1. PEARL Project to Enhance ALSPAC through Record Linkage Kerry Humphries

2. Overview  Summary of ALSPAC  Existing data linkage  PEARL  Benefits of data linkage  Aims/Data sources/Research Governance/Consenting procedure/Pilot study  Beyond PEARL

3. What is ALSPAC? Avon Longitudinal Study of Parents and Children  Established in 1991 by Professor Jean Golding  Cohort study of children and their parents based in the former county of Avon (excluding Bath), England  Original design: “To determine ways in which the individual’s genotype combines with environmental pressures to influence health and development”

4. Study design  Eligibility criteria: Mothers resident in Avon and have an expected date of delivery between 1 st April 1991 and 31 st December 1992  Avon was broadly representative of the UK as a whole and has a relatively stable population  Core sample of 14,541 pregnancies resulting in 14,062 live born children

5. Current sample size  ~ 8500 participated between ages 16- 18  10 000 YP’s attended at least one clinic  Outreach clinics are helping to boost numbers and target young people from socially deprived areas

6. Existing linkage to health and administrative records  Flagging and Tracing data Cancer and Death data Birth records  Education data National Pupil Database (NPD) School and Pupil level data Assessment data (E.g. G.C.S.E’s)

7. Other existing linkage  GIS (Geographic Information System) Geographic location data  Friendship questionnaires Linkage from ALSPAC collected data

8. PEARL

9. Benefits of data linkage in a cohort study  Cost effective  Comprehensive source of data  Obtain data that is less subject to self-report or participation bias  Inform strategies for dealing with missing observations  May help avoid study fatigue

10. PEARL aims  Obtain consent for and establish mechanisms of linkage  Investigate challenges and develop generalisable solutions  Demonstrate the value of linkage-based research  Establish a training programme to share these methods and insights with other researchers

11. Examples of data sources  Health data Patient level primary care and hospital admissions data. Cancer registry.  WPLS (Work and Pensions Longitudinal Study) Employer, benefits and income data  Ministry of Justice Criminal convictions records  GIS (Geographic Information System) Data to inform spatial analyses  Education data National Pupil Database (NPD), Further and Higher Education

12. Research governance Legislation Ethical External Approval Data owners ALSPAC Ethics & Law committee NIGB UoB DPA (ICO) DWP DfE & BIS HMRC MoJ ONS NHS IC Primary Care MCA REC DWP PNC Info Access Panel

13. Safe Haven  Safe Haven governance principals  Approved researchers  Pseudonymised data  Security accreditation ISO 27001 HMG Security Policy Framework

14. PEARL consenting procedure  Ethical approval (LREC)  Qualitative investigation into participants’ understanding and feelings towards data linkage (currently being written up)  Consenting procedure Enrol ALSPAC cohort into the study in their own right now they are adults Send them an enrolment pack consisting of: Invitation letter/Summary leaflet/Detailed information booklet/Consent form (with SAE)

15. Pilot Study  RCT - 2000 young people  Primer postcard (1000)  Main pack (In house and designed)  Reminder 1 postcard  Reminder 2 Phone call/Text Email Postcard

16. Pilot study results so far....  As of 09/06/11 (more consent forms to include) 760 consent forms returned (37%)  Yes to ALSPAC – 720 (95%) Blank – 13 (1%) / No – 27 (4%)  Yes to all data linkage options – 575 (76%)  Mixed response to data linkage options (some yes/some no/some blank – 155 (20%)  No to all options – 30 (4%)

17. Pilot study results so far....  Numbers have dropped off but still receiving 5-10 consent forms a day  Designed packs elicit a quicker response  Telephone reminders had the greatest impact

18. Beyond PEARL  Extend data linkage to: Mothers Fathers Siblings Offspring

19. ALSPAC – Data access  ALSPAC committed to moving towards ‘open access’ solution  Current access arrangements detailed on ALSPAC web site: www.bristol.ac.uk/alspac/sci-com/collab-policy/  www.bristol.ac.uk/alspac Detailed summaries of the resource Data access policy Links to further information

20. PEARL  Bristol John Macleod, George Davey Smith, Andy Boyd, Jonathan Sterne, Matthew Hickman, Andy Ness, Chris Salisbury, Rona Campbell, Sarah Purdy, Paul Gregg, John Henderson, Lindsey Brown, Kate Tilling, Hugh Annett, Dougal Darvill, Glyn Lewis, Anthony Phillips, Jonathan Onslow, Kerry Humphries, Kate Angel  Swansea David Ford, Ronan Lyons  Dundee Frank Sullivan  Leicester Paul Burton, Martin Tobin  Norwegian Institute of Public Health Camilla Stoltenberg  IoP Barbara Maughan  Exeter Peninsula Melvyn Hillsdon  Birmingham/KCL Richard Hobbs, Brendan Delaney, Adel Taweel ALSPAC Strategic Funding: PEARL Funding: