[Vitamin D and COVID-19: a communication far from reality]. / Vitamina D e COVID-19: una comunicazione lontana dalla realtà.

The intake of Vitamin D against COVID-19 has theoretical bases. In the 3-year period of the pandemic, hundreds of favorable observational studies and some small randomized controlled trials (RCTs) have been produced.However, to date, RCTs of larger size and quality have unfavorable results and do not support its use, neither in oral form at various doses nor as injection boluses nor in prophylaxis nor in treatment of COVID-19, not even in severe or critical cases, nor to prevent deaths.The results of a recent sequential meta-analysis of a few RCTs, presented as 'definitive evidence', are biased by the weight of the improper inclusion of an observational study.Interference with correct information, both in the media and in scientific communication, risks obscuring in clinical practice the conclusions of the most valid studies available.

COVID-19 vaccination and all-cause and non-COVID-19 mortality. A revaluation of a study carried out in an Italian Province.

The COVID-19 vaccination prevents COVID-19 specific mortality. Well planned population-based studies, however, are necessary to evaluate the overall effectiveness of vaccination programmes. A study carried out in the province of Pescara is used to illustrate the potential biases that may affect such studies. The Pescara study analysed total and non-COVID-19 mortality and the occurrence of Potentially Vaccine-Related Serious Adverse Events (PVR-SAEs) in vaccinated and unvaccinated people, from January 2021, when vaccines became available, to July 2022. The study reported a lower probability of both total and non-COVID-19 death in vaccinated people. However, the authors did not include in the denominator of the unvaccinated cohort the population experience of the vaccinated cohort before vaccination (immortal time bias). Correcting the denominator of the unvaccinated cohort, the crude death rate of vaccinated and unvaccinated persons becomes the same. For the same reason, the unvaccinated non-COVID-19 mortality was overestimated, as was the mortality of people receiving only one or two vaccine doses. Confounding by indication and the healthy vaccinee bias will also be discussed, as well as the bias deriving by not considering the evolution of risk over time.

[Using face masks outdoor: beginning a debate to rediscuss current policies]. / Mascherine "chirurgiche" all'aperto: avviare un dibattito per ridiscutere le disposizioni attuali.

During the COVID-19 pandemic, international organizations, institutions, and experts firstly recommended face masks for the population only in symptomatic subjects, but today various countries recommend or require their use even outdoor. In Italy, there was an obligation in closed places accessible to the public, including means of transport, and always if the safety distance was not continuously guaranteed. Various regions have long imposed obligations everywhere but at one's own home, and now the mandate has become national. This contribution critically analyses the randomised controlled trials (RCTs) on the effectiveness of medical masks in preventing respiratory infections in university/community contexts and outdoor gatherings, with questions and answers based on reasoning where possible based on evidence. It discusses whether the evidence supporting the WHO positions is weak compared to more stringent policies; it considers some underestimated adverse effects of the prolonged use of masks in the community and especially outdoors, not only by persons doing physical activity. This paper discusses some differences between SARS and COVID-19 in the potential impact of the masks and proposes to consider the most valid evidence available, avoiding prolonged/continuous use without valid needs for face masks, especially outdoors, waiting for others pragmatic RCTs that clarify conclusively a net balance between expected benefits and possible damages. KEYWORDS: facemasks effectiveness; medical masks safety - side effects; medical masks and SARS-CoV-2.

[Educating to properly close the toilet knob taps or to replace them]. / Educare a chiudere in modo corretto i rubinetti a manopola del bagno o a sostituirli.

Systematic reviews have shown a prevalence close to 20% of gastrointestinal symptoms in COVID-19 positive patients, with nearly 40% of patients shedding viral RNA in their faeces, even if it may not be infectious, possibly because of inactivation by colonic fluid.According to current evidence, this virus is primarily transmitted by respiratory droplets and contact routes, including contaminated surfaces. The virus is quite stable on stainless steel, being detected up to 48-72 hours after application. Therefore, some individuals can be infected touching common contaminated surfaces, such as bathroom taps. Taps can be underestimated critical points in the transmission chain of the infection. Indeed, just by turning the knob, people leave germs on it, especially after coughing over their hands, sneezing, and/or blowing their nose. After handwashing with soap, user take back their germs when turning the knob. Paradoxically, the following user collects the germs back on his/her fingers by implementing a preventive measure, maybe before putting food into the mouth or wearing contact lenses.The Italian National Institute of Health recommends to clean and disinfect high-touched surfaces, but it is unrealistic and inefficient to do so after each tap use. As an alternative, new toilets should install long elbow-levers - or at least short levers - provided that people are educated to close them with the forearm or the side of the hand. This is already a standard measure in hospitals, but it is particularly important also in high-risk communities, such as retirement homes and prisons. It would be important also in schools, in workplaces, and even in families, contributing to the prevention both of orofaecal and respiratory infections.In the meantime, people should be educated to close existing knobs with disposable paper towel wipes or with toilet paper sheets.

[New European guidelines for the management of dyslipidaemias: their aggressiveness is not legitimated by current evidence]. / Nuove linee guida europee sulla gestione delle dislipidemie: aggressività non giustificata dalle prove esistenti.

Le linee guida 2019 delle Società europee di cardiologia e dell'aterosclerosi sulla gestione delle dislipidemie hanno aumentato l'aggressività diagnostico-terapeutica e non distinguono prevenzione primaria e secondaria, con parziale eccezione per gli ultra75enni. Raccomandano nuovi target di cLDL: per pazienti a rischio molto alto si raccomanda una riduzione a <55 mg/dl e >=50% rispetto al basale; per pazienti a rischio alto una riduzione a <70 mg/dl e >=50% del basale; per pazienti a rischio moderato una riduzione a <100 mg/dl; per pazienti a rischio basso una riduzione a <116 mg/dl. In base alle carte SCORE e ai dati di mortalità cardiovascolare in Italia, quasi tutti i maschi dai 70 anni e le donne dai 70-75 anni risulterebbero ad alto rischio per solo effetto dell'età. Anche quasi tutti i 60enni sarebbero a rischio moderato, con target di cLDL <100, e spesso necessità di aggiungere costosi ipolipemizzanti per chi già assume statine. Le prove supportano ben poco tale aggressività. Infatti, anche negli studi randomizzati controllati (RCT) i benefici su esiti cardiovascolari non fatali subiscono esagerazioni sistematiche, quello meno distorto e di maggior interesse per gli assistiti è la mortalità totale. Questa, con terapie ipocolesterolemizzanti più intensive, non si è ridotta nelle metanalisi di RCT con pazienti con cLDL tra 80 e <100 mg/dl al basale; con inibitori di PCSK9, pazienti con questi valori mostrano persino tendenza all'aumento della mortalità totale. Dunque, abbassare il cLDL a <80 mg/dl può non giovare neppure ad anziani coronaropatici. A oggi, ciò vale ancora di più per anziani nella popolazione generale, in cui una revisione sistematica di studi di coorte ha mostrato relazioni nulle o più spesso inverse tra cLDL e mortalità. Le nuove linee guida europee forzano le prove disponibili, trascurano il principio di precauzione e non possono esser base per un equo consenso informato.

[Immunocompromised children and non-vaccinated classmates: how massive is this problem?] / Bimbi immunodepressi e compagni di scuola non vaccinati: quanto è grande il problema?

A recurrent topic in the debate on the mandatory immunisations, invoked by doctors, politicians, and parents, is the need to protect the right of immunocompromised children to attend preschool and school without taking serious risks. Data and evidence-based information can greatly reduce excessive fears and unreasonable emotional reactions. This paper presents many reasons for reassessing the issue of the school attendance of immunocompromised children in a more balanced perspective both in terms of absolute risk and of risk related to other common circumstances involving greater comparative risks. The whole community, the immunocompromised subjects, and their caregivers must be educated to face these circumstances every day, with measures and behaviours largely implementable by motivated and adequately informed people. Even physicians - and even more public health doctors - are called to take the responsibility to inform people in a balanced way, and to educate to implement the many evidence-based actions that can protect health, including protection from infectious diseases and their complications, with a commitment consistent with the potential of the available measures.

[Epidemiology of pertussis and prevention strategies: problems and perspectives]. / Epidemiologia della pertosse e strategie di prevenzione: problemi e prospettive.

Pertussis vaccination has made an important contribution to the reduction in incidence of the disease, but internationally pertussis reawakens, even in highly vaccinated population groups. This resurgence seems to be attributable to various reasons: non-optimal efficacy of the vaccine; fairly rapid decay of protective antibody titers in part of the population and above all their inadequacy in preventing infections and transmission of the pathogen also from infected subjects; selective pressure of extensive vaccination with emergence of mutated resistant strains; substantial impossibility of obtaining a herd effect with the vaccines which are available nowadays. The present work analyses the state of scientific knowledge and illustrates various topics that may challenge a prevention based only on the paediatric vaccine obligation using a hexavalent vaccine. Public health strategies must be rethought, considering also different solutions that aim to fight the disease in a more targeted and potentially more effective way, avoiding major damage to people at greater risk. A currently tested strategy is the vaccination of pregnant mothers, but the experimentation of solutions less interfering with the bacterial ecology could be also considered; these solutions may only aim at avoiding major damage to subgroups at greater risk and should be integrated with initiatives to improve surveillance systems, microbiological diagnosis and lifestyle-based prevention.

[Varicella vaccination: scientific reasons for a different strategic approach]. / Vaccinazione antivaricella: argomenti scientifici per possibili strategie diverse dalle attuali.

The Italian Parliament has recently introduced 10 mandatory immunisations, including the one against varicella. For this vaccination, the obligation starts with the birth cohort of 2017, but it is offered free of charge to subjects with a negative history and not previously vaccinated. This paper presents up-to-date evidence on this issue and illustrates a number of critical arguments that may question the opportunity of this choice. Particularly, while the disease is relatively mild in children aged between 1 and 9 years, the risk of worsening its consequences is progressive with age, becoming worst in the elderly, so the vaccination of children may increase the age of the cases. Some vaccine side effects are not trivial and the duration of protection is still uncertain, as well as the cost-effectiveness of mass vaccination and its long-term effects, referring to virus reactivation and to the incidence of Herpes zoster in the general population, which could be increased and anticipated in the long run. Varicella vaccination is not included in international eradication goals and very few Europeans Countries have considered it as a public health priority. A different rational choice could have been to offer a selective vaccination only to adolescents with a negative history of chickenpox; or at least to delay the beginning of the universal campaign in the Italian regions that had not started the mass vaccination yet, evaluating the results over time. Lastly, this paper lists a number of preventive interventions of proven effectiveness and cost-effectiveness, with extraordinary margins of improvement, whose mandatory introduction in the population have never been considered, even as a matter of debate.

A Critical Analysis of All-Cause Deaths during COVID-19 Vaccination in an Italian Province.

Immortal time bias (ITB) is common in cohort studies and distorts the association estimates between the treated and untreated. We used data from an Italian study on COVID-19 vaccine effectiveness, with a large cohort, long follow-up, and adjustment for confounding factors, affected by ITB, with the aim to verify the real impact of the vaccination campaign by comparing the risk of all-cause death between the vaccinated population and the unvaccinated population. We aligned all subjects on a single index date and considered the "all-cause deaths" outcome to compare the survival distributions of the unvaccinated group versus various vaccination statuses. The all-cause-death hazard ratios in univariate analysis for vaccinated people with 1, 2, and 3/4 doses versus unvaccinated people were 0.88, 1.23, and 1.21, respectively. The multivariate values were 2.40, 1.98, and 0.99. Possible explanations of this trend of the hazard ratios as vaccinations increase could be a harvesting effect; a calendar-time bias, accounting for seasonality and pandemic waves; a case-counting window bias; a healthy-vaccinee bias; or some combination of these factors. With 2 and even with 3/4 doses, the calculated Restricted Mean Survival Time and Restricted Mean Time Lost have shown a small but significant downside for the vaccinated populations.