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.

Microbiological surveillance post-reprocessing of flexible endoscopes used in digestive endoscopy: a national study.

INTRODUCTION: Microbiological surveillance of endoscopes is a safety measure for verifying the quality of reprocessing procedures and identifying contaminated devices, but duodenoscope-related outbreaks are still reported. AIM: To assess the effectiveness of duodenoscope reprocessing procedures in Italy. METHODS: Between December 2019 and April 2020, data obtained from microbiological surveillance post-reprocessing in 15 Italian endoscopy units were collected. Sampling was carried out after reprocessing or during storage in a cabinet. In keeping with international guidelines and the Italian position paper, the micro-organisms were classified as high-concern organisms (HCOs) and low-concern organisms (LCOs). FINDINGS: In total, 144 samples were collected from 51 duodenoscopes. Of these, 36.81% were contaminated: 22.92% were contaminated with HCOs and 13.89% were contaminated with LCOs [2.08% with an LCO load of 11-100 colony-forming units (CFU)/device and 0.69% with an LCO load of >100 CFU/device]. The contamination rate was 27.5% in samples collected after reprocessing, 40% in samples collected during storage in a cabinet that was compliant with EN 16442:2015 (C-I), and 100% in samples collected during storage in a cabinet that was not compliant with EN 16442:2015 (NC-I). The respective HCO rates were 15.00%, 27.27% and 66.67%. Correlation between LCO contamination and storage time was demonstrated (Spearman's rho=0.3701; P=0.0026). The Olympus duodenoscope TJFQ180V demonstrated the lowest rate of contamination (29.82%), although the contamination rate was 100% for duodenoscopes stored in an NC-I cabinet. CONCLUSION: Microbiological surveillance, along with strict adherence to reprocessing protocols, may help to detect endoscope contamination at an early stage, and reduce the risk of duodenoscope-associated infections.

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.

Ethical and medico-legal issues of TOETVA procedure and simulation on cadavers: a scoping review.

Conventional open thyroidectomy is still considered the gold standard for thyroid surgery. Transoral endoscopic thyroidectomy vestibular approach (also known as TOETVA) is often considered to be more advantageous than the other approaches, such as minimally invasive video assisted thyroidectomy, thyroidectomy via breast/axillary/retroauricular access, bilateral axillo-breast approach and axillo-bilateral breast approach. In this scoping review, we discuss the risks and the benefits of this surgical approach and its medico-legal and ethical implications, particularly focusing on the importance of practice on cadavers. Currently, there is little scientific evidence supporting TOETVA, since there are few papers on the comparison with the traditional open thyroidectomy that have been published and thus little data on the long-term outcomes of TOETVA are available. Since the better cosmetic outcome currently represents the main indication for this surgical technique, substantial medico-legal and ethical issues arise. Moreover, practice on cadavers can help surgeons to develop the technical and non-technical skills required to perform efficiently and safely this new surgical procedure.

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.

Assessment of seabed litter in the Northern and Central Adriatic Sea (Mediterranean) over six years.

Seabed debris is much less investigated in respect to the sea surface and shores due to sampling difficulties and costs. However, detecting marine benthic litter is fundamental for developing policies aimed at achieving the Good Environmental Status in European Seas by 2020, as requested by the Marine Strategy Framework Directive. This study estimates seafloor litter abundance, composition, spatial distribution and main sources in the North-Central Adriatic Sea (FAO GSA 17) over a six-year period (2011-2016) with 67 stations sampled per year, representing the longest data set for the basin. Litter items collected using a "rapido" trawl were classified in six major categories. The average density of the litter collected over six years was 102.66 ±â€¯41.91 kg/km2. The highest concentration of litter was found in stations close to the coast within 30 m depth with a mean weight of 142.90 ±â€¯27.20 kg/km2, while the lowest value was recorded between 30 and 50 m of depth (41.12 ±â€¯9.62 kg/km2). Plastic was dominant followed by metal and other litter materials. Lost fishing nets and mussel culture debris accounted for 50% of the overall plastic litter collected. These data and the systematic monitoring of marine litter provide useful information to implement necessary measures to manage marine litter and minimize this type of anthropogenic pollution in the Adriatic region.

Macrozoobenthos in the Adriatic Sea ports: Soft-bottom communities with an overview of non-indigenous species.

The present paper is a contribution to the first initiative of the Port Baseline Survey (PBS) for Non-indigenous species (NIS) in the Mediterranean Sea. It presents a report on the soft-bottom macrobenthos from the five Adriatic ports: Bari, Ancona (Italy), Koper (Slovenia), Pula, Rijeka (Croatia), with a focus on the presence and contribution of NIS to native assemblages. Out of 451 species identified, only four were common to all ports. A total of eight NIS were recorded, five in surveyed ports and three in the lagoon connected to the Port of Koper. The highest number of NIS was recorded in Bari, and the highest abundance in Ancona and Bari. Generally, the number, abundance and contribution of NIS seems too low to cause a substantial impact on native communities in surveyed ports. The suitability of methods adopted for PBS for soft-bottom NIS was discussed and suggestion for methodological improvement is provided.

Effects of the installation of offshore pipelines on macrozoobenthic communities (northern and central Adriatic Sea).

Macrozoobenthos living around several pipelines placed at different depths and sediment types in the Western Adriatic Sea was investigated for three years after structures' deployment to detect possible effects due to their installation and presence. Three environmental habitats were considered based on the grain size (silty clay, clayey silt and sand). Samplings were taken within a radius of 100 m from the pipelines and at control sites. Multivariate and univariate analysis showed peculiarities of the three habitats due to the different sediment type, without differences between pipelines and controls inside each group. Silty clay and clayey silt communities appeared quite similar, being mainly represented by opportunistic species typical of the Adriatic coastal area. Benthic populations found at the offshore relict sand were characterized by a higher percentage of sensitive species. Independently of sediment typology, pipelines' installation seems to not affect the benthic populations that appear more influenced by environmental features.

Non-indigenous macrozoobenthic species on hard substrata of selected harbours in the Adriatic Sea.

The intense shipping traffic characterising the Adriatic Sea favours the spread of marine organisms. Yet, a study of 12 Adriatic ports (4 on the western side and 8 on the eastern side of the basin) found that non-indigenous species (NIS) accounted for only 4% of the benthic communities settled on hard substrates. The cirripeds Amphibalanus amphitrite and Balanus trigonus, found in 8 harbours, were the most common invaders followed by Amphibalanus eburneus, the ascidian Styela plicata, and the bivalve Magallana gigas. The highest percentage of NIS was recorded in Venice and Ploce, the harbours with the least rich native communities; the lowest percentage was retrieved in Trieste, Koper, Pula, and Rijeka, the harbours hosting the highest species diversity. In contrast, the ports of Bari and Ancona showed both high NIS percentages and highly diversified communities.

Procedures in endoscope reprocessing and monitoring: an Italian survey.

BACKGROUND: The high diffusion of endoscopes worldwide and the need for effective reprocessing methods requested the development of guidelines and implementation of surveillance procedures at local level. STUDY DESIGN: In order to collect data on everyday's practice and adherence to available guidelines, endoscopy units from different public institutions were surveyed using a dedicated questionnaire. METHODS: Between July and November 2015 a survey was carried in 12 main hospitals from 10 different Italian regions, involving 22 endoscopy units. The state of the art of national and international guidelines was investigated to compare the protocols adopted at local level. RESULTS: In all the surveyed hospitals, the reprocessing activity is based on pre-established protocols in adherence with principal guidelines. Enzymatic detergents, which are recommended by the international guidelines, are used in 55.6% of units and peracetic acid is currently the most widely used chemical disinfectant. Discrepancies were observed in the application of periodic quality controls. CONCLUSION: Updated guidelines are generally applied in reprocessing practice. Quality controls may represent a critical issue to improve effectiveness and surveillance. The whole of acquired data can promote a positive trend towards the application of best practices.

A Clostridium difficile outbreak in an Italian hospital: the efficacy of the multi-disciplinary and multifaceted approach.

INTRODUCTION: We described an outbreak of C. difficile that occurred in the Internal Medicine department of an Italian hospital and assessed the efficacy of the measures adopted to manage the outbreak. METHODS: The outbreak involved 15 patients and was identified by means of continuous integrated microbiological surveillance, starting with laboratory data (alert organism surveillance). Diarrheal fecal samples from patients with suspected infection by C. difficile underwent rapid membrane immuno-enzymatic testing, which detects both the presence of the glutamate dehydrogenase antigen and the presence of the A and B toxins. Extensive microbiological sampling was carried out both before and after sanitation of the environment, in order to assess the efficacy of the sanitation procedure. RESULTS: The outbreak lasted one and a half month, during which time the Committee for the Prevention of Hospital Infections ordered the implementation of multiple interventions, which enabled the outbreak to be controlled and the occurrence of new cases to be progressively prevented. The strategies adopted mainly involved patient isolation, reinforcement of proper hand hygiene techniques, antimicrobial stewardship and environmental decontamination by means of chlorine-based products. Moreover, the multifaceted management of the outbreak involved numerous sessions of instruction/training for nursing staff and socio-sanitary operatives during the outbreak. Sampling of environmental surfaces enabled two sites contaminated by C. difficile to be identified. CONCLUSIONS: Joint planning of multiple infection control practices, together with effective communication and collaboration between the Hospital Infections Committee and the ward involved proved to be successful in controlling the outbreak.

Suicide of isolated inmates suffering from psychiatric disorders: when a preventive measure becomes punitive.

We performed external autopsies and examinations on two inmates who had committed suicide by hanging themselves with their underwear and using the window bars of their cells as ligature points after they had been placed in solitary confinement. In one case, the inmate had even been deprived of her clothing (with the exception to her underwear). Underwear has been rarely described as a means for self-harm and, to the best of our knowledge, no previous study has focused on cases of prison suicides committed using this garment, even though it is available to every inmate. The two cases were very similar; both inmates were young, physically aggressive and in their first week at a new facility; both had been affected by mental disorders, had been prescribed psychotropic medications and had histories of psychiatric hospitalisation. In each case, the psychiatric evaluations had highlighted significant suicidal risk. We discuss these two cases in an attempt to describe the complexity of and contradictions within the management of suicidal inmates at correctional facilities. We aim to propose new strategies and emphasise the need to introduce evidence-based standardised protocols over inhumane, ineffective and simplistic punitive measures in the management of these individuals.

Environmental Impact of Offshore Gas Activities on the Benthic Environment: A Case Study.

Multidisciplinary monitoring of the impact of offshore gas platforms on northern and central Adriatic marine ecosystems has been conducted since 1998. Beginning in 2006, 4-5 year investigations spanning the period before, during, and after rig installation have explored the effects of its construction and presence on macrozoobenthic communities, sediment, water quality, pollutant bioaccumulation, and fish assemblages. In this study, sediment samples collected at increasing distance from an offshore gas platform before, during and after its construction were subjected to chemical analysis and assessment of benthic communities. Ecological indices were calculated to evaluate the ecological status of the area. Ecotoxicological analysis of sediment was performed to establish whether pollutants are transferred to biota. The study applied a before-after control-impact design to assess the effects of rig construction and presence and provide reference data on the possible impacts of any further expansion of the gas extraction industry in the already heavily exploited Adriatic Sea. Only some of the metals investigated (barium, chromium, cadmium, and zinc) showed a different spatial and/or temporal distribution that may be platform-related. In the early phases, the sediment concentrations of polycyclic aromatic hydrocarbons were below the detection limit at all sites; they then became detectable, but without significant spatial differences. The present findings suggest that the environmental effects of offshore gas platforms may be difficult to quantify, interpret, and generalize, because they are influenced by numerous, often local, abiotic, and biotic variables in different and unpredictable ways.

A proposal for limited criminal liability in high-accuracy endoscopic sinus surgery.

The aim of the present study is to propose legal reform limiting surgeons' criminal liability in high-accuracy and high-risk surgery such as endoscopic sinus surgery (ESS). The study includes a review of the medical literature, focusing on identifying and examining reasons why ESS carries a very high risk of serious complications related to inaccurate surgical manoeuvers and reviewing British and Italian legal theory and case-law on medical negligence, especially with regard to Italian Law 189/2012 (so called "Balduzzi" Law). It was found that serious complications due to inaccurate surgical manoeuvers may occur in ESS regardless of the skill, experience and prudence/diligence of the surgeon. Subjectivity should be essential to medical negligence, especially regarding high-accuracy surgery. Italian Law 189/2012 represents a good basis for the limitation of criminal liability resulting from inaccurate manoeuvres in high-accuracy surgery such as ESS. It is concluded that ESS surgeons should be relieved of criminal liability in cases of simple/ordinary negligence where guidelines have been observed.

Operating room environment and surgical site infections in arthroplasty procedures.

BACKGROUND: The rate of surgical site infections (SSI) is strongly influenced by operating room quality, which is determined by the structural features of the facility and its systems and by the management and behavior of healthcare workers. The aim of the present study was to assess microbial contamination in the operating room during hip- and knee-replacement procedures, the behavior of operating room staff and the incidence of SSI through postdischarge surveillance. METHODS: Microbial contamination was evaluated by active and passive sampling at rest and in operating conditions. Organizational and behavioral characteristics were collected through observational assessment. The incidence of SSI was evaluated in 255 patients, and follow-up examinations were carried out 30 and 365 days after the procedure. RESULTS: The mean values of the airborne and sedimenting microbial loads were 12.90 CFU/m3 and 0.02 CFU/cm2/h, respectively. With regard to outcome, the infection rate proved to be 0.89% and was associated with knee-replacement procedures. The microorganism responsible for this superficial infection was Staphylococcus aureus. CONCLUSIONS: Clinical outcomes proved to be satisfactory, owing to the limited microbial load (in both at-rest and operating conditions), the appropriate behavior of the staff, compliance with the guidelines on preoperative antibiotic prophylaxis, and efficient management of the ventilation system.

Epidemiology and biomolecular characterization of carbapenem-resistant klebsiella pneumoniae in an Italian hospital.

OBJECTIVE: To describe the occurrence of CRKP infections in a tertiary care hospital and to analyse the allelic profiles of the clinical strains involved and the most frequent carbapenemases. DESIGN: The study analyzed cases of infection due to CRKP in the period 2013-2014; 147 cases were recorded, most of which (82.31%) were in-hospital infections. SETTING: A hospital in northern Italy. METHODS: We retrospectively collected: data on patient characteristics and the microbiological characteristics of CRKP. Isolates from 72 of the in-hospital cases underwent molecular typing (MLST); in addition, in each isolate, a procedure for the detection of the blaKPC gene was carried out. RESULTS: The in-hospital death rate was 24.0% in 2013 and 37.5% in 2014. However, the difference between these two values did not prove statistically significant (P > .05). Analysis of mortality revealed that bloodstream infections were more frequently associated with death than other infections (χ2 = 14.57, P < .001). The age-adjusted Cox proportional hazard model revealed that the patients with bacteremia due to CRKP had a 3-fold higher risk of death (HR 3.11; 95% CI 1.66 - 5.84, P< .001) than those with infections of other sites. MLST revealed that the prevalent allelic profile was ST 512 (79.62%); the most frequent carbapenemase was KPC-3 (83.8%). CONCLUSIONS: Our results are in line with those of recent studies, which have shown that the spread of CRKP in Italy is a matter of concern and that further efforts have to be made to prevent the potential dissemination of carbapenemase-producing clones of K. pneumoniae, whenever possible.