Large Danish birth cohorts -- what have we learned?
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1 Large Danish birth cohorts -- what have we learned? Opportunities and collaboration Ellen Aagaard Nøhr Professor & midwife Dep. D Gynaecology & Obstetrics eanohr@health.sdu.dk
2 European Birth Cohorts: size vs details vs age Aarhus Birth Cohort & Biobank The Danish National birth Cohort
3 3 Outline For both cohorts Background Data collections Short on research Organization and data access Lessons learned, advise & collaboration
4 Aarhus Birth Cohort (ABC) Ongoing data collection Background Unselected cohort of pregnant women. Established in 1989 Initially only intended as a data collection for 2 PhD-projects. Purpose Research cohort Administrative purposes Quality assessment 4
5 5 Aarhus Birth Cohort (ABC) Data collection
6 Aarhus Birth Cohort (ABC) Data collection Questionnaire data 100,000+ pregnancies 5,000 deliveries per year. Completed in early second trimester. Changing research focus over time. Maintained core questions. Under revision: Postal web-based. Participation rate: 95% % -----? %.
7 ABC Biobank ? Pregnant women, fathers to be, and newborns: Invitation sent with postal questionnnaire Samples collected at early ultrasound at week 12 (48 ml & 4 ml). High quality processing within 2 hours Umbilical cord samples at birth (10 ml + tissue). High quality processing with 24 hours App families recruited per year 12,500 families % complete families.
8 Research 150 scientific papers and 20 PhD theses Epidemiological studies of preterm birth, SGA, survival, neonatal morbidity Biomarkers linked with cohort data. RCTs nested in the cohort. ABC
9 Research 150 scientific papers and 20 PhD theses Epidemiological studies of preterm birth, SGA, survival, neonatal morbidity Biomarkers linked with cohort data. RCTs nested in the cohort. ABC Ongoing FETOTOX project Grant from Danish Council for Strategic Research Persistent organic pollutants and fecundity, growth, and child development. Cohort paper: Data Resource Profile: The Aarhus Birth Cohort Biobank (ABC Biobank).Int.J.Epidemiol. (2013) 42 (6): ABC Biobank
10 Organization and data access Owned by Institute of Clinical Medicine, Aarhus University Hospital. Executive committee ABC Application form at institute website: ge-specialer/gynaekologi-ogobstetrik/afdy/research/internalinformation/perinataledatabaser/ Tine Brink Henriksen Professor, neonatologist Niels Uldbjerg Professor, obstetrician Payment for data extraction costs. Advised to include researchers confident with data.
11 Organization and data access Collaboration between Institute of Clinical Medicine & Department of Public Health. Executive committee ABC Biobank Tine Brink Henriksen Niels Uldbjerg Bodil Hammer Bech Jørn Olsen Ellen Aagaard Nøhr Guidelines for costs & application available Entrance fee + fee per sample + costs for extraction.
12 Lessons learned Lack of money, money, money. Discount solutions with impact on data quality. Few employed in short periods ---- lack of continuity --- double work. No ressources for follow-ups. Cohort survived due to a few doctors hard voluntary work. Tine Brink Henriksen Advice Well-established organization from the beginning Plan for running costs & well-functioning administrative team. Well-defined procedures for data access, prize & coauthor-ship. Frequent, detailed follow-ups: Growth, physiological measures, validated scores & tests, diaries. Focus on frequent outcomes & markers of physical/mental/cognitive function.
13 The Danish National Birth Cohort DNBC Background A research database of exposures In utero Early childhood To examine later risk of disease, ideally from conception until death. 100,000 women recruited in early pregnancy years financial support from the National Research Foundation ( ) and other large grants. 13
14 Main data collection Birth First interview Second interview Third interview Fourth interview Pregnancy Infancy First visit at family doctor 16 weeks 30 weeks ½ year 1½ year Blood samples: Women/newborns. Nutritional questionnaire week 24. Pregnancy outcomes: National Discharge Register The Birth Register
15 Ongoing linkage to Danish health registries and the civil registration system.
16 16 Initial data collection Web-based %
17 DNBC Biobank Situated at Statens Serum Institut, Copenhagen. 2 blood samples from the pregnant woman taken by GPs. 10 ml at gest. week 10: samples 10 ml at gest. week 26: samples 10 ml umbilical cord blood at birth: samples Taken in EDTA tubes and sent by ordinary mail. Transportation time to Copenhagen: 4 hours 48 hours. After arrival at Staten Serum Institute, divided into 5 fractions: 4 whole blood spots on filter paper 3 x plasma 1 x buffycoat
18 Research 314 publications (May 2014). Mainly epidemiological studies: Pregnancy outcomes Child & maternal health Life course approach Biomarkers Genetics, epigenetics Many international collaborations
19 Organization Steering committee (independent of research). Management committee: Jørn Olsen Leader Mads Melbye Anne Marie Nybo Andersen Sjurdur F. Olsen Peter Aaby Ellen Aagaard Nøhr Administrative team (5-6 persons) Data collections and contact with participants at Statens Serum Institut. Datamanagement and database at Aarhus University.
20 Data access An open data source Researchers (worldwide) have free access to reusable data through a VPN connection. All project applications must be approved by the DNBC management & the Steering committees. Normally, no inference with proposed research. Low prize: Only payment for data extraction & VPN connection. Data funded by public money. To make the best use of data. Access to biological samples is restricted. Max 0.1 ml can be applied for. 50% of blood to be kept beyond age 18. See more on
21 Lessons learned & advice Open data source is an important principle. Prioritize well-documented data and independent evaluation committee. Nearly impossible to raise funding for general follow-ups and infrastructure. Be affiliated to institution or grant structure devoted to longterm commitment. Benefit from manageable size and being locally based. Follow-ups are affordable. Access to hospital & municipal facilities. Frequent, detailed follow-ups with clinical examinations. High demand on biological material Just collect as much as possible at baseline and during follow-up.
22 Opportunities for collaboration Establish strong national collaboration across cohorts --International collaboration difficult due to different legislation & data collection. Discuss best strategies for biological material: collection, storage, and access. Collaboration in specific research projects Allows precursor studies to be followed by hard endpoint studies
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