• Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity.

      Jansen, Marleen E; Rigter, T; Rodenburg, W; Fleur, T M C; Houwink, E J F; Weda, M; Cornel, Martina C (2017)
      Advances from pharmacogenetics (PGx) have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.
    • A review to support the derivation of a worst-case dermal penetration value for nanoparticles.

      Gimeno-Benito, Irene; Giusti, Anna; Dekkers, Susan; Haase, Andrea; Janer, Gemma (2020-11-26)
    • Revised taxonomy and nomenclature of rodent Pasteurellaceae: Implications for monitoring.

      Boot, R; Nicklas, W; Christensen, H (2018-01-01)
      Pasteurellosis is a well-recognized disease with similar pathology in all laboratory rodent species. Pasteurella pneumotropica is the most frequently mentioned member of the Pasteurellaceae isolated from mice and rats. Numerous other Pasteurellaceae taxa have been obtained from mice, rats, and other rodent species. Recently, rodent Pasteurellaceae have been submitted to comprehensive genetic and phenotypic (polyphasic) taxonomic studies. As a result they are now classed within six validly published new genera, namely Cricetibacter, Mesocricetibacter, Mannheimia, Muribacter, Necropsobacter, and Rodentibacter. All previously used names such as P. pneumotropica have become obsolete. The new classification forms a firm basis for the correct phenotypic identification of Pasteurellaceae from laboratory animals and for the selection of strains for pathogenicity studies. Consequences of taxonomic changes notably involve molecular methods used for the detection of Pasteurellaceae infection in laboratory animal colonies. Testing may be done using primer sets that detect all Pasteurellaceae taxa or sets developed to detect host-specific members of the family.
    • Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection.

      Fitzner, Julia; Qasmieh, Saba; Mounts, Anthony Wayne; Alexander, Burmaa; Besselaar, Terry; Briand, Sylvie; Brown, Caroline; Clark, Seth; Dueger, Erica; Gross, Diane; et al. (2018-02-01)
      The formulation of accurate clinical case definitions is an integral part of an effective process of public health surveillance. Although such definitions should, ideally, be based on a standardized and fixed collection of defining criteria, they often require revision to reflect new knowledge of the condition involved and improvements in diagnostic testing. Optimal case definitions also need to have a balance of sensitivity and specificity that reflects their intended use. After the 2009-2010 H1N1 influenza pandemic, the World Health Organization (WHO) initiated a technical consultation on global influenza surveillance. This prompted improvements in the sensitivity and specificity of the case definition for influenza - i.e. a respiratory disease that lacks uniquely defining symptomology. The revision process not only modified the definition of influenza-like illness, to include a simplified list of the criteria shown to be most predictive of influenza infection, but also clarified the language used for the definition, to enhance interpretability. To capture severe cases of influenza that required hospitalization, a new case definition was also developed for severe acute respiratory infection in all age groups. The new definitions have been found to capture more cases without compromising specificity. Despite the challenge still posed in the clinical separation of influenza from other respiratory infections, the global use of the new WHO case definitions should help determine global trends in the characteristics and transmission of influenza viruses and the associated disease burden.
    • Rhizosphere Microbiome Assembly and Its Impact on Plant Growth.

      Qu, Qian; Zhang, Zhenyan; Peijnenburg, W J G M; Liu, Wanyue; Lu, Tao; Hu, Baolan; Chen, Jianmeng; Chen, Jun; Lin, Zhifen; Qian, Haifeng (2020-05-06)
    • The Rhythm of Risk: Sexual Behaviour, PrEP Use and HIV Risk Perception Between 1999 and 2018 Among Men Who Have Sex with Men in Amsterdam, The Netherlands.

      Basten, Maartje; den Daas, Chantal; Heijne, Janneke C M; Boyd, Anders; Davidovich, Udi; Rozhnova, Ganna; Kretzschmar, Mirjam; Matser, Amy (2020-12-02)
    • The RiBaTox web tool: selecting methods to assess and manage the diverse problem of chemical pollution in surface waters.

      Kramer, KJM; Sleeuwaert, F; Engelen, G; Muller, C; Brack, W; Posthuma, L (2019-10-21)
    • Ribotype 078 Clostridium difficile infection incidence in Dutch hospitals is not associated with provincial pig farming: Results from a national sentinel surveillance, 2009-2015.

      van Dorp, Sofie M; de Greeff, Sabine C; Harmanus, Céline; Sanders, Ingrid M J G; Dekkers, Olaf M; Knetsch, Cornelis W; Kampinga, Greetje A; Notermans, Daan W; Kuijper, Ed J (2017)
      It has been suggested that the high incidence of ribotype 078 Clostridium difficile infections (CDI) in the Netherlands is related to pig farming.
    • Rijksvaccinatieprogramma: is minder vaccineren een optie?

      Kamp, L; de Melker, H E; van Vliet, J A (2020-09-03)
    • Risk analysis and technology assessment in support of technology development: Putting responsible innovation in practice in a case study for nanotechnology.

      van Wezel, Annemarie P; van Lente, Harro; van de Sandt, Johannes Jm; Bouwmeester, Hans; Vandeberg, Rens Lj; Sips, Adrienne Jam (2018-01)
      Governments invest in "key enabling technologies," such as nanotechnology, to solve societal challenges and boost the economy. At the same time, governmental agencies demand risk reduction to prohibit any often unknown adverse effects, and industrial parties demand smart approaches to reduce uncertainties. Responsible research and innovation (RRI) is therefore a central theme in policy making. Risk analysis and technology assessment, together referred to as "RATA," can provide a basis to assess human, environmental, and societal risks of new technological developments during the various stages of technological development. This assessment can help both governmental authorities and innovative industry to move forward in a sustainable manner. Here we describe the developed procedures and products and our experiences to bring RATA in practice within a large Dutch nanotechnology consortium. This is an example of how to put responsible innovation in practice as an integrated part of a research program, how to increase awareness of RATA, and how to help technology developers perform and use RATA. Integr Environ Assess Manag 2018;14:9-16. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).
    • Risk assessment and risk management

      Landsiedel, Robert; Sauer, Ursula G.; de Jong, Wim H. (2018-01-10)
    • Risk assessment frameworks for nanomaterials: Scope, link to regulations, applicability, and outline for future directions in view of needed increase in efficiency

      Oomen, Agnes G.; Steinhäuser, Klaus Günter; Bleeker, Eric A.J.; van Broekhuizen, Fleur; Sips, Adriënne; Dekkers, Susan; Wijnhoven, Susan W.P.; Sayre, Philip G. (2018-01)
    • Risk Assessment of Per- and Polyfluoroalkyl Substances (PFASs) Mixtures: A Relative Potency Factor Approach.

      Bil, Wieneke; Zeilmaker, Marco; Fragki, Styliani; Lijzen, Johannes; Verbruggen, Eric; Bokkers, Bas (2020-07-30)
    • Risk Assessment of Processes and Products in Industrial Biotechnology.

      Chen, Chao; Reniers, Genserik (2018-09-23)
      Risk assessment has been used extensively as the main approach to prevent accidents in the chemical and process industry. Industrial biotechnology has many of the same hazards as chemical technology, but also encounters biological hazards related to biological agents. Employees in the biotechnology industry are susceptible to health risks because of different types of exposure to harmful agents. The external environment may also be affected by these agents in cases of accidental release. This chapter first presents several traditional risk assessment methods that may be used in industrial biotechnology after comparing differences between industrial biotechnology and chemical technology. Hazard identification in industrial biotechnology is then discussed, for biological as well as traditional hazards. Furthermore, risk assessment of occupational health and safety related to biological hazards is examined using exposure analysis and risk characterization. A two-stage risk assessment method is recommended to assess environmental and ecological risks in industrial biotechnology. Risk analysis of traditional accidents (fire, explosions, and toxic releases) in industrial biotechnology is also described. Graphical Abstract.
    • Risk assessment of substances that are both genotoxic and carcinogenic report of an International Conference organized by EFSA and WHO with support of ILSI Europe.

      Barlow, S; Renwick, A G; Kleiner, J; Bridges, J W; Busk, L; Dybing, Erik; Edler, L; Eisenbrand, G; Fink-Gremmels, J; Knaap, A G A C; et al. (2006-10-01)
      The European Food Safety Authority (EFSA) and the World Health Organization (WHO), with the support of the International Life Sciences Institute, European Branch (ILSI Europe), organized an international conference on 16-18 November 2005 to discuss how regulatory and advisory bodies evaluate the potential risks of the presence in food of substances that are both genotoxic and carcinogenic. The objectives of the conference were to discuss the possible approaches for risk assessment of such substances, how the approaches may be interpreted and whether they meet the needs of risk managers. ALARA (as low as reasonably achievable) provides advice based solely on hazard identification and does not take into account either potency or human exposure. The use of quantitative low-dose extrapolation of dose-response data from an animal bioassay raises numerous scientific uncertainties related to the selection of mathematical models and extrapolation down to levels of human exposure. There was consensus that the margin of exposure (MOE) was the preferred approach because it is based on the available animal dose-response data, without extrapolation, and on human exposures. The MOE can be used for prioritisation of risk management actions but the conference recognised that it is difficult to interpret it in terms of health risk.
    • A risk based sampling design including exposure assessment linked to disease burden, uncertainty and costs

      Pielaat, Annemarie; Chardon, Jurgen E.; Wijnands, Lucas M.; Evers, Eric G. (2018-02)
    • Risk Benefit Assessment of foods: Key findings from an international workshop

      Pires, Sara M.; Boué, Géraldine; Boobis, Alan; Eneroth, Hanna; Hoekstra, Jeljer; Membré, Jeanne-Marie; Persson, Inez Maria; Poulsen, Morten; Ruzante, Juliana; van Klaveren, Jacob; et al. (2018-09)
    • Risk factors associated with sustained circulation of six zoonotic arboviruses: a systematic review for selection of surveillance sites in non-endemic areas.

      Esser, Helen J; Mögling, Ramona; Cleton, Natalie B; van der Jeugd, Henk; Sprong, Hein; Stroo, Arjan; Koopmans, Marion P G; de Boer, Willem F; Reusken, Chantal B E M (2019-05-27)
    • Risk factors for developing acute gastrointestinal, skin or respiratory infections following obstacle and mud run participation, the Netherlands, 2017.

      den Boogert, Elisabeth M; Oorsprong, Danielle M; Fanoy, Ewout B; Leenders, Alexander Cap; Tostmann, Alma; van Dam, Adriana Sg (2019-10-01)