Amyotrophic Lateral Sclerosis and soccer: an internet survey of 29 Italian players

Objectives  Some epidemiological studies have shown a very high risk of  Amyotrophic Lateral Sclerosis (ALS) in Italian male soccer players. Subsequently, the sports newspapers and news agencies have spread the news of 51 male soccer players with reported ALS. Design  We searched for male Italian national soccer players quoted in at least two Internet web sites or in books of journalists from January 1, 1950 to July 31, 2016 with a reported diagnosis of ALS. Results. Thirty nine male soccer players with reported ALS were identified. These subjects were born from 1905 to 1973 (32 deceased 6 living and 1 unknown). In the group of 29 soccer players for which the information was available the mean age at diagnosis was 45.3± 12.2 years; the mean age at onset of symptoms was 46.4± 12.1 years; the mean age at death was 50.9± 12.3 years. An inverse statistically correlation between year of birth and age at onset of symptoms was observed, with a more younger age at onset of symptoms for soccer players born in the recent years (r =-0.65 p<0.01). Conclusions. The ALS Italian male soccer have a clear anticipation of the age of diagnosis respect to European ALS patients. The findings support the possible relation between the soccer and the occurrence of ALS. We believe that an increase in research activity is urgently needed in this field

Survival of Hospitalized COVID-19 Patients in Northern Italy: A Population-Based Cohort Study by the ITA-COVID-19 Network

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 &gt;= 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

Renin-Angiotensin-Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients

Introduction The epidemic due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been spreading globally, raising increasing concerns. There are several controversial hypotheses on the potentially harmful or beneficial effects of antihypertensive drugs acting on the renin-angiotensin-aldosterone system (RAAS) in coronavirus disease 2019 (COVID-19). Furthermore, there is accumulating evidence, based on several observational studies, that angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) do not increase the risk of contracting SARS-CoV-2 infection. On the other hand, conflicting findings regarding the role of ACEIs/ARBs as prognosis modifiers in COVID-19 hospitalised patients have been reported. Objective The aim of this large-scale, retrospective cohort study was to investigate whether prior exposure to ACEIs and/or ARBs was associated with all-cause mortality among over 40,000 hospitalised COVID-19 patients compared with calcium channel blockers (CCBs), a potential therapeutic alternative. Methods This study was conducted using COVID-19 registries linked to claims databases from Lombardy, Veneto and Reggio Emilia (overall, 25% of Italian population). Overall, 42,926 patients hospitalised between 21 February and 21 April 2020 with a diagnosis of COVID-19 confirmed by real-time polymerase chain reaction tests were included in this study. All-cause mortality occurring in or out of hospital, as reported in the COVID-19 registry, was estimated. Using Cox models, adjusted hazard ratios (HRs) of all-cause mortality (along with 95% confidence intervals [CIs]) were estimated separately for ACEIs/ARBs and other antihypertensives versus CCBs and non-use. Results Overall, 11,205 in- and out-of-hospital deaths occurred over a median of 24 days of follow-up after hospital admission due to COVID-19. Compared with CCBs, adjusted analyses showed no difference in the risk of death among ACEI (HR 0.97, 95% CI 0.89-1.06) or ARB (HR 0.98, 95% CI 0.89-1.06) users. When non-use of antihypertensives was considered as a comparator, a modest statistically significant increase in mortality risk was observed for any antihypertensive use. However, when restricting to drugs with antihypertensive indications only, these marginal increases disappeared. Sensitivity and subgroup analyses confirmed our main findings. Conclusions ACEI/ARB use is not associated with either an increased or decreased risk of all-cause mortality, compared with CCB use, in the largest cohort of hospitalised COVID-19 patients exposed to these drugs studied to date. The use of these drugs therefore does not affect the prognosis of COVID-19. This finding strengthens recommendations of international regulatory agencies about not withdrawing/switching ACEI/ARB treatments to modify COVID-19 prognosis

Sindrome della morte improvvisa del lattante (SIDS) in Sicilia: una valutazione dei principali determinanti di accudimento

Aim: to evaluate certain caring behaviors associated with the onset of sudden infant death syndrome (SIDS). Methods: a telephone questionnaire was administered between May and July 2017 to a sample of 1055 Sicilian mothers within 30 days of delivery. A multivariate logistic analysis was conducted considering outcome variables: the sleeping position of the children, exclusive breastfeeding and passive smoking. Results: 62% of the participants place their children in the supine position, 37.9% practice exclusive breastfeeding and 89.0% are not smokers. Being aged &lt; 32 years, having a low level of education and limited economic resources are risk factors for the non-supine positioning of children during sleep. A low level of education, primiparity, non-participation to an antenatal course expose mothers to a greater risk of not practicing exclusive breastfeeding at one month. Postpartum smoking is positively associated with a low level of education. Conclusions: the assessment of the main caring behaviors towards newborns and infants is essential for an effective campaign for reducing the risk of SIDS

How Are the Interests of Incapacitated Research Participants Protected through Legislation? An Italian Study on Legal Agency for Dementia Patients

Patients with dementia may have limited capacity to give informed consent to participate in clinical research. One possible way to safeguard the patients' interests in research is the involvement of a proxy in the recruitment process. In Italy, the system of proxy is determined by the courts. In this study we evaluate the timing for appointment of a legal proxy in Italy and identify predictive variables of appointment.Subjects were recruited among the outpatients seeking medical advice for cognitive complaints at the Centre for Research and Treatment of Cognitive Dysfunctions, University of Milan, "Luigi Sacco" Hospital. The Centre was participating to the AdCare Study, a no-profit randomised clinical trial coordinated by the Italian National Institute of Health. The requirement that informed consent be given by a legal representative dramatically slowed down the recruitment process in AdCare, which was prematurely interrupted. The Centre for Research and Treatment of Cognitive Dysfunctions collected data on the timing required to appoint the legal representatives. Patients diagnosed with dementia and their caregivers were provided information on the Italian law on legal agency (law 6/2004). At each scheduled check-up the caregiver was asked whether she/he had applied to appoint a legal proxy for the patient and the time interval between the presentation of the law, the registration of the application at the law court chancellery and the sentence of appointment was registered. The study involved 169 demented patients. Seventy-eight patients (46.2%) applied to appoint a legal proxy. These subjects were usually younger, had been suffering from dementia for a longer time, had less than two children and made more use of memantine. The mean interval time between the presentation of the law and the patients' application to the law court chancellery was two months. The mean interval time between the patient's application to the law court chancellery and the sentence of appointment was four months.In Italy the requirement that legal representatives be appointed by the courts slows down subjects' participation in research. Other procedures for legal agency of the incapacitated patients may be adopted, taking as examples other EU countries' systems

Sudden Unexpected Deaths and Vaccinations during the First Two Years of Life in Italy: A Case Series Study

Background The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy. Methodology/Principal Findings The reference population comprises around 3 million infants vaccinated in Italy in the study period 1999–2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1–23 months were identified through the death certificates. Vaccination history was retrieved from immunisation registries. Association between immunisation and death was assessed adopting a case series design focusing on the risk periods 0–1, 0–7, and 0–14 days after immunisation. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR = 1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0–7 and 0–14 were 2.0 (95% CI 1.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR = 2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined. Conclusions The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates in Germany. The limited increase in RRs found in Italy appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age

Studio osservazionale comparativo del profilo di sicurezza delle formulazioni di tiotropio

Introduzione. Le Linee Guida per il trattamento della Broncopneumopatia Cronica Ostruttiva (BPCO) prevedono l’utilizzo di farmaci broncodilatatori e, tra questi, degli anticolinergici a lunga durata d’azione. Il tiotropio è il farmaco maggiormente utilizzato e in Italia sono in commercio due device: Handihaler® (dal 2004) e Respimat® (dal 2011). Le evidenze disponibili negli ultimi anni hanno fatto nascere dubbi sul profilo di sicurezza della formulazione Respimat®. Le differenze tra le popolazioni che utilizzano il farmaco nella normale pratica clinica e quelle incluse nei trial clinici potrebbero spiegare i risultati contrastanti tra gli RCT e gli studi osservazionali. Per verificare il segnale di rischio di malattie cardiovascolari, cerebrovascolari e disturbi del ritmo cardiaco è stato condotto uno studio di coorte retrospettivo tra gli utilizzatori incidenti di tiotropio Handihaler® e Respimat® nel periodo 2011-2013, nelle Regioni Lombardia e Umbria. Metodi. Le coorti sono state identificate attraverso le prescrizioni farmaceutiche SSN, che comprende l’erogazione attraverso le farmacie, la distribuzione diretta e per conto. Le informazioni sulle comorbidità e sugli esiti clinici sono state ottenute dalle Schede di Dimissione Ospedaliera (SDO). Gli eventi sono rappresentati da un ricovero per infarto del miocardio e/o per disturbi del ritmo cardiaco nel periodo di esposizione corrente (definito, a partire dalla data di prescrizione, come somma delle DDD più 15 giorni). Ogni soggetto è stato seguito dalla prima prescrizione di tiotropio fino alla prima delle seguenti date: fine del periodo di esposizione; passaggio da una formulazione di tiotropio all’altra (switch); ricovero per uno degli eventi in studio nel periodo corrente; fine dello studio (31.12.2013). Risultati. Sono stati identificati 120.434 soggetti con prescrizione incidente di tiotropio (77% Handihaler® e 23% Respimat®), con un'età media di 73 anni e un rapporto uomini/donne di 1,3. I due gruppi presentavano percentuali diverse nella maggior parte delle comorbidità e dell'uso di farmaci; le patologie più frequenti sono risultate tumori, malattie respiratorie, scompenso cardiaco, malattie cerebrovascolari, diabete e ipertensione. Sono stati osservati 645 eventi durante 159.589 mesi di esposizione corrente di Handihaler® (incidenza: 4,0 per 1.000 mesi persona) e 152 eventi durante 42.965 mesi del Respimat® (incidenza: 6,5 per 1.000 mesi persona). L'hazard ratio, Respimat® vs Handihaler®, è risultato pari a 0,86 (IC 95%: 0,72-1,02). Conclusioni. Questo studio su una popolazione di grande dimensioni, consente di fornire un ulteriore contributo alla valutazione della sicurezza d'uso delle formulazioni di tiotropio

Pap testing in a high-income country with suboptimal compliance levels: A survey on acceptance factors among sicilian women

Cervical cancer screening is uncommon, especially in low-income countries and among lower socioeconomic status people in high-income countries. The aims of this study were to examine the adherence of Sicilian women to Pap testing and to identify the determinants of this in a population with a secondary prevention attitude lower than high-income countries and the national average. A cross-sectional study called “Save Eva in Sicily” was conducted among all women aged 25–64 years, with a sample drawn by the list of general practitioners (GPs), using a proportional sampling scheme, stratified by age and resident population. The study outcome was performing a Pap test within the past three years. The association between the outcome and Pap test determinants was analyzed through a multivariable logistic regression. Among the 365 interviewed women, 66% (n = 243) had a Pap test during the last 3 years. On the other hand, 18% of the other women (n = 66) had performed at least one Pap test previously and 16% (n = 56) had never had a Pap test. In a multivariable model, GPs’ advice (adjusted OR 2.55; 95% CI 1.57–4.14) and perceived susceptibility (adjusted OR 3.24; 95% CI 1.92–5.48) increased the likelihood of the execution of a Pap test. The “Save Eva in Sicily” study identified GP advice and perceived cancer severity as the main correlates of Pap testing among Sicilian women, producing evidence regarding how policy makers can increase compliance. Interventions to increase Pap test adhesion should focus on stimulating GPs to identify patients who regularly do not undergo it and to recommend testing on a regular basis to their patients

Informing women on menopause and hormone therapy: Know The Menopause a multidisciplinary project involving local healthcare system.

Hormone therapy (HT) in the menopause is still a tricky question among healthcare providers, women and mass media. Informing women about hormone replacement therapy was a Consensus Conference (CC) organized in 2008: the project Know the Menopause has been launched to shift out the results to women and healthcare providers and to assess the impact of the cc's statement.And Findings: The project, aimed at women aged 45-60 years, was developed in four Italian Regions: Lombardy, Tuscany, Lazio, Sicily, each with one Local Health Unit (LHU) as "intervention" and one as "control". Activities performed were: survey on the press; training courses for health professionals; educational materials for target populations; survey aimed at women, general practitioners (GPs), and gynaecologists; data analysis on HT drugs' prescription. Local activities were: training courses; public meetings; dissemination on mass media. About 3,700 health professionals were contacted and 1,800 participated in the project. About 146,500 printed leaflets on menopause were distributed to facilitate the dialogue among women and health care professionals. Training courses and educational cascade-process activities: participation ranged 25- 72% of GPs, 17-71% of gynaecologists, 14-78% of pharmacists, 34-85% of midwives.1,281 women interviewed. More than 90% believed menopause was a normal phase in life. More than half did not receive information about menopause and therapies. HT prescription analysis: prevalence fell from 6% to 4% in five years. No differences in time trends before-after the intervention. Major limitations are: organizational difficulties met by LHU, too short time for some local activities.A huge amount of information was spread through health professionals and women. The issue of menopause was also used to discuss women's wellbeing. This project offered an opportunity to launch a multidisciplinary, multimodal approach to menopause looking not only at pharmacological aspects, but also at quality of life and information