Italian National Health System Research Articles

DI-079 Brentuximab Vedotin: from Named Patient Program (NPP) to Italian Law 648/96

BackgroundBrentuximab vedotin (BV) is an antibody-drug conjugate directed to the protein CD30, which is expressed in classical Hodgkin’s lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The drug received...

Qualità e Sostenibilità in Sanità

There are different opinions about the quality of our national health system (NHS): in some rankings it is the second in Europe, while in others it is the 21st. The use of cost-related indicators, instead of clinical-related ones, leads to a severe downgrade of the Italian NHS in the European context. According to the demographic changes of the population, consisting more and more of old people and chronically-ill patients, it is necessary to develop and use clinical process indicators proposed by the scientific societies, thus abandoning the Hospital Discharge File as the clinical quality assessment system: the reduction of the costs shall not be considered a good result without an increase in clinical effectiveness. The use of information flows through the informatics improvement of the so-called “big data”, and the crosscheck of data may be a great help for the development of this process. The Italian NHS will be saved by a strong reduction of costs that starts from the diagnostic appropriateness and clinical efficacy. (Clinical_Management)

Apixaban, Dabigatran, and Rivaroxaban Versus Warfarin for Stroke Prevention in Non-Valvular Atrial Fibrillation: A Cost-Effectiveness Analysis

Non-valvular atrial fibrillation (NVAF) increases the risk of systemic thromboembolic events; therefore, anticoagulant treatment with vitamin K antagonists is widely prescribed. Recently, new oral anticoagulants (NOAs) directly inhibiting thrombin (dabigatran) or factor Xa (rivaroxaban and apixaban) demonstrated their non-inferiority with respect to warfarin in reducing the thromboembolic risk. The aim of this study was to estimate the cost effectiveness of NOAs in an Italian setting. A Markov decision model including ten health states and death was developed, and a 3-month Markov cycle and lifetime horizon were adopted. Transition probabilities and quality of life were estimated from three randomized trials and from additional reports in the literature. Analysis was performed in the context of the Italian National Health System. First- and second-order sensitivity analyses were made to test the robustness of the results. The mean European cost of dabigatran (<euro>2.58/day) was assigned to each NOA. The incremental cost-utility ratio was below <euro>25,000/quality-adjusted life-year (QALY) gained for each NOA and each CHADS2 level, but differences among drugs were found. This result was sensitive to the time in (warfarin) therapeutic range and time horizon. Our analysis suggests that NOAs are a cost-effective treatment for the prevention of stroke in patients with NVAF in the Italian healthcare setting.

Twenty-five-gauge vitrectomy versus 23-gauge vitrectomy in the management of macular diseases: a comparative analysis through a Health Technology Assessment model

Small-gauge vitreoretinal techniques have been shown to be safe and effective in the management of a wide spectrum of vitreoretinal diseases. However, the costs of the new technologies may represent a critical issue for national health systems. The aim of the study is to plan a Health Technology Assessment (HTA) by performing a comparative analysis between the 23- and 25-gauge techniques in the management of macular diseases (epiretinal membranes, macular holes, vitreo-macular traction syndrome). In this prospective study, 45-80-year-old patients undergoing vitrectomy surgery for macular disease were enrolled at the Torino Eye Hospital. In the HTA model we assessed the safety, clinical effectiveness, and cost and financial evaluation of 23-gauge compared with 25-gauge vitrectomies. Fifty patients entered the study; 14 patients underwent 23-gauge vitrectomy and 36 underwent 25-gauge vitrectomy. There was no statistically significant difference in post-operative visual acuity at 1 year between the two groups. No cases of retinal detachment or endophtalmitis were registered at 1-year follow-up. The 23-gauge technique was slightly more expensive than the 25-gauge: the total surgical costs were EUR1217.70 versus EUR1164.84 (p = 0.351). We provide a financial comparison between new vitreoretinal procedures recently introduced in the market and reimbursed by the Italian National Health System and we also stimulate a critical debate about the expensive technocratic model of medicine.

Is variation management included in regional healthcare governance systems? Some proposals from Italy

The Italian National Health System, which follows a Beveridge model, provides universal healthcare coverage through general taxation. Universal coverage provides uniform healthcare access to citizens and is the characteristic usually considered the added value of a welfare system financed by tax revenues.Nonetheless, wide differences in practice patterns, health outcomes and regional usages of resources that cannot be justified by differences in patient needs have been demonstrated to exist. Beginning with the experience of the health care system of the Tuscany region (Italy), this study describes the first steps of a long-term approach to proactively address the issue of geographic variation in healthcare. In particular, the study highlights how the unwarranted variation management has been addressed in a region with a high degree of managerial control over the delivery of health care and a consolidated performance evaluation system, by first, considering it a high priority objective and then by actively integrating it into the regional planning and control mechanism. The implications of this study can be useful to policy makers, professionals and managers, and will contribute to the understanding of how the management of variation can be implemented with performance measurements and financial incentives.

Oral antidiabetic therapy in a large Italian sample: drug supply and compliance for different therapeutic regimens

ObjectivesTo define the main features of patients treated with oral antidiabetics, evaluating monotherapy (MT), loose-dose combination therapy (LDCT) and fixed-dose combination therapy (FDCT); to describe medication adherence to the different therapies; and to evaluate the differences in compliance with the prescribed therapy regimen among prevalent and incident patient cohorts. Study designThis study was a retrospective cohort analysis based on the ARNO database, a national record that tracks reimbursable prescription claims submitted from selected pharmacies to the Italian national health system. In total, 169,375 subjects, from an overall population of 4,040,624 were included in this study. The patients represented 12 different local health units. Each patient had at least one oral antidiabetic prescription claim (A10B ATC code). MethodsPatients were divided into four groups according to their treatment regimen during the recruitment period (1 January 2008–31 December 2008): MT, FDCT, LDCT and switching therapy. A timespan of 5 years was considered, from 4 years before to 1 year after the index date (i.e. date of the prescription selected in the recruitment period). A medication possession ratio (MPR) with a cut-off value of 80% was used to measure medication adherence. Descriptive statistics and multiple logistic regression were used to define the objectives, while P < 0.05 was considered to indicate significance. ResultsThe median age of patients (n = 169,375, prevalence 4.2%) was 70 years [interquartile range (IQR) 17], and 49.1% were females. Considering the entire sample, the median MPRs for the treatment regimens were: MT, 0.73 (IQR 0.53; 43.9% compliant); FDCT, 1 (IQR 0.29, 68,5% compliant); and LDCT, 0.89 (IQR 0.33, 60.3% compliant). FDCT and LDCT were significantly correlated with MPR. Compliance was 48.9% in the prevalent patient cohort (i.e. patients prescribed oral antidiabetic therapy in both prerecruitment and recruitment periods); median MPRs for the treatment regimens were: MT, 0.73 (IQR 0.52); FDCT, 1 (IQR 0.28); and LDCT, 0.90 (IQR 0.32). Compliance was 43.0% in the incident patient cohort (i.e. patients who were first prescribed oral antidiabetic therapy in the recruitment period); median MPRs for the treatment regimens were: MT, 0.70 (IQR, 0.58); FDCT, 1 (IQR 0.34); and LDCT, 0.64 (IQR 0.39). ConclusionsCompliance was better for FDCT than the other therapeutic regimens in the study population. The same trend was observed in both the prevalent and incident patient cohorts. As type 2 diabetes is a chronic lifelong pathology, and multiple agents are often required to achieve glycaemic control, the preference for FDCT in the population, when clinically applicable, could be an effective strategy for functional administration of clinical outcome and sources. Evaluation of specific population fractions (age, sex, compliance, etc.) and specific agents or drug combinations could also be relevant in order to reach the healthcare objectives.

Antidotes supply in emergency from Pavia Poison Control Centre

Objective: Antidotes can play a critical role in the management of poisoned patients. Nevertheless, the inadequate availability of antidotes is a known problem in Italian Emergency Departments (EDs) [1]. In Italy, one of the planned Poison Centre functions is monitoring antidotes demand and managing the antidotes stockpile to ensure their prompt availability in the emergency setting. The antidotes supply by the Pavia Poison Control Centre (PCC) to the Emergency Departments of the National Health System is evaluated. Methods: A retrospective analysis of antidote supply in emergency from PCC from 1 January 2007 to 31 December 2012 was conducted. Antidotes for human poisonings are examined for type, amount e destination. Antidotes mobilization for treatment of animals or preventive stocking (hospitals, industries, other settings) were excluded. Results: 151 cases (20 different antidotes) of supply in emergency were registered; 39 mobilizations were related to fomepizole 1.5 g (min/max, 1-9 vials), 15 calcium gluconate gel (3-21 tubes), 15 N-acetylcysteine (6-50 vials), 12 ViperFab-antivenom (2-6 vials), 12 digoxin immune Fab (2-12 vials), 10 glucagon (30-100 vials), 7 pralidoxime (60-400 vials), 7 succimer (15-180 capsules),5 physotigmine (1-20 vials), 4 Ca-EDTA (1-20 vials), 4 hydroxocobalamin (2-3 kit), 4 penicillamine (100-200 capsules), 4 activated charcoal (3-10 bottles), 4 ethanol (30-50 vials), 2 PEG 400 (2 bottles), 2 sodium thiosulfate (50-100 vials), 2 L-carnitine (15-20 vials), 1 atropine (50 vials), 1 cyproheptadine (2 vials), 1 pyridoxine (18 vials). In 45% of cases, antidotes were provided for immediate administration (availability in 30 minutes). The antidote was supplied in other Italian regions in 47% of cases. Most antidotes were mobilized for ethylene glycol/methanol, hydrofluoric acid, alpha-amanitin, digoxin, viper and beta-blockers poisonings. Conclusion: Antidote stockpiles of Italian EDs are often lacking and sometimes insufficient for a single patient treatment. Forty-five percent of the emergency supply activity involved antidotes that should be available in EDs within 30 minutes, and 20% regarded antidotes not registered in Italy. Mobilizations involved only 29% of Pavia-PCC stockpile: it must be considered that in the analyzed period, there was no request of antidote for industrial accident/mass intoxication or for rare intoxications. Moreover in some cases the PCC moved antidotes from other hospital stockpiles identified through the 'national antidotes data-base' (www.cavpavia.it). This data-base, available since 2006, represents a unique operating system that permits the management and optimization of all the national hospital stockpiles of antidotes. The results point out the critical role of Pavia-PCC in early mobilization of antidotes for timely management of acutely poisoned patients in Italy.

Explaining the Health Costs Associated with Managing Intracranial Aneurysms in Italy

The clinical management of intracranial aneurysms is debated in many countries because of the associated disability risk and costs. Therefore, estimating the costs and explaining their variability will provide important information for decision makers. We aimed to evaluate the acute and post-acute health costs of intracranial aneurysm management and to explain the variability in these costs in the Italian National Health System. An observational study was conducted on 145 patients who were affected by a (single) ruptured or an unruptured intracranial aneurysm. They were consecutively admitted to 14 Italian hospitals between October 2005 and March 2007. The data collected during the initial hospitalization and three follow-up visits were used to assess the 1-year health costs and the patients' health status after discharge. Two multivariate regression models were used to explain the variability in the acute and post-acute costs. The average total cost per patient was <euro>30,813 (evaluation year: 2012). The first model explained the acute costs fairly well and showed that the severity of illness, the admission unit (i.e., intensive care unit vs. another unit of the hospital), and mortality were associated with large, significant (p < 0.05) coefficients. The second model outperformed the first one in explaining the post-acute costs and showed that health status assessed 30 days after discharge was a significant (p < 0.05) predictor of costs. Policies aimed at containing health costs should focus on interventions that help to reduce disability, which is a key predictor of long-term costs.

Patient mobility for cardiac problems: a risk-adjusted analysis in Italy

BackgroundThe Italian National Health System was revised in the last 20 years, introducing new elements such as efficacy, efficiency and competitiveness. Devolution to regional authorities has created a quasi-market system where patients can choose the hospital in which to be treated. Patient mobility therefore becomes an indicator of perceived hospital quality and of financial flows between the regions of Italy. Previous studies analyzed patient mobility in general or by specific disease/diagnosis-related groups but there is a lack of research on the influence of severity of patient condition. The aim of the study was to describe patient mobility, crude and stratified by disease severity, in cardiac surgery units of three health areas (HAs) in Tuscany (Italy).MethodsIn this retrospective observational study, data was gathered from hospital discharge records obtained from the Tuscan Regional Health Agency, Italy. The three HAs (HA1, HA2, HA3) recorded 25,017 planned hospitalizations in cardiac surgery units in the period 2001–2007. Patients were stratified in four All Patient Refined Diagnosis Related Group (APR-DRG) severity levels. Gandy’s nomogram was used to describe how HAs met health care demand and their capacity to attract patients. Cuzick’s test was used to identify significant differences in time trends.ResultsRaw data showed that the HAs met their own local health care demand. Stratifying by APR-DRG severity, it emerged that capacity to meet local demand remained unchanged for zero-to-minor severity levels, but one HA was less able to meet demand for moderate severity levels or to attract patients from other HAs and Regions of Italy. In fact, HA3 showed a decrease in admissions of local residents.ConclusionsThe study highlights important differences between the three HAs that were only revealed by severity stratification: unlike HA3, HA1 and HA2 seemed able to deal with local demand, even after severity stratification. Planners and researchers can benefit from risk stratification data, which provides more elements for correct comparisons and interventions. In the context of patient mobility, the present study is a step in that direction.

Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): study protocol for a randomized controlled trial

BackgroundPoor adherence to pharmacotherapy negatively affects the course and the outcome of schizophreniaspectrum psychoses, enhancing the risk of relapse. Falloon and coworkers developed a Psychoeducation Program aimed at improving communication and problem-solving abilities in patients and their families. This study set out to evaluate changes in adherence to pharmacotherapy in patients diagnosed with schizophrenia-spectrum psychoses, by comparing one group exposed to the Falloon Psychoeducation Program (FPP) with another group exposed to family supportive therapy with generic information on the disorders.Methods340 patients diagnosed with schizophrenia and related disorders according to standardized criteria from 10 participating units distributed throughout the Italian National Health System (NHS), will be enrolled with 1:1 allocation by the method of blocks of randomized permutations. Patients will be reassessed at 6, 12 and 18 months after start of treatment (duration: 6 months).The primary objective is to evaluate changes in adherence to pharmacotherapy after psychoeducation. Adherence will be assessed at three-month intervals by measuring blood levels of the primary prescribed drug using high pressure liquid chromatography, and via the Medication Adherence Questionnaire and a modified version of the Adherence Interview. Secondary objectives are changes in the frequency of relapse and readmission, as the main indicator of the course of the disorder.Enrolled patients will be allocated to the FPP (yes/no) randomly, 1:1, in a procedure controlled by the coordinating unit; codes will be masked until the conclusion of the protocol (or the occurrence of a severe negative event). The raters will be blind to treatment allocation and will be tested for blinding after treatment completion. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate the missing data. The study started recruitment in February 2013; the total duration of the study is 27 months.DiscussionIf the psychoeducation program proves effective in improving adherence to pharmacotherapy and in reducing relapse and readmissions, its application could be proposed as a standard adjunctive psychosocial treatment within the Italian NHS.Trial registrationProtocol Registration System of ClinicalTrials.gov NCT01433094; registered on 20 August 2011; first patient was randomized on 12 February 2013.

Profiling the different needs and expectations of patients for population-based medicine: a case study using segmentation analysis.

BackgroundThis study illustrates an evidence-based method for the segmentation analysis of patients that could greatly improve the approach to population-based medicine, by filling a gap in the empirical analysis of this topic. Segmentation facilitates individual patient care in the context of the culture, health status, and the health needs of the entire population to which that patient belongs. Because many health systems are engaged in developing better chronic care management initiatives, patient profiles are critical to understanding whether some patients can move toward effective self-management and can play a central role in determining their own care, which fosters a sense of responsibility for their own health. A review of the literature on patient segmentation provided the background for this research.MethodFirst, we conducted a literature review on patient satisfaction and segmentation to build a survey. Then, we performed 3,461 surveys of outpatient services users. The key structures on which the subjects’ perception of outpatient services was based were extrapolated using principal component factor analysis with varimax rotation. After the factor analysis, segmentation was performed through cluster analysis to better analyze the influence of individual attitudes on the results.ResultsFour segments were identified through factor and cluster analysis: the “unpretentious,” the “informed and supported,” the “experts” and the “advanced” patients. Their policies and managerial implications are outlined.ConclusionsWith this research, we provide the following: – a method for profiling patients based on common patient satisfaction surveys that is easily replicable in all health systems and contexts;– a proposal for segments based on the results of a broad-based analysis conducted in the Italian National Health System (INHS).Segments represent profiles of patients requiring different strategies for delivering health services. Their knowledge and analysis might support an effort to build an effective population-based medicine approach.

Symptomatic Spinal Degenerative Pathologies: Clinical Results with the Application of Conservative Biochemical Treatments

This work presents results of our experience with oxygen-ozone therapy, which we could experiment inside the Italian National Health System through 3 years. A total of 1920 patients were admitted to our evaluation on the basis of unselected enrollment because of lumbosciatic pain. Patients were divided in three groups: (A) Patients with degenerative disc disease and arthropathy: 509 (26.5%), (B) Patients with failed back surgery syndrome (FBSS): 1027 (53.489%), and (C) Patients with pure herniated lumbar disc: 384 (20%).The perceived quality of result makes oxygen-ozone therapy a useful weapon in the hand of the doctors.

Is decentralization good for your health? Transformations in the Italian NHS

Decentralization is a cornerstone of health policy reforms across Europe and beyond. This article analyses some of the effects of decentralization using the Italian National Health System (NHS) as a case study. The authors evaluate the risks of welfare state retrenchment and the rise of territorial inequalities in accessing healthcare, using document analysis, secondary sources and micro-data elaboration. The analysis does not confirm an overall welfare state retrenchment, but reveals an increase in territorial inequalities. The results highlight a paradox: if decentralization is to be implemented in a country with strong territorial socioeconomic divides and a critical financial situation, it needs a strong central government in order to support and control local authorities. Otherwise, decentralization may cause a zero-sum game where the gains for the better-off regions counterbalance the losses in performance of the weaker ones; a situation which could lead to the growth of social inequalities, including gender inequalities.

Assessment and Improvement of the Italian Healthcare System: First Evidence from a Pilot National Performance Evaluation System

The Italian National Health System (NHS), established in 1978, follows a model similar to the Beveridge model developed by the British NHS (Beveridge 1942; Musgrove 2000). Like the British NHS, healthcare coverage for the Italian population is provided and financed by the government through taxes. Universal coverage provides uniform healthcare access to citizens and is the characteristic usually considered the added value of a welfare system financed by tax revenues. Nonetheless, in Italy the strong policy of decentralization, which has been taking place since the early 1990s, has gradually shifted powers from the state to the 21 Italian regions. Consequently, the state now retains limited supervisory control and continues to have overall responsibility for the NHS in order to ensure uniform and essential levels of health services across the country. In this context, it has become essential, both for the ministry and for regions, to adopt a common performance evaluation system (PES). This article reports the definition, implementation, and first evidences of a pilot PES at a national level. It shows how this PES can be viewed as a strategic tool supporting the Ministry of Health (MoH) in ensuring uniform levels of care for the population and assisting regional managers to evaluate performance in benchmarking. Finally, lessons for other health systems, based on the Italian experience, are provided.

The challenge and the future of health care turnaround plans: Evidence from the Italian experience

Over the last two decades, health policy and governance in Italy have undergone decentralisation at the regional level. The central government was expected to play a guiding role in defining minimum care standards and controlling health expenditures at the regional level in order to keep the entire Italian National Health System (INHS) on track. Although health performance trends have been consistent across regions, public health expenditures have been variable and contributed to a cumulative deficit of 38 billion Euros from 2001 to 2010. To address the deficit, the government called for a resolution introducing a partial bail-out plan and later institutionalised a process to facilitate a turnaround. The upturn started with the development of a formal regional turnaround plan that proposed strategic actions to address the structural determinants of costs. The effectiveness of this tool was widely questioned, and many critics suggested that it was focused more on methods to address short-term issues than on the long-term strategic reconfiguration that is required for regional health systems to ultimately address the structural causes of deficits.We propose an interpretative framework to understand the advantages and disadvantages of turnaround plans, and we apply the findings to the development of policy recommendations for the structure, methods, processes and contexts of the implementation of this tool.

Modelling waiting times in the Italian National Health Service

Understanding health-care utilization is important to design efficient and effective health-care systems. Towards this end, we propose a relatively simple and intuitively appealing microeconometric framework based on a two-part model to investigate the determinants that increase the probability and the length of waiting for a health-care service provision. This article attempts to accommodate all data features in one model focusing on overdispersion in the data due to unobserved heterogeneity and zero-inflation, with an application to the Italian National Health System.

The Pap smear screening as an occasion for smoking cessation and physical activity counselling: baseline characteristics of women involved in the SPRINT randomized controlled trial

BackgroundGender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population.Methods/DesignAmong women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants.DiscussionOut of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit.Trial registration numberISRCTN: ISRCTN52660565

Cost-Effectiveness Analysis of Polymyxin-B Immobilized Fiber Column and Conventional Medical Therapy in the Management of Abdominal Septic Shock in Italy

Introduction: Severe abdominal sepsis and septic shock are common problems in intensive care units (ICUs), and carry high mortality. The purpose of this economic analysis was to determine the cost-effectiveness of polymyxin B immobilized fiber column (PMX-F) plus conventional therapy (CT) (PMX-F-CT) versus CT alone for patients with severe sepsis/septic shock of abdominal origin, in the perspective of the Italian hospital. Methods: This was a retrospective cost-effectiveness analysis (CEA) based on data of clinical efficacy and consumption of resources collected alongside an Italian randomized clinical trial. 64 patients were enrolled following emergency surgery for intra-abdominal infection in 10 tertiary care ICUs from December 2004 to December 2007. Direct medical costs analyzed in the study included the consumption of hospital days, ICU days, catecholamine treatment days, renal replacement therapy days, mechanical ventilation treatment days, and the use of the PMX-F device. Resources were valued using published 2010 tariffs and market values. All-cause hospital mortality was extrapolated to survival as expected life years (LY) per patient/arm: for each survivor, average age-gender-related years of life expectancy were retrieved from national life tables; for deceased patients, only the number of CRF reported survival days was retained. Baseline expected years of survival were weighed by the severity of sepsis, according to individual Acute Physiology and Chronic Health Evaluation (Apache) II scores, showing that age/disease severity were comparable in the two groups before treatment initiation. Life expectancy per patient in each treatment group was thus calculated as the combination of life expectancy from Italian National Statistics Institute life tables and intra-hospital mortality detected in the Early Use of Polymyxin B Hemoperfusion in Abdominal Septic Shock (EUPHAS) study. After all costs and 3% discounted survival years were calculated per patient per treatment arm, the incremental CEA was run to obtain the incremental cost-effectiveness ratio (ICER). Univariate sensitivity analyses and 2,000 bootstrap replications were run to test the robustness of the study results. Results: Based on the expected survival years (mean discounted PMX-F-CT 9.37 LY/patient, CT 4.92 LY/patient; difference for PMX-F-CT 4.45 LY/patient; mean undiscounted PMX-F-CT 13.92 LY/patient, CT 7.19 LY/patient; difference +6.73 LY/patient), and the expected mean cost (PMX-F-CT mean 59,922 EUR/patient, CT mean 42,712 EUR/patient; difference for PMX-F-CT 17,211 EUR/patient), the mean ICER for PMX- F-CT resulted in 3,864 EUR/life year gained (LYG; ICER 2,558/undiscounted LYG). Results of the base-case CEA were confirmed by all sensitivity analyses, with ICER values always well below commonly accepted value thresholds. Conclusion: PMX-F-CT versus CT is a cost-effective intervention for treatment of severe sepsis/septic shock of abdominal origin and could be considered for use in the Italian National Health System hospital setting.

Direct costs in diabetic and non diabetic people: The population-based Turin study, Italy

Background and aimsWe compared direct costs of diabetic and non diabetic people covered by the Italian National Health System, focusing on the influence of age, sex, type of diabetes and treatment. Methods and resultsDiabetic people living in Turin were identified through the Regional Diabetes Registry and the files of hospital discharges and prescriptions. Data sources were linked to the administrative databases to assess health care services used by diabetic (n = 33,792) and non diabetic people(n = 863,123). Data were analyzed with the two-part model; the estimated direct costs per person/year were €3660.8 in diabetic people and €895.6 in non diabetic people, giving a cost ratio of 4.1. Diabetes accounted for 11.4% of total health care expenditure. The costs were attributed to hospitalizations (57.2%), drugs (25.6%), to outpatient care (11.9%), consumable goods (4.4%) and emergency care (0.9%). Estimated costs increased from € 2670.8 in diabetic people aged <45 years to € 3724.1 in those aged >74 years, the latter representing two third of the diabetic cohort; corresponding figures in non diabetic people were € 371.6 and € 2155.9. In all expenditure categories cost ratios of diabetic vs non diabetic people were higher in people aged <45 years, in type 1 diabetes and in insulin-treated type 2 diabetes. ConclusionDirect costs are 4-fold higher in diabetic than in non diabetic people, mainly due to care of the elderly and inpatient care. In developed countries, demographic changes will have a profound impact on costs for diabetes in next years.

Performance management and goal ambiguity

Goal ambiguity influences the effectiveness of performance management systems to drive organizations toward enhanced results. The literature analyzes the antecedents of goal ambiguity and shows the influence of goal ambiguity on the performance of U.S. federal agencies. However, no study has analyzed goal ambiguity in other countries or in health care systems. This study has three aims: to test the validity of a measurement instrument for goal ambiguity, to investigate its main antecedents, and to explore the relationship between goal ambiguity and organizational performance in a large, public, Beveridge-type health care system. A nationwide survey of general managers of the Italian national health system was performed. A factor analysis was used to validate the mono-dimensionality of an instrument that measured goal ambiguity. Structural equation modeling was used to test both the antecedents and the influence of goal ambiguity on organizational performance. Data from 135 health care organizations (53% response rate) were available for analysis. The results confirm the mono-dimensionality of the instrument, the existence of two environmental sources of ambiguity (political endorsement and governance commitment), and the negative relationship between goal ambiguity and organizational performance. Goal ambiguity matters because it may hamper organizational performance. Therefore, performance should be fostered by reducing goal ambiguity (e.g., goal-setting model, funding arrangements, and political support). Mutatis mutandis, our results may apply to public health care systems of other countries or other "public interest" sectors, such as social care and education.