Guidance on the assessment of learning outcomes for those designing procedures and projects - Report of an ETPLAS Working Group.

This document provides assessment criteria for evaluation of each of the Learning Outcomes of the Modules specified (in addition to the Core Modules) for those designing procedures and projects in the Education and Training Framework guidance document by the European Commission and endorsed by the Member States Competent Authorities. This Working Group was tasked to produce these criteria by the Education & Training Platform for Laboratory Animal Science, which was funded by the European Commission to this aim. The assessment criteria address knowledge and skills (including critical thinking) expected to be acquired during education and training of persons preparing to design research procedures and projects using animals under the scope of Directive 2010/63/EU.

European Union Legislation for the Welfare of Animals Used for Scientific Purposes: Areas Identified for Further Discussion.

The Directive 2010/63/EU of the European Parliament and of the Council has been in force for more than a decade and has brought about significant improvements and novel requirements for the welfare of animals used for scientific purposes, while safeguarding research integrity. The Directive sets clear provisions for its scope, the authorization procedures, animal welfare bodies, national committees, cost/benefit analysis, severity classification, retrospective assessment, and statistical reporting, among many others. From this perspective, indicative areas in the existing legislative texts and guidance documents, which may influence animal welfare and scientific integrity, have been identified by the authors after years of working in this field.

Greek Pig Farmers' Perceptions and Experiences of Tail Biting and Tail Docking.

Tail biting is both an important economic and a welfare problem. The primary preventive measure, almost on a routine basis throughout Europe, remains tail docking following a risk analysis. This study aimed to get insight on the perceptions of Greek pig farmers towards tail docking, intervention measures, and risk factors of tail biting, as well as opinions on pig welfare themes.

Association of Variants in the SPTLC1 Gene With Juvenile Amyotrophic Lateral Sclerosis.

Importance: Juvenile amyotrophic lateral sclerosis (ALS) is a rare form of ALS characterized by age of symptom onset less than 25 years and a variable presentation.

Objective: To identify the genetic variants associated with juvenile ALS.

Design, Setting, And Participants: In this multicenter family-based genetic study, trio whole-exome sequencing was performed to identify the disease-associated gene in a case series of unrelated patients diagnosed with juvenile ALS and severe growth retardation.

Assessable learning outcomes for the EU Education and Training Framework core and Function A specific modules: Report of an ETPLAS WORKING Group.

Article 23(2) of the European Union Directive 2010/63/EU, which regulates welfare provisions for animals used for scientific purposes, requires that staff involved in the care and use of animals for scientific purposes be adequately educated and trained before they undertake any such work. However, the nature and extent of such training is not stipulated in the Directive. To facilitate Member States in fulfilling their education and training obligations, the European Commission developed a common Education and Training Framework, which was endorsed by the Member States Competent Authorities.

Comparative Analysis of and Sporadic Disease in a Large Multicenter ALS Population: The Effect of Male Sex on Survival of Positive Patients.

We investigated whether the repeat expansion is associated with specific clinical features, comorbidities, and prognosis in patients with amyotrophic lateral sclerosis (ALS). A cohort of 1417 ALS patients, diagnosed between January 1, 2009 and December 31, 2013 by 13 Italian ALS Referral Centers, was screened for the repeat expansion, and the analyses were performed comparing patients carrying this expansion (ALS-C9Pos) to those negative for this and other explored ALS-related mutations (ALS without genetic mutations, ALSwoGM). Compared to the ALSwoGM group, ALS-C9Pos patients ( = 84) were younger at disease onset, at the first clinical observation and at diagnosis ( < 0.

Information-domain method for the quantification of the complexity of the sympathetic baroreflex regulation in healthy subjects and amyotrophic lateral sclerosis patients.

Background: The sympathetic baroreflex (sBR) adjusts muscle sympathetic nerve activity (MSNA) in response to arterial pressure changes but the relevance of assessing sBR control complexity is unclear.

Objective: We propose a method for the evaluation of sBR control complexity.

Approach: The approach comprises the quantification of complexity of the sBR latency regulation and the assessment of complexity of the relationship linking MSNA burst to R-wave peak regardless of the variability of the sBR latency.

Rapamycin treatment for amyotrophic lateral sclerosis: Protocol for a phase II randomized, double-blind, placebo-controlled, multicenter, clinical trial (RAP-ALS trial).

Introduction: Misfolded aggregated proteins and neuroinflammation significantly contribute to amyotrophic lateral sclerosis (ALS) pathogenesis, hence representing therapeutic targets to modify disease expression. Rapamycin inhibits mechanistic target of Rapamycin (mTOR) pathway and enhances autophagy with demonstrated beneficial effects in neurodegeneration in cell line and animal models, improving phenotype in SQSTM1 zebrafish, in Drosophila model of ALS-TDP, and in the TDP43 mouse model, in which it reduced neuronal loss and TDP43 inclusions. Rapamycin also expands regulatory T lymphocytes (Treg) and increased Treg levels are associated with slow progression in ALS patients.

Cardiovascular diseases may play a negative role in the prognosis of amyotrophic lateral sclerosis.

Background And Purpose: Only a few studies have considered the role of comorbidities in the prognosis of amyotrophic lateral sclerosis (ALS) and have provided conflicting results.

Methods: Our multicentre, retrospective study included patients diagnosed from 1 January 2009 to 31 December 2013 in 13 referral centres for ALS located in 10 Italian regions. Neurologists at these centres collected a detailed phenotypic profile and follow-up data until death in an electronic database.

Comorbidity of dementia with amyotrophic lateral sclerosis (ALS): insights from a large multicenter Italian cohort.

To assess the association, at diagnosis, between amyotrophic lateral sclerosis (ALS) and dementia in a large cohort of well-characterized Italian patients. We investigated the phenotypic profile of 1638 incident patients with definite, probable or laboratory-supported probable ALS, diagnosed from January 2009 to December 2013 in 13 Italian Referral Centers, located in 10 Italian Regions, and classified in two independent subsamples accounting for presence or not of dementia. The collected ALS features, including survival and other follow-up data, were compared between the two subgroups using a one-way analysis of variance and Chi-square test, as appropriate, logistic regression models and Kaplan-Meier survival analysis.

Comparison between K-nearest-neighbor approaches for conditional entropy estimation: Application to the assessment of the cardiac control in amyotrophic lateral sclerosis patients.

The study evaluates the k-nearest-neighbor (KNN) strategy for the assessment of complexity of the cardiac neural control from spontaneous fluctuations of heart period (HP). Two different procedures were assessed: i) the KNN estimation of the conditional entropy (CE) proposed by Porta et al; ii) the KNN estimation of mutual information proposed by Kozachenko-Leonenko, refined by Kraskov-Stögbauer-Grassberger and here adapted for the CE estimation. The two procedures were compared over HP variability recordings obtained at rest in supine position and during head-up tilt (HUT) in amyotrophic lateral sclerosis patients and healthy subjects.

Factors predicting survival in ALS: a multicenter Italian study.

The aim of this multicenter, retrospective study is to investigate the role of clinical characteristics and therapeutic intervention on ALS prognosis. The study included patients diagnosed from January 1, 2009 to December 31, 2013 in 13 Italian referral centers for ALS located in 10 Italian regions. Caring neurologists collected a detailed phenotypic profile and follow-up data until death into an electronic database.

Non-motor involvement in amyotrophic lateral sclerosis: new insight from nerve and vessel analysis in skin biopsy.

Aims: To assess cutaneous sensory and autonomic nerves and the vascular bed in amyotrophic lateral sclerosis (ALS).

Methods: We enrolled 41 patients (M = 20, aged 63.5 ± 11.

Assessment of body composition in Wistar rat offspring by DXA in relation to prenatal and postnatal nutritional manipulation.

Background: This experimental study aims to investigate the impact of combinations of prenatal and postnatal food manipulation on body composition in rat offspring.

Methods: On day 12 of gestation, 100 timed pregnant rats were randomized into two nutritional groups: standard laboratory and 50% starved. Pups born to starved mothers were subdivided, based on birthweight (BiW), into fetal growth restricted (FGR) and non-FGR.

Menopausal Status and Abdominal Obesity Are Significant Determinants of Hepatic Lipid Metabolism in Women.

Background: Android fat distribution (abdominal obesity) is associated with insulin resistance, hepatic steatosis, and greater secretion of large very low-density lipoprotein (VLDL) particles in men. Since abdominal obesity is becoming increasingly prevalent in women, we aimed to investigate the relationship between android fat and hepatic lipid metabolism in pre- and postmenopausal women.

Methods And Results: We used a combination of stable isotope tracer techniques to investigate intrahepatic fatty acid synthesis and partitioning in 29 lean and 29 abdominally obese women (android fat/total fat 0.

Cardiovascular neural regulation is impaired in amyotrophic lateral sclerosis patients. A study by spectral and complexity analysis of cardiovascular oscillations.

Although the clinical hallmark of amyotrophic lateral sclerosis (ALS) is a progressive motor weakness, different combinations of autonomic nervous system (ANS) dysfunction have been described. No clear correlation between ANS abnormalities and ALS clinical characteristics has been found so far. We investigated the cardiovascular neural regulation in ALS with a non-invasive methodology, using spectral and complexity analysis of heart rate variability (HRV) and systolic arterial pressure (SAP) variability.

Exposure of extensively farmed wild boars (Sus scrofa scrofa) to selected pig pathogens in Greece.

Background: Increased density and distribution of wild boar populations are likely to promote interactions and transmission of certain pathogens, not only among wild boar but also from wild boar to livestock or humans and vice versa.

Objective: The purpose of this study was to determine seroprevalence against seven selected pathogens in wild boar living in four different areas in Greece.

Animals And Methods: In total, 359 serum samples were collected from extensively farmed wild boar (Sus scrofa scrofa) originating from four distinct geographical areas throughout Greece from April 2012 to August 2013.

LRP5 regulates human body fat distribution by modulating adipose progenitor biology in a dose- and depot-specific fashion.

Common variants in WNT pathway genes have been associated with bone mass and fat distribution, the latter predicting diabetes and cardiovascular disease risk. Rare mutations in the WNT co-receptors LRP5 and LRP6 are similarly associated with bone and cardiometabolic disorders. We investigated the role of LRP5 in human adipose tissue.

Lower resting and total energy expenditure in postmenopausal compared with premenopausal women matched for abdominal obesity.

The menopause is accompanied by increased risk of obesity, altered body fat distribution and decreased skeletal muscle mass. The resulting decrease in RMR should be accompanied by a compensatory change in energy balance to avoid weight gain. We aimed to investigate habitual energy intake and expenditure in pre- and postmenopausal women matched for abdominal obesity.

Amyotrophic lateral sclerosis outcome measures and the role of albumin and creatinine: a population-based study.

Importance: There is an urgent need to identify reliable biomarkers of amyotrophic lateral sclerosis (ALS) progression for clinical practice and pharmacological trials.

Objectives: To correlate several hematological markers evaluated at diagnosis with ALS outcome in a population-based series of patients (discovery cohort) and replicate the findings in an independent validation cohort from an ALS tertiary center.

Design, Setting, And Participants: The discovery cohort included 712 patients with ALS from the Piemonte and Valle d'Aosta Register for Amyotrophic Lateral Sclerosis from January 1, 2007, to December 31, 2011.

Structural and functional properties of deep abdominal subcutaneous adipose tissue explain its association with insulin resistance and cardiovascular risk in men.

Objective: Fat distribution is an important variable explaining metabolic heterogeneity of obesity. Abdominal subcutaneous adipose tissue (SAT) is divided by the Scarpa's fascia into a deep subcutaneous adipose tissue (dSAT) and a superficial subcutaneous adipose tissue (sSAT) layer. This study sought to characterize functional differences between the two SAT layers to explore their relative contribution to metabolic traits and cardiovascular risk (CVR) profile.