respectively. An overall SIR of 0.92 (95%CI 0.84-1.00) was estimated, and 0.97 (95%CI 0.83-1.12) and 0.89 (95%CI 0.80-0.99) for males and females, respectively. The multivariable logistic regression model identified the use of antidiabetic drugs as unique predictor of SARS-CoV-2 infection (OR = 1.69; 95%CI 1.19-2.40). No association with any DMT was observed. Conclusions: No difference was observed in the incidence of SARS CoV-2 infection in MS patients compared with the general population. DMT does not seem to affect the risk of infection, while the higher incidence in individuals using antidiabetics could reflect the higher prevalence of diabetic population in infected people. Key messages: This study supports previous research suggesting that the incidence of SARS-CoV-2 infection in MS population does not seem to be higher than that in the general population. Disease Modifying Therapy at the moment of infection does not appear to affect the risk of became infected from SARSCoV-2. [ABSTRACT FROM AUTHOR]

Background: In Italy there is evidence of a large variability in health care services and health outcomes. This multi-regional project is funded on Ministry of Health and Health Regional Authorities (code NET-2016-02364191). The aims are: 1) To test the effectiveness of Audit and Feedback (A&F) interventions in improving health professional practices and patients’ outcomes in different settings using both a quantitative and a qualitative approach. 2) To examine factors that may explain variations in the effectiveness of A&F. 3) To evaluate the impact of A&F in reducing avoidable differences in access to effective health care interventions in socioeconomically disadvantaged populations. Methods: In the 7 participating Regions (about 33 million inhabitants) experimental study designs have been implemented in different clinical areas (e.g. before-after controlled study, cluster randomized trial): in Lazio emergency care and chronic diseases care, in Friuli Venezia Giulia emergency care, in Piemonte oncology care, in Emilia Romagna chronic disease care, in Lombardia cardiovascular care, in Calabria deliveries and maternal health, in Sicilia emergency care. The effectiveness of different types of A&F are compared in term of outcomes using health information system databases. Results: Preliminary results show large heterogeneity in developing and conducting A&F, in term of team project composition, type of intervention, clinicians’ behavior to be changed, outcomes indicators, professionals involved, structure and timing of data reporting, actions to be implemented after the intervention. Limited awareness and interest of clinicians in A&F interventions was found. Conclusions: The project represents a unique opportunity to explore how A&F interventions could be better designed. Different A&F strategies will be compared in term of clinical outcomes. The identification of barriers/facilitating factors will supply knowledge on mechanisms and tools to enhance A&F effectiveness. Key messages: The project supports providers in reducing gap between knowledge and practice. The project promotes culture of interprofessional collaboration as a key point for high quality care. [ABSTRACT FROM AUTHOR]

Overdose mortality is the major adverse health effect of drug injection. The potential determinants of overdose death are poorly understood; the aim of this study was to investigate risk factors for overdose mortality among intravenous drug users (IVDU). A cohort of 4200 IVDU attending methadone treatment centres in Rome during the period 1980–1988, was enrolled. Data were collected from clinical records. Vital status and cause of death were ascertained as of 31 December 1988. A matched case-control analysis within the cohort was performed to identify risk factors of death from overdose. All overdose deaths wore included as cases and four controls, matched on year of birth and sex, were selected for each case from among the cohort members still alive at the time of death of the corresponding case. In all, 81 deaths from overdose were identified as cases and compared with 324 controls. A high risk of overdose death occurred among subjects who left treatment compared with those still in treatment (odds ratio (OR]=3.55, 95% confidence interval [CI]; 1.82–6.90). The OR was particularly elevated in the first 12 months after drop-out compared with those retained in treatment (OR=7.98, 95% CI: 3.40–18.73). The risk of overdose death was higher for unmarried compared with married people (OR=2.48, 95% CI: 1.31–4.68); a higher risk of overdose death was also associated with lower educational status and younger age at first drug use, but such association was not statistically significant. Methods to predict drop-out, in order to increase retention in treatment, and strategies to maintain contact with drop outs are warranted to decrease overdose mortality. [ABSTRACT FROM PUBLISHER]

Population groups with a lower socioeconomic status (SES) have a greater risk of disease and mortality. The main objective of this article is to analyze time trends of SES differentials of mortality in Rome from 1900 to 2000. Rome has a population of approximately 2 800 000, according to 1991 census. During the study period 274 537 deaths occurred among residents. Age standardized mortality rates were compared between four SES categories. In the study the inverse association between SES and mortality was confirmed, in each period, for both males and females, a strong positive association between total mortality and low SES existed.