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Veröffentlichung A pilot study on the feasibility of European harmonized Human Biomonitoring: Strategies towards a common approach, challenges and opportunities(2015) Casteleyn, Ludwine; Dumez, Birgit; Becker, Kerstin; Den Hond, Elly; Schoeters, Greet; Castaño, Argelia; Koch, Holger Martin; Angerer, Jürgen; Esteban, Marta; Exley, Karen; Sepai, Ovnair; Bloemen, Louis; Fiddicke, Ulrike; Horvath, Milena; Knudsen, Lisbeth E.; Joas, Anke; Joas, Reinhard; Biot, Pierre; Koppen, C.; Dewolf, M.-C.; Katsonouri, Andromachi; Hadjipanayis, Adamos; Cerna, Milena; Krskova, A.; Kolossa-Gehring, Marike; Nielsen, Jeanette K.S.; Jensen, J.F.; Rudnai, Peter; Közepesy, S.; Mulcahy, M.F.R.; Mannion, R.; Gutleb, Arno C.; Fischer, M.E.; Ligocka, Danuta; Jakubowski, M.; Reis, M.Fátima; Namorado, S.; Lupsa, Ioana-Rodica; Schwedler, Gerda; Gurzau, Anca ElenaIn 2004theEuropeanCommissionandMemberStatesinitiatedactivitiestowardsaharmonizedap-
proach forHumanBiomonitoringsurveysthroughoutEurope.Themainobjectivewastosustainen-
vironmental healthpolicybybuildingacoherentandsustainableframeworkandbyincreasingthe
comparability ofdataacrosscountries.Apilotstudy totestcommonguidelinesforsettingupsurveys
wasconsideredakeystepinthisprocess.Throughabottom-upapproachthatincludedallstakeholders,
a jointstudyprotocolwaselaborated.
FromSeptember2011tillFebruary2012,17Europeancountriescollecteddatafrom1844mother-
child pairsintheframeofDEMOnstrationofastudytoCoordinateandPerformHumanBiomonitoring
on aEuropeanScale(DEMOCOPHES). Mercury inhairandurinarycadmiumandcotininewereselected
as biomarkersofexposurecoveredbysufficient analyticalexperience.PhthalatemetabolitesandBi-
sphenol Ainurinewereaddedtotakeintoaccountincreasingpublicandpoliticalawarenessfor
emerging typesofcontaminantsandtotestlessadvancedmarkers/markerscoveredbylessanalytical
experience.Extensiveeffortstowardschemo-analyticalcomparabilitywereincluded.
The pilotstudyshowed thatcommonapproachescanbefoundinacontextofconsiderablediffer-
ences withrespecttoexperienceandexpertize,socio-culturalbackground,economicsituationandna-
tional priorities.ItalsoevidencedthatcomparableHumanBiomonitoringresultscanbeobtainedinsuch
context.AEuropeannetworkwasbuilt,exchanging information,expertise andexperiences,andpro-
viding trainingonallaspectsofasurvey.Akeychallengewas finding therightbalancebetweenarigid
structure allowingmaximalcomparabilityanda flexibleapproachincreasingfeasibilityandcapacity
building. NextstepsinEuropeanharmonizationinHumanBiomonitoringsurveysincludetheestab-
lishment ofajointprocessforprioritizationofsubstancestocoverandbiomarkerstodevelop,linking
biomonitoring surveyswithhealthexaminationsurveysandwithresearch,andcopingwiththediverse
implementations ofEUregulationsandinternationalguidelineswithrespecttoethicsandprivacy.
©2014ElsevierInc.Allrightsreserved.Veröffentlichung New human biomonitoring methods for chemicals of concern̶the German approach to enhance relevance(2017) Fiddicke, Ulrike; Leng, Gabriele; Kolossa-Gehring, Marike; Angerer, Jürgen; Wolz, BirgitVeröffentlichung New specific and sensitive biomonitoring methods for chemicals of emerging health relevance(2017) Leng, Gabriele; Fiddicke, Ulrike; Gries, Wolfgang; Kolossa-Gehring, MarikeIn this publication the challenges to cope for the aim to obtain innovative biomonitoring methods in our laboratory are visualized for di(2-propylheptyl)phthalate, 2-mercaptobenzothiazole, 3,5-di-tert-butyl-4-hydroxytoluene, 4-nonylphenol, 4-tert-octylphenol, 3-(4-methylbenzylidene)camphor, 4,4'-methylene diphenyl diisocyanate, and Hexabromocyclododecane. For these substances new specific markers were explored based on animal or human kinetic data with urine being the preferred matrix compared to blood. The determination of these markers was complex in all cases, because the sample preparation as well as the detection by high performance liquid chromatography, capillary gas chromatography coupled to tandem mass spectrometers or high resolution mass spectrometry should enable the lowest possible detection limit by use of minimal biological sample volumes. To get a first hint of a possible background level, the analytical methods were applied to urine samples of about 40 persons for each chemical. For Di(2-propylheptyl)phthalate and 2-Mercaptobenzothiazole first results are presented from population biomonitoring. Quelle: http://www.sciencedirect.comVeröffentlichung Human biomonitoring pilot study DEMOCOPHES in Germany: Contribution to a harmonized European approach(2017) Fiddicke, Ulrike; Ißleb, Sissy; Kolossa-Gehring, Marike; Schwedler, Gerda; Seiwert, MargareteHuman biomonitoring (HBM) is an effective tool to assess human exposure to environmental pollutants, but comparable HBM data in Europe are lacking. In order to expedite harmonization of HBM studies on a European scale, the twin projects COPHES (Consortium to Perform Human Biomonitoring on a European Scale) and DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human Biomonitoring on a European Scale) were formed, comprising 35 partners from 27 European countries. In COPHES a research scheme and guidelines were developed to exemplarily measure in a pilot study mercury in hair, cadmium, cotinine and several phthalate metabolites in urine of 6Ń11 year old children and their mothers in an urban and a rural region. Seventeen European countries simultaneously conducted this cross-sectional DEMOCOPHES feasibility study. The German study population was taken in the city of Bochum and in the Higher Sauerland District, comprising 120 mother-child pairs. In the present paper features of the study implementation are presented. German exposure concentrations of the pollutants are reported and compared with European average concentrations from DEMOCOPHES and with those measured in the representative German Environmental Survey (GerES IV). German DEMOCOPHES concentrations for mercury and cotinine were lower than the European average. However, 47% of the children were still exposed to environmental tobacco smoke (ETS) outside their home, which gives further potential for enhancing protection of children from ETS. Compared with samples from the other European countries German participating children had lower concentrations of the phthalate metabolites MEP and of the sum of 3 DEHP-metabolites (MEHP, 5OH-MEHP and 5oxo-MEHP), about the same concentrations of the phthalate metabolites MBzP and MiBP and higher concentrations of the phthalate metabolite MnBP. 2.5% of the German children had concentrations of the sum of 4 DEHP-metabolites and 4.2% had concentrations of MnBP that exceeded health based guidance values, indicating reasons for concern. Continuous HBM is necessary to track changes of pollutant exposure over time. Therefore Germany will continue to cooperate on the harmonisation of European human biomonitoring to support the chemicals regulation with the best possible exposure data to protect Europe's people against environmental health risks. Quelle: http://www.sciencedirect.comVeröffentlichung Human biomonitoring as a tool to support chemicals regulation in the European Union(2017) Ganzleben, Catherine; Antignac, Jean-Philippe; Barouki, Robert; Fiddicke, Ulrike; Kolossa-Gehring, MarikeVeröffentlichung Towards harmonized biobanking for biomonitoring: A comparison of human biomonitoring-related and clinical biorepositories(2020) Lermen, Dominik; Gwinner, Frederik; Fiddicke, Ulrike; Bartel-Steinbach, Martina; Kolossa-Gehring, MarikeHuman biomonitoring (HBM) depends on high-quality human samples to identify status and trends in exposure and ensure comparability of results. In this context, much effort has been put into the development of standardized processes and quality assurance for sampling and chemical analysis, while effects of sample storage and shipment on sample quality have been less thoroughly addressed. To characterize the currently applied storage and shipment procedures within the consortium of the European Human Biomonitoring Initiative (HBM4EU), which aims at harmonization of HBM in Europe, a requirement analysis based on data from an online survey was conducted. In addition, the online survey was addressed to professionals in clinical biobanking represented by members of the European, Middle Eastern and African Society for Biopreservation and Biobanking (ESBB) to identify the current state-of-the-art in terms of sample storage and shipment. Results of this survey conducted in these two networks were compared to detect processes with potential for optimization and harmonization. In general, many similarities exist in sample storage and shipment procedures applied by ESBB members and HBM4EU partners and many requirements for ensuring sample quality are already met also by HBM4EU partners. Nevertheless, a need for improvement was identified for individual steps in sample storage, shipment, and related data management with potential impact on sample and data quality for HBM purposes. Based on these findings, recommendations for crucial first steps to further strengthen sample quality, and thus foster advancement in HBM on a pan-European level are given. © Dominik Lermen et al., 2020Veröffentlichung A phased approach for preparation and organization of human biomonitoring studies(2021) Fiddicke, Ulrike; Kolossa-Gehring, Marike; Tolonen, Hanna; Pack, Kim LauraBackground Human biomonitoring (HBM) studies like other epidemiological studies are costly and time-consuming. They require the administration of questionnaires and collection of biological samples, putting substantial burden on the participants which may result in low participation rates. The growing importance of HBM studies in epidemiology, exposure assessment and risk assessment underline the importance of optimizing study planning, designing and implementation thus minimizing the above-mentioned difficulties. Methods Based on frameworks from survey design and fieldwork preparation of the European Joint Program HBM4EU, the German Environment Surveys and the COPHES/DEMOCOPHES twin projects combined with elements of project management strategies, a Phased Approach has been developed, introducing a step-by-step guideline for the development of epidemiological studies. Results The Phased Approach splits the process of developing a study into six phases: Phase 0 (Scoping and Planning): All aspects that are necessary to conduct a study are compiled and put on the agenda for decision-making. Phase 1 (Preparation and Testing): Instruments (e.g. questionnaires), materials (e.g. guidelines, information), and ethics and data management issues, needing thorough preparation and testing before a study can start. Phase 2 (Initiation): Organization and acquisition of necessary equipment and engaging and training personnel. Phase 3 (Implementation): All procedures that require temporal proximity to the start date of fieldwork, such as obtaining contact information of invitees. Phase 4 (Fieldwork and Analysis): Involvement of participants and chemical analysis of the collected samples. Phase 5 (Results and Evaluation): Final procedures leading to closure of the project, such as providing and communicating results. Conclusions The separation of the planning and conduct of human biomonitoring studies into different phases creates the basis for a structured procedure and facilitates a step-by-step approach reducing costs, warranting high participation rates and increasing quality of conduct. Emphasis is put on a comprehensive scoping phase ensuring high quality of the study design, which is indispensable for reliable results. © 2021 The Authors.Veröffentlichung Challenges to evidence synthesis and identification of data gaps in human biomonitoring(2021) Virgolino, Ana; Santos, Osvaldo; Fiddicke, Ulrike; Costa, Joana; Kolossa-Gehring, MarikeThe increasing number of human biomonitoring (HBM) studies undertaken in recent decades has brought to light the need to harmonise procedures along all phases of the study, including sampling, data collection and analytical methods to allow data comparability. The first steps towards harmonisation are the identification and collation of HBM methodological information of existing studies and data gaps. Systematic literature reviews and meta-analyses have been traditionally put at the top of the hierarchy of evidence, being increasingly applied to map available evidence on health risks linked to exposure to chemicals. However, these methods mainly capture peer-reviewed articles, failing to comprehensively identify other important, unpublished sources of information that are pivotal to gather a complete map of the produced evidence in the area of HBM. Within the framework of the European Human Biomonitoring Initiative (HBM4EU) initiative - a project that joins 30 countries, 29 from Europe plus Israel, the European Environment Agency and the European Commission - a comprehensive work of data triangulation has been made to identify existing HBM studies and data gaps across countries within the consortium. The use of documentary analysis together with an up-to-date platform to fulfil this need and its implications for research and practice are discussed. © 2021 by the authorsVeröffentlichung HBM4EU combines and harmonises human biomonitoring data across the EU, building on existing capacity(2021) Gilles, Liese; Fiddicke, Ulrike; Govarts, Eva; Rambaud, Loïc; Kolossa-Gehring, Marike; Vogel, NinaAs part of the Human Biomonitoring for Europe (HBM4EU) initiative a human biomonitoring (HBM) survey is conducted in 21 countries. This survey builds on existing HBM capacity in Europe by aligning national or regional HBM studies. The survey targets 3 age groups (i) children aged 6-11 years, (ii) teenagers aged 12-19 years and (iii) young adults aged 20-39 years and includes a total of 9493 participants (3151 children, 2953 teenagers and 3389 young adults). Depending on the age group, internal exposure to phthalates and substitute Hexamoll® DINCH, brominated and organophosphorus flame retardants, per-/poly-fluorinated compounds, cadmium, bisphenols and/or polycyclic aromatic hydrocarbons are assessed. The main goal of the programme is to obtain quality controlled and comparable HBM data of exposure to chemicals, prioritized under HBM4EU, with European wide coverage to inform the development of environment and health policies. This paper describes the framework of the HBM4EU survey and the approach that has been applied to align European HBM initiatives across Europe. © 2021 The Authors. Published by Elsevier GmbH.Veröffentlichung A step towards harmonising human biomonitoring study setup on Europeanlevel: materials provided and lessons learnt in HBM4EU(2023) Gilles, Liese; Fiddicke, Ulrike; Cops, Jirka; Kolossa-Gehring, Marike; Pack, Kim LauraInternal exposure of the human body to potentially harmful chemical substances can be assessed by Human Biomonitoring (HBM). HBM can be used to generate conclusive data that may provide an overview of exposure levels in entire or specific population groups. This knowledge can promote the understanding of potential risks of the substances of interest or help monitoring the success of regulatory measures taken on the political level. Study planning and design are key elements of any epidemiologic study to generate reliable data. In the field of HBM, this has been done using differing approaches on various levels of population coverage so far. Comparison and combined usage of the resulting data would contribute to understanding exposure and its factors on a larger scale, however, the differences between studies make this a challenging and somewhat limited endeavour. This article presents templates for documents that are required to set up an HBM study, thus facilitating the generation of harmonised HBM data as a step towards standardisation of HBM in Europe. They are designed to be modular and adaptable to the specific needs of a single study while emphasising minimum requirements to ensure comparability. It further elaborates on the challenges encountered during the process of creating these documents during the runtime of the European Joint Programme HBM4EU in a multi-national expert team and draws up lessons learnt in the context of knowledge management. © 2023 The Authors