Analysis of the excess mortality and factors associated with deaths from COVID-19 versus other causes in Central Tuscany (Italy) in 2020.

OBJECTIVES: to assess the extent of the excess mortality from all causes in 2020 compared to 2015-2019 in Central Tuscany (Italy) as a proxy to estimate COVID-19-related excess mortality and to identify demographic and clinical differences between subjects who died from COVID-19 and those who died from other causes in 2020. DESIGN: descriptive analysis of the temporal trend of general mortality. SETTING AND PARTICIPANTS: the study population is represented by the 1.6 million residents living in the territory of the Central Tuscany Healthcare Authority in Central Italy, i.e., little less than half of the population of Tuscany, in an area of just over one fifth of the entire region, where the provinces of Florence, Pistoia, and Prato are comprised. MAIN OUTCOME MEASURES: using the Italian National Resident Population Registry (ANPR) as a source of mortality data, standardized mortality ratios with 95% confidence intervals were calculated to compare the number of deaths in 2020 with the number of deaths expected on the basis of mortality data from 2015 to 2019. Furthermore, after record linkage with data from the integrated surveillance of cases of SARS-CoV-2 virus infection and with the MaCro dataset of comorbidities, the characteristics of subjects who died from COVID-19 were compared with those of patients who died from other causes using a multivariate logistic regression model; odds ratios with 95% confidence intervals were calculated. RESULTS: a statistically significant excess mortality was observed during the first pandemic wave in March and April, and during the second wave in the fall; it ranged between +9% in March and +51% in November. On the contrary, in January, February, and May, all-cause mortality was significantly lower than in previous years. The male gender, dyslipidaemia, and dementia were positively associated with death from COVID-19 rather than from all other causes. On the contrary, heart failure and recent tumours were more represented among deaths from other causes. CONCLUSIONS: much of the over-mortality observed in spring is attributable to the harvesting effect COVID-19 exerted on a segment of population with serious underlying chronic conditions and who in the previous months had survived a mild winter and a flu season of medium intensity. In the second pandemic wave, in autumn, the impact of both direct and indirect effects of COVID-19 was substantially higher. Consistently with the available evidence, death from COVID-19 was related to the male gender and to clinical conditions such as dyslipidaemia and dementia.

Long-term effects of SARS-CoV-2 vaccination in the nursing home setting.

BACKGROUND: SARS-CoV-2 vaccination has significantly reduced infection, hospitalization, and lethality rates among nursing home (NH) residents, but durability of vaccine effects remains unknown. This study investigated the long-term impact of BNT162b2 SARS-CoV-2 vaccine on breakthrough infection rates in the NHs of Florence, Italy. METHODS: Participants included residents living in Florence NHs as of April 1st, 2021, who had completed the primary SARS-CoV2 vaccination course by February 15th, 2021. Weekly rates of breakthrough infection were calculated between April 1st and October 31st 2021, with 7-day incidence defined as the number of new confirmed SARS-CoV-2-positive residents over the vaccinated resident census. Hospital admissions and deaths were recorded from local administrative and clinical sources. Patients admitted to NHs after April 1st were excluded to avoid confounding effect of different vaccination timing. RESULTS: Among 2271 vaccinated residents (mean age 86.6, 74% female), we recorded 105 cases of breakthrough infections. Rates of breakthrough infection remained very low in the 6 months after vaccination, but started to rise over the following months, peaking at 0.94%, and then became stable around 0.2%-0.3%. Over the study period, infection rates remained low as compared to the incidence of SARS-CoV-2 infection during pre-vaccination period. Overall hospitalization and lethality rates were 8%. CONCLUSIONS: Among vaccinated NH residents, rates of breakthrough SARS-CoV-2 infection, hospitalization and lethality remained low up to 9 months following primary vaccination course. A mild resurgence of SARS-CoV-2 infection, after 6 months from vaccination, suggests a decline of vaccine effectiveness in preventing transmission.

COVID-19, Vulnerability, and Long-Term Mortality in Hospitalized and Nonhospitalized Older Persons.

OBJECTIVE: Studies suggesting that vulnerability increased short-term mortality in older patients with COVID-19 enrolled hospitalized patients and lacked COVID-negative comparators. Aim of this study was to examine the relationship between frailty and 1-year mortality in older patients with and without COVID-19, hospitalized and nonhospitalized. DESIGN: Cohort study. SETTING AND PARTICIPANTS: Patients over 75 years old accessing the emergency departments (ED) were identified from the ED archives in Florence, Italy. METHODS: Vulnerability status was estimated with the Dynamic Silver Code (DSC). COVID-19 hospital discharges (HC+) were compared with non-COVID-19 discharges (HC-). Linkage with a national COVID-19 registry identified nonhospitalized ED visitors with (NHC+) or without COVID-19 (NHC-). RESULTS: In 1 year, 48.4% and 33.9% of 1745 HC+ and 15,846 HC- participants died (P < .001). Mortality increased from 27.5% to 64.0% in HC+ and from 19.9% to 51.1% in HC- across DSC classes I to IV, with HC+ vs HC- hazard ratios between 1.6 and 2.2. Out of 1039 NHC+ and 18,722 NHC- participants, 18% and 8.7% died (P < .001). Mortality increased from 14.2% to 46.7% in NHC+ and from 2.9% to 26% in NHC- across DSC; NHC+ vs NHC- hazard ratios decreased from 5.3 in class I to 2.0 in class IV. CONCLUSIONS AND IMPLICATIONS: In hospitalized older patients, mortality increases with vulnerability similarly in the presence and in the absence of COVID-19. In nonhospitalized patients, vulnerability-associated excess mortality is milder in individuals with than in those without COVID-19. The disease reduces survival even when background risk is low. Thus, apparently uncomplicated patients deserve closer clinical monitoring than commonly applied.

Course and Lethality of SARS-CoV-2 Epidemic in Nursing Homes after Vaccination in Florence, Italy.

Evidence on the effectiveness of SARS-CoV-2 vaccines in nursing home (NHs) residents is limited. We examined the impact of the BNT162b2 mRNA SARS-CoV-2 vaccine on the course of the epidemic in NHs in the Florence Health District, Italy, before and after vaccination. Moreover, we assessed survival and hospitalization by vaccination status in SARS-CoV-2-positive cases occurring during the post-vaccination period. We calculated the weekly infection rates during the pre-vaccination (1 October-26 December 2020) and post-vaccination period (27 December 2020-31 March 2021). Cox analysis was used to analyze survival by vaccination status. The study involved 3730 residents (mean age 84, 69% female). Weekly infection rates fluctuated during the pre-vaccination period (1.8%-6.5%) and dropped to zero during the post-vaccination period. Nine unvaccinated (UN), 56 partially vaccinated (PV) and 35 fully vaccinated (FV) residents tested SARS-CoV-2+ during the post-vaccination period. FV showed significantly lower hospitalization and mortality rates than PV and UV (hospitalization: FV 3%, PV 14%, UV 33%; mortality: FV 6%, PV 18%, UV 56%). The death risk was 84% and 96% lower in PV (HR 0.157, 95%CI 0.049-0.491) and FV (HR 0.037, 95%CI 0.006-0.223) versus UV. SARS-CoV-2 vaccination was followed by a marked decline in infection rates and was associated with lower morbidity and mortality among infected NH residents.

Descriptive Observational Study of Tdap Vaccination Adhesion in Pregnant Women in the Florentine Area (Tuscany, Italy) in 2019 and 2020.

Background: Tdap (Tetanus-Diphtheria-acellular Pertussis) vaccination is nowadays a worldwide-recommended practice to immunize pregnant women. The vaccine administration at the third trimester of pregnancy (as recommended by the WHO) would ensure antibody protection to both the mother and the newborn and has contributed to the significant drop of pertussis cases in infants. The aim of this observational study was to describe for the first time the socio-demographic characteristics and determinants of Tdap vaccination adhesion of pregnant women in the Florentine area. Methods: Information about parents' vaccination status, their citizenship, employment type and mothers' previous pregnancies and/or abortions were collected at the time of birth through the assistance birth certificates (CedAP) both for the years 2019 and 2020. This archive and the regional SISPC (Collective Prevention Healthcare Information System) linked using an anonymous unique personal identifier to retrieve the mother's vaccination status. Results: We found an overall Tdap vaccination adhesion of 43% in 2019 and 47.3% in 2020. Several socio-demographic parameters would determine an increased vaccination adhesion, including parents' geographical origin, mothers' age and educational background, as well as the number of previous deliveries, abortions or voluntary termination of pregnancy. Conclusions: Since not much data are available on this topic in Italy, this study may constitute the baseline information for Tdap vaccination adhesion in pregnant women in the Florentine area (Italy). Thus, future successful vaccination strategies may be designed accordingly.

Caring for nursing home residents with COVID-19: a "hospital-at-nursing home" intermediate care intervention.

BACKGROUND: Nursing home (NH) residents have been dramatically affected by COVID-19, with extremely high rates of hospitalization and mortality. AIMS: To describe the features and impact of an assistance model involving an intermediate care mobile medical specialist team (GIROT, Gruppo Intervento Rapido Ospedale Territorio) aimed at delivering "hospital-at-nursing home" care to NH residents with COVID-19 in Florence, Italy. METHODS: The GIROT activity was set-up during the first wave of the pandemic (W1, March-April 2020) and became a structured healthcare model during the second (W2, October 2020-January 2021). The activity involved (1) infection transmission control among NHs residents and staff, (2) comprehensive geriatric assessment including prognostication and geriatric syndromes management, (3) on-site diagnostic assessment and protocol-based treatment of COVID-19, (4) supply of nursing personnel to understaffed NHs. To estimate the impact of the GIROT intervention, we reported hospitalization and infection lethality rates recorded in SARS-CoV-2-positive NH residents during W1 and W2. RESULTS: The GIROT activity involved 21 NHs (1159 residents) and 43 NHs (2448 residents) during W1 and W2, respectively. The percentage of infected residents was higher in W2 than in W1 (64.5% vs. 38.8%), while both hospitalization and lethality rates significantly decreased in W2 compared to W1 (10.1% vs 58.2% and 23.4% vs 31.1%, respectively). DISCUSSION: Potentiating on-site care in the NHs paralleled a decrease of hospital admissions with no increase of lethality. CONCLUSIONS: An innovative "hospital-at-nursing home" patient-centred care model based on comprehensive geriatric assessment may provide a valuable contribution in fighting COVID-19 in NH residents.

[Chronic diseases and risk of symptomatic COVID-19: results of a case-population study on a sample of patients in the Local Health Unit 'Toscana Centro' (Tuscany Region, Central Italy)]. / Malattie croniche e rischio di ammalarsi di COVID-19 sintomatica: risultati di uno studio case-population su un campione di casi in AUSL Toscana Centro.

BACKGROUND: the COVID-19 pandemic represents a challenge for health systems around the world, with just under 10,000 cases in Tuscany Region (Central Italy) and about 4,500 in the Local Health Unit (LHU) 'Toscana Centro', updated on 11 May 2020. The risk factors reported are several, including age, being male, and some chronic diseases such as hypertension, diabetes, respiratory and cardiovascular diseases. However, the relative importance of chronic diseases is still to be explored. OBJECTIVES: to evaluate the role of chronic diseases on the risk to develop clinically evident (at least mild symptomatic) forms of SARS-CoV-2 infection in the population of the LHU Toscana Centro. DESIGN: case-population study. SETTING AND PARTICIPANTS: 'case' is a subject with SARS-CoV-2 positive swab with at least mild clinical status, who lives in the LHU Toscana Centro area; 'controls' are all people residing in the LHU Toscana Centro area at 1 January 2020. People aged under 30 and patients living in nursing care homes are excluded from the analysis. MAIN OUTCOME MEASURES: the analysis assesses the effect of gender, age, neoplasm, and the main chronic diseases on the onset of an infection with at least mild symptoms by calculating odds ratios (OR) by multivariate logistic regression models (to produce adjusted OR by potential confounders). RESULTS: among the 1,840 cases, compared to the general population, the presence of males and over-60-year-old people is greater. Almost all the considered chronic diseases are more frequent among the cases, compared to the general population. A chronic patient has a 68% greater risk to be positive with at least mild symptoms. Many of the considered diseases show an effect on the risk of getting COVID-19 in a symptomatic form, which remains even adjusting by other comorbidities. The main ones include heart failure, psychiatric disorders, Parkinson's disease, and rheumatic diseases. CONCLUSIONS: these results confirm evidence already shown in other studies on COVID-19 patients and add information on the chronic diseases attributable risk in the population, referred to the symptomatic forms and adjusted by age, gender or the possible copresence of more diseases. These risk estimates should guide prevention interventions by health services in order to protect the chronic patients affected by the pathologies most at risk.

Obesity as a risk factor for hospitalization in COronaVirus Disease-19 (COVID-19) patients: Analysis of the Tuscany regional database.

BACKGROUND AND AIMS: Aim of the present study is to determine the role of obesity as a risk factor for COronaVirus Disease-19 (COVID-19) hospitalization. METHODS AND RESULTS: This observational study was performed using Istituto Superiore di Sanità (ISS) Tuscany COVID-19 database by the Agenzia Regionale Sanità (ARS), including all COVID-19 cases registered until April 30th, 2020, with reported information on chronic diseases. The principal outcome was hospitalization. An age and gender-adjusted logistic regression model was used to assess the association of clinical and demographic characteristics with hospitalization. Further multivariate models were applied. Of 4481 included subjects (36.9% aged over 70 years), 1907 (42.6%) were admitted to hospital. Obesity was associated with hospitalization after adjusting for age and gender. The association of obesity with hospitalization retained statistical significance in a fully adjusted model, including possible confounders (OR: 2.99 [IC 95% 2.04-4.37]). The effect of obesity was more evident in younger (<70 years) than in older (≥70 years) subjects. CONCLUSIONS: The present data confirm that obesity is associated with an increased risk of hospitalization in patients with COVID-19. Interestingly, the association of obesity with hospitalization was greater in younger (<70 years) patients.

Extensive Testing May Reduce COVID-19 Mortality: A Lesson From Northern Italy.

The effects of different COVID-19 swab testing policies in Italy need investigation. We examined the relationship between the number of COVID-19 swab tests (per 10,000 population) performed from February 24 through March 27 and 7-day lagged COVID-19 mortality (per 10,000 population) in four regions of northern Italy. Lombardy, Piedmont, and initially, also Emilia-Romagna, which followed recommendations for limiting swab testing to symptomatic subjects requiring hospitalization, had a much steeper increase in mortality with increasing number of tests performed than Veneto, which applied a policy of broader testing. The relationship between tests performed and mortality declined in Emilia-Romagna in coincidence with a substantial increase in the number of tests performed on March 18. When the cumulative number of tests performed was regressed linearly toward lagged mortality in Lombardy and Veneto, the slope of the regression was 133 in Veneto and 10.4 tests per one death in Lombardy. These findings suggest that the strategy adopted in Veneto, similar to that in South Korea, was effective in containing COVID-19 epidemics and should be applied in other regions of Italy and countries in Europe.