Roberto Satolli

Zadig, scientific publishing

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. It was evaluated in a randomized clinical trial sh...

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). A pragmatic randomised trial carried out i...

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...

Methodological manual on how to organize a Consensus Conference. Language: Italian

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 t...

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 object...

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. This trial ai...

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. T...

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. Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical...

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 nee...

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 abo...

Introduction: To tackle the increasing medicalization of society, healthcare decisions that have consequences on the general population should be shared with citizens. Citizens juries are a method of deliberative democracy, asking citizens to deliberate on issues with consequences on society from the public interest's point of view. Methods: Citize...

ContextIn 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...

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 o...

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...

Partecipasalute survey.

The objective of the article is to examine the extensions of a clinical measure of efficacy, the Number Needed to Treat (NNT), in different settings including screening, scanning, genetic testing and primary prevention, and the associated ethical implications. We examine several situations in which the use of the NNT or NNS (Number Needed to Screen...

L’oncologia è un caso a sé, nella generale evoluzione specialistica della medicina contemporanea.

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. 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 evalu...

An Italian project of deliberative democracy called Giurie dei cittadini, planned within the PartecipaSalute project.2. This project will organise citizens’ juries to deliberate whether offering prostate cancer screening to all men aged 50 and older is worth while. Citizens will be given complete, plain, evidence based information and critical appr...

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. Prospective, multicenter, observational study, lasting 12 months. Eighty-four Italian, adult ICUs. Consecutive patients (3,793) who died in ICU or we...

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. Last access 7/8/20...

Final report Consensus Conference: Informing women about hormone replacement therapy (HRT). This is the final statement written and approved by the Jury of the consensus conference, and officially presented at the end of the celebration of the consensus conference.

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 t...

Il corso per rappresentanti di associazioni di cittadini e pazienti organizzato ogni anno da Partecipasalute può contare ora su una dispensa che ne presenta i principali contenuti: dalla sperimentazione clinica all’informazione in medicina e sanità; dall’incertezza ai conflitti di interesse, ai comitati etici; da come funzio- nano le agenzie regola...

CONSORT checklist. CONSORT checklist as provided by investigators to improve the reporting of the RCT.

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...

Introduction. The interest on the debate of the involvement of consumer and patients' associations is increasing. Between the various interested fields, the clinical research is opening on the citizens' participation in the definition of its agenda and its priorities. ▶ Aims. This article describe a survey carried out in the framework of the activi...

In an effort to ensure that physicians have access to reliable evidence on drug effectiveness and safety, the Italian Drug Agency launched a program to disseminate independent information.

A Consensus Conference was convened by the Italian National Institute of Health on May 5-6, 2005, to address the issue of the screening for hepatitis C virus infection in adults in Italy. It was concluded that a mass screening for hepatitis C virus infection is inappropriate. It was recommended that the following high-risk groups be tested for hepa...

Objective. To describe an independent distance-learning program that adopts evidence based medicine (EBM) methodology in Italy. Methods. An annotated experience of EBM permanent training initiatives developed by the Italian Cochrane Centre and Zadig scientific publisher in partnership with AIFA and the Italian Ministry of Health. Results. The Minis...

Recommendations are made for controlling the transmission of the hepatitis B and hepatitis C viruses from healthcare workers to patients. These recommendations were based both on the literature and on experts' opinions, obtained during a Consensus Conference. The quality of the published information and of the experts' opinions was classified into...

Riassunto La salute, oltre a possedere un intrinseco valo- re individuale e collettivo, rappresenta ormai anche la ragione d'essere per uno dei più floridi e proficui settori economici nei paesi ricchi. Per crescere l'industria della salute deve allargare il proprio mercato e per ciò investe nella ricerca biomedica, cercando però di mantenere il co...