A systematic approach for designing a HBM pilot study for Europe.
The objective of COPHES (Consortium to Perform Human biomonitoring on a European Scale) was to develop a harmonised approach to conduct human biomonitoring on a European scale. COPHES developed a systematic approach for designing and conducting a pilot study for an EU-wide cross-sectional human biomonitoring (HBM) study and for the implementation of the fieldwork procedures. The approach gave the basis for discussion of the main aspects of study design and conduct, and provided a decision making tool which can be applied to many other studies. Each decision that had to be taken was listed in a table of options with their advantages and disadvantages. Based on this the rationale of the decisions could be explained and be transparent. This was important because an EU-wide HBM study demands openness of all decisions taken to encourage as many countries as possible to participate and accept the initiative undertaken. Based on this approach the following study design was suggested: a cross-sectional study including 120 children aged 6-11 years and their mothers aged up to 45 years from each participating country. For the pilot study the children should be sampled in equal shares in an urban and a rural location. Only healthy children and mothers (no metabolic disturbances) should be included, who have a sufficient knowledge of the local language and have been living at least for 5 years at the sampling location. Occupational exposure should not be an exclusion criterion. Recruitment should be performed via inhabitant registries or schools as an alternative option. Measures suitable to increase the response rate should be applied. Preferably, the families should be visited at home and interviewed face-to-face. Various quality control measures to guarantee a good fieldwork performance were recommended. This comprehensive overview aims to provide scientists, EU officials, partners and stakeholders involved in the EU implementation process full transparency of the work carried out in COPHES. Thus this report presents the discussion and consensus in COPHES on the main aspects of designing and conducting fieldwork of a human biomonitoring study. Furthermore, it provides an example for a systematic approach that may be useful to other research groups or pan-European research initiatives. In the study protocol that will be published elsewhere these aspects are elaborated and additional aspects are covered (Casteleyn et al., 2012). Meanwhile the respective pilot study DEMOCOPHES had been conducted and assessed. The results and lessons learned will be published elsewhere.
Federal Environment Agency (UBA), Berlin, Germany. Electronic address: kerstin.becker@uba.de.
Kerstin
K
Becker
Federal Environment Agency (UBA), Berlin, Germany.
Margarete
M
Seiwert
University of Leuven, Leuven, Belgium.
Ludwine
L
Casteleyn
BiPRO GmbH, Munich, Germany.
Reinhard
R
Joas
BiPRO GmbH, Munich, Germany.
Anke
A
Joas
Federal Public Service Health, Food Chain Safety and Environment, Brussels, Belgium.
Pierre
P
Biot
Federal Public Service Health, Food Chain Safety and Environment, Brussels, Belgium.
Dominique
D
Aerts
Instituto de Salud Carlos III, Madrid, Spain.
Argelia
A
Castaño
Instituto de Salud Carlos III, Madrid, Spain.
Marta
M
Esteban
Institute for Prevention and Occupational Medicine of the German Social Accident Insurance - Institute of the Ruhr University Bochum (IPA), Germany.
Jürgen
J
Angerer
Institute for Prevention and Occupational Medicine of the German Social Accident Insurance - Institute of the Ruhr University Bochum (IPA), Germany.
Holger M
HM
Koch
Flemish Institute for Technological Research (VITO), Mol, Belgium.
Greet
G
Schoeters
Flemish Institute for Technological Research (VITO), Mol, Belgium.
Elly
E
Den Hond
Health Protection Agency, London, United Kingdom.
Ovnair
O
Sepai
Health Protection Agency, London, United Kingdom.
Karen
K
Exley
University of Copenhagen, Copenhagen, Denmark.
Lisbeth E
LE
Knudsen
Jožef Stefan Institute, Ljubljana, Slovenia.
Milena
M
Horvat
Environmental Health Science International, Amsterdam, The Netherlands.
Louis
L
Bloemen
Marike
M
Kolossa-Gehring
Federal Environment Agency (UBA), Berlin, Germany.
D000328:Adult; D002648:Child; D032921:Consensus; D003430:Cross-Sectional Studies; D003657:Decision Making; D004781:Environmental Exposure / Q000032:analysis*; D004784:Environmental Monitoring / Q000379:methods*; D004785:Environmental Pollutants / Q000032:analysis*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D009035:Mothers; D010865:Pilot Projects; D012107:Research Design
D004785:Environmental Pollutants
90th reference percentile; 95th reference percentile; COPHES; Czech Republic Environmental Health Monitoring System; DEMOCOPHES; EEA; EHMS; ENNS; EQUAS; ETS; EU; European Environment Agency; External Quality Control System; FLEHS; Fieldwork; French Nutrition and Health Survey; GM; GerES; German Environmental Survey; German Health Interview and Examination Survey; HBM; HBMC; Harmonisation; Human Biomonitoring Commission; ICI; KiGGS; LoQ; NHANES; National Health and Nutrition Examination Survey; RV; RV90; RV95; SES; SOP; Study design; The Flemisch Environment and Health Study; WHO; WP; World Health Organization; environmental tobacco smoke; geometric mean; human biomonitoring; interlaboratory comparison investigation; limit of quantification; reference value; socio-economic status; standard operation procedure; work package