Real-world data: come possono aiutare a migliorare la qualità dell’assistenza

The current COVID pandemic crisis made it even clearer that the solutions to several questions that public health must face require the access to good quality data. Several issues of the value and potential of health data and the current critical issues that hinder access are discussed in this paper. In particular, the paper (i) focuses on “real-world data” definition; (ii) proposes a review of the real-world data availability in our country; (iii) discusses its potential, with particular focus on the possibility of improving knowledge on the quality of care provided by the health system; (iv) emphasizes that the availability of data alone is not sufficient to increase our knowledge, underlining the need that innovative analysis methods (e.g., artificial intelligence techniques) must be framed in the paradigm of clinical research; and (v) addresses some ethical issues related to their use. The proposal is to realize an alliance between organizations interested in promoting research aimed at collecting scientifically solid evidence to support the clinical governance of public healt

Advancing the scientific study of prehospital mass casualty response through a Translational Science process: the T1 scoping literature review stage

PurposeThe European Union Horizon 2020 research and innovation funding program awarded the NIGHTINGALE grant to develop a toolkit to support first responders engaged in prehospital (PH) mass casualty incident (MCI) response. To reach the projects' objectives, the NIGHTINGALE consortium used a Translational Science (TS) process. The present work is the first TS stage (T1) aimed to extract data relevant for the subsequent modified Delphi study (T2) statements.MethodsThe authors were divided into three work groups (WGs) MCI Triage, PH Life Support and Damage Control (PHLSDC), and PH Processes (PHP). Each WG conducted simultaneous literature searches following the PRISMA extension for scoping reviews. Relevant data were extracted from the included articles and indexed using pre-identified PH MCI response themes and subthemes.ResultsThe initial search yielded 925 total references to be considered for title and abstract review (MCI Triage 311, PHLSDC 329, PHP 285), then 483 articles for full reference review (MCI Triage 111, PHLSDC 216, PHP 156), and finally 152 articles for the database extraction process (MCI Triage 27, PHLSDC 37, PHP 88). Most frequent subthemes and novel concepts have been identified as a basis for the elaboration of draft statements for the T2 modified Delphi study.ConclusionThe three simultaneous scoping reviews allowed the extraction of relevant PH MCI subthemes and novel concepts that will enable the NIGHTINGALE consortium to create scientifically anchored statements in the T2 modified Delphi study

Statutory Interpretation as Argumentation

This chapter proposes a dialectical approach to legal interpretation, consisting of three dimensions: a formalization of the canons of interpretation in terms of argumentation schemes; a dialectical classification of interpretive schemes; and a logical and computational model for comparing the arguments pro and contra an interpretation. The traditional interpretive maxims or canons used in both common and civil law are translated into defeasible patterns of arguments, which can be evaluated through sets of corresponding critical questions. These interpretive argumentation schemes are classified in general categories and a distinction is drawn between schemes supporting and rebutting an interpretation. This framework allows conceiving statutory interpretation as a dialectical procedure consisting in weighing arguments pro and contra an interpretation. This procedure is formalized and represented computationally through tools from formal argumentation systems

Targeted therapies: Friends or foes for patient's NK cell-mediated tumor immune-surveillance?

In the last 20 years there has been a huge increase in the number of novel drugs for cancer treatment. Most of them exploit their ability to target specific oncogenic mutations in the tumors (targeted therapies\u2013TT), while others target the immune-checkpoint inhibitor molecules (ICI) or the epigenetic DNA modifications. Among them, TT are the longest established drugs exploited against a wide spectrum of both solid and hematological tumors, often with reasonable costs and good efficacy as compared to other innovative therapies (i.e., ICI). Although they have greatly improved the treatment of cancer patients and their survival, patients often relapse or develop drug-resistance, leading to the impossibility to eradicate the disease. The outcome of TT has been often correlated with their ability to affect not only tumor cells, but also the repertoire of immune cells and their ability to interact with cancer cells. Thus, the possibility to create novel synergies among drugs an immunotherapy prompted scientists and physicians to deeply characterize the effects of TT on immune cells both by in-vitro and by ex-vivo analyses. In this context, NK cells may represent a key issue, since they have been shown to exert a potent anti-tumor activity, both against hematological malignancies and solid tumors. In the present review we will discuss most recent ex-vivo analyses that clarify the effect of TT treatment on patient's NK cells comparing them with clinical outcome and previous in-vitro data

Changes in urinary amino acids excretion in relationship with muscle activity markers over a professional cycling stage race: In search of fatigue markers

The aim of this study was to identify the relationship between metabolic effort, muscular damage/activity indices, and urinary amino acids profile over the course of a strenuous prolonged endurance activity, as a cycling stage race is, in order to identify possible fatigue markers. Nine professional cyclists belonging to a single team, competing in the Giro d'Italia cycling stage race, were anthropometrically characterized and sampled for blood and urine the day before the race started, and on days 12 and 23 of the race. Diet was kept the same over the race, and power output and energy expenditure were recorded. Sera were assayed for muscle markers (lactate dehydrogenase, aspartate aminotransferase, and creatine kinase activities, and blood urea nitrogen), and creatinine, all corrected for plasma volume changes. Urines were profiled for amino acid concentrations, normalized on creatinine excretion. Renal function, in terms of glomerular filtration rate, was monitored by MDRD equation corrected on body surface area. Creatine kinase activity and blood urea were increased during the race as did serum creatinine while kidney function remained stable. Among the amino acids, taurine, glycine, cysteine, leucine, carnosine, 1-methyl histidine, and 3-methyl histidine showed a net decreased, while homocysteine was increased. Taurine and the dipeptide carnosine (\u3b2-alanyl-l-histidine) were significantly correlated with the muscle activity markers and the indices of effort. In conclusion, the metabolic profile is modified strikingly due to the effort. Urinary taurine and carnosine seem useful tools to evaluate the muscle damage and possibly the fatigue status on a long-term basis

Evaluation of the performance of a new OptiScanner™ 5000 system for an intermittent glucose monitoring

Mid-infrared spectral technology has shown a high degree of promise in detecting glucose in plasma. OptiScan Biomedical has developed a glucose monitor based on mid-infrared spectroscopy that withdraws blood samples and measures plasma glucose. The objective of this study was to evaluate the accuracy and performance of the OptiScanner\u2122 5000 system on different pools of blood

Evaluation of bone metabolism markers in patients with chronic benign and malignant pancreatic diseases

Introduction. There are no studies comparing some of the most important markers, such as vitamin D, parathormone (PTH), osteocalcin, bone alkaline phosphatase and calcium, in patients with chronic benign and malignant pancreatic diseases. Aim. To comparatively evaluate serum markers of bone metabolism in patients with chronic pancreatitis and in those with ductal pancreatic adenocarcinoma. Material and Methods. Sixty-three consecutive subjects were studied: 30 patients with a firm diagnosis of chronic pancreatitis and 33 having histologically confirmed pancreatic adenocarcinoma. Serum 25-hydroxyvitamin D, bone alkaline phosphatase, osteocalcin, PTH and calcium were determined using commercially available kits. Results. Taking into consideration the clinical variables of all 63 patients studied, 25-hydroxyvitamin D was inversely correlated with only the body mass index (BMI) (P=0.007) whereas it was not correlated with age (P=0.583) or fecal elastase- 1 concentrations (P=0.556). Regarding the other substances studied, PTH was positively correlated with only the age of the patients (P=0.015). Of the five substances studied, only bone alkaline phosphates were significantly different (P<0.001) between patients with chronic pancreatitis and those with pancreatic ductal adenocarcinoma. Within the two groups of patients, the 23 patients with chronic pancreatitis without diabetes mellitus had serum concentrations of 25-hydroxyvitamin D significantly lower (P=0.045) than those with chronic pancreatitis having diabetes mellitus whereas smokers with pancreatic ductal adenocarcinoma had serum concentrations of calcium significantly higher (P<0.001) as compared to non-smokers. Conclusions. Altered bone metabolism seems to be associated with chronic diseases of the pancreas; however, the mechanism should be better elucidated