Validation of a test meal paradigm to experimentally manipulate meal-related fears: A registered report

Fear is central to conceptualizations of weight and shape-focused eating disorders. The current study will examine the reliability and validity of a test meal paradigm that varies perceptions of fat content to manipulate fear. Undergraduate women with elevated eating pathology (N = 96) will be randomized to one of three test meal conditions: two “low” fat yogurts, two “high” fat yogurts, or one “high” fat and one “low” fat yogurt. In actuality, all yogurts will have the same fat content. Supporting reliability, we hypothesize that self-reported fear and electrodermal activity (psychophysiological index of fear-related arousal) will exhibit good test–retest reliability over a 48-hr period in the “high” fat/“high” fat and “low” fat/“low” fat conditions. Supporting construct validity, self-reported fear and electrodermal activity will be elevated during the “high” versus “low” fat condition and responses to the “high" fat condition will correlate with fear of food, eating, and weight gain. Supporting discriminant validity, self-reported disgust and anger will be comparable in the “high” and “low” fat conditions and will exhibit weak correlations with trait measures of disgust and anger. This experimental paradigm will allow researchers to manipulate fear in order understand the mechanisms by which fear maintains eating pathology.     

The role of concentration?effect relationships in the assessment of QTc interval prolongation

Population pharmacokinetic and pharmacokinetic−pharmacodynamic (PKPD) modelling has been widely used in clinical research. Yet, its application in the evaluation of cardiovascular safety remains limited, particularly in the evaluation of pro-arrhythmic effects. Here we discuss the advantages of disadvantages of population PKPD modelling and simulation, a paradigm built around the knowledge of the concentration−effect relationship as the basis for decision making in drug development and its utility as a guide to drug safety. A wide-ranging review of the literature was performed on the experimental protocols currently used to characterize the potential for QT interval prolongation, both pre-clinically and clinically. Focus was given to the role of modelling and simulation for design optimization and subsequent analysis and interpretation of the data, discriminating drug from system specific properties. Cardiovascular safety remains one of the major sources of attrition in drug development with stringent regulatory requirements. However, despite the myriad of tests, data are not integrated systematically to ensure accurate translation of the observed drug effects in clinically relevant conditions. The thorough QT study addresses a critical regulatory question but does not necessarily reflect knowledge of the underlying pharmacology and has limitations in its ability to address fundamental clinical questions. It is also prone to issues of multiplicity. Population approaches offer a paradigm for the evaluation of drug safety built around the knowledge of the concentration−effect relationship. It enables quantitative assessment of the probability of QT_c interval prolongation in patients, providing better guidance to regulatory labelling and understanding of benefit/risk in specific populations.     

Graft rinse prior to reperfusion in liver transplantation: literature review and online survey within the Eurotransplant community

Graft rinse prior reperfusion in liver transplantation (LT) is believed to reduce the incidence of postreperfusion syndrome and improve clinical outcome. A MEDLINE search was performed to obtain a comprehensive review of the published literature dealing with graft rinse in LT. Moreover, all thirty‐four LT centers in the Eurotransplant (ET) region were invited to participate in an online survey to whether or not graft rinse is performed and whether further research in the field is needed. Seventeen reports have been found to investigate graft rinse protocols in 1894 LT recipients. Eighteen of the thirty centers that participated in the online survey performed graft rinse prior reperfusion in LT. The most commonly used rinse solution was albumin. Nineteen centers stated interest in participating in a multicenter RCT in the field. The published literature does not provide concluding appraisal of the benefit of graft rinse in LT. Graft rinse protocols are not standardized and are based on personal experience. Appropriately designed clinical trials addressing the topic are demanded. The online survey appears to be a helpful tool for the evaluation of clinical practice and future research topics in the transplant community.     

Pilot study assessing the possible benefits of a higher level of implementation of biosecurity measures on farm productivity and health status in Belgian cattle farms

Over the last few years, the interest of decision‐makers and control agencies in biosecurity (BS), aiming at preventing and controlling the introduction and spread of infectious diseases, has considerably increased. Nevertheless, previous studies highlighted a low implementation level of biosecurity measures (BSM), especially in cattle farms; different reasons were identified such as perceived costs, utility, importance, increased workload and lack of knowledge. In order to convince cattle farmers to adopt BSM, it is necessary to gather more information and evidence on their cost‐effectiveness and their importance or utility in terms of disease prevention and control. The objectives of this study were to determine whether the farm or farmers’ profile correlated with the implementation level of BSM and if there was a positive correlation between the BSM implementation and the farm production and health parameters. Data were collected through face‐to‐face interviews conducted in 100 Belgian farms as part of a stratified and randomized survey. The Regional Animal Health Services provided the farm health status and production data. A general BS score and five sub‐scores related to the five BS compartments (bio‐exclusion, bio‐compartmentation, bio‐containment, bio‐prevention and bio‐preservation) were calculated for each farm based on the implementation level of different BSM grouped in 16 domains. The study highlighted a significant and negative correlation between the mortality rates in adult cattle (over 24 months of age) and young calves (aged 0–7 days) and different BS compartment scores. The study also demonstrated that the farms having a higher general BS score were indeed more likely to have a BVD‐free status. These evidence‐based findings are encouraging as they demonstrate the benefits of implementing BSM and could promote their adoption by farmers.