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Aggressive, Metastatic Squamous Cell Carcinoma After a 46-Year-Old History of Chronic Osteomyelitis and Local Infectious Complications: A Case Report
Full text linkMarjolin’s ulcer is a squamous cell carcinoma (SCC) arising from any site of established chronic inflammation, especially with presence of scar tissue.An emblematic case report of locally disseminated SCC arising from a chronic osteomyelitis of the left leg complicated by recurring soft tissue infections lasting since 46 years is presented and discussed according to the available international literature evidence. Concurrent diseases, supporting factors, clinical and histopathological presentation, differential diagnosis, and time and mode of management of this potentially functional- and life-threatening pathological condition are reviewed and discussed to offer a theme to daily clinical care
Sicurezza in sala operatoria: utilizzo della tecnica FMEA/FMECA nel percorso diagnostico pre-analitico del campione biologico dalle sale operatorie ai laboratori
No full text[Safety in the operating room: use of the FMEA/FMECA proactive analysis technique in the pre-analytical diagnostic pathway of the biological sample from the operating room to laboratories]The inaccurate management of biological samples is one of the errors that can occur in the operating room: it can lead to a loss, incorrect labeling or storage of the sample, causing serious consequences for the patient. Proactive analysis of this high-risk process can reduce the possibility of this type of errors, improving patient safety and reliability of activities. A risk analysis technique employing proactive logic is the Failure and Effects Analysis/ Failure Mode, Effects, and Criticality Analysis (FMEA/FMECA).This paper describes an inter-professional and inter-facility project in which the FMEA / FMECA has been applied to the biological sample path from the operating room to the destination laboratories in two healthcare facilities in Bologna: the University Hospital S. Orsola Malpighi (AOU BO) and the Rizzoli Orthopedic Institute (IRCCS IOR). The aim of the project was to improve the safety and the reliability of the routine and urgent diagnostic procedure in these healthcare facilities.Two different working groups, belonging to the two healthcare facilities and composed of operating room doctors and nurses, have implemented the methodological steps of the FMEA/FMECA technique.At the end of the analysis process, 16 failure mode (FM) were identified at the AOU BO and 21 at the IRCCS IOR. Each FM was assigned a risk priority index (RPI) and the main causes and improvement actions to be planned were identified.Interventions were therefore undertaken to improve the safety and reliability of the riskiest welfare practices.A re-evaluation of the RPIs at 6 months-1 year from the improvement interventions will be carried out.The FMEA / FMECA technique gave the opportunity to the professionals involved to approach the adverse event through a new approach, which is the proactive method of risk analysis, using methods and tools for the improvement of patient safety that are independent, at least in part, from the study of the adverse event or near miss, representing an important step towards a real culture of security
"Malasanità": breve osservazione a proposito di un singolare quesito posto ai Consulenti Tecnici d’Ufficio in un caso di accertamento tecnico preventivo ex art. 8 della cosiddetta Legge Gelli-Bianco
No full text["Malasanità": brief observation on a singular question posed to Technical Consultants in a case of prior technical assessment pursuant to art. 8 of the so-called Legge Gelli-Bianco]Abstract non presente. Si riporta l\u27inizio dell\u27editoriale Nel luglio del 2018 il Giudice di un Tribunale riceveva istanza di accertamento tecnico preventivo ex art. 8 della cosiddetta Legge Gelli Bianco (Legge n. 24/2017) [1], che, come è noto, impone, a chi voglia esercitare di fronte al Giudice «un’azione risarcitoria derivante da responsabilità sanitaria, di tentare prima un percorso negoziale al fine di verificare la possibilità di evitare il processo» [2]. Nel caso in questione, il Giudice adíto, ai Consulenti Tecnici d’Ufficio (CTU) nominati poneva il seguente quesito: «Accertare l’entità delle lesioni e postumi permanenti residuate al signor XY a seguito dellamala sanità, il nesso di causa tra le lesioni lamentate e l’operato dei sanitari Usl, nonché la congruità delle spese mediche, la necessità di spese mediche future in modo da addivenire ad una composizione della lite»
Cost-Effectiveness Analysis of Peginterferon Beta-1a in the Treatment of Relapsing-Remitting Multiple Sclerosis in Italy: Results of an Updated Analysis
Full text linkHealthcare Resources Use in Patients with Human Immunodeficiency Virus (HIV). Real-World Evidence From Six Italian Local Health Units
Full text linkAIM: The aim of the study was to evaluate healthcare resource use and related costs for the management of people living with Human Immunodeficiency Virus (PLWHIV) with and without comorbidities, and to compare the burden of comorbidities in PLWHIV to the general population.METHODS: An observational retrospective analysis, based on administrative and laboratory databases from 6 Italian Local Health Units (LHUs) was performed. Individuals receiving either an HIV treatment [Antiretroviral therapy (ART) – ATC code: J05A)], or with an HIV positive laboratory test result between January 1st, 2014 and December 31st, 2014 were included. The date of first ART prescription or positive test of HIV was used as the Index Date (ID). Patients enrolled were followed-up for all time available from the ID (follow-up period) and their clinical characteristics were investigated from one year prior to the ID (characterization period). Comorbidities were measured by using the Charlson Comorbidity Index; findings were compared with those of a sample of the general population with the same age and sex distribution (OsMed 2015). Healthcare resource use and related cost was evaluated during the follow-up period.RESULTS: 1,214 patients were included, 837 were PLWHIV without any comorbidities and 377 were PLWHIV with at least one comorbidity. Mean prevalence of prescriptions for treatment of comorbidities was higher in the HIV-infected population than in the Italian general population. The annual healthcare cost of managing HIV patients with comorbidities, was significantly higher than that for patients without comorbidities (€ 10,615 vs. € 8,665, p < 0.001).CONCLUSIONS: Study results showed that 30% of PLWHIV had at least one comorbidity. The cost of managing PLWHIV who have comorbidities was significantly higher than that of managing PLWHIV without comorbidities. Our data confirm that care and treatment services should be adapted to address the specific needs of people living with both HIV and comorbidities
Compiti e funzioni del medico competente e modalità di svolgimento della professione alla luce della legislazione vigente
No full text[The competent physician for the assessment of risks at work: tasks, functions and conduct in the light of current legislation]Abstract non presente. Si riporta l\u27inizio dell\u27editorialeNella normativa italiana già con il Regio Decreto 530 del 1927 all’art. 6 viene introdotta la figura del medico di fabbrica, e precisato che nelle lavorazioni industriali nelle quali si adoperino o si producano sostanze tossiche o infettanti indicate in un apposito elenco i lavoratori dovranno essere visitati da un medico competente..
Albutrepenonacog alfa (Idelvion®) for the treatment of Italian patients with hemophilia B: a budget impact model
Full text linkBACKGROUND: Enhanced pharmacokinetic profile of albutrepenonacog alfa allows to prolong the interdose period in prophylaxis, maintaining higher trough level, and to reduce dosage needed for bleeding. This improvement could lead to a better efficiency of the hemophilia B treatment.OBJECTIVES: To estimate the impact of this new drug on the Italian National Health System (NHS).METHODS: A model was developed from the NHS perspective to assess the budget impact of treating severe hemophilia B with reimbursed recombinant factor IX over 3 years in Italy. Target population was based on data from the National Registry of Congenital Coagulopathies, which collects data from 54 Hemophilia Treatment Centers. Treatment options were: albutrepenonacog alfa (Idelvion®), eftrenonacog alfa (Alprolix®) and nonacog alfa (BeneFIX®). Annual bleeding rate, dose and infusions needed to treat an episode based on clinical trials data were considered.RESULTS: Mean costs per patient were calculated for prophylaxis and bleeding treatment by age groups. Applying age-specific costs to the expected new pattern of drugs utilization, the impact on the NHS budget was € 6 million of savings cumulated in 3 years. The model results most sensitive to drug dosages. Lower drug consumption in prophylaxis and reduced bleeding rate than the alternatives reduce expenditures. Main limitations of this analysis were the assumptions that all severe patients receive prophylaxis and the lack of consideration of positive effects of hemorrhagic complications reduction (with consequent lower need of physiotherapy/prosthetic substitution).CONCLUSIONS: The introduction of Idelvion® as therapeutic option for hemophilia B is expected to decrease pharmaceutical costs and improve patient’s quality of life due to less frequent infusions
La mediazione trasformativa nell’era della patient revolution. Un modello per la gestione del rischio clinico e legale nelle ASL italiane
No full text[Transformative mediation in the era of the patient revolution. A model for the management of clinical and legal risk in Italian health facilities]Nowadays, too many patients do not perceive that their doctors are exclusively dedicated to care them. This is probably because current health systems are too focused on physicians and diseases, rather than on patients. Such systems are also expensive, fragmented, inefficient and often cynical, generating not only the anger but also the willingness to bring legal claims from many patients. Many scholars, in fact, claim that "too much medicine" can bring more harm than good to the patients and to the health systems themselves, therefore promoting a more sober and respectful medicine. This is the vision of the "patient revolution" and the idea that inspires some other movements that aim to break the vicious circle of greed and cynicism that damages not only patients but also health professionals. Within the same vicious circle, an exponential increase in litigations takes place, as an additional negative effect of the system focused on the disease and on the doctors instead of on the patient.In the present article, we assume that a greater participation of the patient in the choices concerning his/her own health is the fertile ground in which concrete solutions can be found to many problems arising from the current medicine. We therefore analyze the main advantages of active patient participation, which in turn generate a reduction in health conflicts. Based on this analysis, we propose a model in which through various approaches, tools and methods - starting from the upstream prevention of the conflicts - we can also manage them downstream, for the benefit of both patients and health professionals. Finally, we show that within this framework, transformative mediation is an essential approach for weakening many legal disputes and repairing the relational damage generated upstream, where communication has failed or is completely lacking in the clinical practice
Cost-Consequence Analysis of Three Different Diagnostic Strategies in the First- and Second-Line Treatment of Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Full text linkBACKGROUND: Unlike the tissue one, liquid biopsy is a less invasive diagnostic method for the assessment of possible mutations of the tumor, based on the analysis of circulating free DNA (cfDNA) present in the plasma component of the blood. Because blood samples are easily obtainable, plasma biopsy is a non-invasive method, supplementing the more traditional biopsy techniques.AIM: A cost-consequence analysis was conducted to compare the adoption of three different diagnostic strategies in the first- and second-line treatment of locally advanced or metastatic NSCLC: i) tissue strategy (only tissue biopsy for first and second line), ii) combined strategy (first line: tissue biopsy. If unknown, liquid biopsy; second line: liquid biopsy. If negative, tissue biopsy) and iii) potential strategy (first line: tissue biopsy. If unknown or tissue ineligible, liquid biopsy; secondline: liquid biopsy. If negative, tissue biopsy).METHODS: A decision-analytic model was developed considering the Italian NHS’s perspective. We only evaluated direct medical costs (tissue biopsy, management of complications associated with tissue and liquid biopsies) borne by the NHS. The CCA was conducted over a time horizon of 1 year, assuming that for each patient with mNSCLC the diagnosticpathway (first- and second-line treatment) ended within such period. Key variables were tested in the sensitivity analysis.RESULTS: Considering both the first and the second line of treatment, the potential strategy constitutes the cost-effective alternative, characterized by an average cost per correctly identified case (€ 685) lower than that estimated for the combined strategy (€ 732) or for the tissue strategy (€ 1,004). The potential strategy remains cost-effective, also considering the results referred to the first- or second-line treatment only.CONCLUSION: The choice of a correct diagnostic strategy is crucial in order to optimize cancer therapies in the first- and second-line treatment of locally advanced or metastasized NSCLC. The addition to the diagnostic pathway of the liquid biopsy would correctly identify a greater number of cases, supporting the prescription of the best oncological therapy
