Allocation of Users of Mental Health Services to Needs-Based Care Clusters: An Italian Pilot Study.

In Italy, despite strong community-based mental health services, needs assessment is unsatisfactory. Using the Mental Health Clustering Tool (MHCT) we adopted a multidimensional and non-diagnosis dependent approach to assign mental health services users with similar needs to groups corresponding to resources required for effective care. We tested the MHCT in nine Departments of Mental Health in four Italian regions. After a brief training, 318 professionals assessed 12,938 cases with a diagnosis of schizophrenia, depression, bipolar disorder and personality disorder through the MHCT. 53% of cases were 40-59 years, half were females, 51% had a diagnosis of schizophrenia, 48% of cases were clinically severe. Clusters included different levels of clinical severity and diagnostic groups. The largest cluster was 11 (ongoing recurrent psychosis), with 18.9% of the sample, followed by cluster 3 (non-psychotic disorders of moderate severity). The MHCT could capture a variety of problems of people with mental disorders beyond the traditional psychiatric assessment, therefore depicting service population from a different standpoint. Following a brief training, MHCT assessment proved to be feasible. The automatic allocation of cases made the attribution to clusters easy and acceptable by professionals. To what extent clustering provide a sound base for care planning will be the matter of further research.

Assessing the quality of the care offer for people with personality disorders in Italy: the QUADIM project. A multicentre research based on the database of use of Mental Health services.

BACKGROUND: Italy can be viewed as a laboratory to assess the quality of mental healthcare delivered in a community-oriented system, especially for severe mental disorders, such as personality disorders. Although initiatives based on clinical indicators for assessing the quality of mental healthcare have been developed by transnational-organisations, there is still no widespread practice of measuring the quality of care pathways delivered to patients with severe mental disorders in a community-oriented system, especially using administrative healthcare databases. The aim of the study is to evaluate the quality of care delivered to patients with personality disorders taken-in-care by mental health services of four Italian regions (Lombardy, Emilia-Romagna, Lazio, Sicily). METHODS: A set of thirty-three clinical indicators, concerning accessibility, appropriateness, continuity, and safety of care, was implemented using regional healthcare utilization databases, containing data on mental health treatments and diagnosis, hospital admissions, outpatient interventions and exams and drug prescriptions. RESULTS: 31,688 prevalent patients with personality disorders treated in 2015 were identified, of whom 2,331 newly taken-in-care. One-in-10 patients received a standardized assessment, the treatment discontinuity affected half of the cases. 12.7% of prevalent patients received at least one hospitalization, 10.6% in the newly taken-in-care cohort. 6-out-of-10 patients had contact with community-services within 14 days from hospital discharge. Access to psychotherapy and psychoeducational treatments was low and delivered with a low intensity. The median of psychosocial interventions per person-year was 19.1 and 9.4, respectively, in prevalent and newly taken-in-care cases. Nearly 50% of patients received pharmacological treatments. CONCLUSIONS: Healthcare utilization databases were used to systematically evaluate and assess service delivery across regional mental health systems; suggesting that in Italy the public mental health services provide to individuals with personality disorders suboptimal treatment paths.

Using big data and Population Health Management to assess care and costs for patients with severe mental disorders and move toward a value-based payment system.

BACKGROUND: Mental health (MH) care often exhibits uneven quality and poor coordination of physical and MH needs, especially for patients with severe mental disorders. This study tests a Population Health Management (PHM) approach to identify patients with severe mental disorders using administrative health databases in Italy and evaluate, manage and monitor care pathways and costs. A second objective explores the feasibility of changing the payment system from fee-for-service to a value-based system (e.g., increased care integration, bundled payments) to introduce performance measures and guide improvement in outcomes. METHODS: Since diagnosis alone may poorly predict condition severity and needs, we conducted a retrospective observational study on a 9,019-patient cohort assessed in 2018 (30.5% of 29,570 patients with SMDs from three Italian regions) using the Mental Health Clustering Tool (MHCT), developed in the United Kingdom, to stratify patients according to severity and needs, providing a basis for payment for episode of care. Patients were linked (blinded) with retrospective (2014-2017) physical and MH databases to map resource use, care pathways, and assess costs globally and by cluster. Two regions (3,525 patients) provided data for generalized linear model regression to explore determinants of cost variation among clusters and regions. RESULTS: Substantial heterogeneity was observed in care organization, resource use and costs across and within 3 Italian regions and 20 clusters. Annual mean costs per patient across regions was €3,925, ranging from €3,101 to €6,501 in the three regions. Some 70% of total costs were for MH services and medications, 37% incurred in dedicated mental health facilities, 33% for MH services and medications noted in physical healthcare databases, and 30% for other conditions. Regression analysis showed comorbidities, resident psychiatric services, and consumption noted in physical health databases have considerable impact on total costs. CONCLUSIONS: The current MH care system in Italy lacks evidence of coordination of physical and mental health and matching services to patient needs, with high variation between regions. Using available assessment tools and administrative data, implementation of an episodic approach to funding MH could account for differences in disease phase and physical health for patients with SMDs and introduce performance measurement to improve outcomes and provide oversight.

Time-Trends in Air Pollution Impact on Health in Italy, 1990-2019: An Analysis From the Global Burden of Disease Study 2019.

Objectives: We explored temporal variations in disease burden of ambient particulate matter 2.5 µm or less in diameter (PM2.5) and ozone in Italy using estimates from the Global Burden of Disease Study 2019. Methods: We compared temporal changes and percent variations (95% Uncertainty Intervals [95% UI]) in rates of disability adjusted life years (DALYs), years of life lost, years lived with disability and mortality from 1990 to 2019, and variations in pollutant-attributable burden with those in the overall burden of each PM2.5- and ozone-related disease. Results: In 2019, 467,000 DALYs (95% UI: 371,000, 570,000) were attributable to PM2.5 and 39,600 (95% UI: 18,300, 61,500) to ozone. The crude DALY rate attributable to PM2.5 decreased by 47.9% (95% UI: 10.3, 65.4) from 1990 to 2019. For ozone, it declined by 37.0% (95% UI: 28.9, 44.5) during 1990-2010, but it increased by 44.8% (95% UI: 35.5, 56.3) during 2010-2019. Age-standardized rates declined more than crude ones. Conclusion: In Italy, the burden of ambient PM2.5 (but not of ozone) significantly decreased, even in concurrence with population ageing. Results suggest a positive impact of air quality regulations, fostering further regulatory efforts.

Assessment and Monitoring of the Quality of Clinical Pathways in Patients with Depressive Disorders: Results from a Multiregional Italian Investigation on Mental Health Care Quality (the QUADIM Project).

Ensuring adequate quality of care to patients with severe mental disorders remains a challenge. The implementation of clinical indicators aimed at assessing the quality of health care pathways delivered is crucial for the improvement of mental health services (MHS). This study aims to evaluate the quality of care delivered to patients who are taken-into-care with depressive disorders by MHS. Thirty-four clinical indicators concerning accessibility, appropriateness, continuity, and safety were estimated using health care utilization databases from four Italian regions (Lombardy, Emilia-Romagna, Lazio, Sicily). A total of 78,924 prevalent patients treated for depressive disorders in 2015 were identified, of whom 15,234 were newly engaged by MHS. During the year of follow-up, access to psychotherapeutic interventions was low, while the intensity was adequate; 5.1% of prevalent patients received at least one hospitalization in a psychiatric ward (GHPW), and 3.3% in the cohort of newly engaged in services. Five-out-of-10 patients had contact with community services within 14 days after GHPW discharge, but less than half of patients were persistent to antidepressant drug therapy. Furthermore, prevalent patients showed an excess of mortality compared to the general population (SMR = 1.35; IC 95%: 1.26-1.44). In conclusion, the quality of health care is not delivered in accordance with evidence-based mental health standards. Evaluation of health interventions are fundamental strategies for improving the quality and equity of health care.

Bortezomib-based therapy in non-transplant multiple myeloma patients: a retrospective cohort study from the FABIO project.

INTRODUCTION: Randomized clinical trials showed that bortezomib, in addition to conventional chemotherapy, improves survival and disease progression in multiple myeloma (MM) patients not eligible for stem cell transplantation. The aim of this retrospective population-based cohort study is the evaluation of both clinical and economic profile of bortezomib-based versus conventional chemotherapy in daily clinical practice. METHODS: Healthcare utilization databases of six Italian regions were used to identify adult patients with non-transplant MM, who started a first-line therapy with bortezomib-based or conventional chemotherapy. Patients were matched by propensity score and were followed from treatment start until death, lost to follow-up or study end-point. Overall survival (OS) and restricted mean survival time (RMST) were estimated using the Kaplan-Meier method. Association between first-line treatment and risk of death was estimated by a conditional Cox proportional regression model. Average mean cumulative costs were estimated and compared between groups. RESULTS: In the period 2010-2016, 3509 non-transplant MM patients met the inclusion criteria, of which 1157 treated with bortezomib-based therapy were matched to 1826 treated with conventional chemotherapy. Median OS and RMST were 33.9 and 27.9 months, and 42.9 and 38.4 months, respectively, in the two treatment arms. Overall, these values corresponded to a HR of death of 0.79 (95% CI 0.71-0.89) over a time horizon of 84 months. Average cumulative cost were 83,839 € and 54,499 €, respectively, corresponding to an incremental cost-effectiveness ratio of 54,333 € per year of life gained, a cost coherent with the willingness-to-pay thresholds frequently adopted from Western countries. CONCLUSIONS: These data suggested that, in a large cohort of non-transplant MM patients treated outside the experimental setting, first-line treatment with bortezomib-based therapy was associated with a favourable effectiveness and cost-effectiveness profile.

Direct healthcare costs of chronic kidney disease management in Italy: What cost-savings can be achieved with higher biosimilar uptake and more appropriate use of erythropoiesis-stimulating agents?

PURPOSE: Erythropoiesis-stimulating agents (ESAs), are used for treating chronic kidney disease (CKD)-related anemia, contributing to CKD costs. The study was aimed at investigating direct healthcare costs of CKD patients treated with ESAs and the potential savings achievable by increasing the use of biosimilars and preventing inappropriate ESA use. METHODS: A multi-center, cohort study was conducted using claims databases of five large Italian geographic areas. Yearly mean direct healthcare costs per patient were estimated, stratifying by CKD stage. The total yearly cost and potential savings related to ESA use were estimated: (a) considering 25/50/75% of originator ESA substitution with biosimilars; (b) eliminating inappropriate ESA dispensing. RESULTS: During the study period, the ESA-related yearly mean cost represented 17% of total yearly costs in stage I-III, decreasing to 13% in stage IV-V and 6% in dialysis. Among originator users, assuming a 25% of biosimilar uptake, the annual cost-savings of ESA treatment would represent 10.5% of total ESA costs in CKD stage I-V and 7.7% in dialysis. Among incident ESA users for which hemoglobin levels were available, 9% started inappropriately ESA treatment, increasing to 62.0% during the first year of maintenance therapy. Hypothesizing prevention of the first inappropriate ESA dispensing, the total yearly cost-savings would amount to €35 772, increasing to €167 641 eliminating the inappropriate dispensing during maintenance therapy. CONCLUSIONS: Higher use of lowest cost ESA, prevention of inappropriate ESA use as well as other strategies aimed at slowing down the progressive renal impairment are essential for minimizing clinical and economic burden of CKD.

Gender differences in COPD management in a Sicilian general practice setting: a cohort study evaluating the impact of educational interventions.

AIM: The aim of this study was to measure gender differences among COPD patients' quality of care (QOC) before and after two educational interventions in Southern Italy. METHODS: In this prospective cohort study, COPD patients were identified from primary care electronic medical records (EMRs). Twelve process indicators concerning diagnosis, preventative measures and therapeutic processes were developed as a measure of QOC. Educational interventions consisted of clinical seminars and audits on COPD QOC at baseline, and at 12 and 24 months. QOC indicators were stratified by gender: odds ratios (ORs) (males as reference group) of having a good QOC indicator were calculated at baseline, 12 and 24 months, with 95% confidence intervals (CIs) using hierarchical generalised linear models. RESULTS: Of 46 326 people registered in the EMRs, 1463 COPD patients (3.1%) were identified, of which 37% were women. QOC indicators reflecting best practice 24 months after the educational programme were generally not different to baseline, often favouring men. On the other hand, the composite global QOC indicator suggested that while a good overall QOC at baseline was significantly higher in men than women (OR: 0.74; 95% CI: 0.57-0.96), it became nonsignificant at 24 months (OR: 0.96; 95% CI: 0.72-1.29). CONCLUSIONS: Specific QOC indicators among COPD patients often favoured men. However, several gender disparities seen at baseline disappeared at 24 months, suggesting that even general educational interventions which do not target gender can improve the gender disparity in QOC.

Measuring multimorbidity inequality across Italy through the multisource comorbidity score: a nationwide study.

BACKGROUND: Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. A simple multisource comorbidity score (MCS) has been recently developed and validated. A very large real-world investigation was conducted with the aim of measuring inequalities in the MCS distribution across Italy. METHODS: Beneficiaries of the Italian National Health Service aged 50-85 years who in 2018 were resident in one of the 10 participant regions formed the study population (15.7 million of the 24.9 million overall resident in Italy). MCS was assigned to each beneficiary by categorizing the individual sum of the comorbid values (i.e. the weights corresponding to the comorbid conditions of which the individual suffered) into one of the six categories denoting a progressive worsening comorbidity status. MCS distributions in women and men across geographic partitions were compared. RESULTS: Compared with beneficiaries from northern Italy, those from centre and south showed worse comorbidity profile for both women and men. MCS median age (i.e. the age above which half of the beneficiaries suffered at least one comorbidity) ranged from 60 (centre and south) to 68 years (north) in women and from 63 (centre and south) to 68 years (north) in men. The percentage of comorbid population was lower than 50% for northern population, whereas it was around 60% for central and southern ones. CONCLUSION: MCS allowed of capturing geographic variability of multimorbidity prevalence, thus showing up its value for addressing health policy in order to guide national health planning.

Effectiveness and Costs Associated to Adding Cetuximab or Bevacizumab to Chemotherapy as Initial Treatment in Metastatic Colorectal Cancer: Results from the Observational FABIO Project.

Evidence available on the effectiveness and costs of biological therapies for the initial treatment of metastatic colorectal cancer (mCRC) is scarce and contrasting. We conducted a population-based cohort investigation for assessing overall survival and costs associated with their use in a real-world setting. Healthcare utilization databases were used to select patients newly diagnosed with mCRC between 2010 and 2016. Those initially treated with biological therapy (bevacizumab or cetuximab) added to chemotherapy were propensity-score-matched to those treated with standard chemotherapy alone, and were followed up to June 30th, 2018. Kaplan-Meier survival estimates, restricted mean survival time (RMST) and cumulative costs were compared between the two treatment arms. The study cohort included 1896 mCRC patients treated with biological therapy matched to 5678 patients treated with chemotherapy alone. Median overall survival was 21.8 and 20.2 months, respectively. After 84 months of follow-up, RMSTs were 30.9 and 31.9 months (p = 0.193), indicating no differences between the average survival time between treatment arms. Patients treated with biological therapy were associated with higher costs. Cumulative per capita costs were €59,663 and €44,399, respectively. In our study, first-line biological therapy did not improve long-term overall survival and was associated with higher costs as compared to standard chemotherapy.

[Rt or RDt, that is the question!] / Rt or RDt, that is the question!

The article compares two of the most followed indices in the monitoring of COVID-19 epidemic cases: the Rt and the RDt indices. The first was disseminated by the Italian National Institute of Health (ISS) and the second, which is more usable due to the lower difficulty of calculation and the availability of data, was adopted by various regional and local institutions.The rationale for the Rt index refers to that for the R0 index, the basic reproduction number, which is used by infectivologists as a measure of contagiousness of a given infectious agent in a completely susceptible population. The RDt index, on the other hand, is borrowed from the techniques of time series analysis for the trend of an event measurement that develops as a function of time. The RDt index does not take into account the time of infection, but the date of the diagnosis of positivity and for this reason it is defined as diagnostic replication index, as it aims to describe the intensity of the development of frequency for cases recognized as positive in the population.The comparison between different possible applications of the methods and the use of different types of monitoring data was limited to four areas for which complete individual data were available in March and April 2020. The main problems in the use of Rt, which is based on the date of symptoms onset, arise from the lack of completeness of this information due both to the difficulty in the recording and to the absence in asymptomatic subjects.The general trend of RDt, at least at an intermediate lag of 6 or 7 days, is very similar to that of Rt, as confirmed by the very high value of the correlation index between the two indices. The maximum correlation between Rt and RDt is reached at lag 7 with a value of R exceeding 0.97 (R2=0.944).The two indices, albeit formally distinct, are both valid; they show specific aspects of the phenomenon, but provide basically similar information to the public health decision-maker. Their distinction lies not so much in the method of calculation, rather in the use of different information, i.e., the beginning of symptoms and the swabs outcome.Therefore, it is not appropriate to make a judgment of preference for one of the two indices, but only to invite people to understand their different potentials so that they can choose the one they consider the most appropriate for the purpose they want to use it for.

[A regional equity profile to assess the impact of social inequalities on determinants and health outcomes in the population residing in Sicily Region (Southern Italy)]. / Un profilo di equità regionale per la valutazione dell'impatto delle disuguaglianze sociali sui determinanti e sugli esiti di salute nella popolazione residente in Sicilia.

OBJECTIVES: to build an equity profile for assessing the impact of socioeconomic inequalities on the determinants and health outcome in Sicily (Southern Italy). DESIGN: descriptive study aimed to define an equity profile in Sicily by using a rich list of indicators of structure of the resident population and of distribution of determinants and health outcome, derived from the integration of available information and scientific evidence at regional level with high local detail. SETTING AND PARTICIPANTS: the equity profile collects available information on the health status of the population in Sicily, on the determinants, and on the use of health and social services. The characteristics of people or population groups have been explored and can produce inequalities on health which included individual and context socioeconomic status. MAIN OUTCOME MEASURES: using available information sources and study results have explored the effects of the disadvantage on health in the region: mortality, morbidity, oncological incidence, reproductive health, and some of their determinants. RESULTS: the Sicilian population tends to aging. Migration flows tend to compensate the reduction in births in Sicily and it increases the proportion of younger people and women in childbearing age. The proportion of large families tends to get smaller, whereas the proportion of single-component ones increases; the population groups with low education, unemployment, poverty, and income increases. Starting from the first thousand days of life, to continue in the other classes of the population, the different distribution of risk factors on health was identified according to different levels of deprivation. CONCLUSIONS: the Sicilian equity profile has systematized and consolidated previous experiences on the effects of disadvantage on health. Prevention interventions, oriented towards equity, should be based on the results of this study and should take care of the general aspects of actions and, at the same time, focus on vulnerable population groups.

[Evaluating health care of the immigrant population in Italy through indicators of a national monitoring system]. / Valutazione dell'assistenza sanitaria della popolazione immigrata in Italia attraverso alcuni indicatori di un sistema nazionale di monitoraggio.

OBJECTIVES: to evaluate maternal and child healthcare, avoidable hospitalisation, access to emergency services among immigrants in Italy. DESIGN: cross sectional study of some health and health care indicators among Italian and foreign population residing in Italy in 2016-2017. SETTING AND PARTICIPANTS: indicators based on the national monitoring system coordinated by the Italian National Institute for Health, Migration and Poverty (INMP) of Rome, calculated on perinatal care (CedAP), hospital discharge (SDO), emergency services (EMUR) archives for the years 2016-2017, by of the following regions: Piedmont, Trento, Bolzano, Emilia-Romagna, Tuscany, Umbria, Lazio, Basilicata, Sicily. MAIN OUTCOME MEASURES: number and timeliness of pregnancy visits, number of ultrasounds, invasive prenatal investigations; perinatal mortality rates, birth weight, Apgar score at 5 minutes, need for neonatal resuscitation; standardized rates of avoidable hospitalisation and access to emergency services by triage code. RESULTS: more often than Italians, immigrant women have during pregnancy: less than 5 gynaecological examination (16.3% vs 8.5%), first examination after the 12th week of gestational age (12.5% vs 3.8%), less than 2 ultrasounds (3.8% vs 1.0%). Higher perinatal mortality rates among immigrants compared to Italians (3.6 vs 2.3 x1,000). Higher standardized rates (x1,000) among immigrants compared to Italians of avoidable hospitalisation (men: 2.1 vs 1.4; women: 0.9 vs 0.7) and of white triage codes in emergency (men: 62.0 vs 32.7; women: 52.9 vs 31.4). CONCLUSIONS: study findings show differences in access and outcomes of healthcare between Italians and immigrants. National monitoring system of indicators, coordinated by INMP, represents a useful tool for healthcare intervention policies aimed to health equity.

Association of the Individual and Context Inequalities on the Breastfeeding: A Study from the Sicily Region.

Despite the advantages of breastfeeding being widely recognized, the economic level can have an influence on breastfeeding rates, with rich women breastfeeding longer than poor in high-income countries. In Italy, socio-economic differences affect breastfeeding start and continuation among most deprived people, such as in Southern Italy. The objective of the study was to evaluate the prevalence of the initiation and continuation of exclusive breastfeeding and its association with the levels of socio-economic deprivation in Sicily. A prospective cohort study with a two-phase survey in three breastfeeding detection times was conducted. Overall, 1,055 mothers were recruited with a mean age of 31 years. Breastfeeding decreased from 86% during hospitalization to 69% at the first month and 42% at the sixth month, yet at the same time, exclusive breastfeeding increased from 34% to 38% during hospitalization to the first month and went down to 20.2% at the sixth month. The adjusted multivariate analysis showed no association with individual inequalities. On the other hand, the context inequalities had a significant association with the risk of not following exclusive breastfeeding in the deprived class (odds ratio (OR): 2.08, confidence interval (CI) 95% 1.01-4.27) and in the very deprived class (OR: 1.83, CI 95% 1.00-3.38) at the six-month survey. These results indicate that the context inequalities begin to emerge from the return home of the mother and the child.

[Breastfeeding in Sicily Region (Southern Italy): analysis of prevalence, of contextual inequalities, and of other associated risk factors]. / Allattamento al seno in Sicilia: analisi della prevalenza, delle disuguaglianze di contesto e di altri fattori di rischio associati.

OBJECTIVES: to describe the prevalence of breastfeeding in Sicily Region (Southern Italy) and to analyze the socioeconomic status and other major risk factors on the attitudes towards exclusive breastfeeding. DESIGN: information on the practice of breastfeeding in Sicily have been collected from a Regional survey on Sudden Infant Death Syndrome (SIDS). An index of socioeconomic position was created by using data from the 2011 Census of the Italian National Institute of Statistics. SETTING AND PARTICIPANTS: in May 2015, a questionnaire was distributed to all mothers accessing to immunization services in Sicily for the first vaccination of their children. Two hundred seventy-three (273) vaccination centres have been involved, and 2,692 questionnaires were administered. MAIN OUTCOME MEASURES: five socio-economic levels were identified and, for each of them, the prevalence of breastfeeding and the risk factors for nonadherence to exclusive breastfeeding were described. RESULTS: the prevalence of exclusive breastfeeding was 30.6%, unevenly distributed in the region, being the lowest in the Province of Messina (21.4%). Nonadherence to exclusive breastfeeding was associated with the disadvantage of the low context culture (χ2: 14.9), and was more common in the areas with higher socioeconomic deprivation index (odds ratio - OR: 1.81). Among other determinants investigated, being premature was a risk factor for not being breastfed (OR: 1.59). CONCLUSION: the study confirms a low prevalence of breastfeeding in Sicily and its association with the socioeconomic level, being lower among women living in higher disadvantage areas. Moreover, this study confirms the association with co-sleeping practices (rooming-in and bed-sharing) for preterm babies. However, mother-child bed-sharing is not a guarantee for a successful breastfeeding, indeed being associated with a higher risk of SIDS. Finally, the study suggests the need for appropriate interventions focusing on specific high-risk groups.

Developing and validating a novel multisource comorbidity score from administrative data: a large population-based cohort study from Italy.

OBJECTIVE: To develop and validate a novel comorbidity score (multisource comorbidity score (MCS)) predictive of mortality, hospital admissions and healthcare costs using multiple source information from the administrative Italian National Health System (NHS) databases. METHODS: An index of 34 variables (measured from inpatient diagnoses and outpatient drug prescriptions within 2 years before baseline) independently predicting 1-year mortality in a sample of 500 000 individuals aged 50 years or older randomly selected from the NHS beneficiaries of the Italian region of Lombardy (training set) was developed. The corresponding weights were assigned from the regression coefficients of a Weibull survival model. MCS performance was evaluated by using an internal (ie, another sample of 500 000 NHS beneficiaries from Lombardy) and three external (each consisting of 500 000 NHS beneficiaries from Emilia-Romagna, Lazio and Sicily) validation sets. Discriminant power and net reclassification improvement were used to compare MCS performance with that of other comorbidity scores. MCS ability to predict secondary health outcomes (ie, hospital admissions and costs) was also investigated. RESULTS: Primary and secondary outcomes progressively increased with increasing MCS value. MCS improved the net 1-year mortality reclassification from 27% (with respect to the Chronic Disease Score) to 69% (with respect to the Elixhauser Index). MCS discrimination performance was similar in the four regions of Italy we tested, the area under the receiver operating characteristic curves (95% CI) being 0.78 (0.77 to 0.79) in Lombardy, 0.78 (0.77 to 0.79) in Emilia-Romagna, 0.77 (0.76 to 0.78) in Lazio and 0.78 (0.77 to 0.79) in Sicily. CONCLUSION: MCS seems better than conventional scores for predicting health outcomes, at least in the general population from Italy. This may offer an improved tool for risk adjustment, policy planning and identifying patients in need of a focused treatment approach in the everyday medical practice.

[Transcatheter aortic valve implantation versus aortic valve replacement: cost analysis from the regional health service and hospital perspectives]. / I costi di ricovero e follow-up delle procedure di sostituzione valvolare aortica per via percutanea e cardiochirurgica a confronto: analisi secondo le prospettive del Sistema Sanitario Regionale e dell'Ospedale.

BACKGROUND: The aim of this study was to estimate the cost of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) procedures, together with the cost of the first-year hospitalizations following the index ones, in 4 Italian regions where diffusion level of TAVI and coverage decisions are different. METHODS: The cost analysis was performed evaluating 372 patients enrolled consecutively from December 1, 2012 to September 30, 2015. The index hospitalization cost was calculated both from the hospital perspective through a full-costing approach and from the regional healthcare service perspective by applying the regional reimbursement tariffs. The follow-up costs were calculated for one year after the index hospitalization, from the regional healthcare sservice perspective, through the identification of hospital admissions for cardiovascular pathologies after the index hospitalization and computation of the relative regional tariffs. RESULTS: The mean hospitalization cost was € 32 120 for transfemoral TAVI (232 procedures), € 35 958 for transapical TAVI (31 procedures) and € 17 441 for AVR (109 procedures). From the regional healthcare service perspective, the mean transfemoral TAVI cost was € 29 989, with relevant regional variability (range from € 19 987 to € 36 979); the mean transapical TAVI cost was € 39 148; the mean AVR cost was € 32 020. The mean follow-up costs were € 2294 for transfemoral TAVI, € 2335 for transapical TAVI, and € 2601 for AVR. CONCLUSIONS: In our study, transapical TAVI resulted more expensive than transfemoral TAVI, while surgical AVR was cheaper than both (less than 40%). Costs of the transfemoral approach showed great variability between participating regions, probably due to different hospital costs, logistics, patients' selection and reimbursement policy. A central level of control would be appropriate to avoid unjustified differences in access to innovative procedures between different Italian regions.

Development of Guidelines for Health Impact Assessment in Southern Italy.

Health impact assessment (HIA) is a multidisciplinary method aimed at assessing the health effects of policies, plans, and projects using quantitative, qualitative, and participatory techniques. In many European countries, such as in Italy, there is a lack of implementation of HIA procedures and it would be necessary to develop instruments and protocols in order to improve the specific skills of professionals involved in the assessment process. This article aims to describe the development and implementation of HIA guidelines, promoted by the Italian National Agency for Regional Health Services (AGENAS), in 4 Southern Italian regions. Public health search engine and institutional Web sites were consulted to collect international data existing in this field. Monthly workshops were then organized with regional representatives to discuss the scientific literature and to identify the guidelines' contents: source of data, stakeholders, screening- and scoping-phase checklist tools, priority areas, monitoring, and reporting plans. Four regions (Calabria, Campania, Puglia, and Sicilia) took part in the project. This article describes the methodology of development and implementation of HIA guidelines in the Italian context. The tools created to collect data and assess health consequences (such as screening and scoping grids) are reported. This project represents the first structured initiative proposed and supported by the Ministry of Health aiming to introduce HIA in Italy. HIA should be considered a priority in the public health agenda, as a fundamental instrument in helping decision makers to make choices about alternatives to prevent disease/injury and to actively promote health.

How Much Are Biosimilars Used in Clinical Practice? A Retrospective Italian Population-Based Study of Erythropoiesis-Stimulating Agents in the Years 2009-2013.

PURPOSE: To explore the prescription patterns of erythropoiesis-stimulating agents (ESAs) in four large Italian geographic areas, where different health policy interventions to promote biosimilar use in routine care are undertaken. METHODS: A retrospective drug utilization study was conducted during the years 2009-2013. The data sources were the administrative databases of the Tuscany region and of the Caserta, Palermo, and Treviso Local Health Units (LHUs). The characteristics, prevalence, and switching patterns of different ESAs (biosimilars and reference products), stratified by indication for use, were calculated over time and across centers. RESULTS: Overall, 49,491 patients were treated with ESAs during the years 2009-2013 in the four centers. Of these, 41,286 patients (83.4 %) were naive users. The prevalence of ESA use increased from 2.9 to 3.4 per 1000 inhabitants in the years 2009-2011 but decreased thereafter (3.0 per 1000 in 2013). Moreover, the proportion of biosimilar users increased overall from 1.8 % in 2010 to 33.6 % in 2013, with larger increase in Treviso (from 0.0 to 45.0 %) and Tuscany (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). Switching between different ESAs during the first year of therapy was frequent (17.0 %), much more toward reference products than toward biosimilars. CONCLUSION: Overall, the prevalence of ESA use decreased slightly, while use of biosimilar ESAs, especially in naive patients, increased significantly but to different extents in these four large Italian geographic areas. Switching between different ESAs during the first year of treatment was very frequent, which may affect pharmacovigilance monitoring. New strategies are necessary to further improve market penetration of low-cost medicines, such as biosimilars, and also to harmonize effective health policy interventions that aim to reduce pharmaceutical expenses and optimize patient benefit across all regions.

[Health impact assessment of policies for municipal solid waste management: findings of the SESPIR Project]. / Impatto sulla salute delle politiche di gestione dei rifiuti solidi urbani: i risultati del Progetto SESPIR.

The SESPIR Project (Epidemiological Surveillance of Health Status of Resident Population Around the Waste Treatment Plants) assessed the impact on health of residents nearby incinerators, landfills and mechanical biological treatment plants in five Italian regions (Emilia-Romagna, Piedmont, Lazio, Campania, and Sicily). The assessment procedure took into account the available knowledge on health effects of waste disposal facilities. Analyses were related to three different scenarios: a Baseline scenario, referred to plants active in 2008-2009; the regional future scenario, with plants expected in the waste regional plans; a virtuous scenario (Green 2020), based on a policy management of municipal solid waste (MSW) through the reduction of production and an intense recovery policy. Facing with a total population of around 24 million for the 5 regions, the residents nearby the plants were more than 380,000 people at Baseline. Such a population is reduced to approximately 330.000 inhabitants and 170.000 inhabitants in the regional and Green 2020 scenarios, respectively. The health impact was assessed for the period 2008-2040. At Baseline, 1-2 cases per year of cancer attributable to MSW plants were estimated, as well as 26 cases per year of adverse pregnancy outcomes (including low birth weight and birth defects), 102 persons with respiratory symptoms, and about a thousand affected from annoyance caused by odours. These annual estimates are translated into 2,725 years of life with disability (DALYs) estimated for the entire period. The DALYs are reduced by approximately 20% and 80% in the two future scenarios. Even in these cases, health impact is given by the greater effects on pregnancy and the annoyance associated with the odours of plants. In spite of the limitations due to the inevitable assumptions required by the present exercise, the proposed methodology is suitable for a first approach to assess different policies that can be adopted in regional planning in the field of waste management. The greatest reduction in health impact is achieved with a virtuous policy of reducing waste production and a significant increase in the collection and recycling of waste.