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The Italian Ethics Committees protect clinical research participants' rights and well-being guaranteeing also the scientific integrity of the research. In Italy, one of the first countries severely affected by the COVID-19 pandemic, the Ethics Committees activities have been impacted by the virus spreading and subsequent lockdown from 9 March to 16 May 2020. In mid-June 2020, a cross-sectional survey was conducted in Italy, contacting all the 90 local Ethics Committees. The survey's purpose was to analyze (1) the activities carried out by the Ethics Committees during the lockdown;(2) the features of the Ethics Committees submitted studies;and (3) the implementation of standard research evaluation protocols during the pandemic. Regions with higher incidence (HI) and lower incidence (LI) of COVID-19 were compared via the chi-square test. Out of 46 Ethics Committees that participated in the study, 258 questionnaires were obtained. A rise in the number of studies submitted to local Ethics Committees was identified in 75% of the HI, in comparison to 53% in LI regions (p < 0.001). The 15% of participants from HI areas documented a reduction in compliance with the standard research application assessment protocols. In the HI regions, a greater percentage of Ethics Committees professionals have moved to smart working in comparison with LI regions (75% vs 59%;p < 0.001). The influence of COVID-19 on Ethics Committees activities in HI territories has been considerable;the Ethics Committees workload increased dramatically especially in these areas. The smart working has been effective in ensuring the activities of Ethics Committees and the subsequent activation of clinical trials that are potentially useful for coping with the pandemic. However, it was stated that an accurate review of the submitted study documents could not be carried out, with the consequence of offering a favorable opinion on studies of not excellent nature. From the point of view of some Ethics Committee participants, the large number of studies performed in the most affected areas, together with the emergency faced during the lockdown, may have exposed Ethics Committees to the risk of reducing the implementation of ethical standards and standard assessment procedures for research applications.
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BACKGROUND AND AIMS: In 2020, SARS-CoV-2 pandemic had a devastating impact on individuals and on national health systems worldwide. Although being primarily a lung disease, COVID-19-associated systemic inflammation and activation of coagulation/complement cascades lead to multiple organ dysfunction including Acute Kidney Injury (AKI). Our aim is to evaluate AKI prevalence and mortality in hospitalized patients during COVID-19 pandemic in a 500-bed University Hospital. METHOD: Observational study on 945 COVID-19 patients (March-May 2020). Data collection from Board Hospital Discharge and serum creatinine (Lab database). AKI stratification in accordance to KDIGO criteria and evaluation of outcome in the different subgroups. The same methodology was adopted to assess AKI prevalence and outcome in 2018-2019. RESULTS: 351/945 (37.14%) of all hospital admissions for COVID-19 showed AKI further sub-classified as follows: 173 (18.3%) stage 1, 112 (11.9%) stage 2 and 66 (6.9%) stage 3: the control NO AKI group was 594/945 (62.86%). COVID-associated AKI prevalence was higher than that observed in 2018 (total AKI 17.9%, stage 1 10.7%, stage 2 4.5%, stage 3 2.7%) and 2019 (total AKI 17.2%, stage 1 10.1%, stage 2 4.5%, stage 3 2.6%). During COVID-19 pandemic, in-hospital mortality was 27% for NO AKI group, 28% for total AKI group, further subdivided 24% for stage 1, 45% for stage 2 and 42% for stage 3 group, respectively. Mortality was different from that observed during 2018 (NO AKI 3.77%, total AKI 15.2%, stage 1 9.69%, stage 2 17.24%, stage 3 18.9%) and 2019 (NO AKI 3.56%, total AKI 18.35%, stage 1 10.6%, stage 2 20.1%, stage 3 24.3%). In COVID-19 patients, mean age of NO AKI group was 64.6 ys vs. 71.7 ys of total AKI group divided in 71.6 ys for stage 1, 74.3 ys for stage 2 and 67.9 ys for stage 3, respectively. Mean eGFR at admission was 74.2 ml/min for NO AKI group, 61.3 ml/ min for total AKI group divided in 64.3 ml/min for stage 1, 57.8 ml/min for stage 2 and 52.5 ml/min for stage 3. Mean serum creatinine at admission was 1.17 mg/dl in NO AKI group, 1.43 mg/dl for total AKI group divided in1.22 mg/dl for stage 1, 1.4 mg/dl for stage 2 and 2.25 mg/dl for stage 3. Among evaluated comorbidities, only diabetes (p=0,048) and cognitive impairment (p=0,001) were associated with a significant increased risk for AKI development. ICU admission rate was 5% for NO AKI group and 18% for total AKI group divided in 14% for stage 1, 22% for stage 2 and 44% for stage 3. Mean length of hospital stay for NO AKI group was 7.22 days vs 15.08 days for total AKI group divided in 13.67 for stage 1, 15.83 for stage 2 and 21.82 for stage 3. Of note, all different therapies administered to COVID-19 patients did not correlate with AKI incidence. Mean eGFR at discharge was 76 ml/min for NO AKI group vs 66 ml/min for total AKI group divided in 68.7 ml/min for stage 1, 59.3 ml/min for stage 2 and 59.3 ml/min for stage 3. Mean serum creatinine at discharge was 1.14 mg/dl for NO AKI group vs 1.45 mg/dl for total AKI group divided in 1.28 mg/dl for stage 1, 1.58 mg/dl for stage 2 and 2.05 mg/dl for stage 3. CONCLUSION: COVID-19 pandemic is associated with an increased AKI prevalence in hospitalized patients (2-fold increase in all KDIGO stages). AKI associated with an increased risk of mortality: of note, AKI stage2-3 had a strong impact on mortality in comparison to NO AKI group (OR 2.59 and 2.11, respectively). The presence of eGFR >60 ml/min and serum creatinine < 1.2 mg/dl at admission were associated with a lower risk of AKI development: reduced eGFR levels were observed at discharge particularly in AKI stage 2-3. The length of hospital stay and risk of ICU admission depended on AKI incidence and severity. COVID-19 lead to an increased burden for Nephrologists due to increased AKI prevalence: a nephrological follow-up is needed to avoid progression from AKI to chronic kidney disease (CKD).
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Background: COVID-19 is a systemic viral disease currently spreading as a pandemic. A more severe course and prognosis of COVID-19 in systemic lupus erythematosus (SLE) and vasculitis has been reported (1). Several papers have focused on the concerns, healthcare-related behaviors and psychological impact of COVID-19 pandemic among patients with rheumatic diseases, and specifically on SLE patients, showing a trend towards remarkable psychological distress (2-4). To date, no investigation on the psychological effects of quarantine strategy on SLE patients has been carried out. Objectives: To investigate the psychological impact of the lockdown measures adopted in Italy to contrasting the COVID-19 outbreak, on patients with SLE as compared to the general population. Methods: Patients affected by SLE were given an online questionnaire focused on psychological impact and self-perception during the lockdown measures contrasting the COVID-19 outbreak. The survey was focused on COVID-19 concerns, emotional impact, self-perception and changes in daily living activities and relationships. Results were compared with those of PRESTO (imPact of quaRantine mEasures againST cOvid19) project, an Italian survey, which used the same questionnaire, directed to the general population, with or without chronic diseases. A propensity matching procedure has been applied to LEPRE (Lupus Erythematosus PRESTO project) cases and the PRESTO responders with a ratio of 2 versus 1. Results: 64 patients and 1114 unselected people completed the survey. After the matching procedure, patients were compared to 128 matched adults. Missing data were below 6%. The median age among patients was 43 years (I-III interquartile range 35-54.5), 88% were female and 100% Caucasian. The SLE subjects live mainly in detached houses (38/64 vs 348/1114, p<0.0001), having access to a private garden (52/64 vs 625/1112, p<0.0001) and also owning a pet (43/64 vs 508/1114, p<0.001), in comparison with the PRESTO sample living mainly in flats. The psychological impact measured by IES-R, GHQ.12, and CEDS scores were not statistically different between patients and the general population, such as globally COVID-19 concerns and feelings. However, patients perceived more difficulty to find some free time and enjoy it (13/60 vs 48/121, p=0.01) and to be able to solve own problems (47/61 vs 71/120, p=0.02). On the contrary, patients felt more able to cope with the problem and less sad or depressed in comparison with the PRESTO group (17/61 vs 13/120, p=0.003). Moreover, patients missed playing sports/exercise less than general population (12/63 vs 46/128, p=0.02), while they felt more the distance from family and relatives (45/63 vs 42/86, p<0.0001). Conclusion: the COVID-19 pandemic didn't unveil a greater psychological fragility of people living with SLE than the others. By contrast, a coping strategy, including the role of the family and the lifestyle, contributes to resilience of SLE in difficult scenarios such as those presented by the pandemic.
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BACKGROUND: Investigations demonstrated a decrease of admissions for myocardial infarction (MI) during the CoronaVirus Disease-19 (COVID-19) outbreak. No study has evaluated the time required to reverse this downward curve of MI admissions. METHODS: This is a retrospective analysis on patients (N = 2415) admitted to the Emergency Departments for acute MI in nine Italian centers. Primary endpoint was the incidence rates (IRs) of MI admissions in the post-lockdown COVID-19 period (case-period: from May 4 to July 12, 2020) vs. the following control periods: January 1-February 19, 2020 (pre-lockdown period);February 20-May 3, 2020 (intra-lockdown period);May 4-July 12, 2019 (inter-year non-COVID-19 period). RESULTS: IR of admissions for MI in the post-lockdown period was higher than the intra-lockdown period (IR ratio, IRR: 1.60, 95% CI 1.42-1.81;p = 0.0001), was lower than the pre-lockdown period (IRR: 0.86, 0.77-0.96;p = 0.009) and similar to the inter-year non-COVID-19 period (IRR: 0.96, 0.87-1.07;p = 0.47). Within the case period, the increase in MI admissions was more pronounced in earlier vs later weeks (IRR 1.19, 95% CI 1.02-1.38, p = 0.024) and, compared to the inter-year control period, was significant for non ST-segment elevation MI (IRR: 1.25, 95% CI 1.08-1.46, p = 0.004), but was not observed for ST-segment elevation MI (STEMI), where hospitalizations were reduced (IRR 0.76, 95% CI 0.65-0.88, p = 0.0001). CONCLUSIONS: Our study first indicates an increase in the number of admissions for MI after the removal of the national lockdown for COVID-19 in Italy. This increase was prevalent in the first weeks following the lockdown removal, but was under-represented in STEMI patients.