Prevalence and economic cost of malnutrition in Italy: A systematic review and metanalysis from the Italian Society of Artificial Nutrition and Metabolism (SINPE).

OBJECTIVES: Disease-related malnutrition (DRM) is a major public health issue with dramatic consequences on outcomes. However, in Italy a comprehensive and updated overview on national prevalence, in both the adult and pediatric populations, and its burden on the health care environment, is missing. The aim of this systematic literature review and meta-analysis was to identify and summarize the available evidence regarding the prevalence of DRM in Italy from pediatric to adult and older ages, and to project its global costs on the health care system. METHODS: We performed a systematic literature search for articles on epidemiology of DRM in Italy published up to June 2021. Studies reporting data on the prevalence of DRM in community-dwelling individuals with chronic diseases, nursing home patients, and hospitalized patients (medical, surgery, and oncology patients), were selected for inclusion. Methodological quality of the studies was assessed by two independent reviewers using published criteria. An epidemiologic meta-analysis to obtain an aggregate estimate of prevalence of DRM was performed and a model for estimating the cost of illness, based on the application of epidemiologic results to official national hospitalization data, and attribution of relevant unit costs in the national context was constructed. RESULTS: Sixty-seven studies reporting on the prevalence of DRM in Italian populations were included in the final selection; meta-analytical pooling yields mean prevalence estimates of about 50% and 30% in adult and pediatric hospitalized populations, respectively, with even higher findings for residents of long-term care facilities. Modeled projections of DRM-attributable yearly economic effects on the Italian health care system exceed 10 billion € in base case analysis, with the most optimistic estimate still exceeding 2.5 billion €. CONCLUSION: Although comparable in magnitude to data from previous studies in analogous international settings, the diffusion and effects of DRM in the Italian setting is impressive. Increased awareness of these data and proactive fostering of clinical nutrition services are warranted, as prompt identification and treatment of malnutrition have been shown to effectively improve clinical and economic results.

Structured triglycerides versus physical mixtures of medium- and long-chain triglycerides for parenteral nutrition in surgical or critically ill adult patients: Systematic review and meta-analysis.

INTRODUCTION: New generations of parenteral lipid emulsions combine Long Chain Triglycerides (LCTs) with Medium Chain Triglycerides (MCTs) either by physically mixing MCT- and LCT-containing oils or by using synthetically structured triglycerides (STGs). In order to clarify some open issues relating to their comparative effect, in particular in terms of clinical outcomes, pertinent evidence was systematically identified, reviewed and meta-analyzed. METHODS: PubMed, Scopus, Wanfang Data, China Hospital Knowledge Database and Google Scholar were searched for published clinical trials comparing STGs vs. MCTs/LCTs PN regimens administered over 5-7 days in surgical and/or critically ill patients. Two independent investigators performed screening and data extraction using a predefined list of parameters. Data were pooled using RevMan® 5.2. Quality of evidence was assessed according to Cochrane's risk of bias tool. Pre-specified high quality (HQ), incremental analyses and a post hoc subgroup analysis were performed. RESULTS: 21 studies were included. The meta-analysis revealed a significantly better cumulative nitrogen balance (Std. mean difference [95% CI]) (1.34 [0.98-1.7], p < 0.00001), as well as higher values for pre-albumin (24.99 mg/L [6.71-43.27], p < 0.000001), and albumin (1.22 g/L [0.66-1.77] p < 0.0001), while plasma triglycerides were significantly lower (-0.28 mmol/L [-0.41 to -0.15], p < 0.0001) in the STG vs. MCT/LCT group. ALT, AST, and GGT were significantly lower with STGs than with MCTs/LCTs, while for total bilirubin and ALP only a trend was observed. STGs were also associated with a trend to a shorter hospital length of stay (LOS) (-1.74 days [-3.49 to 0.01] p = 0.05). Quality of evidence was affected by an unclear risk of selection bias, mostly due to the lack of detailed reporting (random sequence generation, allocation concealment). For the other domains, most of the weighted information was judged at low risk of bias. HQ estimated effects, incremental and subgroup analyses were consistent with the main analysis. CONCLUSIONS: In postsurgical and/or critically ill patients, the administration of STGs vs. MCT/LCTs was significantly associated with improved protein economy, better liver tolerance and a more efficient triglyceride elimination. With regard to clinical outcomes a strong trend towards reduced LOS was observed for STG patients.

Plasma for fractionation in a public setting: cost analysis from the perspective of the third-party payer.

BACKGROUND: In Italy, within the legal mandate to pursue national self-sufficiency of plasma-derived medical products, the Regions are starting to organise trade to offset imbalances between need and availability. It is, therefore, necessary to determine the full cost to the Regions of plasma collection and handling. Here we report an analysis of plasma production costs in the Department of Transfusion Medicine of Verona Province, Veneto Region. MATERIALS AND METHODS: Plasma is obtained from voluntary, non-remunerated donors from either whole blood or apheresis donation, and in Verona it is collected, validated and distributed only in Regional Health Service facilities, and then delivered to industry for processing. The amounts and costs of materials and activities needed to collect, produce, validate and distribute plasma were obtained from the Department of Transfusion Medicine. Attributable overhead expenses were assumed at 15% of direct costs. When plasma was collected as part of whole blood or from multi-component apheresis, joint costs (the costs of the common manufacturing process before the separation) were allocated to the plasma based on the tariff for single components, taken as proxy of the willingness to pay for them. In an alternative scenario plasma recovered from whole blood donations was considered a by-product. RESULTS: The estimated full cost of each valid unit of plasma derived from whole blood, multi-component apheresis, and plasma-apheresis was about € 30, € 73 and € 170, respectively. The estimated total cost per litre of plasma was € 113 for collection from whole blood and € 276 for collection from apheresis. When plasma recovered from whole blood donations was considered a by-product, its cost per litre was estimated to be € 26. DISCUSSION: Our results suggest that the Italian donor-based system, in addition to its ethical and social values, can supply plasma at an affordable cost, comparable (albeit slightly higher) with costs in other recent analyses.

Cost-effectiveness of blood culture and a multiplex real-time PCR in hematological patients with suspected sepsis: an observational propensity score-matched study.

We evaluated the costs and clinical outcomes of episodes of suspected sepsis in hematological patients. A propensity score-matched study was planned, comparing a retrospective cohort managed with standard assays and a prospective cohort managed with the addition of a molecular assay. Diagnostic procedures and therapy were considered as costs variables. The primary clinical endpoint was sepsis-related mortality, whereas the length of each suspected sepsis episode was investigated as a secondary endpoint. A total of 137 and 138 episodes in the prospective and the retrospective cohorts were studied, respectively; 101 pairs of highly matched episodes were analyzed, evidencing a trend of higher mortality in the retrospective cohort. No difference in length of suspected sepsis episode was observed. Significant savings were observed in the prospective cohort, especially due to reduced costs in antifungal therapy. The apparently more expensive molecular assay favored a more rational use of economic resources without influencing, and probably improving, the clinical outcome.

Stepping down from high dose fluticasone/salmeterol to extrafine BDP/F in asthma is cost-effective.

BACKGROUND: GINA guideline recommends stepping down treatment of asthma patients where control is achieved. The aim of this analysis was to estimate the costs and health outcomes associated with step down of controlled patients on high dose fluticasone/salmeterol (FP/S 1000/100 µg daily) to either medium dose FP/S (500/100 µg) dry powder or extrafine beclometasone/formoterol (BDP/F 400/24 µg) pMDI in three European countries. METHODS: A patient-level simulation Markov model was constructed to enable the simulation of three comparative arms (FP/S 1000/100, FP/S 500/100, BDP/F 400/24). Transition probabilities and healthcare resources consumption were derived from a multinational clinical trial comparing BDP/F 400/24 µg vs. FP/S 500/100 µg as step down therapy in asthma. Direct costs and health state utilities were sourced from public source and published literature. The analysis was conducted from a health system perspective, based on six months horizon. Probabilistic sensitivity analyses were conducted. RESULTS: The ICER (Incremental Cost-Effectiveness Ratio) associated with high dose dry powder FP/S 1000/100 µg vs. extrafine BDP/F 400/24 µg was above 70,000 GBP and 200,000 €/QALY (Quality Adjusted Life Years). An ICER of 29,000 GBP/QALY and above 30,000 €/QALY was associated with medium dose dry powder FP/S 500/100 µg vs. BDP/F 400/24 µg. CONCLUSIONS: It was found that maintaining controlled patients on high dose FP/S is not cost-effective. Extrafine BDP/F 400/24 µg daily can be considered to be a cost-effective option in the countries analyzed to maintain control of asthmatic patients stepped down from high dose FP/S 1000/100 µg daily dry powder or suspension formulations.

Effectiveness and cost-effectiveness of supplemental glutamine dipeptide in total parenteral nutrition therapy for critically ill patients: a discrete event simulation model based on Italian data.

INTRODUCTION: The supplementation of alanyl-glutamine dipeptide in critically ill patients necessitating total parenteral nutrition (TPN) improves clinical outcomes, reducing mortality, infection rate, and shortening intensive care unit (ICU) hospital lengths of stay (LOSs), as compared to standard TPN regimens. METHODS: A Discrete Event Simulation model that incorporates outcomes rates from 200 Italian ICUs for over 60,000 patients, alanyl-glutamine dipeptide efficacy data synthesized by means of a Bayesian random effects meta-analysis, and national cost data has been developed to evaluate the alternatives from the cost perspective of the hospital. Simulated clinical outcomes are death and infection rates in ICU, death rate in general ward, and hospital LOSs. Sensitivity analyses are performed by varying all uncertain parameter values in a plausible range. RESULTS: The internal validation process confirmed the accuracy of the model in replicating observed clinical data. Alanyl-glutamine dipeptide on average results more effective and less costly than standard TPN: reduced mortality rate (24.6% ± 1.6% vs. 34.5% ± 2.1%), infection rate (13.8% ± 2.9% vs. 18.8% ± 3.9%), and hospital LOS (24.9 ± 0.3 vs. 26.0 ± 0.3 days) come at a lower total cost per patient (23,409 ± 3,345 vs. 24,161 ± 3,523 Euro).Treatment cost is completely offset by savings on ICU and antibiotic costs. Sensitivity analyses confirmed the robustness of these results. CONCLUSIONS: Alanyl-glutamine dipeptide is expected to improve clinical outcomes and to do so with a concurrent saving for the Italian hospital.

Organization and estimated patient-borne costs of oral anticoagulation therapy in Italy: results from a survey.

BACKGROUND: The management of the large patient population in Italy receiving long-term oral anticoagulation therapy (OAT) poses organizational challenges that are traditionally approached with a centralized procedure, relying on hospital-based clinics and/or GPs. However, the availability of near-patient testing devices for the monitoring of OAT effectiveness (international normalized ratio measurement) allows for alternative or complementary management models, in which adequately trained patients perform the test themselves and possibly make decisions about dosing adjustments (patient self-monitoring). Patient self-monitoring has been proven to be effective and safe, and is economically attractive. However, in order to assess its potential economic impact in Italy, there is a need for data on current treatment patterns and relative costs, which are currently not available. OBJECTIVE: To establish prevalent management patterns and costs incurred by Italian OAT patients. METHODS: An ad hoc questionnaire was developed and administered to OAT patients with the support of the main Italian OAT patients association. Returned questionnaires were checked for consistency and valid data were summarized. Resources used were costed according to published prices. RESULTS: A total of 4722 valid questionnaires were returned from all over Italy. The prevalent OAT management model in this sample relied on hospital-based anticoagulation clinics. Significant earning losses, transportation costs and other out-of-pocket expenses were incurred by patients, with an estimated mean overall monthly cost of approximately €30 (year 2008 value). There was a wide distribution of costs in this population, depending mainly on monitoring frequency, home-to-clinic distance and employment status. CONCLUSION: This study contributes to clarifying the organizational models of the Italian OAT population and delivers data on treatment patterns and costs that may be used when planning and evaluating alternative management options.

The cost effectiveness and cost utility of valsartan in chronic heart failure therapy in Italy: a probabilistic markov model.

To evaluate the cost effectiveness and cost utility of the use of valsartan in addition to standard therapy for the treatment of patients with chronic heart failure with low left ventricular ejection fraction (LVEF). The study was conducted by means of a cohort simulation based on a probabilistic Markov model and projecting the 23-month follow-up results of the Val-HeFT (Valsartan Heart Failure Trial) study over a 10-year time horizon. The model included four states (New York Heart Association [NYHA] classes II, III, IV, and death), and had a cycle duration of 1 month. Probabilistic simulations were performed using the WinBUGS software for Bayesian analysis. The distribution of patient parameters (sex, age, use of beta-adrenoceptor antagonists, and ACE inhibitors) in the simulated population were derived from the Italian heart failure patient population. Individual mortality data were derived from general mortality data by multiplying by a NYHA state-specific relative risk, while the probability of changing NYHA class was taken from the Val-HeFT data. Costs (2007 values) were calculated from the perspective of the Italian Health Service (IHS) and included costs for drugs and heart failure hospitalizations. Quality-of-life (QOL) weights were obtained by using published health-related QOL data for heart failure patients. A 3.5% annual discount rate was applied. Probabilistic sensitivity analysis was performed on each parameter using original-source 95% confidence interval (CI) values, or a +/-10% range when 95% CI values were unavailable. For the 10-year time horizon, patients were estimated to live for an average of 2.3 years or 1.7 quality-adjusted life-years (QALYs), with slight increases in the valsartan group. In this group, hospitalizations for worsening heart failure were predicted to be significantly reduced and overall treatment costs per patient to decrease by about and U20AC;550. In subgroup analyses, valsartan lost dominance in patients in NYHA II, and in those receiving beta-adrenoceptor antagonists or ACE inhibitors; the mean incremental cost-utility ratio for these groups was 21 240, 129 200, and 36 500 and U20AC;/QALY, respectively. Valsartan in addition to standard therapy is predicted to dominate standard therapy alone in Italian patients with mild to severe heart failure and low LVEF. There are relevant differences among various patient subgroups, and valsartan is expected to be good value for money particularly in the treatment of the most severe and less intensively treated (no ACE inhibitors, no beta-adrenoceptor antagonist) heart failure patients.