Search

Private or public developers, including local authorities and government agencies, have limited operational guidance to include case-relevant health information in environmental reports. In Italy, the absence of technical indications prompted the Ministry of Health to construct a new model of Health Impact Assessment (HIA) for health integration in Environmental Assessment (EA) processes. A coordinating committee set within an inter-institutional working group was assisted by public and private key stakeholders to deliver guidance on HIA. The three research stages of framing, production and delivery were carried out to: (1) frame the context for HIA guidance implementation; (2) produce the operational guideline and tools; (3) train and disclose the guideline to final users. The guideline and the operational procedures were informed by core criteria to achieve a health standard in environmental reporting. The procedures guide the user to carry out a comprehensive assessment of the population health based on the broad determinants. The environmental reporting integrates health through functional components, divided into levels and supported by related flowcharts and checklists. HIA knowledge and skills were provided to facilitate the guideline utilization within the health departments. The guideline embedded the existing EA national legacy, normative and technical. The entire decisional cycle, from strategic planning to project development was covered in the guideline including the screen of proposals. The experience triggered the definition of an environmental health collaborative platform under the Ministry of Health coordination to fill gaps in competence building, sector operational tools development, methodologies harmonization on the national territory.

Background The real impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on overall mortality remains uncertain as surveillance reports have attributed a limited number of deaths to novel coronavirus disease 2019 (COVID-19) during the outbreak. The aim of this study was to assess the excess mortality during the COVID-19 outbreak in highly impacted areas of northern Italy. Methods We analysed data on deaths that occurred in the first 4 months of 2020 provided by the health protection agencies (HPAs) of Bergamo and Brescia (Lombardy), building a time-series of daily number of deaths and predicting the daily standardised mortality ratio (SMR) and cumulative number of excess deaths through a Poisson generalised additive model of the observed counts in 2020, using 2019 data as a reference.Results We estimated that there were 5740 (95% credible set (CS) 5552–5936) excess deaths in the HPA of Bergamo and 3703 (95% CS 3535–3877) in Brescia, corresponding to a 2.55-fold (95% CS 2.50–2.61) and 1.93 (95% CS 1.89–1.98) increase in the number of deaths. The excess death wave started a few days later in Brescia, but the daily estimated SMR peaked at the end of March in both HPAs, roughly 2 weeks after the introduction of lockdown measures, with significantly higher estimates in Bergamo (9.4, 95% CI 9.1–9.7). Conclusion Excess mortality was significantly higher than that officially attributed to COVID-19, disclosing its hidden burden likely due to indirect effects on the health system. Time-series analyses highlighted the impact of lockdown restrictions, with a lower excess mortality in the HPA where there was a smaller delay between the epidemic outbreak and their enforcement.

Background: The real impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on overall mortality remains uncertain as surveillance reports have attributed a limited number of deaths to novel coronavirus disease 2019 (COVID-19) during the outbreak. The aim of this study was to assess the excess mortality during the COVID-19 outbreak in highly impacted areas of northern Italy. Methods: We analysed data on deaths that occurred in the first 4 months of 2020 provided by the health protection agencies (HPAs) of Bergamo and Brescia (Lombardy), building a time-series of daily number of deaths and predicting the daily standardised mortality ratio (SMR) and cumulative number of excess deaths through a Poisson generalised additive model of the observed counts in 2020, using 2019 data as a reference. Results: We estimated that there were 5740 (95% credible set (CS) 5552–5936) excess deaths in the HPA of Bergamo and 3703 (95% CS 3535–3877) in Brescia, corresponding to a 2.55-fold (95% CS 2.50–2.61) and 1.93 (95% CS 1.89–1.98) increase in the number of deaths. The excess death wave started a few days later in Brescia, but the daily estimated SMR peaked at the end of March in both HPAs, roughly 2 weeks after the introduction of lockdown measures, with significantly higher estimates in Bergamo (9.4, 95% CI 9.1–9.7). Conclusion: Excess mortality was significantly higher than that officially attributed to COVID-19, disclosing its hidden burden likely due to indirect effects on the health system. Time-series analyses highlighted the impact of lockdown restrictions, with a lower excess mortality in the HPA where there was a smaller delay between the epidemic outbreak and their enforcement.

Background: diabetes mellitus (dM) is a highly prevalent disease with severe long-term consequences, and a known risk factor for peripheral artery disease (Pad). These two diseases combined are responsible for high morbidity and mortality. The aim of this study is to investigate the burden of Pad in patients with dM, the effect of revascularization on outcomes, and geographical variation in the access to Pad courses of treatment. METHODS: From the healthcare claims of the Lombardy residents (16% of the Italian population) we identifed diabetic patients with PAD as the study population, distinguishing between patients who received revascularization procedures (revasc) and those who did not (norevasc). Patients were classifed by sex, age, comorbidities, mortality, amputation received and direct healthcare cost. resulTs: The dM with Pad study population consisted of 18,344 patients (61% male), aged on average 72 (±10.1) years. Most of them (64%) did not receive any revascularization procedures and 12% of the latter had at least one major amputation. The major amputation rate was signifcantly lower for the Revasc group when compared to the NoRevasc group. Geographical heterogeneity in DM and PAD occurrences as well as in revascularization procedures was detected in the area under study. ConClusions: The present study gives an up-to-date description of the dramatic epidemiologic and economic burden of Pad in diabetic subjects using a truly population-based data and longitudinal follow-up of up to 9 years. it represented a useful tool to evaluate the impact of revascularization and to provide evidence of different outcomes associated with different levels of access to services

Objective: Chronic liver diseases (CLDs) impose a significant socioeconomic burden on patients and the healthcare system, but to what extent remains underexplored. We estimated costs and health-relatedquality- of-life (HRQoL) among patients with CLDs at different stages and with different aetiologies. Design: A cost-of-illness study was conducted. Direct costs, productivity loss and HRQoL were estimated in patients with chronic hepatitis, cirrhosis hepatocellular carcinoma (HCC) or where orthotopic liver transplantation (OLT) had been performed, for hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, or in those with liver disease from other causes. Patients were retrospectively observed for 6 months. The societal perspective was adopted to calculate costs. Results: In total, 1088 valid patients (median age=59.5 years, 60% men) were enrolled. 61% had chronic hepatitis, 20% cirrhosis, 8% HCC and 12% underwent OLT. HCV infection was identified in 52% and HBV infection in 29% of the patients. Adjusted mean direct costs increased from <€200/patient-month in HCVinfected patients with hepatitis to >€3000/patient-month in HBV infected patients with OLT. Antiviral treatment was the cost driver in patients with hepatitis, while hospital costs were the driver in the other subgroups. Absenteeism increased from HBV-infected patients with hepatitis (0.7 day/patient-month) to patients with OLT with other aetiologies (3.7 days/patient-month). HRQoL was on average more compromised in cirrhosis and patients with HCC, than in hepatitis and patients with OLT. HBV-infected patients generated higher direct costs, patients with other aetiologies generated the highest productivity loss and HCV-infected patients reported the worst HRQoL levels. Conclusions: The present study can be considered a benchmark for future research and to guide policies aimed at maximising the cost-effective of the interventions.

Objective: Chronic liver diseases (CLDs) impose a significant socioeconomic burden on patients and the healthcare system, but to what extent remains underexplored. We estimated costs and health-relatedquality- of-life (HRQoL) among patients with CLDs at different stages and with different aetiologies. Design: A cost-of-illness study was conducted. Direct costs, productivity loss and HRQoL were estimated in patients with chronic hepatitis, cirrhosis hepatocellular carcinoma (HCC) or where orthotopic liver transplantation (OLT) had been performed, for hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, or in those with liver disease from other causes. Patients were retrospectively observed for 6 months. The societal perspective was adopted to calculate costs. Results: In total, 1088 valid patients (median age=59.5 years, 60% men) were enrolled. 61% had chronic hepatitis, 20% cirrhosis, 8% HCC and 12% underwent OLT. HCV infection was identified in 52% and HBV infection in 29% of the patients. Adjusted mean direct costs increased from <€200/patient-month in HCVinfected patients with hepatitis to >€3000/patient-month in HBV infected patients with OLT. Antiviral treatment was the cost driver in patients with hepatitis, while hospital costs were the driver in the other subgroups. Absenteeism increased from HBV-infected patients with hepatitis (0.7 day/patient-month) to patients with OLT with other aetiologies (3.7 days/patient-month). HRQoL was on average more compromised in cirrhosis and patients with HCC, than in hepatitis and patients with OLT. HBV-infected patients generated higher direct costs, patients with other aetiologies generated the highest productivity loss and HCV-infected patients reported the worst HRQoL levels. Conclusions: The present study can be considered a benchmark for future research and to guide policies aimed at maximising the cost-effective of the interventions.

Objective: Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs). Methods: Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared. Results: The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years. Conclusion: The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor

Background: Many studies have been conducted in Italy to assess Health-Related Quality-of-Life (HRQoL) in subjects with different diseases. However, no recent HRQoL population norm data were available to make comparisons with diseased populations. We assessed HRQoL norm data using the generic instrument EQ-5D in its standard version (EQ-5D-3L) and with the recently introduced version (EQ-5D-5L). Methods: A survey was conducted on 6,800 individuals, representative of the Lombardy general adult population for age, gender and geographical distribution. Each participant underwent a telephone interview with questions using the EQ-5D-3L and the EQ-5D-5L descriptive systems, the visual analogue scale (EQ-VAS) and socio-demographic data. Results: participants were 48% male, aged on average 51.9 years. With the 3L version, men and women aged 18-35 years reporting a full health state were 71.3% and 56.5%, respectively, those aged ≥ 76 years decreased to 29.5% and 13.5%, respectively. The proportion of respondents reporting no problems decreased with the 5L version. The mean (standard deviation) of the EQ-VAS was 87.7(12.1) and 85.0(15.2) among men and women aged 18-35 years, and 68.0(20.6) and 64.4(23.2) in men and women aged ≥ 76 years. The mean (standard deviation) utility obtained from the 3L version ranged from 0.965(0.068) and 0.944(0.086) among men and women aged 18-35 years, to 0.880(0.123) and 0.829(0.137) in men and women aged ≥ 76 years. Similar results were obtained with the 5L version. Conclusion: HRQoL norm data are now available for the general adult population in Italy, to be used as a reference in clinical sector, economic evaluations and in policy settings.

Objective To assess the cost-effectiveness and cost-utility of Spinal Cord Stimulation (SCS) in patients with failed back surgery syndrome (FBSS) refractory to conventional medical management (CMM). Materials and Methods We conducted an observational, multicenter, longitudinal ambispective study, where patients with predominant leg pain refractory to CMM expecting to receive SCS+CMM were recruited in 9 Italian centers and followed up to 24 months after SCS. We collected data on clinical status (pain intensity, disability), Health-Related Quality-of-Life (HRQoL) and on direct and indirect costs before (pre-SCS) and after (post-SCS) the SCS intervention. Costs were quantified in € 2009, adopting the National Health Service's (NHS), patient and societal perspectives. Benefits and costs pre-SCS versus post-SCS were compared to estimate the incremental cost-effectiveness and cost utility ratios. Results 80 patients (40% male, mean age 58 years) were recruited. Between baseline and 24 months post-SCS, clinical outcomes and HRQoL significantly improved. The EQ-5D utility index increased from 0.421 to 0.630 (p < 0.0001). Statistically significant improvement was first observed six months post-SCS. Societal costs increased from €6600 (pre-SCS) to €13,200 (post-SCS) per patient per year. Accordingly, the cost-utility acceptability curve suggested that if decision makers' willingness to pay per Quality-Adjusted-Life-Years (QALYs) was €60,000, SCS implantation would be cost-effective in 80% and 85% of cases, according to the NHS's and societal point of views, respectively. Conclusions Our results suggest that in clinical practice, SCS+CMM treatment of FBSS patients refractory to CMM provides good value for money. Further research is encouraged in the form of larger, long-term studies.

Objective: To assess the epidemiologic and economic burden of diabetes mellitus (DM) from a longitudinal population-based study.Research Design and Methods: Lombardy Region includes 9.9 million individuals. Its DM population was identified through a data warehouse (DENALI), which matches with a probabilistic linkage demographic, clinical and economic data of different Healthcare Administrative databases. All individuals, who, during the year 2000 had an hospital discharge with a IDC-9 CM code 250.XX, and/or two consecutive prescriptions of drugs for diabetes (ATC code A10XXXX) within one year, and/or an exemption from co-payment healthcare costs specific for DM, were selected and followed up to 9 years. We calculated prevalence, mortality and healthcare costs (hospitalizations, drugs and outpatient examinations/visits) from the National Health Service's perspective.Results: We identified 312,223 eligible subjects. The study population (51% male) had a mean age of 66 (from 0.03 to 105.12) years at the index date. Prevalence ranged from 0.4% among subjects aged ≤45 years to 10.1% among those >85 years old. Overall 43.4 deaths per 1,000 patients per year were estimated, significantly (p<0.001) higher in men than women. Overall, 3,315€/patient-year were spent on average: hospitalizations were the cost driver (54.2% of total cost). Drugs contributed to 31.5%, outpatient claims represented 14.3% of total costs. Thirty-five percent of hospital costs were attributable to cerebro2/cardiovascular reasons, 6% to other complications of DM, and 4% to DM as a main diagnosis. Cardiovascular drugs contributed to 33.5% of total drug costs, 21.8% was attributable to class A (16.7% to class A10) and 4.3% to class B (2.4% to class B01) drugs.Conclusions: Merging different administrative databases can provide with many data from large populations observed for long time periods. DENALI shows to be an efficient instrument to obtain accurate estimates of burden of diseases such as diabetes

Purpose: To assess the performance of the EQ-5D-5L version compared with the standard EQ-5D-3L in a clinical setting targeted at patients with chronic hepatic diseases (CHDs). Methods: We introduced the 5L descriptive system into a cost-of-illness study involving patients with different CHDs. The patients completed a questionnaire including the two versions of the EQ-5D, together with other questions related to their condition. We tested the feasibility, the level of inconsistency, the redistribution properties among consistent responses, the ceiling effect, the discriminative power, and the convergent validity of the 5L compared with the 3L system. Results: A total of 1,088 valid patients were recruited: 62 % male, 19-89 (median = 59) years old. Patients had chronic hepatitis from HCV (31.8 %) or HBV infections (29.3 %) or other causes (7.8 %), 20.4 % had cirrhosis, 11.9 % underwent liver transplantation, and 7.8 % had hepatic carcinoma. Less than 1 % of EQ-5D-5L were returned blank, and 1.6 % or less of missing values were calculated on the dimensions of the partially completed questionnaires. The proportion and weight of inconsistent responses (i.e.; 3L responses that were at least two levels away from the 5L responses) was 2.9 % and 1.2 on average, respectively. Regarding redistribution, 57-65 % of the patients answering level 2 with the 3L version redistributed their responses to levels 2 or 4 with the 5L version. A relative 7 % reduction of the ceiling effect was found. Furthermore, the absolute informativity increased but the relative informativity slightly decreased in every domain, and the convergent validity with the VAS improved. Conclusions: In a clinical setting involving CHD patients, the EQ-5D-5L was shown to be feasible and with promising levels of performance. Our findings suggest that the 5L performs better in at least some of the properties analyzed, and encourage further research to also test other psychometric properties of this new version of t

Objective To estimate a value set for the calculation of Italian-specific quality-adjusted life years (QALYs), based on preferences elicited on EuroQol five-dimensional (EQ-5D) questionnaire health states using the time trade-off technique. Methods The revised standard Measurement and Valuation of Health protocol was followed. Twenty-five health states, divided into three groups and given to 450 subjects, were selected to obtain 300 observations per state. Subjects aged 18 to 75 years were recruited to be representative of the Italian general adult population for age, sex, and geographical distribution. To improve efficiency, face-to-face interviews were conducted by using the Computer Assisted Personal Interviewing approach. Several random effects regression models were tested to predict the full set of EQ-5D questionnaire health states. Model selection was based on logical consistency of the estimates, sign and magnitude of the regression coefficients, goodness of fit, and parsimony. Results The model that satisfied the criteria of logical consistency and was more efficient includes 10 main effect dummy variables for the EQ-5D questionnaire domain levels and the D1 interaction term, which accounts for the number of dimensions at levels 2 or 3 beyond the first. This model has an R 2 of 0.389 and a mean absolute error of 0.03, which are comparable to or better than those of models used in other countries. The utility estimates after state 11111 range from 0.92 (21111) to -0.38 (33333). Italian utility estimates are higher than those estimated in the United Kingdom and Spain and used so far to assess QALYs and conduct cost-utility evaluations in Italy. Conclusions A specific value set is now available to calculate QALYs for the conduction of health economic studies targeted at the Italian health care system. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR)

Background:High-dose therapy with autologous peripheral stem cell transplantation represents today the standard approach for younger multiple myeloma patients. This study aimed to evaluate the long term economic impact of autologous transplantation with respect to conventional therapy.Methods:We retrospectively reviewed the charts of multiple myeloma patients diagnosed at our department between 1986 and 2003 and treated according to the therapy considered standard at the time of diagnosis. Analysis of costs was done by assessing resource utilization and direct costs were measured and monetized before proceeding with the analysis, based on public health service tariffs.Results:Group A including 78 patients treated with Melphalan and Prednisone was compared with Group B including 74 patients who received an autologous transplant. The median overall survival was 3.2 and 5.4 years respectively (p = 0.0002). Mean cost per patient was significantly higher in group B with respect to group A (102373€ vs 23825€; p<0.001). The final quality-adjusted-life-year gain in group B patients as compared to group A was 1.73 QALY, with an incremental cost-effectiveness ratio of 45460€. With a threshold of 75000€ per QALY gained, the cost effectiveness acceptability curve indicated that the probability that autologous transplantation in multiple myeloma is a cost-effective intervention is 90%.Conclusions:The cost of autologous transplantation remains high. The calculated incremental cost-effectiveness ratio, however, given the significant prolongation of overall survival obtained with autologous transplantation, is within an acceptable threshold. Notwithstanding, its high cost should be taken into account when considering the whole cost of multiple myeloma.

Liver diseases (LDs) have a high impact on morbidity, mortality and health-related quality of life (HRQoL). Different LDs may have different effects on patients’ HRQoL. The aim of our study was to assess the reliability and benefit of using a generic HRQoL questionnaire to evaluate the health status of patients with the major liver conditions: hepatitis B (HBV), hepatitis C (HCV), cirrhosis, hepatocellular carcinoma (HCC), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), NAFLD/NASH and patients in the liver transplant list. A naturalistic, prospective, multicenter study has been conducted to generate and validate a set of health care outcomes indicators for the major liver conditions. LDs patients (age>18 years) were enrolled in 3 major Italian medical centers and are still being followed up (median f-up: 13 months). Within this study, socio-demographic, clinical and HRQoL were collected using the EQ-5D-3L, a generic instrument that enables HRQoL to compared within and between clinical conditions and with the general population. It generates a health profile made up of 5 domains (mobility, self care, anxiety/depression, usual activities and pain/discomfort), each one with three levels of severity. It also consists of a visual analogue scale (EQ-5D VAS) which measures overall HRQoL in a range from 0 (worst imaginable health state) to 100 (best imaginable health state). The baseline HRQoL data was analyzed dividing the patients in sub-groups according to the most recently diagnosed and most severe condition. The results reported below focus on the mean VAS. We enrolled 3,217 patients, 64.8% male, aged 19-91 (median=61) years; 95.0% of them filled in the EQ-5D at baseline. Patients in the HCC group were 22.6%, those with compensated cirrhosis were 21.2%, HCV 20.9%, decompensated cirrhosis 10.3%, HBV 9.5%. The HBV group reported the best HRQoL with a mean EQ-5D VAS of 77.8. NAFLD/NASH, HCV and PSC patients had a similar

OBJECTIVES: Liver diseases (LDs) have a high impact on morbidity, mortality and health-related quality of life (HRQoL). LDs may have different impact on patients’ HRQoL. The aim of our study was to evaluate HRQoL in the major liver conditions: hepatitis B(HBV), hepatitis C(HCV), cirrhosis(compensated and decompensated), hepatocellular carcinoma(HCC), autoimmune hepatitis(AIH), primary biliary cirrhosis(PBC), primary sclerosing cholangitis(PSC), NAFLD/NASH, patients in the liver transplant list and post-transplant METHODS: a naturalistic, prospective, multicenter study has been conducted to generate and validate a set of health care outcomes indicators for the major liver conditions. LDs patients (age>18 years) were enrolled in 3 major Italian medical centers and are still being followed up (median f-up:13 months). Within this study, socio-demographic, clinical and HRQoL were collected using the EQ-5D-3L. The HRQoL data was analyzed dividing the patients in sub-groups according to the most recently diagnosed and most severe condition. RESULTS: we enrolled 3,217 patients, 64.8% male, aged 19-91 (median=61) years; 95.0% of them filled in the EQ-5D at baseline visit. Patients in the HCC group were 22.6%; while in the AIH group were 1.6%. The highest percentage of problems in Mobility dimension (39.2%) was reported by decompensated cirrhosis sub-group, the highest percentage in Self-care (22.6%) and Usual Activities (47.1%) by patients in liver transplant list, in Pain/Discomfort (59.2%) by AIH and in Anxiety/Depression (57.8%) by PBC. The HBV sub-group reported the best HRQoL with a mean EQ-5D VAS of 77.8; while AIH and listed for liver transplant patients reported the worst HRQoL levels (mean EQ-5D VAS=67.7 and 63.5, respectively). CONCLUSIONS: our study shows how HRQoL is different between LDs and how it is negatively related with the clinical severity. Understanding the different impact of LDs on the patients’ HRQoL could help physicians and decision makers to better

Background: the aim of this study was to assess healthcare demand of specific groups of population and their costs borne by Italian Health System, using healthcare administrative databases. Methods: demographic, clinical and economic data were obtained from datasets available at the Regional Health System, combined into a data warehouse (DENALI), using a probabilistic record linkage to optimize the data matching process. The study population consisted of more than 1 million people registered in 2005 at one Local Healthcare Unit of Lombardy. Eight different segments were identified. Costs occurring in 2005 for hospital admissions, drug prescriptions, outpatient medical specialist visits were quantified in each segment. Results: healthy people accounted for 53% of the population and cost € 180 per-capita. Subjects with only one chronic disease made up 16% of the population and cost € 916 per-capita, those affected by several chronic diseases accounted for 13% and cost € 3 457 per-capita. Hospitalizations were the cost driver in five segments, ranging from 42% to 89% of total expenditures. Outpatient visits were the cost driver among healthy subjects (54%) and those with a possible chronic disease (42%), while drug costs ranged between 4% ("acute event") and 32% ("one chronic disease"). Overall, healthcare cost was € 809 per-capita. ConclusionS: healthcare costs were mainly determined by people affected by chronic conditions, even if "healthy people" ranked third for total expenditure. These costs need an appropriate identification of healthcare demand, that could be efficiently monitored through the use of administrative databases.

OBJECTIVES: To assess the relationship between the type of chronic liver diseases (CLDs), clinical severity and patients’ HRQoL. METHODS: A naturalistic, multicentre study has been conducting to identify and test quality of care indicators. Adult CLDs patients (age>18 years) have been enrolling at gastroenterology unit of 3 Italian hospitals. We are collecting socio-demographic, clinical and HRQoL data with the EQ-5D-3L. Patients are sub-grouped according to CLD type and to clinical severity using the modified Child-Turcotte-Pugh score: with this instrument, patients are classified as non-cirrhotic, early cirrhotic (class A), advanced cirrhotic (classes B and C). We conducted Kruskall-Wallis tests to assess relationship between EQ-5D-VAS score and disease type or severity score. RESULTS: Results are based on data from 2,221 patients (67% male, median age=62 years), classified into the following subgroups: HCV or HBV chronic hepatitis (36.0%), compensated cirrhosis (CC, 23.5%), hepatocellular carcinoma (HCC, 19.8%), decompensated cirrhosis (DC, 13.5%), patients in evaluation or listed for liver transplant (LT, 7.2%). Non-cirrhotic patients (HCV or HBV chronic hepatitis) had significantly (p<0.001) higher median VAS (80) than patients with any other CLD types (70). In contrast, patients listed for LT had the lowest (p<0.05) median VAS (65) and the highest proportion of patients (58.1%) in Child class B-C. DC patients had a median VAS not significantly different from that of HCC or CC patients (70 versus 70 and 73, respectively). On the other hand, DC patients in child class A showed a significantly (p<0.05) higher median VAS (72.5) than HCC and CC patients in class B-C, who had a median VAS of 70 and 60, respectively. CONCLUSIONS: HRQoL of CLDs patients is significantly related with the Child-Turcotte-Pugh severity score. These results could be useful to understand the impact of the disease severity on patients’ HRQoL and guide some decisions in clinical care

OBJECTIVES. The assessment of individuals’ demand and related costs can guide to allocate healthcare resources and improve access to healthcare. We created a segmentation demand model and we estimated healthcare costs and their determinants within specific and distinguished groups of general population. METHODS. The target population included subjects living in an area of northern Italy registered at one Local Healthcare Unit in 2005 (1,031,684 subjects). On the basis of clinical judgments and literature, we identified eight different segments: subjects unknown to HS, maternity and infancy, elderly, people with one chronic disease (CD), people with more CDs, people with probable or not severe CDs, subjects with acute event, healthy people. To describe these groups and their health demand, we used demographic and healthcare demand data (hospital admissions, drug’s prescriptions, medical specialist visits, diagnostic tests) from administrative databases available at the Lombardy Health System (HS). These were merged adopting probabilistic record linkage (DENALI Data Warehouse) to optimize correct matching of data. RESULTS. Overall, healthcare cost €834 million in 2005 (€809 per-capita). Healthy people were 53% of the sample and cost €180 per-capita. Next more frequent subjects were those with one CD (14%) and cost €916 per-capita, then those with more CDs (13%) who cost €3,457 per-capita. Hospitalizations were the cost driver in five segments (maternity and infancy, elderly, one CD, more CDs, acute event), accounting for 42-89% of total costs. Diagnostic tests and medical visits contributed to 42-45% of total costs among healthy subjects and those with probable CD. Overall, drugs accounted for 24% of costs of sample. CONCLUSIONS. This pioneer demand segmentation model shows an example of how merging different administrative databases makes possible understanding effects of their characteristics on healthcare demand and costs. Research is encouraged to improve the mode