Access to SARS-CoV-2 diagnostic tests: are there barriers for the immigrants in Italy?

OBJECTIVES: to describe the epidemiology of SARS-CoV-2 infection in relation with the use of nasal swabs in the immigrant population in Italy, using data from the COVID-19 national surveillance system and to verify if a difference is present comparing natives and immigrant. DESIGN: descriptive study based on longitudinal health-administrative data. SETTING AND PAR TICIPAN TS: general population of six Italian Regions (Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany, Lazio) covering about 55% of the resident population and 72% of foreigners' population. MAIN OUTCOME MEASURES: regional rates of access to at least a nasal swab, separately by country of origin. RESULTS: across all the periods, a lower rate in the foreigners' group was observed, with the only exception of the period May-June 2021. Considering separately High Migratory Pressure Countries (HMPCs) and Highly Developed Countries (HDCs), a higher proportion of nasal swabs performed in people coming from HDC with respect to HMPCs and natives was noticed. This observation is consistent in males and females. CONCLUSIONS: during the first wave of the pandemic, Italians have had a higher proportion of nasal swabs compared to migrants across all Regions. This difference disappeared in the following periods, probably due to a major availability of diagnostic tests.

Differences in Emergency Department Sepsis Care: Do Race, Sex, and Language Matter?

Study Objectives: Sepsis accounts for half of hospital deaths and is a priority area of quality measurement and improvement by the Centers for Medicare and Medicaid Services (CMS). Social determinants of health have been associated with sepsis outcomes, with racial and ethnically minoritized patients experiencing higher mortality rates and worse outcomes. Standardization of emergency department (ED) sepsis-care protocols and quality measurement have improved sepsis outcomes and are closely tracked. However, it is unknown whether there are differences in ED sepsis care protocol adherence or outcomes by race, sex, or primary language spoken. The Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) measure is a CMS quality measure used to bundle and track multiple elements of sepsis care that are shown to improve sepsis outcomes. This measure includes obtaining blood cultures and serum lactate measurements and timely administration of intravenous fluid and antibiotics, if indicated. In this study, we hypothesized there would be a difference in 3- hour bundle compliance based on differences in race, sex, and/or language spoken. Method(s): We conducted a retrospective chart review of adult ED patients who met SEP-1 reporting guidelines for severe sepsis, septic shock, or sepsis with organ failure, from April 8, 2019 to January 21, 2022 at a large health system in Rhode Island with over 150,000 annual ED visits. We included patients who had 3-hour bundle compliance reported to CMS. Statistical analysis was completed using univariate descriptive analyses and bivariate analyses with a chi-square test of independence. We conducted logistic regression to identify factors associated with 3-hour sepsis bundle compliance and differences in sepsis treatment by race, ethnicity, sex, primary language spoken, and use of an interpreter, adjusting for emergency severity index (ESI), disposition, inpatient department, and COVID test results. Result(s): The study population included 3,182 patients of which 44.6% (1418/3182) were female, 78.4% (2495/3182) white, and 11.3 % (360/3182) were Hispanic or Latino. The majority (85.5%, 2722/3182) spoke English. Among people who spoke a language other than English, over two-thirds (66.3%, 305/460) received an interpreter. Less than a quarter 23.5% (749/3182) had severe sepsis, over a third (35.5%, 1131/3182) had septic shock, and 40.9% (1302/3182) had sepsis with organ failure. Overall compliance with the SEP-1 bundle was low at 44.9% (1430/3182). There were no significant differences in sepsis bundle compliance by patient sex, race, ethnicity, or language spoken. Logistic regression showed a lower likelihood of compliance with the sepsis bundle among patients with severe sepsis compared to sepsis patients with organ failure (aOR 0.77 [95% CI: 0.65-0.90]). Conclusion(s): Our study did not identify a disparity in SEP-1 bundle compliance by sex, race, ethnicity, or language spoken. These findings support the hypothesis that using standardized ED sepsis protocols and measures are important tools to mitigate and/or prevent disparities in ED sepsis care. We also found low compliance with the SEP-1 bundle, with higher compliance noted among individuals with more severe disease, potentially diluting differences that may exist between demographic groups. Future studies are needed in populations with higher SEP-1 compliance to determine whether there are differences by sex, race, or language spoken. No, authors do not have interests to disclose Copyright © 2022

Do newly arrived migrants represent a COVID-19 burden? Data from the Italian information flow : Leuconoe Grazia Sisti

Background Migrants who reach host countries irregularly are often perceived as increasing the COVID-19 burden. Italy is a transit and destination country for migrants who cross the Central Mediterranean route. During the pandemic, all migrants who disembarked on the Italian shores have been COVID-19 tested and quarantined. To investigate the incidence of SARS-CoV-2 infection in this population, the INMP, together with the Italian Ministry of the Interior, set a specific information flow collecting data about the infection and possible outcomes. Methods The observation period was from January 2021 to January 2022. COVID-19 tests used were molecular and antigenic. Positive cases detected both at the arrival and during the quarantine period, have been registered on an ad hoc INMP online platform. Migrants’ SARS-CoV-2 incidence rate (per 1,000) - with 95% CI - was therefore calculated. The Incidence Ratio (IR) was used to compare the migrants’ incidence rate with that of the resident population in Italy, in the same period and corresponding age group. Results Among 70,512 migrants (91% males and 9% females, all <60years old) who landed in Italy during the observation period, 2,861 tested positive, with an incidence rate of 40.6 (39.1-42.1) cases per 1,000. In the same period, an incidence rate of 177.6 (177.5-177.8) has been recorded in the resident population, with an IR of 0.22 (0.22-0.23). 89.9% of cases were males and almost half (49.6%) belonged to the age group 25-39years old. 99% of cases reported no symptoms, no relevant comorbidity has been reported and no cases have been hospitalized. Conclusions Our findings clearly highlight the low rate of SARS-CoV-2 infection in migrants reaching Italy by sea with an incidence rate that is roughly a quarter of that of the resident population, encouraging the opportunity to investigate the reasons for such an observation. Moreover, our study confirms the “healthy migrant effect” in migrants reaching Italy by sea. Key messages Irregular migrants arriving in Italy did not increase the COVID-19 burden in the country, thus alarmism is not justified. Further studies are needed to investigate the reasons for the lower incidence observed.

Differences in the incidence and clinical outcomes of SARS-CoV-2 infection between Italian and non-Italian nationals using routine data.

OBJECTIVES: This study was to compare the incidence and clinical outcomes of SARS-CoV-2 infection between Italian and non-Italian nationals. STUDY DESIGN: We retrospectively analysed data from the COVID-19 Italian integrated surveillance system (14 September 2020 to 17 October 2021). METHODS: We used multivariable Cox proportional hazards models to estimate the hazard ratio (HR) of infection and, among cases, the HRs of death, hospitalisation and subsequent admission to intensive care unit in non-Italian nationals relative to Italian nationals. Estimates were adjusted for differences in sociodemographic characteristics and in the week and region of diagnosis. RESULTS: Of 4,111,067 notified cases, 336,265 (8.2%) were non-Italian nationals. Compared with Italian nationals, non-Italians showed a lower incidence of SARS-CoV-2 infection (HR = 0.81, 95% confidence interval [CI]: 0.80-0.81). However, once diagnosed, they were more likely to be hospitalised (HR = 1.90, 95% CI: 1.87-1.92) and then admitted to intensive care unit (HR = 1.08, 95% CI: 1.04-1.13), with differences larger in those coming from countries with a lower human development index. Compared with Italian cases, an increased rate of death was observed in non-Italian cases from low-human development index countries (HR = 1.41, 95% CI: 1.23-1.62). The HRs of SARS-CoV-2 infection and severe outcomes slightly increased after the start of the vaccination campaign. CONCLUSIONS: Underdiagnosis and delayed diagnosis in non-Italian nationals could explain their lower incidence compared with Italians and, among cases, their higher probability to present clinical conditions leading to worse outcomes. Facilitating early access to vaccination, diagnosis and treatment would improve the control of SARS-CoV-2 transmission and health outcomes in this vulnerable group.

Managing the pandemic in the reception system for migrants: the Italian experience

Issue Italy represents a well-known European transit and destination country for Migrants and Refugees (M&Rs) with more than 77.000 migrants currently hosted in the reception system. Pandemic did not impact the M&Rs' influx with more than 30.000 disembarked in 2020. In line with the WHO and international organizations alerts to protect the health of M&Rs, Italy included M&Rs in its pandemic response. Description of the practice With the mandate of the Ministry of Health and thanks to the collaboration with the Ministry of the Interior and other institutional and governmental bodies, the Italian National Institute for Health, Migration and Poverty developed a comprehensive strategy to protect M&Rs' health in Italy during the COVID-19 pandemic, either into the reception system and outside. Results Interim evidence - based operating procedures including instructions regarding the early detection and the management of potential suspected and confirmed COVID-19 cases, from the first arrival throughout the entire reception system path, have been published. A national survey on the incidence of COVID-19 cases in the reception system has been performed in 2020. Dedicated information flows on the incidence of COVID-19 cases at the arrival in Italy and in the reception system and a periodic monitoring of the implementation of the afore-mentioned operating procedures have been established in 2021. Data collected have shown a daily mean incidence ratio lower for migrants hosted in the reception system than for the general population, as well as the same regarding the new COVID-19 cases among newly arrived migrants. Lessons The strategy adopted was found to be effective in protecting M&Rs' health during the pandemic. In particular, the Italian reception system has globally shown a good performance in limiting the COVID-19 spread. Moreover, the influx of newly arrived migrants did not represent an additional epidemiological risk in terms of burden of infection. Key messages The production of evidence-based procedures and the establishment of effective information flows have proved to be effective in managing and monitoring the pandemic in regards to M&Rs. The Italian reception system has turned to play as a protective factor in limiting the COVID-19 spread and the systematic screening of newly arrived M&Rs did not shown an additional COVID-19 burden.

From conception to 1000 patients: Operationalizing a field hospital in 2 weeks: Javits, NY, NY

INTRODUCTION: The surge of SARS-CoV-2 patients presenting to New York City (NYC) hospitals quickly overwhelmed and outnumbered the available acute care and intensive care resources in NYC. Upon arrival of military medical assets to the Javits Convention Center in New York City, more than 100,000 local residents had already been infected and 5,000 residents had died. METHODS: The JNYMS (Javits New York Medical Station) constructed by the Army Corps of Engineers with a capacity to house more than 4,000 patients. Healthcare professionals from every branch of the uniformed services, augmented by state and local resources, staffed the JNYMS for April, 2020. All patient demographic data was collected on a computerized registry (maintained by the NY Department of Health) and clinical documentation was done using paper charts. RESULTS: During the 28 days of patient intake at the JNYMS, 1,095 SARS-CoV-2 patients were transferred from NYC hospitals. At its peak, the JNYMS accepted 119 patients in a single day (Figure 1), had a maximum census of 453, and had a peak ICU census of 35. The median length of stay was 4.6 days [IQR: 3.1-6.9 days]. 103 patients [9.4%, 95% CI 7.7-11.3] were transferred back to local hospitals (87) or the USNS Comfort (16). There were 6 deaths, for an overall mortality rate of 0.6% [95% CI 0.3-1.2] however 27 ICU patients were transferred back to NYC hospitals, half were on ventilators and the majority were critically ill. CONCLUSIONS: This is the first report of the care provided at the JNYMS. Within 2 weeks, this multi-agency effort was able to mobilize to care for over 1000 SARS-CoV-2 patients with varying degrees of illness in a one-month period. This large-scale mobilization at the height of the epidemic in NYC saved many more lives, as high-level medical care was afforded patients that would have over-loaded New York hospitals. It allowed them to decompress while offering much needed healthcare provider relief. In addition to the volume of patients cared for over this short period of time, this circumstance is unique in that this field hospital provided ICU level of care. Notably, the JNYMS was able to discharge SARS-CoV-2 patients home in under 5 days, with a full supply of their required medications, thus freeing up NY City case management resources for other patients.

Activity of a Phase I Clinical Unit during the COVID-19 pandemic

Background: Enrolment of patients in phase 1 trials is a difficult task everywhere and at every time. It is reported that on average less than one patient per month is enrolled worldwide in phase 1 trials. COVID-19 pandemic has been a further problem during 2020, with many trials closed by the sponsors for logistic reasons and for the fear of causing a fatal infection in cancer patients. Materials and methods: We reviewed the activity of our phase 1 unit in terms of enrolment of new patients during six months, three before and three during COVID-19 pandemia, and of treatment of patients enrolled before the pandemic. Results: Out of 8 trials active at our unit, only one did not close the possibility of enrolling new patients during the pandemic. No treatment was stopped because of the pandemic. During the pandemic we enrolled three new patients in the only one open trial. The same number of new patients had been enrolled during the previous three months. In addition, three further patients were pre-screened during the pandemic resulting not eligible. Operatively, an intensive strategy of testing healthcare workers (nurses, doctors, study coordinators, biologists) with blood testing for anti-COVID19 IgM and IgG, and pharyngeal and nasal swabs was applied. In addition, patients were managed with a triage protocol that similarly included blood testing at each access and swab testing in case of IgM/IgG presence. Overall, no one of the health coworkers resulted positive to blood or swap testing and only one patients was positive to IgM testing, with negative swap and subsequently negative blood testing, possibly representing a false positive case. Sanitization of phase 1 rooms was also performed regularly, once per week or more frequently at need in case of patients or health workers resulting positive to blood testing. Conclusions: Our phase 1 unit was able to maintain the same level of activity during the pandemic, thanks to one trial that was not suspended by the sponsor and this goal was reached thanks to organization and preventive measures set up by the Institutional dedicated professionals. Overall, a good result was achieved in terms of safety of both patients and healthcare workers.