The laboratory promotes research activities for the active participation of citizens, patients and their representatives in the choices and decisions regarding health.
Among the laboratory’s research areas are consensus conferences and citizens' juries, with assessments of their impact; prioritization exercises, training courses for citizens, patients and their representatives aimed at permitting them to understand and interact with the medical and scientific worlds; 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 and websites.
Development and evaluation of a decision-making tool on mammographic screening: “Donna informata-mammografia”
The laboratory coordinates this project, funded through a competitive grant of the AIRC No.IG2015-17274 in collaboration with the Italian Screening Group Mammography GISMa, Italian League for the Fight against Cancer section of Florence, and Zadig, a scientific publishing agency. The project aimed to develop an interactive web information and decision tool for newly invited women to participate in mammographic screening, and to evaluate its effect through a randomized controlled clinical trial in three screening centers per city in each of the following cities: Turin, Florence, Palermo, Reggio Emilia, Milano, and Cuneo. The randomized clinical trial started in September 2017 and ended December 2018 with more than 900 women who completed the final questionnaire. The effect of the tool will be measured on the basis of the knowledge, attitudes and intentions that led to the informed choice of the participating women concerning mammographic screening.
The IN DEEP project: diagnostic tests for people with multiple sclerosis
Based on the previous "IN DEEP-Integrating and Deriving Evidence, Experience, Preference" project developing an informative model for people with multiple sclerosis, the “Fondazione Italiana Sclerosi Multipla-FISM” supported a similar project on the use of magnetic resonance imaging in MS diagnosis, prognosis and monitoring of treatments. The project is coordinated by the “Fondazione IRCCS Istituto neurologico Carlo Besta”. The aim of the project is to provide an information model on magnetic resonance developed in agreement and collaboration with people with multiple sclerosis, clinicians, and researchers. The contents of the information model were developed on the basis of the literature (systematic reviews, and guidelines assessed through AGREE II and AMSTAR2 checklists). The findings and contents were discussed and defined with the project's multidisciplinary advisory board. The final version is now available online (https://www.istituto-besta.it/in-deep), and it will be tested through an online survey.
Corbel Project Document On Informed Consent
Within the European project “CORBEL-Coordinated Research Infrastructures Building Enduring Life-Science Service”, the WP7 group "Common Services Providing Support with Ethics, Legal and Societal Issues" aimed to develop a matrix defining structure and contents of an informed consent template to be used in clinical trials. Based on a review of the literature and a collection of international experiences and examples, the document was drafted and shared with the working group. It was submitted to a group of patient representatives to collect their feedback concerning clarity, completeness, and usefulness. The final document will be promoted within the collaborative groups involved in clinical research, in particular the network of research centers involved in the ECRIN European Clinical Research Infastructure Network.
Multicenter Survey on Knowledge, Attitudes and Experience on Randomised Clinical Trials in Women with Ovarian Cancer
The main purpose of the study is to investigate how familiar women with a diagnosis of ovarian cancer are with the topic of clinical research, in particular randomized and controlled clinical trials, and how they experienced the proposal to participate in a clinical study. The results will allow us to highlight relevant aspects for improved involvement and participation as well as discuss new methods of communication between doctor and patient. The survey will be carried out through two ad-hoc questionnaires designed using the available literature as a starting point and validated through a process that also involved ovarian cancer patients. The protocol and the questionnaires have been finalized. The study protocol was approved by the coordinating ethics committee at the end of October. The study is funded by the Association ACTO Onlus - Alliance against ovarian cancer and will take place in more than 20 Italian clinical centres belonging to the MaNGO (Mario Negri Gynecologic Oncology group) and MITO (Multicenter Italians Trails in Ovarian Cancer) collaborative groups.
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” setting up a specific “Unit of Research”. The laboratory, in collaboration with the Core search team, is responsible for the technical and operational aspects of the project funded by FISM and is, moreover, member of the project’s scientific technical committee. The main aim of this project, that has seen the participation of more than 130 centres up to now, is to create an organized and multicentric structure to collect selected data of Italian patients with multiple sclerosis. The purpose of this data collection is to permit 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 that will gradually replace the current one. This new way of collecting data via the web will also allow new perspectives of data analysis, such as participation in data pools in collaboration with EMA, analysis with regional administrative data, and involvement in ad hoc projects. In the current year, the paediatric module has been also finalized to collect clinical data relating to school and family history and physical development of patients with multiple sclerosis under 18 years of age. “Indagine Data Sharing” Project We organized a cross-sectional online survey to gather knowledge on the current debate, opinions and attitudes of Italian patient and citizen groups on Individual Participant Data (IPD) sharing from clinical studies, in collaboration with researchers from the IMPACT Observatory, Mediterranean Institute for Life Sciences, Split, Croatia; the Department of Epidemiology, Lazio Regional Health Service, ASL Rome and the Centre for Regulatory Policies here at the Mario Negri Institute. A 22-item online questionnaire was sent by e-mail to other 2.000 contacts of patient and citizen groups, and 280 responded. Half of the respondents had some knowledge about the IPD sharing debate.
Industry Funding of Patient and Health Consumer Organisations
A literature review was conducted in collaboration with researchers from the Charles Perkins Center and Faculty of Pharmacy, the University of Sydney, the University of Milan and the Cochrane Hypertension Review Group, and the University of British Columbia, Vancouver, Canada, in order to assess and quantify the financing of the pharmaceutical industry for patient and consumer organizations; the transparency of patient and consumer organizations, and the possible influence of public positions. A total of 5309 references were evaluated and 27 useful studies for data analysis were considered in the final analysis.
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 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. The development and continuous updating of the www.partecipasalute.it website is also a strongpoint of the project. The site is updated with new articles and insights almost every week and every month the newsletter is sent to over 3500 people.
Gynecological cancers and the Mattioli Foundation
Since 1995, the Nerina and Mario Mattioli Foundation Onlus, in close collaboration with the Department of Oncology of the “Istituto Mario Negri IRCCS”, has helped to develop and catalyze interdisciplinary cooperation and facilitate the rapid transfer of knowledge on female tumors, especially ovarian cancer. Ovarian cancer is the sixth most common type of cancer in European women and the leading cause of cancer death related to female genitals. The laboratory is in the executive committee, carrying out its information related activities through the website www.fondazionemattioli.it and developing many collaborations with other research groups.
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. During the year the results of an online survey conducted in collaboration with Altroconsumo entitled "Drugs, exams and prescriptions: give your opinion!” were published.
Quality of Life Projects
As for the previous year, it is on the activity of support and coordination of groups that exploit quality tools that we previous translated and validated. These questionnaires are SF-36, SF-12 and PGWBI that are available on http://crc.marionegri.it/qolsite.
International Consensus on Cardiopulmonary Resuscitation.