The effect of positive pressure ventilation on Acute Kidney Injury (AKI) in COVID-19 Acute Respiratory Distress Syndrome (ARDS). An observational study

Background: Acute kidney injury (AKI) is a common complication of COVID-19 ARDS and is associated with greater risk of mortality (1)). In addition to the direct tubular injury mediated by the virus, indirect mechanisms play a role in AKI development. Positive pressure ventilation, by increasing intrathoracic pressure, leads to a decreased venous return to the heart and to a reduced cardiac output (2). In addition, elevated central venous pressure (CVP) may result in elevated tubular hydrostatic pressure in the encapsulated kidney, which reduces glomerular filtration rate and oxygen delivery (3). We hypothesized that elevated intrathoracic pressure, determined by positive pressure ventilation is associated with an increased risk of AKI. The aim of the study is to assess the association between hemodynamics and ventilatory parameters set during mechanical ventilation and AKI in patients with COVID-19 ARDS. Method(s): This is single center retrospective observational study performed at Papa Giovanni XXIII Hospital Bergamo (Italy). Consecutive patients were enrolled with a diagnosis of COVID-19 and ARDS managed with invasive mechanical ventilation. If patients developed AKI (defined according to KDIGO definition) within 14 days of ICU stay were included in "AKI group", otherwise were classified in "non-AKI group". Demographic characteristics, lab tests and hemodynamic [mean arterial pressure (MAP) and central venous pressure (CVP), fluid balance] and ventilatory parameters [positive end-expiratory pressure (PEEP), plateau pressure (PPlat)] were compared between group using Mann Whitney test. Data are presented as median and 95% CI. Only data registered until the day of the AKI occurrence, in patients in AKI group, or until the day corresponding to the median days between ICU admission and the AKI occurrence calculated before for patients in non-AKI group, were considered for the statistical analysis. Result(s): Among the 140 patients included in the analysis, AKI occurred in 70 (48%) patients and 27 (19%) required continuous renal replacement therapy (CRRT). Table 1 shows comparison between the two groups. Patients in AKI group were older, had higher prevalence of obesity, hypertension and diabetes, had lower MAP and received a greater amount of fluid and furosemide compared to patients in non-AKI group (p<0.05). Only a trend toward a greater CVP was observed in patients with AKI, without reaching a significant difference. Both PEEP and Pplat were set higher in patients with AKI, while the severity of lung disease, measured by PaO2/FiO2 were not different between the two groups. Conclusion(s): In our cohort, higher pressure ventilation was associated with an increased risk of AKI.

Early prediction of efficacy of endocrine therapy (ET) in metastatic breast cancer (MBC): Pilot study with [18F]fluoro-estradiol-17β (18F-FES) PET/CT

Background: Estrogen receptors (ER) are predictive of endocrine responsiveness. However, 30% of ER+ BC patients will relapse despite adjuvant ET and 10 to 20% of metastatic lesions loose the expression of ER. The early identification of endocrine resistant patients may help to improve treatment strategies, especially in the light of innovative drugs recently approved. In the ET-FES trial we evaluated 18F-FES CT/PET as a prediction tool for endocrine responsiveness in ER+ MBC. The ET-FES study was funded by the ERANET-Transcan project. Methods: MBC patients with ER+/HER2- disease, were eligible for the ET/FES study. All patients underwent a baseline [18]F-FES PET/CT in addition to conventional procedures. Patients were classified as endocrine sensitive if overall Standardized Uptake Value (SUV) ≥ 2 and received ET;patients with SUV <2 were randomized to receive ET or chemotherapy (CT). The prognostic role of [18]F-FES PET/CT was assessed for PFS and OS by univariate and multivariate analyses. The primary endpoint was disease progression rate (DPR) at 6 months. Results: From April 2015 to October 2020 146 patients, from 7 EU centers were enrolled: of them, 115 with a mean SUV >2 received ET and 30 with SUV <2 were included in the randomized study. Median follow up was 18.4 months (range 8.0 to 38.3 months) in endocrine sensitive patients (SUV > 2) versus 10.1 months (range 8.0 to 36.8) in patients with SUV <2. Overall, at the time of this analysis 67 patients (45.9%) had disease progression and 37 (25.3%) died. DPR at 6 months was 57% in patients with SUV >2 vs 50% in SUV <2 randomized to ET and 57% in case of CT. DPR at 12 months was 35% vs 17% and 14%, respectively. Median PFS was 7.3 months (IQR 3.8 – 17.3) vs 5.2 (IQR 3.1 – 9.4) vs 7.7 months (IQR 3.0 – 14.0), respectively. OS rate at 12 months was 31% versus 17% versus 14%. Conclusions: The ET-FES clinical trial was prematurely interrupted, due to COVID-19 pandemic. The discriminating ability of this assay was high, leading to a personalized endocrine approach;a considerable proportion of patients with a mean SUV >2 is still on ET. Clinical trial identification: EudraCT 2013-000287-29. Legal entity responsible for the study: Alessandra Gennari - Università del Piemonte Orientale. Funding: AIRC. Disclosure: All authors have declared no conflicts of interest.

LONG-TERM SURVEY STUDY of the IMPACT of COVID-19 on SYSTEMIC AUTOIMMUNE DISEASES. LOW DEATH RATE DESPITE the INCREASED PREVALENCE of SYMPTOMATIC INFECTION. ROLE of PRE-EXISTING INTERSTITIAL LUNG DISEASE and ONGOING TREATMENTS

Background: Patients with autoimmune systemic diseases (ASDs) can be counted among frail populations as regards the predisposition to COVID-19 due to the frequent visceral organ involvement and comorbidities, as well as the ongoing immunomodulating treatments. Objectives: Our long-term multicenter telephone survey prospectively investigated the prevalence, prognostic factors, and outcomes of COVID-19 in Italian ASD patients during the frst 3 pandemic waves. Methods: A large series of 3,918 ASD patients (815 M, 3103 F;mean age 59±12SD years) was consecutively recruited at the 36 referral centers of COVID-19 & ASD Italian Study Group. In particular, ASD series encompassed the following conditions: rheumatoid arthritis (n: 981), psoriatic arthritis (n: 471), ankylosing spondylitis (n: 159), systemic sclerosis (n: 1,738), systemic lupus (172), systemic vasculitis (n: 219), and a miscellany of other ASDs (n: 178). The development of COVID-19 was recorded by means of telephone survey using standardized symptom-assessment questionnaire (1). Results: A signifcantly increased prevalence of COVID-19 (8.37% vs 6.49%;p<0.0001) was observed in our ASD patients, while the cumulative death rate revealed statistically comparable to the Italian general population (3.65% vs 2.95%;p: ns). In particular, among the 328 ASD patients complicated by COVID-19, 57 (17%) needed hospitalization, while mild-moderate manifestations were observed in the large majority of individuals (83%). In addition, 12/57 hospitalized patients died due to severe interstitial pneumonia and/or cardiovascular manifestations. Interestingly, a signifcantly higher COVID-19-related death rate was observed in systemic sclerosis patients compared to the Italian general population (6.29% vs 2.95%;p=0.018). Other adverse prognostic factors to develop COVID-19 were the patients' older age, male gender, pre-existing ASD-related interstitial lung involvement, and chronic steroid treatment. Conversely, patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) showed a signifcantly lower prevalence of COVID-19 compared to those without (3.58% vs 46.99%;p=0.000), as well as the chronic administration of low dose aspirin in a subgroup of SSc patients (with 5.57% vs without 27.84%;p=0.000). Conclusion: The cumulative impact of COVID-19 on ASD patients after the frst 3 pandemic waves revealed less severe than that observed during the frst phase of pandemic (1), especially with regards to the death rate that was comparable to the Italian general population in spite of the increased prevalence of complicating COVID-19 in the same ASD series. Ongoing long-term treatments, mainly csDMARDs, might usefully contribute to generally positive outcomes of in this frail patients' population. Of note, a signifcantly increased COVID-19-related mortality was recorded in only SSc patients' subgroup, possibly favored by pre-existing lung fbrosis. Among different ASD, SSc deserves special attention, since it shares the main pathological alterations with COVID-19, namely the interstitial lung involvement and the endothelial injury responsible for diffuse microangiopathy. Besides SSc, the patients' subgroups characterized by older age, chronic steroid treatment, pre-existing interstitial lung disease, and/or impaired COVID-19 vaccine response (1-3), may deserve well-designed prevention and management strategies.

Emergency calls for time-depending during COVID-19 outbreak in center Italy

In the present study we analysed the emergency calls to the Umbrian Emergency Medical System (reached by dialling the emergency telephone number 118), that occurred for time-dependent-illnesses during the pandemic. Our analysis included all out-of- hospital ACSs, strokes and cardiac arrests electronically stored in the Emergency Department database. During the trimester 1st February- 30th April a total of 61,867 and 63,194 calls were registered in 2019 and 2020, respectively. In year 2020, compared to year 2019, there was a significant reduction in the frequency of calls to 118 for ACS (0.009% vs 0.14% 2=25.71, p=0.01), a non-significant reduction in the calls due to stroke (0.48% vs 0.5% 2=1.1, p=0.2) and cardiac arrest (0.43% vs 0.47%;2=2.85, p=0.09). Overall, these findings strongly suggest that, during the COVID-19 pandemic, a lower attention has been posed to time-dependent illness. This dramatically led to a general underutilization of the emergency medical system, and consequently reduced the number of time-dependent hospitalizations. Considering the differences among ACS calls with respect to stroke calls, we could speculate that patients who have a clinical presentation with mild symptoms have preferred to stay at home, given the widespread fear of going to hospitals.

Medical students at the bedside of COVID-19 patients: motivations and challenges

The SARS-CoV-2 pandemic is putting our healthcare system under exceptional pressure, given the number of affected patients. In a context of limited human healthcare resources, senior medical students represent a valuable workforce that can quickly be mobilized for patient care. This is the approach followed in Switzerland and other countries, in several outpatient structures or inpatient services, including the Department of Internal Medicine, of the Lausanne University Hospital (CHUV). In this article, we first give the floor to students who responded to our call. We conclude with important considerations in terms of students’ clinical supervision. It is reminded that the involvement of students in the care of COVID-19 patients should only occur on a voluntary basis.

Organizational Impacts and Clinical Challenges of the COVID-19 Pandemic on a Swiss Tertiary Internal Medicine Department

The rapid progression of COVID-19 is an organizational challenge for all hospitals. To secure the patient overflow, the Department internal medicine of the University Hospital of Lausanne increased nurse and medical workforces as well as bed capacity by 65%, with extraordinary help from other departments. The implemented crisis management stood upon three pillars: a crisis management team, steering documents and internal communication. In this new form, the Department had already taken care of 442 COVID-19 admissions by April 16, 2020. Alongside organizational challenges, clinical issues such as rapid respiratory distress, clinical suspicions with negative PCR and treatment uncertainties in the absence of sufficient evidence were overcome. Despite the peak of the pandemic appearing to have passed, the next phase could be just as complicated.

Neutralizing antibody responses against SARS-CoV-2 spike receptor-binding domain 13 months after the recovery from the disease.

BACKGROUND: Information regarding the kinetics and longevity of acquired immunity in recovered COVID-19 patients requires thorough analysis and documentation. This is an update to an ongoing monocentric pilot observational study, that longitudinally analyzed the presence of antibodies after SARS-CoV-2 infection. STUDY DESIGN: Antibody titers against nucleocapsid protein (NCP) of SARS-CoV-2 analyzed at 8 months was followed by adoption of a more specific immunoassay, anti-Spike-Receptor binding domain IgG CLIA for analysis at 12 and 13 months post infection. METHODS: MAGLUMI® SARS-CoV-2 S-RBD IgG Chemiluminescence immunoassay (CLIA) was adopted for measurement of antibody titres at 12 and 13 months after SARS-CoV-2 infection. RESULTS: 97% (34 out of 35) patients resulted positive for anti-SARS-CoV-2 RBD IgG at 12 and 13 months. DISCUSSION AND CONCLUSIONS: In areas with vaccine and resource scarcity, vaccination could be prioritized for those individuals who have never been infected or for the ones who have recovered but show the absence of protective antibodies.

Neutralizing antibody responses against SARS-CoV-2 spike receptor-binding domain 13 months after the recovery from the disease

Background: Information regarding the kinetics and longevity of acquired immunity in recovered COVID-19 patients requires thorough analysis and documentation. This is an update to an ongoing monocentric pilot observational study, that longitudinally analyzed the presence of antibodies after SARS-CoV-2 infection. Study design: Antibody titers against nucleocapsid protein (NCP) of SARS-CoV-2 analyzed at 8 months was followed by adoption of a more specific immunoassay, anti-Spike-Receptor binding domain IgG CLIA for analysis at 12 and 13 months post infection. Methods: MAGLUMI R SARS-CoV-2 S-RBD IgG Chemiluminescence immunoassay (CLIA) was adopted for measurement of antibody titres at 12 and 13 months after SARS-CoV-2 infection. Results: 97% (34 out of 35) patients resulted positive for anti-SARS-CoV-2 RBD IgG at 12 and 13 months. Discussion and Conclusions: In areas with vaccine and resource scarcity, vaccination could be prioritized for those individuals who have never been infected or for the ones who have recovered but show the absence of protective antibodies.

COVID-19 and its impact on acute coronary syndrome in-hospital epidemiology: a multifactorial analysis from a single-center Hospital in the north-east region of Italy

We analyze all possible, multifactorial correlations between coronavirus 2019 (COVID-19) pandemic and epidemiological in-hospital epidemiologic variations in ischemic heart disease burden. We developed a simple retrospective study surveying all acute coronary syndrome cases reporting an epidemiological analysis of a single-center University Italian Hospital located in the north-east area of Italy in the city of Gorizia, comparingdata collected in two months (February and March) about the definite diagnosis of myocardial infarction in the years 2019 and 2020 (COVID-19 peak exposure interval) respectively. We retrospectively analyzed data regarding the two months of February and March 2020 about admissions to our Intensive Cardiac Care Unit (ICCU) with a confirmed diagnosis of acute coronary syndrome. Differences among the two study periods were assessed using the chi(2) test. Statistical significances were set at P<0.05. All analyses were conducted using IBM SPSS software version 24.0 (IBM Corp. Armonk, NY, USA). We showed a remarkable decrease of acute coronary syndrome cases diagnosed and admitted to our Intensive Cardiac Care Unit when comparing the interval period between February and March 2019 to the same months of 2020. This rate was significantly lower than either the rate during the earlier period in the same year [95% confidence interval (CI), 0.63 to 0.80;P<0.001]. We showed an overall decrease in diagnosis of acute coronary syndromes during the COVID-19 pandemic;we relate this amount decrease in diagnosis to general underuse of cardiologic public services leading to a reduced number of admissions for acute coronary syndrome cases and possibly undertreatment and death of out-of-hospital, silenced critical clinical cardiologic pictures due to a generalized fear of COVID-19 in-hospital contagion.

Antibody persistency and trend post-SARS-CoV-2 infection at eight months.

Introduction: A large amount of recent research has focused on the nature of immunity elicited by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, particularly its robustness and the duration of protection it offers. As a vaccine's efficacy relies on its ability to induce a protective immune response, these questions remain particularly pertinent. An improved understanding of the immunity offered by the antibodies developed against SARS-CoV-2 in recovered patients is critical for the development of diagnostic tests and vaccines. Methods: Our study aimed at the longitudinal analysis of antibody presence, persistence and its trend over eight months in a group of 30 COVID-19 recovered patients who tested positive by real-time quantitative PCR for SARS-CoV-2 in the period 1-30 March 2020. The subjects were divided into two groups based on disease severity: mild (n=17 subjects) and moderately-severe (n=13 subjects). The MAGLUMI 2019-nCoV lgM/lgG chemiluminescent analytical system (CLIA) assay was used to analyze these antibody titres. Results: IgG antibody persistency was demonstrated in 76.7 % of the subjects (23 out of 30) at eight months post-infection. For the moderately-severe group, the titre trends for both IgM and IgG changed in a statistically significant way throughout the time period with IgM below and IgG above the set cut-off. Conclusions: The results of this study highlight an important point in terms of the association between humoral immune response and disease severity. Patients who have experienced a relatively severe infection might develop a stronger immune response that could persist for a longer period.

SARS-CoV-2 was already circulating in Italy, in early December 2019

OBJECTIVE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) identified in China, in December 2019 determines COronaVIrus Disease 19 (COVID-19). Whether or not the virus was present in Italy earlier the first autochthonous COVID-19 case was diagnosed is still uncertain. We aimed to identify anti-SARS-CoV-2 antibodies in sera collected from 4th November 2019 to 9th March 2020, in order to assess the possible spread of the virus in Italy earlier than the first official national diagnosis. PATIENTS AND METHODS: Anti-SARS-CoV-2 antibodies were evaluated in retrospective serum samples from 234 patients with liver diseases (Hep-patients) and from 56 blood donors (BDs). We used two rapid serologic tests which were confirmed by a validated chemoluminescence assay. RESULTS: Via rapid tests, we found 10/234 (4.3%) IgG-positive and 1/234 (0.4%) IgM-positive cases in the Hep-patient group. Two/56 (3.6%) IgG-positive and 2/56 (3.6%) IgM-positive cases were detected in BD group. Chemoluminescence confirmed IgG-positivity in 3 Hep-patients and 1 BD and IgM-positivity in 1 Hep-patient. RNAemia was not detected in any of the subjects, rendering the risk of transfusion transmission negligible. CONCLUSIONS: Our results suggest an early circulation of SARS-CoV-2 in Italy, before the first COVID-19 cases were described in China. Rapid tests have multiple benefits;however, a confirmation assay is required to avoid false positive results.

Oncology Clinical Trials management during the pandemic-the Italian experience

Background: COVID-19 pandemic, caused by the new SARS-COV-2 virus, has impacted all Italian healthcare areas, including clinical research. This forced a profound reorganization of experimental sites, including the activities of Clinical Trials Units (CTU). Moreover, in March 2020 the Italian Medicines Agency (AIFA) provided guidance on the management of clinical trials in light of the restrictive measures adopted by the Government against the pandemic. Methods: We decided to investigate how the Italian CTUs have reorganized and how smart working is considered truly effective during the emergency. In April 2020 all members of Italian Group of Clinical Research Coordinators were invited to complete a web survey, consisted of 21 questions about the reorganization of CTUs and the managements of trials since the start of pandemic. Results: 142 research professionals completed the survey: 120 Clinical research Coordinators, 21 data managers and 1 biostatistician. Women was 86% (n=122) and the age group 26-35ys was the mainly represented (n=72, 50.7%). A total of 15 on 21 Italian regions were represented with a good national coverage. The majority of respondents (n=121, 85.2%) said that, due to the emergency, their activities were reorganized, mainly through the alternation of smart working and shifts on site (n= 78, 64.5%) or the activation of a totally smart working method (n=33;27.3%). Within the cohort that had the opportunity to work, partially or totally, from home (n=116, 81.7%), most respondents (n=81, 69.8%) stated they benefited from a high level of accessibility to hospital records, in many cases (n= 41, 50.6%) both patient records and shared document areas. In very few cases, the employer has provided additional tools for staff, such as PCs (n=18, 15.5%) or phones (n=1, 0.9%) company while many respondents (n=57, 49.1%) said they had not even received assistance from their IT service. With regard to the opinion on the effectiveness of the smart working activity, the average score was 6.3 on a scale of about 1-10. Conclusion: Most of the Clinical Trials Units have been reorganized so that deferred activities can be carried out away from the hospital, guaranteeing, on average, wide remote access to the necessary documentation. Certainly, it would be necessary to improve the IT and electronic equipment that employees benefit from so as to optimize all activities and ensure rapid and high quality (performances), even in non-emergency situations.

Researchers' Pyramid-trick or treat

Background: During the COVID-19 Coronavirus pandemic, public opinion has returned to a great deal of interest in clinical research and the key role of researchers in periods of health emergency. If on the one hand the emergency has reawakened confidence in the work of researchers in the population, on the other it has revealed leaks in the system that insiders have known for a long time. Italian research has always been characterized by great contradictions. While Italy boasts the most prestigious researchers worldwide, it is highly penalized by low investments and the inability to provide a stable career path to researchers and support staff. A first important step to at least partially solve the problem was the ministerial reform known as ' Researchers' pyramid', an initiative that has been the subject of strong contradictions. Methods: In September 2019, the Italian Group of Data Manager shared an online survey, meant for the italian biomedical research personnel, to investigate opinions about the reform. Results: The questionnaire was completed by 147 respondents, the majority being employed at public IRCCS/IZP (n=78, 53.1%) or public Hospitals/University/Local Health Company (n=50, 34.0%).The respondent's profession was not included in those listed in the Pyramid in the minority of cases (n=28, 19%), while for the greater part it corresponded to a profession included in the 'Clinical Research Assistant' (n=21, 55.1%) and 'Clinical Researcher' categories (n=38, 25.9%). Over half of respondents declared to be optimistic regarding the actual benefit of the reform for employment stability. Over half (63.4%) of the 'not optimistic respondents' considers the Pyramid a false path towards stabilization. Concerns were also expressed in relation to the evaluation criteria during the ten-year period, considered by a third of the interviewed to be too exclusive and often not very suitable. Many individuals (41.5%) report the poor valorization of personnel and much apprehension was recorded relating to the possibility of extending the reform to other institutes. Conclusions: The reform overall seems like an important opportunity for entry level or inexperienced personnel, a watered-down compromise for expert professionals. But above all: only IRCCS are worthy of doing research The fear conveyed from the great majority of the interviewed is that the pyramid is only a trick. When the emergency is over, will institutions finally begin to consider research a real job.

Epidemiology of emergency calls for time-dependent acute illnesses during COVID-19 outbreak in Umbria region (Italy).

The recent literature reported an inverse correlation between COVID-19 pandemic and hospital admissions for Acute Coronary Syndromes (ACS).

Clinical research at the time of COVID-19: A passion or a real job?

Background: During Coronavirus pandemic, public opinion has returned to a great deal of interest in clinical research and the key role of researchers. Particularly in Italy, deeply affected by the emergency, people have returned to believe in the work of health professionals and have loudly asked for a profound research effort, a field hitherto suspiciously looked at. Yet, until then, few had worried about nation's big contradictions as the total nonexistence of the profession of the researcher in the National Health System. The only effort in the recent years has been a ministerial reform ”Researchers’ pyramid”, a 10 year working path characterized by a 5 year contract, renewable once and with annual reconfirmation exams, with the final hope of recognition within the national health system. An initiative that has been the subject of strong contradictions. Methods: In September 2019, the Italian Group of Clinical Research Coordinators shared an online survey, meant for the Italian biomedical research personnel, to investigate opinions about the reform. Results: The questionnaire was completed by 147 respondents, the majority (53.1%) employed at public research institute or public Hospitals/University/Local Health Company (34.0%).Respondent’s job for the greater part corresponded to a profession included in the “Clinical Research Assistant” (55.1%) and “Clinical Researcher” categories (25.9%). Over half declared to be optimistic regarding the actual benefit of the reform for employment stability. Between “not optimistic respondents”, 50% considers Pyramid a false stabilization path. Concerns were also expressed in relation to the evaluation criteria, considered too exclusive and often not suitable by a third of the interviewed. Many individuals (41.5%) report the poor valorization of personnel and much apprehension was recorded relating to the possibility of extending the reform to other institutes. Conclusions: The reform overall seems an important opportunity for entry level personnel, a watered-down compromise for expert professionals. The fear conveyed from the great majority of the interviewed is that the pyramid is only a trick. When the emergency is over, will institutions finally begin to understand the importance of research? A job, not just a passion. Legal entity responsible for the study: Gruppo Italiano Data Manager - CRC. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Revolutionizing clinical trial units in the pandemic era

Background: COVID-19 pandemic has impacted all health care areas, including clinical research, especially in the countries most affected by the emergency, such as Italy. This forced a profound reorganization of experimental sites and Clinical Trials Units (CTU), in accordance with the specific guidelines gradually drawn up by the regulatory agencies. Methods: In April 2020 the Italian Group of Clinical Research Coordinators spread an anonymous web survey consisted of 21 questions about the reorganization of CTUs and the managements of trials since the start of pandemic. Results: 142 representatives of Italian CTUs completed the survey;women was 86% and the age group 26-35 years was the mainly represented (50.7%). A total of 15 on 21 Italian regions were represented with a good national coverage. The majority of respondents (85.2%) said that, due to the emergency, the CTU activity has been reorganized, mainly through the alternation of smart working and shifts on site (64.5%) or the activation of a totally smart working method (27.3%). Within the cohort that had the opportunity to work, partially or totally, from home (81.7%), most respondents (69.8%) stated they benefited from a high level of accessibility to hospital records, in many cases (50.6%) both patient records and shared document areas. In very few cases, the employer has provided additional tools for staff, such as PCs (15.5%) or phones (0.9%) company, while many respondents (49.1%) said they had not even received assistance from their IT service. With regard to the opinion on the effectiveness of the smart working activity,the average score was 6.3 on a scale of about 1–10. Conclusions: Most of the Clinical Trials Units have been reorganized so that deferred activities can be carried out away from the hospital, guaranteeing, on average, wide remote access to the necessary documentation. Certainly, it would be necessary to improve the IT and electronic equipment that employees benefit from so as to optimize all activities and ensure rapid and high-quality performances, even in non-emergency situations. Clinical trial identification: The authors. Legal entity responsible for the study: Gruppo Italiano Data Manager. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Breast surgeons updating on the thresholds of COVID-19 era: results of a multicenter collaborative study evaluating the role of online videos and multimedia sources on breast surgeons education and training.

OBJECTIVE: Current trends show a rise of attention given to breast cancer patients' quality of life and the surgical reconstructive result. Along with this trend, surgical training quality and efficacy are gaining importance and innovative training methods such as online videos shared on social media portals, are becoming main updating tools. In hazardous times like COVID-19 pandemic nowadays, online communication becomes of vital importance and adaptation and innovation are fundamental to keep research and education alive. The authors aimed to investigate the role of video and multimedia sources on the daily activity and surgical training of a representative group of surgeons specifically dedicated to oncologic, oncoplastic and reconstructive breast surgeries. MATERIALS AND METHODS: A survey was produced and administered to 20 major Italian Breast Centers. Collected data were analyzed with Fisher's Exact Test. RESULTS: From October 2019 to March 2020, a total of 320 surveys were collected. Among the responders, there were 188 trainees (intern medical doctors and residents) and 110 faculty, 72% of them belonged to a plastic surgery environment, while 28% to general surgery environment. Almost all respondents have ever watched videos concerning breast surgery. CONCLUSIONS: The results of the study show how breast surgeons rely on videos and web platforms, mostly YouTube, when searching for training info about surgical procedures. Social media offer great opportunities for sharing knowledge and diffusion of new ideas but greater attention to their reliability is mandatory.