concept for a german environmental health birth cohort design and feasibility issues schmidt b,...

Concept for a German Environmental Health

Birth Cohort

Design and Feasibility Issues

Schmidt B, Moebus S, Lösch C, Pieper C, Hoffmann B, Andrich S, Schulz C, Seiwert M, Kolossa-Gehring M, Jöckel K-HInstitute for Medical Informatics, Biometry and Epidemiology

University Hospital of Essen, 2011

2Institute for Medical Informatics, Biometry and Epidemiology University Hospital of Essen, 2011

Objectives

Developing a concept for a German Environmental Health Birth Cohort for the Federal Environment Agency (Umweltbundesamt)

Broad range of environmental health problems

With regard to socioeconomic aspects and migration

Individual exposure assessment, e.g. human biomonitoring

Detection of gene x environment interactions

Current German birth cohorts are medium-sized and focus on special aspects of child health


Developing a concept for a German Environmental Health Birth Cohort for the Federal Environment Agency (Umweltbundesamt)

Broad range of environmental health problems

With regard to socioeconomic aspects and migration

Including Human Biomonitoring

Interaction between genes and environmental risk factors

Current German birth cohorts are medium-sized and focus on special aspects of child health

Large scale birth cohort study needed,100 000 to 200 000 participants,build as a platform for future research.

Objectives


Review of existing birth cohort studies

First idea for design issues and framework

Generating possible research questions1. expert

meeting

Determining design and main research questions

Developing the exposure and outcome assessment 2. expert

meeting

Elaboration of the overall concept

Progress to Date


Main Research Issues

1. The Impact of Environmental Pollutants and Noise on Neurodevelopment and Cognitive Abilities

2. The Impact of Endocrine Disruptors on Reproductive Development

3. The Impact of Environmental Pollutants on Pregnancy and Birth Outcomes

4. The Impact of Indoor/Outdoor Air Pollution and Inhalation Allergens on Asthma, Allergy and Wheezing

5. The Impact of Environmental Pollutants on Obesity, Insulin Resistance and Diabetes


Chemical exposures:e.g., organic/inorganic chemicals, air pollutants, …

Physical exposures:e.g., housing/neighborhood characteristics, noise, …

Biological exposures: e.g., allergens, bacteria, infections, …

Genetics:e.g., DNA, gene expression, ...

Psychosocial exposures: e.g., demographics, family support, health behavior, …

Exposure Measurements


Exposure Measurements

biospecimens: blood, urine, breast milk, cord blood, placenta, meconium, nails/hair, … Pilot study for perinatal sample collection and biobanking

indoor/outdoor air pollution: allergens, particulate matter, volatile organic compounds, … Detailed exposure assessment in subgroup via home visits

noise: noise maps, models and questionnaires, … Detailed noise assessment in subgroup


Recruitment Strategy

Recruitment early in pregnancy ( 1st trimester)

Also: Enrollment at different stages during pregnancy and even shortly after delivery

Therefore: Multimodal approach via gynecologists, prenatal care providers, maternity wards……but also pharmacies or public institutions

Incentives and PR tools needed to make the participant’s benefit clear


Selection of study locations should be based on:

socioeconomic characteristics environmental characteristics demographic characteristics

Also needed: Study centers with experience in

recruitment

taking The German National Cohort into account

Study Locations

JenaMarburg

Augsburg

RegensburgSaarland

Bochum

Münster

Essen

Heidelberg

Mannheim

Freiburg

Leipzig

Halle

BerlinBrandenburg

NeubrandenburgBremen

Hamburg

Hannover

Braunschweig

Kiel

Bonn

Lübeck

Düsseldorf

München

Ludwigshafen

Greifswald


Sample Size

50.000100.000

200.000500.000

0.5%

5%

10%

0

0,2

0,4

0,6

0,8

1

1,2

1,4

1,6

1,8

2

Od

ds

Ra

tio

Cohort Size

Minimal Detectable OR for Environmental Factor

Prev

alen

ce

Autism, Thyroid Dysfunction, Metabolic Syndrome

ADHD, Asthma

Impaired Neurodevelopment, Atopic Dermatitis, Obesity

Design: nested case-control study (case:controls = 1:4)Frequency of environmental exposure: 10%


Data Collection Schedule Pregnancy

1. First trimester 10-12 GW * Medical examinations+ diaries + contacting father+ biol. specimens

Only in subgroup: Home visit to collect environmental samples Home visit

2. Second trimester 22-24 GW * Phone+ bring-in biol. specimens

3. Third trimester 34-36 GW * Medical examinations+ biol. specimens

Birth4. Birth Medical examinations

+ medical records+ biol. specimens

5. First week of life * Questionnaire+ Medical records

* Handing out questionnaires, diaries and contacting father in the case of late enrollment

phone or mail-in questionnaire

health care professional or study center

home visit


Data Collection Schedule Child Development

6. Age 1 Month Questionnaire+ bring-in biol. specimens

7. Age 3 Month Questionnaire

8. Age 6 Month Questionnaire+ bring-in biol. specimens

9. Age 12 Month Medical examinations+ biol. specimens

Only in subgroup: Home visit to collect environmental samples Home visit

10. Age 24 Month Questionnaire

11. Age 3 Years Medical examinations+ biol. specimens

12. Age 4 Years Questionnaire

13. Age 5 Years Questionnaire

14. Age 6 Years Medical examinations + biol. specimens

Follow-up through age 18


Implementation

Evaluation

Full study

Evaluation

Continuing Protocol Development

Evaluation

Update of study planDeveloping study protocol

Feasibility study AFeasibility study BFeasibility study ...

Feasibility studies to explore, e.g., …

…effective strategies to recruit and retain participants.

…cooperation with local health care providers and community-based organizations

…improving response through incentives and public relations

Study Timeline

Start 1. year 2. year 3. year 4. year

Update of study protocol


Next Steps

Announcing the study locations

Feasibility studies in the near future

Expert group for Ethics and Privacy Protection


Acknowledgements

N. Berger, U. of WürzburgK. Birmingham, U. of BristolT. Dwyer, MCRIR. Fehr, LIGA.NRWM. Flechtner-Mors, U. of UlmJ. Genuneit, University of UlmW. Göpel, University of LübeckJ. Golding, University of BristolD. Grabow, KinderkrebsregisterE. Hamelmann, Ruhr-U. BochumT. Harder, UM BerlinJ. Heinrich, Helmholtz C. MunichS. Hirschfeld, ENICHD

U. Ranft, University of Düsseldorf

U. Ravens-Sieberer, UMC Hamburg-E.

O. Razum, University of BielefeldM. Schlaud, Robert-Koch InstituteC. Sommerfeld, BfRK. Stark, Robert-Koch InstituteR. Thyrian, University of GreifswaldH.-E. Wichmann, Helmholtz C. MunichA. Wiesel, University of MainzG. A. Wiesmüller, U. of MünsterB. Wolz, BMUM. Wilhelm, Ruhr-U. BochumI. Zöllner, LGA Ba.-Wü.

A. Hofman, EMC Rotterdam

C. Hornberg, U. of Bielefeld

M. Kersting, FKE Dortmund

W. Kiess, University of Leipzig

F. Klasen, UMC Hamburg-Eppend.

U. Krämer, U. of Düsseldorf

M. Kreuzer, BfSB.-M. Kurth, Robert Koch InstituteK. von Mühlendahl, GAPAMM. Nieuwenhuijsen, CREALA.-M. Nybo Andersen, U. of CopenhagenH. Pohlabeln, BIPS

Federal Environment Agency of Germany (Umweltbundesamt):A. Gieß, M. Kolossa-Gehring, C. Schulz, M. Seiwert

Exposure and outcome assessment for main research issues:R. von Kries, University of MunichW. Ahrens & T. Behrens, University of BremenM. Schmidt, University of Duisburg-EssenS. Lau, University Medicine BerlinA.-G. Ziegler & C. Winkler, Helmholtz Center Munich


Sample Size

50.000100.000

200.000500.000

0.5%

5%

10%

0

0,2

0,4

0,6

0,8

1

1,2

1,4

1,6

1,8

2

Od

ds

Rat

io

Cohort Size

Minimal Detectable OR for GxE Interaction

Autism, Thyroid Dysfunction, Metabolic Syndrome

ADHD, Asthma

Impaired Neurodevelopment, Atopic Dermatitis, Obesity

Design: embedded case-control study (case:controls = 1:4), interaction on multiplicative scale

Risk allele frequency: 10%Environmental exposure: 10%Genetic OR = 1.2 Environmental OR = 1.5

concept for a german environmental health birth cohort design and feasibility issues schmidt b,...

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