Impact of vascular complications after transcatheter aortic valve implantation. VASC-OBSERVANT II sub-study.

BACKGROUND: Trans-femoral (TF) access is the commonest approach for transcatheter aortic valve implantation (TAVI). However this vascular approach is associated with vascular complications (VC) which in turn have prognostic implications. The aim of this study is to evaluate the clinical impact of access site VC in patients undergoing TAVI with newer generation transcatheter prostheses enrolled in the national observational prospective multicenter study OBSERVANT II. METHODS: Vascular events were defined according to the Valve Academic Research Consortium (VARC)-2 criteria. The population enrolled in OBSERVANT II was divided into 3 groups: patients without VC (No-VC), patients with minor VC or percutaneous closure device failure (Minor-VC) and patients with major VC (Major-VC). The primary endpoint was 1-year major adverse cardiac and cerebrovascular event (MACCE), a composite endpoint of all-cause mortality, stroke, myocardial infarction and coronary revascularization. A multivariate Cox regression model was used for risk estimation of MACCE between the three analyzed groups. RESULTS: 2.504 patients were included in this analysis: 2.167 patients in No-VC group; 249 patients in the Minor-VC and 88 patients in the Major-VC. At 1-year Minor-VC group had a freedom from MACCE comparable to the No-VC group, while Major-VC patients had significantly worse outcome (Log-rank test: p = 0.003). These results were driven by higher 1-year mortality in the Major-VC (p < 0.0001). Major-VC was an independent predictor of MACCE in adjusted analysis (hazard ratio 1.89, 95% confidence interval 1.18-3.03, p = 0.008). CONCLUSIONS: Despite a low incidence of major VC with current TF-TAVI devices, our data confirm that major VC is still associated with a significantly worse clinical outcome.

Incidence and predictors of 30-day and 6-month stroke after TAVR: Insights from the multicenter OBSERVANT II study.

BACKGROUND: The incidence and predictors of 30-day stroke after transcatheter aortic valve replacement (TAVR) were derived from early studies investigating first-generation devices. The incidence of 6-month stroke and its related predictors are unknown. AIMS: To investigate the incidence and to identify procedural and patient-related predictors of 30-day and 6-month stroke after TAVR. METHODS: Data from 2753 consecutive patients with severe aortic stenosis undergoing TAVR were obtained from the OBSERVANT-II study, an observational, prospective, multicenter cohort study. The study endpoints were symptomatic 30-day and 6-month stroke after TAVR. RESULTS: The occurrence of a 30-day and 6-month stroke was low (1.3% and 2.4%, respectively) but with significant impact on survival. Aortic valve predilatation (odds ratio [OR]: 2.28, 95% confidence interval [CI]: 1.12-4.65, p = 0.023), diabetes (OR: 3.10, 95% CI: 1.56-6.18, p = 0.001), and left ventricle ejection fraction < 50% (OR: 2.15, 95% CI: 1.04-4.47, p = 0.04) were independent predictors of 30-day stroke, whereas diabetes (sub-distribution hazard ratio [SHR]: 2.07, 95% CI: 1.25-3.42, p = 0.004), pre-existing neurological dysfunction (SHR: 3.92, 95% CI: 1.54-10, p = 0.004), bicuspid valve (SHR: 4.75, 95% CI: 1.44-15.7, p = 0.011), and critical status (SHR: 3.05, 95% CI: 1.21-7.72, p = 0.018) were predictive of 6-month stroke. Conversely, antiplatelet therapy and anticoagulation were protective factors at both 30 days and 6 months. CONCLUSIONS: Stroke after TAVR was rare. Predilatation was the only procedural factor predictive of 30-day stroke, whereas the remaining were patient-related risk factors, suggesting appropriate risk stratification preoperatively.

Relative Survival After Adult Cardiac Surgery: Analysis of the Italian Nationwide Registry Data.

OBJECTIVE: The authors aimed to investigate life expectancy after adult cardiac surgery. SETTING: Nationwide study including University and non-University hospitals. PARTICIPANTS: Consecutive adult patients who underwent heart valve and coronary artery surgery from a nationwide administrative registry. INTERVENTIONS: Surgical procedures on the heart valves and coronary arteries. METHODS: The authors estimated the 10-year relative survival of adult patients who underwent surgery for heart valve diseases and coronary artery disease taken from a nationwide administrative registry. MEASUREMENTS AND RESULTS: Overall, data on 415,472 patients were available for this study. Among them, 394,445 (94.9%) survived 90 days after surgery, and their 10-year survival was 58.0% (95% CI 57.8-58.3); the expected survival was 70.1%, and the relative survival was 0.83 (95% CI 0.82-0.83). Patients who underwent surgical repair of the mitral valve and aortic valve had relative survival of 0.96 and 0.92, respectively. Isolated coronary artery bypass grafting had a relative survival of 0.88. Surgical replacement of the heart valves had a relative survival below 0.80. Poor results with relative survival <0.70 were observed after complex cardiac surgery. Relative survival was <0.60 in patients who underwent double- or triple-valve surgery combined with coronary artery surgery. The authors observed markedly lower relative survival among women (0.77, 95% CI 0.77-0.78) compared with men (0.86, 95% CI 0.85-0.86) at 10 years. Such a difference was observed after almost all different procedures. CONCLUSIONS: The present findings provided a picture of the real expectation in terms of the late survival of patients after having undergone adult cardiac surgery. This information should be communicated to patients and their relatives before surgery, and it may be relevant in the decision-making process and in planning tertiary prevention.

Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

BACKGROUND: Because of poor knowledge of risks and benefits, prophylactic explantation of high BIA-ALCL risk breast implant (BI) is not indicated. Several surgical risks have been associated with BI surgery, with mortality being the most frightening. Primary aim of this study is to assess mortality rate in patients undergoing breast implant surgery for aesthetic or reconstructive indication. MATERIALS AND METHODS: In this retrospective observational cohort study, Breast Implant Surgery Mortality rate (BISM) was calculated as the perioperative mortality rate among 99,690 patients who underwent BI surgery for oncologic and non-oncologic indications. Mean age at first implant placement (A1P), implant lifespan (IL), and women's life expectancy (WLE) were obtained from a literature review and population database. RESULTS: BISM rate was 0, and mean A1P was 34 years for breast augmentation, and 50 years for breast reconstruction. Regardless of indication, overall mean A1P can be presumed to be 39 years, while mean BIL was estimated as 9 years and WLE as 85 years. CONCLUSION: This study first showed that the BISM risk is 0. This information, and the knowledge that BI patients will undergo one or more revisional procedures if not explantation during their lifetime, may help surgeons in the decision-making process of a pre-emptive substitution or explant in patients at high risk of BIA-ALCL. Our recommendation is that patients with existing macrotextured implants do have a relative indication for explantation and total capsulectomy. The final decision should be shared between patient and surgeon following an evaluation of benefits, surgical risks and comorbidities. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Social determinants of mental health in Italy: the role of education in the comparison of migrant and Italian residents.

Mental health is impacted by social, economic, and environmental factors, the Social Determinants of Health (SDH). Migrants experiencing precarious living and working conditions may be more at risk of poor mental health than the majority population.This paper aims to evaluate the relationship of educational attainment and other SDH with depressive symptoms among the resident population, including Italians and migrants.This study examined the respondents to the Italian "Progressi delle Aziende Sanitarie per la Salute in Italia" (PASSI) surveillance system, 2014-18. The sample of 144.055 respondents is composed of the resident working adults aged 25-69 with Italian citizenship (n = 136.514) and foreign citizenship (n = 7.491).Findings show that among Italians high level of education appears to be a protective factor for mental health, in accordance with the international evidence (adjPR: tertiary education 0,74 p-value = 0.000). However, among immigrants high level of education is associated with the presence of depressive symptoms (adjPR: tertiary education: 1.61 p-value = 0.006), particularly for men (adjPR: tertiary education: 2.40 p-value = 0.006). The longer the length of stay in Italy for immigrants the higher the risk of depressive symptoms: adjPR for 10+ years: 2.23 p-value = 0.005.The data show that high education could represent a risk factor for mental health of immigrants. Moreover, among migrants there are some significant mental health inequities between male and female related to the duration of stay in Italy, economic activity and educational level.Considering that health is related to the nature of society as well as to access to technical solutions, multicultural societies require culturally oriented interventions for tackling health inequities. This means developing evidence-based policies in order to tackle health inequalities in the population as a whole, including culturally oriented measures in the larger framework of developing diversity sensitive services.

Risk of SARS-CoV-2 infection in migrants and ethnic minorities compared with the general population in the European WHO region during the first year of the pandemic: a systematic review.

BACKGROUND: Migrants and ethnic minorities have suffered a disproportionate impact of the COVID-19 pandemic compared to the general population from different perspectives. Our aim was to assess specifically their risk of infection in the 53 countries belonging to the World Health Organization European Region, during the first year of the pandemic. METHODS: We conducted a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO CRD42021247326). We searched multiple databases for peer-reviewed literature, published on Medline, Embase, Scisearch, Biosis and Esbiobase in 2020 and preprints from PubMed up to 29/03/2021. We included cross-sectional, case-control, cohort, intervention, case-series, prevalence or ecological studies, reporting the risk of SARS-CoV-2 infection among migrants, refugees, and ethnic minorities. RESULTS: Among the 1905 records screened, 25 met our inclusion criteria and were included in the final analysis. We found that migrants and ethnic minorities during the first wave of the pandemic were at increased exposure and risk of infection and were disproportionately represented among COVID-19 cases. However, the impact of COVID-19 on minorities does not seem homogeneous, since some ethnic groups seem to be more at risk than others. Risk factors include high-risk occupations, overcrowded accommodations, geographic distribution, social deprivation, barriers to access to information concerning preventive measures (due to the language barrier or to their marginality), together with biological and genetic susceptibilities. CONCLUSIONS: Although mixed methods studies will be required to fully understand the complex interplay between the various biological, social, and cultural factors underlying these findings, the impact of structural determinants of health is evident. Our findings corroborate the need to collect migration and ethnicity-disaggregated data and contribute to advocacy for inclusive policies and programmatic actions tailored to reach migrants and ethnic minorities.

New approach to implement cancer patient care: The valutazione percorso rete oncologica campana (ValPeROC)-experience from an Italian oncology network.

OBJECTIVE: The primary goal of the Campania Oncology Network (ROC) was to reduce cancer delay and care fragmentation through the establishment of cancer-specific multidisciplinary oncologic groups (GOMs) and diagnostic and therapeutic assistance paths (PDTAs). METHODS: Five cancer centres of the ROC, with their own cancer specific GOM, were selected. In our analysis, we have focused on four neoplasms: lung, colon, ovarian and prostate cancers. The median time for pre-GOM and GOM Times was calculated for each tumour site. Univariate and multivariate logistic regressions were performed to individuate risk factors for pre-GOM and GOM Time. RESULTS: Significant differences were observed for prostate cancer compared to other patients either for pre-GOM or GOM Times. Significant risks were found for ovarian and prostate cancers in pre-GOM time and for prostate cancer in GOM-Time. CONCLUSIONS: This experience will produce knowledge and data to guide decision-making and to manage more effectively the challenges of fighting cancer in Campania region. The Valutazione Percorso Rete Oncologica Campana (ValPeROC) study evaluates, for the first time, the ROC activity, through the analysis of key performance indices. Pre-GOM and GOM Time represent the quality of the entire regional health system and are useful to define models, which can evaluate the performance of the ROC over time.

Impact of myocardial revascularization on long-term outcomes in a nationwide cohort of first acute myocardial infarction survivors.

The long-term clinical benefits of myocardial revascularization in a contemporary, nationwide cohort of acute myocardial infarction (AMI) survivors are unclear. We aimed to compare the mortality rates and clinical outcomes at 8 years of patients admitted in Italy for a first AMI managed with or without myocardial revascularization during the index event. This is a national retrospective cohort study that enrolled patients admitted for a first AMI in 2012 in all Italian hospitals who survived at 30 days. The outcomes of interest were all-cause mortality, major cardio-cerebrovascular events (MACCE), and re-hospitalization for heart failure (HF) at 8 years. Time to events was analysed using a Cox and Fine and Gray multivariate regression model. A total of 127 431 patients with AMI were admitted to Italian hospitals in 2012. The study cohort consisted of 62 336 AMI events, of whom 63.8% underwent percutaneous or surgical revascularization ≤30 days of the index hospital admission. At 8 years, the cumulative incidence of all-cause death was 36.5% (24.6% in revascularized and 57.6% in not revascularized patients). After multiple corrections, the hazard ratio (HR) for all-cause mortality in revascularized vs. not revascularized patients was 0.61 (P < 0.0001). The rate of MACCE was 45.7% and 65.8% (adjusted HR 0.83; P < 0.0001), while re-hospitalizations for HF occurred in 17.6% and 29.8% (adjusted HR 0.97; P = 0.16) in AMI survivors revascularized and not revascularized, respectively. In our contemporary nationwide cohort of patients at their first AMI episode, those who underwent myocardial revascularization within 1 month from the index event compared to those not revascularized presented an adjusted 39% risk reduction in all-cause mortality and 17% in MACCE at 8-year follow-up.

Predictors of nurses' attitudes and knowledge towards pain management in Italy. A cross-sectional study in the hospital settings.

INTRODUCTION: Pain is multidimensional, and as such it is the chief reason patients require urgent health care services. If inadequately assessed and untreated, pain may negatively impact on the quality of life of the patient. Pain management is an essential part of Nursing. The aim to this study is to examine the level of knowledge and attitudes with regard to pain among Italian nurses who work in clinical settings. METHODS: The Ferrell and McCaffery's Knowledge and Attitudes Survey Regarding Pain was distributed to 266 nurses employed in one specialized hospital in Rome, Italy. The staff in the survey work in three different settings: the intensive care unit, the sub-intensive care unit, and an ordinary ward. Descriptive statistics were employed and a logistic regression model was performed to evaluate the factors that may influence the attitude and knowledge of care providers. RESULTS: 49.6% of the sample correctly answered items about attitudes, 47.4% about knowledge, and 36.5% about assessment. The results show that the odds ratio of developing positive attitudes towards pain was 1.76 times higher in nurses employed in the sub-intensive care unit than in other settings. There are no statistically significant associations of knowledge between setting, sex or education. CONCLUSIONS: Our survey revealed a limited overall level of knowledge and attitudes with regards to pain management among nurses. Implementing specific training for health professionals, starting with academic education, is therefore a priority. Further research is needed on a larger sample of Italian nurses.

HLA-B*44 and C*01 Prevalence Correlates with Covid19 Spreading across Italy.

The spread of COVID-19 is showing huge, unexplained, differences between northern and southern Italy. We hypothesized that the regional prevalence of specific class I human leukocyte antigen (HLA) alleles, which shape the anti-viral immune response, might partly underlie these differences. Through an ecological approach, we analyzed whether a set of HLA alleles (A, B, C), known to be involved in the immune response against infections, correlates with COVID-19 incidence. COVID-19 data were provided by the National Civil Protection Department, whereas HLA allele prevalence was retrieved through the Italian Bone-Marrow Donors Registry. Among all the alleles, HLA-A*25, B*08, B*44, B*15:01, B*51, C*01, and C*03 showed a positive log-linear correlation with COVID-19 incidence rate fixed on 9 April 2020 in proximity of the national outbreak peak (Pearson's coefficients between 0.50 and 0.70, p-value < 0.0001), whereas HLA-B*14, B*18, and B*49 showed an inverse log-linear correlation (Pearson's coefficients between -0.47 and -0.59, p-value < 0.0001). When alleles were examined simultaneously using a multiple regression model to control for confounding factors, HLA-B*44 and C*01 were still positively and independently associated with COVID-19: a growth rate of 16% (95%CI: 0.1-35%) per 1% point increase in B*44 prevalence; and of 19% (95%CI: 1-41%) per 1% point increase in C*01 prevalence. Our epidemiologic analysis, despite the limits of the ecological approach, is strongly suggestive of a permissive role of HLA-C*01 and B*44 towards SARS-CoV-2 infection, which warrants further investigation in case-control studies. This study opens a new potential avenue for the identification of sub-populations at risk, which could provide Health Services with a tool to define more targeted clinical management strategies and priorities in vaccination campaigns.

[Urban health and inequalities in highly socially marginalised settings in Rome]. / Salute urbana e disuguaglianze a Roma in contesti a elevata marginalità sociale.

OBJECTIVES: to describe hospitalisation, access to emergency care, and mortality of people living in marginalized urban areas which include public housing buildings in the North-West suburb of Rome, and to compare the results with those observed among people living in the neighbouring area. DESIGN: cross sectional study. SETTING AND PARTICIPANTS: resident population in the XIII and XIV Municipality of Rome, subdivided into five urban areas, in 2011-2018. MAIN OUTCOME MEASURES: hospitalisation, access to emergency care, and mortality rates and rates ratios based on hospital discharges and emergency department visits derived from the Health Information Systems and from the Mortality Registry of Lazio Region (Central Italy), stratified by urban areas. RESULTS: the results show a higher use of hospital assistance and emergency care services as well a higher mortality among residents of urban areas characterized by marginalization and social disadvantage in the North-West suburb in Rome, compared to the surrounding area. The association is stronger for the residents of ex-Bastogi, a compound particularly marginalised and socially disadvantaged, where excesses in hospitalisation, emergency care admission, and mortality of +60%, +150%, and +140%, respectively, occurred. CONCLUSIONS: the excesses of hospital use, emergency care visits, and mortality observed among the residents of marginalized urban areas suggest the need to reorganize the preventive and primary care services considering the socioeconomic disadvantage in such housing contexts. The use of both qualitative and quantitative approaches allows to understand the complexity of such contexts.

Epidemiology of Chronic Pain in the Latium Region, Italy: A Cross-Sectional Study on the Clinical Characteristics of Patients Attending Pain Clinics.

In Italy, chronic pain affects more than a quarter of the population, whereas the average European prevalence is 21%. This high prevalence might be due to the high percentage of Italian people who do not receive treatment, even after the passing of law 38/2010 (the right to access pain management in Italy), which created a regional network for the diagnosis and treatment of noncancer chronic pain. Italian epidemiologic studies on chronic pain are scanty, and this observational, multicenter, cross-sectional study is the first to investigate the clinical characteristics of patients who attended the pain management clinics in the Latium Region, Italy, for the management of their noncancer chronic pain. A total of 1,606 patients (mean age 56.8 years, standard deviation ± 11.4), 67% women, were analyzed. Severe pain was present in 54% of the sample. Women experienced pain and had it in two or more sites more often than men (57% vs. 50%, p = .02; and 55.2% vs. 45.9%, p < .001, respectively). Chronic pain was musculoskeletal (45%), mixed (34%), and neuropathic (21%). In more than 60% of the cases, chronic pain was continuous, and in 20% it had lasted for more than 48 months; long-lasting pain was often neuropathic. Low back (33.4%) and lower limbs (28.2%) were the main locations. Severe intensity of pain was statistically significantly associated with female gender (odds ratio [OR] 1.39; 95% confidence interval [CI] 1.06-1.84); with International Classification of Diseases, Ninth Revision, codes for chronic pain syndrome (OR 2.14; 95% CI 1.55-2.95); and with continuous pain (OR 2.02; 95% CI 1.54-2.66). Neuropathic pain and mixed pain were significantly associated with number of sites, and a trend seemed to be present (OR 2.11 and 3.02 for 2 and 3 + sites; 95% CI 1.59-2.79 and 2.00-4.55, respectively).

[Undocumented immigrants: what do we know about their health?] / Capitolo 8: Gli immigrati irregolari: cosa sappiamo della loro salute?

In Italy, immigrants represent a "fuzzy" set, to which it is difficult to apply dichotomous categories as a classification (i.e., regular/irregular, economic/forced, etcetera). These categories lose its meaning when used to study health phenomena. Rather, the epidemiological profile of such a heterogeneous population depends on the varying influence of health determinants in the life-course of migration. This article builds on those assumptions, and analyses the health of irregularly- staying immigrants by adopting a global approach to the migration phenomenon. The article aims at identifying cross-sectional elements of continuity and epidemiological dynamics in the different categories. Different factors, strictly interacting with each other, strongly influence the resulting picture. Specific push-factors primarily influence the starting phases ("healthy migrant effect") and the final stages of the migration process ("salmon effect"). These factors determine good health in these groups, but are also interwined with other dynamics, connected both with the social integration process ("exhausted migrant effect") and the relation with health services, which depends on the regional and local contexts of reference. Such dynamics have been thoroughly examined for "economic migrants" arriving on the Italian coasts. However, nowadays there is important evidence that the "healthy migrant effect" can be also applied to incoming international protection seekers, as demonstrated, for example, by the low prevalence of imported infectious diseases (including tuberculosis). Mental health deserves special attention and a particular final focus, for it is a topic still not adequately addressed, in spite of the high incidence of psychic problems, caused by violence endured either before or during the journey. In the framework of migration phenomena, health issues of irregularly staying immigrants stands hence as most vulnerable, due to the overlapping effects of departure and travel conditions, and of marginalization experienced by a wide group of them in the host Country. It is, therefore, essential to pursue a balanced management of this phenomenon - rich both in implications and in opportunities - by developing highly inclusive and evidence-based public policies.

Attitude and Knowledge of Pain Management Among Italian Nurses in Hospital Settings.

Pain is multidimensional, and, as such, the chief reason patients seek urgent healthcare services. If inadequately assessed and untreated, pain may negatively impact on the quality of life of the patient. Treating pain is an important step in regaining control over quality of life. The objective of the present study is to examine the level of knowledge and types of approach among Italian nurses who deal with pain assessment and management. The Ferrell and McCaffery's Knowledge and Attitudes Survey Regarding Pain (KASRP) was distributed to 286 nurses employed in one of the biggest specialized hospitals in Rome, Italy. The interviewed staff work at three different settings, according to the healthcare assistance they are required to provide: intensive care unit (ICU), subintensive care unit (SICU), and ordinary ward (OW). Descriptive statistics, including frequencies and means, as well as analysis of chi-square (p < .05), were used to compare differences in scores by demographic characteristics of the participants and different settings. A logistic regression model was performed to evaluate the factors that may influence the attitude to pain and the level of knowledge of care providers. Results have shown that the odds of developing positive attitudes towards pain management were 1.62 times higher (95% CI: .92 to 2.85) in nurses employed in SICUs than in those working in OWs, while the odds of possessing a satisfactory level of knowledge was 1.76 times higher (95% CI: .93 to 3.31) among nurses in ICUs than those in OWs. A "good assessment" was better for SICU (OR = 2.17, p < .05) and ICU (OR = 3.20, p < .05) nurses. Our survey has highlighted an overall limited level of knowledge in the assessment and management of pain among the nursing staff. It is therefore a priority to implement specific training to healthcare providers from different fields, who may respond differently to patients with pain. On the other hand, further investigations are required on a greater sample of Italian nurses to better understand how to overcome the most problematic barriers to achieving good pain assessment and control.

Dressed or undressed? How to measure children's body weight in overweight surveillance?

OBJECTIVE: To simplify body weight measurement and, particularly, to encourage children and their parents to participate in the Italian nutritional surveillance system OKkio alla SALUTE, children were measured with clothes and then the weight was corrected for the estimated weight of the clothes. In the present study we compared the children's weight measured in underwear, as recommended by the WHO (WWHO), with that obtained using the OKkio alla SALUTE protocol (WOK) and investigated how the latter affects the calculation of BMI and the assessment of overweight and obesity prevalence. DESIGN: Weight (twice in close sequence, with and without clothing) and height were measured. A checklist was used to describe the type of clothing worn. The estimated weight of clothing was subtracted from the WOK. BMI was calculated considering both values of weight and height; ponderal status was defined using both the International Obesity Task Force and WHO BMI cut-offs. SETTING: Thirty-seven third grade classes of thirteen primary schools in Rome and in two towns in the Lazio Region were recruited. SUBJECTS: The anthropometric measurements were taken on 524 children aged 8-9 years. RESULTS: The error in the calculation of BMI from WOK was very low, 0·005 kg/m2 (95 % CI -0·185, 0·195 kg/m2); the agreement between the percentages of overweight (not including obesity) and obese children calculated with the two methods was very close to 1 (κ = 0·98). CONCLUSIONS: The error in BMI and in nutritional classification can be considered minor in a surveillance system for monitoring overweight/obesity, but eases the procedure for measuring children.

The Use of ICD-9-CM Coding to Identify COVID-19 Diagnoses and Determine Risk Factors for 30-Day Death Rate in Hospitalized Patients in Italy: Retrospective Study.

BACKGROUND: In Italy, it has been difficult to accurately quantify hospital admissions of patients with a COVID-19 diagnosis using the Hospital Information System (HIS), mainly due to the heterogeneity of codes used in the hospital discharge records during different waves of the COVID-19 pandemic. OBJECTIVE: The objective of this study was to define a specific combination of codes to identify the COVID-19 hospitalizations within the HIS and to investigate the risk factors associated with mortality due to COVID-19 among patients admitted to Italian hospitals in 2020. METHODS: A retrospective study was conducted using the hospital discharge records, provided by more than 1300 public and private Italian hospitals. Inpatient hospitalizations were detected by implementing an algorithm based on specific International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code combinations. Hospitalizations were analyzed by different clinical presentations associated with COVID-19 diagnoses. In addition, 2 multivariable Cox regression models were performed among patients hospitalized "due to COVID-19" from January 1 to December 31, 2020, to investigate potential risk factors associated with 30-day death and the temporal changes over the course of the pandemic; in particular, the 30-day death rates during the first and the second waves were analyzed across 3 main geographical areas (North, Center, and South and Islands) and by discharge wards (ordinary and intensive care). RESULTS: We identified a total of 325,810 hospitalizations with COVID-19-related diagnosis codes. Among these, 73.4% (n=239,114) were classified as "due to COVID-19," 14.5% (n=47,416) as "SARS-CoV-2 positive, but not due to COVID-19," and 12.1% (n=39,280) as "suspected COVID-19" hospitalizations. The cohort of patients hospitalized "due to COVID-19" included 205,048 patients, with a median age of 72 years and a higher prevalence of male patients (n=124,181, 60.6%). The overall 30-day death rate among hospitalized patients due to COVID-19 was 9.9 per 1000 person-days. Mortality was lower for women (hazard ratio [HR]=0.83; P<.001) and for patients coming from high migration pressure countries, especially Northern Africans (HR=0.65; P<.001) and Central and Eastern Europeans (HR=0.66; P<.001), compared to patients coming from Italy and high-income countries. In the southern regions and the Islands, mortality was higher compared to the northern regions (HR=1.17; P<.001), especially during the second wave of COVID-19 among patients with a transfer to intensive care units (HR=2.52; P<.001). CONCLUSIONS: To our knowledge, the algorithm is the first attempt to define, at a national level, selection criteria for identifying COVID-19 hospitalizations within the HIS. The implemented algorithm will be used to monitor the pandemic over time, and the patients selected in 2020 will be followed up in the next years to assess the long-term effects of COVID-19.

[Continuing medical education (Cme/Ecm) on medical devices in Italy: a review for the 2019-2021 period.] / Offerta formativa Ecm in materia di dispositivi medici: una ricognizione nazionale per il triennio 2019-2021.

INTRODUCTION: Health technology assessment (Hta) is a multidisciplinary process that uses explicit methods to determine the value of a health technology across various domains. It aims at supporting decision-makers in promoting an equitable, efficient, and high-quality healthcare system. During 2023, the Italian Minister of Health officially endorsed the National program for Hta on medical devices 2023-2025 (Pnhta), aligning with EU Regulation 2017/745 and EU Regulation 2017/746. A key objective of Pnhta is to launch a continuous training initiative targeting all professionals within the Italian Health Service to enhance their knowledge and usability of Hta. To support this effort, a national analysis of educational offerings on medical devices (MD) during the 2019-2021 triennium was undertaken. METHODS: The Italian database of accredited Continuing medical education (Cme/Ecm) events was queried using relevant keywords. A descriptive analysis of the educational offerings was conducted based on variables already provided by the database. The analysis was structured according to pre-identified categories related to the courses' objectives ("correct use", "appropriate use", "procurement", "expert patient") and clinical-care areas of interest. RESULTS: Overall, 1,450 training events were included in the analysis. Courses specifically focused on MD were less than 2% of all Cme/Ecm events. The number of participants trained in MD-related topics decreased in 2020 compared to 2019 (14,787 vs 32,784). However, the average number of credits per course and per participant increased in both 2020 and 2021. Distance learning showed an upward trajectory, rising from 16 events in 2019 to 132 in 2021. Regarding the courses' objectives, 73.2% of events concerned the "proper use" of MD, 31.9% focused on their "appropriateness", 14.7% on "updates", 1.2% on "procurement", while no course was specifically dedicated to the "expert patient". Most of the events were related to dentistry/orthodontics (50.4%), followed by orthopedics (8.1%), laparoscopic, general, and plastic surgery (7%). The telemedicine sector has grown, almost quadrupling the number of educational events offered in 2021 compared to 2019 (12 vs 46). CONCLUSIONS: Future Hta training should encompass a diverse range of thematic areas and should place particular emphasis on procurement issues, as well as the involvement of adequately trained patients and caregivers. Finally, the increase in telemedicine-focused courses during the triennium suggests the need for further reflection on this topic. KEY WORDS: Continuing medical education, Hta, medical devices, telemedicine.