Inequality in access to COVID-19 vaccines: an annual experience in Verona (Italy) : Anna Sartorello

COVID-19 vaccination campaigns involved massive resources worldwide. However, the disparity in vaccine accessibility is a global issue. The study evaluated whether birthplace is a barrier to healthcare access in a high-income country (HIC). The retrospective cohort study included fully vaccinated adults in the Verona district between 27/12/2020 and 31/12/2021. In Italy, the vaccination was opened at different times according to the risk category. Two multiple linear regression models explored the relationship between (1) days before getting the first shot (IV) and (2) the distance between the municipality of residence and the vaccination point, and age, sex, and Income Group (IG, as defined by the World Bank). Distance (km) was estimated with Q-GIS. Results are reported as Marginal Effect at the Mean (MEM) with a confidence interval of 0.95. 500,001 first doses were included, with a mean age of 47 years (SD = 21) and a mean IV of 47.5 days. 6% of the sample was UpperMiddle (UMIC), 6% Lower-Middle (LMIC), and 0.3% Low-Income Countries (LIC). The mean age was higher for HIC (p < 0.05). Male outnumbered females in LMIC (61%) and LIC (69%), but not in HIC and UMIC (p < 0.001). LMIC and LIC were vaccinated at local facilities (5.8%) and pharmacies (4.2%) more than other groups (3%) and at hub centers less (p < 0.05). The IV was lower for subjects from HIC (p < 0.05) with a MEM of 24 [22;26] for LIC, 21 [21;22] for LMIC and 27 [26;27] for UMIC. Men from UMIC (9 [4;14]), LMIC (7 [6;8]) and LIC (4 [3;5]) had a higher IV than women. All variables being equal, IV decreased with age (MEM -0.48 [-0.49;-0.47]). Distance was shorter for LMIC and LIC than for HIC (p < 0.05). The MEM on the distance of the Income group was -2.8 [-3.5;-2.2] for LIC and -2.0 [-2.1;-1.8] for LMIC (p < 0.05). The Income Group of one’s birth country is a barrier to vaccine accessibility in Italy, a HIC. Hence, we address public health workers to improve access to vaccination in community settings to narrow this gap. Key messages • Birthplace Income Group could be linked to vaccine accessibility in High Income Countries. • Public Health stakeholders should consider community and social barriers to healthcare access when planning health interventions.

Epidemiological factors affecting health service utilization in diabetic patients in Ethiopia : Roberto Benoni

Diabetes-related deaths reached 2 million in 2019. The highest percentage of undiagnosed diabetes (59.7%) was observed in Africa, where accessibility to health services is pivotal to improving the outcome of diabetic patients. The study aims to assess the association between diabetic patients’ epidemiological factors and accessibility to healthcare services in a low-income country. The retrospective cohort study included diabetes-related outpatient department (OPD) visits and hospitalizations from 01/01/2018 to 31/08/2021 at St Luke Hospital (Ethiopia). Potential predictors were sociodemographic factors, COVID-19 cases, mean monthly temperature, and precipitations. The ARIMA method was applied to OPD visits and hospitalizations time series. OPD visits increased over time (p < 0.001) while hospitalizations were stable. The time series model was ARIMA(0,1,1) for OPD visits and ARIMA(0,0,0) for hospitalizations. Diabetes OPD patients were 1,685 (F = 732, 43%). Females had an average of 16% fewer OPD accesses per month (p = 0.002). Patients missing follow-up were 801 (48%). The time between follow-ups was longer as age increased (p < 0.001). There were 57 fewer forecast OPD visits per month on average using COVID-19 cases as ARIMA regressor. OPD visits decreased differently by geographic area as COVID-19 cases increased (p < 0.001). Hospitalized patients for diabetes were 408, 85 (20.8%) newly diagnosed. The odds ratio (OR) of diagnosis at admission was lower as age increased (OR 0.98, p = 0.009). Compared to type 1 diabetes, hospitalized females with type 2 (117-39.7%) were fewer than males (p = 0.019). Readmissions were 52, 10 (19.2%) within 30 days, without OR difference by sex, age, or diabetes type. Despite an increase in OPD visits for diabetic patients over the study period, the number of losses at follow-up and diagnoses at hospitalization remains high. Gender and age influenced service utilization. Females’ access to care is still problematic (concept of “missing women”). Key messages • Primary health care should be implemented to improve access to health services and diabetes management. • Ensuring equity in healthcare accessibility should be a priority in low-income countries.

Experience in Communicating Vaccine Side Effects in a Covid-19 Population Vaccination Centre in North-East Italy

Introduction: Our hospital operated a population vaccination centre (CVP) in Verona between March and August 2021, administering an average of 2000-2500 anti-SARS-CoV-2 vaccinations per day. Risk communication offers a methodology for assessing the risk perception of vaccines;managing high volumes of activity may need to consider the ways and processes of communicating the risk of adverse events [1-2]. Objective(s): What to improve for better risk communication in CVP during a mass-vaccination campaign;compare the differences between reports detected by hospital, regional, and national pharmacovigilance. Method(s): A fact sheet was produced based on the guidance of the ministry of health and the drug agency. It was possible to look up information regarding vaccine adverse events during online booking. Multiple videowall were installed before the medical check. Healthcare workers were trained on adverse event risk communication and reporting methods: an online dataset was collected and share online to physicians involved in the vaccination campaign. Moreover through a surveillance conducted between March and August 2021, we asked users about their level of satisfaction with the information they received regarding to clarity, completeness of information received, and informed consent form. We collected adverse event reports from the Verona hospital through 2021;we collected data from regional reports and from AIFA reports. We compared the hospital data with regional and national data. Result(s): Survey collected 3871 answers;about information area 71.10% were ''extremely satisfied''. Who were dissatisfied request for more information materials at each stage of vaccination: before (information about vaccines), during (information about procedures and side effects) and after the vaccination session (more complete information on how to report adverse events). Staff area (medical and nurse) collected 88.40% ''extremely satisfied''. AOVR collected 392 reports of adverse events (356 [99.82%] non serious and 36 [9.18%] serious);Veneto collected 15.982 (14.513 [90.82%] non serious and 1.468 [9.18%] serious);National data were 97.846 (83.967 [85.93%] non serious and 13.741 [14.06%] serious) [3-5]. Conclusion(s): The management of risk communication during the operation of a population centre (CVP) was perceived with satisfaction by the users. The values of adverse event reports received by AOVR's pharmacovigilance system are comparable with regional data and serious events are lower than national data. Integrations in risk communication may be useful at different points in the vaccination process.

The AOUI Verona Task Force for Improvement of Post-Market Clinical Surveillance for Medical Device

Introduction: Post-marketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or medical device (MD) after it has been released on market and is an important part of science of pharmacovigilance. PMS is considered one of the most critical aspects of the new EU-MDR 2017/745. In AOUI Verona the pharmacist in charge of MD vigilance reports adverse events to Pharmacovigilance's Regional Service and Ministry of Health. For many years there has been a collaboration between Pharmacy and Hospital Risk Management by sharing clinical information about incidents, failures, serious deteriorations or potential deficiency related to MD safety use. This multidisciplinary collaboration is the fundamental aspect to improve protection of health and safety patients, healthcare professionals and all users reducing the likelihood of reoccurring incidents. Unfortunately during Covid-19 a lack of training and staff awareness significantly reduced spontaneous incident reporting. Objective(s): Aim of the present study is analyze PMS data and organize hospital staff training to increase PMS and spontaneous incident reporting. Method(s): Over the years Pharmacy and Risk Management keep a database for recording and monitoring data on MD adverse events. The Cross-check analysis of databases allows to intercept all incident or failure occurred. Result(s): From 2019, recorded data show a decrease of 30% related to MD incidents or failures (2019: N = 120;2020: N = 67;2021: N = 45) and some Operating Units are less likely to reporting. In 2021 the clinical risk manager received 56 incident reports and only 45 of these to Pharmacy too. 22 were filled in by surgical departments, of which 4 by pediatricians and 18 by adult specialists. The total number of reports shows that 80% have reached the pharmacy office, while the percentage ratio between the two sectors is expected to be 100%. Conclusion(s): The PMS management in AOUI requires a strong collaboration of all figures involved in this process. For this reason, training and awareness-raising must be carried out in a widespread and continuous way. In AOUI Hospitals we are organizing training meetings to sharing information between various professional skills so that any problems arising are quickly identified. One target for 2022 is a participation to training events for at least one doctor and nurse for each hospital unit.

Experience in Communicating Vaccine Side Effects in a Covid-19 Population Vaccination Centre in North-East Italy: An International Journal of Medical Toxicology and Drug Experience

Introduction: Our hospital operated a population vaccination centre (CVP) in Verona between March and August 2021, administering an average of 2000-2500 anti-SARS-CoV-2 vaccinations per day. Risk communication offers a methodology for assessing the risk perception of vaccines;managing high volumes of activity may need to consider the ways and processes of communicating the risk of adverse events [1-2]. Objective: What to improve for better risk communication in CVP during a mass-vaccination campaign;compare the differences between reports detected by hospital, regional, and national pharmacovigilance. Methods: A fact sheet was produced based on the guidance of the ministry of health and the drug agency. It was possible to look up information regarding vaccine adverse events during online booking. Multiple videowall were installed before the medical check. Healthcare workers were trained on adverse event risk communication and reporting methods: an online dataset was collected and share online to physicians involved in the vaccination campaign. Moreover through a surveillance conducted between March and August 2021, we asked users about their level of satisfaction with the information they received regarding to clarity, completeness of information received, and informed consent form. We collected adverse event reports from the Verona hospital through 2021;we collected data from regional reports and from AIFA reports. We compared the hospital data with regional and national data. Results: Survey collected 3871 answers;about information area 71.10% were extremely satisfied. Who were dissatisfied request for more information materials at each stage of vaccination: before (information about vaccines), during (information about procedures and side effects) and after the vaccination session (more complete information on how to report adverse events). Staff area (medical and nurse) collected 88.40% extremely satisfied. AOVR collected 392 reports of adverse events (356 [99.82%] non serious and 36 [9.18%] serious);Veneto collected 15.982 (14.513 [90.82%] non serious and 1.468 [9.18%] serious);National data were 97.846 (83.967 [85.93%] non serious and 13.741 [14.06%] serious) [3-5]. Conclusion: The management of risk communication during the operation of a population centre (CVP) was perceived with satisfaction by the users. The values of adverse event reports received by AOVRs pharmacovigilance system are comparable with regional data and serious events are lower than national data. Integrations in risk communication may be useful at different points in the vaccination process.

The AOUI Verona Task Force for Improvement of Post-Market Clinical Surveillance for Medical Device: An International Journal of Medical Toxicology and Drug Experience

Introduction: Post-marketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or medical device (MD) after it has been released on market and is an important part of science of pharmacovigilance. PMS is considered one of the most critical aspects of the new EU-MDR 2017/745. In AOUI Verona the pharmacist in charge of MD vigilance reports adverse events to Pharmacovigilance's Regional Service and Ministry of Health. For many years there has been a collaboration between Pharmacy and Hospital Risk Management by sharing clinical information about incidents, failures, serious deteriorations or potential deficiency related to MD safety use. This multidisciplinary collaboration is the fundamental aspect to improve protection of health and safety patients, healthcare professionals and all users reducing the likelihood of reoccurring incidents. Unfortunately during Covid-19 a lack of training and staff awareness significantly reduced spontaneous incident reporting. Objective: Aim of the present study is analyze PMS data and organize hospital staff training to increase PMS and spontaneous incident reporting. Methods: Over the years Pharmacy and Risk Management keep a database for recording and monitoring data on MD adverse events. The Cross-check analysis of databases allows to intercept all incident or failure occurred. Results: From 2019, recorded data show a decrease of 30% related to MD incidents or failures (2019: N = 120;2020: N = 67;2021: N = 45) and some Operating Units are less likely to reporting. In 2021 the clinical risk manager received 56 incident reports and only 45 of these to Pharmacy too. 22 were filled in by surgical departments, of which 4 by pediatricians and 18 by adult specialists. The total number of reports shows that 80% have reached the pharmacy office, while the percentage ratio between the two sectors is expected to be 100%. Conclusion: The PMS management in AOUI requires a strong collaboration of all figures involved in this process. For this reason, training and awareness-raising must be carried out in a widespread and continuous way. In AOUI Hospitals we are organizing training meetings to sharing information between various professional skills so that any problems arising are quickly identified. One target for 2022 is a participation to training events for at least one doctor and nurse for each hospital unit.

Estimating COVID-19 recovery time in a cohort of Italian healthcare workers who underwent surveillance swab testing.

OBJECTIVES: The COVID-19 pandemic is putting a huge strain on the provision and continuity of care. The length of sickness absence of the healthcare workers as a result of SARS-CoV-2 infection plays a pivotal role in hospital staff management. Therefore, the aim of this study was to explore the timing of COVID-19 recovery and viral clearance, and its predictive factors, in a large sample of healthcare workers. STUDY DESIGN: This is a retrospective cohort study. METHODS: The analysis was conducted on data collected during the hospital health surveillance programme for healthcare staff at the University Hospital of Verona; healthcare workers were tested for SARS-CoV-2 through RT-PCR with oronasopharyngeal swab samples. The health surveillance programme targeted healthcare workers who either had close contact with SARS-CoV-2-infected patients or were tested as part of the screening-based strategy implemented according to national and regional requirements. Recovery time was estimated from the first positive swab to two consecutive negative swabs, collected 24 h apart, using survival analysis for both right-censored and interval-censored data. Cox proportional hazard was used for multivariate analysis. RESULTS: During the health surveillance programme, 6455 healthcare workers were tested for SARS-CoV-2 and 248 (3.8%, 95% confidence interval [CI]: 3.4-4.3) reported positive results; among those who tested positive, 49% were asymptomatic, with a median age of 39.8 years, which is significantly younger than symptomatic healthcare workers (48.2 years, P < 0.001). Screening tests as part of the health surveillance programme identified 31 (12.5%) of the positive cases. Median recovery time was 24 days (95% CI: 23-26) and 21.5 days (95% CI: 15.5-30.5) in right- and interval-censoring analysis, respectively, with no association with age, sex or presence of symptoms. Overall, 63% of participants required >20 days to test negative on two consecutive swabs. Hospitalised healthcare workers (4.8%) were older and had a significantly longer recovery time compared with non-hospitalised healthcare workers in both analyses (33.5 vs 24 days, P = 0.005). CONCLUSIONS: Recovery from COVID-19 and viral clearance may take a long time, especially in individuals who are hospitalised. To detect asymptomatic cases, screening programmes for healthcare workers is recommended.

COVID-19 pandemic: an Italian single institution's experience and lessons learned by public health residents' workforce.

Methods: We hereby provide a systematic description of the response actions in which the public health residents' workforce was pivotal, in a large tertiary hospital. Background: The Coronavirus Disease 2019 pandemic has posed incredible challenges to healthcare workers worldwide. The residents have been affected by an almost complete upheaval of the previous setting of activities, with a near total focus on service during the peak of the emergency. In our Institution, residents in public health were extensively involved in leading activities in the management of Coronavirus Disease 2019 pandemic. Results: The key role played by residents in the response to Coronavirus Disease 2019 pandemic is highlighted by the diversity of contributions provided, from cooperation in the rearrangement of hospital paths for continuity of care, to establishing and running new services to support healthcare professionals. Overall, they constituted a workforce that turned essential in governing efficiently such a complex scenario. Conclusions: Despite the difficulties posed by the contingency and the sacrifice of many training activities, Coronavirus Disease 2019 pandemic turned out to be a unique opportunity of learning and measuring one's capabilities and limits in a context of absolute novelty and uncertainty.

Psychological impact of COVID-19 pandemic on healthcare workers in a highly burdened area of north-east Italy.

AIMS: Healthcare workers exposed to coronavirus 2019 (COVID-19) patients could be psychologically distressed. This study aims to assess the magnitude of psychological distress and associated factors among hospital staff during the COVID-19 pandemic in a large tertiary hospital located in north-east Italy. METHODS: All healthcare and administrative staff working in the Verona University Hospital (Veneto, Italy) during the COVID-19 pandemic were asked to complete a web-based survey from 21 April to 6 May 2020. Symptoms of post-traumatic distress, anxiety and depression were assessed, respectively, using the Impact of Event Scale (IES-R), the Self-rating Anxiety Scale (SAS) and the Patient Health Questionnaire (PHQ-9). Personal socio-demographic information and job characteristics were also collected, including gender, age, living condition, having pre-existing psychological problems, occupation, length of working experience, hospital unit (ICUs and sub-intensive COVID-19 units vs. non-COVID-19 units). A multivariable logistic regression analysis was performed to identify factors associated with each of the three mental health outcomes. RESULTS: A total of 2195 healthcare workers (36.9% of the overall hospital staff) participated in the study. Of the participants, 35.7% were nurses, 24.3% other healthcare staff, 16.4% residents, 13.9% physicians and 9.7% administrative staff. Nine per cent of healthcare staff worked in ICUs, 8% in sub-intensive COVID-19 units and 7.6% in other front-line services, while the remaining staff worked in hospital units not directly engaged with COVID-19 patients. Overall, 63.2% of participants reported COVID-related traumatic experiences at work and 53.8% (95% CI 51.0%-56.6%) showed symptoms of post-traumatic distress; moreover, 50.1% (95% CI 47.9%-52.3%) showed symptoms of clinically relevant anxiety and 26.6% (95% CI 24.7%-28.5%) symptoms of at least moderate depression. Multivariable logistic regressions showed that women, nurses, healthcare workers directly engaged with COVID-19 patients and those with pre-existing psychological problems were at increased risk of psychopathological consequences of the pandemic. CONCLUSIONS: The psychological impact of the COVID-19 pandemic on healthcare staff working in a highly burdened geographical of north-east Italy is relevant and to some extent greater than that reported in China. The study provides solid grounds to elaborate and implement interventions pertaining to psychology and occupational health.