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Health Technology Assessment on the use of the Wearable Cardioverter Defibrillator in Patients with Myocardial Infarction and with ICD Explant
Full text linkThe objective of the present work is to conduct a Health Technology Assessment (HTA) on the use of the Wearable Cardioverter Defibrillator (WCD) in patients at risk of Sudden Cardiac Arrest (SCA) following Myocardial Infarction (MI) or with an explanted Implantable Cardioverter Defibrillator (ICD)
Promuovere il coinvolgimento dei pazienti per migliorare la sicurezza in chirurgia
No full textBackground: Patient safety has become essential with increasing complexity of health systems and the consequent increase in patient damage. Clinical risk management aims to prevent and reduce the risks, errors and damages that occur to patients during health care. The direct involvement of patients in care pathways can be both an important source of information on potential risks and a resource for improving safety.Objective: To improve patient safety in surgery by promoting the active involvement of patients admitted to an orthopedic department.Method: After check-in, a checklist was administered to the patients, consisting of 21 items that took into consideration the good practices to be applied in surgery. The checklists returned by the patients at the end of their stay were analyzed to identify any areas for improvement.Results: From July 2019 to September 2019, the checklists were administered to 76 patients who underwent hip or knee arthroplasty, admitted to an orthopedic ward. 63% of the delivered checklists were returned by the patients. The analysis made it possible to verify that good practices for safety in surgery are effectively applied by health personnel. However, some critical areas were identified on which to intervene with improvement actions.Conclusions: This work demonstrates that patient involvement can help improve the safety of the surgical path, in order to prevent potential adverse events. Further studies are needed with sufficient sample power to validate the findings of this work
Corrigendum: An Integrated Management Model of Patients With Atrial Fibrillation: The Experience of the Local Health Unit Tuscany North-West/1
Full text linkThere was an error in the description of GLORIA-AF registry program at page 10 in this Supplement by Casolo et al. [Farmeconomia. Health economics and therapeutic pathways 2019; 20(Suppl 1): 3-16; https://doi.org/10.7175/fe.v20i1S.1454]. The online version has been corrected on February 12, 2020
The Economic Burden of Different Multiple Sclerosis Courses: Analysis from Italian Administrative and Clinical Databases
No full textINTRODUCTION: Poor specific economic information are available for the different Multiple Sclerosis (MS) courses: relapsing remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS). This study aims to fill this gap.METHODS: A cost of illness study was conducted. Clinical information of patients treated in a major MS Center located in Lombardy, in the period 2004-2010, were linked with administrative data of Lombardy Healthcare System. We assessed the mean cost per patient-year and its association with different MS characteristics.RESULTS: The study identified 869 patients (83.9% RRMS, 8.5% SPMS, 7.2% PPMS). RRMS reported the highest cost per patient-year with a mean of € 5,623 in Expanded Disability Status Scale (EDSS) 0-3, € 8,675 in EDSS 3.5-6.5, and € 7,451 in EDSS 7-9. The PPMS patients reported the lower annual mean cost per patient in all EDSS categories. The mul-tivariate analysis reported a significant association between cost per patient-year and EDSS categories, relapse and use of Disease Modifying Therapies but not to MS courses, age and sex.CONCLUSION: This study provides a complete picture of MS courses direct costs at the different disability levels. The results can help to better understand the burden of each MS courses and the cost-effectiveness of different interventions
Treatment With Efmoroctocog Alfa (Elocta®) in Hemophilia: A Case Series
Full text linkHemophilia A is a rare X-linked disease that occurs as a result of a defect in the FVIII-encoding gene. The reduction or absence of plasma FVIII compromises the coagulation cascade, resulting in frequent bleeds, especially in joints or soft tissues. Currently, replacement therapy with coagulation factor concentrates is the gold standard for the treatment of FVIII deficiency.Herein, we report a case series of five hemophilia A patients treated with an extended half-life recombinant human coagulation factor, FVIII-Fc fusion protein (efmoroctocog alfa). The prophylactic regimen for each patient was individualized based on their pharmacokinetic profile.Compared to previous prophylactic treatments, most patients received a reduced weekly dose of concentrate, all underwent a reduced frequency of administration, the annualized bleeding rates (ABR) and hemophilia joint health scores (HJHS) were stable or improved. The half-life of efmoroctocog alfa and the 72-hour trough levels were higher than those observed in the A-LONG Phase III trial.In conclusion, all patients reported clinical improvements and general subjective wellbeing in the absence of significant safety concerns after switching to efmoroctocog alfa.
Clinical Impact of two Different Diagnostic Strategies in the First- and Second-Line Treatment of Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Full text linkBACKGROUND: A histopathological and mutational diagnosis has become a priority in the correct choice of the most appropriate cancer therapy for NSCLC. In the absence of a molecular analysis, the therapeutic choice will be directed towards platinum-based chemotherapy, thus preventing, in the presence of a specific mutation, the benefits deriving from the administration of a target therapies (TT).AIM: the present analysis was carried out with the aim of estimating the clinical impact, expressed in terms of progression free survival (PFS), associated with the use of the combined strategy (tissue biopsy and liquid biopsy) or the tissue strategy in the EGFR+ mNSCLC population.METHODS: A pre-existing cost-consequence model was adapted to estimate the annual number of mNSCLC patients with or without the EGFR mutation in order to decide the oncological treatment to be administered in first (1L) or second line (2L). In 1L, against the presence of the EGFR mutation, the administration of a Tyrosine Kinase Inhibitor (TKI), such as osimertinib, gefitinib, erlotinib or afatinib, was considered; in the absence of the EGFR mutation, the administration ofstandard platinum-based chemotherapy was instead considered. With reference to 2L, in the presence of the EGFR T790M mutation, only osimertinib was considered. In the absence of the EGFR T790M mutation, the administration of the standard platinum-based chemotherapy was also considered. The PFS data associated with each of the drugs considered were extrapolated from the respective clinical studies. Key variables were tested in the sensitivity analysis.RESULTS: The adoption of the combined strategy (tissue biopsy and liquid biopsy), by virtue of a greater number of patients treated with TKIs, would make it possible to increase the average PFS in the range of 1.1-3,7 months in the 1L and by 1.4 months in the 2L.CONCLUSION: These results show how the adoption of a correct diagnostic strategy is critical in order to optimize the choice of the therapeutic path in the 1L and 2L of mNSCLC. The addition of the liquid biopsy to the classic diagnostic path (tissue biopsy) would in fact allow to obtain an increase in therapeutic efficacy (average PFS)
Limitazione della responsabilità sanitaria in tempi di emergenza da COVID-19
No full text[Abstract non presente. Si riporta l\u27inizio dell\u27editoriale]Nell’odierno contesto storico, gravato da un’emergenza sanitaria senza precedenti, ci si domanda sotto quali forme la responsabilità medica debba essere inquadrata e quali siano le singole responsabilità che possano essere addebitate all’esercente la professione sanitaria, di cui all’art. 7 della legge 8 marzo 2017, n. 24, e alla struttura sanitaria..
Cognitive-Behavioral and Pharmacological Treatments for Insomnia: A Combined Approach
Full text linkInsomnia is the most prevalent sleep disorder (10-40%). It is defined as the subjective perception of difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity for sleep and that results in some form of daytime impairment. Among the typical symptoms, there are fatigue, decreased mood or irritability, general malaise, and cognitive impairment. According to the International Classification of Sleep Disorders 3rd edition, ICSD-3, it has been defined as chronic (lasting more than three months) or short-term insomnia (less than three months).In clinical practice, the usual therapeutic approach is pharmacological (benzodiazepines, z drugs, slow wave sleep enhancers), even if the American Academy of Sleep Medicine (AASM), the American College of Physicians (ACP), and the European Sleep Research Society (ESRS) guidelines suggest that the first clinical choice should be non-pharmacological (cognitive behavioral therapy). A combined (non-pharmacological and pharmacological)approach could be considered in poor responders to manage drug dependence and to increase compliance to treatment and patients’ quality of life
Hypercalcemia and Nephrogenic Diabetes Insipidus: Rare and Life-Threatening Effects of Lithium Intoxication
Full text linkLithium is the most effective therapy for bipolar and schizoaffective disorders. Despite its efficacy, lithium has a narrow therapeutic index and adverse effects are frequent. Lithium intoxication (LI) generally affects brain, but less frequently can affect kidneys, thyroid, and parathyroid.Here, we report the case of a patient with lithium neurotoxic effects complicated by parathyroid and renal adverse effects. The patient was a 52-year-old woman treated with lithium, who was recently diagnosed with hypercalcemia and hyperparathyroidism.She was admitted for severe agitation, confusion, and diffuse tremor. Despite serum lithium and calcium normalization, laboratory tests revealed a life-threatening hypernatremia caused by nephrogenic diabetes insipidus (NDI). Hemodialysis was started, but after the first treatment the patient died for cardiac arrest.Neurological symptoms of LI may occur even if the dosage is close to the normal therapeutic range. Hypercalcemia and NDI are rare, but should be promptly diagnosed and treated. In case of poor clinical outcome, hemodialysis should be performed independently of lithium serum level