1. EUCCONET International Workshop Bergen, 15th – 17th June 2011 Arild Sunde MoBa Generation Linkage

2. Outline The MoBa Data Linkages we do Generation linkage

3. Questionnaires Responses Q1 (17 weeks)101.600 Q2 (22 weeks)96.700 Q3 (30 weeks)94.300 Q4 (6 months)89.700 Q5 (18 months)66.800 Q6 (3 years)51.400 Q5 (5 years)14.700 Q7 (7 years)14.200 Q8 (8 years)3.300 Q Father (17 weeks)76.700 MoBaFlu15.000

4. Biological Material Full blood EDTA Plasma EDTA RNA (child) DNA Urine (mother week 18) Sample typeCount K11-Blood from pregnant woman, week 1817.509 K12-Blood + Urine from pregnant woman, week 1881.872 K2-Blood from mother after birth86.442 M-Blood from father, week 18 in pregnancy73.314 B- Cord blood from newly born child92.612 Others: A, KA, MA, W23, W292.239

5. MoBaStudy - Generic logistics and LIMS system  Participant administration  Questionnaire dispatchments based on user defined rules  Sample management  Sample retrieval  Communicates with laboratory robots  Reports  Dynamic letters (Merge letters defined by users)  Standard reports  User defined reports  All user interface labels, menus and messages are defined in the database  User rights (visibility, update access) to all interface components are defined in the database  Change/audit log for all database fields  Code 128 Barcode labels for questionnaires, sample tubes, racks, shelves and freezers  MSSQLServer 2005 database  Client application developed in VisualStudio 2005 (.NET/C#)  PDA version for Sample retrievals – PDALab  From 2011: Communication with RTS A4 Sample-Store™  Dual language support  Used by 3 independent studies as of September 2010  Easy setup for new studies

6. MoBaData – Generic questionnaire data management system  Maintains data and metadata for all questionnaires  Linked to MoBaStudy participants by barcode  Automatically create storage tables based on Readsoft Eyes & Hands ™ description files  Automatically create storage tables based on a data files  Track questionnaire versions and linking between versions  Loading data files while controlling record and field structure according to questionnaire definition  Meta data in two languages  Quality control  User rights  Reports  Define, test and modify quality control rules  View questionnaire images and compare to data  View scanned data by marking a field on the image file  Data extraction (shopping list)  Create SAS and SPSS data files with metadata (variable- and value labels)  Tracks data changes  Oracle 11 database  Client application developed in Visual Studio 2005 (.NET/C#)  Easy setup for new studies

7. Linkage key - SSN Since 1964 every citizen of Norway has a unique Social Security number DDMMYY##### Also available to temporary residents, work permit holders etc. XML message sent from hospital after birth Used for all records; bank, school, insurance, hospitals etc.

8. Norwegian Population Registry-DSF SSN, and history Mother’s and father’s SSN Date of birth Name, and history Maiden name Address, and history Address code Maritial status Live status

9. Keep track of individuals Mother’s SSN from hospital ultra sound lists Father’s SSN from consent form Child’s name from linkage to DSF and Medical Birth Registry-MFR Mothers and fathers SSN Expected date of birth -160, +30 days Monthly updates from DSF Store changes of all fields in our database

10. Linkages Routine link for quality control and updates DSF, MFR Included in the consent MFR located here Local copy of DSF Project specific linkages Researchers order MoBa Data linked to their data or other registries Requires application to the Regional Ethical committee Information letter must be sent to participants

11. We receive data with SSN. Link and add MoBa data. We send our participant’s SSN with an ID and get back data for the participants and add MoBa data We send our participant’s SSN with an ID to a registry. The registry identifies the candidates. The registry and we send data for the candidates with the same ID to the researcher Each data source pseudonymised before linkage A third party does the linkage. Direct access to the data for linkage Data sent to researchers is always deidentified or anonymized Ways we link to other registries

12. National Population Registry Medical Birth Registry National Twin Registry Norwegian Patient Registry Cause of Death Registry Norwegian Prescription Database Norwegian Cancer Registry MIDIA NewGeneris And many more...

13. Generation linkage MoBa–Norwegian Mother and Child Cohort 100000 participating pregnancies 11+ questionnaires, avg. 16 pages 20000 variables Biological material ( Blood, DNA,RNA,plasma,Urin) MBR-Norwegian Medical Birth registry Started 1967 Information about mother’s health before and during pregnancy, smoking, use of folic acid, occupation, use of medication, diabetes, epilepsy, information on the birth, procedures and information on the child Mother, father and child’s unique SSN

14. Aim Affects of previous generation’s and siblings sicknesses Affects of heredity and environment What is linked All MoBa participants’ questionnaires and MBR record are linked to all siblings MBR record, and each of the parents MBR records.

15. Gives us health information about: MoBa children Both parents Grandparents Full and half siblings Consent and reservation Linkage of participant to MBR is included in the MoBa consent form Linkage to siblings and parents required application to the Regional Ethical committee Written information had to be sent to all participants Option for reservation against the linkage (total of 35) Data anonymized after linkage

16. Deterministic linkage Both MoBa and MBR contains SSN of the child, mother and father (if available) The National Population Registry used for cross checks Requires 100% match on SSN

17. Results 108255 participating children with MBR birth record 77683 mothers with MBR birth records 68424 fathers with MBR birth records 84682 non participating siblings from mother 14718 non participating siblings from father 12585 mothers with no MBR birth record 21361 fathers with no MBR birth record

18. Each person was given a role: Child: Participating child Mother: Mother of a participating child Father: Father of a participating child Sibling: Sibling of a participating child

19. Roles RoleCount Child 73174 Mother 90007 Father 89636 Sibling 99356 Child/Sibling 35037 Mother/Sibling 222 Father/Sibling 110 Mother/Father 2