Variations of the quality of care during the COVID-19 pandemic affected the mortality rate of non-COVID patients with hip fracture (preprint)

Introduction. As COVID-19 roared through the world, governments worldwide enforced containment measures that affected various treatment pathways, including those for hip fracture (HF). This study aimed to measure process and outcome indicators related to the quality of care provided to non-COVID-19 elderly patients affected by HF in Emilia-Romagna, a region of Italy severely hit by the pandemic. Methods. We collected the hospital discharge records of all patients admitted to the hospitals of Emilia-Romagna with a diagnosis of HF from January to May in the years 2019/2020. We analyzed surgery rate, surgery timeliness, length of hospital stay, timely rehabilitation, and 30-day mortality for each HF patient. We evaluated monthly data (2020 vs. 2019) with the chi-square and t-test, where appropriate. Logistic regression was used to investigate the differences in 30-day mortality. Results. Our study included 5379 patients with HF. In April and May 2020, there was a significant increase in the proportion of HF patients that did not undergo timely surgery. In March 2020, we found a significant increase in mortality (OR = 2.22). Female sex (OR = 0.52), age [≥]90 years (OR = 4.33), surgery after 48 hours (OR = 3.08) and not receiving surgery (OR = 6.19) were significantly associated with increased mortality. After adjusting for the aforementioned factors, patients hospitalized in March 2020 still suffered higher mortality (OR = 2.21). Conclusions. Our results show a reduction in the overall quality of care provided to non-COVID-19 elderly patients affected by HF. The mortality rate of patients with HF increased significantly in March 2020. Patients' characteristics and variations in processes of care partially explained this increase. Our analysis reveals the importance of including process and outcomes indicators, for both acute and post-acute care management issues, in emergency preparedness plans, to monitor healthcare systems' capacities and capabilities.

COVID-19 and regional differences in the timeliness of hip-fracture surgery: an interrupted time-series analysis (preprint)

Background. It is of great importance to examine the impact of the healthcare reorganization adopted to confront the COVID19 pandemic on the quality of care provided by healthcare systems to non COVID 19 patients. The aim of this study is to assess the impact of the COVID19 national lockdown (March 9, 2020) on the quality of care provided to patients with hip fracture (HF) in Piedmont and Emilia-Romagna, 2 large regions of northern Italy severely hit by the pandemic. Methods. We calculated the percentage of HF patients undergoing surgery within 2 days of hospital admission. An interrupted time-series analysis was performed on weekly data from December 11, 2019 to June 9, 2020 (6 months), interrupting the series in the 2nd week of March. The same data observed the year before were included as a control time series with no intervention (lockdown) in the middle of the observation period. Results. Before the lockdown, 2day surgery was 69.9% in Piedmont and 79.2% in Emilia-Romagna; after the lockdown, these proportions were equal to 69.8% (-0.1%) and 69.3% (-9.9%), respectively. While Piedmont did not experience any drop in the amount of surgery, Emilia-Romagna exhibited a significantly decline at a weekly rate of -1.29% (95% CI = -1.71 to -0.88). Divergent trend patterns in the 2 study regions reflect local differences in pandemic timing as well as in healthcare services capacity, management, and emergency preparedness.

ROCCA study protocol and interim analysis on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino: an observational study using active surveillance (preprint)

OBJECTIVE To assess the safety of the Sputnik V (Gam-COVID-Vac) COVID-19 vaccine through participant-based active surveillance from the Republic of San Marino vaccination campaign. DESIGN AND SETTING This is a nation-wide cohort study in the Republic of San Marino to monitor any Adverse Events Following Immunisation (AEFI) with the Sputnik V. PARTICIPANTS Adults aged 18-89 years who had at least one dose of Sputnik V administered and who responded or accessed to an e-questionnaire sent via email, QR-code or were live/phone interviewed about the 7 days after the first vaccine dose (n=2,558) and 7 days after the second dose (n=1,288). Exclusion criteria were inability to understand nor to answer the questionnaire properly. MAIN OUTCOME MEASURES Rates of overall AEFI short-term and long-term (3 months). Secondary outcomes focus on subgroups of the population presenting specific comorbidities. Being this an interim analysis, long-term data (3 months) is still being collected, especially for vulnerable populations, including subjects with comorbidities and the youngest age groups. RESULT The median age of participants was 68 years. 56% were females. After the first dose, vaccine recipients described both local and systemic reactions in 16.4% of cases, 25.8% reported systemic reactions only, and 10.2% reported local symptoms only. After the second dose, both local and systemic reactions were reported in 31.9% of cases, 18.5% reported systemic reactions only, and 16.1% reported local symptoms only. Main symptoms were local pain (24.8% for first dose and 43.8% for the second), asthenia (23.8% and 31.9%), headache (18.5% and 21.0%), and joint pain (16.5% and 21.9%). In the population over 60, recipients having reported AEFI after the first dose could be a predictor of AEFI recurrence after the second dose (p<0.001). 81.8% of those reporting second-dose AEFI, reported AEFI after the first dose, while amongst those not having reported any AEFI after the first dose, 18.2% reported AEFI after the second dose. CONCLUSION The ROCCA interim analysis confirmed a good tolerability profile in the over 60 years age group after both doses regarding short-term solicited AEFI to Sputnik V (Gam-COVID-Vac).

Influence of sex on disease severity in children with COVID-19 and Multisystem Inflammatory Syndrome in Latin America (preprint)

Data from adult studies how that COVID-19 is more severe in men than women. However, no data are available for the pediatric population. For this reason, we performed this study aiming to understand if sex influenced disease severity and outcomes in a large cohort of latin-american children with COVID-19 and Multisystem Inflammatory Syndrome (MIS-C). We found that a higher percentage of male children developed MIS-C (8.9% vs 5% in females) and died (1.2% and 0.4% in females), although on multivariate adjusted analyses the only statistically significant difference was found in need of hospitalization, with females less frequently admitted compared with boys (25.6% vs 35.4%). This data are preliminary and need further independent studies to better assess the role of sex.

Antibiotic prescriptions in children with COVID-19 and Multisystem Inflammatory Syndrome: a multinational experience in 990 cases from Latin America (preprint)

BackgroundTo date, there are no comprehensive data on antibiotic use in children with COVID-19 and Multisystem Inflammatory Syndrome (MIS-C). MethodsMulticenter cohort study from 5 Latin American countries. Children 17 years of age or younger with microbiologically confirmed SARS-CoV-2 infection or fulfilling MIS-C definition were included. Antibiotic prescriptions were collected and factors associated with their use were calculated. Findings990 children were included, with a median age of 3 years (interquartile range 1-9). Of these, 69 (7.0%) were diagnosed with MIS-C. The prevalence of antibiotic use was 24.5% (n = 243). MIS-C with (OR = 45.48) or without (OR = 10.35) cardiac involvement, provision of intensive care (OR = 9.60), need for hospital care (OR = 6.87), pneumonia and/or ARDS detected through chest X-rays (OR = 4.40), administration of systemic corticosteroids (OR = 4.39), oxygen support, mechanical ventilation or CPAP (OR = 2.21), pyrexia (OR = 1.84), and female sex (OR = 1.50) were independently associated with increased use of antibiotics. On the contrary, lower respiratory tract infections without radiologic evidence of pneumonia/ARDS and not requiring respiratory support (OR = 0.34) were independently associated with decreased use of antibiotics. There was significant variation in antibiotic use across the hospitals. ConclusionsOur study showed a relatively high rate of antibiotic prescriptions in children with COVID-19 and in particular in those with severe disease or MIS-C. Importantly, we found a significant variation in reasons for prescriptions of antibiotics and type of chosen therapies, as well in hospital practices, highlighting current uncertainties and lack of guidelines for the recognition of bacterial infections in children with COVID-19. Prospective studies are needed to provide better evidence on the recognition and management of bacterial infections in COVID-19 children. What is knownCOVID-19 may worsen antibiotic prescription practices What this newCOVID-19 and MIS-C children frequently received antibiotics There was a wide variation in antibiotic prescriptions among institutions, highlighting the lack of practicle guidelines in the use of antibiotics in children with COVID-19

Forecasting COVID-19-Associated Hospitalizations under Different Levels of Social Distancing in Lombardy and Emilia-Romagna, Northern Italy: Results from an Extended SEIR Compartmental Model (preprint)

The outbreak of coronavirus disease 2019 (COVID-19) was identified in Wuhan, China, in December 2019. As of April 17, 2020, more than 2 million cases of COVID-19 have been reported worldwide. Northern Italy is one of the world’s centers of active coronavirus cases. In this study, we predicted the spread of COVID-19 and its burden on hospital care under different conditions of social distancing in Lombardy and Emilia-Romagna, the two regions of Italy most affected by the epidemic. To do this, we used a Susceptible-Exposed-Infectious-Recovered (SEIR) deterministic model, which encompasses compartments relevant to public health interventions such as quarantine. A new compartment L was added to the model for isolated infected population, i.e., individuals tested positives that do not need hospital care. We found that in Lombardy restrictive containment measures should be prolonged at least until early July to avoid a resurgence of hospitalizations; on the other hand, in Emilia-Romagna the number of hospitalized cases could be kept under a reasonable amount with a higher contact rate. Our results suggest that territory-specific forecasts under different scenarios are crucial to enhance or take new containment measures during the epidemic.