The Correct e-Mixtures (A fully validated EHR, the way forward)

Brendan Delaney

Guy’s and St Thomas’ Charity Chair in Primary Care Research

Requirements of observational research• 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• 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 ArchitectureGPRD warehouse

CTMS

CCS

LEPIS

LEPIS

LEPIS

SiS

Workbench

Clinical trial data management system

LEPIS: Local Eligible Participant Identification Service CCS: Central

Control Service

Feasibility and recruitment of prevalent cases

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

The electronic Primary Care Research Network (ePCRN)

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

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Type 2 DM study

• Question: Relationship between SNPs and response to oral T2DM medication

• Genotype-Phenotype record linkage study– Privacy model– Record linkage (browsing, selecting, extracting)– Data quality tool– Provenance tool

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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)

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Overall Architecture

Distributed Nodes

Middleware (Distributed Infrastructure)

End User Tools and Services

Support Services

Data source or collectionCare Zone Non-care Zone

Primary data

Primary data

Secondary data in DB

Data use

Research ZoneCompatible

use

incompatible useIdentifiable

dataGenetic

data

Medical dataNon-

identifiable

Data controller:Different national definitions for personal data, sensitive data, controller / processor, re-use of data for scientific purpose

research

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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