["Donnainformata-mammografia": a decision aid developed and validated in the Italian setting].

The decision aid "Donnainformata-mammografia" (https://www.donnainformata-mammografia.it/en/) has been developed with the aim of providing clear information on the benefits and harms of breast cancer screening, and the controversies on the relationship between mortality reduction and overdiagnosis.

A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.

Background: Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA).

Clinical ethics consultation among Italian ethics committee: A mixed method study.

Objective: The general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings.

Deciding on cystic fibrosis carrier screening: three citizens' juries and an online survey.

Background: Health technology assessment and ethical issues have to be dealt with in deciding on national carrier screening for cystic fibrosis (CF)-the most frequent severe autosomal recessive disease in Caucasian populations and several stakeholders need to be involved. A citizens' jury is one way to ask citizens to deliberate on controversial topics in the interests of a society. The aims of this project were to gather opinions about CF carrier screening through citizens' jury deliberations and to match them with the findings of a large online consultation survey open to the general population, people with CF and families and health professionals.

Compassionate use programs in Italy: ethical guidelines.

Background: This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program (CUP) issue.

[Decision aid and informed decision on breast cancer screening: the "DonnaInformata-Mammografia" project.].

Unlabelled: In Italy women aged 50-69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patient associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health.

Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial.

Background: In Italy women aged 50-69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patients associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health.

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project.

Background: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe.

Methods: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence.

Involving a Citizens' Jury in Decisions on Individual Screening for Prostate Cancer.

Aims: Most public health agencies and learned societies agree that the prostate-specific antigen (PSA) test in asymptomatic men should not be recommended, on account of its potential for harm. Yet PSA is still widely used as a screening test and is not being abandoned. This remains a significant public health issue, and citizens' engagement is needed.

Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?

The Ebola outbreak that has devastated parts of west Africa represents an unprecedented challenge for research and ethics. Estimates from the past three decades emphasise that the present effort to contain the epidemic in the three most affected countries (Guinea, Liberia, and Sierra Leone) has been insufficient, with more than 24,900 cases and about 10,300 deaths, as of March 25, 2015. Faced with such an exceptional event and the urgent response it demands, the use of randomised controlled trials (RCT) for Ebola-related research might be both unethical and infeasible and that potential interventions should be assessed in non-randomised studies on the basis of compassionate use.

Cystic fibrosis: to screen or not to screen? Involving a Citizens' jury in decisions on screening carrier.

Context: In recent years, the continuous improvements in molecular biology techniques have made it possible to detect carriers for several genetic conditions, including cystic fibrosis (CF). In some countries, CF carrier screening is offered to increasing subset of the general population. Offering of carrier screening at a population level should not be decided by local health authorities only, without consulting citizens' preferences.

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

Background: 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.

Methods: 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".

Does a consumer training work? a follow-up survey of the PartecipaSalute training programs.

Background: When properly trained through training programs on epidemiology, clinical research and healthcare policy, members of patients'/consumers' organizations could be helpful for a patient-oriented healthcare system. Since 2006 the not for profit project PartecipaSalute has organized periodic editions of a training program for representatives of citizens'/patients' organizations. After five editions of this training program, a survey of the long-term satisfaction and the impact on activities has been carried out.

Press coverage of hormone replacement therapy and menopause.

Objective: To evaluate the information reported by Italian press articles about hormone replacement therapy (HRT) and menopause, in terms of completeness, clarity of language and transparency.

Study Design: In the framework of the Consensus Conference Informing women about hormone replacement therapy, 225 articles published from 2000 to 2007 in Italian lay press were evaluated. Health magazines, weekly news magazines, newspapers, women's magazines and medical practitioners' journals were selected.

End-of-life decision-making and quality of ICU performance: an observational study in 84 Italian units.

Purpose: To appraise the end-of-life decision-making in several intensive care units (ICUs) and to evaluate the association between the average inclination to limit treatment and overall survival at ICU level.

Design: Prospective, multicenter, observational study, lasting 12 months.

Setting: Eighty-four Italian, adult ICUs.

Informing women about hormone replacement therapy: the consensus conference statement.

Background: The risks/benefits balance of hormone replacement therapy is controversial. Information can influence consumers' knowledge and behavior; research findings about hormone replacement therapy are uncertain and the messages provided by the media are of poor quality and incomplete, preventing a fully informed decision making process. We therefore felt that an explicit, rigorous and structured assessment of the information needs on this issue was urgent and we opted for the organisation of a national consensus conference (CC) to assess the current status of the quality of information on hormone replacement therapy (HRT) and re-visit recent research findings on its risks/benefits.

Menopause: knowledge, attitude and practice among Italian women.

Objectives: Investigating women's knowledge, attitude and practice in relation to menopause and systemic hormone therapy (HT) through a sample survey implemented within the preliminary works for the Consensus Conference "Informing women on hormone replacement therapy" that took place in Turin in May 2008 [Available at www.partecipasalute.it.

Clinical evidence continuous medical education: a randomised educational trial of an open access e-learning program for transferring evidence-based information - ICEKUBE (Italian Clinical Evidence Knowledge Utilization Behaviour Evaluation) - study protocol.

Background: In an effort to ensure that all physicians have access to valid and reliable evidence on drug effectiveness, the Italian Drug Agency sponsored a free-access e-learning system, based on Clinical Evidence, called ECCE. Doctors have access to an electronic version and related clinical vignettes. Correct answers to the interactive vignettes provide Continuing Medical Education credits.