This was a retrospective cohort study designed to estimate the incidence of COVID-19 infection in hospital worker’s in Trieste public hospitals. The study was conducted in Azienda Sanitaria Universitaria Giuliana Isontina (ASUGI) in Maggiore and Cattinara hospitals, a tertiary medical center that employs approximately 4300 workers. The hospitals have implemented since April 15, 2020 a policy of routinely screening for all workers using nasopharyngeal swabs and PCR-based virus detection. In addition, each case of SARS-CoV-2 infection in health care workers (HCWs) or patients triggered an epidemiological investigation that included the repetition of nasopharyngeal swabs and the collection and recording of symptoms. All hospital workers can receive the vaccination from the first day of the vaccination campaign and throughout the study period on a priority basis.
Data were retrieved from the hospital information system data base, that aggregates data from multiple sources including personnel files, vaccination reports, laboratory data bases, digitized epidemiological questionnaire.
Ethics approval and review were performed according to declaration of Helsinky and were obtained from the Comitato Etico Unico Regionale (CEUR) along with a waiver of written informed consent.
Definition of follow-up period for incidence of COVID-19 in hospitals’ workers (phase 1 of the study)
The follow-up started with the first index case identified in Trieste hospitals in March 1, 2020 and continued till May 31, 2021.
The PCR tests were performed according to the screening policy of the hospitals. The screening policy changed during the course of the study as follow: in March only health care workers (HCWs) with respiratory symptoms or in contact with a COVID-cases were tested (period 1), from April 15, 2020 to May 31, 2021 all hospitals’ workers including technicians and administrative staff were screened depending of their risk of SARS-CoV-2 exposure (weekly for HCWs in COVID-19 wards and monthly for the others). After the vaccination start (December 27, 2021) routinely screening continued with the same protocol.
All hospitals’ workers had open and free access to PCR testing at their own discretion. Hospitals’ workers who did not undergo at least one PCR testing during the study period were excluded from the analysis. Workers that contracted SARS-CoV-2 infection during the study contributed to the group of COVID-19 workers while the others were assigned to COVID-19 negative (-) group.
To calculate the incidence of COVID-19 diseases SARS-CoV-2 infected previously were excluded from the analysis.
Group assignment for evaluate the efficacy of vaccination (phase II of the study)
Hospitals’ workers who received at least 1 vaccine dose between December 27, 2020 and February 28, 2021 were assigned to the vaccinated group. The control group was composed of hospitals’ workers who did not receive any doses of the BNT162b2 vaccine during this period.
To calculate the incidence of COVID-19 diseases in vaccinated and non-vaccinated workers, subjects with previous COVID-19 infection were excluded from the analysis.
The follow-up period for each worker was defining as starting from March 1, 2021 to May 31, 2021. Participants were censored at the first positive PCR test result or in May, 31.
Definitions
The risk of exposure to COVID-19 subject was classified high for persons working in COVID-19 dedicated wards, medium for persons working in Internal Medicine I and II (where inpatients with respiratory symptoms were hospitalized waiting for a diagnosis), low for workers in other wards and very low for administrative staff and technicians. In case of exposure to various risk situation, the highest risk level of exposure was used.
Participants COVID-19 were defined symptomatic if they had any of the following: temperature greater than 37.5°C, upper respiratory symptoms (sore throat, cough, and rhinorrhea), lower respiratory symptoms (pneumonia, dyspnea), loss of sense of taste or smell, diarrhea, others (myalgia, malaise, and headache). Symptoms were obtained at the first PCR test and from post-infection epidemiological interviews performed by the Unit of Occupational Medicine involved in infection and prevention control. The participants were considered fully vaccinated more than 7 days after the second dose of the vaccine.
Study outcomes
The primary outcome was the incidence of SARS-CoV-2 infection in hospitals’ workers from the start of the pandemic to February 28, 2021. The secondary outcome was the incidence of SARS-CoV-2 infection from March 1 to May 31, 2021 in vaccinated and non-vaccinated workers. Outcomes were analyzed for pre-defined subgroups according to age, sex, work task, wards according to the estimated level of exposure.
Statistical analysis
Continuous variables are expressed as mean and standard deviation (SD) for normally distributed variables and as median (interquartile range) for non-normally distribute variables. Categorical variables are expressed as number (percentage) of hospital workers within each group The groups were compared using t test for normally distributed continuous variables and chi-square tests for categorical variables. Missing values for categorical variables were considered as separate category. A significance for p < 0.05 two sided was considered significant.
Incidence rate analysis
The incidence rates were defined as the number of positive SARS-CoV-2 cases divided by number of person—days during the surveillance time.
The adjusted incidence rate ratio (IRR) was estimated using a multivariate Poisson regression model with confirmed cases as a response variables and group assignment (COVID-19 positive and negative for study phase I and vaccinated and, non-vaccinated for study phase II), age sex work tasks, wards and number of PCR tests for each health care workers in the time frame under observation. The IRRs were computed by exponentiating the group assignment coefficient from the final regression model and 95% CI s and P values were estimated from the model.
All statistical analysis was performed using STATA (StataCorp LLC, College Station, Texas USA).