Ambient air pollution and hypertensive disorders of pregnancy in Rome.

BACKGROUND: Ambient air pollution has been associated with hypertensive disorders of pregnancy (HDP), but few studies rely on assessment of fine-scale variation in air quality, specific subtypes and multi-pollutant exposures. AIM: To study the impact of long-term exposure to individual and mixture of air pollutants on all and specific subtypes of HDP. METHODS: We obtained data from 130,470 liveborn singleton pregnacies in Rome during 2014-2019. Spatiotemporal land-use random-forest models at 1 km spatial resolution assigned to the maternal residential addresses were used to estimate the exposure to particulate matter (PM2.5 and PM10), nitrogen dioxide (NO2), and ozone (O3). RESULTS: For PM2.5, PM10 and NO2, there was suggestive evidence of increased risk of preeclampsia (PE, n = 442), but no evidence of increased risk for all subtypes of HDP (n = 2297) and gestational hypertension (GH, n = 1901). For instance, an interquartile range of 7.0 µg/m3 increase in PM2.5 exposure during the first trimester of pregnancy was associated with an odds ratio (OR) of 1.06 (95% confidence interval: 0.81, 1.39) and 1.04 (0.92, 1.17) after adjustment for NO2 and the corresponding results for a 15.7 µg/m3 increase in NO2 after adjustment for PM2.5 were 1.11 (0.92, 1.34) for PE and 0.83 (0.76, 0.90) for HDP. Increased risks for HDP and GH were suggested for O3 in single-pollutant models and for PM after adjustment for NO2, but all other associations were stable or attenuated in two-pollutant models. CONCLUSIONS: The results of our study suggest that PM2.5, PM10 and NO2 increases the risk of PE and that these effects are robust to adjustment for O3 while the increased risks for GH and HDP suggested for O3 attenuated after adjustment for PM or NO2. Additional studies are needed to evaluate the effects of source-specific component of PM on subtypes as well as all types of HDP which would help to target preventive actions.

Steroid use in measles: A retrospective cohort study during the 2017 outbreak in tertiary referral center, Rome and Latina, Italy.

INTRODUCTION: Since early January 2017, a new measles outbreak in Italy has been observed. The aim of the study was to compare features between adults and children measles cases and evaluate the effect of steroid treatment on the above parameters. METHODS: A retrospective multicenter, descriptive study was performed. We analyzed all patients admitted to the Department of Public Health and Infectious Diseases, Sapienza University, Rome and Latina, from January 2017 to December 2017 and discharged with diagnosis of measles. RESULTS: We identified 113 patients discharged with the diagnosis of measles infection cases of which 59 adults and 54 children (≤16 years). In adult population 32 patients (54 %) were males, with a median age of 30.5 years old and all unvaccinated (100 %). Keratoconjunctivitis 30 (50 %) was the most frequent complication. In pediatric population 27 (50 %) patients were males, with a median age of 3 years old. Information on measles vaccination status was available for only 21 (38.8 %) of cases. Keratoconjunctivitis 40 (74 %) was the most frequent complication. Analyzing the differences between adult and pediatric patients we found that children were significantly more likely to have keratoconjunctivitis and diarrhea as complications than adults in which the rate of thrombocytopenia and hepatitis was highest. Thirty-nine adult subjects (66 %) have been treated with systemic corticosteroids. CONCLUSIONS: Pediatric patients differ from adults in complications and liver involvement. Regarding steroids use, although there is no clear indication of steroid use during measles, there is no evidence of a worse outcome in our cases series.

Protection of gender health and fight against gender violence during the COVID-19 pandemic: the experience of our street clinic in a disadvantaged suburb of Rome Metropolitan City.

OBJECT: In this study, we evaluated health, social inequalities and risk to gender violence of women living in a disadvantaged degraded suburb of Rome Metropolitan City, during COVID-19 pandemic. METHODS: The study included 779 women referring to primary care services of Medicina Solidale Institute for gynecological/breast examinations (209), medical and support aid for the children (383) and COVID-19 test execution (187). RESULTS: The data show that most women (68%) were unemployed or had an irregular job. The request of support varied depending on the ethnicity: while healthcare support was requested mostly by African female community, the COVID-19 test, mandatory for public transportation and work, was a need of the east-european community. Both these communities referred to Medical Solidale primary care service for the healthcare and food/clothing support for their children. It is interesting to note that the requests from the Italian women community was elevated in terms of personal healthcare, support for the children and COVID-19 test execution. The access to the national health system (NHS) resulted a complex administrative procedure despite the original social-ethnic communities. The vast majority of women lacked awareness of their crucial role for supporting the family entity, while inadequacy was commonly reported. CONCLUSIONS: This study confirms a critical condition for women living in disadvantaged neighborhoods, whose vulnerability is further worsened by the limited access to primary care assistance with serious consequences for health and quality of life. Prevention and treatment, especially for the most vulnerable subjects, should be a priority for the public health system.

Risk factors and effect on mortality of superinfections in a newly established COVID-19 respiratory sub-intensive care unit at University Hospital in Rome.

BACKGROUND: Little is known on the burden of co-infections and superinfections in a specific setting such as the respiratory COVID-19 sub-intensive care unit. This study aims to (i) assess the prevalence of concurrent and superinfections in a respiratory sub-intensive care unit, (ii) evaluate the risk factors for superinfections development and (iii) assess the impact of superinfections on in-hospital mortality. METHODS: Single-center retrospective analysis of prospectively collected data including COVID-19 patients hospitalized in a newly established respiratory sub-intensive care unit managed by pneumologists which has been set up from September 2020 at a large (1200 beds) University Hospital in Rome. Inclusion criteria were: (i) COVID-19 respiratory failure and/or ARDS; (ii) hospitalization in respiratory sub-intensive care unit and (iii) age > 18 years. Survival was analyzed by Kaplan-Meier curves and the statistical significance of the differences between the two groups was assessed using the log-rank test. Multivariable logistic regression and Cox regression model were performed to tease out the independent predictors for superinfections' development and for mortality, respectively. RESULTS: A total of 201 patients were included. The majority (106, 52%) presented severe COVID-19. Co-infections were 4 (1.9%), whereas 46 patients (22%) developed superinfections, mostly primary bloodstream infections and pneumonia. In 40.6% of cases, multi-drug resistant pathogens were detected, with carbapenem-resistant Acinetobacter baumannii (CR-Ab) isolated in 47%. Overall mortality rate was 30%. Prior (30-d) infection and exposure to antibiotic therapy were independent risk factors for superinfection development whereas the development of superinfections was an independent risk factors for in-hospital mortality. CR-Ab resulted independently associated with 14-d mortality. CONCLUSION: In a COVID-19 respiratory sub-intensive care unit, superinfections were common and represented an independent predictor of mortality. CR-Ab infections occurred in almost half of patients and were associated with high mortality. Infection control rules and antimicrobial stewardship are crucial in this specific setting to limit the spread of multi-drug resistant organisms.

[Employment sector and respiratory mortality in Rome and Turin longitudinal metropolitan studies]. / Settore occupazionale e mortalità respiratoria negli studi longitudinali metropolitani di Roma e Torino.

OBJECTIVES: to assess the association between the occupational sector and respiratory mortality in the metropolitan longitudinal studies of Rome and Turin. DESIGN: retrospective cohort study. SETTING AND PARTICIPANTS: the 2011 census cohorts of residents of Rome and Turin aged 30 years and older who had worked for at least one year in the private sector between 1970s and 2011 was analysed. The individuals included in the study were followed from 9 October 2011 to 31 December 2018. Occupational history was obtained from archives of private sector contributions at the National Social Insurance Agency (INPS) and then was linked to data from the longitudinal studies. MAIN OUTCOME MEASURES: the study outcome was non-malignant respiratory mortality. The exposure of interest was whether or not individuals had worked in one of the 25 occupational sectors considered (agriculture and fishing, steel industry, paper and printing, pharmaceuticals, manufacturing, textile, energy and water, food and tobacco industry, non-metal mining, glass & cement industry, metal processing, electrical construction, footwear and wood industry, construction, trade, hotel and restaurants, transportation, insurance, healthcare, services, laundries, waste management, hairdressing, cleaning services, and gas stations). The association between the occupational sector and respiratory mortality, adjusted for potential confounders (age, marital status, place of birth, educational level), was estimated using Cox models. All analyses were stratified by sex and city. RESULTS: a total of 910,559 people were analysed in Rome and 391,541 in Turin. During the eight years of follow-up, 4,133 people in Rome and 2,772 people in Turin died from respiratory causes. The sectors associated with high respiratory mortality in both cities among men were footwear and wood industry (adjusted HR for age: 1.37 (95%CI 1.07-1.76) and 1.48 (95%CI 1.08-2.03) in Rome and Turin, respectively), construction (HR: 1.31 (95%CI 1.20-1.44) in Rome and 1.51 (95%CI 1.31-1.74) in Turin), hotel and restaurant sector (HR: 1.25 (95%CI 1.07-1.46) in Rome and 1.68 (95%CI 1.20-2.33) in Turin), and cleaning services (HR: 1.57 (95%CI 1.19-2.06) in Rome and 1.97 (95%CI 1.51-2.58) in Turin). Some sectors had high respiratory mortality only in one of the two cities: in Rome, the food& tobacco industry, and gas stations, while in Turin, the metal processing industry. Among female workers, the cleaning services sector was associated with higher respiratory mortality in both Rome and Turin (HR: 1.52, 95%CI 1.27-1.82, e 1.58, 95%CI 1.17-2.12, respectively). CONCLUSIONS: the data confirm the previously known associations between occupational sectors and respiratory mortality for exposures characteristic of specific sectors, such as construction, hotel and restaurant sector, and cleaning services. The differences reported between the two cities reflect the different composition of the workforce and the size of the two study populations. Administrative social insurance data can provide helpful information for epidemiological studies of occupational exposure.

Diagnostic Yield of Colonoscopy in Patients With Symptoms Compatible With Rome IV Functional Bowel Disorders.

BACKGROUND & AIMS: There is little data on the diagnostic yield of colonoscopy in patients with symptoms compatible with functional bowel disorders (FBDs). Previous studies have only focused on diagnostic outcomes of colonoscopy in those with suspected irritable bowel syndrome using historic Rome I-III criteria, whilst having partially assessed for alarm features and shown markedly conflicting results. There is also no colonoscopy outcome data for other FBDs, such as functional constipation or functional diarrhea. Using the contemporaneous Rome IV criteria we determined the diagnostic yield of colonoscopy in patients with symptoms compatible with a FBD, stratified diligently according to the presence or absence of alarm features. METHODS: Basic demographics, alarm features, and bowel symptoms using the Rome IV diagnostic questionnaire were collected prospectively from adults attending out-patient colonoscopy in 2019. Endoscopists were blinded to the questionnaire data. Organic disease was defined as the presence of inflammatory bowel disease, colorectal cancer, or microscopic colitis. RESULTS: 646 patients fulfilled symptom-based criteria for the following Rome IV FBDs: IBS (56%), functional diarrhea (27%) and functional constipation (17%). Almost all had alarm features (98%). The combined prevalence of organic disease was 12%, being lowest for functional constipation and IBS-constipation (∼6% each), followed by IBS-mixed (∼9%), and highest amongst functional diarrhea and IBS-diarrhea (∼17% each); p = .005. The increased prevalence of organic disease in diarrheal versus constipation disorders was accounted for by microscopic colitis (5.7% vs. 0%, p < .001) but not inflammatory bowel disease (7.2% vs. 4.0%, p = .2) or colorectal cancer (4.2% vs. 2.3%, p = .2). However, 1-in-4 chronic diarrhea patients - conceivably at risk for microscopic colitis - did not have colonic biopsies taken. Finally, only 11 of 646 (2%) patients were without alarm features, in whom colonoscopy was normal. CONCLUSIONS: Most patients with symptoms of FBDs who are referred for colonoscopy have alarm features. The presence of organic disease is significantly higher in diarrheal versus constipation disorders, with microscopic colitis largely accounting for the difference whilst also being a missed diagnostic opportunity. In those patients without alarm features, the diagnostic yield of colonoscopy was nil.

A multi-step machine learning approach to assess the impact of COVID-19 lockdown on NO2 attributable deaths in Milan and Rome, Italy.

BACKGROUND: Air pollution is one of the main concerns for the health of European citizens, and cities are currently striving to accomplish EU air pollution regulation. The 2020 COVID-19 lockdown measures can be seen as an unintended but effective experiment to assess the impact of traffic restriction policies on air pollution. Our objective was to estimate the impact of the lockdown measures on NO2 concentrations and health in the two largest Italian cities. METHODS: NO2 concentration datasets were built using data deriving from a 1-month citizen science monitoring campaign that took place in Milan and Rome just before the Italian lockdown period. Annual mean NO2 concentrations were estimated for a lockdown scenario (Scenario 1) and a scenario without lockdown (Scenario 2), by applying city-specific annual adjustment factors to the 1-month data. The latter were estimated deriving data from Air Quality Network stations and by applying a machine learning approach. NO2 spatial distribution was estimated at a neighbourhood scale by applying Land Use Random Forest models for the two scenarios. Finally, the impact of lockdown on health was estimated by subtracting attributable deaths for Scenario 1 and those for Scenario 2, both estimated by applying literature-based dose-response function on the counterfactual concentrations of 10 µg/m3. RESULTS: The Land Use Random Forest models were able to capture 41-42% of the total NO2 variability. Passing from Scenario 2 (annual NO2 without lockdown) to Scenario 1 (annual NO2 with lockdown), the population-weighted exposure to NO2 for Milan and Rome decreased by 15.1% and 15.3% on an annual basis. Considering the 10 µg/m3 counterfactual, prevented deaths were respectively 213 and 604. CONCLUSIONS: Our results show that the lockdown had a beneficial impact on air quality and human health. However, compliance with the current EU legal limit is not enough to avoid a high number of NO2 attributable deaths. This contribution reaffirms the potentiality of the citizen science approach and calls for more ambitious traffic calming policies and a re-evaluation of the legal annual limit value for NO2 for the protection of human health.

The additional value of lung cancer screening program in identifying unrecognized diseases.

BACKGROUND: A systematic examination of low-dose CT (LDCT) scan, beside lung nodules, may disclose the presence of undiagnosed diseases, improving the efficacy and the cost/efficacy of these programs. The study was aimed at evaluating the association between LDCT scan findings and non-oncologic and oncologic diseases. METHODS: The LDCT scan of participants to the "Un Respiro per la vita"® lung cancer screening program were checked and abnormal findings, beside lung nodules, recorded. First admission to the acute care because of cardiovascular (CD), respiratory (RD) and oncological diseases (OD) in the following three years were retrieved. The association of LDCT scan abnormal findings with CD, RD and OD was assessed through univariable and multivariable logistic regression models. RESULTS: Mean age of 746 participants was 62 years (SD:5), 62% were male. 11 (1.5%) received a diagnosis of lung cancer. 16.1% participants were admitted to the acute care in the following three years: 8.6% for CD, 4.3% for RD and 5.2% for OD. Valve calcification (OR 2.02, p:0.02) and mucus plugs (OR 3.37, p:0.04) were positively associated with CD, while sub-pleural fibrosis had a protective role (OR 0.47, p:0.01). Lung nodules > 8 mm (OR 5.54, p: < 0.01), tracheal deviation (OR 6.04, p:0.01) and mucus plugs (OR 4.00, p:0.04) were positively associated with OD admissions. Centrilobular emphysema OR for RD admissions was 1.97 (p:0.06). CONCLUSIONS: The observed association between selected LDCT findings and ensuing CD, RD and OD suggests that the information potential of LCDT goes beyond the screening of lung cancer.

Effects of COVID-19 lockdown in Milan urban and Rome suburban acoustic environments: Anomalous noise events and intermittency ratio.

The COVID-19 pandemic affected the acoustic environment worldwide, entailing relevant reductions of equivalent noise levels (LAeq) during this exceptional period. In the context of the LIFE+ DYNAMAP project, two wireless acoustic sensor networks were deployed in Milan and Rome. Taking advantage of the built-in identification of anomalous noise events (ANE) in the sensors, this work analyses the effects of the COVID-19 lockdown in both urban and suburban acoustic environments from January to June 2020, considering the distribution of ANEs and the intermittency ratio (IR) as an indicator of the impact of noise on population. The results show statistically significant increments of ANEs in Rome during the lockdown, mainly on weekends, and especially at night, despite the significant decrease in salient events. Differently, ANEs decrease during the lockdown in Milan, mostly at daytime, as a result of population confinement. Although the IR increases in several urban locations, most sensed locations show a relevant decrease in IR during the confinement, which represents a noteworthy reduction of the negative impact of noise in the population of both cities. During the post-lockdown period, all the scores start to return to those observed in the pre-lockdown, but still remaining higher than in 2019.

[Impact of the COVID-19 epidemic on total and cause-specific mortality in Rome (Italy) in 2020]. / Impatto dell'epidemia di COVID-19 sulla mortalità totale e per causa a Roma nel 2020.

OBJECTIVES: to estimate the impact of the COVID-19 epidemic on total and cause-specific mortality in people residing and dead in the Municipality of Rome (Italy) in 2020, and to describe the causes of death of subjects with SARS-CoV-2 infection confirmed by molecular test. DESIGN: descriptive analysis of total and cause-specific mortality in 2020 in Rome and comparison with a reference period (2015-2018 for total mortality and 2018 for cause-specific mortality); descriptive analysis of cause-specific mortality in the cohort of SARS-CoV-2 infected subjects. SETTING AND PARTICIPANTS: 27,471 deaths registered in the Lazio mortality-cause Registry, relating to people residing and died in the municipality of Rome in 2020, 2,374 of which died from COVID-19.MAIN OUCOME MEASURES: all-cause mortality by month, gender, age group and place of death, cause-specific mortality (ICD-10 codes). RESULTS: in the municipality of Rome in 2020, an excess of mortality from all causes equal to +10% was observed, with a greater increase in the months of October-December (+27%, +56%, and +26%, respectively) in people aged 50+, with the greatest contribution from the oldest age groups (80+) who died in the nursing homes or at home. Lower mortality was observed in the age groups 0-29 years (-30%) and 40-49 years (-13%). In 2020, COVID-19 represents the fourth cause of death in Rome after malignant tumours, diseases of the circulatory system, and respiratory diseases. Excess mortality was observed from stroke and pneumonia (both in men and women), from respiratory diseases (in men), from diabetes, mental disorders, dementia and Parkinson's disease (in women). On the contrary, mortality is lower for all cancers, for diseases of the blood and haematopoietic organs and for the causes of the circulatory system. The follow-up analysis of SARS-CoV-2 positive subjects residing in Rome shows that a share of deaths (about 20%) reports other causes of death such as cardiovascular diseases, malignant tumours, and diseases of the respiratory system on the certificate collected by the Italian National Statistics Institute. CONCLUSIONS: the 2020 mortality study highlighted excesses for acute and chronic pathologies, indicative of possible delays in the diagnosis or treatment of conditions indirectly caused by the pandemic, but also a share of misclassification of the cause of death that is recognized as COVID-19 death.

Retrospective analysis of seroprevalence in a cohort of university students of Rome (Italy) between September 2020 and July 2021.

BACKGROUND: the reopening of Universities in a COVID-19 pandemic context represented a potential source of virus transmission among students. OBJECTIVES: to measure the SARS-CoV-2 real circulation among university students attending the University of Rome 'Niccolò Cusano' by seroprevalence analysis. DESIGN: retrospective study based on a point-of-care (POC) SARS-CoV-2 rapid qualitative serological screening performed on asymptomatic students attending the University. SETTING AND PARTICIPANTS: between September 2020 to July 2021 at Niccolò Cusano University, 9,588 SARS-CoV-2 lateral-flow rapid qualitative antibody assays were performed on a total of 2,423 asymptomatic students. Among them, 389 individuals with compulsory attendance were tested every 10 days for a minimum observational period of 7 months. MAIN OUTCOME MEASURES: the prevalence of SARS-CoV-2 IgM/IgG antibodies was estimated at more levels. It was calculated: 1. the number of positive cases detected among the total number of students tested during the screening period; 2. the cumulative seroprevalence over the time, and the seroprevalence distribution over the months; 3. the duration of seropositivity after SARS-CoV-2 infection in the known previous infected students repeatedly tested. RESULTS: a total of 112 participants had a SARS-CoV-2 positive IgG and/or IgM antibodies test, 39 of them with a documented history of previous infection. In the remaining 73 cases, 24 were confirmed with an external quantitative serological analysis and identified as individuals with unknown previous SARS-CoV-2 exposure, 17 resulted false positive and 32 subjects were excluded. The total seroprevalence was 2.6% (95%CI 2.0%-3.3%) and among the 63 confirmed seropositive cases, 75% had detectable IgG antibodies, 3% had IgM antibodies, and 22% were positive for both IgM and IgG antibodies. In the 389 repeatedly-tested students, 36 students were positive to SARS-CoV-2 antibodies, 14 with unknown previous infection, and 22 with known previous infection. Among these, 50% retained immune memory up to 4 months post infection and 27% of cases retained seropositivity up to 7 months. CONCLUSIONS: the data collected has been useful to measure a real epidemiological rate of the virus spread in a cohort of students in Italy as well as to obtain information on the antibodies seropositivity duration in individuals with previous infection.

SARS-CoV-2 diagnostics in the virology laboratory of a University Hospital in Rome during the lockdown period.

Italy was one of the most affected nations by coronavirus disease 2019 outside China. The infections, initially limited to Northern Italy, spread to all other Italian regions. This study aims to provide a snapshot of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) epidemiology based on a single-center laboratory experience in Rome. The study retrospectively included 6565 subjects tested for SARS-CoV-2 at the Laboratory of Virology of Sapienza University Hospital in Rome from 6 March to 4 May. A total of 9995 clinical specimens were analyzed, including nasopharyngeal swabs, bronchoalveolar lavage fluids, gargle lavages, stools, pleural fluids, and cerebrospinal fluids. Positivity to SARS-CoV-2 was detected in 8% (527/6565) of individuals, increased with age, and was higher in male patients (P < .001). The number of new confirmed cases reached a peak on 18 March and then decreased. The virus was detected in respiratory samples, in stool and in pleural fluids, while none of gargle lavage or cerebrospinal fluid samples gave a positive result. This analysis allowed to gather comprehensive information on SARS-CoV-2 epidemiology in our area, highlighting positivity variations over time and in different sex and age group and the need for a continuous surveillance of the infection, mostly because the pandemic evolution remains unknown.

Caring for the carers: Advice for dealing with sleep problems of hospital staff during the COVID-19 outbreak.

Hospital staff are at the frontline in the COVID-19 outbreak. The stressors they experience may induce sleep problems in a population already at risk. Sleep deprivation, long shifts and insomnia in hospital staff have been associated with individual, organizational and public health hazards. These include increased risk of mental and somatic disorders, altered immune responses, medical errors, misunderstandings, drowsy driving and burnout. In March 2020, the World Health Organization called for providing access to mental health and counselling for health professionals involved in the COVID-19 outbreak. To answer this call, we propose practical advice for the management of sleep problems (sleep deprivation, insomnia and shift work) that can be included in supportive interventions. The advice is based on psychobiological principles of sleep regulation and on guidelines for the treatment of insomnia and was implemented within an initiative offering psychological support to the staff of three university hospitals in Rome.

Real-life appraisal on blood pressure targets achievement in adult outpatients at high cardiovascular risk.

BACKGROUND AND AIM: Although hypertension guidelines highlight the benefits of achieving the recommended blood pressure (BP) targets, hypertension control rate is still insufficient, mostly in high or very high cardiovascular (CV) risk patients. Thus, we aimed to estimate BP control in a cohort of patients at high CV risk in both primary and secondary prevention. METHODS AND RESULTS: A single-center, cross-sectional study was conducted by extracting data from a medical database of adult outpatients aged 40-75 years, who were referred to our Hypertension Unit, Rome (IT), for hypertension assessment. Office BP treatment targets were defined according to 2018 ESC/ESH guidelines as: a)<130/80 mmHg in individuals aged 40-65 years; b)<140/80 mmHg in subjects aged >65 years. Primary prevention patients with SCORE <5% were considered to be at low-intermediate risk, whilst individuals with SCORE ≥5% or patients with comorbidities were defined to be at very high risk. Among 6354 patients (47.2% female, age 58.4 ± 9.6 years), 4164 (65.5%) were in primary prevention with low-intermediate CV risk, 1831 (28.8%) in primary prevention with high-very high CV risk and 359 (5.6%) in secondary prevention. In treated hypertensive outpatients, uncontrolled hypertension rate was significantly higher in high risk primary prevention than in low risk primary prevention and secondary prevention patients (18.4% vs 24.4% vs. 12.5%, respectively; P < 0.001). In high risk primary prevention diabetic patients only 10% achieved the recommended BP targets. CONCLUSIONS: Our data confirmed unsatisfactory BP control among high-risk patients, both in primary and secondary prevention, and suggest the need for a more stringent BP control policies in these patients.

Functional gastrointestinal disorders in children: agreement between Rome III and Rome IV diagnoses.

To evaluate the agreement between the Rome III and Rome IV criteria in diagnosing pediatric functional gastrointestinal disorders (FGIDs), we conducted a prospective cohort study in a public school in Cali, Colombia. Children and adolescents between 11 and 18 years of age were given the Spanish version of the Questionnaire on Pediatric Functional Gastrointestinal Disorders Rome III version on day 0 and Rome IV version on day 2 (48 h later). The study protocol was completed by 135 children. Thirty-nine (28.9%) children were excluded because of not following the instructions of the questionnaire. The final analysis included data of 96 children (mean 15.2 years old, SD ± 1.7, 54% girls). Less children fulfilled the criteria for an FGID according to Rome IV compared to Rome III (40.6% vs 29.2%, p=0.063) resulting in a minimal agreement between the two criteria in diagnosing an FGID (kappa 0.34, agreement of 70%). The prevalence of functional constipation according to Rome IV was significantly lower compared to Rome III (13.5% vs 31.3%, p<0.001), whereas functional dyspepsia had a higher prevalence according to Rome IV than Rome III (11.5% vs 0%).Conclusion: We found an overall minimal agreement in diagnosing FGIDs according to Rome III and Rome IV criteria. This may be partly explained by the differences in diagnostic criteria. However, limitations with the use of questionnaires to measure prevalence have to be taken into account. What is Known: • The Rome IV criteria replaced the previous Rome III criteria providing updated criteria to diagnose functional gastrointestinal disorders (FGIDs). • Differences found between Rome IV and historic Rome III FGID prevalence may have been affected by changes in prevalence over time or differences in sample characteristics. What is New: • We found a minimal agreement between Rome III and Rome IV FGID diagnosis, especially in the diagnoses of functional constipation, irritable bowel syndrome, and functional dyspepsia. • The minimal agreement may be partly explained by changes in diagnostic criteria, but limitations with the use of questionnaires to measure prevalence have to be taken into account.

Sperm cryopreservation during the SARS-CoV-2 pandemic.

PURPOSE: Sperm cryopreservation is fundamental in the management of patients undergoing gonadotoxic treatments. Concerns have risen in relation to SARS-CoV-2 and its potential for testicular involvement, since SARS-CoV-2-positive cryopreserved samples may have unknown effects on fertilization and embryo safety. This study therefore aimed to analyze the safety of sperm cryopreservation for cancer patients after the onset of the pandemic in Italy, through assessment of the risk of SARS-CoV-2 exposure and viral RNA testing of semen samples. METHODS: We recruited 10 cancer patients (mean age 30.5 ± 9.6 years) referred to our Sperm Bank during the Italian lockdown (from March 11th to May 4th 2020) who had not undergone a nasopharyngeal swab for SARS-CoV-2 testing. Patients were administered a questionnaire on their exposure to COVID-19, and semen samples were taken. Before cryopreservation, SARS-CoV-2 RNA was extracted from a 150 µl aliquot of seminal fluid in toto using QIAamp viral RNA kit (Qiagen) and amplified by a real time RT PCR system (RealStar SARS-CoV2 RT PCR, Altona Diagnostics) targeting the E and S genes. RESULTS: The questionnaire and medical interview revealed that all patients were asymptomatic and had had no previous contact with COVID-19 infected patients. All semen samples were negative for SARS-CoV-2 RNA. CONCLUSION: This preliminary assessment suggests that a thorough evaluation (especially in the setting of a multidisciplinary team) and molecular confirmation of the absence of SARS-CoV-2 in seminal fluid from asymptomatic cancer patients may assist in ensuring the safety of sperm cryopreservation.

Validation of the risk stratification score in idiopathic pulmonary fibrosis: study protocol of a prospective, multi-centre, observational, 3-year clinical trial.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is characterized by a poor prognosis, with a progressive decline in lung function and considerable variability in the disease's natural history. Besides lung transplantation (LTx), the only available treatments are anti-fibrosing drugs, which have shown to slow down the disease course. Therefore, predicting the prognosis is of pivotal importance to avoid treatment delays, which may be fatal for patients with a high risk of progression. Previous studies showed that a multi-dimensional approach is practical and effective in the development of a reliable prognostic score for IPF. In the RIsk Stratification scorE (RISE), physiological parameters, an objective measure of patient-reported dyspnea and exercise capacity are combined to capture different domains of the complex pathophysiology of IPF. METHODS: This is an observational, multi-centre, prospective cohort study, designed to reflect common clinical practice in IPF. A development cohort and a validation cohort will be included. Patients newly diagnosed with IPF based on the ATS/ERS criteria and multi-disciplinary discussion will be included in the study. A panel of chest radiologists and lung pathologists will further assess eligibility. At the first visit (time of diagnosis), and every 4-months, MRC dyspnea score, pulmonary function tests (FEV1, FVC and DLCO), and 6-min walking distance will be recorded. Patients will be prospectively followed for 3 years. Comorbidities will be considered. The radiographic extent of fibrosis on HRCT will be recalculated at a 2-year interval. RISE, Gender-Age-Physiology, CPI and Mortality Risk Scoring System will be calculated at 4-month intervals. Longitudinal changes of each variable considered will be assessed. The primary endpoint is 3-year LTx-free survival from the time of diagnosis. Secondary endpoints include several, clinically-relevant information to ensure reproducibility of results across a wide range of disease severity and in concomitance of associated pulmonary hypertension or emphysema. DISCUSSION: The objective of this study is to validate RISE as a simple, straightforward, inexpensive and reproducible tool to guide clinical decision making in IPF, and potentially as an endpoint for future clinical trials. TRIAL REGISTRATION: U.S National Library of Medicine Clinicaltrials.gov, trial n. NCT02632123 "Validation of the risk stratification score in idiopathic pulmonary fibrosis". Date of registration: December 16th, 2015.

Knowledge, attitude, barriers, professional behaviour and possible interventions: a survey on healthcare-associated infections among the healthcare workers of an intensive care unit in a large teaching hospital in Rome.

Methods: A questionnaire of 36 questions was developed and administered to assess socio-occupational characteristics, knowledge of Healthcare-associated infections, attitudes and barriers encountered in compliance with hygiene standards, self-analysis of professional behaviour, and proposals for new interventions. Variables were evaluated by univariate analysis, and multivariable logistic regression models were constructed to identify predictors of adequate knowledge, positive attitude and appropriate professional behaviour. Background: Healthcare-associated infections are the main complications of hospitalization. A bottom-up approach, where the Healthcare workers involved play a key role, can be adopted to limit the Healthcare-associated infections burden. To this end, a survey was conducted in the main intensive care unit of Umberto I Teaching Hospital of Rome, where an active surveillance system has been in place since April 2016. Results: Overall, 79/89 Healthcare workers completed the questionnaire. Multivariate analysis showed that Healthcare workers, who participated in ward meetings to share active surveillance reports, were more likely to have adequate knowledge (aOR=4.21, 95% CI: 1.36-13.07). Only job type seemed to be a predictor of adequate behaviour, since nurses and physicians were more likely to show adequate behaviour than residents in training (aOR=0.21, 95% CI: 0.06-0.74). Direct observation of compliance with standard hygiene precautions and the identification of 'local champions' to manage Healthcare-associated infections' issues were the most requested interventions. Conclusions: Our study suggests that the training of healthcare professionals is a key factor in preventing and containing the spreading of Healthcare-associated infections. Moreover, by encouraging greater Healthcare workers' involvement, we conclude that a bottom-up approach is likely to improve Healthcare-associated infections' prevention and management.

Novel Variants of Respiratory Syncytial Virus A ON1 Associated With Increased Clinical Severity of Bronchiolitis.

BACKGROUND: A study of respiratory syncytial virus-A (RSV A) genotype ON1 genetic variability and clinical severity in infants hospitalized with bronchiolitis over 6 epidemic seasons (2012-2013 to 2017-2018) was carried out. METHODS: From prospectively enrolled term infants hospitalized for bronchiolitis, samples positive for RSV A ON1 (N = 139) were sequenced in the second half of the G gene. Patients' clinical data were obtained from medical files and each infant was assigned a clinical severity score. ANOVA comparison and adjusted multinomial logistic regression were used to evaluate clinical severity score and clinical parameters. RESULTS: The phylogenetic analysis of 54 strains showed 3 distinct clades; sequences in the last 2 seasons differed from previous seasons. The most divergent and numerous cluster of 2017-2018 strains was characterized by a novel pattern of amino acid changes, some in antigenic sites. Several amino acid changes altered predicted glycosylation sites, with acquisition of around 10 new O-glycosylation sites. Clinical severity of bronchiolitis increased in 2016-2017 and 2017-2018 and changed according to the epidemic seasons only. CONCLUSIONS: Amino acid changes in the hypervariable part of G protein may have altered functions and/or changed its immunogenicity, leading to an impact on disease severity.

Nose-pharyngeal swabs as a screening test for SARS-CoV-2 infection in patients with scheduled elective surgery: the experience of the Hygiene Service of the Local Health Authority Roma 1.

ABSTRACT: The COVID-19 (COrona Virus Disease 2019), due to the SARS-COV-2 (Severe Acute Respiratory Syndrome Corona Virus 2) has been an unprecedented global challenge for the healthcare systems (1).