COVID-19 Vaccine Refusal and Delay among Adults in Italy: Evidence from the OBVIOUS Project, a National Survey in Italy.

BACKGROUND: Vaccine hesitancy was defined by the World Health Organization (WHO) in 2019 as a major threat to global health. In Italy, reluctance to receive vaccines is a widespread phenomenon that was amplified during the COVID-19 pandemic by fear and mistrust in government. This study aims to depict different profiles and characteristics of people reluctant to vaccinate, focusing on the drivers of those who are in favor of and those who are opposed to receiving the COVID-19 vaccine. METHODS: A sample of 10,000 Italian residents was collected. A survey on COVID-19 vaccination behavior and possible determinants of vaccine uptake, delay, and refusal was administered to participants through a computer-assisted web interviewing method. RESULTS: In our sample, 83.2% stated that they were vaccinated as soon as possible ("vaccinators"), 8.0% delayed vaccination ("delayers"), and 6.7% refused to be vaccinated ("no-vaccinators"). In general, the results show that being female, aged between 25 and 64, with an education level less than a high school diploma or above a master's degree, and coming from a rural area were characteristics significantly associated with delaying or refusing COVID-19 vaccination. In addition, it was found that having minimal trust in science and/or government (i.e., 1 or 2 points on a scale from 1 to 10), using alternative medicine as the main source of treatment, and intention to vote for certain parties were characteristics associated with profiles of "delayers" or "no-vaccinators". Finally, the main reported motivation for delaying or not accepting vaccination was fear of vaccine side effects (55.0% among delayers, 55.6% among no-vaccinators). CONCLUSION: In this study, three main profiles of those who chose to be vaccinated are described. Since those who are in favor of vaccines and those who are not usually cluster in similar sociodemographic categories, we argue that findings from this study might be useful to policy makers when shaping vaccine strategies and choosing policy instruments.

Physical Well-Being of Children and Adolescents during the SARS-CoV-2 Pandemic: Findings from the "Come te la Passi?" Cross Sectional Survey in Bologna, Italy.

BACKGROUND: The COVID-19 had a strong impact on the physical and general well-being of the youngest. In Italy, citizens were forced to change their habits, especially during the national lockdown, causing increased levels of sedentary and unhealthy behaviors. "Come te la passi?" was a cross-sectional study aimed at investigating changes in the physical activity levels (PA) and well-being of children and adolescents in the City of Bologna. METHODS: An anonymous survey was administered to parents/guardians of children and adolescents aged 6-18 years. RESULTS: 1134 questionnaires were collected during June 2021; 457 (40.3%) were females, and the mean age was 13.0 ± 3.4 years. Regarding the general well-being perception, 61.3% of the participants reported concerns about the future, 46.3% reported sleep difficulties, and 72.8% reported experiencing attention difficulty, with higher percentages among adolescents. Considering the PA frequency, an overall reduction was found, with the percentage of those who rarely did PA and those who frequently did PA both increasing. No gender differences were found. CONCLUSIONS: Our findings suggest that the current pandemic has strongly impacted the well-being of children and adolescents. It appears to have primarily affected adolescents, with a significant reduction in PA levels, even after the end of the national lockdown.

Social Determinants of Health and Distance Learning in Italy in the Era of the SARS-CoV-2 Pandemic.

OBJECTIVES: To investigate the experiences by distance learning (DL) method during the first wave of the SARS-CoV-2 pandemic in Italy, and to search for correlations with purported experiences and respective levels of social determinants of health (SDH). STUDY DESIGN AND METHODS: Cross-sectional online survey, investigating various SDH and parents' attitude towards DL, proposed 6 months after the beginning of the pandemic to a sample population of parents with school-aged children throughout Italy. RESULTS: A total of 3791 questionnaires were analyzed. Non-Italian parents complained more frequently of difficulties in providing support to their children in DL due to poor digital skills (p = 0.01), lack of good-quality digital equipment (p = 0.01), problems with the Italian language (p < 0.001), and a lower level of education (p < 0.001). When parents lived apart, greater difficulties in concentration in children using DL (p = 0.05) and a lower parental capacity to support DL (p = 0.002) were reported. Adequate digital structures appeared related to living in owned compared to rented property, higher levels of parental education, and better familial financial situations. CONCLUSIONS: Students from families with financial difficulties and low levels of parental education, or even those living in houses for rent or having separated parents, may be disadvantaged in an educational context since the introduction of DL.

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

INTRODUCTION: As COVID-19 roared through the world, governments worldwide enforced containment measures that affected various treatment pathways, including those for hip fractures (HFs). 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 (pre-pandemic period) and 2020 (pandemic period). We analyzed surgery rate, surgery delays, 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). Male sex (OR = 1.92), 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: There was a reduction in the overall quality of care provided to non-COVID-19 elderly patients affected by HF, whose mortality increased in March 2020. Patients' characteristics and variations in processes of care partially explained this increase. Policymakers and professionals involved in the management of COVID-19 patients should be aware of the needs of patients with other health needs, which should be carefully investigated and included in future emergency preparedness and response plans.

ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance.

Background: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context. Methods: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021. Findings: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs. Interpretation: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac. Funding: None.

Social Determinants of Health and Distance Learning in Italy in the Era of the SARS-CoV-2 Pandemic

Objectives: To investigate the experiences by distance learning (DL) method during the first wave of the SARS-CoV-2 pandemic in Italy, and to search for correlations with purported experiences and respective levels of social determinants of health (SDH). Study design and methods: Cross-sectional online survey, investigating various SDH and parents’ attitude towards DL, proposed 6 months after the beginning of the pandemic to a sample population of parents with school-aged children throughout Italy. Results: A total of 3791 questionnaires were analyzed. Non-Italian parents complained more frequently of difficulties in providing support to their children in DL due to poor digital skills (p = 0.01), lack of good-quality digital equipment (p = 0.01), problems with the Italian language (p < 0.001), and a lower level of education (p < 0.001). When parents lived apart, greater difficulties in concentration in children using DL (p = 0.05) and a lower parental capacity to support DL (p = 0.002) were reported. Adequate digital structures appeared related to living in owned compared to rented property, higher levels of parental education, and better familial financial situations. Conclusions: Students from families with financial difficulties and low levels of parental education, or even those living in houses for rent or having separated parents, may be disadvantaged in an educational context since the introduction of DL.

Gam-COVID-Vac (Sputnik V) and Pfizer-BioNTech Vaccines Adverse Events following Immunization in Patients Affected by Parkinson's Disease and Multiple Sclerosis: A Longitudinal Study.

The Republic of San Marino COVID-19 vaccination campaign used Gam-COVID-Vac and Pfizer-BioNTech vaccines. To assess adverse events following immunization (AEFIs), approximately 6000 vaccine recipients were monitored by the ROCCA study, including subgroups with Parkinson's Disease (PD) and Multiple Sclerosis (MS). The purpose of this study is to evaluate short-term AEFIs through a 1-month follow-up. We conducted a longitudinal study, using active surveillance to evaluate the safety profiles of COVID-19 vaccines in PD and MS patients. Participants were actively administered a standardized online questionnaire to collect information on AEFIs. Among all PD and MS assisted by the San Marino hospital, a total of 82 patients completed the questionnaires. One week after administration of the first dose, vaccine recipients reported AEFIs in 26% of cases in the PD group, 67% in the MS group, and 68% in the control group. Participants reported slightly higher rates of AEFIs after dose 2 compared with dose 1, being 29%, 75%, and 78% for PD, MS, control group, respectively. Most of the reported symptoms were mild. Patients with PD and MS reported few AEFIs after administration of the COVID-19 vaccines. The frequency of AEFIs in the PD population was significantly lower than in the control group.

The Diagnostic Accuracy and Clinimetric Properties of Screening Instruments to Identify Frail Older Adults Attending Emergency Departments: A Protocol for a Mixed Methods Systematic Review and Meta-Analysis.

BACKGROUND: Prompt and efficient identification and stratification of patients who are frail is important, as this cohort are at high risk of adverse healthcare outcomes. Numerous frailty screening tools have been developed to support their identification across different settings, yet relatively few have emerged for use in emergency departments (EDs). This protocol provides details for a systematic review aiming to synthesize the accumulated evidence regarding the diagnostic accuracy and clinimetric properties of frailty screening instruments to identify frail older adults in EDs. METHODS: Six electronic databases will be searched from January 2000 to March 2021. Eligible studies will include adults aged ≥60 years screened in EDs with any available screening instrument to identify frailty (even if not originally designed for this purpose). Studies, including case-control, longitudinal, and cohort studies, will be included, where instruments are compared to a reference standard to explore diagnostic accuracy. Predictive accuracy for a selection of outcomes, including mortality, institutionalization, and readmission, will be assessed. Clinical and methodological heterogeneity will be examined, and a random effects meta-analysis performed if appropriate. CONCLUSION: Understanding whether frailty screening on presentation to EDs is accurate in identifying frailty, and predicting these outcomes is important for decision-making and targeting appropriate management.

The impact of health policies and vaccine rollout on the COVID-19 pandemic waves in Italy.

Background: Over the course of the COVID-19 pandemic in Italy, different response measures were taken to contain the spread of the virus. These include a variety of non-pharmaceutical interventions and a mass vaccination campaign. While not definitive, epidemiological measures provide some indication of the impact of such measures on the dynamics of the pandemic and lessons to better prepare for future emergencies. Objective: To describe the impact of vaccine rollout and health policies on the evolution of the COVID-19 pandemic in Italy from March 2020 to October 2021 using a set of epidemiological indicators. Methods: We performed a time-trend analysis of new confirmed COVID-19 cases, patients in hospital, and deaths. Using line charts, we informally assessed the relationship of these indicators with the immunization campaign and other health policies. Daily aggregate data were gathered from GitHub repositories of certified data from Italy's Government and Civil Protection. Results: The immunization coverage increased starting in March 2021, with a parallel decrease in COVID-19 infections, hospitalizations, and deaths. Despite different implementation approaches, the vaccine coverage growth rate had a similar pattern across regions. A comprehensive approach including measures such as requiring face masks and a "Green Pass" to enter indoor places also helped contain the pandemic. Conclusions: The vaccine rollout had a major effect on COVID-19 in Italy, especially on hospitalizations and deaths. Before the vaccine was available, however, other non-pharmaceutical interventions also helped to contain the spread of the virus and mitigate its effect on the population.

Effects of the SARS-CoV-2 pandemic on women affected by endometriosis: a large cross-sectional online survey.

INTRODUCTION: The SARS-CoV-2 pandemic has forced healthcare providers to reorganize their activities to protect the population from infection, postponing or suspending many medical procedures. Patients affected by chronic conditions were among the most affected. In the case of catastrophes, women have a higher lifetime prevalence of post-traumatic stress disorder (PTSD), and those with endometriosis have higher anxiety levels, making them fragile in such circumstances. MATERIALS AND METHODS: In this cross-sectional study, conducted in May 2020, we considered all women aged ≥18 years, followed up at our referral centre for endometriosis. Patients were sent an anonymous 6-section questionnaire via email, containing different validated tools for the evaluation of anxiety levels and the risk of PTSD. A multivariable linear regression was performed to assess the impact of patients' characteristics on the distress caused by the SARS-COV-2 pandemic. RESULTS: Among the 468 women recruited, 68.8% were quite-to-extremely worried about not being able to access gynaecologic care, with almost one-third of them scoring ≥33 on the IES-R. Older age and increased levels of anxiety were associated with higher risks of PTSD (age: b = 0.28, 95% CI = 0.12 - 0.44; GAD-7: b = 1.71, 95% CI = 1.38 - 2.05), with up to 71.8% of patients with severe anxiety (GAD-7 > 15) having an IES-R score ≥33 suggestive for PTSD. Women who could leave home to work showed lower levels of PTSD (b = -4.79, 95% CI = -8.44 to - 1.15, ref. unemployed women). The implementation of telemedicine in routine clinical practice was favourably viewed by 75.6% of women. DISCUSSION: Women with endometriosis are particularly exposed to the risk of PTSD during the SARS-CoV-2 pandemic, especially if they are older or have higher levels of anxiety. Gynaecologists should resort to additional strategies, and telemedicine could represent a feasible tool to help patients cope with this situation.KEY MESSAGESThe COVID-19 pandemic significantly impacted the lives of women with endometriosis, who appeared to have a considerable risk of PTSD.Older age, higher anxiety levels and unemployment were independently associated with the risk of developing PTSD.Clinicians should develop successful alternative strategies to help patients cope with this situation, and telemedicine might represent an applicable and acceptable solution.

Acute Abdomen and Appendicitis in 1010 Pediatric Patients With COVID-19 or MIS-C: A Multinational Experience from Latin America.

BACKGROUND: To date, there are only sporadic reports of acute abdomen and appendicitis in children with coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C). METHODS: Children 17 years of age or younger assessed in 5 Latin American countries with a diagnosis of microbiologically confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and children fulfilling MIS-C definition were included. For children with acute abdomen, we investigate main radiologic patterns, surgical treatment and intraoperative findings, outcomes. FINDINGS: One-thousand ten children were enrolled. Forty-two children (4.2%) had a clinical diagnosis of acute abdomen. Four (9.5%) were diagnosed with MIS-C and did not undergo surgery. The remaining 38 children (3.8%) underwent abdominal surgery due to suspected appendicitis, 34 of them (89.7%) had an intraoperative diagnosis of acute appendicitis (AA), while 4 of them had nonsurgical findings. Eight children died (0.8%), none of them being diagnosed with appendicitis. Children with AA were significantly older than those without (P < 0.0001). Children with complicated appendicitis had more frequently fever (85.7% vs. 60%), intestinal distension on the abdominal radiograph (7.1% vs. none), leukocytosis (85.7% vs. 40%) and high levels of C-reactive protein (35.7% vs. 5%), although differences were not statistically significant. CONCLUSIONS: Our study showed that children may present with acute abdomen during COVID-19 or MIS-C, which is not always associated with intraoperative findings of appendicitis, particularly in case of MIS-C. Further studies are needed to better characterize children with acute abdomen during COVID-19 or MIS-C, to avoid delay in diagnosis of surgical conditions and at the same time, minimize unnecessary surgical approaches.

Impact of COVID-19 on Timing of Hip-Fracture Surgeries: An Interrupted Time-Series Analysis of the Pre/Post-Quarantine Period in Northern Italy.

BACKGROUND: To assess whether the imposition of the coronavirus disease 2019 (COVID-19) national quarantine (March 10, 2020) resulted in a shift in the proportion of patients operated for hip fracture on the day of admission, the following day and two days after admission in the region of Piedmont, northern Italy. METHODS: Interrupted time-series analysis (ITSA) comparing hospitalization rate and timing of hip-fracture surgeries between pre- and post-quarantine period. The same data observed in Piedmont the year before were included as a control time series with no "intervention" (quarantine) in the middle of the observation period. RESULTS: We found that 70.3% and 69.4% of hip-fracture patients received surgery within 2 days of hospital admission in the 16 weeks before and after the national quarantine, respectively. One-day surgery went from 46.0% to 46.5%, and same-day surgery from 13.3% to 12.4%. Unchanged trends were confirmed by ITSA after controlling for the 32-week time-series observed the year before. In the second week of March 2020, there was a borderline significant decrease in weekly hospital admissions for hip fractures as compared with that of the same week of March 2019 (-1.95 per 100 000, 95% CI = -4.10 to 0.21, P value = .075), followed by a weekly significant increase in the hospitalization rate (+0.14 per 100 000, 95% CI = 0.01 to 0.27, P value = .039), although the difference-in-differences of slopes failed to achieve statistical significance (0.19 per 100 000, 95% CI = -0.03 to 0.41, P value = .090). CONCLUSION: Our study shows that the timing of hip-fracture surgery was unchanged during the lockdown period. This suggests that the healthcare systems can be resilient and able to guarantee a high-quality and safe healthcare to hip-fracture patients, even in the most challenging working conditions.

ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance.

BACKGROUND: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was to describe the adverse events following immunization (AEFIs) with this vaccine through participant-based active surveillance in the country. METHODS: Beginning from 4 March to 8 April 2021, a nationwide study was conducted on San Marino's population aged 18-89 years who received one or two doses of Sputnik V. E-questionnaire dissemination occurred through e-mails, QR-codes or live/phone interviews ~7 days after the first and second vaccine dose. A descriptive analysis was conducted to quantify AEFI incidence on both occasions, stratifying results by type and severity of symptoms. FINDINGS: Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache and joint pain. INTERPRETATION: Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs. FUNDING: None.

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

BACKGROUND: It is of great importance to examine the impact of the healthcare reorganization adopted to confront the COVID-19 pandemic on the quality of care provided to non-COVID-19 patients. The aim of this study is to assess the impact of the COVID-19 national lockdown (March 9, 2020) on the quality of care provided to patients with hip fracture (HF) in Piedmont and Emilia-Romagna, two 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, 2-day 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 significant decline at a weekly rate of -1.29% (95% CI [-1.71 to -0.88]). Divergent trend patterns in the two study regions reflect local differences in pandemic timing as well as in healthcare services capacity, management, and emergency preparedness.

Sleep disorders reveal distress among children and adolescents during the Covid-19 first wave: results of a large web-based Italian survey.

BACKGROUND: Measures to contain the Covid-19 pandemic led to significant lifestyle changes for children and adolescents mainly related to the closure of schools and recreational activities, reduced social interaction, and increased family concerns. METHODS: A cross-sectional online survey of 78 questions investigating social determinants of health, mood changes, symptoms of anxiety, increase in sleep disorders and unusual repetitive movements was offered to parents living in Italy with children ≤18 years; including families of children with disabilities, autism spectrum disorders, chronic diseases, and specific learning disabilities. The survey was conducted on the Qualtrics platform 6 months after the beginning of the pandemic and distributed in hospitals and paediatricians' waiting rooms as well as through social networks. The primary outcomes were the increase in sleep disorders among children and adolescents. Possible risk factors were investigated through multivariable regression. RESULTS: Six thousand two hundred ten volunteer parents responded to the questions concerning mood changes, sleep disorders and unusual repetitive movements, and were included in the present study. The majority were female (91.8%) and Italian (97.0%). 72.7% answered that their children had become more nervous, worried, or sad (80.2% in children with learning disabilities); 77.6% reported feelings of loneliness and 69.3% more difficulties in children falling asleep, 30.2% in staying asleep, and 18.7% an increase in nightmares and/or sleep terrors. Statistical analysis identified socioeconomic status, parent's job loss, food insecurity, family attitude toward the pandemic, and children's mood swing, feelings of loneliness, or missing outdoor activities, as major risk factors for sleep disorders. CONCLUSION: The first Covid-19 lockdown impacted children's and adolescents' health through an increase in sleep disorders. In the following phases of the pandemic, this evidence may be useful to investigate and treat these disorders as well as make decisions about containment health policies concerning this age group.

High rates of antibiotic prescriptions in children with COVID-19 or multisystem inflammatory syndrome: A multinational experience in 990 cases from Latin America.

AIM: This study aims to assess rates of antibiotic prescriptions and its determinants in in children with COVID-19 or Multisystem Inflammatory Syndrome (MIS-C). METHODS: Children <18 years-old assessed in five Latin Americas countries with a diagnosis of COVID-19 or MIS-C were enrolled. Antibiotic prescriptions and factors associated with their use were assessed. RESULTS: A total of 990 children were included: 921 (93%) with COVID-19, 69 (7.0%) 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. There was significant variation in antibiotic use across the hospitals. CONCLUSION: Our study showed a high rate of antibiotic prescriptions in children with COVID-19, in particular in those with severe disease or MIS-C. Prospective studies are needed to provide better evidence on the recognition and management of bacterial infections in COVID-19 children.