Predictors of COVID-19 Readmission Among Patients Previously Hospitalized for SARS-CoV-2.

Introduction: Predictors of coronavirus disease 2019 (COVID-19)-related rehospitalization remain underexplored. This study aims to identify the main risk factors associated with rehospitalizations due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reinfections among residents of Lombardy, northern Italy.

Methods: A retrospective observational study was conducted using two linked administrative databases covering demographic data, comorbidities, hospital records, and COVID-19 data of Lombardy residents.

Does syndromic surveillance assist public health practice in early detecting respiratory epidemics? Evidence from a wide Italian retrospective experience.

Background: Large-scale diagnostic testing has been proven ineffective for prompt monitoring of the spread of COVID-19. Electronic resources may facilitate enhanced early detection of epidemics. Here, we aimed to retrospectively explore whether examining trends in the use of emergency and healthcare services and the Google search engine is useful in detecting Severe Acute Respiratory Syndrome Coronavirus outbreaks early compared with the currently used swab-based surveillance system.

Trajectories of biologic drug use before, during and after pregnancy: an Italian cohort study from the VALORE project.

Background: Monitoring biologic drug therapy during pregnancy in women with immune-mediated inflammatory diseases (IMIDs) is crucial to ensure treatments align with evidence-based practices.

Research Design And Methods: A retrospective cohort study based on healthcare claims data from eight Italian regions was conducted, analyzing deliveries between 2009 and 2021. The study included women receiving biologic drugs within nine months before their last menstruation.

Impact of COVID-19 disease and COVID-19 vaccinations on hospital admissions for neurological diseases in the Lombardia over-12 population. Data from a self-controlled case series analysis.

Introduction: The influence of COVID19 vaccination on the risk of different neurological diseases has been subject of intense investigation. No large scale results have been published so far in the population of around 10 million people of Lombardia in Italy.

Methods: Linkable administrative health databases from the Lombardia region were used.

Maintenance immunosuppressive therapy in liver transplantation: results from CESIT study, an Italian retrospective cohort study.

Objectives: To investigate the use of maintenance immunosuppressive treatments following liver transplantation and to compare their risk-benefit profiles in clinical practice.

Design: Retrospective multicentrer cohort study.

Setting: Four Italian regions (Lombardy, Veneto, Lazio, Sardinia).

Temporal trends (2003-2018) of in-hospital and 30-day mortality in patients hospitalized with acute heart failure.

Background: Limited temporal data on in-hospital mortality trends of patients hospitalized with acute heart failure (AHF) have been reported. We evaluated whether, in AHF hospitalized patients, the rate of in-hospital and 30-day mortality, and 30-day re-hospitalization for AHF have changed in the past 15 years.

Methods And Results: We examined administrative data from the Lombardy region, Italy and analysed data of all adults hospitalized for AHF from 2003 to 2018.

Association of non-cardiac comorbidities and sex with long-term Re-hospitalization for heart failure.

Heart failure (HF) often coexists with non-cardiac comorbidities (NCC), but their association with long-term HF re-hospitalizations is not defined. Using the Lombardy Regional Health Database, that includes >10 million residents, we assessed the risk of re-hospitalization for HF after first HF discharge as a function of NCC, employing age- and sex-adjusted Cox proportional-hazard models. Kaplan Meier curves for HF re-hospitalizations were stratified for number of NCC.

Characteristics and outcomes of patients with cancer hospitalized with new onset acute heart failure.

Aims: Limited evidence exists regarding the outcomes of cancer patients hospitalized with new onset acute heart failure (AHF). We assessed the in-hospital mortality and 1 year outcomes of cancer patients admitted for new onset AHF, taking into account both past and active cancer status as well as cancer site.

Methods: We examined administrative data of adult patients hospitalized with a first episode of AHF from 2003 to 2018 in Lombardy, Italy.

Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study.

Background And Objective: Cases of appendicitis were identified in the pivotal randomized clinical trial on BNT162b2 mRNA vaccine and reported from coronavirus disease 2019 (COVID-19) vaccine pharmacovigilance systems. Three cohort studies and two self-controlled case series (SCCS) studies evaluating the association between mRNA vaccines and appendicitis reported discordant results. To address this uncertainty, the present study examines in a large population, with a SCCS design, the association between mRNA (BNT162b2 and mRNA-1273) and, for the first time, viral vector (ChAdOx1-S and Ad26.

Medical occurrence and safety of SARS-CoV-2 vaccination outside of the hospital setting.

During COVID-19 pandemic, vaccination has been strongly recommended and advocated to prevent COVID-19 infection and adverse outcomes, particularly among at-risk populations. The vaccination against SARS-CoV-2 (COVAC) occurred at off-site locations capable of accommodating large crowds, distinct from the hospital setting, where a team of intensivists, emergency physicians, and nurses, ensuring prompt medical attention (medical occurrences, MO) in cases of adverse event following immunization. Our aims were to estimate the incidence of MO, and to assess its association with demographics, and vaccine characteristics.

Development and Validation of a META-Algorithm to Identify the Indications of Use of Biological Drugs Approved for the Treatment of Immune-Mediated Inflammatory Diseases from Claims Databases: Insights from the VALORE Project.

Purpose: This research aimed to develop and validate a META-algorithm combining individual immune-mediated inflammatory disease (IMID)-specific algorithms to identify the exact IMID indications for incident biological drug users from claims data within the context of the Italian VALORE project.

Methods And Patients: All subjects with at least one dispensing of TNF-alpha inhibitors, anti-interleukin agents, and selective immunosuppressants approved for IMIDs were identified from claims databases of Latium region in Italy (observation period: 2010-2020). Validated coding algorithms for identifying individual IMIDs from claims databases were found from published literature and combined into a META-algorithm.

[Analysis of predictive factors for non-adherence to organized screening for colorectal and breast cancers in the pre-pandemic period (2018-2019) in Lombardy Region (Northern Italy)].

Background: according to the International Agency for Cancer Research on Cancer, in 2022, breast cancer is the most common cancer in the Italian population, followed by colorectal cancer. Oncological screenings represent an effective secondary prevention strategy to counteract colorectal and breast cancers, significantly reducing mortality. In Lombardy Region (Northern Italy), screening programmes have been active since 2007, but adherence, especially in specific population subgroups, remains lower than expected.

Switching patterns of biological drugs in patients with psoriasis and psoriatic arthritis: insight from the VALORE database network.

Background: Switch patterns among different biologics and from originators to biosimilars (and vice versa) can be complex in patients with psoriasis (PsO) and psoriatic arthritis (PsA).

Objective: The aim of this study was to describe switching patterns of biological drugs in PsO/PsA patients and to explore predictors of multiple switches and switch-back.

Research Design And Methods: A large-scale retrospective cohort study was conducted using the Italian VALORE database.

Cost-effectiveness of outpatient adherence to recommendations for monitoring of patients hospitalized for heart failure.

Aims: A set of indicators to assess the quality of care for patients hospitalized for heart failure was developed by an expert working group of the Italian Health Ministry. Because a better performance profile measured using these indicators does not necessarily translate to better outcomes, a study to validate these indicators through their relationship with measurable clinical outcomes and healthcare costs supported by the Italian National Health System was carried out.

Methods And Results: Residents of four Italian regions (Lombardy, Marche, Lazio, and Sicily) who were newly hospitalized for heart failure (irrespective of stage and New York Heart Association class) during 2014-2015 entered in the cohort and followed up until 2019.

A NLP-based semi-automatic identification system for delays in follow-up examinations: an Italian case study on clinical referrals.

Background: This study aims to propose a semi-automatic method for monitoring the waiting times of follow-up examinations within the National Health System (NHS) in Italy, which is currently not possible to due the absence of the necessary structured information in the official databases.

Methods: A Natural Language Processing (NLP) based pipeline has been developed to extract the waiting time information from the text of referrals for follow-up examinations in the Lombardy Region. A manually annotated dataset of 10 000 referrals has been used to develop the pipeline and another manually annotated dataset of 10 000 referrals has been used to test its performance.

Post-marketing active surveillance of Guillain Barré Syndrome following COVID-19 vaccination in persons aged ≥12 years in Italy: A multi-database self-controlled case series study.

Background: Recently published studies have reported association of COVID-19 vaccine ChAdOx1-S (Vaxzevria) with Guillain Barré Syndrome (GBS). Less is known about the safety of other COVID-19 vaccines with respect to GBS outcome. This study investigated the association of COVID-19 vaccines with GBS in more than 15 million persons aged ≥12 years in Italy.

Comparing clinical trial population representativeness to real-world users of 17 biologics approved for immune-mediated inflammatory diseases: An external validity analysis of 66,639 biologic users from the Italian VALORE project.

To date, no population-based studies have specifically explored the external validity of pivotal randomized clinical trials (RCTs) of biologics simultaneously for a broad spectrum of immuno-mediated inflammatory diseases (IMIDs). The aims of this study were, firstly, to compare the patients' characteristics and median treatment duration of biologics approved for IMIDs between RCTs' and real-world setting (RW); secondly, to assess the extent of biologic users treated for IMIDs in the real-world setting that would not have been eligible for inclusion into pivotal RCT for each indication of use. Using the Italian VALORE distributed database (66,639 incident biologic users), adult patients with IMIDs treated with biologics in the Italian real-world setting were substantially older (mean age ± SD: 50 ± 15 years) compared to those enrolled in pivotal RCTs (45 ± 15 years).

Immunosuppression with Generics in Liver and Kidney Transplantation: A Real-World Evidence Study.

Purpose: This study evaluates the use, benefit-risk profile, and economic impact of generic immunosuppressants (tacrolimus-TAC, cyclosporine-CsA, and mycophenolate-MYC) in kidney and liver transplant recipients compared to brand-name drugs.

Patients And Methods: A retrospective multicentre observational study, involving four Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data. The analysis focused on incident patients who received kidney and liver transplants between 2013 and 2019 and evaluated the use of generic of CsA, TAC, and MYC during the 30-day period following discharge.

Access to SARS-CoV-2 vaccination in immigrants in Italy, by geographical area of origin.

Objective: Immigrants are commonly considered disadvantaged and at high risk of not receiving appropriate care, including vaccination. This study aimed to evaluate the access to SARS-CoV-2 vaccination in immigrants, by geographical area of origin, compared with Italian citizens. We also evaluated sex differences in vaccine's coverage by geographical area of origin.

Determinants of immunosuppressive therapy in renal transplant recipients: an Italian observational study (the CESIT project).

Background: Very scanty evidence is available on factors influencing the choice of immunosuppressive drug therapy after kidney transplantation.

Methods: An Italian multiregional real-world study was conducted integrating national transplant information system and claims data. All patients undergoing kidney transplantation for the first time during 2009-2019 (incident patients) were considered.