[The EASY-NET research programme: background, structure, and methodology]. / Il programma di rete EASY-NET: razionale, struttura e metodologie.

This is the first contribution of a series of interventions describing the EASY-NET research program (Bando Ricerca Finalizzata 2016, funds 2014-2015; NET-2016-02364191). Here, the objective is to illustrate the background and the research question, the structure and organization, the methodologies and the expected results of the programme. The main theme is audit&feedback (A&F), a proven and widespread technique for improving the quality of health care. EASY-NET, funded by the Italian Ministry of Health and by the governments of the participating Italian Regions, starts its research activities in 2019 with the aim of evaluating the effectiveness of A&F in improving care for different clinical conditions in various organizational and legislative contexts. The research network involves seven Italian Regions, each conducting specific research activities described by as many work packages (WP): Lazio (the leading Region, coordinator of the research activities), Friuli Venezia Giulia, Piedmont, Lombardy, Emilia-Romagna, Calabria, and Sicily. The involved clinical areas include the management of chronic diseases, emergency care for acute conditions, surgery in the oncological area, the treatment of heart disease, obstetrics, and the use of caesarean section and post-acute rehabilitation. The involved settings concern the community, the hospital, the emergency room, and the rehabilitation facilities. Different experimental or quasi-experimental study designs are applied in each WP to achieve specific objectives of the specific clinical and organizational context. In all WPs, the process and outcome indicators are calculated on the basis of the Health Information Systems (HIS) and, in some cases, they are integrated with measures obtained from ad hoc data collections. The programme aims to contribute to the scientific evidence on A&F also exploring the obstacles and favourable factors for its effectiveness and to promote its implementation in the health service, with the ultimate aim of improving the access to healthcare and the health outcomes for citizens.

[Fake paper factories: root cause solutions are needed.] / Gli articoli scientifici fabbricati: servono soluzioni di sistema.

The pressure to publish academic papers for career advancement and technological innovations have fostered the growth of a new phenomenon, the serial fabrication of articles to be submitted to scientific journals. Papers with fake content are produced by specialised publishing agencies. Journal editors and publishers increased vigilance and control, tightening the peer review process and using anti-plagiarism software. But, being a systemic issue, it is not easy to find the solution and action must be taken on its causes: greater awareness of research ethics is needed, specific training for young doctors and - in the long run - an appropriate use of artificial intelligence, which should become a tool for protecting the integrity of knowledge.

[Who is the author of a scientific article?] / Chi è l'autore di un articolo scientifico?

Authorship is increasingly discussed in international journals: in fact, the authorship and position of authors influence professional careers, the acquisition of funding, and individual and institutional reputation. International associations of editors of academic journals call for vigilance in cases of misconduct: ghostwriting and guest or gift authorship are frequent and penalise especially younger researchers and women. However, authorship is a concept in the making, strongly influenced not only by the social and ethical context, but also by technology. Today, artificial intelligence is an important aid for the editorial boards of academic journals. But it is likely to become a support for authors in the future as well, given the success of automatic writing software.

Italian health professionals on the mandatory COVID-19 vaccine: An online cross-sectional survey.

Italy was the first country in Europe to make vaccination against COVID-19 mandatory for healthcare professionals by imposing restrictions in cases of non-compliance. This study investigates the opinions of the Italian healthcare professionals' categories affected by the regulation. We performed a qualitative online survey: the questionnaire comprised both close- and open-ended questions. The final dataset included n = 4,677 valid responses. Responses to closed-ended questions were analyzed with descriptive statistics. The framework method was applied for analyzing the open-ended questions. The sample spanned all health professions subject to compulsory vaccination, with a prevalence of physicians (43.8%) and nurses (26.3%). The vaccine adhesion before the introduction of the obligation was substantial. 10.4% declared not to have adhered to the vaccination proposal. Thirty-five percent of HPs who opted not to get vaccinated said they experienced consequences related to their choice. The trust in the vaccine seems slightly cracked, demonstrating overall vaccine confidence among professionals. Nonetheless, our results show that whether (or not) professionals adhere to vaccination is not a reliable indicator of consent to how it was achieved. There are criticisms about the lawfulness of the obligation. The data show a great variety of participants interpreting their roles concerning public and individual ethics. The scientific evidence motivates ethics-related decisions-the epidemic of confusing and incorrect information affected professionals. The Law triggered an increased disaffection with the health system and conflicts between professionals. Dealing with the working climate should be a commitment to assume soon.

[Presumed guilty. Falsification and fabrication of data in scientific publications.] / Presunti colpevoli. Falsificazione e fabbricazione di dati nelle pubblicazioni scientifiche.

The falsification of results and the fabrication of scientific research data are on the rise. Famous researchers see their articles pulled from leading journals. Often, however, this editorial malpractice does not harm the reputation of the authors, who continue to progress in their careers. The solution cannot come from a greater awareness of researchers, sponsors, regulatory agencies or research institutions: the incentives for malpractice are too strong. We need a new international governance of research and communication.

[The Liberati's principles ten years later.] / I Liberati's principles dieci anni dopo.

Ten years after the death of Alessandro Liberati, the authors wonder how much the principles that guided the action of the founder of the Italian Cochrane Centre are still relevant. The guiding star of Liberati's professional life was the fight for useful research aimed at solving problems relevant to patients and their families. Consistently with the work of other researchers such as Sir Iain Chalmers and Paul Glasziou - they have recently offered important contribution on these issues - Alessandro Liberati worked hard to guarantee open, accessible, and transparent research to citizens, health decision makers and health professionals. Unfortunately, his final call to design a new research governance remained unanswered. Research is still too focused on individual therapeutic interventions rather than on overall care strategies. Studies are still too often unpublished or only partially published. Research is still influenced by conflicts of interest and peer review is often biased. Much work remains to be done, to ensure that publicly funded research is guided by the real needs of citizens and patients.

[Pandemic emergency as a stress test for the health system.] / Emergenza pandemica come stress test per il sistema sanitario.

One year after the beginning of the health and social emergency, the health system shows its strengths and weaknesses. Among these, inadequacy of facilities, deficiencies of continuity between hospital and territory, inconsistent information and lack of bidirectional communication between institutions and citizens, uncertainties of data about therapies and the emphasis given to the role of opinion leaders. To get out of the pandemic, a change of perspective is needed: governments must not just support industrial investments but must they must encourage better and community-useful research and communication.

[Ethics in health communication.] / Etica della comunicazione in ambito biomedico.

Health communication must be based on open and multi-dimensional dialogue involving all stakeholders: public and private institutions, health professionals, industries, associations and, above all, citizens. Currently, communication suffers many problems related to bad research (unethical research, falsification of data, conflict of interest, incomplete reporting, spin and plagiarism) and to the limits of an academic system that does rewards quantity more than quality. A turnaround is needed, based on five major changes: establishing rules that can actually be followed; improve the quality of scientific information; accept and encourage open confrontation; allow citizens to be able to express and assert their needs; transform uncertainty from limit to value. The "Liberati's principles" must be reaffirmed: an honest communication must make the results of the research accessible to those who have to make decisions that affect their health; researchers must engage in studies that promise benefits to citizens and are not just useful to one's career or industry; before opening up new research fronts it is necessary to exhaust the potential of research already started; the definition of research priorities must be a transparent and shared process; the best evidence is the most relevant for citizens and patients. These principles and all ethical issues related should be part of educational programs for all health operators and researchers.

[Professional societies and conflict of interests governance.] / Società scientifiche e governo dei conflitti di interesse.

The complexity of health systems often implies a condition of conflict of interests for many of the players involved: health professionals, managers of the NHS, pharmaceutical, medical devices or food industries, publishers and communication agencies, conference event organizers. Conflict of interests is a condition of risk, not a sentence of guilt: for this reason, conflict of interests should be managed through information and training of health personnel. Scientific societies play an important role being active in updating their members (conferences, meetings, e-learning and residential training courses) and influencing healthcare with the production of clinical practice guidelines. Professional associations must be active to foster the integrity of their members and to minimize the risk of conflict of interests, also to avoid wasting resources, making the health system fairer and more sustainable.

Information needs on precision medicine: a survey of Italian health care professionals.

BACKGROUND: Despite advances in technology development for precision medicine, obstacles remain as barriers to progress and change. In this context simple questions arise: what is the level of understanding of precision medicine among healthcare professionals? We tried to address this question with a survey whose objective was to explore the perception and understanding of precision medicine. METHODS: A questionnaire was administered to a sample made of oncologists, clinical and hospital pharmacists, pharmacologists and infectiologists in the context of five different Italian national congresses. Participation in the survey was voluntary and anonymous. RESULTS: The questionnaire was filled-in by a total number of 1113 professionals out of 3670 registered participants in the congresses. About half of respondents stated they were not sufficiently informed about precision medicine, and infectiologists were the ones who felt less informed. Most respondents agreed with the basic principles and definitions of precision medicine and believed this new approach is going to require deep changes in healthcare. CONCLUSIONS: Our findings show that healthcare professionals have partial knowledge on this topic and that there is a significant association between respondents' knowledge and their clinical specialty. However, despite some misconceptions about precision medicine, a genuine interest and familiarity with its basic principles seems to emerge.

[Plagiarism. A fools' errand.] / Il plagio nella scienza. Le bugie hanno le gambe corte.

An old Italian proverb states that lies have short legs. In other words, in the end you get found out. This is exactly what happened to an Italian researcher who acted as a referee for a manuscript submitted in 2015 to Annals of Internal Medicine. After a negative report (which presumably led to the rejection of the submission) he submitted a manuscript which was essentially the same. But he and his accomplices got found out and paraded in front of the world in an earth-shatteringly polite "Dear Plagiarist" letter by the first robbed author: Dr Michael Dansinger. Dr Dansiger's letter is a model of polite logic and an ethical masterpiece, the fake article got retracted and the thief's institution contacted. No reply so far, a depressingly familiar theme in contemporary research. We wonder why we carry on with a system which is completely broken. Commercial interests, reporting bias, secrecy, ethically dubious studies and inertia are the ingredients of contemporary research and publication practices. Editorial peer review, a scholarly practice originating in a more genteel era, is clearly unable to do much other than lend a very thin veneer of credibility to this pandemic of junk which is threatening healthcare budgets and the ethics of the next generation of researchers. We need a complete reform of the system which could give back some credibility to the "e" of evidence-based medicine. Complete lawful transparency, public reimbursement of interventions only on the basis of independently generated evidence and research ethics as a part of an international curriculum for budding researchers are urgently needed. These should be linked to publishers' complete disclosure of their sources of income and custodial sentences for those who abuse positions of trust. Meanwhile, stay away from anything implausible and non-replicable (as they probably are).

[Real-world evidence.] / Real-world evidence.

Real-world evidence is among the most frequently discussed issues at professional medical conferences and meetings. It refers to data and information derived from sources such as electronic health records, disease or product registries, and observational research. Looking for an accelerated approval of new pharmaceutical products and devices, real-world evidence is considered a useful tool to confirm data collected for regulatory purposes. Anyway, randomised controlled trials still remain the gold standard of clinical research, in order to minimize bias and to evaluate the effectiveness of a clinical intervention. A pragmatic approach and quasi-randomised trials to shorten length and costs of the studies can be considered. The problem lies with the quality of data rather than with the context in which evidence is gathered.