Robotic thymectomy in thymic tumours: a multicentre, nation-wide study.

OBJECTIVES: Robotic thymectomy has been suggested and considered technically feasible for thymic tumours. However, because of small-sample series and the lack of data on long-term results, controversies still exist on surgical and oncological results with this approach. We performed a large national multicentre study sought to evaluate the early and long-term outcomes after robot-assisted thoracoscopic thymectomy in thymic epithelial tumours. METHODS: All patients with thymic epithelial tumours operated through a robotic thoracoscopic approach between 2002 and 2022 from 15 Italian centres were enrolled. Demographic characteristics, clinical, intraoperative, postoperative, pathological and follow-up data were retrospectively collected and reviewed. RESULTS: There were 669 patients (307 men and 362 women), 312 (46.6%) of whom had associated myasthenia gravis. Complete thymectomy was performed in 657 (98%) cases and in 57 (8.5%) patients resection of other structures was necessary, with a R0 resection in all but 9 patients (98.6%). Twenty-three patients (3.4%) needed open conversion, but no perioperative mortality occurred. Fifty-one patients (7.7%) had postoperative complications. The median diameter of tumour resected was 4 cm (interquartile range 3-5.5 cm), and Masaoka stage was stage I in 39.8% of patients, stage II in 56.1%, stage III in 3.5% and stage IV in 0.6%. Thymoma was observed in 90.2% of patients while thymic carcinoma occurred in 2.8% of cases. At the end of the follow-up, only 2 patients died for tumour-related causes. Five- and ten-year recurrence rates were 7.4% and 8.3%, respectively. CONCLUSIONS: Through the largest collection of robotic thymectomy for thymic epithelial tumours we demonstrated that robot-enhanced thoracoscopic thymectomy is a technically sound and safe procedure with a low complication rate and optimal oncological outcomes.

Corrigendum: The new Italian registry of infantile thrombosis (RITI): a reflection on its journey, challenges and pitfalls.

[This corrects the article DOI: 10.3389/fped.2023.1094246.].

Management of Pediatric Foreign Body Injuries during the COVID-19 Pandemic: Results of an International Survey.

The COVID-19 pandemic has had direct and indirect effects on daily life. In hospitals, the impact of the pandemic was observed in the diagnostic and therapeutic workflow. In this work, we explored potential changes in activities related to the treatment of foreign body injuries (FBIs) in children and the behavioral habits of physicians during the first wave of the pandemic. An online survey was conducted among physicians of the Susy Safe network. The survey comprised items related to respondent information, reference center characteristics, the treatment of FBIs during the COVID-19 pandemic, and a modified COVID-19 Anxiety Scale (CAS). The survey was distributed among the Susy Safe project international network surveillance registry for FBIs. A total of 58 physicians responded to the survey, including 18 (32%) from Europe and 16 (28%) from South America. The respondents indicated that the estimated number of aspirated foreign bodies during the pandemic was lower than or the same as that before the pandemic (43, 74%), and the same was observed for ingested foreign bodies (43, 74%). In univariable logistic regression, no single predictor was associated with a delay in routine care for children or an increasing tendency of medical personnel to avoid procedures. The workflow of physicians involved in the management of FBIs in children has not changed drastically during the COVID-19 pandemic, especially in emergency departments.

Automatic Forecast of Intensive Care Unit Admissions: The Experience During the COVID-19 Pandemic in Italy.

The experience of the COVID-19 pandemic showed the importance of timely monitoring of admissions to the ICU admissions. The ability to promptly forecast the epidemic impact on the occupancy of beds in the ICU is a key issue for adequate management of the health care system.Despite this, most of the literature on predictive COVID-19 models in Italy has focused on predicting the number of infections, leaving trends in ordinary hospitalizations and ICU occupancies in the background.This work aims to present an ETS approach (Exponential Smoothing Time Series) time series forecasting tool for admissions to the ICU admissions based on ETS models. The results of the forecasting model are presented for the regions most affected by the epidemic, such as Veneto, Lombardy, Emilia-Romagna, and Piedmont.The mean absolute percentage errors (MAPE) between observed and predicted admissions to the ICU admissions remain lower than 11% for all considered geographical areas.In this epidemiological context, the proposed ETS forecasting model could be suitable to monitor, in a timely manner, the impact of COVID-19 disease on the health care system, not only during the early stages of the pandemic but also during the vaccination campaign, to quickly adapt possible preventive interventions.

Intraoperative Ultrasound-Guided Conserving Surgery for Breast Cancer: No More Time for Blind Surgery.

BACKGROUND: Breast-conserving surgery (BCS) still remains a blind surgery despite all available tumor localization methods. Intraoperative ultrasound (IOUS) allows real-time visualization during all resection phases. METHODS: This was a prospective observational cohort study conducted at the Veneto Institute of Oncology between January 2021 and June 2022. Patients with ductal carcinoma in situ, T1-2 invasive cancer, or post-neoadjuvant tumors, suitable for BCS, were recruited. All breast cancer lesion types were included, i.e. solid palpable, solid non-palpable, non-solid non-palpable, and post-neoadjuvant treatment residual lesions. Eligible participants were randomly assigned to either IOUS or traditional surgery (TS) in a 1:1 ratio. The main outcomes were surgical margin involvement, reoperation rate, closest margin width, main specimen and cavity shaving margin volumes, excess healthy tissue removal, and calculated resection ratio (CRR). RESULTS: Overall, 160 patients were enrolled: 80 patients were allocated to the TS group and 80 to the IOUS group. IOUS significantly reduced specimen volumes (16.8 cm3 [10.5-28.9] vs. 24.3 cm3 [15.0-41.3]; p = 0.015), with wider closest resection margin width (2.0 mm [1.0-4.0] vs. 1.0 mm [0.5-2.0] after TS; p < 0.001). Tumor volume to specimen volume ratio was significantly higher after IOUS (4.7% [2.5-9.1] vs. 2.9% [0.8-5.2]; p < 0.001). IOUS yielded significantly better CRR (84.5% [46-120.8] vs. 114% [81.8-193.2] after TS; p < 0.001), lower involved margin rate (2.5 vs. 15%; p = 0.009) and reduced re-excision rate (2.5 vs. 12.5%; p = 0.032). CONCLUSIONS: IOUS allows real-time resection margin visualization and continuous control during BCS. It showed clear superiority over TS in both oncological and surgical outcomes for all breast cancer lesion types. These results disfavor the paradigm of blind breast surgery.

Pediatric Injury Surveillance From Uncoded Emergency Department Admission Records in Italy: Machine Learning-Based Text-Mining Approach.

BACKGROUND: Unintentional injury is the leading cause of death in young children. Emergency department (ED) diagnoses are a useful source of information for injury epidemiological surveillance purposes. However, ED data collection systems often use free-text fields to report patient diagnoses. Machine learning techniques (MLTs) are powerful tools for automatic text classification. The MLT system is useful to improve injury surveillance by speeding up the manual free-text coding tasks of ED diagnoses. OBJECTIVE: This research aims to develop a tool for automatic free-text classification of ED diagnoses to automatically identify injury cases. The automatic classification system also serves for epidemiological purposes to identify the burden of pediatric injuries in Padua, a large province in the Veneto region in the Northeast Italy. METHODS: The study includes 283,468 pediatric admissions between 2007 and 2018 to the Padova University Hospital ED, a large referral center in Northern Italy. Each record reports a diagnosis by free text. The records are standard tools for reporting patient diagnoses. An expert pediatrician manually classified a randomly extracted sample of approximately 40,000 diagnoses. This study sample served as the gold standard to train an MLT classifier. After preprocessing, a document-term matrix was created. The machine learning classifiers, including decision tree, random forest, gradient boosting method (GBM), and support vector machine (SVM), were tuned by 4-fold cross-validation. The injury diagnoses were classified into 3 hierarchical classification tasks, as follows: injury versus noninjury (task A), intentional versus unintentional injury (task B), and type of unintentional injury (task C), according to the World Health Organization classification of injuries. RESULTS: The SVM classifier achieved the highest performance accuracy (94.14%) in classifying injury versus noninjury cases (task A). The GBM method produced the best results (92% accuracy) for the unintentional and intentional injury classification task (task B). The highest accuracy for the unintentional injury subclassification (task C) was achieved by the SVM classifier. The SVM, random forest, and GBM algorithms performed similarly against the gold standard across different tasks. CONCLUSIONS: This study shows that MLTs are promising techniques for improving epidemiological surveillance, allowing for the automatic classification of pediatric ED free-text diagnoses. The MLTs revealed a suitable classification performance, especially for general injuries and intentional injury classification. This automatic classification could facilitate the epidemiological surveillance of pediatric injuries by also reducing the health professionals' efforts in manually classifying diagnoses for research purposes.

The new Italian registry of infantile thrombosis (RITI): A reflection on its journey, challenges and pitfalls.

Introduction: Thrombotic events in neonates and children represent a rare although severe occurrence in view of the associated risk of mortality and sequelae. Quality evidence is limited in this field, and registry studies provide an essential base for research. The aim of this paper is to present the new Italian Registry of Infantile Thrombosis (RITI), set it into the scene of international thrombosis and stroke registries, and provide some insight on the challenges associated with registry management. Methods: We present the detailed structure and content of the new RITI registry, a brief overview of its main data, and a reflection on its features, pitfalls and the main challenges related to its management. Results: The RITI, initially started in 2007 and officially re-launched in 2017 after structural modifications, is a non-interventional retrospective and prospective registry study collecting data on neonatal and pediatric patients (0-18 years) who experienced a systemic or cerebral thrombotic event in Italy. The RITI is managed by a multidisciplinary team with expertise in pediatric thrombosis, and participation is open to all Italian physicians, on a voluntary basis. The overall aim of the registry is to acquire new evidence to better characterize the population of children with thrombotic events and improve their management and outcome. 48 Italian pediatric and intensive care units are actively involved in the RITI, including 85 medical doctors from 16 Italian regions. A total of 1,001 neonates and children affected by cerebral or systemic thrombosis have been enrolled. Discussion: The RITI is one of the largest available European registries of neonatal and pediatric thrombosis. National registries like the RITI represent a model for the study of rare conditions based on multidisciplinary and multicenter collaboration, aimed at overcoming the limitations due to small populations of patients, and creating a network of experts for patient referral and continuous education. Moreover, registry studies have a pivotal role in the research on pediatric thrombosis, due to the limited feasibility of high-quality studies. In our experience, the main critical stages, pitfalls and challenges in registry management include adequate registry designing, diffusion, data completeness and quality control.

Morbidity and mortality after anesthesia in early life in Italy. A subgroup analysis of the NECTARINE Trial.

BACKGROUND: Recent literature on neonatal anesthesia focuses on the importance of keeping physiology within the ranges of normality to improve the long-term neurological outcome. The Neonate and Children audit of Anesthesia pRactice IN Europe (NECTARINE) showed a derangement of one or more than one physiological parameters during anesthesia needing a medical intervention in 35.2% of 6592 anesthesia procedure performed in infants up to 60 weeks postmenstrual age. METHODS: Subanalysis of the Italian NECTARINE cohort providing a snapshot of anesthesia management, incidence of clinical events requiring intervention during anesthesia, and morbidity and mortality at 30 and 90 days. Secondary aim was to compare outcomes between Italy and Europe. RESULTS: Twenty-three Italian centers recruited 501 patients (63% male, 37% female) undergoing 611 procedures (441 surgical and 170 non-surgical) with a mean gestational age at birth of 38 weeks. Events requiring a medical intervention during anesthesia occurred in 177 cases (28.9%), lower than those reported in Europe (35.3%). The majority of events concerned episodes of cardiovascular instability, most commonly due to hypotension. The incidence of mortality at 30 days was 2.7%, consistent with the European incidence. CONCLUSIONS: Anesthetizing neonates is challenging. It is crucial that neonatal anesthesia practice is performed in specialized centers to maximize the potential positive outcome. We recommend a certification of quality for Institutions providing care for very young patients.

Predictive models in extracorporeal membrane oxygenation (ECMO): a systematic review.

PURPOSE: Extracorporeal membrane oxygenation (ECMO) has been increasingly used in the last years to provide hemodynamic and respiratory support in critically ill patients. In this scenario, prognostic scores remain essential to choose which patients should initiate ECMO. This systematic review aims to assess the current landscape and inform subsequent efforts in the development of risk prediction tools for ECMO. METHODS: PubMed, CINAHL, Embase, MEDLINE and Scopus were consulted. Articles between Jan 2011 and Feb 2022, including adults undergoing ECMO reporting a newly developed and validated predictive model for mortality, were included. Studies based on animal models, systematic reviews, case reports and conference abstracts were excluded. Data extraction aimed to capture study characteristics, risk model characteristics and model performance. The risk of bias was evaluated through the prediction model risk-of-bias assessment tool (PROBAST). The protocol has been registered in Open Science Framework ( https://osf.io/fevw5 ). RESULTS: Twenty-six prognostic scores for in-hospital mortality were identified, with a study size ranging from 60 to 4557 patients. The most common candidate variables were age, lactate concentration, creatinine concentration, bilirubin concentration and days in mechanical ventilation prior to ECMO. Five out of 16 venous-arterial (VA)-ECMO scores and 3 out of 9 veno-venous (VV)-ECMO scores had been validated externally. Additionally, one score was developed for both VA and VV populations. No score was judged at low risk of bias. CONCLUSION: Most models have not been validated externally and apply after ECMO initiation; thus, some uncertainty whether ECMO should be initiated still remains. It has yet to be determined whether and to what extent a new methodological perspective may enhance the performance of predictive models for ECMO, with the ultimate goal to implement a model that positively influences patient outcomes.

Changing patterns and clinical outcomes of hospitalized patients with COVID-19 severe pneumonia treated with remdesivir according to vaccination status: results from a real-world retrospective study.

Since the beginning of Coronavirus Disease 2019 (COVID-19) pandemic, many drugs have been purposed for the treatment of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Remdesivir emerged as an encouraging antiviral drug for patients with documented severe COVID-19-related pneumonia. Although several studies about remdesivir effectiveness exist, no study investigated the effect of the combination of remdesivir with the vaccination status. The aim of this study was to assess whether the administration of remdesivir could show some differences in terms of clinical outcomes in patients vaccinated against SARS-CoV-2 versus those who were not. The primary outcome was the in-hospital mortality. The secondary outcomes were 30-days mortality, the need for ICU admission and for oxygen supplementation. This is a retrospective cohort study including all consecutive adult patients hospitalized for severe COVID-19 at the Padua University Hospital (Italy), between September 1st, 2020, and January 31st, 2022, and who received a 5-days course of remdesivir. A total of 708 patients were included, 467 (66%) were male, and the median age was 67 (IQR: 56-79) years. To better estimate the outcomes of interest, a propensity score weighted approach was implemented for vaccination status. A total of 605/708 patients (85.4%) did not complete the vaccination schedule. In-hospital mortality rate was 5.1% (n = 36), with no statistically significant difference between the unvaccinated (n=29, 4.8%) and vaccinated (n=7, 6.8%; p=0.4) patients. After propensity score matching, mortality between the two groups remained similar. However, both the need for ICU and oxygen supplementation were significantly lower in the vaccinated group. Our finding suggests that a complete vaccination course could have an impact in reducing the need for transfer in ICU and for high-flow therapy in moderate-to-severe COVID-19 patients treated with remdesivir.

Early Treatments of Fragile Children with COVID-19-Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study.

(1) Background: SARS-CoV-2 infection is notably mild in children, though comorbidities may increase the risk of hospitalization and may represent a risk for increased disease severity. There is an urgent need for targeted therapies with an acceptable efficacy and safety profile. To date, most of the medicines for COVID-19-specific treatment are prescribed off-label for children due to a lack of clinical trials and consequent evidence in this population. (2) Methods: This was a retrospective, observational study investigating the safety of treatments for the prevention of severe COVID-19 in fragile pediatric patients who received monoclonal antibodies and antivirals for mild-to-moderate symptoms between December 2021 and July 2022. (3) Results: Thirty-two patients were included. Monoclonal antibodies were prescribed to 62%, intravenous antivirals to 22%, and oral antivirals to 16% of children. Sotrovimab was the most frequently prescribed drug among monoclonal antibodies and overall (59%). The second most prescribed drug was remdesivir (22%). No severe adverse drug reaction was reported. There was no progression to severe disease and no death cases due to COVID-19 or drug administration. At drug-type stratification, resolution of symptoms and swab positivity time showed no difference between the two groups at 7 and 28 days. Off-label prescriptions were 84% overall, and in similar proportions between the two groups. (4) Conclusions: in this small sample, antivirals seemed safe and showed no differences in efficacy as compared to MAbs for the early treatment of COVID-19 in fragile children, thus representing a valuable choice, even when administered off-label.

Physical activity assessment with wearable devices in rheumatic diseases: a systematic review and meta-analysis.

OBJECTIVES: In the management of rheumatic musculoskeletal disorders (RMDs), regular physical activity (PA) is an important recognized non-pharmacological intervention. This systematic review and meta-analysis aims to evaluate how the use of wearable devices (WDs) impacts physical activity in patients with noninflammatory and inflammatory rheumatic diseases. METHODS: A comprehensive search of articles was performed in PubMed, Embase, CINAHL and Scopus. A random-effect meta-analysis was carried out on the number of steps and moderate-vigorous physical activity (MVPA). Univariable meta-regression models were computed to assess the possibility that the study characteristics may act as modifiers on the final meta-analysis estimate. RESULTS: In the analysis, 51 articles were included, with a total of 7488 participants. Twenty-two studies considered MVPA outcome alone, 16 studies considered the number of steps alone, and 13 studies reported information on both outcomes. The recommended PA threshold was reached for MVPA (36.35, 95% CI 29.39, 43.31) but not for daily steps (-1092.60, -1640.42 to -544.77). Studies on patients with fibromyalgia report a higher number (6290, 5198.65-7381.62) of daily steps compared with other RMDs. Patients affected by chronic inflammatory arthropathies seemed to fare better in terms of daily steps than the other categories. Patients of younger age reported a higher overall level of PA than elderly individuals for both the number of steps and MVPA. CONCLUSION: Physical activity can be lower than the recommended threshold in patients with RMDs when objectively measured using WD. WDs could be a useful and affordable instrument for daily monitoring physical activity in RMDs and may support an increase in activity levels. PROSPERO TRIAL REGISTRATION: CRD42021227681, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=227681.

Regulatory and Educational Initiatives to Prevent Food Choking Injuries in Children: An Overview of the Current Approaches.

Choking injuries are one of the major causes of death among children ages 0-3, and most of these injuries are related to food. This work provides an overview of the current recommendations for food choking prevention and educational targets as a basis for developing a unified common set of knowledge for primary prevention policies development. Guidelines published by professional membership organizations and national governments in the English language were considered. All of these guidelines provide lists of hazardous food items and recommendations for food preparation to minimize choking hazard. Together with recommendations for food preparation, also recommendations aimed at stakeholders (food manufacturers, health care providers, and public authorities) are provided, underlining that this severe public health problem should be further addressed by adopting integrated public health interventions. Our overview stressed the importance of developing educational and primary prevention policies to sensitize adult supervisors and to regulate dangerous food products in the market.

A Deep Learning Approach to Estimate the Incidence of Infectious Disease Cases for Routinely Collected Ambulatory Records: The Example of Varicella-Zoster.

The burden of infectious diseases is crucial for both epidemiological surveillance and prompt public health response. A variety of data, including textual sources, can be fruitfully exploited. Dealing with unstructured data necessitates the use of methods for automatic data-driven variable construction and machine learning techniques (MLT) show promising results. In this framework, varicella-zoster virus (VZV) infection was chosen to perform an automatic case identification with MLT. Pedianet, an Italian pediatric primary care database, was used to train a series of models to identify whether a child was diagnosed with VZV infection between 2004 and 2014 in the Veneto region, starting from free text fields. Given the nature of the task, a recurrent neural network (RNN) with bidirectional gated recurrent units (GRUs) was chosen; the same models were then used to predict the children's status for the following years. A gold standard produced by manual extraction for the same interval was available for comparison. RNN-GRU improved its performance over time, reaching the maximum value of area under the ROC curve (AUC-ROC) of 95.30% at the end of the period. The absolute bias in estimates of VZV infection was below 1.5% in the last five years analyzed. The findings in this study could assist the large-scale use of EHRs for clinical outcome predictive modeling and help establish high-performance systems in other medical domains.

Systemic Catheter-Related Venous Thromboembolism in Children: Data From the Italian Registry of Pediatric Thrombosis.

Background: Central venous catheters (CVCs) represent one of the main risk factors for venous thrombotic events (VTEs) in children. Methods: We studied the Italian Registry of Pediatric Thrombosis (RITI) with regard to systemic radiologically confirmed CVC-related VTEs (CVC-VTEs) occurred during 6.5 years in children aged 29 days to 18 years. Results: A total of 78 CVC-VTEs were included, which occurred in 76 patients (40/76, 53% males). CVC-VTEs comprised 67 non-cardiac VTEs (86%) and 11 intracardiac thrombotic events (ICTEs) (14%); the median age at onset was 19 and 17 months, respectively. The most frequent reason for CVC insertion was supportive therapy. The catheters were placed percutaneously in 85% of cases (56/66) and surgically in the remaining 15% (10/66). Peripherally inserted central catheters (PICCs) were used in 47% (31/66) cases, partially implanted catheters in 42% (28/66), non-implantable catheters in 7% (5/66), and totally implanted catheters (Port) in 2% (1/66). CVC-VTEs were symptomatic in 77% of cases (60/78), while in the remaining 23%, they were incidentally detected on the imaging performed for the underlying condition. The median time between CVC insertion and the onset of symptoms was 10 days in non-cardiac VTEs and 39 days in ICTEs. Doppler ultrasound was the diagnostic technique most frequently used. The venous compartment most frequently affected was the veins of the lower extremities (52%, 43/73). Anti-thrombotic treatment was administered in 96% of CVC-VTEs (75/78). About 2.6% (2/76) of patients experienced a second thrombotic event. At discharge, post-thrombotic syndrome was reported in 13.5% (5/37) events with available data, CVC replacement in 10.8% (4/47), and ischemic necrosis with toe finger amputation in 2.7% (1/37). Three patients died due to an underlying condition; no CVC-VTE-related deaths were reported. Conclusions: We have carried out a registry-based study on CVC-VTEs in the children in Italy, providing the data that may help improve the detection and management of this CVC-related complication.

Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy.

Several European countries suspended or changed recommendations for the use of Vaxzevria (AstraZeneca) for suspected adverse effects due to atypical blood-clotting. This research aims to identify a reference point towards the number of thrombotic events expected in the Italian population over 50 years of age who received Vaxzevria from 22 January to 12 April 2021. The venous thromboembolism (VT) and immune thrombocytopenia (ITP) event rates were estimated from a population-based cohort. The overall VT rate was 1.15 (95% CI 0.93-1.42) per 1000 person-years, and the ITP rate was 2.7 (95% CI 0.7-11) per 100,000 person-years. These figures translate into 83 and two expected events of VT and ITP, respectively, in the 15 days following the first administration of Vaxzevria. The number of thrombotic events reported from the Italian Medicines Agency does not appear to have increased beyond that expected in individuals over 50 years of age.

Monitoring Public Perception of Health Risks in Brazil and Italy: Cross-Cultural Research on the Risk Perception of Choking in Children.

One of the most relevant public health issues among pediatric injuries concerns foreign body (FB) aspiration. The risk perception of choking hazards (CH) and risk perception, in general, are complex multifactorial problems that play a significant role in defining protective behavior. Risk prevention policies should take this aspect into account. A lack of scientific knowledge of FB injury risk perception may be evidenced in Brazil and other newly developed countries. This study aims to characterize the differences and peculiarities in risk perception of CH between Italian and Brazilian populations. The risk perception among adults in Italy and Brazil between September and October 2017 was investigated in a survey. A Multiple Correspondence Analysis was carried out to identify the latent components characterizing the risk perception in Italian and Brazilian population samples. The most relevant dimension characterizing risk perception is the "Professional-educational status and the related perception of Risk" (13% of factorial inertia). The Italians identify batteries and magnets as the most dangerous choking risks (20% of responses). On the other hand, Brazilian people, mainly manual laborers (22%) with secondary or primary education (94%), perceive coins as the most dangerous items (30% of responses, p < 0.001). Socio-economic issues characterize the subjective risk perception of Italian and Brazilian survey respondents. In this framework, data-driven prevention strategies could be helpful to tailor intervention strategies to the cultural context to which they are addressed.