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Background and aim: Unplanned extubation (UE) in Intensive Care Units (ICU) is an indicator of quality and safety of care. UEs are classified in: accidental extubations, if involuntarily caused during nursing care or medical procedures; self-extubation, if determined by the patient him/herself. In scientific literature, the cumulative incidence of UEs varies from 0.3% to 35.8%. The aim of this study is to explore the incidence of UEs in an Italian university general ICU adopting a well-established protocol of tracheal tube nursing management and fixation. Methods: retrospective observational study. We enrolled all patients undergone to invasive mechanical ventilation from 1st January 2008 to 31st December 2016. Results: in the studied period 3422 patients underwent to endotracheal intubation. The UEs were 35: 33 self extubations (94%) and 2 accidental extubations (6%). The incidence of UEs calculated on 1497 patients intubated for more than 24 hours was 2.34%. Instead, it was 1.02%, if we consider the whole number of intubated patients. Only in 9 (26%) cases out of 35 UEs the patient was re-intubated. No deaths consequent to UE were recorded. Conclusions: The incidence of UEs in this study showed rates according to the minimal values reported in scientific literature. A standardized program of endotracheal tube management (based on an effective and comfortable fixing system) seems to be a safe and a valid foundation in order to maintain the UE episodes at minimum rates.

INTRODUCTION: Biosimilar products play an important role in improving the access to biological medicines for an increased number of patients and enhancing the financial sustainability of the health systems. AIM: To assess the cost saving potential associated with the introduction of two biosimilars (Benepali ® and Flixabi ® ) vs. their respective reference biological products on the European and Italian markets. METHODS: A budget impact model was developed to estimate the cost saving of the hypothetical introduction of Benepali ® and Flixabi ® vs. Enbrel ® and Remicade ® , respectively, in three European countries. The analysis was conducted from the payer perspective, over a 3-year period. In addition, the same model was used to assess the impact of Benepali ® vs. Enbrel ® in three Italian regions over a 2-year period. The model compares the costs associated with the current treatment patterns, used to manage patients with all the conditions which Benepali ® and Flixabi ® are authorized for, with that of a hypothetical treatment pattern in which biosimilar products have been introduced. Only direct costs associated with the drug acquisition were considered. The model was constructed using published country- or region-specific data, where available. Annual drug acquisition costs were calculated using the dosing information from SPCs and country-/region-specific price lists. RESULTS: The introduction of Benepali ® and Flixabi ® in the biologic therapeutic setting of three European countries resulted in substantial cost savings across the entire scenario, with different penetration over a 3-year period. Similarly, over a 2-year horizon, the introduction of Benepali ® in the biologic therapeutic setting of three Italian regions resulted in significant cost savings. In all cases, the greater savings were observed in the scenario where the biosimilars’ penetration was higher. CONCLUSIONS: The introduction of Benepali ® and Flixabi ® has a substantial cost saving potential for the Italian and European health systems, and the budget impact is sensitive to the uptake rates of the biosimilars market.

The clinical pattern of Metastatic ColoRectal Cancer patients, receiving first-line infusional 5-FU or oral capecitabine (CAP) chemotherapies, was valorized in the perspective of the Italian NHS. A cost-minimization analysis was implemented on the basis of retrospective data from 5 centers. 202 subjects: 126 receiving 5-FU-association, 10 5-FU-monotherapy; 31 CAP-association, 35 CAP-monotherapy. Therapeutic patterns differed as to chemotherapy administration resources consumption: 5-FU was administered in Day Hospital and CAP in the outpatient setting. Mean total cost/patient was in the range of € 6,841 (monotherapy-5-FU)- € 12,620 (association-5-FU) and € 2,056 (monotherapy-CAP)-€ 9,745 (association-CAP). The infusional administration route of 5-FU was the driver of costs.

The aim of this review was to summarize recent findings on patients’ adherence and persistence to antihypertensive (AHT) therapy. A literature search was performed using MEDLINE for original studies published in the English language between April 2003 and July 2008. According to selection criteria, the review included 47 papers classified into the following groups: (i) studies assessing overall behaviour towards treatment; (ii) studies differentiating among AHT classes; and (iii) studies comparing specific AHTs. It was not possible to perform a meta-analysis due to the wide variety of study designs, objectives and definitions. However, some strong messages emerged: non-adherent patients have higher blood pressure (BP) values, which lead to a higher risk of cardiovascular events; angiotensin II type 1 receptor antagonists (angiotensin receptor blockers) are the AHTs with the best patient adherence and persistence to treatment; better treatment adherence is observed in patients using fixed versus extemporaneous AHT combinations. Improving BP control is pivotal to reduce cardiovascular events, allowing for a better use of healthcare resources, and

Objectives To evaluate resource utilization and related costs in the management of hemophilic patients with Factor VIII inhibitors.

Gastro-esophageal reflux disease (GERD) is a common medical problem with a broad spectrum of symptoms and varying degrees of severity and frequency. Most patients with GERD, regardless of endoscopic status, suffer symptomatic relapses within few months from stopping acid suppressant therapy, thus requiring long term management of their disease to prevent relapses. On-demand therapy (i.e., medication taken as needed to relieve symptoms) might be an effective modality of long-term treatment in patients with non-erosive gastro-esophageal reflux disease. An economic evaluation, the ONE (ON-demand treatment with Esomeprazole) study, was conducted to assess costs and consequences over a 6-month period with the 20 mg esomeprazole on-demand strategy compared to the 20 mg once daily continuous therapy in patients with GERD. The ONE study was a multicentre, randomised, open-label, parallel-group trial conducted in 451 specialist clinics in Italy. A cost-consequence analysis was performed in the societal and NHS perspective. Resource utilisation data associated with direct medical costs, direct non-medical costs and indirect costs were collected in the study. Time to first relapse was defined as time to the patient’s first contact with the investigator because of unsatisfactory symptoms’ control. In addition, investigators assessed the presence of GERD symptoms at each scheduled visit. In total 6017 patients aged ≥18 years with symptoms suggesting GERD (heartburn, with or without acid regurgitation, for at least 4 days/week during the last 2 weeks) were enrolled into the study and underwent endoscopic examination (EGDS) to exclude patients with grade II–IV esophagitis, according to the Savary-Miller’s classification. The treatment maintenance phase started after resolution of symptoms achieved with a 4-week acute treatment with esomeprazole 40 mg once daily. Results of the 4-week treatment confirmed the efficacy of esomeprazole 40 mg once daily in the acute treatment of GERD, as shown by the high response rate, with 87.5% of patients achieving symptom resolution. Patients treated on-demand had the same relapse rate over 6 months than patients maintained on continuous treatment, but their control of symptoms was less effective. A statistically significant difference between the continuous treatment arm and the on demand treatment arm emerged from the analysis of direct and total medical costs. The cost of study medication was the most relevant variable because of the reduced consumption with the on demand strategy versus the continuous treatment strategy. Results of this trial suggest that on-demand treatment with esomeprazole 20 mg may be an advantageous therapeutic alternative in the long-term treatment of GERD patients without esophagitis, requiring a careful management by the treating physician in order to constantly monitor the effectiveness in symptoms control.

Proton Pump Inhibitors (PPIs) (Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole and Esomeprazole), one of the most commonly prescribed classes of medications in the primary care setting, are considered a major advance in the treatment of acid-peptic diseases. In Italy PPIs are reimbursed by National Health Service on the basis of CUF (Commissione Unica del Farmaco) 1 and 48 Notes. In 2002 and 2003 a significant increase in PPIs consumption and expenditure have been documented, showing differences between regions. The aim of this study is to investigate and monitor, at regional level, type and entity of PPIs use through a drug utilization study, evaluating prescribing behaviour and compliance of PPIs treatments with CUF Notes indications. The study has been carried out on a sample of 436 General Practitioners belonging to 22 Piemonte’s ASL (Aziende Sanitarie Locali). The data analysis shows that acid-related pathologies are significantly more common in patients with at least 50 years of age and the most frequent condition is represented by gastroesophageal reflux disease. Despite the general conditions of PPIs use by General Practitioners in terms of duration and dosage of therapy result in most cases (from 49% to 80% for duration and from 54% to 97% for dosage) compliant with what proposed by CUF Notes, in some cases the same CUF Notes indications seem to be not observed. Consequently the Piemonte Region has decided to plan a guideline on PPIs rational use. Such guideline, expected to be introduced in the regional area, may also be considered as an instrument able to lead to a more appropriate expenditure for this drug class. Moreover, in order to control PPIs expenditure, pharmacoeconomic methodologies can be applied allowing to identify the most cost - effective active substance and therapeutic scheme, overcoming CUF Notes which consider all PPIs use under the same reimbursement conditions.

Objective: The objective of this analysis was to compare the costs, benefits and cost effectiveness of two dosage regimens of cerivastatin (0.2 and 0.4 mg/day) with Italian National Health Service (NHS) reimbursed comparative statins in the primary prevention of coronary heart disease in Italy. This study is part of a broader analysis undertaken in five European countries. Design and Setting: A cost-effectiveness analysis (CEA) was performed, as the interventions have the same treatment objectives but vary in terms of magnitude of effectiveness. This CEA compared alternative treatments both in the NHS and from societal perspectives. Patients: A coronary heart disease risk assessment model, based on intervention study data from the Lipid Research Clinics Coronary Primary Prevention Trial, was used. This was augmented with demographic, disease, life expectancy, pharmacological and economic data for patients with coronary heart disease in Italy. Results: In terms of average cost effectiveness, our analysis showed that cerivastatin 0.2 mg/day compared favourably with pravastatin 20 mg/day, and compared similarly with simvastatin 20 mg/day in all age groups studied. The study also demonstrated that cerivastatin 0.4 mg/day compared favourably with both simvastatin 40 mg/day and pravastatin 20 mg/day. These results were consistent for both the NHS and societal perspective. The incremental cost per life-year gained [in 1998 Italian lire (L)] of simvastatin versus cerivastatin ranged from about L40 million [or Euro (Eur)20 658] to greater than L650 million (or Eur335 697). Cerivastatin 0.2 mg/day was more cost-effective than pravastatin 20 mg/day, while the incremental cost per life-year gained for cerivastatin 0.4 mg/day versus pravastatin 20 mg/day ranged from L11.1 million (or Eur5733) to L31.8 million (or Eur16 423) in the three age groups (35 to 39 years, 50 to 54 years and 65 to 69 years) for both perspectives. Conclusions: The results of this study showed that in primary prevention, average cost-effectiveness ratios of cerivastatin compared favourably with those of the other pharmacological interventions available on the Italian market.

Background Stroke is one of the most relevant reasons of death and disability worldwide. Many cost of illness studies have been performed to evaluate direct and indirect costs of ischaemic stroke, especially within the first year after the acute episode, using different methodologies. Methods We conducted a longitudinal, retrospective, bottom-up cost of illness study, to evaluate clinical and economic outcomes of a cohort of patients affected by a first cerebrovascular event, including subjects with ischaemic, haemorrhagic or transient episodes. The analysis intended to detect direct costs, within 1, 2 and 3 years from the index event. Clinical patient data collected in regional disease registry were integrated and linked to regional administrative databases to perform the analysis. Results The analysis of costs within the first year from the index event included 800 patients. The majority of patients (71.5%) were affected by ischaemic stroke. Overall, per patient costs were €7,079. Overall costs significantly differ according to the type of stroke, with costs for haemorrhagic stroke and ischaemic stroke amounting to €9,044 and €7,289. Hospital costs, including inpatient rehabilitation, were driver of expenditure, accounting for 89.5% of total costs. The multiple regression model showed that sex, level of physical disability and level of neurological deficit predict direct healthcare costs within 1 year. The analysis at 2 and 3 years (per patient costs: €7,901 and €8,874, respectively) showed that majority of costs are concentrated in the first months after the acute event. Conclusions This cost analysis highlights the importance to set up significant prevention programs to reduce the economic burden of stroke, which is mostly attributable to hospital and inpatient rehabilitation costs immediately after the acute episode. Although some limitation typical of retrospective analyses the approach of linking clinical and administrative database is a power tool to obtain useful information for healthcare planning.

Introduction This study's aim was to assess economic data regarding the home assistance burden for advanced non-small cell lung cancer (NSCLC) patients in Italy. Patients and Methods One hundred four NSCLC patients in second-line chemotherapy (2LC) or in supportive therapy (ST) were enrolled in 18 Italian oncology departments and were observed for 3 months. The main caregiver's workload was assessed monthly by a task scale; other caregivers' activities were also registered. Eastern Cooperative Oncology Group performance status was assessed by physicians, and patients completed the Lung Cancer Symptoms (LCS) subscale. Formal caregiving time was valued according to market prices; informal caregiving hours were valued using the wage rate for an equivalent service. Covariance analysis was performed to check for influential factors in assistance costs. Results The mean age of the total sample was 65.5 years, and prevalence of males was over 80%. In over 70% of cases, the principal caregiver was patient's spouse, living with the patient and not working. Principal caregiver support was the main cost item: €2.368 in 2LC and €2.805 in ST, representing 74% of total trimonthly assistance costs. Regression analysis showed a positive correlation between the severity of symptoms and the costs of assistance. The caregiving burden was higher in patients with bone and/or cerebral metastases; other metastasis sites seemed to have no impact on assistance costs. Conclusion Considering quality of life as the ultimate health outcome, clinicians are challenged to contribute to a research and policy agenda that holds burden of care in due consideration.

Summary Background: Quality of life has been assessed in a large, multicentre randomized, open label study. Aim: To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro-oesophageal reflux disease patients at 451 gastroenterological centres in Italy. Methods: Adult gastro-oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II–IV oesophagitis according to Savary–Miller's classification. Burden of gastro-oesophageal reflux disease was measured at baseline by the generic questionnaire Short-Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7-point scale. Results: A comparison between Short-Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro-oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4-week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P

Objective: To assess the impact of best-eye and worst-eye visual acuity (BEVA and WEVA, respectively) on health-related quality of life and utility in patients with wet age-related macular degeneration. Design: This cross-sectional, prospective, observational, multicenter study was performed in France, Germany, and Italy. Patients were stratified into 4 severity groups (BEVA, 20/40; WEVA, 20/200). Patients completed the National Eye Institute 25-Item Visual Function Questionnaire, the Macular Disease Quality of Life Scale, and the Health Utility Index 3. Analysis of variance was used to adjust for age, sex, and country. Results: Patients (N = 360) were mainly female (59.6%), with a mean age of 77 years and mean time since age-related macular degeneration diagnosis of 2.3 years. Health Utility Index 3 scores decreased with VA severity from 0.62 to 0.39. The National Eye Institute 25-Item Visual Function Questionnaire global score decreased with VA severity from 67.0 to 40.7 and was related to the BEVA (P < .001) and WEVA (P = .03). Corresponding changes were observed on the general vision, distance vision, driving, and mental health dimensions. The average weighted impact score on the Macular Disease Quality of Life varied from -4.6 to -2.6, decreasing with VA severity. Both eyes contributed to the average weighted impact score. Conclusion: The BEVA and WEVAs influenced vision-related quality of life independently, as measured by the National Eye Institute 25-Item Visual Function Questionnaire and Macular Disease Quality of Life Scale.

PURPOSE. To estimate the prevalence rates of depression and anxiety in patients with wet age-related macular degeneration (AMD) and the relationship with visual acuity and to develop a simple algorithm for depression screening. METHODS. This cross-sectional, prospective, observational, multicenter study was performed in France, Germany, and Italy. Retina specialists at 10 centers per country each enrolled 12 consecutive patients with wet ARMD. Patients were stratified into four severity groups by using best eye (BE) and worst eye (WE) visual acuity (VA) thresholds (BE:VA 20/40 and WE:VA 20/200). Patients rated themselves on the Hospital Anxiety and Depression Scale (HADS). Analysis of variance was performed to estimate the effect of VA severity levels on HADS scores adjusted on age, gender, and country. RESULTS. Patients (females 609/6) were recruited, with a mean age of 77 years and 2.3 years' disease duration. Mean BE:VA at inclusion was 0.49 logMar (logarithm of the minimum angled of resolution) and NW:VA 1.0 logMar. The prevalence of severe depression increased from 0% (BE:VA >= 20/40+WE:VA >= 20/200) to 7.6% (BE:VA < 20/40+)WE:VA < 20/200), whereas anxiety was unrelated to VA loss. Moreover, total depression scores were strongly associated with VA severity (P = 0.006), but not total anxiety scores (P = 0.840). Responses to two HADS items ("I still enjoy things I used to enjoy"; "I can enjoy a good book or radio or television program") identified 95% of severely to moderately depressed patients. CONCLUSIONS. Self-rated depression in patients with AMD was associated with VA severity level. It should, therefore, be relatively easy for ophthalmologists to implement the screening procedure and refer identified patients to psychiatrists for proper assessment and treatment.

Upon penetration in an unfertilized Xenopus egg bathed in 1 10 Ringer, the voltage recorded by a microelectrode shows an abrupt jump to a negative voltage ( E p ) followed by a rapid depolarization to a steady value ( E r ) ( E p = −39.4 ± 1.9 mV and E r = −11.5 ± 0.5 SE, 54 eggs from 9 females). The same is true for fertilized eggs impaled 16–35 min after insemination ( E p = −29.5 ± 2.1 mV, E r = −11.5 ± 0.9 mV, SE, 18 eggs from 3 females). The voltage recorded by a second microelectrode inserted into the same egg does not show the transient initial negativity. The stationary level of the membrane potential is close to the diffusion potential calculated from the Goldman equation with equal permeabilities for all the relevant ions. It is concluded that the low resting potentials measured in Xenopus eggs before and after fertilization are largely due to damage caused by the electrode. Using an upper limit of −39 mV for the true membrane potential and correlating the input resistance with the stationary membrane potential, a lower limit of 22 MΩ (about 1 MΩ cm 2 ) for the membrane resistance can be obtained. Insertion of a microelectrode during the first 3 min after insemination shows a steady positive potential while, at later times (3–16 min postinsemination), a positive peak followed by a repolarization can be observed. This indicates that the measurement of the peak of the fertilization potential is not seriously affected by the electrode penetration while its time course after the first 3 min may be deformed by the presence of a large leakage conductance.