Workplace aggression against healthcare workers in a Spanish healthcare institution between 2019 and 2021: The impact of the COVID-19 pandemic.

Objectives: Describe the incidence of first aggressions among healthcare workers (HCWs) before and during the COVID-19 pandemic in a Spanish healthcare institution, according to workers' socio-occupational characteristics and analyze the impact of the pandemic on it. Methods: A cohort involving HCWs who worked in the institution for at least 1 week each year from 1 January 2019 to 31 December 2021. Adjusted relative risks (aRR) were estimated using generalized estimating equations and negative binomial models to calculate the differences in WPA between the different time periods. All analyses were stratified by gender. Results: Among women, the incidence was 6.8% (6.0; 7.8) during the pre-COVID-19 period, 6.0% (5.2; 7.0) during the COVID-19 baseline and 5.1% (4.3; 5.9) during the COVID-19 endline; and 4.6% (3.4; 6.1), 5.3% (4.1; 6.8) and 4.4% (3.5; 5.8), respectively, among men. Among men, the incidence of WPA was 4.6 (3.4; 6.1), 5.3 (4.1; 6.8), and 4.4% (3.5; 5.8), respectively. These incidences were significantly higher among male nurses and aides [11.1 (8.0; 15.4), 12.3 (8.9; 16.6), and 9.3% (6.5; 13.3) during each period] and psychiatric center workers [women: 14.7 (11.2; 19.0), 15.4 (11.8; 19.8), and 12.4% (9.2; 16.6); men: 12.3 (7.2; 20.0), 17.8 (11.6; 26.2), and 14.3% (8.8; 22.4)]. Among women, the risk of WPA was 23% lower in the post-COVID-19 period compared to before the pandemic [aRR = 0.77 (0.64; 0.93)], while the risk during the COVID-19 baseline was not significantly different [aRR = 0.89 (0.74; 1.06)]. Conclusions: The COVID-19 pandemic led to an unexpected decrease in first-time WPA against HCWs. However, ~5% of HCWs experienced at least one incidence of aggression in the last follow-up year. Healthcare managers should continue to increase the prevention of aggression against HCWs, especially among vulnerable groups with a higher level of incidence.

[Critical patients COVID-19 Has changed the management and outcomes in the ICU after 1 year of the pandemic?A multicenter, prospective, observational study]. / Pacientes críticos COVID-19 ¿Ha variado el manejo y resultados en la UCI tras 1 año de pandemia? Estudio multicéntrico, prospectivo, observacional.

OBJECTIVE: To compare the clinical characteristics, treatments, and evolution of critical patients with COVID-19 pneumonia treated in Intensive Care Units (ICU) after one year of pandemic. METHODOLOGY: Multicenter, prospective study, which included critical COVID-19 patients in 9 ICUs in northwestern Spain. The clinical characteristics, treatments, and evolution of patients admitted to the ICU during the months of March-April 2020 (period 1) were compared with patients admitted in January-February 2021 (period 2). RESULTS: 337 patients were included (98 in period 1 and 239 in period 2). In period 2, fewer patients required invasive mechanical ventilation (IMV) (65% vs 84%, p <0.001), using high-flow nasal cannulas (CNAF) more frequently (70% vs 7%, p <0.001), ventilation non-invasive mechanical (NIMV) (40% vs 14%, p <0.001), corticosteroids (100% vs 96%, p = 0.007) and prone position in both awake (42% vs 28%, p = 0.012), and intubated patients (67% vs 54%, p = 0.034). The days of IMV, ICU stay and hospital stay were lower in period 2. Mortality was similar in the two periods studied (16% vs 17%). CONCLUSIONS: After 1 year of pandemic, we observed that in patients admitted to the ICU, CNAF, NIMV, use of the prone position, and corticosteroids have been used more frequently, reducing the number of patients in IMV, and the length of stay in the ICU and hospital stay. Mortality was similar in the two study periods.

Critical patients COVID-19 has changed the management and outcomes in the ICU after 1 year of the pandemic? A multicenter, prospective, observational study.

OBJECTIVE: To compare the clinical characteristics, treatments, and evolution of critical patients with COVID-19 pneumonia treated in Intensive Care Units (ICU) after one year of pandemic. METHODOLOGY: Multicenter, prospective study, which included critical COVID-19 patients in 9 ICUs in northwestern Spain. The clinical characteristics, treatments, and evolution of patients admitted to the ICU during the months of March-April 2020 (period 1) were compared with patients admitted in January-February 2021 (period 2). RESULTS: 337 patients were included (98 in period 1 and 239 in period 2). In period 2, fewer patients required invasive mechanical ventilation (IMV) (65% vs 84%, p < 0.001), using high-flow nasal cannulas (CNAF) more frequently (70% vs 7%, p < 0.001), ventilation non-invasive mechanical (NIMV) (40% vs 14%, p < 0.001), corticosteroids (100% vs 96%, p = 0.007) and prone position in both awake (42% vs 28%, p = 0.012), and intubated patients (67% vs 54%, p = 0.034). The days of IMV, ICU stay and hospital stay were lower in period 2. Mortality was similar in the two periods studied (16% vs 17%). CONCLUSIONS: After 1 year of pandemic, we observed that in patients admitted to the ICU, CNAF, NIMV, use of the prone position, and corticosteroids have been used more frequently, reducing the number of patients in IMV, and the length of stay in the ICU and hospital stay. Mortality was similar in the two study periods.

Non-Pharmacological Preventive Measures Had an Impact on COVID-19 in Healthcare Workers before the Vaccination Effect: A Cohort Study.

Healthcare workers have been and still are at the forefront of COVID-19 patient care. Their infection had direct implications and caused important challenges for healthcare performance. The aim of this study is to assess the impact of non-pharmacological preventive measures against COVID-19 among healthcare workers. This study is based on a dynamic cohort of healthcare workers (n = 5543) who had been hired by a Spanish hospital for at least one week during 2020. Negative binomial regression models were used to estimate the incidence rate and the rate ratio (RR) between the two waves (defined from 15 March to 21 June and from 22 June to 31 December), considering natural immunity during the first wave and contextual variables. All models were stratified by socio-occupational variables. The average COVID-19 incidence rate per 1000 worker-days showed a significant reduction between the two waves, dropping from 0.82 (CI95%: 0.73-0.91) to 0.39 (0.35-0.44). The adjusted RR was 0.54 (0.48-0.87) when natural immunity was acquired during the first wave, and contextual variables were considered. The significant reduction of the COVID-19 incidence rate could be explained mainly by improvement in the non-pharmacological preventive interventions. It is needed to identify which measures were more effective. Young workers and those with a replacement contract were identified as vulnerable groups that need greater preventive efforts. Future preparedness plans would benefit from these results.

The mRNA-1273 Vaccine Induces Cross-Variant Antibody Responses to SARS-CoV-2 With Distinct Profiles in Individuals With or Without Pre-Existing Immunity.

mRNA-based vaccines effectively induce protective neutralizing antibodies against SARS-CoV-2, the etiological agent of COVID-19. Yet, the kinetics and compositional patterns of vaccine-induced antibody responses to the original strain and emerging variants of concern remain largely unknown. Here we characterized serum antibody classes and subclasses targeting the spike receptor-binding domain of SARS-CoV-2 wild type and α, ß, γ and δ variants in a longitudinal cohort of SARS-CoV-2 naïve and COVID-19 recovered individuals receiving the mRNA-1273 vaccine. We found that mRNA-1273 vaccine recipients developed a SARS-CoV-2-specific antibody response with a subclass profile comparable to that induced by natural infection. Importantly, these antibody responses targeted both wild type SARS-CoV-2 as well as its α, ß, γ and δ variants. Following primary vaccination, individuals with pre-existing immunity showed higher induction of all antibodies but IgG3 compared to SARS-CoV-2-naïve subjects. Unlike naïve individuals, COVID-19 recovered subjects did not mount a recall antibody response upon the second vaccine dose. In these individuals, secondary immunization resulted in a slight reduction of IgG1 against the receptor-binding domain of ß and γ variants. Despite the lack of recall humoral response, vaccinees with pre-existing immunity still showed higher titers of IgG1 and IgA to all variants analyzed compared to fully vaccinated naïve individuals. Our findings indicate that mRNA-1273 vaccine triggered cross-variant antibody responses with distinct profiles in vaccinees with or without pre-existing immunity and suggest that individuals with prior history of SARS-CoV-2 infection may not benefit from the second mRNA vaccine dose with the current standard regimen.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.