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Objective This study aimed to analyze the effectiveness of root‐shape inserts mounted on a reciprocating handpiece during the procedure of root surface debridement (RSD) on extracted teeth. Three different approaches were compared: ultrasonic scaling, employment of root‐shape inserts mounted on a reciprocating handpiece, and a combination of both. Materials and Methods A total of 51 extracted teeth were divided into three groups. The first group was instrumented with an ultrasonic scaler, the second group with flexible root‐shape inserts mounted on a reciprocating handpiece (grain size 40, 15, and 4 μm), whereas the final group underwent a combination of both approaches. The time required for the instrumentation was taken. The specimens were subjected to optical and scanning electron microscopy (SEM), and the photographs were evaluated by three examiners who were blinded to the study. The parameters included were: SEM roughness index (SRI) for the roughness calculation, remaining calculus Index (RCI) to evaluate the residual calculus deposits, and loss of tooth substance index (LTSI) to evaluate the loss of tooth substance caused by instrumentation. Result The results revealed that the time taken for the instrumentation was on average longer when the root‐shape inserts were employed alone, meanwhile the combined approach did not show significant difference in comparison with the ultrasonic scaling. The lower average RCI was obtained with a combined approach. The use of root‐shape inserts seems to cause a moderate increase in LTSI, especially in a combined approach, whereas it resulted in a better average SRI. Conclusion The employment of root‐shape inserts seems to be effective in the RSD for its ability to obtain a smooth and calculus‐free instrumented surface, especially when used in combination with an ultrasonic scaler, and their use can so represent a valid approach to be tested in further in vivo studies.

The association between chronic use of metformin and risk of gastric cancer (GC) has been investigated with contradicting results. We aimed to study the association between chronic use of metformin and GC by using data from the Stomach cancer Pooling (StoP) Project, an epidemiological consortium of case-control studies on GC.Data from three studies of the StoP Project with available information on metformin intake were analyzed. Multivariable logistic regression models were used to estimate study-specific odds ratios (ORs) and 95% confidence intervals (CIs) for the association between chronic use of metformin and GC risk. Analyses were adjusted for sex, age, socioeconomic status, body mass index, smoking status, alcohol drinking status, and history of diabetes. Study-specific ORs and 95% CIs were then pooled with a random-effects model. The dose-response relationship between the duration of metformin intake and GC was assessed with a one-stage logistic model, and the duration of intake was modelled using second-order fractional polynomials.The OR of GC in metformin users versus non-users was 1.01 (95% CI=0.61, 1.67). The association between metformin and GC did not change among different strata of study participants' characteristics or when restricting the analyses to those with a history of diabetes. The dose-response analysis showed a slightly reducing trend in the OR of GC and a borderline significant association with increasing duration of metformin intake.The results of our study do not clearly support an association between chronic use of metformin and GC, warranting further research.

Background The risk of occupationally related lung cancer, as well as pleural mesothelioma, in association with genetic polymorphisms, has been investigated with contradictory results. This systematic review aims to summarize the current knowledge on the relationship between genetic polymorphisms, occupational exposures, and lung cancer and pleural mesothelioma. Methods We searched MEDLINE, ISI Web of science, and SCOPUS online databases for all articles published in English language up to September 2016. Studies were considered eligible if they had assessed the association between occupational exposures and lung cancer/pleural mesothelioma in relation to genetic polymorphisms. Results Sixteen studies were included, of which eleven on lung cancer and six on mesothelioma, of which one was in common. NAT2 slow acetylator genotype confers an increased risk of pleural mesothelioma in subjects exposed to asbestos (OR=2.10; 95% CI=1.10-4.10), especially in combination with the GSTM1 null genotype (OR=3.60; 95% CI=1.30-9.60). GSTT1 null and CYP1A1 Msp1 T6235C (T/C+C/C) genotype carriers exposed to arsenic, uranium, asbestos and other chemical agents have an increased risk of lung cancer respect to not exposed wild type genotypes (OR=1.33; 95% CI=0.67-2.64, OR=2.20; 95% CI=1.11-4.35, respectively). Conclusion Genetic polymorphisms might modulate individual susceptibility to lung cancer and pleural mesothelioma in occupationally exposed subjects.

Objective The extent of vertical transmission (VT) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from mothers their fetuses or neonates is still uncertain. We aimed to determine the incidence of VT. Study Design In this prospective cohort study. All mother diagnosed with SARS-CoV-2 infection at the time of delivery or up to 1 week prior and their neonates, managed in a tertiary referral hospital for pregnancy complicated by coronavirus disease 2019 (COVID-19) in Rome, from April 2 to December 22, 2020, were included. Maternal infection was defined as nasopharyngeal swab test results positive for SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR). Biological samples were collected before, at, and after delivery to test positivity for SARS-CoV-2 RT-PCR and anti-SARS-CoV-2-specific antibodies. Results The cohort included 95 women and 96 neonates with documented SARS-CoV-2 test results. Four neonates (4.2%) tested positive. The incidence of VT, according to the guidance criteria for diagnosing perinatal SARS-CoV-2 infection, was 5.2%. Neonatal symptoms were due to prematurity or fetal distress: symptomatic infants had lower median (min–max) gestational age, 38.1 (29.3–40.6) versus 39.3 (33.9–41.9) weeks (p = 0.036), and 1-minute and 5-minute Apgar scores, 9 (3–9) versus 9 (7–10) (p = 0.036) and 10 (6–10) versus 10 (8–10) (p = 0.012), respectively, than asymptomatic infants and needed more frequent assistance in the delivery room (22.2 vs 2.5%; p = 0.008). Only six (7.1%) neonates had anti-SARS-CoV-2-specific antibodies, despite the ongoing maternal infection. Conclusion The incidence of VT is low as is the detection of specific anti-SARS-CoV-2 antibodies in cord blood when infection is contracted late in pregnancy. This would suggest poor protection of infants against horizontal transmission of the virus. Key Points

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Background Mechanical ventilation is still needed in most preterm newborns, even in the non-invasive ventilation era. Ventilator-induced lung injury is one of the known pathogenetic factors of bronchopulmonary dysplasia (BPD) in preterm newborns. Lung injury has several patterns including surfactant dysfunction. Some recent trials have showed that a late surfactant administration can improve respiratory outcome in preterm babies still on invasive ventilation after the first week of life. Unfortunately, these results are still not conclusive. Moreover, giving surfactant after a recruitment manoeuvre in High Frequency Oscillatory Ventilation (HFOV) was shown to be safe and to reduce mortality in extremely preterm infants in a recent RCT. Our aim is to test the hypothesis that endotracheal administration of poractant-alfa preceded by a recruitment manoeuvre in HFOV in preterm infants still requiring mechanical ventilation at 7-10 days of life could facilitate extubation. Methods/Design: This will be an unblinded monocentric pilot trial that will be conducted in a III level Neonatal Intensive Care Unit at Fondazione Policlinico Agostino Gemelli IRCCS in Rome - Italy. Preterm newborns with a gestational age < 28 weeks still requiring invasive mechanical ventilation at 7-10 days of life with a fraction of inspired oxygen (FiO2) of more than 0.30 and/or an oxygenation index of 8 or more for at least 6 hours will be eligible for the study. Patients will be randomly assigned to intervention or to standard care. Intervention group infants will receive up to 4 doses of Poractant-alfa every 12 hours, each dose preceded by a recruitment manoeuvre in HFOV, until extubation. Primary endpoint will be the first successful extubation. Discussion Surfactant therapy is nowadays recommended in case of RDS in the first days of life but little is known about its effects in ventilator-dependant preterm newborns. Late administration of surfactant could help healing the lung of preterm babies in which RDS is evolving in a chronic pulmonary insufficiency of prematurity. The findings of this pilot trial will permit evaluation of the study design for a full-scale RCT. Trial registration: Clinicaltrials.gov – ID NCT04825197. Registered 12 April 2021, https://clinicaltrials.gov/ct2/home

Background: Prior epidemiologic studies on the association between diabetes and gastric cancer risk provided inconclusive findings, while traditional, aggregate data meta-analyses were characterized by high between-study heterogeneity. Objective: To investigate the association between type 2 diabetes and gastric cancer using data from the ‘Stomach Cancer Pooling (StoP) Project’, an international consortium of more than 30 case–control and nested case–control studies, which is large and provides harmonized definition of participants’ characteristics across individual studies. The data have the potential to minimize between-study heterogeneity and provide greater statistical power for subgroup analysis. Methods: We included 5592 gastric cancer cases and 12 477 controls from 14 studies from Europe, Asia, North America, and South America in a two-stage individual-participant data meta-analysis. Random-effect models were used to estimate summary odds ratios (ORs) and their corresponding 95% confidence intervals (CIs) by pooling study-specific ORs. Results: We did not find an overall association between diabetes and gastric cancer (pooled OR = 1.01, 95% CI, 0.94–1.07). However, the risk of cardia gastric cancer was significantly higher among individuals with type 2 diabetes (OR = 1.16, 95% CI, 1.02–1.33). There was no association between diabetes and gastric cancer risk in strata of Helicobacter pylori infection serostatus, age, sex, BMI, smoking status, alcohol consumption, fruit/vegetable intake, gastric cancer histologic type, and source of controls. Conclusion: This study provides additional evidence that diabetes is unrelated to gastric cancer overall but may be associated with excess cardia gastric cancer risk. This work was supported by Associazione Italiana per la Ricerca sul Cancro (AIRC), Project no. 21378 (Investigator Grant); Fondazione Italiana per la Ricerca sul Cancro (FIRC); Italian League for the Fight Against Cancer (LILT); European Cancer Prevention (ECP) Organization; and University of Pittsburgh Medical Center (UPMC) Start-up Grant (to H.N.L.). Sí

Multiple Sclerosis (MS) is a disease that often results in motor and/or cognitive disability. Despite the increasing availability of effective drug therapies, rehabilitation is very important means of counteracting the progression of disability and improving physical function, impacting social participation and improving quality of life. Several rehabilitation approaches can be used in the context of neuro-motor rehabilitation, but there is insufficient evidence for them in the literature.This study has the twofold purpose of: (i) investigate whether rehabilitation according to Bobath Concept can improve balance and some aspects of cognitive function in MS patients; (ii) explore whether the ability to improve postural control, an indirect index of adaptive neuroplasticity, is preserved in MS patients and whether it can be improved with rehabilitation.This is an independent wait-listed study. Forty people with MS (pwMS) were enrolled: patients in the Bobath group underwent 8 weeks of rehabilitation according to the Bobath Concept. For aim 1, pwMS were assessed at baseline (T0), at the end of the 8 weeks of treatment (T1) and after 8 weeks of observation (T2) with motor and cognitive scales. For aim 2, the same 40 pwMS were matched with healthy controls and were subjected to a postural learning task using the force platform at T0, T1 and T2.Patients in Bobath group scored better on balance and cognitive function at T1, but this improvement was not maintained at T2. All patients were less accurate than controls in the postural learning task at each assessment; however, patients also demonstrated an increase in accuracy after training, similar to that of healthy controls. The learning curve was better for patients randomized to the active group than the waitlist at T1 time, but this advantage was not maintained at the T2 assessment.In light of the results, this study supports the use of rehabilitation according to Bobath Concept to improve balance control and some executive functions in MS. Despite worse baseline performance, pwMS were able to learn a postural control task on par with healthy controls. Also, supports the hypothesis that adaptive plasticity is preserved despite MS and can be promoted by rehabilitation.

Background: Identification of screening tests for the detection of head and neck cancer (HNC) at an early stage is an important strategy to improving prognosis. Our objective was to identify plasma circulating miRNAs for the diagnosis of HNC (oral and laryngeal subsites), within a multicenter International Head and Neck Cancer Epidemiology consortium. Methods: A high-throughput screening phase with 754 miRNAs was performed in plasma samples of 88 cases and 88 controls, followed by a validation phase of the differentially expressed miRNAs, identified in the screening, in samples of 396 cases and 396 controls. Comparison of the fold changes (FC) was carried out using the Wilcoxon rank-sum test and the Dunn multiple comparison test. Results: We identified miR-151-3p (FC = 1.73, P = 0.007) as differentially expressed miRNAs in the screening and validation phase. The miR-151-3p was the only overexpressed miRNA in validation sample of patients with HNC with early stage at diagnosis (FC = 1.81, P = 0.008) and it was confirmed upregulated both in smoker early-stage cases (FC = 3.52, P = 0.024) and in nonsmoker early-stage cases (FC = 1.60, P = 0.025) compared with controls. Conclusions: We identified miR-151-3p as an early marker of HNC. This miRNA was the only upregulated in patients at early stages of the disease, independently of the smoking status. Impact: The prognosis for HNC is still poor. The discovery of a new diagnostic biomarker could lead to an earlier tumor discovery and therefore to an improvement in patient prognosis.

Background: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel intraperitoneal drug delivery method of low-dose chemotherapy as a pressurized aerosol in patients affected by peritoneal cancer of primary or secondary origin. We performed a systematic review and meta-analysis with the aim of assessing the feasibility, safety, and efficacy of PIPAC. Methods: A systematic literature search was performed using Medline and Web of Science databases from 1 January 2011, to inception, to 31 December 2021. Data were independently extracted by two authors. The Newcastle-Ottawa Scale was used to assess the quality and risk of bias of studies. Meta-analysis was performed for pathological response, radiological response, PCI variation along treatment, and for patients undergoing three or more PIPAC. Pooled analyses were performed using the Freeman–Tukey double arcsine transformation, and 95% CIs were calculated using Clopper–Pearson exact CIs in all instances. Results: A total of 414 papers on PIPAC were identified, and 53 studies considering 4719 PIPAC procedure in 1990 patients were included for analysis. The non-access rate or inability to perform PIPAC pooled rate was 4% of the procedures performed. The overall proportion of patients who completed 3 or more cycles of PIPAC was 39%. Severe toxicities considering CTCAE 3–4 were 4% (0% to 38.5%). In total, 50 studies evaluated deaths within the first 30 postoperative days. In the included 1936 patients were registered 26 deaths (1.3%). The pooled analysis of all the studies reporting a pathological response was 68% (95% CI 0.61–0.73), with an acceptable heterogeneity (I2 28.41%, p = 0.09). In total, 10 papers reported data regarding the radiological response, with high heterogeneity and a weighted means of 15% (0% to 77.8%). PCI variation along PIPAC cycles were reported in 14 studies. PCI diminished, increased, or remained stable in eight, one and five studies, respectively, with high heterogeneity at pooled analysis. Regarding survival, there was high heterogeneity. The 12-month estimated survival from first PIPAC for colorectal cancer, gastric cancer, gynecological cancer and hepatobiliary/pancreatic cancer were, respectively, 53%, 25%, 59% and 37%. Conclusions: PIPAC may be a useful treatment option for selected patients with PM, with acceptable grade 3 and 4 toxicity and promising survival benefit. Meta-analysis showed high heterogeneity of data among up-to-date available studies. In a subset analysis per primary tumor origin, pathological tumor regression was documented in 68% of the studies with acceptable heterogeneity. Pathological regression seems, therefore, a reliable outcome for PIPAC activity and a potential surrogate endpoint of treatment response. We recommend uniform selection criteria for patients entering a PIPAC program and highlight the urgent need to standardize items for PIPAC reports and datasets.

ObjectiveTo evaluate the effect of volume guarantee (VG) combined with high-frequency oscillatory ventilation (HFOV) on respiratory and other physiological parameters immediately after lung recruitment and surfactant administration in HFOV elective ventilated extremely low gestational age newborns (ELGAN) with respiratory distress syndrome (RDS).DesignObservational study.SettingTertiary neonatal intensive care unit.PatientsTwenty-two ELGANs of 25.5 ± 1.1 weeks of gestational age requiring invasive mechanical ventilation and surfactant administration for RDS during the first 6 h of life.InterventionsAll infants intubated in delivery room, were managed with elective HFOV and received surfactant after a lung recruitment manoeuver. Eleven infants received HFOV + VG and were compared with a control group of 11 infants receiving HFOV alone. HFOV was delivered in both groups by Dräger Babylog VN500 ventilator (Dräger, Lubeck, Germany).Main Outcome MeasuresVariations and fluctuations of delivered high-frequency tidal volume (VThf), fluctuation of pressure amplitude (ΔP) and partial pressure of CO2 (pCO2) levels after recruitment manoeuver and immediately after surfactant administration, in HFOV + VG vs. HFOV ventilated infants.ResultsThere were no significant differences in the two groups at starting ventilation with or without VG. The mean applied VThf per kg was 1.7 ± 0.3 ml/kg in the HFOV group and 1.7 ± 0.1 ml/kg in the HFOV + VG group. Thirty minutes after surfactant administration, HFOV group had a significant higher VThf/Kg than HFOV + VG (2.1 ± 0.3 vs. 1.6 ± 0.1 ml/kg, p < 0.0001) with significantly lower pCO2 levels (43.1 ± 3.8 vs. 46.8 ± 1.5 mmHg, p = 0.01), 54.4% of patients having pCO2 below 45 mmHg. Measured post-surfactant ΔP values were higher in HFOV group (17 ± 3 cmH2O) than in HFOV + VG group (13 ± 3 cmH2O, p = 0.01).ConclusionHFOV + VG maintains pCO2 levels within target range and reduces VThf delivered variations more consistently than HFOV alone after surfactant administration.

Costello syndrome (CS) is a rare disorder caused by activating dominantly acting germline variants in the HRAS gene. CS is defined by a clinical phenotype characterized by a distinctive gestalt, multiple congenital anomalies, and increased risk to develop tumors. Hypoglycemia and hypercholesterolemia have been reported to occur in affected individuals, but the underlying molecular events remain to be characterized. Here, we provided data on glucose/lipid metabolism and amino acid profile of a large single-center cohort of individuals affected by CS to systematically assess the extent of metabolic dysregulation characterizing this disorder and optimize patient management.

Background. Gastric cancer (GC) is the fifth most common type of cancer and the fourth most common cause of cancer-related mortality. Although the risk of GC and peptic ulcer disease (PUD) is known to be increased by H. pylori infection, evidence regarding the direct relationship between PUD and GC across ethnicities is inconclusive. Therefore, we investigated the association between PUD and GC in the Stomach cancer Pooling (StoP) consortium. Methods. History of peptic ulcer disease was collected using a structured questionnaire in 11 studies in the StoP consortium, including 4106 GC cases and 6922 controls. The two-stage individual-participant data meta-analysis approach was adopted to generate a priori. Unconditional logistic regression and Firth’s penalized maximum likelihood estimator were used to calculate study-specific odds ratios (ORs) and 95% confidence intervals (CIs) for the association between gastric ulcer (GU)/duodenal ulcer (DU) and risk of GC. Results. History of GU and DU was thoroughly reported and used in association analysis, respectively, by 487 cases (12.5%) and 276 controls (4.1%), and 253 cases (7.8%) and 318 controls (6.0%). We found that GU was associated with an increased risk of GC (OR = 3.04, 95% CI: 2.07–4.49). No association between DU and GC risk was observed (OR = 1.03, 95% CI: 0.77–1.39). Conclusions. In the pooled analysis of 11 case–control studies in a large consortium (i.e., the Stomach cancer Pooling (StoP) consortium), we found a positive association between GU and risk of GC and no association between DU and GC risk.

BackgroundMost countries initially deployed COVID-19 vaccines preferentially in elderly populations. Population-level vaccine effectiveness may be heralded by an increase in the proportion of deaths among non-elderly populations that were less covered by vaccination programs.MethodsWe collected data from 40 countries on age-stratified COVID-19 deaths during the vaccination period (1/14/2021-5/31/2021) and two control periods (entire pre-vaccination period and excluding the first wave). We meta-analyzed the proportion of deaths in different age groups in vaccination versus control periods in countries with low vaccination rates; (2) countries with age-independent vaccination policies; and (3) countries with standard age-dependent vaccination policies.FindingsCountries that prioritized vaccination among older people saw an increasing share of deaths among 0-69 year old people in the vaccination versus the two control periods (summary prevalence ratio 1·32 [95 CI% 1·24-1·41] and 1·35 [95 CI% 1·26-1·44)]. No such change was seen on average in countries with age-independent vaccination policies (1·05 [95 CI% 0·78-1·41 and 0·97 [95 CI% 0·95-1·00], respectively) and limited vaccination (0·93 [95 CI% 0·85-1·01] and 0·95 [95 CI% 0·87-1·03], respectively). Prevalence ratios were associated with the difference of vaccination rates in elderly versus non-elderly people. No significant changes occurred in the share of deaths in age 0-49 among all 0-69 deaths in the vaccination versus pre-vaccination periods.InterpretationThe substantial shift in the age distribution of COVID-19 deaths in countries that rapidly implemented vaccination predominantly among elderly may herald the population level-effectiveness of COVID-19 vaccination and a favorable evolution of the pandemic towards endemicity with fewer elderly deaths.FundingThis study received no specific funding.

Background: Due to its high incidence, evaluating performance of care delivered to breast cancer patients is a crucial issue. The multidisciplinary panel E.Pic.A. (Economic Appropriateness of an Integrated Care Pathway) defined a set of key performance indicators (KPIs) to evaluate economic waste in breast cancer healthcare interventions. Methods: The E.Pic.A. panel identified the principal KPIs that are crucial within the breast cancer care pathway to evaluate the performance of care. KPIs were defined taking into account their reliability, validity, usability and feasibility of measurement through the linkage between multiple routine healthcare data sources. Results: Seven KPIs were identified: three on instrumental diagnostics, two on surgery and two on treatment. The three KPIs regarding instrumental diagnostics are aimed at assessing the inappropriateness of diagnostic tests performed before and after the index surgery. The two KPIs regarding surgery measure the inappropriateness of possible repeated interventions considering the time elapsed from the index surgery. The two KPIs regarding oncologic therapy measure the inappropriateness about the administration time of adjuvant therapy and radiotherapy considering the time elapsed from the index surgery. Conclusion: E.Pic.A methodology could help to evaluate economic waste in healthcare interventions with the objective of redirecting resources to interventions with greater value. (HTA & Market Access)

Background: Nitrous oxide is widely used to induce sedation; however, its use outside of operating rooms – such as in ambulatory rooms – is not properly controlled by norms. In the lack of supervision, there is a chance of workplace exposures for the operators engaged in the outpatient use of nitrous oxide. The aim of this research is to assess nitrous oxide exposure in gastroenterology outpatient settings. Methods: We performed an observational study with a first step marked by nitrous oxide environmental testing in a gastroenterology outpatient care where colonoscopies were practiced; environmental research was supported by biological monitoring with urinary N2O analysis in exposed operators. The research was conducted in the absence and then in the presence of a collective security device (Niki mask). Results: The study was rolled out in 10 sessions of day shift procedures, totaling 4105 samples. The average nitrous oxide concentration in the environment was 27.58 (SD 1.76) and 449.59 (SD 35.29), respectively with and without Niki Mask; the distribution of gases in the environment under investigation was not homogeneous (Anova test p.001). Biological testing revealed a substantial rise in urinary concentration of 8.97 (p.001) between the start and the end of the shift, and the use of the Niki mask was effective (p=.003). Conclusions: The exposure levels reported in environmental sampling exceed the limits of 50 ppm (the value set for operating rooms in Italy) as well as the value of 25 ppm (NIOSH threshold value), indicating a significant issue in the outpatient use of nitrous oxide. It is evident that technical measures are needed to contain the occupational risk from Nitrous oxide exposure outside of operating rooms, and that even the basic use of Niki masks would not be sufficient to minimize professional exposure and protect workers; for the exposure results detected in this research, it is also plain that exposures must be subject to health surveillance.

The development and implementation of the approaches of personalized medicine for disease prevention are still at infancy, although preventive activities in healthcare represent a key pillar to guarantee health system sustainability. There is an increasing interest in finding informative markers that indicate the disease risk before the manifestation of the disease (primary prevention) or for early disease detection (secondary prevention). Recently, the systematic collection and study of clinical phenotypes and biomarkers consented to the advance of Rehabilomics in tertiary prevention. It consents to identify relevant molecular and physiological factors that can be linked to plasticity, treatment response, and natural recovery. Implementation of these approaches would open avenues to identify people at high risk and enable new preventive lifestyle interventions or early treatments targeted to their individual genomic profile, personalizing prevention and rehabilitation. The integration of personalized medicine into prevention may benefit citizens, patients, healthcare professionals, healthcare authorities, and industry, and ultimately will seek to contribute to better health and quality of life for Europe’s citizens.

Healthcare workers are at the forefront against COVID-19, worldwide. Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS was enlisted as a COVID-19 hospital, the healthcare workers deployed to COVID-19 wards were separated from those with limited/no exposure, whereas the administrative staff were designated to work from home. Between 4 June and 3 July 2020, an investigation was conducted to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG) antibodies among the employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity, and predictive values were determined with reverse-transcription polymerase chain reaction on nasal/oropharyngeal swabs as the diagnostic gold standard. The participants enrolled amounted to 4777. Seroprevalence was 3.66% using the POC test and 1.19% using the venous blood test, with a significant difference (p &lt, 0.05). The POC test sensitivity and specificity were, respectively, 63.64% (95% confidence interval (CI): 62.20% to 65.04%) and 96.64% (95% CI: 96.05% to 97.13%), while those of the venous blood test were, respectively, 78.79% (95% CI: 77.58% to 79.94%) and 99.36% (95% CI: 99.07% to 99.55%). Among the low-risk populations, the POC test’s predictive values were 58.33% (positive) and 98.23% (negative), whereas those of the venous blood test were 92.86% (positive) and 98.53% (negative). According to our study, these serological tests cannot be a valid alternative to diagnose COVID-19 infection in progress.

In several hospitals worldwide, healthcare workers are currently at the forefront against coronavirus disease 2019 (COVID-19). Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS has been enlisted as a COVID hospital, healthcare workers deployed to COVID wards were separated from those with limited or no exposure, whereas administrative staff was destined to work-from-home. Between June 4 and July 3 2020, an investigation was carried out to evaluate seroprevalence of SARS-CoV-2 IgG antibodies among employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity and predictive values were determined with reverse-transcription polymerase chain reaction (RT-PCR) on nasal/oropharyngeal swabs as gold standard.Four thousand, seven hundred seventy-seven participants were enrolled. Seroprevalence was 3.66% using the POC test and 1.19% using venous blood test, with a significant difference between the two (p < 0.05).POC sensitivity and specificity were, respectively, 63.64% (95% confidence interval (CI): 62.20% to 65.04%) and 96.64% (95% CI: 96.05% to 97.13%), while those of the venous blood test were, respectively, 78.79% (95% CI: 77.58% to 79.94%) and 99.36% (95% CI: 99.07% to 99.55%). Among low-risk population, point-of-care’s predictive values were 58.33% (positive) and 98.23% (negative) whereas venous blood test’s were 92.86% (positive) and 98.53% (negative). In conclusion, point-of-care tests have low diagnostic accuracy, while venous blood tests seem to show an overall poor reliability.

Breast Cancer (BC) is the leading cause of death due to cancer in women. Ensuring equitable, quality-assured and effective care has increased the complexity of BC management. This systematic review reports on the state-of-the art of available literature investigating the enactment of personalized treatment and patient-centered care models in BC clinical practice, building a framework for the delivery of personalized BC care within a Patient-Centered model. Databases were searched for articles (from the inception to December 2020) reporting on Patient-Centered or Personalized Medicine BC management models, assessing success factors or limits. Out of 1885 records, 25 studies were included in our analysis. The main success factors include clearly defined roles and responsibilities within a multi-professional collaboration, appropriate training programs and adequate communication strategies and adopting a universal genomic language to improve patients’ involvement in the decision-making process. Among detected barriers, delays in the use of genetic testing were linked to the lack of public reimbursement schemes and of clear indications in timing and appropriateness. Overall, both care approaches are complementary and necessary to effectively improve BC patient management. Our framework attempts to bridge the gap in assigning a central role played by shared decision-making, still scarcely investigated in literature.

Summary Background The importance of lung recruitment before surfactant administration has been shown in animal studies. Well designed trials in preterm infants are absent. We aimed to examine whether the application of a recruitment manoeuvre just before surfactant administration, followed by rapid extubation (intubate-recruit-surfactant-extubate [IN-REC-SUR-E]), decreased the need for mechanical ventilation during the first 72 h of life compared with no recruitment manoeuvre (ie, intubate-surfactant-extubate [IN-SUR-E]). Methods We did a randomised, unblinded, controlled trial in 35 tertiary neonatal intensive care units in Italy. Spontaneously breathing extremely preterm neonates (24 + 0 to 27 + 6 weeks' gestation) reaching failure criteria for continuous positive airway pressure within the first 24 h of life were randomly assigned (1:1) with a minimisation algorithm to IN-REC-SUR-E or IN-SUR-E using an interactive web-based electronic system, stratified by clinical site and gestational age. The primary outcome was the need for mechanical ventilation in the first 72 h of life. Analyses were done in intention-to-treat and per-protocol populations, with a log-binomial regression model correcting for stratification factors to estimate adjusted relative risk (RR). This study is registered with ClinicalTrials.gov , NCT02482766 . Findings Of 556 infants assessed for eligibility, 218 infants were recruited from Nov 12, 2015, to Sept 23, 2018, and included in the intention-to-treat analysis. The requirement for mechanical ventilation during the first 72 h of life was reduced in the IN-REC-SUR-E group (43 [40%] of 107) compared with the IN-SUR-E group (60 [54%] of 111; adjusted RR 0·75, 95% CI 0·57–0·98; p=0·037), with a number needed to treat of 7·2 (95% CI 3·7–135·0). The addition of the recruitment manoeuvre did not adversely affect the safety outcomes of in-hospital mortality (19 [19%] of 101 in the IN-REC-SUR-E group vs 37 [33%] of 111 in the IN-SUR-E group), pneumothorax (four [4%] of 101 vs seven [6%] of 111), or grade 3 or worse intraventricular haemorrhage (12 [12%] of 101 vs 17 [15%] of 111). Interpretation A lung recruitment manoeuvre just before surfactant administration improved the efficacy of surfactant treatment in extremely preterm neonates compared with the standard IN-SUR-E technique, without increasing the risk of adverse neonatal outcomes. The reduced need for mechanical ventilation during the first 72 h of life might facilitate implementation of a non-invasive respiratory support strategy. Funding None.

Although there is a clear relationship between family history (FH) and the risk of gastric cancer (GC), quantification is still needed in relation to different histological types and anatomical sites, and in strata of covariates. The objective was to analyze the risk of GC according to first-degree FH in a uniquely large epidemiological consortium of GC. This investigation includes 5946 cases and 12,776 controls from 17 studies of the Stomach Cancer Pooling (StoP) Project consortium. Summary odds ratios (OR) and the corresponding 95% confidence intervals (CIs) were calculated by pooling study-specific ORs using fixed-effect model meta-analysis techniques. Stratified analyses were carried out by sex, age, tumor location and histological type, smoking habit, socioeconomic status, alcohol intake and fruit consumption. The pooled OR for GC was 1.84 (95% CI: 1.64–2.04, I2 = 6.1%, P heterogeneity = 0.383) in subjects with vs. those without first-degree relatives with GC. No significant differences were observed among subgroups of sex, age, geographic area or study period. Associations tended to be stronger for non-cardia (OR = 1.82, 95% CI: 1.59–2.05 for subjects with FH) than for cardia GC (OR = 1.38, 95% CI: 0.98–1.77), and for the intestinal (OR = 1.92, 95% CI: 1.62–2.23) than for the diffuse histotype (OR = 1.62, 95% CI: 1.28–1.96). This analysis confirms the effect of FH on the risk of GC, reporting an approximately doubled risk, and provides further quantification of the risk of GC according to the subsite and histotype. Considering these findings, accounting for the presence of FH to carry out correct prevention and diagnosis measures is of the utmost importance.

Background: Artificial Intelligence (AI) is increasingly used for process management in daily life. In the medical field AI is becoming part of computerized systems to manage information and encourage the generation of evidence. Here we present the development of the application of AI to IT systems present in the hospital, for the creation of a DataMart for the management of clinical and research processes in the field of breast cancer. Materials and methods: A multidisciplinary team of radiation oncologists, epidemiologists, medical oncologists, breast surgeons, data scientists, and data management experts worked together to identify relevant data and sources located inside the hospital system. Combinations of open-source data science packages and industry solutions were used to design the target framework. To validate the DataMart directly on real-life cases, the working team defined tumoral pathology and clinical purposes of proof of concepts (PoCs). Results: Data were classified into &ldquo, Not organized, not &lsquo, ontologized&rsquo, data&rdquo, &ldquo, Organized, not &lsquo, and &ldquo, Organized and &lsquo, Archives of real-world data (RWD) identified were platform based on ontology, hospital data warehouse, PDF documents, and electronic reports. Data extraction was performed by direct connection with structured data or text-mining technology. Two PoCs were performed, by which waiting time interval for radiotherapy and performance index of breast unit were tested and resulted available. Conclusions: GENERATOR Breast DataMart was created for supporting breast cancer pathways of care. An AI-based process automatically extracts data from different sources and uses them for generating trend studies and clinical evidence. Further studies and more proof of concepts are needed to exploit all the potentials of this system.

The effectiveness of virtual reality (VR) in the motor and cognitive rehabilitation of patients with severe acquired brain injury (sABI) is unclear. This randomized, controlled, crossover, single-blinded, pilot study investigates the cognitive and motor effects of lower limb robotic therapy with and without VR visual feedback in a group of patients with ABI. A total of 23 patients with ABI were randomized into two groups: one group (VR-NVR) underwent a 2-week rehabilitation for the lower limbs training with a robotic device (Omego®) with VR feedback, followed by 2 weeks without VR; the other group (NVR-VR) performed the protocol in the opposite order. Patients were evaluated at baseline, after two and four weeks of treatment using the Level of Cognitive Functioning scale (LCF), Disability Rating Scale (DRS), and Motricity Index for Lower Limb (MI-LL) in the most affected limb. At the end of the intervention, both groups significantly improved in all the outcomes. A significant difference was found between VR treatment versus non-VR treatment for LCF (p = 0.024) and for DRS (p = 0.043) after the second week, while no significant differences were found in the group NVR-VR at T1. Our study indicates how the combination of robotic treatment with VR is effective in enhancing the recovery of cognitive function in patients with ABI, also improving disability and muscular function. Further, VR seems to enhance the early recovery process of motor and cognitive functions.

The last fifteen years have seen the emergence of Public Health Genomics (PHG), a multidisciplinary field related to the effective and responsible translation of genome-based knowledge and technologies to improve population health. While at the beginning the main concern of PHG was that genetic/genomic applications should be evaluated rigorously before entering into clinical and public health (PH) practice, now the main matter is around the fact that there are some genetic/genomic applications with proved efficacy and cost-effectiveness that should be implemented and become citizens’ rights. In any case, there is a critical need for a robust evaluation process, that takes into account also context-related dimensions (delivery models, economic evaluation and organizational aspects) to facilitate the implementation of these technologies. Systematic reviews of full economic evaluations of genetic/genomic applications are of paramount importance to identify all feasible health programs involving a defined use of a particular genetic/genomic application and to recognize which health programs can maximize the value of that genetic/genomic application. Cost-effectiveness analyses may be useful also in the early stages of the evaluation process to assess which characteristics of a genetic/genomic application need to be improved. Finally, the implementation of genetic/genomics applications requires specific training efforts for public health professional to increase their current level of competence. All these issues are addressed in this chapter, using the population health perspective and the point of view of PH.

Background Italy was the first European country to implement a national lockdown because of the COVID-19 pandemic. Worldwide, this pandemic had a huge impact on the mental health of people in many countries causing similar reaction in terms of emotions and concerns at the population level. Our study investigated the impact of the COVID-19 pandemic on psychological well-being in a cohort of Italian university students. Methods We conducted a cross-sectional survey in the period immediately after the first lockdown through the administration of a questionnaire on the personal websites of students attending their undergraduate courses at the Università Cattolica del Sacro Cuore. We used the Patient-Health-Engagement-Scale, Self-Rating-Anxiety-Scale, and Self-Rating-Depression-Scale to assess engagement, anxiety symptoms, and depression symptoms of our sample. Results The sample size was 501 subjects, of which 35.33% were classified as anxious and 72.93% as depressed. Over 90% of respondents had good understanding of the preventive measures despite over 70% suffered from the impossibility of physically seeing friends and partners. Around 55% of students would have been willing to contribute much more to face the pandemic. An increase in the occurrences of anxiety was associated with being female, being student of the Rome campus, suffering from the impossibility of attending university, being distant from colleagues, and being unable of physically seeing one's partner. Performing physical activity reduced this likelihood. Conclusions University students are at risk of psychological distress in the case of traumatic events. The evolution of the pandemic is uncertain and may have long-term effects on mental health. Therefore, it is crucial to study the most effective interventions to identify vulnerable subgroups and to plan for acute and long-term psychological services to control and reduce the burden of psychological problems.

Head and neck cancer (HNC) represents the sixth most common cancer and the seventh cause of cancer-related deaths worldwide. Because of HNC high mortality and morbidity a support from the development of new biomarkers and personalized care for patients is needed. The role of micro-RNAs (miRs), as new epigenetic biomarkers, aimed at improving early diagnosis, predicting prognosis and establishing effective cancer therapies, has recently received considerable attention. The aim of this study was to conduct an umbrella review that synthetizes all the findings of systematic reviews already available in literature that investigate the prognostic role of miRs as potential biomarkers in the field of tertiary prevention of HNC. We selected systematic reviews, published in English until December 2019, related to human HNC with meta-analysis of observational studies that reported quantitative prognostic measures, Hazard Ratios (HRs), of Overall Survival (OS) or Disease-Free Survival (DFS). The methodological quality of the included reviews was assessed using the Assessment of Multiple Systematic Reviews AMSTAR 2 tool. Six systematic reviews were included in the umbrella review. The most reported miRNAs were: miR21; the Let7 family (c,d,g), miR17, 18 family, 20a, 29 family, 125b, 375. A total of 4 reviews assessed miR-21 expression in HNC patients, all showing its upregulation. The most frequently studied miR was miR21 which was reported either in the OS and DFS statistical analyses. The OS analysis showed a significant lower prognosis when miR21 was upregulated. It is involved in oncogenic and oncosuppressive cell signals pathways: the overexpression of miR21 was shown to be associated with cell proliferation, migration, invasion and survival. Recently the cumulative effects of sets of miRs has been increasingly studied and they might be stronger predictor of survival than single. The role of miRNAs as a prognostic biomarker specifically in HNC still need to be investigated. Key messages Some miRs were demonstrated to have as tumor-suppressing and oncogenic roles according to their level of regulation (up/down-regulation) in Head and Neck cancer patients. The role of miRs as prognostic biomarkers in HNC patients still need to be addressed by performing large scale to verify and enhance the power of evidence and clinical utility of these.

Introduction Various single nucleotide polymorphisms (SNPs) have been associated with Head and Neck Cancer (HNC) susceptibility and prognosis. The pathogenesis of HNC is related to alterations in metabolite concentrations. Dietary intake may also influence the metabolic profile. We aimed to evaluate the association between serologic metabolites on the one hand and on the other hand HNC related SNPs and dietary intake. Methods This study included participants from the Erasmus Rucphen Family Study (ERF). We identified the SNPs associated with HNC from the GWAS Catalog, reaching genome-wide significance at P Results The study included 2758 participants, in whom 820 metabolites were analyzed. Four SNPs showed a significant association with circulating metabolites: rs174549 with phosphatidylcholine diacyl (β = 0.45; p-value= 7.17 × 10− 40), rs310518 with lipoprotein IDL sub-fraction, rs1229984 with triglycerides and rs1494961 with propionylcarnitine. The minor variant allele of the 4 SNPs showed increased level of the metabolites in blood. As to the association diet and metabolite concentration, significant associations were found for dairy products with sphingomyelin, fish intake with phosphatidylcholines, cholesterol esters with vegetables and myoinositol with fruits intake. When the results of both analyses were merged, 5 metabolites were found to be associated with dietary variables and rs174549. In the minor allele carriers, phosphatidylcholines increased with consumption of fish and phosphatidylethanolamine increased with consumption of diary products. Conclusions The genetic variants rs174549, which is a determinant of genetic HNC susceptibility, is associated with phosphatidylcholines and phosphatidylethanolamine in the circulation. Key messages In the minor allele carriers of rs174549, phosphatidylcholine diacyl level in circulation increased with consumption of fish. In the minor allele carriers of rs174549, phosphatidylethanolamine level in circulation increased with consumption of diary products.

Background Previous findings suggest there might be an inverse association between body mass index (BMI) and overall (OS) and Head and Neck-specific survival. The aim of this study was to investigate the prognostic role of BMI in the largest available cohort of HNC patients. Methods We performed a pooled analysis of studies participating at the INHANCE consortium. Cases were adults with HNCs of the oral cavity, oropharynx, hypopharynx and larynx. We used cox's proportional hazards models to estimate the relationship between BMI and overall and HNC-specific mortality. Sensitivity analysis were performed according to tumour location, smoking status and length of follow-up. Results The study included 9484 patients from 10 centres worldwide for a median follow-up of 48 months (IQR: 18-69). Overall 3623 patients (38.2%) died from all-causes and 1493 (15.7%) from HNC. Compared to patients with a normal weight, overweight or obese was associated with a longer HNC-specific survival (HR = 0.58, 95% CI: 0.35-0.95, HR = 0.37, 95% CI: 0.17-0.78, respectively), while underweight was associated to a shorter survival (HR = 1.73, 95% CI: 1.36-2.21). Results were heterogeneous according to tumour site, with the strongest effect among oropharynx and oral cavity cancer sites. When we restricted the analysis among patients with a follow-up longer than 5 years, underweight (HR = 5.17, 95% CI: 3.02-8.86) was associated with shorter HNC-specific survival. Conclusions Our findings suggest low BMI values are at diagnosis increase mortality in HNC patients. The protective effect of high BMI might be partially explained by residual confounding and reverse causality, so that further research is needed to clarify the potential role in tertiary prevention of BMI. Key messages BMI at diagnosis is a prognostic factor of HNC. Low BMI values predict unfavourable outcomes.

Objective Head and neck cancer (HNC) is the sixth leading cancer worldwide with approximately 600,000 new cases per year. Several studies suggest that HNC survivors may have an increased risk of developing second primary cancers (SPCs). A systematic review and meta-analysis was performed aiming to quantify the overall and site-specific risk of metachronous SPCs in HNC survivors. Methods PubMed, Web of Science and Scopus were searched to identify studies published until October 2019. Studies investigating the standardised incidence ratio (SIR) of metachronous SPC were included. A random-effects meta-analysis was performed to calculate the overall and site-specific SIRs. Newcastle-Ottawa Scale was used to assess the study's quality. Heterogeneity was quantified using the I2 statistics and explored using meta-regression. Results Twenty-six studies were included in the systematic review. Studies differed by the definition of metachronous SPC used. For the meta-analyses, the studies were grouped according to these definitions. In the three groups, the overall risk of metachronous SPC was increased. The highest SPC risk was for oropharynx, oesophagus and lung. Conclusions Head and neck cancer survivors are at increased overall risk of metachronous SPCs. The canonical upper aerodigestive sites, HNLE (head and neck, oesophagus and lung), were the SPC sites with the highest risk. Implication for cancer survivors Our results emphasise the importance of targeted surveillance strategies aimed at early detection and tertiary preventive interventions.

Background Physical activity (PA) has been recognized as a protective factor against several types of cancer, though robust evidence related to Gastric Cancer (GC) are lacking. This study aimed to establish whether leisure-time PA can prevent GC using data from a large pooled analysis of case-control studies within the Stomach cancer Pooling (StoP) Project.Methods Five case-control studies from StoP project collected data on PA, for a total of 2,415 cases and 9,722 controls. Subjects were classified into three leisure-time PA categories, either none/low, intermediate or high, based on study-specific tertiles. We used a two-stage approach. Firstly, we applied multivariable logistic regression models to obtain study-specific odds ratios (ORs) and corresponding 95% confidence intervals (CIs). Afterwards, we used a random-effect models for estimating pooled effect estimates. Heterogeneity across studies was assessed using Q and I 2 statistics. We performed stratified analyses according to demographic, lifestyle and clinical covariates.Results The pooled ORs for GC risk were 0.90 (95% CI: 0.72, 1.13) for intermediate, and 0.72 (95% CI: 0.57, 0.91) for high levels of leisure-time PA. There was no evidence of significant heterogeneity in outcome estimates ( I 2 = 49.7%; p=0.094 for intermediate; I 2 = 42.9%, p=0.135 for high levels of exposure). GC risk estimates did not differ across strata of selected covariates.Conclusions Our study is the largest pooled analysis that provides insights about protective effects of high levels of recreational PA on GC risk. Although our results should be confirmed from large cohort studies, the implications have relevant public health significance.

BackgroundAn individual’s lifetime risk of Coronary Artery Disease (CAD) is determined by a combination of genetic and lifestyle factors. Whilst adherence to a healthy lifestyle can help individuals with high genetic risk reduce their lifetime risk of CAD, the extent to which blood lipid levels affect CAD risk in individuals with varying genetic risk remains unknown. To explore how genetics, blood lipids and CAD risk interact, we derived a novel genome-wide polygenic risk score (PRS) for CAD. We then applied the PRS to individuals from the UK Biobank and divided them into Low PRS (bottom 10 percentiles of PRS distribution), Intermediate PRS (PRS in the 10th-90th percentiles), and High PRS (top 10 percentiles), and further stratified individuals by blood lipid levels.ResultsWe found that the elevated CAD risk conferred by high low-density lipoprotein cholesterol (LDL-C) was modified by the interaction with PRS (P-value interaction: 190 mg/dL; HR 2.77; 95% CI, 2.33-3.28). Furthermore, individuals with High PRS but whose lipid levels were below the following thresholds did not have a significantly increased risk for incident CAD: LDL-C 190 mg/dl) did not have increased CAD risk, which was comparable to individuals with Intermediate PRS and Optimal LDL-C (ConclusionsOur results have important implications for the primary prevention of coronary artery disease. Currently, healthy individuals with Borderline LDL-C (130-159 mg/dL) are not considered to be at high risk of CAD. Here we demonstrate that the combination of Borderline LDL-C and High PRS results in CAD relative risk which is greater than individuals without high polygenic risk, but whose LDL-C levels are high enough for statins to be recommended (>190 mg/dL). This analysis therefore demonstrates that PRS can identify a proportion of the population who are at high-risk of CAD but who are invisible to current approaches for assessing CAD risk. Moreover, of perhaps greater significance is the evidence that individuals who have a combination of High PRS and Optimal blood lipid levels do not have greater risk of CAD than individuals without high polygenic risk and the same Optimal blood lipid levels. Our results suggest that high polygenic risk for CAD could be overcome by controlling blood lipid levels. We propose that incorporating PRS into CAD risk assessment early in life could allow individuals at high polygenic risk to benefit from tailored blood lipid guidelines and avoid lifetime exposure to potentially damaging PRS-dependent LDL-C levels.

Medical practitioners are increasingly adopting a personalized medicine (PM) approach involving individually tailored patient care. The Personalized Prevention of Chronic Diseases (PRECeDI) consortium project, funded within the Marie Skłodowska Curie Action (MSCA) Research and Innovation Staff Exchange (RISE) scheme, had fostered collaboration on PM research and training with special emphasis on the prevention of chronic diseases. From 2014 to 2018, the PRECeDI consortium trained 50 staff members on personalized prevention of chronic diseases through training and research. The acquisition of skills from researchers came from dedicated secondments from academic and nonacademic institutions aimed at training on several research topics related to personalized prevention of cancer and cardiovascular and neurodegenerative diseases. In detail, 5 research domains were addressed: (1) identification and validation of biomarkers for the primary prevention of cardiovascular diseases, secondary prevention of Alzheimer disease, and tertiary prevention of head and neck cancer; (2) economic evaluation of genomic applications; (3) ethical-legal and policy issues surrounding PM; (4) sociotechnical analysis of the pros and cons of informing healthy individuals on their genome; and (5) identification of organizational models for the provision of predictive genetic testing. Based on the results of the research carried out by the PRECeDI consortium, in November 2018, a set of recommendations for policy makers, scientists, and industry has been issued, with the main goal to foster the integration of PM approaches in the field of chronic disease prevention.

Italy was the first European country to implement a national quarantine, with 71 days of total lockdown as a result of the COVID-19 outbreak. This study investigated the effects of the COVID-19 pandemic on the mental health and psychological well-being of a sample of Italian university students. A cross-sectional survey was conducted in the period immediately following the end of lockdown through the administration of a questionnaire on the personal websites of students attending their undergraduate courses at Universita Cattolica del Sacro Cuore.The Patient Health Engagement Scale, the Self-Rating Anxiety Scale, and the Self-Rating Depression Scale were used to assess engagement, anxiety symptoms, and depression symptoms, respectively.The sample size was 501, of whom 35.33% were classified as anxious and 72.93% as depressed, although with a prevalence of mild symptoms. Over 90% of respondents reported understanding the preventive measures of the lockdown despite over 70% suffering from the impossibility of seeing their friends and partners. Over 55% of students would have been willing to contribute much more to facing the pandemic. An increase in the occurrences of anxiety was associated with being female, being students of the Rome campus (Central Italy), suffering from the impossibility of attending university, distance from colleagues, and the impossibility of seeing one’s partner. Performing physical activity reduced such a probability. Borderline risk factors for the occurrence of depression were being a student at the Rome campus and suffering from the distance to one’s fellow students. Funding Statement: No funding was received for this study. Declaration of Interests: All authors confirm that they have no conflicts of interest or competing interests. Ethics Approval Statement: The protocol of the study was approved by the Ethics Committee of the Policlinico Universitario A. Gemelli IRCCS and by the Internal Board of the University.

Background and aim Increased intestinal permeability plays a key role in the pathogenesis of fat deposition in the liver. The aim of our study was to assess whether a single nucleotide polymorphism of protein tyrosine phosphatase non-receptor type 2 (PTPN2) (rs2542151 T→G), involved in intestinal permeability, may be associated with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM). Methods and results We recruited a prospective cohort of NAFLD subjects and matched controls. Clinical data, PTPN2 genotype and laboratory data were collected for each patient. Results were stratified according to liver histology and diabetes. We enrolled 566 cases and 377 controls. PTPN2 genotype distribution did not significantly differ between patients and controls. In the entire population, patients with PTPN2 rs2542151 T→G (dominant model) have a higher prevalence of diabetes; 345 patients (60.9%) underwent liver biopsy: 198 (57.4%) had steatohepatitis and 75 (21.7%) had advanced fibrosis. At multiple logistic regression analysis PTPN2 rs2542151 T→G was associated with T2DM (OR 2.14, 95% CI 1.04–4.40, P = 0.03). Patients who underwent liver biopsy, rs2542151 T→G of PTPN2 was independently associated with severe steatosis (OR 2.00, 95% CI 1.17–3.43, p = 0.01) and severe fibrosis (OR 2.23, 95% CI 1.06–4.72, P = 0.03). Conclusion Our study shows that NAFLD patients with rs2542151 T→G of PTPN2 have a higher severity of fatty liver disease and a higher prevalence of T2DM. These results suggest that individual genetic susceptibility to intestinal permeability could play a role in liver disease progression.

BACKGROUND: The association between height and risk of gastric cancer has been studied in several epidemiological studies with contrasting results. The aim of this study is to examine the association between adult height and gastric cancer within a large pooled analysis of case-control studies members of the Stomach cancer Pooling (StoP) Project consortium. METHODS: Data from 18 studies members of the StoP consortium were collected and analyzed. A multivariable logistic regression model was used to estimate the study-specific odds ratios (ORs) and 95% confidence intervals (CIs) for the association between 10-cm increase in height and risk of gastric cancer. Age, sex, tobacco smoking, alcohol consumption, social class, geographical area and Helicobacter pylori (H. pylori) status were included in the regression model. Resulting estimates were then pooled with random-effect model. Analyses were conducted overall and in strata of selected variables. RESULTS: A total of 7562 cases and 19 033 controls were included in the analysis. The pooled OR was 0.96 (95% CI 0.87-1.05). A sensitivity analysis was performed restricting the results to the studies with information on H. pylori status, resulting in an OR of 0.97 (95% CI 0.79-1.20). CONCLUSION: Our study does not support a strong and consistent association between adult height and gastric cancer.

The early identification of gastric cancer (GC) represents a major clinical challenge. We conducted a systematic review of studies evaluating the miRNA expression profiling as a diagnostic tool in GC.We performed a search of PubMed, ISI Web of Science and SCOPUS databases for studies on diagnostic miRNAs and GC, published in English up to October 2017. Eligibility criteria included case-control studies evaluating blood or tissue-based miRNA expression profiles, and incorporating at least two detection phases (screening and validation).We included 27 eligible studies, that reported on 97 deregulated miRNAs either in blood or tissue, out of which 30 were reported in at least two studies. Among 22 studies on tissue-diagnostic miRNAs, 13 consistently upregulated miRNAs (miR-214, miR-21, miR-103, miR-107, miR-196a, miR-196b, miR-7, miR-135b, miR-222, miR-23b, miR-25, miR-92 and miR-93), and six consistently downregulated miRNAs (miR-148a, miR-375, miR-133b, miR-30a, miR-193a and miR-204) were reported. Ten miRNAs with inconsistent direction of expression in tissues were identified. Among the five studies performed on blood samples, only one miRNA was consistently upregulated (miR-20a).This review shows that some tissue or blood miRNAs may be considered as potential biomarkers for GC diagnosis, that urgently needs to be confirmed from large prospective studies.

Objective To compare short-term application of nasal high-frequency oscillatory ventilation (nHFOV) with nasal continuous positive airway pressure (nCPAP). Working hypothesis nHFOV improves CO2 removal with respect to nCPAP in preterm infants needing noninvasive respiratory support and persistent oxygen supply after the first 72 h of life. Study design Multicenter non-blinded prospective randomized crossover study. Patient selection Thirty premature infants from eight tertiary neonatal intensive care units, of mean ± SD 26.4 ± 1.8 weeks of gestational age and 921 ± 177 g of birth weight. Methodology Infants were randomly allocated in a 1:1 ratio to receive a starting treatment mode of either nCPAP or nHFOV delivered by the ventilator CNO (Medin, Germany), using short binasal prongs of appropriate size. A crossover design with four 1-h treatment periods was used, such that each infant received both treatments twice. The primary outcome was the mean transcutaneous partial pressure of CO2 (TcCO2 ) value during the 2-h cumulative period of nHFOV compared with the 2-h cumulative period of nCPAP. Results Significantly lower TcCO2 values were observed during nHFOV compared with nCPAP: 47.5 ± 7.6 versus 49.9 ± 7.2 mmHg, respectively, P = 0.0007. A different TcCO2 behavior was found according to the random sequence: in patients starting on nCPAP, TcCO2 significantly decreased from 50.0 ± 8.0 to 46.6 ± 7.5 mmHg during nHFOV (P = 0.001). In patients starting on nHFOV, TcCO2 slightly increased from 48.5 ± 7.8 to 49.9 ± 6.7 mmHg during nCPAP (P = 0.13). Conclusions nHFOV delivered through nasal prongs is more effective than nCPAP in improving the elimination of CO2 .

With the aim to dissect the effect of adult height on head and neck cancer (HNC), we use the Mendelian randomization (MR) approach to test the association between genetic instruments for height and the risk of HNC. 599 single nucleotide polymorphisms (SNPs) were identified as genetic instruments for height, accounting for 16% of the phenotypic variation. Genetic data concerning HNC cases and controls were obtained from a genome-wide association study. Summary statistics for genetic association were used in complementary MR approaches: the weighted genetic risk score (GRS) and the inverse-variance weighted (IVW). MR-Egger regression was used for sensitivity analysis and pleiotropy evaluation. From the GRS analysis, one standard deviation (SD) higher height (6.9 cm; due to genetic predisposition across 599 SNPs) raised the risk for HNC (Odds ratio (OR), 1.14; 95% Confidence Interval (95%CI), 0.99–1.32). The association analyses with potential confounders revealed that the GRS was associated with tobacco smoking (OR = 0.80, 95% CI (0.69–0.93)). MR-Egger regression did not provide evidence of overall directional pleiotropy. Our study indicates that height is potentially associated with HNC risk. However, the reported risk could be underestimated since, at the genetic level, height emerged to be inversely associated with smoking.

The objectives of the study were to calculate the standardised mortality rates (SMRs) for COVID-19 in European Union/European Economic Area countries plus the UK and Switzerland and to evaluate the correlation between SMRs and selected indicators in the first versus the subsequent waves until 23 June 2021. We used indirect standardisation (using Italy as the reference) to compute SMRs and considered 16 indicators of health and social well-being, health system capacity and COVID-19 response. The highest SMRs were in Belgium, the UK and Spain in the first wave (1.20–1.84) and in Hungary, Czechia and Slovakia in the subsequent waves (2.50–2.69). Human Development Index (HDI), life expectancy, urbanisation and healthcare expenditure had positive correlations with SMR in the first wave (rho=0.30–0.46), but negative correlations (rho=−0.67 to −0.47) in the subsequent waves. Retail/recreation mobility and transit mobility were negatively correlated with SMR in the first wave, while transit mobility was inversely correlated with SMR in the subsequent waves. The first wave hit most hard countries with high HDI, high life expectancy, high urbanisation, high health expenditures and high tourism. This pattern may reflect higher early community seeding and circulation of the virus. Conversely, in the subsequent waves, this pattern was completely inversed: countries with more resources and better health status did better than eastern European countries. While major SMR differences existed across countries in the first wave, these differences largely dissipated by 23 June 2021, with few exceptions.

IntroductionPrecision health requires citizens that are empowered to orient health decisions towards their personal values, aware of the benefits and risks, and committed to sharing their personal data to trustful institutions. Effective citizen engagement initiatives are fundamental for the success of a precision health approach.ObjectiveTo provide an overview of citizen engagement initiatives in precision health in European Union (EU) member states.DesignScoping review.MethodsThe electronic databases PubMed, Web of Science, CINAHL and Embase were searched to include articles published in English. Furthermore, desk research was conducted in English, Dutch, French, Italian and Spanish. Articles or reports regarding ongoing initiatives of citizen engagement in precision health conducted in EU member states and published from January 2015 to July 2020 were considered eligible. A quality assessment of the retrieved entries using Critical Appraisal Skills Programme tool was conducted.ResultsWe identified nine documents, which reported eight ongoing citizen engagement initiatives, with substantial variability. Government agencies, non-governmental organisations and scientific societies were the main organisers and funders. Most of the initiatives were conducted in the UK. Genomics was the most emphasised aspect of precision health in these initiatives. Among the identified initiatives, both in-person and digital means were reported.ConclusionOur work provides an overview of current citizen engagement initiatives in the EU that can be useful for stakeholders interested in designing and developing precision health projects enriched by meaningful citizen participation.PROSPERO registration numberCRD42020193866.

Bioelectrical impedance analysis (BIA) is an inexpensive, non-invasive and fast method to assess body composition. Little is known of the interaction between anti IL 12/23 treatment and body composition. The aim of this study was to evaluate 6- and 12-month changes in body weight, Body Mass Index (BMI) and body composition assessed by BIA in psoriatic patients treated with anti-IL-12/23.Demographic and clinical data were collected for each enrolled patient. Physical examination, anthropometric assessment, Psoriasis Area and Severity Index (PASI) assessment and body composition by BIA (single-frequency 50 kHz), were assessed at baseline and at 6 and 12 months of treatment.A significant decrease in body weight, compared to baseline, in BMI, Fat Mass at month 6 and a significant increase at month 12 for body cellular mass (BCM) and Phase Angle (PhA) were observed. In addition, a significant increase was found for intracellular water.At baseline, psoriatic patients showed a lower BCM and a lower mean PhA score. During ustekinumab treatment, the mean PhA and BCM scores increased with an improvement in psoriatic disease. Thus, ustekinumab can be an effective drug for improving not only psoriasis but also the general clinical status of patients.

This study was undertaken to evaluate the association between demographics, lifestyle habits, and clinical data and overall survival (OS), recurrence and second primary cancer (SPC) in patients with first primary head and neck cancer (HNC). We retrospectively reviewed data from 482 patients treated at the "Agostino Gemelli" Teaching Hospital, Rome, between 2002-2012 for primary HNC. Individual parameters were evaluated for association with specific outcomes such as OS, cancer recurrence and second primary cancer (SPC) appearance using hazard ratios (HR) and 95% confidence intervals (CIs). Five-year OS was 60.6% for all HNC cases, 49.0% for oral cavity, 54.8% for oropharynx, 50.0% for hypopharynx and 63.4% for larynx. Predictors of OS were older age (HR = 1.04; 95% CI: 1.02-1.05) and advanced tumour stage (HR = 2.00; 95% CI: 1.41-2.84). The risk of recurrence was associated with drinking 8-14 drinks per week (HR = 1.73; 95% CI: 1.00-2.97). The risk of developing SPC increased with advanced tumour stage (HR = 2.75; 95% CI: 1.39-5.44) and with smoking for more than 40 years (HR = 3.68; 95% CI: 1.10-12.30). OS differed among HNC sites. Increasing age was an unfavourable predictor of HNC OS. Tumour stage was a prognostic factor both for OS and for risk of developing SPC. Alcohol and tobacco consumption were prognostic factors for recurrence and SPC, respectively.È stata condotta un’analisi retrospettiva su 482 pazienti con diagnosi di tumore testa-collo arruolati presso l’ ospedale “Agostino Gemelli” di Roma. L’associazione tra fattori demografici, clinici e comportamentali con la overall survival (OS), il rischio di ricorrenza ed il rischio di un secondo tumore primitivo è stata stimata usando gli Hazard Ratio (HR) e gli intervalli di confidenza al 95% (CIs). La OS considerando tutte le sedi tumorali è stata del 60%, mentre considerando le singole sedi tumorali è risultata del 49.0% per il cavo orale, 54.8% per l’orofaringe, 50.0% per l’ipofaringe e 63.4% per la laringe. Un’età avanzata alla diagnosi (HR = 1.04; 95% CI: 1.02-1.05) ed un avanzato stadio del tumore (HR = 2.00; 95% CI: 1.41-2.84) sono risultati fattori significativamente associati con la OS. Il rischio di ricorrenza è risultato associato con il consumo di alcolici (HR = 1.73; 95% CI: 1.00-2.97). Il rischio di sviluppare un secondo tumore primitivo è risutlato associato con uno stadio avanzato del tumore primario (HR = 2.75; 95% CI: 1.39-5.44) e con l’aver fumato per più di 40 anni (HR = 3.68; 95% CI: 1.10-12.30). In conclusione abbiamo notato che la OS differisce tra le sedi tumorali del tumore testa-collo. Lo stadio tumorale è risultato essere associato sia con la OS che con il rischo di sviluppare un secondo tumore primitivo. Il consumo di alcol e di tabacco sono risultati essere fattori prognostici, rispettivamente, per la ricorrenza e per l’insorgenza di un secondo tumore primitivo.

The aim of this study is to evaluate the association between adherence to Mediterranean diet (MD) and gastric cancer (GC). A case-control study was carried out at the Fondazione Policlinico 'A. Gemelli' (Rome, Italy) from 2003 to 2015. A total of 223 incident cases and 223 controls were interviewed. Dietary intake was assessed through a validated food frequency questionnaire that collected information on more than 25 food items. The association between adherence to MD and risk of GC was quantified by calculating Odds Ratios (OR) and 95% confidence intervals (CI). The analysis reports that a higher adherence to MD is associated with a reduced risk of GC (OR: 0.70; 95% CI: 0.61-0.81). A high consumption of vegetables (OR: 0.34; 95% CI: 0.14-0.85), legumes (OR: 0.13; 95% CI: 0.06-0.29), and fish (OR: 0.33; 95% CI: 0.15-0.68), as well as low consumption of meat (OR: 0.29; 95% CI: 0.10-0.85) and alcohol (OR: 0.46; 95% CI: 0.24-0.90) are consistently related to a lower risk of GC. Our study indicates a protective role of the MD eating pattern and MD individual components against GC. Our results showed a beneficial role of high vegetable, legume, and fish consumption, along with low intake of alcohol and meat in the development of GC.