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Cross-jurisdictional data linkage of Commonwealth data
The experience of the VALiD project
Katherine DuszynskiDiscipline of Paediatrics, UNIVERSITY OF ADELAIDE
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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
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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
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Vaccine Assessment using Linked Data (VALiD) Safety Study
STUDY 2Effectiveness &
efficiency of linkage vs. passive & active
surveillance
STUDY 1Trialling the
feasibility of data linkage at a national
level
STUDY 3Feasibility of
obtaining consent (RCT opt-on/opt-off
consent mechanisms)
STUDY 4Legal 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
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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
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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
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SAVeS
• 700,000 ACIR records linked with 174,000 admission & ED records from 2 major SA paediatric hospitals
• Childhood vaccination and convulsions, ITP & asthma
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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)
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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 – 1st linked dataset (ACIR-NDI)– 2nd linked dataset (ACIR-hospital datasets), pending
approval acquisition
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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
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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
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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
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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
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Policy constraints
• Additional conditions of data use & access– Accredited integrating
authority for linkage AIHW, ABS
– Data access & storage• Remote access
computing environment SURE
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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
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Cost
Category $
Commonwealth ACIR dataset provision $11K
Jurisdictional data extraction & processing* $0-35K
AIHW data linkage services $21-40K
SURE workspace, access & dataset storageProject 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
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Timeline
20132012 20142011201020092008
(May) A
CIR data extracted, (Ju
n) data transfe
r
to AIHW, (Oct) fi
rst data lin
kage attempt
(Jun) A
CIR data reissue, (A
ug) linkage repeated
Remaining Jurisd
ictional Ethics Approvals s
ecured
(Oct) First
linked dataset tr
ansferre
d to SURE
(Aug) Consultation commenced
(May) Cmwlth
Ethics Approval
(Apr) Cmwlth
Public Interest Certificate granted
(Dec) AIHW Ethics A
pproval
(Nov) Meeting of re
levant Cmwlth
agencies
(Apr) 1st J
urisdictional Ethics A
pproval
(Nov) First Ethics A
pplication submitted
Commonwealth approval 3.75 years
ACIR data transfer to
AIHW1 year
Linkage & outcome
data integration
1.2 years
Transfer to SURE
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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
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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
