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Profili di responsabilità infermieristica in un caso di amputazione dell’avambraccio da errata pratica infusionale in neonato prematuro
No full text[Nursing responsibility profiles in a case of forearm amputation by wrong infusion practice in a premature newborn]This article refers to the case of a premature newborn twin (23 weeks of gestation + 6). Of the two brothers, only one survived, in a highly compromised state of health that led to a notable and dramatic series of clinical events: infectious complications, chronic renal failure, viscera herniation, intestinal perforation, and thrombocytopenia, treated with various infusions of platelet concentrates.During an infusion of platelet concentrate, an extravasation occurred with important tissue infarction. The lesion created, secondary to ischemic necrosis, evolves into dry necrosis, from the hand to the whole forearm, and leads to the amputation of the right forearm, despite the various attempts, pharmacological and surgical, experienced to avoid the extrema ratio.The purpose of this article is to analyze what happened considering scientific clinical evidence and the profile of responsibilities related to nursing practice
Personalized medicine: biomarkers and companion diagnostics
Full text linkGreat expectations are bound to the current evolution of medicine to personalized medicine. Thanks to rapid advances in genomics and molecular biology, new markers can be revealed for the presence of or susceptibility to a disease, or response to treatment. On such markers, diagnostic tests can be based; companion diagnostics (CDx, often called In Vitro devices) are diagnostic tests “coupled” with a therapeutic drug, aimed at assessing its applicability to a specific class of patients. As well as exemplifying some already implemented CDx applications, the purpose of this article is to highlight potentials and problems of personalized medicine today. In particular, the opportunity is analyzed for the co-development of a new drug and its CDx, through a parallel base research. This approach is promoted by the regulatory agencies but, due to scientific and economic factors implicit in the process, it is taking-off slowly. Personalized medicine deserves to grow and to expand, first of all because it simultaneously promises to substantially improve patient care and to make big costs savings for healthcare systems. From this point of view, all stakeholders (diagnostics manufacturers, clinical testing laboratories, pharmaceutical firms, the Department of health, and other bodies) should talk to each other in order to support the advancement of personalized medicine
Estimating the cost-effectiveness of treatment for prevention of thromboembolic events in at-risk adults with non-valvular atrial fibrillation
Full text linkINTRODUCTION: The direct oral anticoagulants (DOACs) have demonstrated a more predictable effect and a more favorable risk-benefit ratio compared to the standard oral anticoagulant treatment for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF).AIM: To estimate the efficiency of DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban vs. warfarin), in the prevention of clinical events in adult patients with NVAF.METHODS: A deterministic incremental cost-effectiveness analysis was performed to evaluate the avoidance of a clinical event and the incremental cost per avoided clinical event, in a hypothetical population of 100,000 adult patients with NVAF, over 1-year period. In the absence of head-to-head comparison trials between DOACs, relative risks were derived from a network meta-analysis. Clinical events considered include stroke/systemic embolism (SE) and major bleeding. Only direct health costs related to the management of clinical events and drug acquisition costs were considered. Clinical event management costs were derived from literature and from the Diagnosis Related Group (DRG) tariffs. Net annual treatment costs were calculated based on the daily dose reported in the Summary of Product Characteristics (SPCs) and the ex-factory price of each drug.RESULTS: Among DOACs, apixaban was associated with the highest net clinical benefit with 1,064 avoided events over 1 year, compared to warfarin (728 major bleeding events and 336 strokes/SE). Furthermore, apixaban is the most efficient DOAC, with a cost per avoided event equal to € 16,672 vs. warfarin (€ 24,120 for edoxaban 60 mg, € 36,777 for dabigatran 150 mg).CONCLUSION: Apixaban has the highest potential net clinical benefit among DOACs for patients with NVAF and the least incremental cost per avoided event for the Italian National Health Service
Nel merito dei rapporti medico legali vigenti tra le assicurazioni sociali: la gestione della malattia, la surrogazione e il cumulo tra prestazioni previdenziali nella loro concreta applicazione.
No full textThe article looks at the relationships between the two main Italian Social Security Insurance Institutes: the National Institute of Social Security (INPS) and the National Institute for Insurance against Accidents at Work (INAIL).The aim of the article, resulting from the daily working practices of the two Authors, is to examine the various sectors in which the two institutions are often confronted: the management of compensable illness, the subrogation, and the cases of accumulation of social security benefits provided by the two institutions for disabled persons.Some practical examples are reported in order to facilitate the reader the easy understanding of the issues addressed
[Meningococcal meningitis: a case of serogroup W in an underage migrant]
Full text linkMeningococcal disease is a worldwide infection associated with different forms and degrees of severity. In Europe and Italy, the most frequent capsular serogroups of Neisseria meningitidis are B and C. The incidence of the disease is higher in 0-4-year-old children and very significant (or elevated) also in adolescents and young adults. Numerous cases of serogroup W have recently been reported during episodes of mass gathering, as well as outbreaks in the African Meningitis Belt.In 2016, also the Local Health Unit of Viterbo had to deal with a case of serogroup W meningitis in a two-year-old Nigerian migrant child, hosted in a hospitality center. Health surveillance procedures and chemoprophylaxis for contacts were quickly activated and no secondary cases were found. This experience allowed us to make considerations about the meningococcal disease from a clinical, epidemiological, and preventive point of view, emphasizing the usefulness of the current Italian surveillance System
L’anagrafe dell’handicap della Provincia autonoma di Trento: aggiornamento dei dati al 31 dicembre 2016
No full text[The register of the handicap of the Autonomous Province of Trento: updating the data as of December 31, 2016] The Authors, examining the Italian welfare system and the contents of Law 104/92 (“Framework Law for assistance, social integration, and rights of the handicapped”), present a statistical analysis of the handicap database in Province of Trento.The Law 104/92 aims, among others, at guaranteeing the respect for human dignity, as well as the rights to freedom and autonomy of persons with disabilities, while promoting their integration in families, schools, work and society; preventing and removing negative conditions that stop the human development, the highest possible level of autonomy and participation in social life, as well as the enjoyment of civil, political and patrimonial rights; achieving a functional and social rehabilitation of people with physical and sensory impairment, while ensuring adequate services and prevention, care and rehabilitation measures, as well as a legal and economic protection; preparing adequate initiatives to overcome marginalization and social exclusion
Autodeterminazione e responsabilità sanitaria: le trasfusioni di sangue nei pazienti Testimoni di Geova
No full text[Self-determination and medical liability: blood transfusion in Jehovah\u27s Witnesses patients] The present article begins with a brief analysis of the biblical reasons why Jehovah\u27s Witnesses refuse transfusions, to analyze the right to self-determination of a patient, which is exercised through the express informed consent to medical treatment.Then, the article examines three situations that a doctor who is treating a Jehovah\u27s Witness may face: a non-urgent clinical situation that allows different treatment choices; a condition that requires treatment choices obliged but deferrable over time; and, finally, a situation that forces the doctor to a single therapeutic choice not postponed and predictable
Cost-effectiveness analysis of empagliflozin in the treatment of patients with type 2 diabetes and established cardiovascular disease in Italy, based on the results of the EMPA-REG OUTCOME study
Full text linkINTRODUCTION: The EMPA-REG OUTCOME trial demonstrated the efficacy of empagliflozin in the treatment of type 2 diabetes (T2D) with a previous history of cardiovascular (CV) disease. The drug is currently reimbursed for T2D Italian patients, but the reduction of CV mortality and morbidity shown in the trial opens a new treatment perspective in those patients with associated high CV risk.OBJECTIVE: Cost-effectiveness analysis of empagliflozin for the treatment of T2D patients with a previous history of CV disease, from the Italian National Health Service (NHS) perspective.METHODS: The analysis was performed with an individual simulation model, which can predict the time to CV events or death through a set of time-dependent regressions estimated on the patient-level data of the EMPA-REG OUTCOME trial. This design allows the direct simulation of long-term outcomes and costs without the need for surrogate endpoints.The model was adapted to the Italian setting, considering local epidemiological data, baseline quality of life (QoL) utility, background mortality and unit costs from current prices and tariffs. The cost perspective was that of the Italian NHS and the horizon of the simulation was lifetime. Costs and benefits were discounted at a 3.5% rate.RESULTS: Base case results were estimated on a cohort of 5,000 patients, which ensured the convergence of the simulation. Patients treated with empagliflozin in add-on to the standard of care (SoC) lived on the average 13.8 undiscounted years as compared to 11.8 years of patients on SoC alone. The gain in discounted quality-adjusted life years (QALYs) was 1.0, due to improved survival and QoL linked to the reduced incidence of CV events and CV mortality. The incremental cost-effectiveness ratio (ICER) was 4,811 €/QALY, well below the commonly applied threshold of 30,000-50,000 €/QALY.CONCLUSION: Empagliflozin in add-on to the SoC is a highly cost-effective strategy for the treatment of T2D patients with known CV disease in the Italian setting
A general model for the estimation of societal costs of lost production and informal care in Italy
Full text linkWe developed a general model for estimating and comparing disease- and treatment-specific lost paid/unpaid production (due to premature death and reduced ability) and informal care received (due to reduced ability) in Italy, starting from survival, demographic and Health-Related Quality of Life (HRQoL) data. Assuming the disease is not selecting a systematically different population in terms of mean wage than the general public, age- and gender-specific yearly production values are estimated combining data from the last Italian Time-Use-Survey on time dedicated to paid and unpaid (household, caring and volunteering) activities, with a) the last Italian Wage-Structure-Survey, for paid activities (Human Capital approach), and b) market prices for an equivalent service, for unpaid production (Proxy Good approach). To avoid double counting, age- and gender-specific maximum care needs are approximated with time dedicated to eating and personal care,reported in TUS. Present monetary values of future productivity and informal care are estimated applying a 3.5% annual discount rate. Lost life years due to a particular condition/treatment are estimated by comparison of its survival curve with the corresponding age- and gender-normalized survival curve of the general Italian population. The degrees of reduced productivity and need for informal care for remaining life years are estimated by comparison of condition-/treatment-specificreported HRQoL data with demographically matched Italian norms. Our results will be useful for cost-effectiveness and budget impact analyses conducted from the perspective of the Italian society and we encourage the inclusion of these costs in economic evaluations to allow decision makers to be fully informed about the costs and consequences of their decisions on healthcare interventions