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To investigate the extent to which frailty is associated with infection-related hospitalizations in older men and women, and to explore whether, among women, previous exposure to endogenous estrogens in terms of age at menopause and number of pregnancies modify such a relationship.The sample comprised 2784 participants in the Progetto Veneto Anziani aged ≥65 years. At baseline and after 4.4 years, frailty was identified according to the presence of three or more of the following: weakness, exhaustion, weight loss, low physical activity, and low walking speed. A passive follow-up on infection-related hospitalizations and mortality was performed for 10 years of observation through linkage with regional registers.The association between frailty and infection-related hospitalizations was assessed through mixed-effects Cox regressions.Frailty was significantly associated with a 78 % higher risk of infection-related hospitalization, with stronger results in men (hazard ratio = 2.32, 95 % confidence interval 1.63-3.30) than in women (hazard ratio = 1.54, 95 % confidence interval 1.18-2.02). Focusing on women, we found a possible modifying effect for the number of pregnancies but not menopausal age. Women who had experienced one or no pregnancy demonstrated a higher hazard of infection-related hospitalization as a function of frailty (hazard ratio = 3.00, 95 % confidence interval 1.58-5.71) than women who had experienced two or more pregnancies (hazard ratio = 1.68, 95 % confidence interval 1.18-2.39).Frailty in older age increases the risk of infection-related hospitalizations, especially in men. The "immunologic advantage" of the female sex in younger age seems to persist also after menopause as a function of the number of pregnancies a woman has experienced.

BackgroundIn immunosuppression after transplantation, several multi-drug approaches are used, involving calcineurin inhibitors (CNI: tacrolimus-TAC or cyclosporine-CsA), antimetabolites (antiMs), mammalian target of rapamycin inhibitors (mTORis), and corticosteroids. However, data on immunosuppressive therapy by organ and its space–time variability are lacking.MethodsAn Italian multicentre observational cohort study was conducted using health information systems. Patients with incident transplant during 2009–2019 and resident in four regions (Veneto, Lombardy, Lazio, and Sardinia) were enrolled. The post-transplant immunosuppressive regimen was evaluated by organ, region, and year.ResultsThe most dispensed regimen was triple-drug therapy for the kidneys [tacrolimus (TAC) + antiM + corticosteroids = 41.5%] and heart [cyclosporin + antiM + corticosteroids = 36.6%] and double-drug therapy for liver recipients (TAC + corticosteroids = 35.4%). Several differences between regions and years emerged with regard to agents and the number of drugs used.ConclusionA high heterogeneity in immunosuppressive therapy post-transplant was found. Further studies are needed in order to investigate the reasons for this variability and to evaluate the risk–benefit profile of treatment schemes adopted in clinical practice.

to describe trends of overall and intensive care hospitalization for COVID-19 since the beginning of the pandemic in Italy until June 2021, and to compare the results between foreign and Italian population.retrospective observational study.hospital discharges of 28 million people living in Lombardy, Piedmont, Emilia-Romagna (Northern Italy), Toscana and Lazio (Central Italy) occurred between 22.02.2020 and 02.07.2021 in the hospitals located in each considered Region.two weekly outcomes were examined: 1. the overall number of COVID-19 hospitalizations; 2. the number of COVID-19 hospitalizations in intensive care units.a higher COVID-19 overall and intensive care unit hospitalization was found among the foreign population compared to Italians. The association emerged only after the adjustment for age, and it was consistent among all Regions, though less marked in Lombardy. The association varied across epidemic phases.the issue of vulnerability of migrants to the risk of severe COVID-19 calls for a diversity-sensitive approach in prevention. The specific country of origin and the prevalence of preventable co-morbidities that are often underestimated in the migrant populations, and related to COVID-19 complications, should be taken into consideration in future analyses.

to examine the differences in SARS-CoV-2 infection and hospitalization rates among migrant populations in Veneto Region (Northern Italy), according to the geographic area of origin.all residents in Veneto Region aged65 years were included in the analyses. All subjects infected by SARS-CoV-2 and hospitalized for COVID-19 were identified by means of the regional biosurveillance system.age- and gender-specific infection and hospitalization rates were stratified by geographic area of origin and were estimated using the number of incident cases over the resident population in Veneto on 01.01.2021. Incidence rate ratios (IRR) for infection and hospitalization rates were estimated using a Poisson model, adjusted for age and gender, among migrants compared to Italians.compared to Italians, SARS-CoV-2 infection rates were significantly higher among migrants from Central and South America and Central and South Asia, lower among those from North Africa and High-Income Countries (HIC), and were approximately halved for those coming from Other Asian Countries (mainly represented by China). Hospitalization rates were significantly higher for all migrant populations when compared to Italians, with the exception of those coming from HIC. Neither age nor gender seemed to modify the association of the geographic area of origin with SARS-CoV-2 infection and hospitalization rates. IRR for SARS-CoV-2 infection of migrants compared to Italians showed how migrants from Other Asian Countries had the lowest infection rates (-53%), followed by people from HIC (-25%), North Africa (-21%), and Eastern Europe (-10%). Higher infection rates were present for Central and South America and Central and South Asia (+17% and +10, respectively). Hospitalization rates were especially high among migrants from Central and South Asia, Africa, and Central and South America, ranging from 1.84 to 3.14 times those observed for Italians.a significant heterogeneity in SARS-CoV-2 infection and hospitalization rates of migrant populations from different geographic areas of origin were observed. The significantly lower incidence rate ratio for infections, compared to that observed for hospitalizations, is suggestive of a possible under-diagnosis of SARS-CoV-2 infection among migrant populations. Public health efforts should be targeted at increasing support among migrants to contrast the spread of the pandemic by potentiating vaccination campaigns, contact tracing, and COVID-19 diagnostic tests.

to describe differences in the incidence of SARS-CoV-2 infections between Italians and foreigners residing in seven Italian Regions during the different phases of the pandemic and by gender.retrospective observational study.all confirmed SARS-CoV-2 infections from 02.02. 2020 to 16.07.2021 in the seven Regions under study were included. Italian resident population calculated by the National Institute of Statistics as of 01.01.2020 was used to calculate the rates. The considered period is divided into 5 sub-periods (phases).number of confirmed SARS-CoV-2 infections in the five phases of the pandemic and crude rates by citizenship (Italian vs foreign). Distribution of infections by age group and by week. Crude and age-adjusted incidence rates ratios (IRR) were calculated, by Region, gender, and phase of the pandemic.an epidemic curve delay was observed in foreigners in the first phase of the epidemic, in particular in the northern Regions, the most affected in that phase. The first phase of the epidemic was characterized by a greater proportion of cases occurred in people aged over 60 years than the other phases, both in Italians and in foreigners. The incidence among foreigners is higher during the summer of 2020 (intermediate period: June-September 2020) and during the last period (May-July 2021) in all Regions. The overall figure shows a lower incidence among foreigners than Italians, except for males in Tuscany.the lower incidence rates among foreigners should be interpreted with caution as the available data suggest that it is at least partly attributable to less access to diagnostic tests. Regional differences found in the study deserve further research together with the effect of gender and country of origin.

to analyze the difference of the SARS-CoV-2 infection impact between Italian and foreigner subjects, evaluating the trend of infections and access to diagnostic tests (molecular or antigenic swabs for the detection of SARS- CoV-2) in the two different populations, inducing the detection of new positive cases in the population.retrospective population study for the period February 2020-June 2021.Italian and foreign resident population on 1st January of the years 2020 and 2021 in the Regions participating to the project: Piedmont, Lombardy, Veneto, Emilia-Romagna (Northern Italy), Tuscany, Lazio (Central Italy), and Sicily (Southern Italy).in the two populations, for every week and aggregated by macropandemic period were calculated: • the test rate (people tested on the population); • the swab positivity rate (positive subjects on those who are tested); • the new positives (positive subjects on study population); • the percentage of foreigners among the new positive cases. The ratio of the value of the indicators in the foreign and Italian populations (with 95% confidence interval) was calculated to evaluate the association between nationality (Italian vs not Italian) and outcome. The analyses were conducted at the regional level and at pool level.the trend of new positives by nationality (Italian vs not Italian) has a similar tendency in the different pandemic waves. However, the incidence of new positives during pandemic waves among foreigners is lower than in Italians, while it tends to increase during intermediate periods. Except for the summer periods, foreigners are less tested than Italians, but the percentage of new positives out of the total of new ones tested is higher among foreigners compared to Italians. The relative weight of new positives among foreigners tends to increase in periods with the greatest risk of inflow of SARS-CoV-2 for foreigners.the epidemic trends in the two populations are similar, although foreigners tend to show lower incidence values, probably in part because they are tested less frequently. Furthermore, in foreigners compared to Italians, there is a greater risk of contracting SARS-CoV-2 infection, especially in periods of relaxation of containment Coronavirus measures, reopening of national borders, production and commercial activities.

Objectives To ascertain if the use of hydroxychloroquine(HCQ)/cloroquine(CLQ) and other conventional DMARDs (cDMARDs) and rheumatic diseases per se may be associated with COVID-19-related risk of hospitalization and mortality. Methods This case–control study nested within a cohort of cDMARD users was conducted in the Lombardy, Veneto, Tuscany and Lazio regions and Reggio Emilia province. Claims databases were linked to COVID-19 surveillance registries. The risk of COVID-19-related outcomes was estimated using a multivariate conditional logistic regression analysis comparing HCQ/CLQ vs MTX, vs other cDMARDs and vs non-use of these drugs. The presence of rheumatic diseases vs their absence in a non-nested population was investigated. Results A total of 1275 patients hospitalized due to COVID-19 were matched to 12 734 controls. Compared with recent use of MTX, no association between HCQ/CLQ monotherapy and COVID-19 hospitalization [odds ratio (OR) 0.83 (95% CI 0.69, 1.00)] or mortality [OR 1.19 (95% CI 0.85, 1.67)] was observed. A lower risk was found when comparing HCQ/CLQ use with the concomitant use of other cDMARDs and glucocorticoids. HCQ/CLQ was not associated with COVID-19 hospitalization as compared with non-use. An increased risk for recent use of either MTX monotherapy [OR 1.19 (95% CI 1.05, 1.34)] or other cDMARDs [OR 1.21 (95% CI 1.08, 1.36)] vs non-use was found. Rheumatic diseases were not associated with COVID-19-related outcomes. Conclusion HCQ/CLQ use in rheumatic patients was not associated with a protective effect against COVID-19-related outcomes. The use of other cDMARDs was associated with an increased risk when compared with non-use and, if concomitantly used with glucocorticoids, also vs HCQ/CLQ, probably due to immunosuppressive action.

Background Coronavirus disease 2019 (COVID-19) global pandemic has strikingly high mortality rate with hypercoagulability state being part of the imputed mechanisms. We aimed to compare the rates of in hospital mortality in propensity score matched cohorts of COVID-19 patients in chronic anticoagulation versus those that were not. Methods In this population-based study in the Veneto Region, we retrospectively reviewed all patients aged 65 years or older, with a laboratory-confirmed COVID-19 diagnosis. We compared, after propensity score matching, those who received chronic anticoagulation for atrial fibrillation with those who did not. Results Overall, 4697 COVID-19 patients fulfilled inclusion criteria, and the propensity score matching yielded 559 patients per arm. All-cause mortality rate ratio was significantly higher among non-anticoagulated patients (32.2% vs 26.5%, p = 0.036). On time to event analysis, all-cause mortality was found lower among anticoagulated patients, although the estimate was not statistically significant. (HR 0.81, 95%CI 0.65–1.01, p = 0.054). Conclusion Among elderly patients with COVID-19, those on chronic oral anticoagulant treatment for atrial fibrillation seem to be at lower risk of all-cause mortality compared to their propensity score matched non-anticoagulated counterpart. This finding needs to be confirmed in further studies., Highlights • COVID-19 infection has strikingly high mortality rate. • Hypercoagulability has been imputed as one of the pathological mechanisms. • Anticoagulation may improve outcomes in COVID-19 infection. • We found chronic anticoagulation to be related to lower mortality in COVID-19 patients.

Background: Breast, cervical, and colorectal cancer screening are evidence-based interventions recommended by most governmental agencies and scientific societies. The aim of this review is to assess the quality of guidelines on screening and to describe differences according to the context in which they were produced.Methods: A literature search of the main databases, websites on health care, and guidelines, as well as the websites of several scientific societies was carried out in order to identify the most recent guidelines (since 2000) on cervical, breast, and colorectal cancer screening. Only documents written in Italian or English were included. Two investigators independently assessed quality by using the AGREE (Appraisal of Guidelines, Research and Evaluation in Europe) instrument.Results: Thirty-three, 32, and 18 relevant documents for cervical, breast, and colorectal cancer, respectively, were identified. Only some documents (19, 12 and 13 for cervical, breast, and colorectal cancer, respectively) could be evaluated with AGREE. Items included in the domain “scope and purpose” obtained the highest scores, followed by “clarity of presentation” domain, while “applicability”, “patient involvement,” and “conflict of interest disclosure” domains obtained the lowest scores. The quality did not improve in more recent documents. Documents produced by governmental agencies, on average, had higher scores than documents by scientific societies, particularly for “stakeholder involvement” and “applicability”.Conclusions: Documents from different countries and health systems differ in terms of the main recommendations given and in the quality of the documents. Those produced by governmental agencies have a more multidisciplinary authorship and pay more attention to applicability than do those produced by scientific societies. societies.

OBJECTIVE: To estimate patient and health care delays in the diagnosis of PTB and to evaluate associated factors.METHODS: PTB incident cases ≥18 years diagnosed between September 2010 and September 2011 in the Lazio region; information on symptoms and date of onset, health professionals contacts, diagnostic exams performed, and drugs prescribed before diagnosis were collected through a standardized questionnaire. The total delay (TD) was divided into patient delay (PD: from symptoms onset to first contact with healthcare services) and health system delay (HSD: from first contact to diagnosis).RESULTS: 278 cases were evaluated. Median PD,HSD, and TD, were 31, 15, and 77.5 days, respectively. The median PD, HSD, and TD were significantly lower in foreign born patients (26, 10.5, 63.5, vs. 45, 36, 100 days, respectively). Other factors independently associated with longer delay were: absence of fever and presence of weight loss for PD; prior unspecific treatment, absence of cough, consult with a general practitioner, visit to an outpatient clinic, and a PD CONCLUSIONS: In Italy, the delay in TB diagnosis is similar to that estimated in other European countries. Results indicate that actions aimed to reduce diagnostic delay should be primarily addressed to Italian patients.

Introduction COVID-19 case fatality rate in hospitalized patients varies across countries and studies. Reliable estimates, specific for age, sex, and comorbidities, are needed to monitor the epidemic, to compare the outcome in different settings, and to correctly design trials for COVID-19 interventions. The aim of this study was to provide population-based survival curves of hospitalized COVID-19 patients. Materials and methods A cohort study was conducted in three areas of Northern Italy, heavily affected by SARS-CoV-2 infection (Lombardy and Veneto Regions, and Reggio Emilia province), using a loco-regional COVID-19 surveillance system, linked to hospital discharge databases. We included all patients testing positive for SARS-CoV-2 RNA by RT-PCR on nasopharyngeal/throat swab samples who were hospitalized from 21 February to 21 April 2020. Kaplan-Meier survival estimates were calculated at 14 and 30 days for death in any setting, stratifying by age, sex, and the Charlson Index. Results Overall, 42,926 hospitalized COVID-19 patients were identified. Patients' median age was 69 years (IQR: 57-79), 62.6% were males, and 6.0% had a Charlson Index ≥3. Survival curves showed that 22.0% (95% CI 21.6-22.4) of patients died within 14 days and 27.6% (95% CI 27.2-28.1) within 30 days from hospitalization. Survival was higher in younger patients and in females. The negative impact of comorbidities on survival was more pronounced in younger age groups. Conclusion The high fatality rate observed in the study (28% at 30 days) suggests that studies should focus on death as primary endpoint during a follow-up of at least one month.

IntroductionCardiovascular benefits deriving from physical activity are well known, but it is unclear whether physical activity trajectories in late life are associated with different risks of cardiovascular diseases.MethodsProgetto Veneto Anziani (Pro.V.A.) is a cohort study of 3099 Italians aged ≥65 years with baseline assessment in 1995–1997 and follow-up visits at 4 and 7 years. Surveillance was extended to 2018 by linkage with hospital and mortality records. Prevalent and incident cardiovascular diseases (coronary heart disease, heart failure and stroke) were identified through clinical examination, questionnaire, or hospital records. Moderate to vigorous physical activity was considered as a time-varying variable. Physical activity trajectories were categorised as: stable-low, high-decreasing, low-increasing and stable-high. Exposure was also assessed at 70, 75, 80 and 85 years.ResultsOverall, physical activity was associated with lower rates of incident cardiovascular diseases. A significant risk reduction was present among men and was stronger earlier in late life (70–75 years). Trajectories of stable-high physical activity were associated with a significantly lower risk of cardiovascular outcomes among men (HR 0.48, 95% CI 0.27 to 0.86) compared with those with stable-low trajectories (p for trend 0.002). No significant association was found with stroke. The greatest cardiovascular risk reduction was observed for >20 min/day of physical activity, and was more marked at 70 years.ConclusionIncreasingly active trajectories of physical activity were associated with lower rates of cardiovascular diseases and overall mortality. Promoting at least 20 min/day of physical activity early in late life seems to provide the greatest cardiovascular benefits.

to describe the epidemiology of SARS-CoV-2 infection in relation with the use of nasal swabs in the immigrant population in Italy, using data from the COVID-19 national surveillance system and to verify if a difference is present comparing natives and immigrant.descriptive study based on longitudinal health-administrative data.general population of six Italian Regions (Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany, Lazio) covering about 55% of the resident population and 72% of foreigners' population.regional rates of access to at least a nasal swab, separately by country of origin.across all the periods, a lower rate in the foreigners' group was observed, with the only exception of the period May-June 2021. Considering separately High Migratory Pressure Countries (HMPCs) and Highly Developed Countries (HDCs), a higher proportion of nasal swabs performed in people coming from HDC with respect to HMPCs and natives was noticed. This observation is consistent in males and females.during the first wave of the pandemic, Italians have had a higher proportion of nasal swabs compared to migrants across all Regions. This difference disappeared in the following periods, probably due to a major availability of diagnostic tests.

There has been an increase in surgical interventions in frailer elderly with concomitant chronic diseases. The purpose of this paper was to evaluate the impact of aging and comorbidities on outcomes in patients who underwent surgery for the treatment of colorectal cancer (CRC) in Veneto Region (Northeastern Italy). This is a retrospective cohort study in patients ≥ 40 years who underwent elective or urgent CRC surgical resection between January 2013 and December 2015. Independent variables included: age, sex, and comorbidities. We analyzed variables associated with the surgical procedure, such as stoma creation, hospitalization during the year before the index surgery, the surgical approach used, the American Society of Anesthesiologists (ASA) score, and the Charlson Comorbidity Index score. Eight thousand four hundred and forty-seven patients with CRC underwent surgical resection. Patient age affected both pre- and post-resection LOS as well as the overall survival (OS); however, it did not affect the 30-day readmission and reoperation rates. Multivariate analysis showed that age represented a risk factor for longer preoperative and postoperative LOS as well as for 30-day and 365-day mortality, but it was not associated with an increased risk of 30-day reoperation and 30-day readmission. Chronic Heart Failure increased the 30-day mortality risk by four times, the preoperative LOS by 51%, and the postoperative LOS by 33%. Chronic renal failure was associated with a 74% higher 30-day readmission rate. Advanced age and comorbidities require a careful preoperative evaluation and appropriate perioperative management to improve surgical outcomes in older patients undergoing elective or urgent CRC resection.

AIMS To compare mortality between anticoagulated atrial fibrillation patients and general population and among anticoagulation specific categories [direct oral anticoagulants (DOACs) vs. vitamin K antagonists(VKA)]. METHODS This was a population-based study including all residents in the Veneto Region aged 18 years or older. Administrative claims from July 2013 to September 2017 were used to identify anticoagulation-naive atrial fibrillation patients. Propensity score matching was employed to compare patients on new and old anticoagulants. RESULTS Overall, 17 225 patients on direct anticoagulants were 1 : 1 matched to patients on VKA (49% males, median age 77 years). Mortality was higher with respect to the general population by 22 and 39% among patients on direct anticoagulants and VKA, respectively. Mortality from intracranial hemorrhage in the direct anticoagulant group was similar to that in the general population [standardized mortality ratio: 1.06, 95% confidence intervals (CI) 0.76-1.48], whereas it almost doubled in VKA group (1.92, 95% CI 1.49-2.46). When directly compared with the VKA cohort, the risk of death from intracranial hemorrhage halved with DOACs (hazard ratio 0.56, 95% CI 0.37-0.84). CONCLUSION The mortality rate of anticoagulated atrial fibrillation patients is increased with respect to the general population, particularly among patients treated with VKAs. The mortality rate for intracranial bleeding with DOACs is similar to that observed in the general population.

to assess the impact of a cement plant emissions on mortality, hospitalizations, and cancer incidence in the residents of the municipality of Pederobba (Veneto Region, Northern Italy).retrospective residential cohort study.the study was conducted in Pederobba and in 7 neighbouring municipalities (Cavaso Del Tomba, Cornuda, Crocetta del Montello, Monfumo, Segusino, Valdobbiadene, Vidor). The cohort included 12,116 residents in Pederobba (151,784 person-years) and 49,004 residents in the neighbouring municipalities (660,268 person-years) in the period 1996-2017. On the basis of the model estimate of the annual average concentration of nitrogen dioxide (NO2), the municipality of Pederobba was divided into an area with higher exposure of NO2 and another one at lower exposure of NO2. Two comparisons were made: the first between the residents in Pederobba and residents in the neighbouring municipalities; the second between people residing in Pederobba in the higher and in the lower exposure areas.analysis of cause-specific mortality and hospitalization and cancer incidence, with particular attention to the diseases for which there is evidence of association with exposure to air-pollutants. For cancer incidence, available data were limited to the municipalities of Pederobba, Cavaso Del Tomba, Cornuda, Crocetta del Montello, and Monfumo for the period 1996-2015.the comparison among Pederobba and the 7 neighbouring municipalities showed that within Pederobba residents there was: • a slight increase in the risk of death from all causes in women, due to circulatory diseases (HR 1.29; 95%CI 1.15-1.45), in particular ischaemic heart disease (HR 1.55; 1.27-1.89) and cerebrovascular diseases (HR 1.35; 1.06-1.72); • a moderate increase in hospitalizations for circulatory diseases, such as heart failure (HR 1.17; 1.00-1.37) and cerebrovascular diseases (HR 1.41; 1.17 -1.70), especially in elderly women; • a slight increase in hospitalizations for respiratory diseases, especially in older women (HR 1.19; 1.04-1.37); • no difference were observed in cancer incidence, neither for all nor for single cancer sites, in both genders.The comparison between residents in the higher exposure area and those in the lower exposure area showed no difference in mortality, hospitalizations, and cancer incidence.higher mortality and hospitalization rates from circulatory and respiratory causes detected in Pederobba compared to the neighbouring municipalities were not confirmed by the comparison between residents in the higher and in the lower exposure area. Overall, data did not show a clear, well-characterized relationship between the exposure to pollutants emitted by the cement plant and the onset of chronic diseases. The excess of mortality and hospitalization for cardiovascular and cerebrovascular diseases, reported especially in older women, deserves further investigation, because of the complex cause-effect relations of these diseases.

Anticoagulation therapy is central for the management of stroke in patients with non-valvular atrial fibrillation (NVAF). Persistence with oral anticoagulation is essential to prevent thromboembolic complications.We performed a population-based retrospective cohort study in the Veneto Region (north-eastern Italy, about 5 million inhabitants) using the regional health system databases. Naïve patients initiating direct oral anticoagulants (DOACs) for stroke prevention in NVAF from July 2013 to September 2017 were included in the study. Patients were identified using Anatomical Therapeutic Chemical (ATC) codes, excluding other indications for anticoagulation therapy using ICD-9CM codes. Treatment persistence was defined as the time from initiation to discontinuation of the therapy, including any therapeutic switching among DOACs. Baseline characteristics and comorbidities associated to the persistence of therapy with DOACs were explored by means of Kaplan-Meier curves and assessed through Cox regression.Naïve patients initiating direct oral anticoagulants for stroke prevention in NVAF identified in a 4.25-year period are 17,920. After one year, the persistence to the DOACs is 72.9%. Approximately 9.8% of the discontinuations are due to switch to vitamin k antagonists (VKAs). On multivariate analysis, factors negatively affecting persistence were female gender, age65 years, renal disease and history of bleeding. On the other hand, persistence was better in patients with hypertension, previous cerebral ischemic events, and previous acute myocardial infarction.In this study of real world data, one out four naive patients stopped treatment with DOACs within 12 months. Some characteristics may identify patients with poor persistence.

The age- and gender-related cardio-metabolic changes may limit the applicability of guidelines for the prevention of cardiovascular diseases (CVD) in older people. We investigated the association of cardiovascular risk profile with 20-year all-cause and CVD-mortality in older adults, focusing on age- and gender-specific differences. This prospective study involved 2895 community-dwelling individuals aged ≥65 years who participated in the Pro.V.A study. The sum of achieved target levels (smoking, diet, physical activity, body weight, blood pressure, lipids, and diabetes) recommended by the European Society of Cardiology 2016 guidelines was assessed in each participant. From this sum, cardiovascular risk profile was categorised as very high (0-2), high (3), medium (4), low (5), and very low (6-7 target levels achieved). All-cause and CV mortality data over 20 years were obtained from health registers. At Cox regression, lower cardiovascular risk profile was associated with reduced 20-year all-cause mortality in both genders, with stronger results for women (HR = 0.42 [95%CI:0.25-0.69] and HR = 0.61 [95%CI:0.42-0.89] for very low vs. very high cardiovascular risk profile in women and men, respectively). This trend was more marked for CVD mortality. Lower cardiovascular risk profile was associated with reduced all-cause and CVD mortality only in men 75 years, while the associations persisted in the oldest old women. A lower cardiovascular risk profile, as defined by current guidelines, may reduce all-cause and CVD mortality in older people, with stronger and longer benefits in women. These findings suggest that personalised and life-course approaches considering gender and age differences may improve the delivery of preventive actions in older people.The online version contains supplementary material available at 10.1007/s10433-021-00620-y.

Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review published in 2007, 2009, 2010, and 2011. The evidence summarised in this review does not include results from studies from the current COVID-19 pandemic.To assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses.We searched CENTRAL, PubMed, Embase, CINAHL on 1 April 2020. We searched ClinicalTrials.gov, and the WHO ICTRP on 16 March 2020. We conducted a backwards and forwards citation analysis on the newly included studies.We included randomised controlled trials (RCTs) and cluster-RCTs of trials investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, and gargling) to prevent respiratory virus transmission. In previous versions of this review we also included observational studies. However, for this update, there were sufficient RCTs to address our study aims. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence. Three pairs of review authors independently extracted data using a standard template applied in previous versions of this review, but which was revised to reflect our focus on RCTs and cluster-RCTs for this update. We did not contact trialists for missing data due to the urgency in completing the review. We extracted data on adverse events (harms) associated with the interventions.We included 44 new RCTs and cluster-RCTs in this update, bringing the total number of randomised trials to 67. There were no included studies conducted during the COVID-19 pandemic. Six ongoing studies were identified, of which three evaluating masks are being conducted concurrent with the COVID pandemic, and one is completed. Many studies were conducted during non-epidemic influenza periods, but several studies were conducted during the global H1N1 influenza pandemic in 2009, and others in epidemic influenza seasons up to 2016. Thus, studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID-19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high-income countries; crowded inner city settings in low-income countries; and an immigrant neighbourhood in a high-income country. Compliance with interventions was low in many studies. The risk of bias for the RCTs and cluster-RCTs was mostly high or unclear. Medical/surgical masks compared to no masks We included nine trials (of which eight were cluster-RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and seven in the community). There is low certainty evidence from nine trials (3507 participants) that wearing a mask may make little or no difference to the outcome of influenza-like illness (ILI) compared to not wearing a mask (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.82 to 1.18. There is moderate certainty evidence that wearing a mask probably makes little or no difference to the outcome of laboratory-confirmed influenza compared to not wearing a mask (RR 0.91, 95% CI 0.66 to 1.26; 6 trials; 3005 participants). Harms were rarely measured and poorly reported. Two studies during COVID-19 plan to recruit a total of 72,000 people. One evaluates medical/surgical masks (N = 6000) (published Annals of Internal Medicine, 18 Nov 2020), and one evaluates cloth masks (N = 66,000). N95/P2 respirators compared to medical/surgical masks We pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). There is uncertainty over the effects of N95/P2 respirators when compared with medical/surgical masks on the outcomes of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; very low-certainty evidence; 3 trials; 7779 participants) and ILI (RR 0.82, 95% CI 0.66 to 1.03; low-certainty evidence; 5 trials; 8407 participants). The evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirator compared to a medical/surgical mask probably makes little or no difference for the objective and more precise outcome of laboratory-confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; moderate-certainty evidence; 5 trials; 8407 participants). Restricting the pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies. One ongoing study recruiting 576 people compares N95/P2 respirators with medical surgical masks for healthcare workers during COVID-19. Hand hygiene compared to control Settings included schools, childcare centres, homes, and offices. In a comparison of hand hygiene interventions with control (no intervention), there was a 16% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.84, 95% CI 0.82 to 0.86; 7 trials; 44,129 participants; moderate-certainty evidence), suggesting a probable benefit. When considering the more strictly defined outcomes of ILI and laboratory-confirmed influenza, the estimates of effect for ILI (RR 0.98, 95% CI 0.85 to 1.13; 10 trials; 32,641 participants; low-certainty evidence) and laboratory-confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials; 8332 participants; low-certainty evidence) suggest the intervention made little or no difference. We pooled all 16 trials (61,372 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. The pooled data showed that hand hygiene may offer a benefit with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.84 to 0.95; low-certainty evidence), but with high heterogeneity. Few trials measured and reported harms. There are two ongoing studies of handwashing interventions in 395 children outside of COVID-19. We identified one RCT on quarantine/physical distancing. Company employees in Japan were asked to stay at home if household members had ILI symptoms. Overall fewer people in the intervention group contracted influenza compared with workers in the control group (2.75% versus 3.18%; hazard ratio 0.80, 95% CI 0.66 to 0.97). However, those who stayed at home with their infected family members were 2.17 times more likely to be infected. We found no RCTs on eye protection, gowns and gloves, or screening at entry ports.The high risk of bias in the trials, variation in outcome measurement, and relatively low compliance with the interventions during the studies hamper drawing firm conclusions and generalising the findings to the current COVID-19 pandemic. There is uncertainty about the effects of face masks. The low-moderate certainty of the evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of randomised trials did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks during seasonal influenza. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness. Harms associated with physical interventions were under-investigated. There is a need for large, well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, especially in those most at risk of ARIs.

BackgroundCOVID-19 case fatality rate in hospitalized patients varies across countries and studies, but reliable estimates specific for age, sex, and comorbidities are needed to design trials for COVID-19 interventions. Aim of this study is to provide population-based survival curves of hospitalized COVID-19 patients.MethodsA cohort study was conducted in Lombardy, Veneto, and Reggio Emilia using COVID-19 registries linked to hospital discharge databases containing patient clinical histories. All patients with positive SARS-CoV-2 RT-PCR test on oral/nasopharyngeal swabs hospitalized from 21st February to 21st April 2020 were identified. Kaplan Meier survival estimates were calculated at 14 and 30 days for death in any setting, stratifying by age, sex and Charlson Index.FindingsOverall, 42,926 hospitalized COVID-19 patients were identified. Patients’ median age was 69 years (IQR: 57-79), 62·6% were males, 69·4% had a Charlson Index of 0. In total, 11,205 (26·1%) patients died over a median follow-up of 24 days (IQR: 10-35). Survival curves showed that 22·0% of patients died within 14 days and 27·6% within 30 days of hospitalization. Survival was higher in younger patients and in females. Younger patients with comorbidities had a lower survival than older ones with comorbidities.InterpretationOver 27% of hospitalized COVID-19 patients died within one month in three areas of Northern Italy that were heavily affected by SARS-CoV-2 infection. Such a high fatality rate suggests that trials should focus on survival and have follow-up of at least one month.FundingThe study did not receive any external funding.Research in contextEvidence before this studyTwo recent systematic reviews with meta-analyses report case fatality rates of three to four percent in COVID-19 patients. Most studies on hospitalized cohorts report only slightly higher figures. These figures do not correspond to those derived from routinely collected clinical data in most European countries, reporting a 10% case fatality rate which has been increasing over time since the epidemic started.Robust and precise survival estimates of hospitalized COVID-19 patients which take into account prognostic factors such as age, sex and burden of comorbidities are needed to design appropriate phase II and phase III clinical studies of drugs targeting COVID-19.Added value of this studyIn this study we present the first survival estimates by age, sex and Charlson index for a large population-based cohort of Italian hospitalized COVID-19 patients.Implications of all the available evidenceOver 27% of COVID-19 patients died within one month from hospital admission. Such a high fatality rate suggests that studies should prioritize mortality as primary outcome. Furthermore, we found that the fatality rate reaches a plateau 30 days after hospitalization, suggesting that studies should have at least one month of follow up to observe deaths; shorter follow-up could lead to overestimation of treatment benefits.

OBJECTIVETo assess the effectiveness of hand hygiene, surface disinfecting, and other hygiene interventions in preventing or reducing the spread of illnesses from respiratory viruses.DESIGNUpdate of a systematic review and meta-analysis focussing on randomised controlled trials (RCTs) and cluster-RCTs (c-RCTs) evidence only.DATA SOURCESEligible trials from the previous Cochrane review, search of the Cochrane Central Register of Controlled Trials, PubMed, Embase and CINAHL from 01 October 2010 to 01 April 2020, and forward and backward citation analysis of included studies.DATA SELECTIONRCTs and c-RCTs involving people of any age, testing the use of hand hygiene methods, surface disinfection or cleaning, and other miscellaneous barrier interventions. Face masks, eye protection, and person distancing are covered in Part 1 of our systematic review. Outcomes included acute respiratory illness (ARI), influenza-like illness (ILI) or laboratory-confirmed influenza (influenza) and/or related consequences (e.g. death, absenteeism from school or work).DATA EXTRACTION AND ANALYSISSix authors working in pairs independently assessed risk of bias using the Cochrane tool and extracted data. The generalised inverse variance method was used for pooling by using the random-effects model, and results reported with risk ratios (RR) and 95% confidence intervals (CIs).RESULTSWe identified 51 eligible trials. We included 25 randomised trials comparing hand hygiene interventions with a control; 15 of these could be included in meta-analyses. We pooled 8 trials for the outcome of ARI. Hand hygiene showed a 16% relative reduction in the number of participants with ARI (RR 0.84, 95% CI 0.82 to 0.86) in the intervention group. When we considered the more strictly defined outcomes of ILI and influenza, the RR for ILI was 0.98 (95% CI 0.85 to 1.14), and for influenza the RR was 0.91 (95% CI 0.61 to 1.34). Three trials measured absenteeism. We found a 36% relative reduction in absentee numbers in the hand hygiene group (RR 0.64, 95% CI 0.58 to 0.71). Comparison of different hand hygiene interventions did not favour one intervention type over another. We found no incremental effects of combining hand hygiene with using face masks or disinfecting surfaces or objects.CONCLUSIONSDespite the lack of evidence for the impact of hand hygiene in reducing ILI and influenza, the modest evidence for reducing the burden of ARIs, and related absenteeism, justifies reinforcing the standard recommendation for hand hygiene measures to reduce the spread of respiratory viruses. Funding for relevant trials with an emphasis on adherence and compliance with such a measure is crucial to inform policy and global pandemic preparedness with confidence and precision.

BACKGROUND: the Covid-19 pandemic has provoked a huge of clinical and epidemiological research initiatives, especially in the most involved countries. However, this very large effort was characterized by several methodological weaknesses, both in the field of discovering effective treatments (with too many small and uncontrolled trials) and in the field of identifying preventable risks and prognostic factors (with too few large, representative and well-designed cohorts orcase-control studies). OBJECTIVES: in response to the fragmented and uncoordinatedresearch production on Covid-19, the italian Association of Epidemiology (AIE) stimulated the formation of a working group (WG) with the aims of identifying the most important gaps in knowledge and to propose a structured research agenda of clinical and epidemiological studies considered at high priority on Covid-19, including recommendations on the preferable methodology. METHODS: the WG was composed by 25 subjects, mainly epidemiologists, statisticians, and other experts in specific fields, who have voluntarily agreed to the proposal. The agreement on a list of main research questions and on the structure of the specific documents to be produced were defined through few meetings and cycles of document exchanges. RESULTS: twelve main research questions on Covid-19 were identified, covering aetiology, prognosis,interventions, follow-up and impact on general and specific populations (children, pregnant women). For each of them, a two-page form was developed, structured in: background, main topics, methods (with recommendations on preferred study design and warnings for bias prevention) and an essential bibliography. CONCLUSIONS: this research agenda represents an initial contribution to direct clinical and epidemiological research efforts on high priority topics with a focus on methodological aspects. Further development and refinements of this agenda by Public Health Authorities are encouraged.

Aim: The use of oral anticoagulant drugs in patients with atrial fibrillation and one non-gender related risk factors is challenging. We compared the efficacy and safety of DOACs vs VKAs in low risk patients. Methods: We performed a population-based retrospective cohort study in anticoagulation-naive atrial fibrillation patients. The cohort was identified, characterized and followed-up using data from administrative claims, drug prescriptions archive, and regional inpatient and discharge register. Event-rates were assessed using as treated analysis. Hazard ratios (HR) of stroke and major bleeding were estimated by Cox regression analysis. Results: Overall, we identified 1829 patients treated with DOACs and 6083 patients treated with VKAs, that accumulated 2097 and 4681 person-years of follow up, respectively. Half of patients were in the 65-75 age group, while almost 38% were female. Stroke rates were lower with DOACs as compared to VKAs: 0.14% person-years versus 0.28% person-years (HR 0.50, 95%CI 0.14–1.74). Major bleeding (0.81% person-years versus 1.09% person-years (HR 0.80, 95%CI 0.46–1.40)) and intracranial hemorrhage (0.33% person-years versus 0.42% person-years (HR 0.85, 95%CI 0.36–2.04) were also lower with DOACs. Mortality rate with DOACs was 1.2% person-years and 1.1 person-years with VKA (HR 1.21, 95%CI 0.74-1.96) mostly driven by death from cancer in the DOACs group. Conclusions: In low risk patients with atrial fibrillation, there is a benefit (although non-significant) with DOACs as compared to VKAs. Other studies are required to directly test this finding.

Background The Italian National Health Service (NHS) provides universal coverage to all citizens, granting primary and hospital care with a copayment system for outpatient and drug services. Financing of Local Health Trusts (LHTs) is based on a capitation system adjusted only for age, gender and area of residence. We applied a risk-adjustment system (Johns Hopkins Adjusted Clinical Groups System, ACG® System) in order to explain health care costs using routinely collected administrative data in the Veneto Region (North-eastern Italy). Methods All residents in the Veneto Region were included in the study. The ACG system was applied to classify the regional population based on the following information sources for the year 2015: Hospital Discharges, Emergency Room visits, Chronic disease registry for copayment exemptions, ambulatory visits, medications, the Home care database, and drug prescriptions. Simple linear regressions were used to contrast an age-gender model to models incorporating more comprehensive risk measures aimed at predicting health care costs. Results A simple age-gender model explained only 8% of the variance of 2015 total costs. Adding diagnoses-related variables provided a 23% increase, while pharmacy based variables provided an additional 17% increase in explained variance. The adjusted R-squared of the comprehensive model was 6 times that of the simple age-gender model. Conclusions ACG System provides substantial improvement in predicting health care costs when compared to simple age-gender adjustments. Aging itself is not the main determinant of the increase of health care costs, which is better explained by the accumulation of chronic conditions and the resulting multimorbidity.

Introduction Anticoagulation therapy is central for the management of stroke in patients with non-valvular atrial fibrillation (NVAF). Persistence with oral anticoagulation is essential to prevent thromboembolic complications. Purpose To assess persistence levels of DOACs and look for possible predictors of treatment discontinuity in NVAF patients. Methods We performed a population-based retrospective cohort study in the Veneto Region (north-eastern Italy, about 5 million inhabitants) using the regional health system databases. Naïve patients initiating direct oral anticoagulants (DOACs) for stroke prevention in NVAF from July 2013 to September 2017 were included in the study. Patients were identified using Anatomical Therapeutic Chemical (ATC) codes, excluding other indications for anticoagulation therapy using ICD-9CM codes. Treatment persistence was defined as the time from initiation to discontinuation of the therapy. Baseline characteristics and comorbidities associated to the persistence of therapy with DOACs were explored by means of Kaplan-Meier curves and assessed through Cox regression. Results Overall, 17920 patients initiated anticoagulation with DOACs in the study period. Most patients were older than 74 years old, while gender was almost equally represented. Comorbidities included hypertension (72%), diabetes mellitus (17%), congestive heart failure (9%), previous stroke/TIA (20%), and prior myocardial infarction (2%). After one year, the persistence to anticoagulation treatment was 82.7%, while the persistence to DOAC treatment was 72.9% with about 10% of the discontinuations being due to switch to VKAs. On multivariate analysis, factors negatively affecting persistence were female gender, younger age ( Persistence to DOAC therapy Conclusion This real-world data show that within 12 months, one out of four anticoagulation-naïve patients stop DOACs, while one out of five patients stop anticoagulation. Efforts should be made to correct modifiable predictors and intensify patient education.

Background Only fragmentary data are available on the burden of non-communicable diseases among immigrants in Europe, mostly limited to mortality by cause. Aim of the study is to investigate the prevalence of cardiovascular diseases across different immigrant groups in the Veneto Region (North-Eastern Italy). Methods The resident population aged 20–59 was classified according to country of citizenship. The Adjusted Clinical Groups System was adopted to identify selected cardiovascular conditions by linkage of Hospital Discharge Records, Emergency Room visits, Chronic disease registry for copayment exemptions, the Home care database, and drugs reimbursed by the Regional Health Service. Age standardized prevalence rates were compared across population groups, and rate ratios (RR) with 95% confidence intervals (CI) were computed taking the Italian population as reference. Results The prevalence of diabetes was higher across all immigrant groups compared to Italians. Specific risk patterns could be identified associated to different ethnicities: South Asian immigrants were at very high risk of diabetes, dyslipidemia, and ischemic heart disease (males RR 2.3, CI 1.9–2.8; females RR 2.0, CI 1.2–3.5). Immigrants from Africa were affected by high rates of hypertension, cerebrovascular diseases, and heart failure, with a more pronounced unfavorable profile among females (hypertension RR 3.0, CI 2.6–3.3; cerebrovascular diseases RR 1.7, CI 1.1–2.7). Conclusions Wide differences in the prevalence of cardiovascular diseases could be detected across immigrant groups. These findings represent a first step towards systematic chronic disease surveillance by ethnicity, a fundamental tool for shaping culturally-tailored prevention strategies.

To investigate the excess mortality registered in the Veneto Region (Northern Italy) in 2015. A Seasonal Autoregressive Integrated Moving Average Model was applied to predict overall mortality expected in 2014–2015 based on that observed in 2000–2013. The annual percent change in age-standardized rates (APC) was estimated for specific causes of death in 2007–2015. Compared to 2014, the number of deaths and the overall age-standardized mortality increased in 2015 by 7.8 and 4.5%, respectively. When accounting for time trends, the observed mortality was lower than expected in 2014 (−4.5%) and slightly higher in 2015 (+1.1%). In 2015, mortality increased especially for causes with an already rising trend: neurologic/psychiatric (APC = 1.2; 95% Confidence Interval 0.3–2.0%) and infectious diseases (APC = 5.9; 3.6–8.2%). Short-term changes and long-term trends in mortality must be interpreted within the frame of a rapid growth in the population of elderly subjects affected by multiple comorbidities.

The knowledge of ethnic-specific health needs is now essential to design effective health services and population-based prevention strategies. However, data on migrant populations living in Southern Europe are limited. The study is designed to investigate ethnic inequalities in hospitalization for acute myocardial infarction (AMI) in the Veneto region (Italy). Hospital admissions for AMI in Veneto for the whole resident population aged 20-59 years during 2008-2013 were studied. Age and gender-specific AMI hospitalization rates for immigrant groups (classified by country of origin according to the United Nations geoscheme) and Italians were calculated. The indirect standardization method was used to estimate standardized hospitalization ratios (SHR) for each immigrant group, with rates of Italian residents as a reference. Overall, 8200 AMI events were retrieved, 648 among immigrants. The highest risk of AMI is seen in South Asians males (SHR 4.2, 95% CI 3.6-4.9) and females (SHR 2.5, 95% CI 1.4-4.5). AMI rates in South Asian males sharply increase in the 30-39 years age class. Other immigrant subgroups (Eastern Europe, North Africa, Sub-Saharan Africa, other Asian countries, Central-South America, high-income countries) displayed age- and gender-adjusted hospitalization rates similar to the native population. Present findings stress the urgent need for implementation of ethnic-specific health policies in Italy. The awareness about the high cardiovascular risk in subjects from South Asia must be increased among general practitioners and immigrant communities.

Ugo Fedeli,1 Alfredo De Giorgi,2 Nicola Gennaro,1 Eliana Ferroni,1 Massimo Gallerani,3 Dimitri P Mikhailidis,4 Roberto Manfredini,2 Fabio Fabbian2 1Epidemiological Department, Veneto Region, 2Department of Medical Sciences, Clinica Medica Unit, School of Medicine, University of Ferrara, 3Department of Internal Medicine, University Hospital of Ferrara, Ferrara, Italy; 4Department of Clinical Biochemistry (Vascular Disease Prevention Clinic), University College London Medical School, London, UK Background: COPD is among the major causes of death, and it is associated with several comorbid conditions. Chronic kidney disease (CKD) is frequently diagnosed in older people living in Western societies and could impact COPD patients’ mortality. We evaluated the relationship between burden of comorbidities, CKD, and mortality in a population-based cohort of patients discharged with a diagnosis of COPD.Methods: A longitudinal cohort study was conducted evaluating 27,272 COPD patients. Recruitment of COPD subjects and identification of CKD and other comorbidities summarized by the Charlson comorbidity index (CCI) were based on claims data coded according to the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). Severity of COPD was classified by hospital diagnosis or exemption from medical charges due to respiratory failure or previous hospitalizations for COPD. The impact of comorbidities on survival was assessed by Cox regression.Results: Less than 40% of patients were still alive at the end of a median follow-up of 37months (17months for patients who died and 56months for those alive at the end of follow-up). After adjustment for age, gender, and severity score of COPD, CKD (hazard ratio=1.36, 95% confidence interval 1.30–1.42) independently from comorbidities summarized by the CCI was a significant risk factor for mortality.Conclusion: In spite of limitations due to the use of claims data, long-term survival of COPD patients was heavily affected by the presence of CKD and other comorbidities. Keywords: COPD, chronic kidney disease, Charlson comorbidity index, mortality, comorbidity

Combined inhaled therapy in chronic obstructive pulmonary disease (COPD) is commonly used, but its benefits remain controversial. We assessed the effect of tiotropium in reducing COPD exacerbations when combined with long-acting β2 agonists (LABA) and/or inhaled corticosteroids (ICS). This new-user cohort study is based on administrative data from 3 Italian regions. We identified adults hospitalized for COPD from 2006 to 2009 who were newly prescribed a fixed LABA/ICS combination (double therapy). We classified patients according to whether tiotropium was also prescribed (triple therapy), using both intention-to-treat and as-treated approaches, and followed them for 1 year. COPD exacerbations were measured as outcomes. Multivariate and propensity score-adjusted hazard ratios (HRs, 95%CI) were calculated with Cox regression models. We identified 5717 new users of LABA/ICS of which 31.9% initiated triple therapy. In the intention-to-treat analysis, the multivariate adjusted HR for moderate, severe, and any exacerbations were 1.02 (95%CI 0.89-1.16), 0.92 (95%CI 0.76-1.12), and 1.08 (95%CI 0.91-1.28), respectively. The propensity score adjustment produced similar results. In the subcohort of patients with previous exacerbations, triple therapy was significantly associated with reduced risk of moderate exacerbations, compared to double therapy (HR 0.68, 95%CI 0.48-0.98 in intention-to-treat approach). In conclusion, the addition of tiotropium to LABA/ICS did not reduce COPD exacerbations compared to LABA/ICS alone. A protective role for moderate exacerbations was found in patients at risk of frequent exacerbations. Given the impact of exacerbations on health status and prognosis, it is crucial to target COPD patients for optimal treatment.

INTRODUZIONE Ragazzi e ragazze, uomini e donne si differenziano biologicamente e nelle loro relazioni sociali e di potere lungo tutto l'arco della loro vita. In epidemiologia ambientale i termini sesso (legato alla dimensione biologica) e genere (legato alla dimensione sociale) sono spesso confusi e usati in modo intercambiabile, trascurando il fatto che le 2 dimensioni interagiscono tra loro e che entrambe possono l'influenzare esposizione ed effetto. OBIETTIVI Se la dimensione di genere è rilevante nel definire l'esposizione e il percorso concentrazione- esposizione, la dimensione biologica lo è nel percorso esposizione-dose-dose efficace-effetto sanitario, che a sua volta può essere influenzato da differenze di genere nel riconoscimento della malattia e nell'accesso all'assistenza. L'applicazione di una adeguata metodologia possono evitare di incorrere in errori, quali la ricerca di una concordanza tra i dati riferiti ai due sessi, interpretata come elemento rafforzativo dell'evidenza. METODI Due studi epidemiologici vengono riletti attraverso le evidenze derivate dalla letteratura scientifica internazionale sulle differenze di genere in epidemiologia. Il primo riguarda gli effetti a breve termine dell'inquinamento atmosferico sulla salute a Brindisi. Il secondo è uno studio di coorte su mortalità e ricoveri a Viggiano e Grumento Nova in Basilicata. RISULTATI In entrambi gli studi emergono differenze significative tra i due generi. Nel caso di Brindisi si registra un incremento statisticamente significativo di ricoveri per cause respiratorie per le donne per incrementi di concentrazione di NO2. Nello studio di coorte nelle aree a maggiore esposizione è stato stimato un rischio maggiore di mortalità per cause circolatorie più forte per le donne. Le ipotesi esplicative discusse in letteratura sono indirizzate a sottolineare sia la dimensione di suscettibilità biologica che quella socioculturale. Nell'ultimo caso la relazione genere-esposizione può essere approfondita attraverso il diverso ruolo sociale e occupazionale, che porterebbe i maschi a trascorrere un tempo maggiore lontano dalla residenza, indebolendo l'efficacia della matrice spaziale di esposizione. CONCLUSIONI Oltre a migliorare l'interpretazione dei risultati di uno studio epidemiologico, l'analisi di genere può contribuire a chiarire le differenze di possibili fonti di modificazione degli effetti e mirare opportunamente gli interventi di salute pubblica. La stratificazione dei dati epidemiologici per genere rappresenta solo un punto di partenza. Le evidenze scientifiche a cui si ispira il Piano Nazionale per la medicina di genere mettono in evidenza come sia necessario analizzare sempre le domande di ricerca iniziali, che nel caso dell'epidemiologia ambientale vuol dire cercare di capire se e quanto tali domande catturino adeguatamente l'esposizione di uomini e donne e se non esistano bias di genere negli indicatori di outcome sanitari considerati.

Background Sparse population-based data are available on the prevalence and etiology of chronic liver disease (CLD) in Italy. The study aims to assess the role of hepatitis B virus (HBV) and hepatitis C virus (HCV) infection in CLD according to age, gender and ethnicity. Methods Clinically diagnosed CLD in the general population aged 20–59 years in the Veneto Region (North-Eastern Italy) were identified through the Adjusted Clinical Groups System, by record linkage of the archive of subjects enrolled in the Regional Health System with Hospital Discharge Records, Emergency Room visits, Chronic disease registry for copayment exemptions, and the Home care database. Age-standardized prevalence rates (PR) were computed in Italians and immigrants, based on country of citizenship. Results Overall 22,934 subjects affected by CLD in 2016 were retrieved, 21% related to HBV and 43% to HCV infection. The prevalence of HCV-related CLD was higher in males, peaking at 50–54 years (males = 11/1000; females = 4/1000). The PR of HBV-related CLD was almost negligible in the Italian population (1/1000), and higher among immigrants, especially from East Asia (males = 17/1000; females = 11/1000) and Sub-Saharan Africa (males = 13/1000; females = 10/1000). Conclusion Specific population sub-groups identified by age, gender, and ethnicity, were demonstrated to be at increased risk, and these trends are in line with global epidemiological patterns of viral hepatitis.

Based on different estimation methods, mortality attributable to atrial fibrillation (AF) has been demonstrated to increase over time in developed countries, reaching a share ranging from 1% to 5% of overall deaths. To assess the whole burden of AF-associated mortality, all diseases mentioned in death certificates of subjects aged ≥45 years resident in the Veneto Region (Northeastern Italy) were analyzed for the 2008 to 2013 period. The prevalence of common chronic co-morbidities was compared between deaths with mention of AF and a sample of age-matched deaths without reported AF. The disease was mentioned among conditions contributing to death in 25,834 subjects, corresponding to 9.8% of all regional deaths. Rates of AF-associated mortality were higher in men and increased steeply with age, being above 1 per 100 among residents aged ≥85 years. Compared with non-AF-associated deaths, the strongest associations were observed between AF and hypertensive diseases (prevalence ratio 1.62, 95% CI 1.57 to 1.67), cardiac valve disorders (2.43, 2.25 to 2.61), cardiomyopathies (1.93, 1.70 to 2.19), cerebrovascular diseases (1.55, 1.50 to 1.60), and chronic obstructive pulmonary disease (1.49, 1.42 to 1.57). AF-associated mortality resulted higher than previously reported, probably due to aging of the population with multiple predisposing diseases, an increased recognition of AF among the elderly, and a raised awareness of certifying physicians about the importance of AF. Analyses of all diseases mentioned in death certificates underscored the interaction of AF with several other circulatory and respiratory disorders in pathologic networks leading to an increased risk of death.

Aims We assessed the influence of patient and General Practitioner (GP) characteristics on the adherence to process of care indicators for non-insulin-treated type 2 diabetes management in the Veneto Region (northeastern Italy). Methods Among non-insulin-treated diabetic patients aged 18–84 years identified by multiple information sources, we assessed the measurement of glycated hemoglobin, microalbumin, and lipids through the year 2013. Patients’ variables included gender, age, citizenship, and the attendance to Diabetes Clinics, while GP characteristics were gender, age and an attitude score derived from a questionnaire. The influence of patient and GP variables were investigated through multilevel regression with the execution of two HbA1c tests in 2013 as the outcome. Results Out of 139,935 study subjects, more than 70% had at least one HbA1c test in 2013; this percentage decreased to about 40% for two HbA1c examinations. 67% of patients had an assessment of lipid profile, while 45% underwent a microalbumin test. These percentages were lower for immigrant patients and increased with age until the 65–74 years age class. Patients attending Diabetes Clinics were usually better monitored than those who did not. In this latter group, female gender (risk ratio 1.08, 1.02–1.14), younger age (risk ratio 1.15, 1.06–1.25) and high attitude score of GPs (risk ratio 1.20, 1.13–1.27) were associated with a better management. Conclusions Both patient and GP variables influence the adherence to process of care indicators. The implementation of effective strategies of disease management at the primary care level may improve the control of glycemic and cardiovascular risk factors.

The laparoscopic approach is increasingly adopted in colorectal cancer surgery; however, its role in elderly patients is controversial. We sought to examine the relationship between age and short-term outcomes following laparoscopic surgery for colorectal cancer (CRC). Data of patients 65 + years old who underwent laparoscopic surgery for CRC between 2002 and 2014 were retrieved from the administrative National Italian Hospital Discharge Dataset. Patients were divided into three age categories (65–74, 75–84, and 85 +). The impact of age on length of stay, 30-day readmission, in-hospital mortality, and postoperative complications was evaluated. During the study period, 47,704 patients underwent laparoscopic surgery for CRC. The median postoperative length of stay was 9 days, and 30-day readmission and in-hospital mortality were 4.4% and 0.9%, respectively. Age was found to be an independent risk factor of prolonged length of stay and increased in-hospital mortality. With respect to patients in 65–74 years age category, patients aged 75–84 years and those aged 85 + years had a higher risk of complications (OR 1.43, 95% CI 1.36–1.50, and OR 2.00, 95% CI 1.83–2.17, respectively). However, no statistically significant association was found between age and anastomotic leakage or surgical site infection (p = 0.29, and p = 0.58, respectively). In patients with CRC who underwent laparoscopic surgery, age was found to be an independent risk factor for prolonged length of stay, in-hospital mortality, and global postoperative complications. These findings should be considered when planning laparoscopic surgery in elderly patients.

Public health strategies for malaria in endemic countries aim to prevent transmission of the disease and control the vector. This historical analysis considers the strategies for vector control developed during the first four decades of the twentieth century. In 1925, policies and technological advances were debated internationally for the first time after the outbreak of malaria in Europe which followed World War I. This dialogue had implications for policies in Europe, Russia and the Middle East, and influenced the broader international control agenda. The analysis draws on the advances made before 1930, and includes the effects of mosquito-proofing of houses; the use of larvicides (Paris Green) and larvivorous fish (Gambusia); the role of large-scale engineering works; and the emergence of biological approaches to malaria. The importance of strong government and civil servant support was outlined. Despite best efforts of public health authorities, it became clear that it was notoriously difficult to interrupt transmission in areas of moderately high transmission. The importance of combining a variety of measures to achieve control became clear and proved successful in Palestine between 1923 and 1925, and improved education, economic circumstances and sustained political commitment emerge as key factors in the longer term control of malaria. The analysis shows that the principles for many of the present public health strategies for malaria have nearly all been defined before 1930, apart from large scale usage of pesticides, which came later at the end of the Second World War. No single intervention provided an effective single answer to preventing transmission, but certainly approaches taken that are locally relevant and applied in combination, are relevant to today’s efforts at elimination.

Background The global real-life impact of non-vitamin K antagonist oral anticoagulants (NOACs) introduction in the healthcare system in a setting of well-managed vitamin K antagonist (VKA) therapy has not been specifically addressed. Methods We did a population-based retrospective cohort study in naive patients initiating oral anticoagulants for stroke prevention in atrial fibrillation in a region with a well-managed VKA therapy. NOAC and VKA cohorts were identified using Anatomical Therapeutic Chemical (ATC) codes, while excluding other indications for anticoagulation therapy using ICD-9CM codes. Propensity score was conducted using two different approaches: stratification and 1:1 matching. Event-rates were assessed using both an intention to treat (ITT) and as treated analyses. Results Of the 137,800 selected patients, 40,411 (6923 treated with NOACs and 33,488 with VKAs) were identified (June 2013–December 2015). Overall ischaemic stroke and major bleeding risk did not significantly differ between the groups both in the ITT and as treated analyses. Noteworthy, intracranial bleeding risk was lower with NOACs (stratified model HR=0.69; 95%CI 0.48–0.99; 1:1 matched model HR=0.73; 95%CI 0.47–1.13) reaching statistical significance in the as treated analysis in both stratified and 1:1 matched models (HR=0.51; 95%CI 0.32–0.80 and HR=0.52; 95%CI 0.30–0.90, respectively). Conclusion Despite well-managed anticoagulation with VKAs, NOACs' introduction has a positive global impact in the public healthcare system in terms of effectiveness and safety especially by lowering intracranial bleeding.