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2020 will be remembered worldwide as the year of COVID-19 outbreak. The onset of this pandemic abruptly changed everybody's life and, in a particular manner, doctors' lives. Our hand surgery department became rapidly one of the first COVID-19-specialized wards in Italy, impacting considerably the authors' routines and activities. In this paper, the authors focus on how the demographics of patients with hand trauma changed and how they had to modify their activity. The authors retrospectively took into consideration all patients reaching their emergency department (ED) with hand trauma between 9 March 2020 (the day of the beginning of the first lockdown in Italy) and 8 March 2021 and compared them to those who reached the ED in the three previous years. Authors have analyzed the number of patients, their gender and age, the severity of their trauma, where the trauma occurred, the type of lesion, the percentage of patients who underwent surgery, and the percentage of patients who had an emergency admission. In the last year, the number of patients reaching the ED for a hand trauma has been reduced by two thirds (975 patients during the past year), the mean age of those patients has slightly increased, the severity of cases has increased, places of trauma and type of lesions have changed, and, lastly, the percentage of patients needing surgery who were admitted immediately has increased. This paper shows how the type of patients reaching the ED changed and discusses how surgeons evolved and modified their habits in treating those patients during the first lockdown and the year that followed. [ABSTRACT FROM AUTHOR]

Background: The coronavirus disease 2019 (COVID-19) pandemic has found the whole world unprepared for its correct management. Italy was the first European country to experience the spread of the SARS-CoV-2 virus at the end of February 2020. As a result of hospital overcrowding, the quality of care delivered was not always optimal. A substantial number of patients admitted to non-ICU units could have been treated at home. It would have been extremely useful to have a score that, based on personal and clinical characteristics and simple blood tests, could have predicted with sufficient reliability the probability that a patient had or did not have a disease that could have led to their death. This study aims to develop a scoring system to identify which patients with COVID-19 are at high mortality risk upon hospital admission, to expedite and enhance clinical decision making. Methods: A retrospective analysis was performed to develop a multivariable prognostic prediction model. Results: Derivation and external validation cohorts were obtained from two Italian University Hospital databases, including 388 (10.31% deceased) and 1357 (7.68% deceased) patients with confirmed COVID-19, respectively. A multivariable logistic model was used to select seven variables associated with in-hospital death (age, baseline oxygen saturation, hemoglobin value, white blood cell count, percentage of neutrophils, platelet count, and creatinine value). Calibration and discrimination were satisfactory with a cumulative AUC for prediction mortality of 0.924 (95% CI: 0.893–0.944) in derivation cohorts and 0.808 (95% CI: 0.886–0.828) in external validation cohorts. The risk score obtained was compared with the ISARIC 4C Mortality Score, and with all the other most important scores considered so far, to evaluate the risk of death of patients with COVID-19. It performed better than all the above scores to evaluate the predictability of dying. Its sensitivity, specificity, and AUC were higher than the other COVID-19 scoring systems when the latter were calculated for the 388 patients in our derivation cohort. Conclusions: In conclusion, the CZ-COVID-19 Score may help all physicians by identifying those COVID-19 patients who require more attention to provide better therapeutic regimens or, on the contrary, by identifying those patients for whom hospitalization is not necessary and who could therefore be sent home without overcrowding healthcare facilities. We developed and validated a new risk score based on seven variables for upon-hospital admission of COVID-19 patients. It is very simple to calculate and performs better than all the other similar scores to evaluate the predictability of dying. [ABSTRACT FROM AUTHOR]

Myasthenia gravis (MG) is the most common neuromuscular junction disorder. We evaluated the MG incidence rate in the province of Ferrara, Northern Italy, over two time frames (2008–2018 and 2019–2022, i.e., the COVID-19 pandemic) and considered early-onset (EOMG), late-onset (LOMG), and thymoma- and non-thymoma-associated MG. Moreover, in the second period, we assessed its possible relationship with SARS-CoV-2 infection or COVID-19 vaccination. We used a complete enumeration approach to estimate the MG incidence and its temporal trend. For the period of 2008–18, 106 new cases were identified (mean incidence rate 2.7/100,000 people). The highest rates were observed for the over-70 age group and in rural areas, with 17% of thymoma-associated MG. During the COVID-19 period, 29 new cases were identified (average incidence rate 2.1/100,000 people), showing a marked (though not statistically significant) decrease in the mean annual incidence compared to the previous period. Again, the highest rate was observed for the over-70 age group. The first period was in line with our previous observations for the period between 1985 and 2007, highlighting a rising incidence of LOMG and a marked decrease in EOMG. During the COVID-19 period, incidence rates were lower in the first years whereas, when the pandemic ended, the previous trend was confirmed. [ABSTRACT FROM AUTHOR]

Vitamin D (VitD) is largely used in Italy, often inappropriately; thus, an evaluation of its safety is a crucial issue. This study analyses the adverse reactions (ARs) associated with the use of products containing VitD (VitDps) reported to the Italian National Pharmacovigilance and Phytovigilance networks. From March 2002 to August 2022, a total of 643 and 127 reports concerning 903 and 215 ARs were retrieved from Pharmacovigilance and Phytovigilance networks, respectively. Overall, 332 (29.6%) ARs were classified as serious, and the most described ones were hypercalcaemia, renal failure and tachycardia. Serious AR risk was significantly higher for subjects using more than four concomitant products (OR 2.44 [95% CI 1.30–4.60]) and VitD doses higher than 1000 IU/day (OR 2.70 [95% CI 1.30–5.64]). In Italy, there was a modest decrease in AR reporting, despite the slightly increased use of VitD during the COVID-19 pandemic. To the best of our knowledge, this is the first study describing all VitDps-related ARs observed in the Italian general population. Since underreporting is the main limitation of the safety reporting systems, the necessity to continue ARs monitoring, also using real-world data on VitDps prescription, use and outcome patterns is highlighted. [ABSTRACT FROM AUTHOR]

Background. Evidence has shown a close association between COVID-19 infection and renal complications in both individuals with previously normal renal function and those with chronic kidney disease (CKD). Methods. The aim of this study is to evaluate the in-hospital mortality of SARS-CoV-2 patients according to their clinical history of CKD or estimated glomerular filtration rate (eGFR). This is a prospective multicenter observational cohort study which involved adult patients (≥18 years old) who tested positive with SARS-CoV-2 infection and completed their hospitalization in the period between November 2020 and June 2021. Results. 1246 patients were included in the study, with a mean age of 64 years (SD 14.6) and a median duration of hospitalization of 15 days (IQR 9–22 days). Cox's multivariable regression model revealed that mortality risk was strongly associated with the stage of renal impairment and the Kaplan–Meier survival analysis showed a progressive and statistically significant difference (p < 0.0001) in mortality according to the stage of CKD. Conclusion. This study further validates the association between CKD stage at admission and mortality in patients hospitalized for COVID-19. The risk stratification based on eGFR allows clinicians to identify the subjects with the highest risk of intra-hospital mortality despite the duration of hospitalization. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular sequelae after COVID-19 are frequent. However, the predictors for their occurrence are still unknown. In this study, we aimed to assess whether myocardial injury during COVID-19 hospitalization is associated to CV sequelae and death after hospital discharge. Methods: In this prospective observational study, consecutive patients who were admitted for COVID-19 in a metropolitan COVID-19 hub in Italy, between March 2021 and January 2022, with a ≥ 1 assessment of high sensitivity cardiac troponin I (hs-cTnI) were included in the study, if they were alive at hospital discharge. Myocardial injury was defined as elevation hs-cTnI > 99th percentile of the upper reference limit. The incidence of all-cause mortality and major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, admission for acute or chronic coronary syndrome, hospitalization for heart failure, and stroke/transient ischemic attack) at follow-up were the primary outcomes. Arrhythmias, inflammatory heart diseases, and/or thrombotic disorders were analyzed as well. Results: Among the 701 COVID-19 survivors (mean age 66.4 ± 14.4 years, 40.2% female), myocardial injury occurred in 75 (10.7%) patients. At a median follow-up of 270 days (IQR 165, 380), all-cause mortality (21.3% vs. 6.1%, p < 0.001), MACCE (25.3% vs. 4.5%, p < 0.001), arrhythmias (9.3% vs. 5.0%, p = 0.034), and inflammatory heart disease (8.0% vs. 1.1%, p < 0.001) were more frequent in patients with myocardial injury compared to those without. At multivariate analysis, myocardial injury (HR 1.95 [95% CI:1.05–3.61]), age (HR 1.09 [95% CI:1.06–1.12]), and chronic kidney disease (HR 2.63 [95% CI:1.33–5.21]) were independent predictors of death. Myocardial injury (HR 3.92 [95% CI:2.07–7.42]), age (HR 1.05 [95% CI:1.02–1.08]), and diabetes (HR 2.35 [95% CI:1.25–4.43]) were independent predictors of MACCE. Conclusion: In COVID-19 survivors, myocardial injury during the hospital stay portends a higher risk of mortality and cardiovascular sequelae and could be considered for the risk stratification of COVID-19 sequelae in patients who are successfully discharged. [ABSTRACT FROM AUTHOR]

This study aimed to explore the impact of the pandemic on medical students' mental health in Italy using a repeated cross-sectional survey with a nested longitudinal subsample (first timepoint: 2018; second: 2020/2021). Three research questions (RQs) were investigated. Study 1 (longitudinal sub-sample) explored whether medical students had higher levels of depressive symptoms and stress during the pandemic compared with a pre-pandemic period (RQ1) and what variables were associated with these conditions during the pandemic adjusting for baseline levels (RQ2). Study 2 (repeated cross-sectional data) aimed to examine whether medical students had higher levels of these conditions during the pandemic compared with their same-year peers during a pre-pandemic period (RQ3). In Study 1, higher levels of depressive symptoms and stress were shown during the pandemic (RQ1). Multivariable models highlighted associations between poor mental health and worsening of the judgment of medical school choice, worsened psychological condition due to the pandemic, economic repercussions due to the pandemic, and baseline levels of symptoms (RQ2). In Study 2, our findings reported higher levels of depressive symptoms and stress during the pandemic, also adjusting for other variables (RQ3). In conclusion, depressive symptoms and stress were greater during the pandemic. The most relevant variables were pandemic-related items and medical school choice judgment. [ABSTRACT FROM AUTHOR]

Italy was the first Western country to face a massive SARS-CoV-2 outbreak. The limited information initially available on the natural course of the disease required caution in the discharge of patients accessing health facilities. This resulted in overcrowded health facilities and emergency services. In this context, improvements of other forms of hospital care assistance were needed. This study shows the results of the first Italian remote monitoring program for COVID-19 patients. The program was implemented by the Azienda Socio Sanitaria (ASST) Lodi (Italy) by using the innovative Zcare software®. Data generated during patient recruitment, monitoring, and discharge were extracted from the Zcare software and statistically analysed. Data refer to a sample of 1196 patients enrolled in the remote monitoring program in 2020. Patients reported symptoms mainly during the first week. The most frequently reported symptoms were general fatigue, cough, and loss of taste and smell (dysosmia). More than 80% of patients reported a saturation level below 96% at least once, and more than 70% had a temperature above 37 °C. Active monitoring of reported symptoms provided valuable insights into the disease's natural history during its less severe acute phase. Only 109 individuals visited the emergency department at least once in the first 100 days of monitoring. Of these, 101 had COVID-19 infection, 69 of whom were hospitalized following a first clinical assessment at the emergency department. The ASST Lodi's telemedicine strategy for COVID patients appears to be a viable alternative to hospitalization. This strategy enables the provision of proper care while making resources available for more critically ill patients, and enhances the availability of resources available for more critically ill patients. [ABSTRACT FROM AUTHOR]

At the very beginning of the European spread of SARS-CoV-2, Piedmont was one of the most affected regions in Italy, with a strong impact on healthcare organizations. In this study, we evaluated the characteristics and outcomes of the COVID-19 patients in an entire region during the first three pandemic waves, identifying similarities and differences in the SARS-CoV-2 epidemic's timeline. We collected the health-administrative data of all the Piedmont COVID-19 patients infected during the first three pandemic waves (1 March 2020–15 April 2020; 15 October 2020–15 December 2020; 1 March 2021–15 April 2021, respectively). We compared differences among the waves in subjects positive for SARS-CoV-2 and in patients admitted to ICU. Overall, 18.621 subjects tested positive during the first wave (405 patients/day), 144.350 (2366.4 patients/day) in the second, and 81.823 (1778.8 patients/day) in the third. In the second and third waves, we observed a reduction in median age, comorbidity burden, mortality in outpatients, inpatients, and patients admitted to ICU, in intubation, invasive ventilation and tracheostomy, and a parallel increase in the use of CPAP. Our study confirmed a trend towards younger and healthier patients over time but also showed an independent effect of the period on mortality and ICU admission. The appearance of new viral variants, the starting of vaccination, and organizational improvements in tracking, outpatients and inpatients management could have influenced these trends. [ABSTRACT FROM AUTHOR]

The relationship between skeletal muscle mass at the beginning of the post-acute rehabilitation phase and rehabilitation outcomes has been scarcely investigated. The aim of this study was to investigate the impact of the existence of sarcopenia upon admission to a post-acute COVID-19 patient rehabilitation unit on body composition and functional and respiratory capacity at discharge. Thirty-four post-acute COVID-19 patients were referred to our Rehabilitation Unit from different COVID Hospitals in northern Italy. Body weight loss, body composition, handgrip strength, functional parameters, oxygen saturation and related perception of dyspnea in several positions were measured before and after a 28-day multidisciplinary rehabilitation program. Spirometry was performed only upon admission. The intervention included psychiatric support, cognitive behavioral therapy, nutritional therapy and physiotherapy, including aerobic and resistance training. Training volume was 45 min/session, 6 sessions/week. Upon admission, the prevalence of sarcopenia among our patients was 58%. In all of the 34 patients, we observed a trend of improvement in all of the respiratory, body composition, muscle strength and functional parameters considered. Monitoring muscle mass and strength in post-acute COVID-19 patients appears to be a key predictor of rehabilitation outcomes. Early diagnosis of sarcopenia therefore appears to be of paramount importance in the management of post-acute COVID-19 patients. [ABSTRACT FROM AUTHOR]

The Pfizer/BioNtech Comirnaty vaccine (BNT162b2 mRNA COVID-19) against SARS-CoV-2 is currently in use in Italy. Antibodies to evaluate SARS-CoV-2 infection prior to administration are not routinely tested; therefore, two doses may be administered to asymptomatic previously exposed subjects. The aim of this study is to assess if any difference in antibody concentration between subjects exposed and not exposed to SARS-CoV-2 prior to BNT162b2 was present after the first dose and after the second dose of vaccine. Data were retrospectively collected from the clinical documentation of 337 healthcare workers who underwent SARS-CoV-2 testing before and after BNT162b2. Total anti RBD (receptor-binding domain) antibodies against SARS-CoV-2′s spike protein were measured before and 21 days after the first dose, and 12 days after the second dose of BNT162b2. Twenty-one days after the first dose, there was a statistically significant difference in antibody concentration between the two groups, which was also maintained twelve days after the second dose. In conclusion, antibody response after receiving BNT162b2 is greater in subjects who have been previously exposed to SARS-CoV-2 than in subjects who have not been previously exposed to the virus, both after 21 days after the first dose and after 12 days from the second dose. Antibody levels, 21 days after the first dose, reached a titer considered positive by the test manufacturer in the majority of subjects who have been previously infected with SARS-CoV-2. Evaluating previous infection prior to vaccination in order to give the least effective number of doses should be considered. [ABSTRACT FROM AUTHOR]

Background: CORACLE is a retrospective and prospective, regional multicenter registry, developed to evaluate risk factors for mortality in a cohort of patients admitted with SARS-CoV-2 infection within non-intensive wards. Methods: The primary objective was to estimate the role of several prognostic factors on hospital mortality in terms of adjusted Odds Ratios (aOR) with multivariable logistic regression models. Results: A total of 1538 patients were enrolled; 42% were female, and 58% were >70 years old. Deceased patients were 422 (27%), with a median age of 83 years (IQR (Inter Quartile Range) 76–87). Older age at admission (aOR 1.07 per year, 95%CI 1.06–1.09), diabetes (1.41, 1.02–1.94), cardiovascular disease (1.79, 1.31–2.44), immunosuppression (1.65, 1.04–2.62), estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (3.53, 2.26–5.51), higher C-reactive protein values and a decreased PaO2/FiO2 ratio at admission were associated with a higher risk of hospital mortality. Amongst patients still alive on day 7, only hydroxychloroquine (HCQ) treatment was associated with reduced mortality (0.57, 0.36–0.90). Conclusions: Several risk factors were associated with mortality in SARS-CoV-2 positive patients. Although HCQ seems to be the only factor significantly associated with reduced mortality, this result is in contrast with evidence from randomized studies. These results should be interpreted in light of the study limitations. [ABSTRACT FROM AUTHOR]

Early reports from Asia suggested that increased serum levels of the muscular enzyme creatine-(phospho)-kinase (CK/CPK) could be associated with a more severe prognosis in COVID-19. The aim of this single-center retrospective cohort study of 331 consecutive COVID-19 patients who were hospitalized during Italy's "first wave" was to verify this relationship, and to evaluate the role of possible confounding factors (age, body mass index, gender, and comorbidities). We subdivided our cohort in two groups, based on "severe" (n = 99) or "mild" (n = 232) outcomes. "Severe" disease is defined here as death and/or mechanical invasive ventilation, in contrast to "mild" patients, who were discharged alive with no need for invasive ventilation; this latter group could also include those patients who were treated with non-invasive ventilation. The CK levels at admission were higher in those subjects who later experienced more severe outcomes (median, 126; range, 10–1672 U/L, versus median, 82; range, 12–1499 U/L, p = 0.01), and hyperCKemia >200 U/L was associated with a worse prognosis. Regression analysis confirmed that increased CK acted as an independent predictor for a "severe" outcome. HyperCKemia was generally transient, returning to normal during hospitalization in the majority of both "severe" and "mild" patients. Although the direct infection of voluntary muscle is unproven, transient muscular dysfunction is common during the course of COVID-19. The influence of this novel coronavirus on voluntary muscle really needs to be clarified. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic that has hit the world in the year 2020 has put a strain on our ability to cope with events and revolutionized our daily habits. On 9 March, Italy was forced to lockdown to prevent the spread of the infection, with measures including the mandatory closure of schools and nonessential activities, travel restrictions, and the obligation to spend entire weeks in the same physical space. The aim of this study was to assess the impact of the COVID-19 pandemic and lockdown measures on quality of life (QoL) in a large Italian sample, in order to investigate possible differences in QoL levels related to both demographic and pandemic-specific variables. A total of 2251 Italian adults (1665 women, mainly young and middle adults) were recruited via a snowball sampling strategy. Participants were requested to answer to an online survey, which included demographic and COVID-related information items, and the World Health Organization Quality of Life BREF questionnaire (WHOQOL-BREF). The results showed statistically significant differences in QoL depending on a number of variables, including sex, area of residence in Italy, and being diagnosed with a medical/psychiatric condition. To our knowledge, this is the first study to assess QoL during COVID-19 pandemic in Italy, therefore the present findings can offer guidelines regarding which social groups are more vulnerable of a decline in QoL and would benefit of psychological interventions. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic represents a major stressor for the psychological health of people worldwide. In the UK, the COVID19-Psychological Research Consortium Study (C19PRC) launched to evaluate the psychological impact of COVID-19 in the general population and its implications. The project was then extended to Italy and several other countries. This article provides an overview of the Italian C19PRC study and its replication of two specific findings from the UK C19PRC. In the first part, the relationship between anxiety and somatic symptomatology is examined. In the second part, we analyze the association between several factors and psychological health outcomes: depression/anxiety, traumatic stress, COVID-19 anxiety. In line with the study conducted in the UK, an online survey was administered to the adult Italian general population. The sample included 1038 respondents (age, mean = 49.94, SD = 16.14, 51.15% females) taken from four regions: Lombardia, Veneto, Lazio, and Campania. The relationship between predictors and outcomes was evaluated by means of logistic regression models. Somatic indices showed a positive association with anxiety, worse somatic symptoms were associated with mourning a loss of a beloved one due to COVID-19 and with precarious health conditions. Females showed a higher incidence of psychological issues. No differences in anxiety, depression, and traumatic stress were found across regions but the Campania region showed the most severe somatic symptomatology. In the second analysis, the factors associated with more severe psychological outcomes (i.e., anxiety and/or depression, traumatic stress, and COVID-19 related anxiety) were younger age, the presence of minors in the household, traumatic stressors, and precarious health conditions. No differences across regions emerged. The Italian results correspond to the UK findings for anxiety, depression, and traumatic stress. Both in the UK and Italy, the factors associated with worse psychological health were gender (female), younger age, having children, pre-existing health issues (both for oneself or someone close), and the moderate/high perceived risk of contracting COVID-19 within one month. In Italy, unlike the UK, lower household income and having (had) COVID-19 were not associated with poorer mental health. The psychological impact of COVID-19 can last for months; future research should explore all aspects of the psychological burden of COVID-19 in order to implement psychological interventions and promote psychological health. [ABSTRACT FROM AUTHOR]

Since the World Health Organization declared the novel coronavirus outbreak a global health emergency, Italy's lockdown was declared on 9 March 2020. Elective orthopedic surgery was forced to stop to allow the healthcare system to face the emergency. However, many orthopedic oncology cases could not be postponed. The aim of this study was to report the experience in managing sarcoma patients and the reorganization of a cancer center in an attempt to maintain it free from COVID-19. A Coronavirus Crisis Unit was established by the health directorate coordination in order to adopt specific procedures. General rules of screening and social distancing were applied in different health settings (entrance check point, hospital inward, outpatient clinic, operative room). Regarding oncologic orthopedics, priority was given to bone and soft tissue sarcomas, metastases and aggressive benign tumors at risk of impending or pathologic fracture. Precise indications were followed to manage first outpatient visits, patients undergoing surgery and follow-up. Meticulous adherence to rules among patients and personnel and collaboration between leadership and medical staff in order to continue to perform multidisciplinary treatment protocols, maintain the availability of infrastructural spaces and source protective equipment, swabs and screening samples have been successful in the aim towards a safe cure for cancer patients. [ABSTRACT FROM AUTHOR]

We statistically investigate the Coronavirus Disease 19 (COVID-19) pandemic, which became particularly invasive in Italy in March 2020. We show that the high apparent lethality or case fatality ratio (CFR) observed in Italy, as compared with other countries, is likely biased by a strong underestimation of the number of infection cases. To give a more realistic estimate of the lethality of COVID-19, we use the actual (March 2020) estimates of the infection fatality ratio (IFR) of the pandemic based on the minimum observed CFR and analyze data obtained from the Diamond Princess cruise ship, a good representation of a "laboratory" case-study from an isolated system in which all the people have been tested. From such analyses, we derive more realistic estimates of the real extent of the infection as well as more accurate indicators of how fast the infection propagates. We then isolate the dominant factors causing the abnormal severity of the disease in Italy. Finally, we use the death count—the only data estimated to be reliable enough—to predict the total number of people infected and the interval of time when the infection in Italy could end. [ABSTRACT FROM AUTHOR]

The present work develops an accurate prediction model of the COVID-19 pandemic, capable not only of fitting data with a high regression coefficient but also to predict the overall infections and the infection peak day as well. The model is based on the Verhulst equation, which has been used to fit the data of the COVID-19 spread in China, Italy, and Spain. This model has been used to predict both the infection peak day, and the total infected people in Italy and Spain. With this prediction model, the overall infections, the infection peak, and date can accurately be predicted one week before they occur. According to the study, the infection peak took place on 23 March in Italy, and on 29 March in Spain. Moreover, the influence of the total and partial lockdowns has been studied, without finding any meaningful difference in the disease spread. However, the infected population, and the rate of new infections at the start of the lockdown, seem to play an important role in the infection spread. The developed model is not only an important tool to predict the disease spread, but also gives some significant clues about the main factors that affect to the COVID-19 spread, and quantifies the effects of partial and total lockdowns as well. [ABSTRACT FROM AUTHOR]