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Veröffentlichung 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 Added value of combining health examination surveys and human biomonitoring studies(2019) Tolonen, Hanna; Andersson, Anna-Maria; Holmboe, Stine Agergaard; Kolossa-Gehring, MarikeVeröffentlichung Added value of combining health examination surveys and human biomonitoring studies(2019) Tolonen, Hanna; Andersson, Anna-Maria; Holmboe, Stine Agergaard; Kolossa-Gehring, MarikeVeröffentlichung Environmental substances associated with osteoporosis - a scoping review(2021) Elonheimo, Hanna; Kolossa-Gehring, Marike; Tolonen, Hanna; Lange, RosaIntroduction: Osteoporosis is a disease having adverse effects on bone health and causing fragility fractures. Osteoporosis affects approximately 200 million people worldwide, and nearly 9 million fractures occur annually. Evidence exists that, in addition to traditional risk factors, certain environmental substances may increase the risk of osteoporosis. Methods: The European Human Biomonitoring Initiative (HBM4EU) is a joint program coordinating and advancing human biomonitoring in Europe. HBM4EU investigates citizens' exposure to several environmental substances and their plausible health effects aiming to contribute to policymaking. In HBM4EU, 18 priority substances or substance groups were selected. For each, a scoping document was prepared summarizing existing knowledge and health effects. This scoping review is based on these chemical-specific scoping documents and complementary literature review. Results: A possible link between osteoporosis and the body burden of heavy metals, such as cadmium (Cd) and lead (Pb), and industrial chemicals such as phthalates and per- and poly-fluoroalkyl substances (PFASs) was identified. Conclusions: Evidence shows that environmental substances may be related to osteoporosis as an adverse health effect. Nevertheless, more epidemiological research on the relationship between health effects and exposure to these chemicals is needed. Study results are incoherent, and pervasive epidemiological studies regarding the chemical exposure are lacking. © 2021 by the authorsVeröffentlichung Implementation and coordination of an ethics framework in HBM4EU - Experiences and reflections(2023) Knudsen, Lisbeth E.; Tolonen, Hanna; Scheepers, Paul T. J.; Splanemann, Pia; Weise, Philipp; Kolossa-Gehring, MarikeHuman biomonitoring involves the use of human samples and data to investigate exposure to environmental chemicals and their impact on human health. HBM4EU developed a coordinated and harmonized approach involving 29 countries in Europe plus Israel. Addressing ethical issues has been an indispensable prerequisite, from the application phase, grant agreement, project performance to the closing of the project. HBM4EU has established a better understanding of the ethics in such projects and the need for a standardised way of reporting and handling of ethics and data exchange, securing compliance with ethics standards, transparency, transferability and sustainability. The main reflections were: Knowledge: Ethics awareness, norms and practices are dynamic and increased throughout the project, much learning and experience is achieved by practice and dialogue. Attitude: Rules and standards were very diversely known and needed to adhere to local practices. Assistance: Good results achieved from webinars, training, help desk, and individual consultations. Standardisation: Was achieved by templates and naming convention across documents. Management: The establishment of the SharePoint directory with uploading of all requested documents assisted collaboration and exchange. Also, a designated task for ethics within the management/coordination work package and the enthusiasm of the task leader were essential. Compliance: Some, but not all partners were very good at complying with deadlines and standards. Transferability and sustainability: All documents are archived in the SharePoint directory while a system assuring updating is recommended. Transparency: Assured by public access to annual ethics reports. The ethics reports bridged to the annual work plans (AWPs). Evaluation: The Ethics Check by the Commission was successful. © 2022 The AuthorsVeröffentlichung What is required to combine human biomonitoring and health surveys?(2022) Tolonen, Hanna; Kolossa-Gehring, Marike; Moore, Sonja; Lermen, DominikObtaining holistic information about health and health determinants at the population level should also include data on environmental risk factors of health. So far, only a few countries have combined, at the national level, health and human biomonitoring (HBM) surveys to collect extensive information on health, lifestyles, biological health determinants and environmental exposures. This paper will provide guidelines on how to combine health and HBM surveys and what is the added value of doing so. Health and HBM surveys utilize similar infrastructure and data collection methods including questionnaires, collection and analysis of biological samples, and objective health measurements. There are many overlapping or comparable steps in these two survey types. At the European level, detailed protocols for conducting a health examination survey or HBM study exists separately but there is no protocol for a combined survey available by now. Our recommendations for combined health and HBM surveys focus on a cross-sectional survey on general population aged 6-79 years. To avoid unnecessary participant burden, for the selection of included measurements basic principle would be to ensure that results of the measurements have a public health relevance and clear interpretation. Combining health and HBM surveys into one survey would produce an extensive database for research to support policy decisions in many fields such as public health and chemical regulations. Combined surveys are cost-effective as only one infrastructure is needed to collect information and recruit participants. © 2022 The Author(s).