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Objective: This study aims to estimate the incidence of Vestibular neuritis (VN) in three different districts in Italy, its epidemiological features, and the prevalence of comorbidities associated with it., Methods: An observational prospective study of 198 patients referred to ENT departments in Siena, Grosseto, and Cuneo was carried out over a 2-year period. Each patient underwent a complete otoneurologic examination in the first 48 h from the onset of symptoms and a brain MRI in the early stages of the disease. The follow-up lasted for 1 year., Results: The total VN incidence rate of the three municipalities was 48.497 (95% CI: 48.395-48.598) and its standardized value was 53.564 (95% CI: 53.463-53.666). The total VN incidence rate for the whole sample (municipality and district of the three centers) was 18.218 (95% CI: 18.164-18.272), and its standardized value was 20.185 (95% CI: 20.129-20.241). A significant difference was highlighted between patients living in the city compared to those living in the surrounding area ( p < 0.000), this may be due to the ease of reaching the otoneurological referral center., Conclusion: The total incidence rate for the three municipalities was 48.497. This result is higher than previously reported studies., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Mandalà, Salerni, Ferretti, Bindi, Gualtieri, Corallo, Viberti, Gusinu, Fantino, Ponzo, Astore, Boccuzzi and Nuti.)

Fluoroquinolones (FQs) represent an class of antibiotics of medical importance, but their use has been restricted due to their ecologic impact and associated side effects. The reduction of FQs use is an important goal of antimicrobial stewardship programs (ASP). This work describes an ASP focused on overall antibiotics and FQs consumption reduction. From January 2021, an ASP was implemented in a 700-bed teaching hospital. The ASP was based on: (i) antibiotics consumption monitoring system (DDD/100 bed days); (ii) mandatory antibiotic prescription-motivation (using a dedicated informatic format) with the goal of >75% of motivated prescriptions; and (iii) data feedback and training on FQs use indications. We evaluated the impact of the intervention on overall systemic antibiotics and FQs consumption according to the objectives posed by Italian PNCAR (National Action Plan on Antimicrobial Resistance). A decrease of 6.6% in antibiotic use was observed (2019 vs. 2021). Notably, the FQs consumption fell by 48.3% from 7.1 DDD/100 bd in 2019 to 3.7 DDD/100 bd in 2021 ( p < 0.001). After six months of mandatory antibiotic prescription-indication, all units achieved the target set. The study suggests that a simple, bundled ASP intervention can be rapidly effective obtaining the objectives of PNCAR on the reduction of overall antibiotics and FQs consumption.

Coronavirus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has quickly spread all over the globe from China. Pleural involvement is not common; around 5-10% of patients can develop pleural effusion and little is known about the involvement of pleural structures in this new infection.A 61-year-old male kidney transplant patient with a history of multiple biopsy-confirmed acute rejections and chronic allograft rejection was admitted to our COVID-19 Unit with dry cough, exertional dyspnea, oliguria, and abdominal distension. Lung ultrasound imaging, chest X-ray, and CT scan showed left pleural effusion and atelectasis of the neighboring lung parenchyma. RT-PCR was positive for SARS-CoV-2 in the pleural fluid and cytology showed mesothelial cells with large and multiple nuclei, consistent with a cytopathic effect of the virus.This is one of few reports describing detection of SARS-CoV-2 in the pleural fluid and to the best of our knowledge, is the first to document the simultaneous presence of a direct cytopathic effect of the virus on mesothelial cells in a kidney transplant patient with COVID-19 pneumonia. The pleura proved to be a site of viral replication where signs of a direct pathological effect of the virus on cells can be observed, as we report here. RT-PCR for SARS-CoV-2 should be part of routine examination of pleural effusion even in patients with mild respiratory symptoms or with comorbidities that seem to explain the cause of effusion.

Objective: The study was aimed to compare the impact of thumb base osteoarthritis (TBOA) on pain, function, and quality of life in patients with erosive or non-erosive hand osteoarthritis (HOA)., Methods: This observational retrospective study included 232 patients: 64 with erosive HOA (EHOA) and concomitant TBOA, 36 with isolated EHOA, 97 with non-erosive HOA (non-EHOA) and TBOA, and 35 with isolated non-EHOA. Hand pain by a visual analogue scale (VAS), Functional Index for Hand Osteoarthritis (FIHOA) score, Health Assessment Questionnaire (HAQ), the Medical Outcomes Study 36-Item Short Form (SF-36), and the possible correlations between VAS and FIHOA with radiological score were assessed., Results: No differences were found between EHOA with TBOA and isolated EHOA in VAS and FIHOA scores; opposite, there was a significant difference in VAS (p < 0.01) and FIHOA (p < 0.001) between subjects with non-EHOA and TBOA and patients with only non-EHOA. VAS and FIHOA values resulted slightly higher in patients with EHOA and TBOA vs non-EHOA and TBOA; they were significantly more elevated in EHOA and TBOA group compared to isolated non-EHOA (p ≤ 0.001) and in isolated EHOA vs isolated non-EHOA (p < 0.01 and p < 0.001, respectively). HAQ, SF-36 resulted significantly better in isolated non-EHOA patients compared to the other groups. Finally, we observed a significant correlation between FIHOA and all the Kallman scales in EHOA patients with TBOA and between FIHOA and Kallman's thumb score in non-EHOA-TBOA group., Conclusions: EHOA has a more severe clinical burden than non-EHOA; the presence of TBOA appeared an important determinant of pain and disability in non-EHOA.Key Points• Each subset of HOA can have a different impact on pain and functionality, with EHOA determining more severe effects on hand symptoms and disability than non-EHOA.• The presence of TBOA appeared an important determinant of pain and disability in non-EHOA, but not in EHOA.• Our findings support the need for an individualized therapy for each phenotype of hand osteoarthritis.

Prostate cancer is one of the most common diagnosed cancers in men and the waiting time has become an important issue not only for clinical reasons, but also mostly for the psychological implications on patients. The aim of our study was to review and analyze the literature on waiting times for prostate cancer. In February-March 2019 we performed a search for original peerreviewed papers in the electronic database PubMed (MEDLINE). The key search terms were "prostate cancer AND waiting list", "prostate cancer AND waiting times". We included in our narrative review articles in Italian, English or French, published in 2009-2019 containing original data about the waiting times for prostate cancer. The literature search yielded 680 publications. Finally, we identified 8 manuscripts eligible for the review. The articles were published between 2010 and 2019; the studies involved a minimum of 16 to a maximum of 95438 participants. Studies have been conducted in 6 countries. The waiting times from cancer suspicion to histopathological diagnosis and to treatment had an important reduction in the last years, and this constant decrease could lead to an increase of patients' satisfaction., (©Copyright: the Author(s).)

Introduction: Health-related quality of life in chronic low back pain (LBP) is an important issue since various individual factors such as perceived loss of autonomy, inability to continue daily life and anxiety can contribute to maintenance or deterioration of this condition. Health-related quality of life is also important because it can predict the probability of recovery or recrudescence over time. In the literature, there is no systematic review on this topic. The present paper describes a protocol of the first systematic review and meta-analysis aimed at summarising the data on health-related quality of life in patients with chronic LBP compared with healthy controls. Gender, age and comorbidity of psychiatric disorders (mood or anxiety disorders) will be explored as moderators. Studies will be included if they used a case-control design comparing adults with chronic LBP to healthy controls on health-related quality of life through validated interviews/questionnaires., Methods and Analysis: According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, a systematic review and meta-analysis will be conducted from 10th to 17th January 2020. Independent reviewers will search published/unpublished studies through electronic databases (Scopus, PubMed, EMBASE and the Cochrane Library) and additional sources, will extract the data and assess the methodological quality through the Newcastle-Ottawa Scale. Random-effect meta-analysis will be carried out by calculating effect sizes as Cohen's d indices. Publication bias will be assessed and moderators of the effect sizes will be investigated through weighted least squares meta-regression.The knowledge whether health-related quality of life is better or worse as a function of some individual characteristics may suggest personalised care pathways according to a precision medicine approach., Ethics and Dissemination: The current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals., Prospero Registration Number: CRD42019131749., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Lumbar spinal stenosis (LSS) is a common degenerative spine disease associated with a strong impairment in various quality of life areas, particularly the ability to perform work-related activity. Depression is a condition frequently associated. There is no comprehensive review on quality of life and objective functional impairment in LSS. This paper presents the protocol of the first systematic review and meta-analysis summarising evidence about quality of life and functional impairment in patients with LSS compared with healthy controls. Comorbid depressive disorders, age, gender, LSS duration, disability, pain severity and study methodological quality will be investigated as moderators., Methods: The protocol is reported according to PRISMA-P guidelines. Studies will be included if they were conducted on patients aged 18 years old or older with primary LSS and if they reported data on differences in the levels of quality of life or objective functional impairment between patients with LSS and healthy controls. Independent reviewers will search published/unpublished studies through electronic databases and additional sources, will extract the data and assess the methodological quality. Random-effects meta-analysis will be carried out by calculating effect sizes as Cohen's d indices. Heterogeneity will be examined by the I 2 and the Q statistics. Moderators will be investigated through meta-regression., Conclusions: A summary of the evidence on quality of life and functional impairment in LSS may suggest clinical and occupational health medicine strategies aimed to timely detect and prevent these outcomes. Higher percentages of patients with LSS with depression may be expected to be related to poorer quality of life. Depressive comorbidity might impact negatively on quality of life because it is associated with dysfunctional coping, disability and psychophysiological symptoms., Ethics and Dissemination: The current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals., Review Registration: CRD42019132209., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The association between post-traumatic stress disorder (PTSD) and medical comorbidities is controversial since most studies focused on specific comorbidity and victim types. In Italy, data on this issue are scarce. A comprehensive evaluation of all the ICD medical categories co-occurring in PTSD may orient assessment and treatment during clinical and forensic practice. This is the first study evaluating all the ICD physical comorbidities and gender-related differences in Italian PTSD patients. Eighty-four PTSD patients (36 females, 48 males) were included. The Clinician-Administered PTSD Scale, Mini International Neuropsychiatric Interview and Davidson Trauma Scale were administered., Results: Most patients had a PTSD consequent to an accident and half of them presented extreme symptom severity. No gender differences emerged on symptom severity/duration and age at the event. Metabolic (39.29%), circulatory (20.24%) and musculoskeletal systems/connective tissue diseases (17.86%) were the most frequent comorbidities. Metabolic/circulatory diseases were more frequent among males (p = 0.019 and p = 0.027, respectively) while females more frequently showed neoplasms (p = 0.039). Physical comorbidities represent a serious complication in PTSD patients and are more prevalent than in the Italian population. While gender is not associated with symptom presentation, it seems to play a key role in specific comorbidities including metabolic, circulatory and neoplastic diseases.

Objectives: Medical comorbidities affect outcome in elderly patients with hip fracture. This study was designed to preliminarily evaluate the usefulness of a hip-fracture unit led by an internal medicine specialist., Methods: In-hospital and 3-month outcomes in patients with hip fracture were prospectively evaluated in 121 consecutive patients assessed before and followed after surgery by a multidisciplinary team led by internal medicine specialist; 337 consecutive patients were recalled from ICD-9 discharge records and considered for comparison regarding in-hospital mortality., Results: In the intervention period, patients treated within 48 hours were 54% vs. 26% in the historical cohort (P<0.0001). In-hospital mortality remained stable at about 2.3 per 1000 person-days. At 3 months, 10.3% of discharged patients had died, though less than 8% of patients developed postoperative complications (mainly pneumonia and respiratory failure). The presence of more than 2 major comorbidities and the loss of 3 or more BADL were independent predictors of death. 50/105 patients recovered previous functional capacity, but no independent predictor of functional recovery could be identified. Mean length of hospital stay significantly decreased in comparison to the historical cohort (13.6± 4.7 vs 17 ± 5 days, p = 0.0001). Combined end-point of mortality and length of hospitalization < 12 days was significantly lower in study period (27 vs 34%, p <0.0132)., Conclusions: Identification and stabilization of concomitant clinical problems by internal medicine specialists may safely decrease time to surgery in frail subjects with hip fracture. Moreover, integrated perioperative clinical management may shorten hospital stay with no apparent increase in in-hospital mortality and ultimately improve the outcome. These results are to be confirmed by a larger study presently ongoing at our institution.

The Italian National Outcome Programme has assessed the performance of Italian hospitals regarding several clinical performance indicators, including 30-daymortality after admission for acute myocardial infarction. Risk adjustment was obtained using demographic and comorbidity data based on the hospital discharge databases in the index admission, as well as in those of the previous two years. Noticeably, the ICD-9-CM 410.7* classification coding for NSTEMI (Non-ST elevation myocardial infarction)myocardial infarction, i.e. the less severe form, was not used, due to known variability in its use. We found that hospital-specific adjusted relative risk of death versus the national mean, as computed by the programme, is negatively associated with the proportion of NSTEMI infarctions at each Tuscan and Florentine hospital, coherently with the hypothesis of a selection by the emergency network, which addresses STEMI (ST elevation myocardial infarction) patients to hospitals offering haemodynamic laboratory with reperfusive services. Individual level clinical data of 3,200 patients in the AMI-Florence study in the period April 2008-March 2010 found that ICD-9-CM410.7* is underused. The analysis based on hospital discharge diagnoses (410.7* vs. other 410* codes) cannot explain differences in mortality among Florentine hospitals, as opposed to the use of a classification of myocardial infarction type (STEMI vs. NSTEMI) based on clinical data collected in AMI-Florence.

Background: This study, carried out at the Florence Teaching Hospital Careggi (AOUC), reports the technological evaluation, through the use of Health Technology Assessment (HTA), on the application of mitral clips in the treatment of mitral insufficiency., Objective: The assessment, carried out by analyzing the clinical, technological, social, procedural, safety and economic elements, sought to answer the following research questions: Evaluation of the general technological status of the mitral clips in the treatment process of mitral regurgitation, with particular reference to traditional methods; and contextualisation of the analyses within the hospital structure, by identifying criticality issues and improvements., Methods: The methodology was based on the following steps: technological description; areas of evaluation and the selection of Key Performance Indicators; research of scientific facts and the collection of expert opinions; evaluation and reporting of findings., Results: The results are based on an analysis which included a total of 50 indicators, effectively evaluating 86.5% of them, from the least from the clinical sector (80%) to the most in the areas of procedure, safety and social (100%). Traditional surgery (repair or valve replacement) still represents the gold standard for the treatment of mitral regurgitation due to its maturity both on a technological and clinical level. The minimally invasive procedures which use the mitral clips present interesting opportunities both on a social level (minimum stay in hospital and no post-operative rehabilitation) and clinical level, especially as an alternative to medication, even if they are still at an emergent level (the long-term results are unknown) and complex to use. From the clinical point of view they show some interesting findings related to immediate and post-operative mortality (none during the operation and a minor and equal amount 30 days and 12 months later in comparison to traditional methods) whilst economically, despite the fact that the cost of the device is greater than those used in traditional interventions, the cost-refund relationship does not show significant differences compared to the traditional types of treatment., Conclusion: The HTA evaluation of minimally invasive technologies that use clips for the treatment of mitral regurgitation shows, in the hospital setting, very interesting results, particularly for inoperable patients, where the clinical and social improvements are significant compared to pharmacological treatments, whilst for 'operable' patients, the traditional techniques are still the most appropriate.

Background: A fundamental element of the social and safety function of a health structure is the need to guarantee continuity of clinical activity through the continuity of technology., Objective: This paper aims to design a Decision Support System (DSS) for medical technology evaluations based on the use of Key Performance Indicators (KPI) in order to provide a multi-disciplinary valuation of a technology in a health structure., Methods: The methodology used in planning the DSS followed the following key steps: the definition of relevant KPIs, the development of a database to calculate the KPIs, the calculation of the defined KPIs and the resulting study report. Finally, the clinical and economic validation of the system was conducted though a case study of Business Continuity applied in the operating department of the Florence University Hospital AOU Careggi in Italy., Results: A web-based support system was designed for HTA in health structures. The case study enabled Business Continuity Management (BCM) to be implemented in a hospital department in relation to aspects of a single technology and the specific clinical process. Finally, an economic analysis of the procedure was carried out., Conclusions: The system is useful for decision makers in that it precisely defines which equipment to include in the BCM procedure, using a scale analysis of the specific clinical process in which the equipment is used. In addition, the economic analysis shows how the cost of the procedure is completely covered by the indirect costs which would result from the expenses incurred from a broken device, hence showing the complete auto-sustainability of the methodology.

Background: Human albumin solutions are used in a range of medical and surgical problems. Licensed indications are the emergency treatment of shock and other conditions where restoration of blood volume is urgent, burns, and hypoproteinaemia. Human albumin solutions are more expensive than other colloids and crystalloids., Objectives: To quantify the effect on mortality of human albumin and plasma protein fraction (PPF) administration in the management of critically ill patients., Search Strategy: We searched the Cochrane Injuries Group trials register, Cochrane Central Register of Controlled Trials, Medline, Embase and BIDS Index to Scientific and Technical, Proceedings: Reference lists of trials and review articles were checked, and authors of identified trials were contacted. The search was last updated in August 2004., Selection Criteria: Randomised controlled trials comparing albumin/PPF with no albumin/PPF, or with a crystalloid solution, in critically ill patients with hypovolaemia, burns or hypoalbuminaemia., Data Collection and Analysis: We collected data on the participants, albumin solution used, mortality at the end of follow up, and quality of allocation concealment. Analysis was stratified according to patient type., Main Results: We found 32 trials meeting the inclusion criteria and reporting death as an outcome. There were 1632 deaths among 8452 trial participants. For hypovolaemia, the relative risk of death following albumin administration was 1.01 (95% confidence interval 0.92-1.10). This estimate was heavily influenced by the results of the SAFE trial, which contributed 91% of the information (based on the weights in the meta-analysis). For burns, the relative risk was 2.40 (1.11-5.19) and for hypoalbuminaemia the relative risk was 1.38 (0.94-2.03). There was no substantial heterogeneity between the trials in the various categories (chi2 = 21.86, df = 25, p = 0.64). The pooled relative risk of death with albumin administration was 1.04 (0.95-1.13)., Conclusions: For patients with hypovolaemia there is no evidence that albumin reduces mortality when compared with cheaper alternatives such as saline. There is no evidence that albumin reduces mortality in critically ill patients with burns and hypoalbuminaemia. The possibility that there may be highly selected populations of critically ill patients in which albumin may be indicated remains open to question. However, in view of the absence of evidence of a mortality benefit from albumin and the increased cost of albumin compared to alternatives such as saline, it would seem reasonable that albumin should only be used within the context of well concealed and adequately powered randomised controlled trial., Plain Language Summary: There is no evidence that giving human albumin to replace lost blood in critically ill or injured people improves survival when compared to giving saline. Trauma, burns or surgery can cause people to lose large amounts of blood. Fluid replacement, giving fluids intravenously (into a vein), is used to help restore blood volume and hopefully reduce the risk of dying. Blood products (including human albumin), non-blood products or combinations can be used. The review of trials found no evidence that albumin reduces the risk of dying. Albumin is very expensive in which case it may be better to use cheaper alternatives such as saline for fluid resuscitation.

Background: Pneumonia is an important cause of mortality in intensive care units. The incidence of pneumonia in such patients ranges between 7 and 40%, and the crude mortality from ventilator associated pneumonia may exceed 50%. Although not all deaths in patients with this form of pneumonia are directly attributable to pneumonia, it has been shown to contribute to mortality in intensive care units independently of other factors that are also strongly associated with such deaths., Objectives: The objective of this review was to assess the effects of antibiotics for preventing respiratory tract infections and overall mortality in adults receiving intensive care. Search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2003), which contains the Acute Respiratory Infections (ARI) Group specialised trials register; MEDLINE (January 1966 to September 2003); EMBASE (January 1990 to September 2003); proceedings of scientific meetings and reference lists of articles from January 1984 to December 2002. We also contacted investigators in the field. Selection criteria. Randomised trials of antibiotic prophylaxis for respiratory tract infections and deaths among adult intensive care unit patients. Data collection and analysis. At least two reviewers independently extracted data and assessed trial quality., Results: Overall 36 trials involving 6922 people were included. There was variation in the antibiotics used, patient characteristics and risk of respiratory tract infections and mortality in the control groups. In 17 trials (involving 4295 patients) that tested a combination of topical and systemic antibiotic, the average rates of respiratory tract infections and deaths in the control group were 36% and 29% respectively. There was a significant reduction of both respiratory tract infections (odds ratio 0.35, 95% confidence interval [CI] 0.29-0.41) and total mortality (odds ratio 0.78, 95% CI 0.68-0.89) in the treated group. On average 5 patients needed to be treated to prevent one infection and 21 patients to prevent one death. In 17 trials (involving 2664 patients) that tested topical antimicrobials alone (or comparing topical plus systemic versus systemic alone) the rates of respiratory tract infections and deaths in the control groups were 30 and 26% respectively. There was a significant reduction of respiratory tract infections (odds ratio 0.52, 95% CI 0.43-0.63), but not in total mortality (odds ratio 0.97, 95% CI 0.81-1.16) in the treated group., Conclusions: A combination of topical and systemic prophylactic antibiotics reduces respiratory tract infections and overall mortality in adult patients receiving intensive care. A treatment based on the use of topical prophylaxis alone reduces respiratory infections, but not mortality. The risk of occurrence of resistance as a negative consequence of antibiotic use was appropriately explored only in the most recent trial by de Jonge, which did not show any such effect.