Surgical reorganization during the COVID-19 pandemic and impact on case-mix and surgical site infections: A multicenter cohort study in Italy.

BACKGROUND: The coronavirus 2019 (COVID-19) pandemic led to major disruptions in surgical activity, particularly in the first year (2020). The objective of this study was to assess the impact of surgical reorganization on surgical outcomes in Northern Italy in 2020 and 2021. METHODS: A retrospective cohort study was conducted among 30 hospitals participating in the surveillance system for surgical site infections (SSIs). Abdominal surgery procedures performed between 2018 and 2021 were considered. Predicted SSI rates for 2020 and 2021 were estimated based on 2018-2019 data and compared with observed rates. Independent predictors for SSI were investigated using logistic regression, including procedure year. RESULTS: 7605 procedures were included. Significant differences in case-mix were found comparing the three time periods. Observed SSI rates among all patients in 2020 were significantly lower than expected based on 2018-2019 SSI rates (p 0.0465). Patients undergoing procedures other than cancer surgery in 2020 had significantly lower odds for SSI (odds ratio, OR 0.52, 95 % confidence interval, CI 0.3-0.89, p 0.018) and patients undergoing surgery in 2021 had significantly higher odds for SSI (OR 1.49, 95 % CI 1.07-2.09, p 0.019) compared to 2018-2019. CONCLUSIONS: Enhanced infection prevention and control (IPC) measures could explain the reduced SSI risk during the first pandemic year. IPC practices should continue to be reinforced beyond the pandemic context.

Characteristics of the health districts in Italy and their implication in primary health care policies: an analysis of socio-demographic trends.

Introduction: The Health District (HD) is a critical component of Italy's National Health Service, responsible for ensuring Primary Health Care (PHC) services in response to community health needs. The Italian government established a national strategic reform program, the National Recovery and Resilience Plan (PNRR), starting in 2022, with a series of health interventions to reorganize the PHC setting, the main reform being the Ministerial Decree 77/2022 (DM77). Our study aimed to provide a description of socio-demographic data and to assess the correlation between HDs, in order to suggest health intervention priorities in PHC reforms. Materials and methods: We conducted our analysis using a cross-sectional record linkage of data from multiple sources to compare organizational and socio-demographic variables. A dataset was created with each of the 21 Italian Regions' HDs data of population, land area, mean age, ageing index, old-age dependency ratio, birth rate and death rate. The Inland Areas Project data was integrated for a socio-economic perspective. Results: Our study identified comparable groups of HDs, considering demographical, socio-economic and geographical aspects. The study provides a baseline understanding of the Italian situation prior to the implementation of DM77. It also highlights that inhabitants number cannot be the only variable to take into account for the definition of Italian HDs organisation and PHC reform, providing intercorrelated variables that take into account geographic location, demographic data, and socio-economic aspects. Conclusion: By acknowledging the interplay of demographic, socio-economic, and geographic factors, policymakers can tailor interventions to address diverse community needs, ensuring a more effective and equitable PHC system.

Distance learning in primary health care: an Italian experience among medical residents to integrate public health and primary health care.

Investing in Primary Health Care (PHC) is crucial for the future of Public Health (PH), although recent studies highlighted the lack of training in PHC within Italian Residency Schools. This article intends to show the experience and impact of a training course focused on standardizing the knowledge of medical residents in Hygiene and preventive medicine regarding PHC. The strength of the intervention was to demonstrate the feasibility of a unique and homogeneous educational path throughout the national territory. From the results of the evaluation questionnaires, a strong approval of the training experience emerged, with a significant improvement in the perceived knowledge of the subject.

Hip prosthesis and colon surgery, a decade of surveillance on surgical site infections in Italy, a prospective cohort study: rates, trends, and disease burden in DALYs.

BACKGROUND: Surveillance programs are a key element of interventions aiming to reduce rates of surgical site infections (SSIs). The aim of this study was to evaluate rates and trends of SSIs following hip arthroplasty and colon surgery procedures in Piedmont, a region in North-western Italy, from 2010 to 2019. Further, we aimed to assess the burden of SSIs in terms of Disability-Adjusted Life-Years (DALYs). METHODS: A prospective cohort study was conducted among 42 hospitals participating in the surveillance system. Procedure-specific SSI rates were calculated and the 2010 - 2019 trend was evaluated using Spearman's Rho test. Patients were stratified according to age, sex and infection risk index according to life expectancy in order to calculate DALYs, using a modified version of the ECDC's BCoDE toolkit: disease models for both procedure types were adapted to incorporate long-term disability associated with SSIs. RESULTS: Overall, 20,356 hip arthroplasty and 11,011 colon surgery procedures were monitored over 10 years and were included in our analyses. Hip arthroplasty and colon surgery cumulative SSIs rates were 1.5% and 8% respectively. Using the Spearman's Rho test, we evaluated a significant downward trend from 2010 to 2019 for colon surgery interventions (Rs - 0.7, p < 0.05), while there was no difference for hip arthroplasty. (Rs - 0.04, p > 0.05). Regarding disease burden, a total of 955.3 (95%CI 837.7-1102.98) and 208.65 (95%CI 180.87-240.90) DALYs were calculated for SSIs following hip arthroplasty, whilst 76.58 (95%CI 67.15-90.71) and 38.62 (95% CI 33.09-45.36) DALYs for SSIs in colon surgery, in 2010 and 2019, respectively. CONCLUSIONS: The significant decrease both in terms of incidence and DALYs found in this study for colon surgery and the stability for hip arthroplasty support the role of surveillance networks in improving quality of care. Despite the smaller SSI rate, the burden associated with SSIs following hip arthroplasty was higher, which is important to consider in light of the aging population in Italy.

Mortality and Case Fatality Rates Associated With Surgical Site Infections: A Retrospective Surveillance Study.

Background: Surgical site infections (SSIs) have been associated with increases in terms of costs, hospital stay, morbidity, and mortality. We aimed to assess trends in SSIs monitored through 10 years of surveillance activities in our region, and to describe mortality attributable to SSIs in the two most frequently monitored surgical procedures: colorectal surgery and hip arthroplasty. Methods: A retrospective cohort study was conducted among the 42 hospitals participating in the surveillance network of our region in northern Italy. All colorectal and hip arthroplasty procedures performed between January 1st, 2010, and December 31st, 2019, and monitored through the surveillance system were included in the study. Surgical site infection rates, overall mortality, case fatality rates (CFR), and mortality attributable to SSIs were evaluated overall and by year of participation in the surveillance program. Results: In total, 11,417 colon surgery and 20,804 hip arthroplasty procedures were included. Among colon surgery procedures, SSI rates decreased from 9.21% in 2010 to 5.7% in 2019. A significant decreasing trend was found for overall mortality (p = 0.008), which progressively decreased from 4.96% in 2010 to 2.96% in 2019. Among hip arthroplasty procedures, no significant trend emerged for SSI and mortality rates. Considering the 10-year period, the CFR was 6.62% and 3.7% for SSIs after colon surgery and hip arthroplasty procedures, respectively. Conclusions: The impact of SSIs on the clinical outcomes of patients undergoing surgery highlights the importance of SSI surveillance.

Antibody responses to BNT162b2 SARS-CoV-2 mRNA vaccine among healthcare workers and residents of long-term care facilities: A cohort study in Northern Italy.

Background and Aims: Long-term care facilities (LTCFs) have been severely impacted by COVID-19, with a disproportionate amount of SARS-CoV-2 infections and related deaths occurring among residents. Methods: This study is part of an ongoing multicenter, prospective cohort study conducted among healthcare workers (HCWs) and residents of 13 LTCFs in Northern Italy designed to evaluate SARS-CoV-2 specific immunoglobulin class G (IgG) titers before and following vaccination with Pfizer/BNT162b2 SARS-CoV-2 mRNA vaccine (two doses of vaccine, 21 days apart). Serum samples were obtained from participants (t0) before vaccination, and (t1) 2 weeks after and analyzed to determine anti-S1 IgG antibodies. Results: Five hundred and thirty-four participants were enrolled (404 subjects participated in both blood draws). Seropositivity was 50.19% at t0 and 99% at t1, with a significant difference in IgG titers. A higher proportion of residents were seropositive at t0 compared with HCWs, with significantly higher IgG titers among residents at both t0 and t1. Pre-existing immunity also had a significant effect on postvaccination IgG titers. However, a significant difference in titers at t1 between HCWs and residents considering only participants seropositive at t0 was found, with higher median titers among previously seropositive residents. Conclusion: Findings of this study provide scientific evidence endorsing the policy of universal vaccination in LTCFs.

The Italian policy of mandating SARS-CoV-2 vaccination for healthcare workers: Analysis of the policy processes and preliminary outcomes.

BACKGROUND: Italy experienced the first outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Europe, and was among the most hardly hit European countries. Growing evidence suggests healthcare workers (HCWs) are at increased risk of SARS-CoV-2 infection. Infection in HCWs can lead to cross-transmission and increase community transmission. Italy was the first country in Europe to introduce mandatory vaccinations against SARS-CoV-2 for HCWs, on April 1, 2021. AIM: To describe the policy processes and preliminary results of the introduction of compulsory vaccination against SARS-CoV-2 for HCWs in Italy. RESULTS AND CONCLUSION: In Italy, the adoption of the policy was possible in the context of the public health and economic crisis resulting from the pandemic, with support from the scientific community and among favorable political conditions. Preliminary data suggest the policy has so far had a positive impact on increasing vaccine uptake and lowering infection rates among HCWs. Hopefully, the lack of serious vaccine-related adverse events and the growing evidence on vaccine effectiveness will progressively strengthen vaccine confidence among HCWs. In the context of a global pandemic, the Italian experience could provide insight for policymakers in other countries considering similar policies. Further, the ethical, legal, and policy challenges raised by the current public health emergency could be used to inform future pandemic preparedness plans.

Serological Responses up to 9 Months following COVID-19 mRNA Vaccination in Residents and Health-Care Workers of Long-Term Care Facilities: A Multicenter Prospective Cohort Study in Northern Italy.

Long-term care facilities (LTCFs) were severely affected by COVID-19, in particular in Northern Italy. We aimed to assess antibody responses among residents and healthcare workers (HCWs) of 13 LTCFs through serum samples collected at three time points: prior to, two weeks, and 9 months after receiving Pfizer/BNT162b2 SARS-CoV-2 mRNA vaccine (respectively t0, t1, and t2). IgG antibodies targeted towards the S1 domain of the spike protein were measured, and results were expressed in binding antibody units (BAU/mL). Friedman's average rank test was performed to compare antibody titres between the three time points. Two logistic regression models were built to identify independent predictors of (1) developing and (2) maintaining a significant antibody response to vaccination, using a previously identified threshold. In total, 534 subjects were enrolled (371 HCWs and 163 residents). The antibody titres at t1 were the highest; at t2, the IgG titres significantly decreased, remaining however 10 times higher compared to titres at t0. Previous infection was the only significant predictor of developing and maintaining a response over threshold in both models. Results of this study provided further insights on the humoral response elicited by vaccination, and on host factors determining variations in its magnitude and kinetics.

Seroprevalence of infection-induced SARS-CoV-2 antibodies among health care users of Northern Italy: results from two serosurveys (October-November 2019 and September-October 2021).

OBJECTIVES: The objective was to estimate the seroprevalence of SARS-CoV-2 in autumn 2019 (before case zero was identified in Italy) and 2021 among residual sera samples from health care users in the Piedmont region of northwestern Italy. METHODS: Two serosurveys were conducted. Using a semiquantitative method, samples were tested for the presence of immunoglobulin G (IgG) antibodies against the S1 domain of the spike protein. Samples with positive test results from the 2019 survey were independently retested using a multiplex panel to detect IgG antibodies against the receptor binding domain, S1 and S2 domains, and nucleocapsid. Samples with positive test results from the 2021 survey underwent repeat testing with enzyme-linked immunosorbent assay to detect anti-nucleocapsid IgG antibodies. Prevalence rates according to gender and age groups, together with their respective 95% confidence intervals (CIs), were calculated. RESULTS: Overall, the proportion of samples with positive test results was 2/353 in 2019 and 22/363 in 2021, with an estimated seroprevalence of 0.27% (95% CI 0-1.86) and 6.21% (95% CI 3.9-9.31) in 2019 and 2021 respectively. CONCLUSION: Results of this study support the hypothesis that the virus was circulating in Italy as early as autumn 2019. The role of these early cases in broader transmission dynamics remains to be determined.

A cross-sectional study of SARS-CoV-2 seropositivity among healthcare workers and residents of long-term facilities in Italy, January 2021.

Long-term care facilities (LTCFs) are high-risk settings for SARS-CoV-2 infection. This study aimed to describe SARS-CoV-2 seropositivity among residents of LTCFs and health-care workers (HCWs). Subjects were recruited in January 2021 among unvaccinated HCWs of LTCFs and hospitals and residents of LTCFs in Northern Italy. Information concerning previous SARS-CoV-2 infections and a sample of peripheral blood were collected. Anti-S SARS-CoV-2 IgG antibodies were measured using the EUROIMMUN Anti-SARS-CoV-2 QuantiVac ELISA kit (EUROIMMUN Medizinische Labordiagnostika AG). For subjects with previous COVID-19 infection, gender, age, type of subject (HCW or resident), and time between last positive swab and blood draw were considered as possible determinants of two outcomes: the probability to obtain a positive serological result and antibody titer. Six hundred and fifty-eight subjects were enrolled. 56.1% of all subjects and 65% of residents presented positive results (overall median antibody titer: 31.0 RU/ml). Multivariable models identified a statistically significant 4% decrease in the estimated antibody level for each 30-day increase from the last positive swab. HCWs were associated with significant odds for seroreversion over time (OR: 0.926 for every 30 days, 95% CI: 0.860-0.998), contrary to residents (OR: 1.059, 95% CI: 0.919-1.22). Age and gender were not factors predicting seropositivity over time. Residents could have a higher probability of maintaining a seropositive status over time compared to HCWs.

Surgical site infection prevention through bundled interventions in hip replacement surgery: A systematic review.

BACKGROUND: Bundles have shown to improve patient outcomes in several settings. Surgical site infections (SSIs) following joint replacement surgery are associated with severe outcomes. We aimed to determine the effectiveness of non-pathogen specific bundled interventions in reducing SSIs after hip arthroplasty procedures. MATERIALS AND METHODS: A systematic review and meta-analysis were conducted according to the PRISMA statement guidelines (PROSPERO registration number CRD42020203031). PubMed, Embase and Cochrane databases were searched for studies evaluating SSI prevention bundles in hip replacement surgery, excluding studies evaluating pathogen-specific bundles. Records were independently screened by two authors. The primary outcome was the SSI rate in intervention and control groups or before and after bundle implementation. Secondary outcomes of interest were bundle compliance and the number and type of bundle components. A meta-analysis was conducted using raw data, by calculating pooled relative risk (RR) SSI estimates to assess the impact of bundled interventions on SSI reduction. RESULTS: Eleven studies were included in the qualitative review and four studies comprising over 20 000 patients were included in the quantitative synthesis. All included studies found bundles were associated with reduced SSI rates. The pooled RR estimated from the fixed-effects model was 0.76 (95% confidence interval 0.61-0.96, p 0.022) with 49.8% heterogeneity. CONCLUSIONS: Results support the effectiveness of non-pathogen specific bundled interventions in preventing SSIs following hip arthroplasty. A "core" group of evidence-based elements for bundle development were identified.