Factors affecting safe and healthy diet in older adults in Italy: results of a preliminary study performed in a community-dwelling sample.

OBJECTIVE: To investigate, through a questionnaire, older adults' demographic and socio-economic characteristics, knowledge, attitudes and practices in terms of food safety and healthy diet; and to develop dietary and hygiene indices able to represent participants' nutritional and food safety behaviour, exploring their association with demographic and socio-economic factors. DESIGN: One-year cross-sectional study. SETTING: Gemelli Teaching Hospital (Rome, Italy). PARTICIPANTS: People aged ≥65 years, Italian speaking, accessing the Centre of Ageing Medicine. RESULTS: Mean age of the sample was 74 (sd 7·7) years. Subjective perception of a safe diet was high: 64·2 % of respondents believed they have a balanced diet. Interviewees got informed about proper nutrition mainly from television, magazines, newspapers, Internet (29·9 %) and from health professionals (34·8 %) such as dietitians, whereas 15·4 % from general practitioners. Regarding food safety, 33·8 % of participants reported to consume expired food, even more than once per month; between 80 and 90 % of participants reported to follow food safety practices during preparation and cooking, even though 49·3 % defrosted food at room temperature. Calculated dietary and hygiene indices showed that the elderly participants were far from having optimal nutritional and food safety behaviours. CONCLUSIONS: These results suggest it is necessary to increase the awareness of older adults in the matter of healthy diet and food safety. Specific and targeted educational interventions for the elderly and their caregivers could improve the adoption of recommended food safety practices and safe nutritional behaviours among older adults.

Prevalence and determinants of resistance mutations in HIV-1-infected patients exposed to integrase inhibitors in a large Italian cohort.

OBJECTIVES: The aim of the study was to analyse the prevalence of integrase resistance mutations in integrase strand transfer inhibitor (INSTI)-experienced HIV-1-infected patients and its predictors. METHODS: We selected HIV-1 integrase sequences from the Antiviral Response Cohort Analysis (ARCA) database, derived from INSTI-experienced patients between 2008 and 2017. Differences in the prevalence of resistance to raltegravir (RAL), elvitegravir (EVG) and dolutegravir (DTG) were assessed by χ2 test and predictors of resistance were analysed by logistic regression. RESULTS: We included 462 genotypes from INSTI-exposed individuals: 356 'INSTI-failing' patients and 106 'previously INSTI-exposed' patients (obtained a median of 42 weeks after INSTI discontinuation [interquartile range (IQR) 17-110 weeks]). Overall, at least low-level resistance (LLR) to any INSTI (Stanford 8.5 algorithm) was detected in 198 (42.9%) cases. The most frequent INSTI resistance mutation was N155H, followed by Q148H/K/R, G140A/C/S, E138A/K/T and Y143C/H/R. Y143R and E138A were more prevalent in viral subtype B versus non-B [5.2 versus 1.5%, respectively (P = 0.04), and 3.1 versus 0%, respectively (P = 0.02)]. Overall, the Q148H/K/R plus G140A/C/S and/or E138A/K/T pattern, defining an intermediate level of resistance to DTG, was detected in 70 (15%) cases. Independent predictors of at least LLR to any INSTI were current use versus past use of INSTIs, a lower genotypic sensitivity score (GSS) for contemporary antiretroviral drugs used, and having an integrase sequence obtained in calendar year 2016 as compared to 2008-2009. CONCLUSIONS: The results support integrase resistance testing in INSTI-experienced patients. Emergence of INSTI resistance is facilitated by the reduced genetic barrier of the regimen as a consequence of resistance to companion drugs. However, INSTI resistance may become undetectable by standard population sequencing upon INSTI discontinuation.

On the normativity of evidence - Lessons from philosophy of science and the "VALIDATE" project.

"Evidence" is a key term in medicine and health services research, including Health Technology Assessment (HTA). Randomized clinical trials (RCTs) have undoubtedly dominated the scene of generating evidence for a long period of time, becoming the hallmark of evidence-based medicine (EBM). However, due to a number of misunderstandings, the lay audience and some researchers have sometimes placed too much trust in RCTs compared to other methods of investigation. One of the principal misunderstandings is to consider RCTs findings as isolated and self-apparent pieces of information. In other words, what has been essentially lacking was the awareness of the value-context of the evidence and, in particular, the value- and theory-ladenness (normativity) of scientific knowledge. This paper aims to emphasize the normativity that exists in the production of scientific knowledge, and in particular in the conduct of RCTs as well as in the performance of HTA. The work is based on some lessons learned from Philosophy of Science and the European project "VALIDATE" (VALues In Doing Assessments of healthcare TEchnologies"). VALIDATE was a three-year EU Erasmus+ strategic partnerships project (2018-2021), in which training in the field of HTA was further optimized by using insights from political science and ethics (in accordance with the recent definition of HTA). Our analysis may reveal useful insights for addressing some challenges that HTA is going to face in the future.

Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

Ethics of digital therapeutics (DTx).

Digital therapeutics (DTx) are a subset of digital health which are often coupled with artificial intelligence (A.I.) techniques and machine learning systems. DTx differ from common wellness apps or medication reminder tools in that they require "rigorous" clinical evidence. They are emerging as a new treatment option and are being applied in a variety of areas, including type II diabetes, hypertension, chronic respiratory problems, obesity, insomnia, Alzheimer's disease, various types of dementia or addiction (smoking, alcohol, drugs), anxiety, depression, autism, learning disabilities, and attention deficits. Today, there are roughly 35 to 40 products on the market, 8 of which approved by regulatory agencies. The value of the global DTx market was estimated at USD 1.8 billion in 2018, and it is expected to reach USD 8.9 billion by 2027. Implementing DTx across healthcare systems raises a number of ethical concerns. The present article aims to provide an overview of the main ethical issues pertaining the assessment, implementation, and use of this emerging technology. The final purpose is to support and facilitate an open and transparent deliberation with regard to DTx.

[On therapeutic use of stem cells and the sources of morality]. / Sull'utilizzo delle cellule staminali a fini terapeutici e le fonti della moralità.

The Article deals with the ethical issues around the therapeutic utilization of stem cells (SC), particularly facing with factors of morality: i.e., object of the human action, aims and circumstances. Crucial ethical questions are recognized in the last factor (circumstances), particularly: the origin and the availability of SC, the consequences of the therapeutic action through SC, the diffusion/communication of scientific data around the clinical use of SC. The paper assumes the perspective of the ethics considered as practical-normative science, centered on the human person (as a whole) as the value of reference.

[AIDS and forensic medicine. I. The framework of the debate]. / AIDS: attualità intorno al dibattito etico-deontologico e medico-legale. I. Le coordinate generali.

The ethical debate regarding the AIDS is very rich both at the theoretical and practical level, but--unlike what it is happening for other sectors, e.g. the euthanasia--these two aspects are integrated, shaping a true interdisciplinary job of ethical evaluation, in which clinicians, medical examiners, ethicists, nurses, clinical psychologists, economists and politicians are met. The utilized methodology will be to identify the human act in the light of the patient's good and the common good of the society. These are strong references and broadly shared in general sense, but they become problematic if we want to identify, and we should have to do it, the contents of such "goods". The authors intend to appraise the quality of a Centre for Research and Healthcare for AIDS patients, also considering the "performance measures".

[AIDS and forensic medicine: II. the particular issues]. / AIDS: attualità intorno al dibattito etico-deontologico e medico-legale. II. Le questioni particolari.

The article deals with some issues of forensic medicine relevance, as well as ethical one, about HIV+/AIDS condition, which still represent open problems in regulations and in the case-law. Particularly, in the light of the specific Italian regulations (namely, the Law 5 June 1990 no. 135), the Authors address the juridical fundaments of the care of HIV+/AIDS patients, reaffirming the obligation for all the healthcare professionals to give care in every case of infection from HIV. Secondly, the issue of the diagnostic tests and the screenings is faced, sustaining the obligatoriness to gain an adequate previous consent by the subject and, however, only for clinical necessity and in his/her best interest. Finally, the delicate matter of the professional secrecy is examined, of the guardianship of confidentiality and of the partner notification is examined. In general, although the doctrine and jurisprudence not justify the transmission of HIV+/AIDS patient's personal data, yet the specific matter is not easily resolvable exclusively in juridical terms, because it is necessary remind also the extra-juridical--that is ethical--nature of deontological norms.

Prioritization of high-cost new drugs for HCV: making sustainability ethical.

Hepatitis C virus (HCV) infection is a major health problem worldwide. Chronic HCV infection may in the long run cause cirrhosis, hepatic decompensation and hepatocellular carcinoma, with an ultimate disease burden of at least 350,000 deaths per year worldwide. The new generation of highly effective direct acting antivirals (DAA) to treat HCV infection brings major promises to infected patients in terms of exceedingly high rates of sustained virological response (SVR) but also of tolerability, allowing even the sickest patients to be treated. Even in the face of the excellent safety and efficacy and wide theoretical applicability of these regimens, their introduction is currently facing cost and access issues denying their use to many patients in need. Health systems in all countries are facing a huge problem of distributive justice, since while they should guarantee individual rights, among which the right to health in its broader sense, therefore not limited to healing, but extended to quality of life, they must also grant equal access to the healthcare resources and keep the distribution system sustainable. In the face of a disease with a relatively unpredictable course, where many but not of all chronically infected will eventually die of liver disease, selective allocation of this costly resource is debatable. In most countries the favorite solution has been a stratification of patients for prioritization of treatment, which means allowing Interferon-free DAA treatment only in patients with advanced fibrosis or cirrhosis, while keeping on hold persons with lesser stages of liver disease. In this report, we will perform an ethical assessment addressing the issues linked to access to new therapies, prioritization and eligibility criteria, analyzing the meaning of the term "distributive justice" and the different approaches that can guide us (individualistic libertarianism, social utilitarianism and egalitarianism) on this specific matter. Even if over time the price of new DAA will be reduced through competition and eventual patent expiration, the phenomenon of high drug costs will go on in the next decades and we need adequate tools to face the problems of distributive justice that come with it.

Why is it so difficult to integrate ethics in Health Technology Assessment (HTA)? The epistemological viewpoint.

Ethics has been identified as a key element in Health Technology Assessment (HTA) since its conception. However, ethical issues are still not frequently addressed explicitly in HTA. Several valuable reasons have been identified. The basis of the article is the claim that ethics is often not part of HTA for "epistemological reasons". Hence, the main aim of the contribution is to explore in more details and emphasize them by using the fact/value dichotomy. Our conclusion is that current HTA configuration is predominantly based on the comparison among objective and empirically testable "facts", whilst ethics is not empirically testable. In this sense, there is a sort of "epistemological gap", which can explain why it is so difficult to integrate ethics in HTA. We suggest that the epistemological differences among the various domains of HTA are addressed more explicitly.

Research Ethics Committees and clinical research in Italy: where are we going?

Italian Ethics Committees (ECs) have entered a new phase because of the recent Law no. 189 of November 8 2012 and the Ministry of Health Decree of February 8 2013. The new norms have introduced important changes. In fact, ECs are now established not to serve a single hospital or research institution but to serve even Regions. Moreover, they are established on the basis of the number of inhabitants, research sites and expected amount of clinical trials. The implementation of the news norms into practice have produced a drastic reduction in the number of ECs. This fact could raise some issues but it could obtain some benefits. The paper explains the main steps of ECs and clinical research development in Italy. Special attention will be paid to recent trends. Moreover, the new norms will be illustrated, showing possible issues and benefits connected to their implementation.

E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards.

Patient recruitment is a critical point of today's clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.

Ethical aspects of Fecal Microbiota Transplantation (FMT).

The importance of human microbiota in preserving human organism healthy is nowadays well acknowledged. The alteration of the microbiota can be the consequence of a persistent use of antibiotics or immunosuppressive medications or abdominal irradiation or surgery, wrong diet, or can be caused by surgery or anatomical condition. These alterations can cause many infections and diseases that today can be treated with Fecal Microbiota Transplantation (FMT), also called Bacteriotherapy, that is the administration of a fecal solution from a donor into the intestinal tract of a recipient. Although to date, FMT appears to be safe and without serious adverse effects, there are some ethical issues that are worthy to be investigated. The aim of this article is to highlight these issues in order to give some notes for a better implementation of this particular clinical practice.

Human outbreak of trichinellosis associated with the consumption of horsemeat in Italy.

Trichinellosis is endemic among sylvatic mammals in Italy, though it causes only few infections in humans, usually due to the consumption of pork from pigs grazing in wild areas or from wild boars. Most cases of human trichinellosis in Italy are due to th

[Comparison of methods for the diagnosis of urinary obstruction in women]. / Metodi a confronto per la diagnosi di ostruzione minzionale nella donna.

The International Continence Society does not offer secure guidelines for the diagnosis of micturitional obstruction. The problem has been extensively addressed in relation to male voiding difficulties. Little is known on the subject in female patients. Two criteria for the diagnosis of obstructed micturition are in clinical use. The Sussett formula divides the maximum micturitional pressure by the square of the corresponding maximum urinary flow rate. Two cutoffs, corresponding approximately to the 90th and 95th centiles can be used (0.15, and 0.5). A more complex graphic nomogram developed by Schafer plots maximum flow versus maximum detrusor pressure, identifying obstruction and detrusor dysfunction simultaneously according to the author. We feel that these methods, extensively tested on a male population, can both be used on a female population. We noticed that in some instances the results were different. 469 women referred for micturitional disturbances underwent pressure/flow studies. 62 (13.2%) were obstructed according to the Schafer nomogram, 103 (21.9%) and 31 (6.6%) respectively using the Sussett mathematical formula using two different cutoffs (0.15 and 0.5). The two methods identify the same patients only if micturitional pressures are normal (40 to 60 cmH2O) to high (over 60 cmH2O) and the Sussett formula is used with a higher (95th centile) cutoff. This means that both methods are clearly insufficient in the diagnosis of obstruction if detrusor function is impaired. This can happen in case of chronic retention due to detrusor failure after a long-standing obstruction or for primary failures due to central nervous system lesions. Extreme care should be exercised if pressure-flow studies indicate obstruction at low micturitional pressures.(ABSTRACT TRUNCATED AT 250 WORDS)

[Unstable bladder and Sjögren syndrome. Clinical case]. / Vescica instabile e morbo di Sjogren. Caso clinico.

A female patient developed severe detrusor instability years after a diagnosis of Sjogren syndrome. A common etiology could be possible if an association with viral demyelinization in Sjogren patients is confirmed. Vaginal Sicca syndrome was present and responded to a topical androgen-oestriol association with definite cytologic improvement. Anticholinergics were tolerated and moderately effective. Low initial dose were slowly increased (over three months) to avoid excessive mouth dryness and avoid gastrooesophageal symptoms.

[Forceps delivery and long term follow-up urinary incontinence]. / Applicazione di forcipe e incontinenza urinaria a distanza di tempo.

553 patients undergoing complete urodynamic evaluation were investigated concerning mode of delivery. Forceps delivery was not associated with worsened urethral competence and significant risk of subsequent incontinence.