Background: 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.
|Journal||International Journal of Hygiene and Environmental Health|
|Publication status||Published - Mar 2021|
Bibliographical noteFunding Information:
This document has been created for the HBM4EU project. HBM4EU has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 733032 .
This document has been created for the HBM4EU project. HBM4EU has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 733032. This Phased Approach was developed in the framework of the Horizon 2020 project HBM4EU (WP7 ?Survey design and fieldwork preparation?) (www.hbm4eu.eu) and based on experiences from the development of the COPHES/DEMOCOPHES projects (Becker et al. 2014; Fiddicke et al. 2015; Den Hond et al. 2015; European Commission, 2013b; COPHES, 2013) and the German GerES studies (Schulz et al. 2007).
- Planning in phases
- Project management
- Study development
- Study protocol