1. 1 Cross-jurisdictional data linkage of Commonwealth data The experience of the VALiD project Katherine Duszynski Discipline of Paediatrics, UNIVERSITY OF ADELAIDE

2. 2 Acknowledgements Funding support: This research was supported under Australian Research Council's Linkage Projects funding scheme (Project number LP0882394). Additional financial and/or in-kind support was provided by the following organisations: – South Australian Department of Health, – New South Wales Department of Health – Surveillance of Adverse Events Following Vaccination in Victoria (SAEFVic) at the Royal Children’s Hospital (Victoria) and – the Australian Paediatric Surveillance Unit (APSU) at the Children’s Hospital at Westmead (NSW). Chief investigators: A/Prof. Mike Gold, Prof. Annette Braunack-Mayer, Prof. Philip Ryan, Dr Lee Taylor, Maureen Watson, A/Prof. Jim Buttery, Prof. John McNeil, A/Prof. Jane Fremantle, Prof. Colin Thomson, Prof. Elizabeth Elliott, Prof. Paul Effler, A/Prof. Peter Richmond, A/Prof. Stephen Lambert. Project team: A/Prof. Mike Gold, Prof. Annette Braunack-Mayer, Prof. Philip Ryan, Katherine Duszynski, Dr Jesia Berry & Dr Vicki Xafis. Vaccine Assessment using Linked Data Safety Study

3. 3 Vaccine safety surveillance: Can and should we link data at a national level?  Identifying & assessing adverse events following immunisation (AEFIs) Vaccine Assessment using Linked Data Safety Study

4. 4 Vaccine Assessment using Linked Data (VALiD) Safety Study STUDY 2 Effectiveness & efficiency of linkage vs. passive & active surveillance STUDY 1 Trialling the feasibility of data linkage at a national level STUDY 3 Feasibility of obtaining consent (RCT opt-on/opt-off consent mechanisms) STUDY 4 Legal and ethical aspects of consent (Theoretical & empirical)  Relative effectiveness & efficiency of data linkage compared with passive surveillance  Is informed consent is legally, ethically & technically required for vaccine safety data linkage?  Recommendations regarding use of data linkage as a vaccine safety assessment mechanism BASED ON PROJECT DATA, CITIZENS’ JURY DECIDES Objectives To explore the feasibility of linking Commonwealth and State health data from different jurisdictions To examine the community acceptability of data linkage for vaccine safety To examine the ethical and legal barriers of data linkage for vaccine safety

5. 5 Background Benefits of vaccination well-established Vaccination universally recommended & administered to healthy individuals including, vulnerable populations, e.g. children,newborns, pregnant women, elderly Low tolerance of risk from a vaccine reaction Loss of confidence in vaccines Decrease in coverage Resurgence in vaccine preventable disease

6. 6 Background At time of licensure, safety information is incomplete Risks of vaccination – Post-licensure vaccine safety assessment through recognition of ‘side- effects’ (AEFI) Australia’s approach to AEFI reporting - ‘passive surveillance’ – Limitations  non-mandated, incomplete/varied report detail, inability to identify eligible population, stimulated reporting (disproportionate rate reporting) Alternate mechanism for AEFI identification: – linking administrative data collections e.g. hospital admissions and immunisation registries

7. 7 SAVeS 700,000 ACIR records linked with 174,000 admission & ED records from 2 major SA paediatric hospitals Childhood vaccination and convulsions, ITP & asthma

8. 8 Data sources for linkage Australian Childhood Immunisation Register National Death Index (NDI) Integrated South Australian Activity Collection Emergency Department Data Collection Hospital Morbidity Data Collection Emergency Department Data Collection Admitted Patient Data Collection Emergency Department Data Collection Victorian Admitted Episodes Dataset Victorian Emergency Minimum Dataset Hospital Admitted Patient Data Collection Emergency Department Information System 12 data sources: ACIR - Childhood immunisations National mortality data (NDI) Jurisdictional hospital separations & ED presentations data (5 states) Two linked datasets: 1.ACIR – NDI (1999-2010) 2.ACIR – hospital separations/ED presentations (2003-2013)

9. 9 Achievements Acceptability study components – RCT (n=1,129 parents) of opt-in vs opt-out consent for vaccine safety surveillance using data linkage – Health Monitor CATI survey (n=2,002), collating community views on vaccine safety – In-depth interviews (n=26), values and beliefs regarding data linkage and related ethical issues – Citizens’ jury (‘Under what circumstances is it acceptable to link data for the purposes of vaccine safety surveillance’) Feasibility study – 1 st linked dataset (ACIR-NDI) – 2 nd linked dataset (ACIR-hospital datasets), pending approval acquisition

10. 10 Key findings – acceptability, consent… Acceptability – Strong public support for vaccine safety surveillance using data linkage (94-96%) Consent – Preference for minimal consent (opt-out 40%, no consent 30%) vs opt-in (24%) Privacy protection – High confidence in privacy protections being adequately enforced (75-88%) Prioritising -Public benefit of vaccine safety assessment outweighs need for consent

11. 11 Complexities of achieving a national integrated vaccine safety dataset Key questions – Who controls the data? – What processes are required for access? – What policies constrain data availability/accessibility? – Are there any technical restrictions to datasets or data linkage methodology? – What is the cost? Healthcare provision – national vs State responsibilities – 8-9 jurisdictions Governance Procedural/ Access Policy Technical issues Cost

12. 12 Governance Australian Childhood Immunisation Register – Legislative protections e.g. Privacy Act, Health Insurance Act – Operational & administrative agency review – Policy authority – Public Interest Certificate (secured in April 2012) National Death Index – Legislation (AIHW Act) – Data custodian oversight Jurisdictional data collections – State-specific privacy and health information statutes – Data custodian oversight – Executive health approval

13. 13 Jurisdictional procedural/access approvals Approval process – Multiple agencies – Multi-layered (Jurisdictional) Expression of interest/Draft Application for Data Formal Application For Data – Data custodian in-principle support, – Technical feasibility endorsement form jurisdiction Ethical approval – Waiver of consent & approval for secondary data use – 12 ethics applications Ancillary approvals e.g. Medicare External Requests Review Committee, Local Area Health Service Executives, Data Integration Risk Assessment Institutional & researcher agreements Commonwealth confidentiality poll

14. 14 Policy constraints Additional conditions of data use & access – Accredited integrating authority for linkage  AIHW, ABS – Data access & storage Remote access computing environment  SURE

15. 15 Technical/methodological limitations Jurisdictional dataset variations: – No national identifier – Limitations in available data identifiers required for linkage e.g. minimal in Vic, SA ED – Date range of available identifiers e.g. WA 1970 (public), QLD 1995 (public), SA 2003 – Minimum data set (variable) differences – Sensitive variables e.g. hospital identifiers, full DOB – Restricted access to analysis variables e.g. postcode vs SLA/SEIFA Data linkage methodology – Commonwealth & jurisdictional differences in linkage process Variations on best practice methodology for data linkage Jurisdictional preference for direct provision of analysis data to SURE

16. 16 Cost Category$ Commonwealth ACIR dataset provision$11K Jurisdictional data extraction & processing * $0-35K AIHW data linkage services$21-40K SURE workspace, access & dataset storage Project establishment fee User access fee ($1,000-$4,000) ** Project maintenance fee (year 2 onwards) Archive (data retention) $19K $5K $1-4K/year $2K/year $80-120/year Project personnel? * Cost determined by no. of datasets, individuals, study date range & new **Cost depends on level of access required, size of linked dataset, number of users. Estimated cost for VALiD (excluding personnel) = $134,000

17. 17 Timeline 2013 2012 2014 20112010 20092008 (May) ACIR data extracted, (Jun) data transfer to AIHW, (Oct) first data linkage attempt (Jun) ACIR data reissue, (Aug) linkage repeated Remaining Jurisdictional Ethics Approvals secured (Oct) First linked dataset transferred to SURE (Aug) Consultation commenced (May) Cmwlth Ethics Approval(Apr) Cmwlth Public Interest Certificate granted (Dec) AIHW Ethics Approval (Nov) Meeting of relevant Cmwlth agencies (Apr) 1st Jurisdictional Ethics Approval (Nov) First Ethics Application submitted Commonwealth approval 3.75 years ACIR data transfer to AIHW 1 year Linkage & outcome data integration 1.2 years Transfer to SURE

18. 18 Summary of key issues Opaque Commonwealth approval process Involvement of multiple Commonwealth agencies Convoluted & layered authorisation process Multiple ethics approvals Ancillary approvals and agreements Policy directives: appointed data linkage agency (AIHW) & data curating facility (SURE) Dataset & linkage process variations

19. 19 Recommendations Development of alternative models to facilitate data linkage approvals, circumventing transactions with multiple ‘brokers’ Ethics harmonisation for linkage studies Establish a research/surveillance focused unique identifier Establish a national minimum dataset for linkage Legislation mandating collection of serious and selected AEFIs

20. 20 michael.gold @adelaide.edu.au katherine.duszynski@adelaide.edu.au. Contact