Translational Research and Patient Safety in Europe TRANSFoRm: Requirements analysis for the learning healthcare system

Translational Research and Patient Safety in Europe

TRANSFoRm: Requirements analysis for the learning

healthcare system.


SAFER CLINICAL PRACTICE

MORE RESEARCH EVIDENCE

TRANSFoRm-INTEGRATION-INTEROPERABILITY-SERVICES

KNOWLEDGE TRANSLATION

EPIDEMIOLOGICAL STUDIES AND RCTS

The learning healthcare system


Demonstration and dissemination

User requirementsDevelopment andEvaluation

WP7SYSTEMS AND SERVICES FOR DATA INTEGRATION

WP 1RESEARCH USE CASES

WP 2PATIENT SAFETY USE CASE

ICT

WP8DEMONSTRATION

INDUSTRYCONTRACT RESEARCHORGACADEMIA

WP9DISSEMINATION

WEBSITEPUBLICATIONWORKSHOPSPROTOTYPESCOLLABORATIONINFRASTRUCTURETECHNOLOGY PLATFORMS

WP10 MANAGEMENT


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?


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]


PPI consumptionAgeGenderBMINSAID/ASA

Matched controls

IdentificationIdentification

Reported cancer cases

Research database

eHR

Population registry

Cancer registry

IdentificationIdentificationTracking -10 yrsTracking -10 yrs

Drug registry

PPI

Option 2: Case control studyOption 2: Case control study

GERD Case-control study


eCRF0PHCPHC

WebWeb

eCRF EVENT DRIVEN eCRF12eCRF-.5

Wash outPPI testRandomization

Verification

Q0 Q3 Q6 Q9 Q12Q-.5

eCRFeCRF Data collection

GERD RCT


Overall requirements tableRequirement 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


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


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


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


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


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


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


Web questionnaire

Database (personal)

eHR

Data extraction

GPGP

Other databases

CRF

Database (anonymous)

ResearcherResearcher

Functional eCRF tool


PatientPatient GPGP

Web questionnaire

eCRF

Database

eHR

reminders

alarm alarm

Data extraction

ResearcherResearcher

Other databases

Database managerDatabase manager

Subject portal for PROM


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


Documents

Translational Research and Patient Safety in Europe TRANSFoRm: Requirements analysis for the learning healthcare system