[Show abstract][Hide abstract] ABSTRACT: Abstract Within the European Environment and Health Action Plan an initiative to establish a coherent human biomonitoring approach in Europe was started. The project COPHES (COnsortium to Perform Human biomonitoring on a European Scale ) developed recommendations for a harmonized conduct of a human biomonitoring (HBM) survey which came into action as the pilot study DEMOCOPHES (DEMOnstration of a study to COordinate and Perform Human biomonitoring on a European Scale). Seventeen European countries conducted a survey with harmonized instruments for, inter alia, recruitment, fieldwork and sampling, in autumn/winter 2011/2012. Based on the countries' experiences of conducting the pilot study, following lessons learnt were compiled: the harmonized fieldwork instruments (basic questionnaire, urine and hair sampling) turned out to be very valuable for future HBM surveys on the European scale. A school approach was favoured by most of the countries to recruit school-aged children according to the established guidelines and country specific experiences. To avoid a low participation rate, intensive communication with the involved institutions and possible participants proved to be necessary. The communication material should also include information on exclusion criteria and offered incentives. Telephone contact to the participants the day before fieldwork during the survey can prevent the forgetting of appointments and first morning urine samples. To achieve comparable results on the European scale, training of interviewers in all issues of recruitment, fieldwork and sampling through information material and training sessions is crucial. A survey involving many European countries needs time for preparation and conduct. Materials for quality control prepared for all steps of recruitment, fieldwork and sampling proved to be important to warrant reliable results.
Environmental Research 08/2015; 141:15-23. DOI:10.1016/j.envres.2014.08.039 · 4.37 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Abstract A communication strategy was developed by The Consortium to Perform Human Biomonitoring on a European Scale (COPHES), as part of its objectives to develop a framework and protocols to enable the collection of comparable human biomonitoring data throughout Europe. The framework and protocols were tested in the pilot study DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human biomonitoring on a European Scale). The aims of the communication strategy were to raise awareness of human biomonitoring, encourage participation in the study and to communicate the study results and their public health significance. It identified the audiences and key messages, documented the procedure for dissemination of results and was updated as the project progressed. A communication plan listed the tools and materials such as press releases, flyers, recruitment letters and information leaflets required for each audience with a time frame for releasing them. Public insight research was used to evaluate the recruitment material, and the feedback was used to improve the documents. Dissemination of results was coordinated in a step by step approach by the participating countries within DEMOCOPHES, taking into account specific national messages according to the needs of each country. Participants received individual results, unless they refused to be informed, along with guidance on what the results meant. The aggregate results and policy recommendations were then communicated to the general public and stakeholders, followed by dissemination at European level. Several lessons were learnt that may assist other future human biomonitoring studies. Recruitment took longer than anticipated and so social scientists, to help with community engagement, should be part of the research team from the start. As a European study, involving multiple countries, additional considerations were needed for the numerous organisations, different languages, cultures, policies and priorities. Therefore, communication documents should be seen as templates with essential information clearly indicated and the option for each country to tailor the material to reflect these differences. Future studies should consider setting up multidisciplinary networks of medical professionals and communication experts, and holding training workshops to discuss the interpretation of results and risk communication. Publicity and wide dissemination of the results helped to raise awareness of human biomonitoring to the general public, policy makers and other key stakeholders. Effective and timely communication, at all stages of a study, is essential if the potential of human biomonitoring research to improve public health is to be realised.
Environmental Research 08/2015; 141:31-41. DOI:10.1016/j.envres.2014.12.003 · 4.37 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Abstract COPHES/DEMOCOPHES has its origins in the European Environment and Health Action Plan of 2004 to “develop a coherent approach on human biomonitoring (HBM) in Europe”. Within this twin-project it was targeted to collect specimens from 120 mother-child-pairs in each of the 17 participating European countries. These specimens were investigated for six biomarkers (mercury in hair; creatinine, cotinine, cadmium, phthalate metabolites and bisphenol A in urine). The results for mercury in hair are described in a separate paper. Each participating member state was requested to contract laboratories, for capacity building reasons ideally within its borders, carrying out the chemical analyses. To ensure comparability of analytical data a Quality Assurance Unit (QAU) was established which provided the participating laboratories with standard operating procedures (SOP) and with control material. This material was specially prepared from native, non-spiked, pooled urine samples and was tested for homogeneity and stability. Four external quality assessment exercises were carried out. Highly esteemed laboratories from all over the world served as reference laboratories. Web conferences after each external quality assessment exercise functioned as a new and effective tool to improve analytical performance, to build capacity and to educate less experienced laboratories. Of the 38 laboratories participating in the quality assurance exercises 14 laboratories qualified for cadmium, 14 for creatinine, 9 for cotinine, 7 for phthalate metabolites and 5 for bisphenol A in urine. In the last of the four external quality assessment exercises the laboratories that qualified for DEMOCOPHES performed the determinations in urine with relative standard deviations (low/high concentration) of 18.0/2.1% for cotinine, 14.8/5.1% for cadmium, 4.7/3.4% for creatinine. Relative standard deviations for the newly emerging biomarkers were higher, with values between 13.5 and 20.5% for bisphenol A and between 18.9 and 45.3% for the phthalate metabolites. Plausibility control of the HBM results of all participating countries disclosed analytical shortcomings in the determination of Cd when using certain ICP/MS methods. Results were corrected by reanalyses. The COPHES/DEMOCOPHES project for the first time succeeded in performing a harmonized pan-European HBM project. All data raised have to be regarded as utmost reliable according to the highest international state of the art, since highly renowned laboratories functioned as reference laboratories. The procedure described here, that has shown its success, can be used as a blueprint for future transnational, multicentre HBM projects.
International Journal of Hygiene and Environmental Health 06/2014; 217(6):653–666. DOI:10.1016/j.ijheh.2013.12.002 · 3.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Abstract 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.
International Journal of Hygiene and Environmental Health 03/2014; 217(2-3):312-322. DOI:10.1016/j.ijheh.2013.07.004 · 3.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Human biomonitoring is an important tool for the evaluation of environmental exposure to contaminants. The data that are obtained from these studies might be compared to appropriate reference values (RVs) in a specific population. The RVs were derived from the rounded values of the upper limit of the 95th confidence interval of the 95th percentile for lead (Pb), cadmium (Cd) and mercury (Hg) in blood from adults in the metropolitan area of Sao Paulo (MASP), Brazil to investigate the association between blood metals and sociodemographic and lifestyle factors. Blood samples from 653 nonsmoking blood donors without occupational exposure to the studied metals were collected in 2006. Our evaluations distinguished a younger group (18-39 years) and an older group (40-65 years). RVs in the younger group were 60μgPb/L and 4μgHg/L for men and 47μgPb/L and 4μgHg/L for women. RVs in the older group were 80μgPb/L and 5μgHg/L for men and 63μgPb/L and 6μgHg/L for women. The RV for Cd was 0.6μg/L for adults aged 18-65 years. Pb and Cd levels demonstrated a significant association with sex and age. Male blood contained 50% more Pb, and the older group exhibited 23% more Pb. Fish consumption and amalgam fillings were primarily related to Hg levels. RVs for lead were similar to the Czech Republic and Germany but higher than the US population. The RV for Cd in Brazil was well below the RVs of these countries. The RVs for Hg in Brazil were similar to the US but higher than Germany and the Czech Republic.
International journal of hygiene and environmental health 06/2012; 216(3). DOI:10.1016/j.ijheh.2012.05.010 · 3.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Human biomonitoring of nickel has gained interest in environmental medicine due to its wide distribution in the environment and its allergenic potential. There are indications that the prevalence of nickel sensitization in children is increased by nickel exposure and that oral uptake of nickel can exacerbate nickel dermatitis in nickel-sensitive individuals. Urinary nickel measurement is a good indicator of exposure. However, data on nickel levels in urine of children are rare. For the first time, the German Environmental Survey on children (GerES IV) 2003-2006 provided representative data to describe the internal nickel exposure of children aged 3-14years in Germany. Nickel was measured after enrichment in the organic phase of urine by graphite furnace atomic absorption spectrometry with Zeeman background correction. Nickel levels (n=1576) ranged from <0.5 to 15μg/l. Geometric mean was 1.26μg/l. Multivariate regression analysis showed that gender, age, socio-economic status, being overweighted, consumption of hazelnut spread, nuts, cereals, chocolate and urinary creatinine were significant predictors for urinary nickel excretion of children who do not smoke. 20.2% of the variance could be explained by these variables. With a contribution of 13.8% the urinary creatinine concentration was the most important predictor. No influence of nickel intake via drinking water and second hand smoke exposure was observed.
International journal of hygiene and environmental health 04/2012; 216(2). DOI:10.1016/j.ijheh.2012.03.008 · 3.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The German Federal Environment Agency carried out its fourth German Environmental Survey (GerES IV), which is the first survey on children only and the environment-related module of the German Health Interview and Examination Survey for Children and Adolescents (German acronym: KiGGS), conducted by the Robert Koch Institute (RKI). The German Environmental Surveys are nationwide population studies conducted to determine the exposure to environmental pollutants, to explore exposure pathways and to identify sub-groups with higher exposure. GerES IV was conducted on randomly selected 1790 children aged 3-14 years from the cross-sectional sample of KiGGS. The participants of GerES IV lived in 150 sampling locations all over Germany. Field work was carried out from May 2003 to May 2006. The response rate in GerES IV was 77.3%. Due to the fact that participation in GerES IV was limited to children that had previously participated in the KiGGS study, the total response rate in GerES IV resulted in 52.6%. Response rates did neither differ significantly between West and East Germany, nor between different community sizes, age groups and gender. The basic study programme included blood samples, morning urine, tap water and house dust as well as comprehensive questionnaire-based interviews. In addition, subgroups were studied with regard to "noise, hearing capacity and stress hormones", "chemical contamination of indoor air" and "biogenic indoor contamination". A key element of the field work in GerES IV was a home visit to carry out interviews, conduct measurements and collect samples. An exception was blood sampling which was carried out within KiGGS. The quality of field work, data collection, evaluation, and chemical, biological and physical analyses was successfully evaluated by internal and external quality assurance. This comprehensive overview aims at giving other research groups the opportunity to compare different study designs or to adapt their own design to get comparable results.
International journal of hygiene and environmental health 03/2012; 215(4):435-48. DOI:10.1016/j.ijheh.2012.02.002 · 3.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The COPHES network started to test the feasibility of a coherent human biomonitoring (HBM) approach by conducting a Pilot Study (DEMOCOPHES). A prerequisite for a successful implementation of an EU-wide approach is, inter alia, that fieldwork can be conducted in a harmonised way in all participating countries.
To develop a common protocol for fieldwork was a challenging task because country-specific restrictions and
definitions had to be integrated. The developed and harmonized protocols, strategies and scientific tools finally supplied the basis to recruit and examine internal exposure of 120 mother and child pairs to mercury, cadmium, cotinine and phthalates in 17 and BPA in 8 countries.
During the implementation of the protocols in the countries it was revealed that a selection of children via schools was preferred to a selection via inhabitant registries in most countries, and that the definition of the degree of urbanization of the sampling locations had to be country specific. Participation rate in most countries was lower than expected although in several countries a choice between a home or an examination centre visit was offered. Countries only demanded minor changes of the questionnaires provided. Elements for quality control were successfully applied: fieldwork manuals, interviewer training and check-lists for internal and external quality control.
An EU-wide HBM approach is feasible on the basis of a well reasoned recruitment concept and SOPs for all steps of fieldwork. The lessons learned from DEMOCOPHES fieldwork and the respective recruitment help to optimize this approach.
COPHES and DEMOCOPHES are funded by the EU (FP7 244237 and LIFE09ENV/BE/000410).
Keywords: HBM,fieldwork, COPHES, DEMOCOPHES, recruitment, EU-wide, lessons learned
[Show abstract][Hide abstract] ABSTRACT: Production of chemicals, use of products and consumer goods, contamination of food as well as today's living conditions are related to a substantial exposure of humans to chemicals. Safety of human beings and the environment has to be safeguarded by producers and government. Human biomonitoring (HBM) has proven to be a useful and powerful tool to control human exposure and facilitate risk assessment. Therefore, the German Federal Environment Agency (Umweltbundesamt, UBA) employs two major HBM tools, the German Environmental Survey (GerES) and the German Environmental Specimen Bank (ESB). GerES is a nationwide population representative study on HBM and external human exposure, which has, inter alia, been used to identify lead in tap water, lead dustfall, time spent in traffic, and age of dwelling as exposure sources for lead and, thus, to derive risk reduction measures. The ESB is a permanent monitoring instrument and an archive for human specimens. Retrospective monitoring of phthalates and bisphenol A provides a continuous historical record of human exposure in Germany, over the last decades. Additionally it revealed that estimations of human exposure based on production and consumption data may supply misleading information on human exposure. HBM data demonstrated that (a) the use if the restricted isomer di-n-butylphthalat decreased while di-i-butylphthalate levels remained constant and (b) human bisphenol A exposure might be overestimated without monitoring data. The decrease of polycyclic aromatic hydrocarbon-exposure proves the success of German environmental policy after German re-unification. In addition to GerES and ESB UBA is involved in different co-operation networks, the two most prominent of which are (1) the harmonization of HBM in Europe (ESBIO; Expert Team to Support Biomonitoring in Europe, COPHES/DEMOCOPHES; Consortium to Perform Human Biomonitoring on a European Scale/Demonstration of a study to Coordinate and Perform Human Biomonitoring on a European Scale) and (2) the co-operation between BMU and the German Chemical Industry Association (VCI). In the latter project emphasis will be placed on substances with a potential relevance for health and on substances to which the general population might potentially be exposed to a considerable extent and for which HBM methods are not available up to now.
International journal of hygiene and environmental health 12/2011; 215(2):120-6. DOI:10.1016/j.ijheh.2011.10.013 · 3.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Different aspects of the environmental tobacco smoke (ETS) exposure of children in Germany have been investigated in the German Environmental Survey for Children (GerES IV). The field work of GerES IV was conducted from 2003 to 2006 using questionnaires, indoor air monitoring and human biomonitoring. About half of Germany's 3- to 14-year-old children lived in households with at least one smoker. The number of smokers in the household had a significant influence on the concentrations of several indoor air contaminants (VOC and aldehydes). Human biomonitoring data on cotinine were used to identify the levels of exposure to ETS. Urinary cotinine is correlated with several predictors of ETS and is also associated with other toxicants in non-smoking children, e.g. cadmium. Temporal comparison indicated that in the last 15 years no decrease of children's ETS exposure has been achieved in Germany.