Influence of X-ray spectrum and bowtie filter characterisation on the accuracy of Monte Carlo simulated organ doses: Validation in a whole-body CT scanning mode.

Purpose: For patient-specific CT dosimetry, Monte Carlo dose simulations require an accurate description of the CT scanner. However, quantitative spectral information and information on the bowtie filter material and shape from the manufacturer is often not available. In this study, the influence of different X-ray spectra and bowtie filter characterisation methods on simulated CT organ doses is studied.

Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review.

Background: Working with patients through meaningful patient engagement (PE) and incorporating patient experience data (PXD) is increasingly important in medicines and medical device development. However, PE in the planning, organization, generation, and interpretation of PXD within regulatory and health technology assessment (HTA) decision-making processes remains challenging. We conducted a global review of the PE and PXD landscape to identify evolving resources by geography to support and highlight the potential of integration of PE and PXD in regulatory assessment and HTA.

Challenge tests reveal limited outgrowth of proteolytic Clostridium botulinum during the production of nitrate- and nitrite-free fermented sausages.

Nitrate and nitrite salts perform a versatile role in fermented meats, including the inhibition of food pathogens (in particular proteolytic group I Clostridium botulinum). Despite the increasing interest in clean-label products, little is known about the behaviour of this pathogen in response to the removal of chemical preservatives from fermented meat formulations. Therefore, challenge tests with a cocktail of nontoxigenic group I C.

Improving the Aromatic Profile of Plant-Based Meat Alternatives: Effect of Myoglobin Addition on Volatiles.

Market demand for palatable plant-based meat alternatives is on the rise. One of the challenges is formulating products with sensorial characteristics similar to conventional meat. In this study, the effect of myoglobin on the aromatic profile of plant-based meat alternatives was assessed.

Influence of aging time, temperature and relative humidity on the sensory quality of dry-aged Belgian Blue beef.

The objective of this study was to evaluate the effect of aging period (0, 3, 6 or 9 weeks), aging temperature (2 versus 6 °C at 75% relative humidity, experiment 1) and relative humidity (70 versus 90% at 2 °C, experiment 2) on the sensory traits, oxidative stability and proteolysis of Belgian Blue beef. For each experiment, eight loins (M. longissimus thoracis et lumborum) from four animals (left and right side) were assigned to one of the two treatments (n = 4).

Sexual violence in medical students and specialty registrars in Flanders, Belgium: a population survey.

Background: Sexual violence has globally been recognized as harmful to young people's health. In medical school, which is a highly competitive environment, the risk is supposedly even bigger. In this study we firstly aimed to investigate the magnitude and precipitating factors of sexual violence in medical students and specialty registrars in Flanders, Belgium.

Valorisation of tainted boar meat in patties, frankfurter sausages and cooked ham by means of targeted dilution, cooking and smoking.

Because of the need to abolish the castration of piglets without anaesthesia/analgesia, the pig industry is searching for a mode of action for the valorisation of meat with boar taint, an off-odour in entire male pigs. Carcasses with boar taint were selected by means of sensory and chemical analysis, after which patties with different levels of tainted boar meat were produced, as well as cooked ham and Frankfurter sausages using different smoke condensates and cooking temperatures. For these products orthonasal and retronasal boar taint odour were assessed by a trained expert panel.

Culture and Process Change as a Priority for Patient Engagement in Medicines Development.

Patient Focused Medicines Development (PFMD) is a not-for-profit independent multinational coalition of patients, patient stakeholders, and the pharmaceutical industry with interests across diverse disease areas and conditions. PFMD aims to facilitate an integrated approach to medicines development with all stakeholders involved early in the development process. A key strength of the coalition that differentiates it from other groups that involve patients or patient groups is that PFMD has patient organizations as founding members, ensuring that the patient perspective is the starting point when identifying priorities and developing solutions to meet patients' needs.

Position statement from the European Board and College of Obstetrics & Gynaecology (EBCOG): The use of medicines during pregnancy - call for action.

Less than 10% of medicines approved by the FDA since 1980 have provided enough information as regards risks for birth defects associated with their use (Adam et al. (2011) [1]). Nevertheless, it is estimated that over 90% of pregnant women take over-the-counter (OTC) or prescription medication (Ke et al.

Position Statement from the European Board and College of Obstetrics & Gynaecology (EBCOG) : The use of medicines during pregnancy: call for action.

Less than 10% of medicines approved by the FDA since 1980 have provided enough information as regard risks for birth defects associated with their use [1]. Nevertheless, it is estimated that over 90% of pregnant women take over-the-counter (OTC) or prescription medication [2]. Considering the fact that the use of medication in the period before conception and during lactation can also influence the development of the child, information on the impact of their usage during reproductive life is important for everyone.

Formation of naturally occurring pigments during the production of nitrite-free dry fermented sausages.

This study investigates the potential of producing red coloured dry fermented sausages without the addition of nitrite and/or nitrate. Therefore, the formation of zinc protoporphyrin IX (Zn(II)PPIX) as naturally occurring pigment, and the interrelated protoporphyrin IX (PPIX) and heme content were evaluated during nitrite-free dry fermented sausage production at different pH conditions. Zn(II)PPIX was only able to form in dry fermented sausages at pH conditions higher than approximately 4.

Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action.

The purpose of medicines is to improve patients' lives. Stakeholders involved in the development and lifecycle management of medicines agree that more effective patient involvement is needed to ensure that patient needs and priorities are identified and met. Despite the increasing number and scope of patient involvement initiatives, there is no accepted master framework for systematic patient involvement in industry-led medicines research and development, regulatory review, or market access decisions.

Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations.

To raise awareness and promote dialogue leading to action, this article provides proceedings on ethical and legal considerations associated with medicine use during pregnancy discussed during the 2014 DIA Medicines and Pregnancy Forum. A key focus of discussion at the forum was "When is it ethically appropriate to include or unethical not to include pregnant patients in clinical studies, and how can ethical barriers be addressed?" Also debated was the question "What are the most appropriate methods to collect and share data on medication use in pregnancy, and what is the best process for sharing such information?" Goals of the forum were to gain participant alignment on answers to these ethical questions, offer rationale for the answers, and provide insight into which stakeholders might be needed to facilitate discussion and action. Participants felt that under the right circumstances, drug research in pregnant women is justified and necessary.

Patient Engagement by Pharma-Why and How? A Framework for Compliant Patient Engagement.

Engagement is increasingly recognized as a decisive factor for health-related outcomes in people living with a medical issue. It is their experience that drives this engagement. Therefore, providers who seek to develop better solutions, including medicines, must gain a deeper understanding of the patient experience.

Clinical Data for Informed Medication Use in Pregnancy: Strengths, Limitations, Gaps, and a Need to Continue Moving Forward.

The objective of this paper is to explore the strengths, weaknesses, gaps, and needs in research on medication use in pregnancy, where opportunities have been bypassed to develop standards and collaborations for collecting data to better understand how medications can impact clinical outcomes in pregnant women and developing fetuses. The availability of existing data and the methods of its capture are reviewed, including registries, claims and health record databases, and meta-analyses. The paper focuses on why these efforts have not fundamentally provided benefit-risk information and clinical treatment algorithms for medication use in pregnant women.

A Proposed Framework to Address Needs of Clinical Data for Informed Medication Use in Pregnancy.

The objective of this paper is to communicate a proposed framework for addressing research limitations and communication barriers that contribute to a lack of data for making clinical treatment decisions about medication use in pregnancy. To address this global public health concern, a cross-stakeholder coalition composed of several workstreams is proposed. The intent is to foster collaborative discussion regarding potential solutions to address gaps in communication, engagement, and data generation and collection.

The occurrence of N-nitrosamines, residual nitrite and biogenic amines in commercial dry fermented sausages and evaluation of their occasional relation.

Regarding food borne intoxications, the accumulation of biogenic amines must be avoided in all kinds of food products. Moreover, biogenic amines can function as precursors for the formation of carcinogenic N-nitrosamines when nitrite is present. To estimate the food safety of the dry fermented sausages available on the Belgian market, a screening of the residual sodium nitrite and nitrate contents, biogenic amines and volatile N-nitrosamine concentrations was performed on 101 samples.

Interactions between bacterial isolates from modified-atmosphere-packaged artisan-type cooked ham in view of the development of a bioprotective culture.

Growth and metabolite production of three dominant bacterial isolates (Carnobacterium divergens 3M14, Leuconostoc carnosum 3M42, and Brochothrix thermosphacta RMS6) from modified-atmosphere-packaged (MAP), artisan-type cooked ham were assessed for their interactions in view of the development of a bioprotective culture. During monoculture experiments in cooked ham simulation medium, Leuc. carnosum 3M42 converted the available glucose into lactic acid and ethanol, whereas the two other strains produced additional metabolites such as acetic acid and 3-methyl-1-butanol.

Spinal radiographic changes in ankylosing spondylitis: association with clinical characteristics and functional outcome.

Objective: To determine which patients with ankylosing spondylitis (AS) have radiographic spinal damage and to investigate the relation between radiographic spinal changes and limitations in physical function.

Methods: A cross-sectional nationwide study in Belgium of patients with AS under the care of a rheumatologist. The treating physician completed a questionnaire including clinical disease manifestations and laboratory findings (HLA-B27 and C-reactive protein), and classified spinal radiographs into 3 categories: (1) no AS-related spinal abnormalities; (2) syndesmophytes; and (3) spinal ankylosis.

The epidemiology of ankylosing spondylitis and the commencement of anti-TNF therapy in daily rheumatology practice.

Objectives: This study aimed to describe the epidemiology of ankylosing spondylitis (AS) in rheumatology practice at the beginning of the anti-TNF (tumour necrosis factor) era, and to evaluate the initiation of anti-TNF therapy in a clinical setting where prescription is regulated by the authority's imposed reimbursement criteria.

Methods: Between February 2004 and February 2005, all Belgian rheumatologists in academic and non-academic outpatient settings were invited to register all AS patients who visited their practice. A random sample of these patients was further examined by an in-depth clinical profile.

Classification and management of allergic rhinitis patients in general practice during pollen season.

Background: Allergic rhinitis (AR) represents a major challenge in primary care. The Allergic Rhinitis and its Impact on Asthma (ARIA) group proposed a new classification for AR and developed evidence-based guidelines for the management of this disease. We conducted this study to further characterize the classes of AR described by ARIA, and to evaluate whether the management of AR in general practice is in accordance with the ARIA guidelines.