Testing a new taxonomic model for the assessment of medical devices: Is it plausible and applicable? Insights from HTA reports and interviews with HTA institutions in Europe

Objective

Medical devices (MDs) encompass a broad and heterogeneous range of technologies. While practices vary considerably across countries, MDs often find application in patient care with little or no evaluation of their effectiveness and safety following market approval. A recently proposed taxonomy of MDs considered devices from the viewpoint of Health Technology Assessment (HTA). The aim of the work presented here was to test its plausibility and applicability by considering real-world HTA practices.

Regurgitations in a Lamb with Acute Coenurosis-A case Report

Coenurosis is a disease of the central nervous system in sheep, caused by Coenurus cerebralis, the larval stage of Multiceps multiceps, which inhabits the small intestine of Canidae. A case of regurgitations in a 2.5 month old lamb with acute coenurosis is being reported. The lamb was presented with a sudden onset of ataxia and regurgitations for 10 days. The post-mortem examination revealed 4 immature C. cerebralis cysts between 0.5 and 1.5 cm in diameter located in the brainstem and cerebellum, and histopathological examination revealed multifocal pyogranulomatous meningoencephalitis, so a diagnosis of acute coenurosis was established. Thus, acute coenurosis should be included in the differential diagnosis of regurgitations in lambs.     

In vitro and in vivo antitumor activity of platinum(II) complexes with thiosemicarbazones derived from 2-formyl and 2-acetyl pyridine and containing ring incorporated at N(4)-position: synthesis, spectroscopic study and crystal structure of platinum(II) complexes with thiosemicarbazones, potential anticancer agents

Reactions of thiosemicarbazones of 2-formyl and 2-acetyl pyridine and containing an azepane ring (hexamethyleneiminyl ring) incorporated at N(4)-position, HL(1) (1) and HL(2) (2) with platinum(II) afforded the complexes, [Pt(L(1))Cl] (3) and [Pt(L(2))Cl] (4). Characterization of the compounds was accomplished by means of elemental analysis and spectroscopic techniques NMR, UV-vis and IR spectroscopy. The single-crystal X-ray structure of complex [Pt(L(2))Cl] (4) shows that the ligand monoanion coordinates in a planar conformation to the metal via the pyridyl N atom, the imine-N atom, and thiolato S-atom. Compounds 1-4 have been evaluated for antiproliferative activity in vitro against three human cancer cell lines: MCF-7 (human breast cancer cell line), T24 (bladder cancer cell line), A-549 (non-small cell lung carcinoma) and a mouse L-929 (a fibroblast-like cell line cloned from strain L). Ligand 2 exhibited high activity as anticancer agent against all four cancer cell lines, while ligand 1 exhibited selectivity against MCF-7, L-929 cell lines and complex 4 against A-549, T-24 cancer cell lines. Also, the acute toxicity and antitumor activity were evaluated on leukemia P388-bearing mice. Complex 3 afforded five to six cures against leukemia P388. The in vivo results of the antitumor activity show the two platinum complexes as very effective chemotherapeutic antileukemic agents.     

A qualitative study of early childhood educators' beliefs and practices regarding children's socioemotional development

Existing research underscores the significance of early childhood experiences in the childcare context for the development of socioemotional skills and competencies. However, the practices adopted within childcare for the enhancement of children's socioemotional development and the factors mediating these practices are less adequately researched. The present study contributes to this understanding, through studying the perceptions of 34 educators working in childcare centres in Greece with regard to children's socioemotional development and its promotion. Results showed that although they acknowledged the significance of social and emotional competencies for children's adjustment, learning and well-being, they did not report consistent use of practices having as a goal the promotion of such skills. Explanations involve on the one hand the lack of formal policy and the existence of structural barriers and on the other hand a perception that socioemotional development is mostly affected by factors beyond their influence. Results are discussed in relation to prior research and in terms of their implications for designing interventions, curricula and staff training.     

Higher circulating resistin protein and PBMCs resistin mRNA levels are associated with increased prevalence of small dense LDL particles in coronary artery disease patients

Recent in vitro experiments have indicated that human resistin increases the number of lipoprotein particles secreted by the human hepatocytes and also influences their quality, in terms of generating more proatherogenic lipid particles. The aim of this study is to investigate associations of plasma resistin and peripheral blood mononuclear cells (PBMCs) resistin messenger RNA (mRNA) levels with different prevalence of small, dense low‐density lipoprotein particles (sdLDL) in patients with indications for coronary angiography. This study included 65 patients requiring coronary angiography. There were 41 patients without significant stenosis and 24 patients with significant stenosis in at least one major coronary artery. Circulating resistin was measured by enzyme‐linked immunosorbent assay; PBMC resistin mRNA was determined by real‐time polymerase chain reaction. The LDL and high density lipoprotein subclasses were determined by gradient gel electrophoresis. Plasma resistin (P = 0.031) and PBMCs resistin mRNA (P = 0.004) were significantly higher in patients with proportion of sdLDL particles ≥ 50%, compared to the group with relative proportion of sdLDL particles < 50%. Plasma resistin correlated positively with creatinine (r = 0.456, P < 0.001) and resistin mRNA (r = 0.298, P = 0.014) but negatively with body mass index (r = ?0.254, P = 0.034) and total cholesterol (r = ?0.286, P = 0.021). Multiple linear regression analysis revealed LDL particle diameter as the only independent predictor of resistin mRNA (R² = 0.258; adjR² = 0.190). A significant association between resistin, both PBMCs mRNA and plasma protein, and the relative proportion of sdLDL particles in the circulation of coronary artery disease patients has been established, which implies that increased gene expression of resistin in PBMCs and higher resistin concentration in plasma are related to pro‐atherogenic LDL particle phenotype.     

Impact of the Level of Adherence to Mediterranean Diet on the Parameters of Metabolic Syndrome: A Systematic Review and Meta-Analysis of Observational Studies

High adherence to the Mediterranean diet (MD) has been associated with a lower prevalence of Metabolic Syndrome (MetS). The present study aimed to investigate the impact of MD adherence on parameters of MetS. A systematic literature search was performed in PubMed, Cochrane Central Registry of Clinical Trials (CENTRAL), Scopus, EMBASE, Web of Science and Google Scholar databases. Observational studies that recorded adherence to MD and components/measures of the MetS, such as waist circumference (WC), blood pressure (BP), fasting blood glucose (FBG), high-density lipoprotein (HDL) cholesterol and triglycerides (TG), were included in this study. A total of 58 studies were included in our study. WC and TG were significantly lower in the high adherence MD group (SMD: −0.20, (95%CI: −0.40, −0.01), SMD: −0.27 (95%CI: −0.27, −0.11), respectively), while HDL cholesterol was significantly higher in the same group (SMD: −0.28 (95%CI: 0.07, 0.50). There was no difference in FBG and SBP among the two groups (SMD: −0.21 (95%CI: −0.54, 0.12) & SMD: −0.15 (95%CI: −0.38, 0.07), respectively). MD may have a positive impact on all parameters of MetS. However, further research is needed in this field.     

Quantitative structure -- activity relationships (QSARs) of thrombin inhibitors: review,evaluation and comparative analysis

Thrombin has become an important target for designing antithrombotic drugs in the recent years. Thus, we have undertaken a QSAR analysis aimed at individuating the physicochemical properties governing the inhibitory activity of such compounds. The QSAR equations for ten series of derivatives have been calculated and discussed. The series studied are all those that we found in the literature suitable for a QSAR study. The equations we obtained show that the main physicochemical properties affecting the inhibitory activity are almost the same for all the series and can be individuated by the use of proper parameters. The conclusions of this analysis can be summarized as follows: a). hydrophobicity plays a critical role; b). steric factors are also significant but in some cases the collinearity between steric and hydrophobic parameters does not allow one to draw any final conclusion.     

Novel thiazolyl,thiazolinyl and benzothiazolyl Schiff bases as possible lipoxygenase's inhibitors and anti-inflammatory agents

In continuation of our previous research, several new thiazolyl/thiazolinyl/benzothiazolyl Schiff bases have been designed, synthesized and identified. The referred compounds are reported to act as lipoxygenase inhibitors affecting inflammation and/or psoriasis. The compounds were screened for their reducing activity (with the stable free radical 1,1-diphenyl-2-picryl-hydrazyl, DPPH) and for inhibition of soybean lipoxygenase (LOX). Anti-inflammatory activity was examined in vivo using the carrageenin induced mice paw edema (32.6-75%). The results are discussed in terms of structural and physicochemical characteristics of the compounds. Compound 2d possessed the highest inhibition 75%.