Budget impact analysis of the use of paricalcitol for the treatment of secondary hyperparathyroidism in chronic kidney disease

OBJECTIVE: Evaluation of the budget impact of the use of paricalcitol (compared to alternative treatment) for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) when used at two different timing of therapy.METHODS: Two Markov models related to a different timing of treatment have been developed: the intermediate stage of chronic kidney disease (CKD3) and the dialysis stage. The analysis was conducted with the perspective of the Italian National Health System and over a 5-year time horizon. The clinical and economic data used in the model were derived from the literature and other assumptions were made based on the opinion of clinical experts. Univariate sensitivity analysis was conducted to test the robustness of the results.RESULTS: The base case shows that starting paricalcitol treatment from the dialysis stage (considering 13,311 possible candidates) is associated with a reduction in direct costs from € 1,782,921,351 to € 1,622,357,209 over 5 years. Furthermore, considering a collective of 1,000 subjects eligible and starting treatment with paricalcitol since the intermediate stages of the CKD, is associated with an overall cost saving of € 1,197,500.DISCUSSION AND CONCLUSIONS: Paricalcitol is expected to be cost-saving in patients with SHPT in Italy considering both the therapeutic indications of the drug. Moreover, despite the higher cost of using paricalcitol in pre-dialysis stage, an early treatment of SHPT determine an overall decrease in direct medical costs

Evaluation of drinking patterns and their impact on alcohol-related aggression: a national survey of adolescent behaviours

BACKGROUND: Although there have been a wide range of epidemiological studies examining the impact of patterns of alcohol consumption among adolescents, there remains considerable variability in both defining these patterns and the ability to comprehensively evaluate their relationship to behavioural patterns. This study explores a new procedure for defining and evaluating drinking patterns and integrating well-established indicators. The composite measure is then used to estimate the impact of these patterns on alcohol-related aggressive behaviour among Italian adolescents. METHODS: Data were collected as part of the 2011 European School Survey Project on Alcohol and other Drugs (ESPAD). A national sample of 14,199 students aged 15–19 years was collected using an anonymous, self-administered questionnaire completed in a classroom setting. Drinking patterns were established using principal component analysis. Alcohol-related aggression was analysed as to its relationship to patterns of drinking, behaviour of friends towards alcohol use, substance use/abuse, school performance, family relationships and leisure activities. RESULTS: Several specific drinking patterns were identified: “Drinking to Excess” (DE), “Drinking with Intoxication” (DI) and “Drinking but Not to Excess” (DNE). A higher percentage of males were involved in alcohol-related aggression compared with females. In males, the DE and DI patterns significantly increased the likelihood of alcohol-related aggression, whereas the DNE pattern was negatively associated. Similar results were found in females, although the DI pattern was not significantly associated with alcohol-related aggression. Overall, cigarette smoking, illegal drug use, truancy, limited parental monitoring, frequent evenings spent outside of the home and peer influence associated strongly with alcohol-related aggression. CONCLUSIONS: Our findings suggest that drinking patterns, as uniquely monitored with an integrated metric, can: 1) explain drinking habits better than commonly used indicators of alcohol use and 2) provide a better understanding of behavioural risks such as alcohol-related aggression. Environmental background also appears to strongly associate with this type of aggressive behaviour

Analisi di rete basata sul modello matematico dei grafi, sperimentazione nell\u27ambito del progetto BINET

The research activity carried out in BINET project aims at designing a Business Intelligence framework based on Social Network technology, better known as Complex Networks in the healthcare field, in order to establish a platform to analyze data through non-conventional graph methodologies and interfaces (graph data-browsing). Scientific validation of methodologies used by the framework is carried out in the healthcare field and focuses on the analysis of therapeutic, time and spatial associations among the various treatments, such as outpatient, drug prescriptions, length of hospital stays etc., received by the patients recruited for the study, to find out correlations between treatments at the individual level and enabling patient "follow-up". Another aspect of the validation concerns the analysis of papers extracted from epidemiological and clinical databases in order to identify emerging technologies, standard of care, "benchmarking" among various operational units dealing with the same pathologies, as well as population profiling to enable identification of homogeneous groups, from a socio-demographic point of view and healthcare demand, subject to tailored prevention campaigns. A more specific application deals with the analysis of drug prescriptions to find out correlations between patient pathology profiles (derived from all treatments and diagnosis received by patients) and prescriptive behaviors of their general practitioners in order to define shared "guidelines" and identify standard practices to compare with practice guidelines. The document describe some sperimentation in these area

Prognostic value of high-dose dipyridamole stress myocardial contrast perfusion echocardiography

The addition of myocardial perfusion (MP) imaging during dipyridamole real-time contrast echocardiography improves the sensitivity to detect coronary artery disease, but its prognostic value to predict hard cardiac events in large numbers of patients with known or suspected coronary artery disease remains unknown

Comparative prediction of cardiac events by wall motion, wall motion plus coronary flow reserve, or myocardial perfusion analysis: a multicenter study of contrast stress echocardiography

ObjectivesThis study sought to determine whether the increasing difficulty of assessing wall motion (WM), Doppler coronary flow reserve on the left anterior descending coronary artery (CFR-LAD), and myocardial perfusion (MP) during stress echocardiography (SE) was justified by increasing prognostic information in patients with known or suspected coronary artery disease.BackgroundThe use of echocardiographic contrast agents during SE permits the assessment of both CFR-LAD and MP, but their relative incremental prognostic value is undefined.MethodsThis study followed a multicenter cohort of 718 patients for 16 months after high-dose dipyridamole contrast SE for evaluation of known or suspected coronary artery disease. The ability of WM, CFR-LAD, and MP to predict cardiac events was studied by multivariable models and risk reclassification.ResultsAbnormal SE was detected as a reversible WM abnormality in 18%, reversible MP defect in 27%, and CFR-LAD <2 in 38% of subjects. Fifty cardiac events occurred (annualized event rate 6.0%). A normal MP stress test had a 1-year hard event rate of 1.2%. The C-index of outcomes prediction based on clinical data was improved with MP (p < 0.001) and WM/CFR-LAD (p = 0.037), and MP (p = 0.003) added to clinical and WM data. Net risk reclassification was improved by adding MP (p < 0.001) or CFR-LAD (net reclassification improvement p = 0.001) in addition to clinical and WM data. The model including clinical data, WM/CFR-LAD, and MP performed better than that without MP did (p = 0.012).ConclusionsThe multiparametric assessment of WM, CFR-LAD and MP during stress testing in patients with known or suspected coronary artery disease is feasible. Contrast SE allowed better prognostication, irrespective of the use of CFR-LAD or MP. The addition of either CFR-LAD or MP assessment to standard WM analysis and clinical parameters yielded progressively higher values for the prediction of cardiac events and may be required in today's intensively treated patients undergoing SE, because their average low risk of future cardiac events requires methods with higher predictive sensitivity than that available with standalone WM assessment

New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System

Objective: To perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile.Design: An early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone.Setting: The Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen.Participants: Hypothetical patients with diabetic foot infection (DFI) grades I/IIB.Interventions: The PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs.Main Outcomes: Days within which the clinical target was achieved and direct health costs for patients' management.Results: Additional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7-28 days, ICERs varied from about 1 to 70 for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7-28 days, BI was 8,100,000 to 700,000, with saving less than 2,000,000 with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process.Conclusion: The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system

AI Cardiac MRI Scar Analysis Aids Prediction of Major Arrhythmic Events in the Multicenter DERIVATE Registry

Scar; MRI; Arrhythmic eventsCicatriu; Ressonància magnètica; Esdeveniments arítmicsCicatriz; Resonancia magnética; Eventos arrítmicosBackground Scar burden with late gadolinium enhancement (LGE) cardiac MRI (CMR) predicts arrhythmic events in patients with postinfarction in single-center studies. However, LGE analysis requires experienced human observers, is time consuming, and introduces variability. Purpose To test whether postinfarct scar with LGE CMR can be quantified fully automatically by machines and to compare the ability of LGE CMR scar analyzed by humans and machines to predict arrhythmic events. Materials and Methods This study is a retrospective analysis of the multicenter, multivendor CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy (DERIVATE) registry. Patients with chronic heart failure, echocardiographic left ventricular ejection fraction (LVEF) of less than 50%, and LGE CMR were recruited (from January 2015 through December 2020). In the current study, only patients with ischemic cardiomyopathy were included. Quantification of total, dense, and nondense scars was carried out by two experienced readers or a Ternaus network, trained and tested with LGE images of 515 and 246 patients, respectively. Univariable and multivariable Cox analyses were used to assess patient and cardiac characteristics associated with a major adverse cardiac event (MACE). Area under the receiver operating characteristic curve (AUC) was used to compare model performances. Results In 761 patients (mean age, 65 years ± 11, 671 men), 83 MACEs occurred. With use of the testing group, univariable Cox-analysis found New York Heart Association class, left ventricle volume and/or function parameters (by echocardiography or CMR), guideline criterion (LVEF of ≤35% and New York Heart Association class II or III), and LGE scar analyzed by humans or the machine-learning algorithm as predictors of MACE. Machine-based dense or total scar conferred incremental value over the guideline criterion for the association with MACE (AUC: 0.68 vs 0.63, P = .02 and AUC: 0.67 vs 0.63, P = .01, respectively). Modeling with competing risks yielded for dense and total scar (AUC: 0.67 vs 0.61, P = .01 and AUC: 0.66 vs 0.61, P = .005, respectively). Conclusion In this analysis of the multicenter CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy (DERIVATE) registry, fully automatic machine learning–based late gadolinium enhancement analysis reliably quantifies myocardial scar mass and improves the current prediction model that uses guideline-based risk criteria for implantable cardioverter defibrillator implantation. ClinicalTrials.gov registration no.: NCT0335264

Myocardial structural, perfusion and metabolic correlates of left bundle branch block mechanical derangement in patient with dilated cardiomyopathy

Background-Left bundle branch block (LBBB) influences upon regional left ventricular (LV) structure, perfusion and metabolism were not thoroughly investigated in dilated cardiomyopathy (DCM) patients. Methods and Results-Eleven DCM patients with LBBB (69?11 years, LV ejection fraction[EF]: 35?8%) and 7 DMC patients without LBBB (58?9 years, LV EF: 37?10%) were studied by cardiac magnetic resonance (CMR) and positron emission tomography (PET). Left ventricle was divided in 3 regions: septum, adjacent (anterior-inferior) and lateral. Regional midwall circumferential strain, maximum shortening (&#1013;peak) and strain rate were obtained from tagged CMR. Systolic stretch index (SSI) was calculated as positive strain rate (stretching) divided by total strain rate. Myocardial metabolic rate of glucose (MMRG), resting and hyperemic myocardial blood flow (MBF) were quantitated using 2-[18F]fluoro-2-deoxyglucose and [13N]ammonia PET, respectively. Conversely from non LBBB patients, LBBB patients showed highly inhomogeneous systolic deformation pattern which changed gradually moving from discoordinate [(SSI: 0.485 (0.284)] and poorly contracting (&#1013;peak: -1.14?0.96%) septum to coordinate [SSI: 0.002 (0.168)] and strongly contracting (&#1013;peak: -13.63?2.58%) lateral region (both P<0.0001). This pattern was closely matched to MMRG distribution disclosing lowest, intermediate and highest values respectively in the septum, adjacent and lateral regions (P<0.0001). Septal-to-lateral thickness ratio was lower in LBBB than non LBBB patients (P=0.03). In both groups, LV distribution of resting and hyperemic MBF and MBF reserve did not differ significantly. Conclusions-In DCM patients, the extensive LV contraction abnormalities induced by LBBB caused regional myocardial metabolic and structural remodeling without consistent changes in blood flows.-

RarERN Path: a methodology towards the optimisation of patients’ care pathways in rare and complex diseases developed within the European Reference Networks

Background: In 2017, the European Commission has launched the European Reference Networks (ERNs), virtual networks involving healthcare providers across Europe. The aim of the ERNs is to tackle complex and rare diseases and conditions that require highly specialized treatment and a concentration of knowledge and resources. The ERN on rare and complex connective tissue and musculoskeletal diseases (ERN ReCONNET) is one of the 24 ERNs approved that aims to improve the management of Rare and Complex Connective Tissue and Musculoskeletal Diseases. Objective: The RarERN Path methodology aims to create a single reference organisational model for patients’ care pathways which, if applied in different contexts, helps to ensure an improved, cost-effective and patient-centred equal care to rare and complex diseases. Methods: Starting from existing standard methods for the creation and elaboration of patients’ care pathways, a specific methodology was created in order to take advantage of the distinctive and peculiar characteristics of the ERNs. Specifically, the development of the RarERN Path methodology involved different stakeholders: health economists, clinicians and researchers expert in rare and complex diseases, communication experts, experts in patients’ involvement and narrative medicine and policy-makers. Results: The RarERN Path methodology foresees six consecutive phases, each with different and specific aims. Specifically, the six phases are represented by: Phase 1—mapping of existing patients’ care pathways and patients’ stories; Phase 2—design of an optimised common patients’ care pathway; Phase 3—consensus on an optimised common patients’ care pathway; Phase 4—key performance indicators definition; Phase 5—refinement; Phase 6—pilot phase (optional). Conclusion: The application of RarERN Path to the different disease-specific and geographical contexts would help to ensure an improved, cost-effective and patient-centred equal care to rare and complex diseases across Europe as well as a possible tangible action towards the integration of ERNs into the different European healthcare systems