The Laboratory promotes research activities for an active and informed participation of citizens, patients and their representatives on engagement, choices and decisions regarding health issues.
The Laboratory’s research activities and methods are: consensus conferences and citizens' juries, with assessments of their impact; prioritization exercises, training courses for citizens, patients and their representatives aimed at allow them to understand and interact in partnership with the medical and scientific experts; and projects for the evaluation of information aimed at the public on diseases, treatments and lifestyles, as well as the development of information tools such as decision aids, App and websites.
Italian Register of Multiple Sclerosis Project
The project is promoted by “Fondazione Italiana Sclerosi Multipla FISM Onlus” and “Università degli Studi Aldo Moro di Bari, Dipartimento Scienze Mediche di Base, Neuroscienze ed Organi di Senso”, and funded by FISM. The Laboratory is in charge for the technical and methodological aspects of the project and is member of the project’s scientific board. The main aim of this project, more than 140 participant centres, is to create an organized and multicentric structure to collect selected data of Italian persons with multiple sclerosis. The purpose of this data collection is to allow epidemiological research to improve knowledge about the disease’s causes and treatments. The Laboratory is involved - in addition to the coordination, management and organization of activities related to data collection - in the development of a web-based data collection tool. This new way of collecting data is allowing new perspectives of data analysis, such as participation in data pools in collaboration with European Medicine Agency EMA, analysis with regional administrative data, and involvement in ad hoc projects.
CCE_DART - Building Data Rich Clinical Trials Project
Strategies for cancer treatment are evolving and precision oncology is considered to be the future in the fight against cancer, but research suffers from methodological and organizational issues when patients populations are highly selected. In order to overcome these difficulties and to test new technological and methodological approaches, the European consortium of excellence clinical centres “Cancer Core Europe” is defining the Basket of Baskets (BoB) study protocol, aimed at studying precision treatments incorporating a molecular profiling platform. The DART project – Building Data Rich Clinical Trials – is funded by European Union (grant agreement No 965397) and developed within the CCE consortium, is developing informatic tools for the management of trials and integrating imaging with molecular markers of tumor progression and drugs response together with the development of new methodological approaches for clinical trials. As part of the project, the Laboratory is promoting the active involvement of patients through the development of a web platform with different information tools, iEnter, iConsent and iParticipate.
Health technology assessment for cystic fibrosis carrier screening
The project aims at investigating the introduction of a cystic fibrosis (CF) carrier screening offered to the general population. In particular, it assesses if the carrier screening approach could bring advantages or disadvantages, both for individuals and for the Italian National Healthcare Service (NHS) – Regional healthcare service. To achieve the aforementioned objective, a Health Technology Assessment (HTA) approach grounded on the dimensions of the EUnetHTA Core Model (https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf) in on going. As suggested by the EUnetHTA Core Model, several dimensions are analysed: · Relevance of CF, and current offer of carrier testing, · Description and technical characteristics of available testing procedures / tests, · Efficacy and safety of different modalities of screening offer, · Costs and economic evaluation, · Ethical, social, legal aspects, and organizational impact. These dimensions are analysed through different approaches 1) systematic literature reviews; 2) health economics tools for economic evaluation and budget impact analysis, and 3) qualitative approach through questionnaires and interviews aimed at health professionals (geneticist, gynaecologists, general practitioners…), persons with CF, families of persons with CF, general population. The principal investigator is Carlo Castellani, head of the Cystic Fibrosis Center IRCCS Istituto Giannina Gaslini, Genova. The project is coordinated by the Laboratory and the Center for Regulatory Policies in Healthcare - and is carried out in collaboration with the Carlo Cattaneo University - LIUC of Castellanza (VA) . The project is supported by a multidisciplinary board. The project is funded by the Cystic Fibrosis Research Foundation.
Breast cancer and follow-up
The project "Periodic follow up after diagnosis and therapies in disease-free and asymptomatic breast cancer patients: towards a personalization of follow-up strategies" is promoted and financed by the Lombardy Region and coordinated by the Fondazione IRCCS Istituto Tumori di Milano. The project aims to study the follow-up of breast cancer in disease-free and asymptomatic patients, evaluating the many and different components of assistance, impact and outcomes. Not only the point of view of clinicians and literature, in support of care choices, but also the impact on women's lives as well as their opinions and preferences. The Laboratory is engaged in different areas: survey of impact of the follow-up of breast cancer women, interviews on opinions of patient associations in the Lombardy region and Gap analysis between groups of clinicians involved in the follow-up.
Opinions, perceptions, and attitudes of citizens on the current model of medicine research and development and price setting mechanisms
Equity of access to medicines is an essential component of citizens’ healthcare rights but it can be limited by the high prices of medicines. To explore the opinions, perceptions, and attitudes of citizens on the current model of medicine research and development (R&D) and price setting mechanisms, BEUC, the European Consumer Organisation, with Altroconsumo for the Italian branch, commissioned a series of focus groups in Italy, Spain and Nederland. The Laboratory and the Center for Regulatory Policies in Healthcare are the methodological unit in charge of planning, conduction and analysis of the Italian focus groups. Several topics have been addressed: process and mechanism of R&D, confidentiality of R&D costs, revenues by pharma, public funding, reimbursement procedures, confidentiality of the actual drugs’ prices, factors at stake in the definition of drugs’ prices, value of a new drug. The sofosbuvir example has been discussed as a case study to illustrate the overall topics. The project has been funded by Altroconsumo Edizioni srl.
MaReMoTo - Making Research in Multidisciplinary Oncological Treatment Organizations
The project has been submitted to Program ERASMUS + KA2 2021 Small-scale partnerships in adult education - and the action was eligible for UE funding. Its main objective is to train skills in qualitative research methodology according to a multidisciplinary and multicultural perspective, which include skills in the field of involving the public and patients in research. Among the expected results: a Syllabus describing the training offer on the methodology of qualitative research; a training course in qualitative research and related platform, in English, accessible remotely and aimed at health professionals; an intensive course at the end of distance learning; a shared research protocol for multidisciplinary and multicentre research. The research units in partnership are: The Local Health Authority, IRCCS of Reggio Emilia - Qualitative research unit which coordinates the project; the Mario Negri Institute for Pharmacological Research, Laboratory of medical research and consumer involvement; Universidad De Castilla, La Mancha – Spagna; University St Kliment Ohridski Bitola – Macedonia.
Public and patient involvement in gynaecologic oncology
The project “Public and patient involvement in gynaecological oncology research: a survey on clinicians’ opinion” is promoted and coordinated by the Laboratory and funded by Nerina and Mario Mattioli Foundation Onlus. Public and patient involvement (PPI) is internationally considered to be important and necessary in clinical research and many findings about the improvements of its quality, relevance and outcomes are available. Despite this, currently only few studies actively involved patients in gynaecologic oncology research and mostly, data and information about clinicians’ opinions on PPI are missing. Having a clear picture of PPI in oncology research, mostly on clinicians’ point of view, attitudes and training needs, is fundamental in order to incentivize a participatory approach through which address the research towards questions relevant to people with illness and improve studies feasibility. With this aim, a survey will be conducted on two collaborative groups working in gynaecologic oncology active through National territory. The results will allow the promotion and development of future research projects on PPI in gynaecologic oncology and in clinical research, together with the development of projects on clinicians’ training on PPI.
PartecipaSalute: A Strategic Alliance Between Patient Groups, Citizens And Scientific Medical Communities
This project, a milestone for the Laboratory, was carried out in collaboration with the Italian Cochrane Center and the journalistic and editorial agency Zadig starting from 2003. Its aim is to direct patient associations and citizens toward a greater participation in the issues of health care and medical choices. The project, and, above all, the related working group, remains an important point of reference for activities involving citizens in the health debate.
Slow Medicine: “To Do More Isn’t To Do Better”
With the aim of recommending only interventions based on proven effectiveness without exposing citizens to possible risks of over-diagnosis and over-treatment, Slow Medicine is supporting the project “Doing more does not mean doing better”. PartecipaSalute, partner of the project, has collaborated in several initiatives.
Quality of Life
The Laboratory supports groups that exploit quality of life tools that we previous translated and validated.
The questionnaires are SF-36, SF-12 and PGWBI and are available here.
International Consensus on Cardiopulmonary Resuscitation.