Search

Every vaccine that is marketed for mass use, in large populations or worldwide, is characterised by high efficacy and rare adverse reactions. The latter are not identified in the regulatory trials, but in phase IV evaluation during use in the real world, the ones regulated by vaccination calendars or vaccination campaigns. The assessment of the benefit to risk ratio is only possible over time with appropriate monitoring of the risks attributable to the vaccine, but also to other causes. When the benefit is determined by the need to deal with a worldwide infection with dramatic outcomes and to rapidly counteract, or at least contain, a virus, as is the case with COVID-19, the benefit to risk ratio estimate is invalidated by numerous factors and the relationship may be completely altered. In this case, the criteria for using the vaccine become critical instead: the identification of the target population, priorities, vaccination strategies, characteristics and availability of the vaccine. The use of these criteria must also be monitored to achieve an optimal, safe and effective performance. This is the most critical aspect, particularly during a pandemic, as the first 6 months of vaccination against COVID-19 have shown. The definition, monitoring and evaluation of the observed and expected positive, symptomatic and deceased cases, the adverse reactions, and the antibody titres and their duration are the essential elements for estimating the benefit to risk ratio. Such a timely and effective approach was planned only in some countries. The priority, target populations for vaccination were identified everywhere, from the start, as being …

Women who were previously treated for breast cancer (BC) are an important particular subgroup of women at intermediate BC risk. Their breast follow-up should be planned taking in consideration a 1.0-1.5 % annual rate of loco-regional recurrences and new ipsilateral or contralateral BCs during 15-20 years, and be based on a regional/district invitation system. This activity should be carried out by a Department of Radiology integrating screening and diagnostics in the context of a Breast Unit. We recommend the adoption of protocols dedicated to women previously treated for BC, with a clear definition of responsibilities, methods for invitation, site(s) of visits, methods for clinical and radiological evaluation, follow-up duration, role and function of family doctors and specialists. These women will be invited to get a mammogram in dedicated sessions starting from the year after the end of treatment. The planned follow-up duration will be at least 10 years and will be defined on the basis of patient's age and preferences, taking into consideration organizational matters. Special agreements can be defined in the case of women who have their follow-up planned at other qualified centers. Dedicated screening sessions should include: evaluation of familial/personal history (if previously not done) for identifying high-risk conditions which could indicate a different screening strategy; immediate evaluation of mammograms by one or, when possible, two breast radiologists with possible addition of supplemental mammographic views, digital breast tomosynthesis, clinical breast examination, breast ultrasound; and prompt planning of possible further workup. Results of these screening sessions should be set apart from those of general female population screening and presented in dedicated reports. The following research issues are suggested: further risk stratification and effectiveness of follow-up protocols differentiated also for BC pathologic subtype and molecular classification, and evaluation of different models of survivorship care, also in terms of cost-effectiveness.

Epidemics and pandemics are natural events recurring over the time: their impact can be appropriately minimised but most countries only rely on emergency response. The European Decision 1082/2013 on serious cross-border threats to health is innovative in recognising risk communication as an essential tool in coping with public health emergencies of international concern (PHEIC). The Decision serves as proper context for the EU-funded ASSET (Action plan in Science in Society in Epidemics and Total pandemics) research project that aims to create the blueprint for a better response to PHEIC, through improved forms of dialogue and better cooperation at different levels on Science-in-Society (SiS) issues (governance, engagement, ethics, gender, science education, open access). A Mobilization and Mutual Learning (MML) approach was developed through the ASSET Strategic and Action Plans toward different targets and relevant stakeholders. An integrated participatory approach needs to be recognized into the national plans for preparedness and response.

This position paper, issued by ICBR/SIRM and GISMa, summarizes the evidence on DBT and provides recommendations for its use. In the screening setting, DBT in adjunct to digital mammography (DM) increased detection rate by 0.5-2.7‰ and decreased false positives by 0.8-3.6% compared to DM alone in observational and double-testing experimental studies. The reduction in recall rate could be less prominent in those screening programs which already have low recall rates with DM. The increase in radiation exposure associated with DM/DBT protocols has been solved by the introduction of synthetic mammograms (sDM) reconstructed from DBT datasets. Thus, whenever possible, sDM/DBT should be preferred to DM/DBT. However, before introducing DBT as a routine screening tool for average-risk women, we should wait for the results of randomized controlled trials and for a statistically significant and clinically relevant reduction in the interval cancer rate, hopefully associated with a reduction in the advanced cancer rate. Otherwise, a potential for overdiagnosis and overtreatment cannot be excluded. Studies exploring this issue are ongoing. Screening of women at intermediate risk should follow the same recommendations, with particular protocols for women with previous BC history. In high-risk women, if mammography is performed as an adjunct to MRI or in the case of MRI contraindications, sDM/DBT protocols are suggested. Evidence exists in favor of DBT usage in women with clinical symptoms/signs and asymptomatic women with screen-detected findings recalled for work-up. The possibility to perform needle biopsy or localization under DBT guidance should be offered when DBT-only findings need characterization or surgery.

The media can play an important role in influencing both the demand and supply of medical treatments, regardless of evidence of effectiveness. This can be highlighted by recent experiences in Italy following publicity for a new unproven treatment in Italy, which it was claimed was highly successful in treating a wide range of cancers. The media role in influencing both health authorities to fund large scale trials of the intervention and patients awareness and expectations of therapy are discussed. The changes in Italian media over the last 20 years have seen a reduction in the numbers of specialist medical journals, with increased emphasis placed on sensationalism rather than accuracy. The media though has the potential to play in future an important strategic role in disseminating accurate information on issues pertaining to health.