Transcript Document

The Correct eMixtures (A fully
validated EHR, the
way forward)
Brendan Delaney
Guy’s and St Thomas’ Charity Chair in Primary Care
Research
Requirements of observational
research
•
•
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•
Data description
Cohort management
Data quality
Data linkage
– Semantic interoperability
– Privacy
– Matching
Requirements of interventional
research
• Feasibility
– Simple via distributed search
– Complex via CPRD
• Recruitment
– Privacy requirements
• Data management
– eSource
• Adverse Event Reporting
What tools exist currently
• Legacy systems
– Electronic Health Record Systems
– Web based data collection forms and CTDMS
– Clinical trial administration systems
• Projects in pilot and deployment
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CPRD Observational research platform
Wellcome Trust eLung and RetroPro
ePCRN
FP7 TRANSFoRm
OBSERVATIONAL RESEARCH
PLATFORM AND INCIDENT CASE
RECRUITMENT
CPRD
• A Primary care clinical data warehouse
• Vision EHR (~20%)
• 600 clinics out 2500 clinics in the UK (out of
10300 clinics)
• provides a good sample UK primary care data
Expanding to other three UK eHR vendors
– 50-60% coverage of UK pop
– More streamlined and daily updates
– Linkage
eLUNG and RETROPRO
• eLUNG: antibiotics vs standard care for COPD
exacerbation
• RETROPRO: comparative study of different
types of statins
• Recruitment at point of care (LEPIS)
• Feasibility studies funded by HTA and
Wellcome Trust
The Approach
• Local autonomous agents to identify potential
participants and facilitate their recruitment
• Interactive agents:
• with the physician
• Non-intrusive to the physician healthcare process
• Can easily be dismissed but yet has memory of GP
actions
• Standardised and vocabulary controlled
• Scalable and highly configurable
Agent-based Technology
Autonomous
• provides configurable flexibility
• adaptive to user requirements
• non-intrusive behaviour
• Asynchronous automation
• agents self-update their knowledge/registry
• configure for performance needs
Overall Architecture
GPRD
warehouse
Clinical trial data
management system
LEPIS
CTMS
LEPIS
Workbench
LEPIS
LEPIS: Local
Eligible Participant
Identification
Service
CCS
SiS
CCS: Central
Control Service
FEASIBILITY AND RECRUITMENT
OF PREVALENT CASES
The electronic Primary Care Research
Network (ePCRN)
 Funded 2004-7 by National Institutes of
Health ‘Roadmap’ Program – pilot.
 Facilitates recruitment by establishing a
secure distributed query process for eHRs to
identify eligible subjects
 Proof of concept interoperable clinical trial
data management system for Primary Care
 NIHR NSPCR, Wellcome Trust (CPRD,
ALSPAC), HTA, EU FP7
Confidentiality and data security
 Confidentiality - for subjects not having
consented to use of their data for research
 Search reports only ‘counts’ - NO DATA is
extracted
 Subjects are flagged locally
 Security
 OGSA-DAI & GTK4(certificates and
authorisation)
Define eligibility criteria
Define the clinical problem semantically
Define further clinical problems, drugs or vital signs
Count eligible community subjects
Research network director approval tool
ADVANCED OBSERVATIONAL
PLATFORM AND EMBEDDED
ELECTRONIC CASE REPORT
FORMS
Existing methods of trial data
management are limited
 No standardization of electronic case report
forms (CRFs), timelines etc.
 No reusability of data elements
 No standardization of data structures
 No automatic linkage of data elements and
data structures
TRANSFoRm Consortium
Aims of TRANSFoRm
• To develop methods, models, services,
validated architectures and demonstrations to
support:
– Epidemiological research using GP records,
including genotype-phenotype studies and other
record linkages
– Research workflow embedded in the EHR
– Decision support for diagnosis
2
Type 2 DM study
• Question: Relationship between SNPs and
response to oral T2DM medication
• Genotype-Phenotype record linkage study
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Privacy model
Record linkage (browsing, selecting, extracting)
Data quality tool
Provenance tool
2
GORD Treatment study
• Question: Effectiveness of on-demand v
continuous PPI
• RCT with event-initiated patient-related
outcome measures
– Trigger within EHR
– Semantic Mediator
– eCRF tool (embedded in EHR)
2
Overall Architecture
End User Tools and Services
Support Services
Middleware (Distributed Infrastructure)
Distributed Nodes
Data source or collection
Care Zone
Non-care Zone
Secondary
data in DB
Primary
data
Data controller:
Primary
data
research
Different national definitions for
personal data, sensitive data,
controller / processor, re-use of
data for scientific purpose
Identifyng data
Private
data
Medical data
Nonidentifiable
Identifiable
data
Genetic
data
Data use
Research Zone
Compatible
use
incompatibl
e use
eSource two models
Discussion
• Ongoing mainly EU-funded projects will
provide a stream of innovations in:
– Computable representations of study designs
– Interoperability
– Data quality
– Privacy, security and provenance
– Workflow
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