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BackgroundCase reports of Guillain Barrè syndrome (GBS) following the Coronavirus Disease 2019 (COVID-19) vaccines administration have been reported. This study investigated the risk of GBS after vaccination with anti-COVID-19 vaccines (BNT162b2/Tozinameran; mRNA-1273/Elasomeran, ChAdOx1-S and Ad26.COV2-S) in the population aged ≥12 years in Italy.MethodsWe conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases. The outcome was the first diagnosis of GBS between 27 December 2020 and 30 September 2021.Exposure risk period were days 0 (vaccination day) through 42 days following each of the 2 vaccine doses. The remaining periods were considered as non at risk (baseline) period.The SCCS model, adapted to event-dependent exposures, was fitted using unbiased estimating equations to estimate relative incidences (RIs) and excess of cases (EC) per 100,000 vaccinated by dose and vaccine product. Calendar period was included as time-varying confounder in the model.ResultsThe study included 15,986,009 persons who received at least one dose of Covid-19 vaccine. During the 42-day risk interval there were a total of 67 cases of GBS after the first dose and 41 cases after the second dose. In the 42-day risk interval, increased risks were observed after the administration of first dose (RI=6.83; 95% CI 2.14-21.85) and second dose (RI=7.41; 95% CI 2.35-23.38) for mRNA-1273 vaccine, corresponding to 0.4 and 0.3 EC per 100,000 vaccinated, respectively. Increased risk was also observed after the first dose of ChAdOx1-S vaccine (RI=6.52; 95% CI 2.88-14.77), corresponding to 1.0 EC per 100,000 vaccinated. There was no evidence of increased risk of GBS after vaccination with BNT162b2 and Ad26.COV2-S vaccines.In the subgroup analysis by sex an increased risk of GBS was observed among both males and females after mRNA-1273 vaccine. in males an increased risk was observed after the first dose, with a borderline significance (RI=5.26; 95% CI 0.94-29.42; p=0.06) and the second dose (RI=16.50; 95% CI 3.01-90.56) and in females after the first dose (RI=13.44; 95% CI 2.83-63.80). There was also evidence of an increased risk after a first dose of ChAdOx1-S in males (RI=4.94; 95% CI 1.84-13.28) and females (RI=7.14; 95% CI 1.94-26.19).In the subgroup analysis by age, there was evidence of an increased risk of GBS with mRNA-1273 vaccine among those aged ≥60 years after the first (RI=8.03; 95% CI 2.08-31.03) and second dose (RI=7.71; 95% CI 2.38-24.97). After a first dose of ChAdOx1-S there was evidence of an increased risk of GBS in those aged 40-59 (RI=4.50; 95% CI 1.37-14.79) and in those aged ≥60 years (RI=6.84; 95% CI 2.56-18.28). There was no evidence of increased risk of GBS after vaccination with BNT162b2 and Ad26.COV2-S vaccines in the subgroup analysis by age and sex.Study limitations include that the outcome was not validated through review of clinical records, the possibility of time-dependent residual confounding and the imprecision of the obtained estimates in the subgroup analysis due to the very low number of events.ConclusionsIt is important the continuous monitoring of the suspected adverse events of the COVID-19 vaccines as key component of any vaccination program. Results from this large SCCS study showed an increased risk of GBS after first and second dose of mRNA-1273 and first dose of ChAdOx1-S. However, these findings were compatible with a small number of EC. Our data are reassuring regarding BNT162b and Ad26.COV2-S vaccines with respect to GBS outcome. No increased risk of GBS was detected following each of BNT162b vaccine dose nor any increased risk after Ad26.COV2-S vaccine dose.

Population-based cancer registration methods are subject to internationally-established rules. To ensure efficient and effective case recording, population-based cancer registries widely adopt digital processing (DP) methods. At the Veneto Tumor Registry (RTV), about 50% of all digitally-identified (putative) cases of cancer are further profiled by means of registrars’ assessments (RAs). Taking these RAs for reference, the present study examines how well the registry’s DP performs. A series of 1,801 (putative) incident and prevalent cancers identified using DP methods were randomly assigned to two experienced registrars (blinded to the DP output), who independently re-assessed every case. This study focuses on the concordance between the DP output and the RAs as concerns cancer status (incident versus prevalent), topography, and morphology. The RAs confirmed the cancer status emerging from DP for 1,266/1,317 incident cancers (positive predictive value [PPV] = 96.1%) and 460/472 prevalent cancers (PPV = 97.5%). This level of concordance ranks as “optimal”, with a Cohen’s K value of 0.91. The overall prevalence of false-positive cancer cases identified by DP was 2.9%, and was affected by the number of digital variables available. DP and the RAs were consistent in identifying cancer topography in 88.7% of cases; differences concerned different sites within the same anatomo-functional district (according to the International Agency for Research on Cancer [IARC]) in 9.6% of cases. In short, using DP for cancer case registration suffers from only trivial inconsistencies. The efficiency and reliability of digital cancer registration is influenced by the availability of good-quality clinical information, and the regular interdisciplinary monitoring of a registry’s DP performance.

ObjectivesTo investigate the association between SARS-CoV-2 mRNA vaccines, BNT162b2 and mRNA-1273, and myocarditis/pericarditis.DesignSelf-Controlled Case Series study (SCCS) using national data on COVID-19 vaccination and emergency care/hospital admissions.SettingItalian Regions (Lombardia, Friuli Venezia Giulia, Veneto, Lazio).Participants2,861,809 individuals, aged 12-39 years, vaccinated with the first doses of mRNA vaccines (2,405,759 BNT162b2 and 456,050 mRNA-1273) between 27 December 2020 and 30 September 2021.Main outcome measuresFirst diagnosis of myocarditis/pericarditis within the study period. The incidence of events in the exposure risk periods (0-21 days from the vaccination day, subdivided in three equal intervals) for first and second dose was compared with baseline period. The SCCS model was fitted using conditional Poisson regression to estimate Relative Incidences (RI) and Excess of Cases (EC) per 100,000 vaccinated by dose, age, gender and brand.ResultsDuring the study period, 441 participants aged 12-39 years developed myocarditis/pericarditis (346 BNT162b2 and 95 mRNA-1273). During the 21-day risk interval there were 114 cases of myocarditis/pericarditis (74 BNT162b2 and 40 mRNA-1273) corresponding to a RI of 1.27 (0.87-1.85) and 2.16 (1.50-3.10) after first and second dose, respectively.An increased risk of myocarditis/pericarditis at [0-7) days was observed after first [RI=6.55; 95% Confidence Interval (2.73-15.72); EC per 100,000 vaccinated=2.0 (1.5-2.3)] and second dose [RI=7.59 (3.26-17.65); EC=5.5 (4.4-5.9)] of mRNA-1273 and after second dose of BNT162b2 [RI=3.39 (2.02-5.68); EC=0.8 (0.6-1.0)]. In males, an increased risk at [0-7) days was observed after first [RI=12.28, 4.09-36.83; EC=3.8 (3.1-4.0)] and second dose [RI=11.91 (3.88-36.53); EC=8.8 (7.2-9.4)] of mRNA-1273 and after second dose of BNT162b2 [RI=3.45 (1.78-6.68); EC=1.0 (0.6-1.2)]. In females, an increased risk at [0-7) days was observed after second dose of BNT162b2 [RI=3.38 (1.47-7.74); EC=0.7 (0.3-0.9)]. At [0-7) days an increased risk following second dose of BNT162b2 was observed in the 12-17 years old [RI=5.74, (1.52-21.72); EC=1.7 (0.7-1.9)] and in 18-29 years old [RI=4.02 (1.81-8.91); EC=1.1 (0.6-1.3)]. At [0-7) days an increased risk after first [RI=7.58 (2.62-21.94); EC=3.5 (2.4-3.8)] and second [RI=9.58 (3.32-27.58); EC=8.3 (6.7-9.2)] dose of mRNA-1273 was found in 18-29 years old and after first dose in 30-39 years old [RI=6.57 (1.32-32.63); EC=1.0 (0.3-1.1)].ConclusionsThis population-based study indicates that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years, whereas no association was observed in older subjects. The risk increased after the second dose and in the youngest for both vaccines, remained moderate following vaccination with BNT162b2, while was higher in males following vaccination with mRNA-1273. The public health implication of these findings should be weighed in the light of the overall efficacy and safety profile of both vaccines.

Communication is a fundamental infrastructure for a public establishment; it represents element for relationship’s creations and it plays an essential role in the creation and reinforcement of the indispensable relationship of mutual trust between citizens and institution. Communication allows information exchanges and it allows the ad- ministrative actions exercise (to decide, coordinate, regulate and govern): so it is considered a governance tool. Therefore, the hospital has started a path of internal and external communication with specific brand reputation actions, also in the awareness of the important historical moment that the institution is going through, both in terms of changing its structure and in the pandemic context.

Objectives: The aim of this paper is to demonstrate how, while remaining within a specific field such as medicine, it is possible to use different languages depending on the target audience (doctors, professionals from other fields or patients) in order to improve its degree of health literacy. In particular, the aim is to show how even the definition of a disease, which should in principle be unambiguous, can in fact be linguistically adapted to the reader's basic knowledge. Methodology: Five definitions of mesothelioma are examined, analysed lexically, syntactically and graphically. Specifically, this comparison is made on three main levels, which in turn have different nuances: popular, including definitions from Wikipedia and the UK Mesothelioma patient portal; intermediate, corresponding to the Collins English language dictionary; and specialist, with definitions from the MeSH thesaurus and the Orphanet database. Results: At the end of the comparative analysis, it is possible to state that in linguistic and Health Literacy terms there is no single definition for this rare disease but as many definitions as there are targets. In particular, they vary in syntactic structure, graphic form and vocabulary, as they have to use technicalities typical of the medical field but have different nuances of complexity. Conclusion: A comparison of the definitions shows that the degree of readability does not always correspond to that of comprehensibility. The analysis demonstrates that it is difficult to explain complex medical concepts to practitioners and patients in a simple, clear and usable way and that this requires specific techniques of Health Literacy, related to both the linguistic and graphic aspects. The comparison of definitions is therefore a methodological premise for the creation of brochures dedicated to mesothelioma and the revision of the "Mai soli" site for mesothelioma patients.

Background Colorectal cancer (CRC) screening programs based on fecal immunochemical testing (FIT) generate substantial pressure on colonoscopy capacity in Europe. Thus, a relevant proportion of FIT-positive patients undergo colonoscopy after the recommended 30-day interval, which may be associated with an excess CRC risk. Methods In a cohort of 50–69-year-old patients undergoing biennial rounds of FIT (OC-Hemodia latex agglutination test; cutoff 20 µg hemoglobin/g feces) between 2004 and 2017, we assessed the outcome at colonoscopy (low/high risk adenoma/CRC/advanced stage CRC) among FIT-positive patients, according to different time intervals. The association of each outcome with waiting time, and demographic and clinical factors, was analyzed through multivariable analysis. Results 123 138/154 213 FIT-positive patients (79.8 %) underwent post-FIT colonoscopy. Time to colonoscopy was ≤ 30 days, 31–180 days, and ≥ 181 days in 50 406 (40.9 %), 71 724 (58.3 %), and 1008 (0.8 %) patients, respectively. At colonoscopy, CRC, high risk adenoma, and low risk adenoma were diagnosed in 4813 (3.9 %), 30 500 (24.8 %), and 22 986 (18.7 %) patients, respectively. An increased CRC prevalence at colonoscopy was observed for a time to colonoscopy of ≥ 270 days (odds ratio [OR] 1.75, 95 % confidence interval [CI] 1.15–2.67), whereas it was stable for waiting times of Conclusion In a European FIT-based screening program, post-FIT colonoscopy after 9 months was associated with an increased risk of CRC and CRC progression.

Objective Colorectal cancer (CRC) screening programmes based on the guaiac faecal occult blood test (gFOBT) reduce CRC-specific mortality. Several studies have shown higher sensitivity with the faecal immunochemical test (FIT) compared with gFOBT. We carried out an ecological study to evaluate the impact of FIT-based screening programmes on CRC mortality. Design In the Veneto Region (Italy), biennial FIT-based screening programmes that invited 50–69-year-old residents were introduced in different areas between 2002 and 2009. We compared CRC mortality rates from 1995 to 2011 between the areas where screening started in 2002–2004 (early screening areas (ESA)) and areas that introduced the screening in 2008–2009 (late screening areas (LSA)) using Poisson regression models. We also compared available data on CRC incidence rates (1995–2007) and surgical resection rates (2001–2012). Results Before the introduction of screening, CRC mortality and incidence rates in the two areas were similar. Compared with 1995–2000, 2006–2011 mortality rates were 22% lower in the ESA than in the LSA (rate ratio (RR)=0.78; 95% CI 0.68 to 0.89). The reduction was larger in women (RR=0.64; CI 0.51 to 0.80) than in men (RR=0.87; CI 0.73 to 1.04). In the ESA, incidence and surgery rates peaked during the introduction of the screening programme and then returned to the baseline (2006–2007 incidence) or dropped below initial values (surgery after 2007). Conclusions FIT-based screening programmes were associated with a significant reduction in CRC mortality. This effect took place much earlier than reported by gFOBT-based trials and observational studies.

Purpose Mortality from liver cirrhosis has sharply declined in most countries in the last few decades, but includes only a fraction of deaths due to chronic liver disease. Methods Mortality records for liver cirrhosis, liver cancer, viral hepatitis, and the three disease categories combined were extracted for the period 1995 to 2010 in the Veneto Region (northeastern Italy). The presence of a birth cohort effect was assessed by fitting Poisson regression models. The alcoholic or viral etiology was retrieved through multiple causes of death analysis for the years 2008 to 2010. Results Liver cirrhosis mortality represented only one-third of all liver disease deaths; this proportion was even smaller for deaths with a viral etiology and among elderly people. Through the study period, age-standardized rates declined by 50% for liver cirrhosis, and by 30% (world standard) or by 25% (regional standard) for all liver diseases; the reduction in proportional mortality was limited to 11%. Mortality rates started to decline in subjects born after the early 1920s. Conclusions The decline in mortality was smaller than that reported by standard statistics for chronic liver disease; these statistics should routinely include viral hepatitis and liver cancer deaths. When available, multiple causes of death data should be analyzed.

Background: Many international guidelines address appropriateness, prescribing variability and drug-related expenditure in primary dyspepsia management. Aims: To evaluate the impact on general practitioner (GP) practice and healthcare costs of a participatory intervention to modify primary dyspepsia and Helicobacter pylori (Hp) infection management, by standardised implementation of an international guideline in the local setting, through a prospective, controlled before-and-after study. Methods: Primary dyspepsia management was monitored in the Local Health District of Padua; 63 of all 354 local GPs (total patient population: 82,284) took part in a primary-care improvement programme. Measured variables were: mean prescribed gastroscopies/1,000 registered patients, mean expenditure/1,000 registered patients for antisecretories (H2 blockers) and proton pump inhibitors (PPIs), inter-GP prescribing variability and adherence to guidelines, analysed through prospectively filled-out reports on GP consultations for dyspepsia. A 3-month pre-survey period was compared with a 6-month intervention period following implementation of an agreed guideline. Results: Compared to non-participating GPs, intervention yielded a 30 and 26.4% reduction in H2-blocker and PPI expenditure, respectively. Application of the guideline led to an upward trend in endoscopy prescriptions, coupled with a 7% increase in appropriate referrals. Intra-group variability marginally decreased; guideline compliance rose slightly. Conclusions: Participatory intervention can reduce prescribing variability among GPs and inappropriate esophagogastroduodenoscopies, lowering related costs. Results may not have been spectacular, but in view of the number of patients involved, they may have an important impact on Local Health District expenditure.

Background It is not clear whether environmental exposure to dioxin affects the general population. The aim of this research is to evaluate sarcoma risk in relation to the environmental pollution caused by dioxin emitted by waste incinerators and industrial sources of airborne dioxin. The study population lives in a part of the Province of Venice (Italy), where a population-based cancer registry (Veneto Tumour Registry – RTV) has been active since 1987. Methods Two hundred and five cases of visceral and extravisceral sarcoma, confirmed by microscopic examination, diagnosed from 01.01.1990 to 31.12.1996, were extracted from the RTV database. Diagnoses were revised using the actual pathology reports and clinical records. For each sarcoma case, three controls of the same age and sex were randomly selected from the population files of the Local Health Units (LHUs). The residential history of each subject, whether case or control, was reconstructed, address by address, from 1960 to the date of diagnosis. All waste incinerators and industrial sources of airborne dioxin in the Province of Venice were taken into account, as was one very large municipal waste incinerator outside the area but close to its boundaries. The Industrial Source Complex Model in Long Term mode, version 3 (ISCLT3), was used to assess the level of atmospheric dispersion. A specific value for exposure was calculated for each point (geo-referenced address) and for each calendar year; the exposure value for each subject is expressed as the average of specific time-weighted values. The analysis takes into account 172 cases and 405 controls, aged more than 14 years. Results The risk of developing a sarcoma is 3.3 times higher (95% Confidence Interval – 95% CI: 1.24 – 8.76) among subjects, both sexes, with the longest exposure period and the highest exposure level ; a significant excess of risk was also observed in women (Odds Ratio OR = 2.41, 95% CI: 1.04 – 5.59) and for cancers of the connective and other soft tissue (International Classification of Diseases, ninth Revision – ICD-IX 171), both sexes (OR = 3.27, 95% CI: 1.35 – 7.93). Conclusion Our study supports the association between modelled dioxin exposure and sarcoma risk.

Many international guidelines address appropriateness, prescribing variability and drug-related expenditure in primary dyspepsia management.To evaluate the impact on general practitioner (GP) practice and healthcare costs of a participatory intervention to modify primary dyspepsia and Helicobacter pylori (Hp) infection management, by standardised implementation of an international guideline in the local setting, through a prospective, controlled before-and-after study.Primary dyspepsia management was monitored in the Local Health District of Padua; 63 of all 354 local GPs (total patient population: 82,284) took part in a primary-care improvement programme. Measured variables were: mean prescribed gastroscopies/1,000 registered patients, mean expenditure/1,000 registered patients for antisecretories (H(2) blockers) and proton pump inhibitors (PPIs), inter-GP prescribing variability and adherence to guidelines, analysed through prospectively filled-out reports on GP consultations for dyspepsia. A 3-month pre-survey period was compared with a 6-month intervention period following implementation of an agreed guideline.Compared to non-participating GPs, intervention yielded a 30 and 26.4% reduction in H(2)-blocker and PPI expenditure, respectively. Application of the guideline led to an upward trend in endoscopy prescriptions, coupled with a 7% increase in appropriate referrals. Intra-group variability marginally decreased; guideline compliance rose slightly.Participatory intervention can reduce prescribing variability among GPs and inappropriate esophagogastroduodenoscopies, lowering related costs. Results may not have been spectacular, but in view of the number of patients involved, they may have an important impact on Local Health District expenditure.

Background There is evidence that colorectal cancer (CRC) screening programmes based on guaiac fecal occult blood test reduce CRC-specific mortality. Several studies showed higher performances of fecal immunochemical test (FIT) compared to guaiac test. In Italy most CRC screening programmes utilize FIT, but data on their impact on mortality are lacking. Methods In the Veneto Region (north-east of Italy), FIT screening programmes were activated in different areas between 2002 and 2009. Subjects 50-69 years old are invited every two years to perform FIT and, if positive, are referred to colonoscopy. We compared CRC mortality between areas where screening was activated in 2002-2004 (early screening areas ESA) and in 2008-2009 (late screening areas LSA). For ESA and LSA we computed CRC mortality rates of 50-74 years old subjects in 2002-2011 and the Annual Percent Change (APC), with 95% Confidence intervals (CI95%). The association between mortality time trends and screening activation was evaluated by a Poisson regression model with an interaction term between year and area, adjusting for age and gender. To evaluate whether changes in mortality reflected different underlying incidence rates, we analyzed CRC incidence from 1995 to 2006 (last year available) of the two areas included in the Veneto Cancer Registry. Results The mid-period 50-74yrs resident population of ESA and LSA was respectively 288,125 and 357,486. In the study period CRC mortality rates in ESA declined from 45.7 per 100,000 in 2002 to 36.2 in 2011. In LSA mortality was stable around 45 per 100,000 (FIgure 1).The APC was -3.5% (CI95% -5.3% to -1.6%) in ESA and -0.5% (CI95% -2.5% to 1.5%) in LSA. Poisson regression showed a significant interaction between area and year, with a 2.8% (p=0.029) reduction of mortality rates attributable to screening per year. The estimated reduction of CRC mortality in ESA vs LSA was 25% over the whole study period. However, the association between area and mortality rates was observed only in females (6.2% annual reduction, p=0.004) but not in males. The incidence rates in LSA progressively increased between 1995 and 2006, with a APC of +1.4% (CI95% 0.8% to 2.0%) over the whole period. The ESA showed an increase between 2000 and 2003 (APC +9.9%; CI95% 5.9% to 14.1%) followed by a steep reduction (APC -22.4%; CI95% -35.1% to -7.4%)(Figure 2). Conclusion The ESA showed a 25% reduction of CRC mortality compared to the LSA, independent from underlying incidence rates. This ecological study represents one of the first evidences of the impact on mortality of FIT screening programmes. Further research on this topic is needed.