TRANSFoRm: Requirements analysis for the learning healthcare system.

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TRANSFoRm Requirements analysis for the learning
healthcare system.

• Brendan Delaney,1 Paul vanRoyen,2 Adel Taweel,1
  Lars Agreus,3 Mark McGilchrist,4 Robert Verheij,5
  Wolfgang Kuchinke,6 Theo Arvanitis,7 on behalf of
  the TRANSFoRm Consortium.
• 1Kings College London, UK 2University of
  Antwerp, Belgium, 3Karolinska Institutet, Sweden,
  4Univesity of Dundee, UK, 5NIVEL, The
  Netherlands, 6University of Dusseldorf, Germany,
  7University of Birmingham, UK.
• www.transformproject.eu
• TRANSFoRm is partially funded by the European
  Commission  - DG INFSO (FP7 247787)

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The learning healthcare system
EPIDEMIOLOGICAL STUDIES AND RCTS
KNOWLEDGE TRANSLATION
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Demonstration and dissemination
User requirements Development and Evaluation
ICT
WP7 SYSTEMS AND SERVICES FOR DATA INTEGRATION
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Diabetes use case research questions

• RQ1 Are well selected single nucleotide
  polymorphisms (SNPs ) in T2D patients associated
  with the development of complications as coronary
  artery disease and retinopathy in a sample of at
  least 10.000 subjects from the European Union
  population?
• RQ2 Are well selected single nucleotide
  polymorphisms (SNPs) in T2D patients associated
  with variations in drug response to oral
  antidiabetics?
• RQ3 Which genetic markers (SNPs) are associated
  with T2D related complications as diabetic
  nephropathy?

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GERD research questions

• What is the association between the development
  of esophageal carcinoma and length of GERD
  history/ PPI use?
• Case-control study
• What is the effectiveness of on demand v
  continuous use of PPI in GERD?
• RCT

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GERD Case-control study
Option 2 Case control study
Identification
Identification
Tracking -10 yrs
Cancer registry
Drug registry
Reported cancer cases
PPI
eHR
Population registry
PPI consumption Age Gender BMI NSAID/ASA
Matched controls
Research database
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GERD RCT
PHC
eCRF0
eCRF EVENT DRIVEN
eCRF12
eCRF-.5
eCRF
Verification
Data collection
Web
Q0
Q3
Q6
Q9
Q12
Q-.5
Wash out PPI test Randomization
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Overall requirements table
Requirement Note Use case
Authorisation Explicit or general Cohort and case-control, RCT
Consent Informed or explicit Cohort and case-control, RCT
Linked phenotype Maintained and refreshed Cohort and case-control
Genetic data Browsing and selection Cohort and case-control
Recruitment Embedded real-time in eHR, manages contact and consent Cohort and RCT
eCRF A functional tool rather than an CTDMS Cohort and RCT
Research subject portal Patient Related Outcome Measures Cohort and RCT
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Modeling Consent

• Consent for entry into an RCT requires informed
  consent
• Consent for re-use of data requires explicit
  consent
• Therefore
• Potentially eligible subjects become research
  subjects after consent
• Two different types of consent are needed

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Authorization

• Control of release of data is encapsulated in a
  functional zone model in order to clarify the use
  and access to different types of data
• Consent and authorization are used to control the
  flow of data

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Rapid phenotyping

• The system needs to support
• Rich semantic queries of the target data
• Assembly of a cohort
• Repeat data collection from this cohort by
  tracking and updates at time intervals specified
  in the study protocol

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Access to genotype

• Access to SNP data for the selected cohort
• Linkage of phenotype data with SNP data for same
  patients using pseudonymzation
• Browsing and extraction of available SNPs for
  analysis
• Protection mechanisms for vicarious identification

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Real time recruitment

• Crucial to incident case recruitment
• Embedded within/alongside the eHR
• Standards-based plug and play
• Integration with clinical workflow
• Requires EN/ISO13606 to integrate detailed
  clinical models and archetypes
• Business model

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Recruitment service

• For prevalent case recruitment
• Can be based on asynchronous rather than
  synchronous services
• May incorporate a data warehousing solution
• May involve data linkage

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Functional eCRF tool
Web questionnaire
eHR
Other databases
Data extraction
Database (personal)
CRF
GP
Database (anonymous)
Researcher
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Subject portal for PROM
Patient
GP
Database manager
alarm
reminders
alarm
alarm
Web questionnaire
eCRF
eHR
Other databases
Data extraction
Database
Researcher
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Current progress

• Use case development
• Experimental background to DSS
• Survey of network capacity and IT resource
• Model of data comparability
• Legal and ethical survey
• Provenance framework
• Security Framework
• QA Framework

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