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Thermal stability of hepatitis E virus assessed by a molecular biological approach

Background: Hepatitis E virus (HEV) is a pathogen of emerging concern in industrialized countries. The consumption of wild boar meat has been identified as one risk factor for autochthonous HEV infections. Only limited information is available about thermal stability of HEV, mainly due to the lack of rapid and efficient cell culture systems for measurement of HEV infectivity. Methods: A molecular biological method was implemented in order to distinguish disassembled from intact viral particles using RNase treatment followed by quantitative real-time RT-PCR. The method was applied to a wild boar liver suspension containing HEV genotype 3. Results: Time-course analyses indicated that the decline of protected RNA could be described by a biphasic model with an initial decrease followed by a stationary phase. The stationary phase was reached after 1 hour at 4°C, 3 days at 22°C and 7 days at 37°C with log reductions of 0.34, 0.45 and 1.24, respectively. Protected RNA was detectable until the end of the experiments at day 50 or 70. Heat exposure for 1 minute resulted in a log reduction of 0.48 at 70°C and increased with higher temperatures to 3.67 at 95°C. Although HEV infectivity titration by inoculation of the liver suspension onto three cell lines did not succeed, the results of the RNase-based method are in accordance with published cell culture-based data. Conclusions: Measurement of intact viral particles using the RNase-based method may provide data on the stability of RNA viruses when cell culture-based infectivity titrations are not efficient or not available. The method enables processing of large sample numbers and may be suitable to estimate stability of HEV in different types of food

Minimum Information Required to Annotate Food Safety Risk Assessment Models (MIRARAM)

Abstract In the last decades, mathematical models and model-based simulations became important elements not only in the area of risk assessment concerning microbiological and chemical hazards but also in modelling biological phenomena in general. Unfortunately, many of the developed models are published in non-standardized ways, which hinders efficient exchange, re-use and continuous improvement of models within the risk assessment domain. The establishment of guidelines for model annotation is an important pre-condition to overcome these obstacles. Additionally, implementation of annotation guidelines can improve transparency, quality control and even aid the clarification of intellectual property rights. Here, we address the question of "What is the minimum set of metadata that should be provided for a model in the risk assessment domain?". The proposed guideline focuses on food safety risk assessment models and is called "Minimum Information Required to Annotate food safety Risk Assessment Models (MIRARAM)". MIRARAM supports the model creator during the model documentation step and could also be used as a checklist by scientific journal editors or database curators. Software developers could take up MIRARAM and develop easy-to-use software tools or new features in existing programs that can help model creators to provide proposed model annotations in harmonized file formats. Based on experiences from similar guidelines in related scientific disciplines (like systems biology), it is expected that MIRARAM could contribute to the promotion of application and re-use of models as well as to implementing more standardized quality control in the food safety modelling domain

One Health Surveillance Codex: promoting the adoption of One Health solutions within and across European countries

Cross-sector communication, collaboration and knowledge exchange are still significant challenges for practical adoption of the One Health paradigm. To address these needs the “One Health Surveillance Codex” (OHS Codex) was established to provide a framework for the One Health community to continuously share practical solutions (e.g. tools, technical resources, guidance documents and experiences) applicable for national and international stakeholders from different One Health Surveillance sectors. Currently, the OHS Codex provides a number of resources that support the adoption of the OH paradigm in areas linked to the harmonization and interpretation of surveillance data. The OHS Codex framework comprises four high-level “action” principles, which respectively support collaboration, knowledge exchange, data interoperability, and dissemination. These principles match well with priority areas identified in the “Tripartite Guide to Addressing Zoonotic Diseases in Countries” published by WHO, FAO and OIE. Within each of the four principles, the OHS Codex provides a collection of useful resources as well as pointers to success stories for the application of these resources. As the OHS Codex is designed as an open-source community framework, it will continuously evolve and adapt to the needs of the OH community in the future

Evaluation of two family-based intervention programs for children affected by rare disease and their families – research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design

Background: Families of children with rare diseases (i.e., not more than 5 out of 10,000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and its siblings. Although families caring for children with rare diseases are known to be at risk for mental disorders, the evaluation of special programs under high methodological standards has not been conducted so far. Moreover, the implementation of interventions for this group into regular care has not yet been accomplished in Germany. The efficacy and cost-effectiveness of a family-based intervention will be assessed. Methods/design: The study is a 2x2 factorial randomized controlled multicenter trial conducted at 17 study centers throughout Germany. Participants are families with children and adolescents affected by a rare disease aged 0 to 21 years. Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months. Topics discussed in the interventions include coping, family relations, and social support. Families in the control condition will receive treatment as usual. The primary efficacy outcome is parental mental health, measured by the Structured Clinical Interview for DSM-IV (SCID-I) by blinded external raters. Further outcomes will be assessed from the parents’ as well as the children’s perspective. Participants are investigated at baseline, 6, 12 and 18 months after randomization. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed. Discussion: This paper describes the implementation and evaluation of two family-based intervention programs for Children Affected by Rare Disease and their Family’s Network (CARE-FAM-NET) in German standard care. A methodologically challenging study design is used to reflect the complexity of the actual medical care situation. This trial could be an important contribution to the improvement of care for this highly burdened group. Trial registration: German Clinical Trials Register: DRKS00015859 (registered 18 December 2018) and ClinicalTrials.gov: NCT04339465 (registered 8 April 2020). Protocol Version: 15 August 2020 (Version 6.1). Trial status: Recruitment started on 1 January 2019 and will be completed on 31 March 2021. © 2020, The Author(s)

Harmonized terms, concepts and metadata for microbiological risk assessment models: the basis for knowledge integration and exchange

In the last decades the microbial food safety community has developed a variety of valuable knowledge (e.g., mathematical models and data) and resources (e.g., databases and software tools) in the areas of quantitative microbial risk assessment (QMRA) and predictive microbiology. However, the reusability of this knowledge and the exchange of information between resources are currently difficult and time consuming. This problem has increased over time due to the lack of harmonized data format and rules for knowledge annotation. It includes the lack of a common understanding of basic terms and concepts and of a harmonized information exchange format to describe and annotate knowledge. The existence of ambiguities and inconsistencies in the use of terms and concepts in the QMRA and predictive microbial (PM) modelling necessitates a consensus on their refinement, which will allow a harmonized exchange of information within these areas. Therefore, this work aims to harmonize terms and concepts used in QMRA and PM modelling spanning from high level concepts as defined by Codex Alimentarius, Food and Agriculture Organization (FAO) and World Health Organization (WHO), up to terms generally used in statistics or data and software science. As a result, a harmonized schema for metadata that allows consistent annotation of data and models from these two domains is proposed. This metadata schema is also a key component of the Food Safety Knowledge Markup Language (FSK-ML), a harmonized format for information exchange between resources in the QMRA and PM modelling domain. This work is carried out within a research project that aims to establish a new community resource called Risk Assessment Modelling and Knowledge Integration Platform (RAKIP). This platform will facilitate the sharing and execution of curated QMRA and PM models using the foundation of the proposed harmonized metadata schema and information exchange format. Furthermore, it will also provide access to related open source software libraries, converter tools and software-specific import and export functions that promote the adoption of FSK-ML by the microbial food safety community. In the future, these resources will hopefully promote both the knowledge reusability and the high quality information exchange between stakeholders within the areas of QMRA and PM modelling worldwide

The RAKIP Initiative and it’s solutions

The RAKIP Initiative is a community-driven effort supported by 11 European risk assessment and research institutions that aims at enabling efficient exchange and re-use of predictive models (and underlying data). It addresses the need of researchers to find, apply and customize existing models irrespective of the programming language or software used for model generation. With this the RAKIP Initiative also supports general knowledge exchange, transparency and reproducibility in the risk assessment domain, as currently the exchange of predictive models (and underlying data) is difficult and time consuming. The foundation of the solutions developed by RAKIP partners is the open FAIR Scientific Knowledge eXchange format (FSKX) that can be applied to a broad range of model classes and data. Based on FSKX a number of services and tools to search, download, apply, modify, create, combine, execute and share models online or with desktop software tools were developed. This presentation will explain the underlying principles of RAKIP, introduce the RAKIP-Web model repository and showcase open-source software tools that support FSKX. It will also present recent achievements from currently ongoing software and content development projects. As the RAKIP Initiative is designed as a community-driven effort this presentation will conclude with recommendations on how to support or contribute