Transcript Document

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.
1King’s
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.
TRANSFoRm is partially funded by the European Commission - DG INFSO (FP7
247787)
Translational Research and Patient Safety in Europe
The learning healthcare system
SAFER CLINICAL
PRACTICE
KNOWLEDGE
TRANSLATION
TRANSFoRm
-INTEGRATION
-INTEROPERABILITY
-SERVICES
EPIDEMIOLOGICAL
STUDIES AND RCTS
MORE RESEARCH
EVIDENCE
Translational Research and Patient Safety in Europe
Demonstration and dissemination
User requirements
Development and
Evaluation
WP8
ICT
DEMONSTRATION
INDUSTRY
CONTRACT
RESEARCH
ORG
ACADEMIA
WP 1
RESEARCH
USE CASES
WP 2
WP7
SYSTEMS AND
SERVICES FOR
DATA
INTEGRATION
PATIENT
SAFETY USE
CASE
WP9
DISSEMINATION
WEBSITE
PUBLICATION
WORKSHOPS
PROTOTYPES
COLLABORATION
INFRASTRUCTURE
TECHNOLOGY
PLATFORMS
WP10 MANAGEMENT
Translational Research and Patient Safety in Europe
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?
Translational Research and Patient Safety in Europe
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]
Translational Research and Patient Safety in Europe
GERD Case-control study
Option 2: Case control study
Identification
Tracking
-10 yrs
Identification
Drug registry
Cancer registry
PPI
Reported cancer
cases
eHR
Population registry
PPI consumption
Age
Gender
BMI
NSAID/ASA
Matched
controls
Research database
Translational Research and Patient Safety in Europe
GERD RCT
PHC
eCRF-.5
eCR
F
Verification
Web
Q-.5
eCRF0
eCRF EVENT DRIVEN
eCRF12
Data collection
Q0
Q3
Q6
Wash out
PPI test
Randomization
Translational Research and Patient Safety in Europe
Q9
Q12
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
Cohort and RCT
eHR, manages contact and
consent
eCRF
A functional tool rather
than an CTDMS
Cohort and RCT
Research subject portal
Patient Related Outcome
Measures
Cohort and RCT
Translational Research and Patient Safety in Europe
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
Translational Research and Patient Safety in Europe
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
Translational Research and Patient Safety in Europe
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
Translational Research and Patient Safety in Europe
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
Translational Research and Patient Safety in Europe
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
Translational Research and Patient Safety in Europe
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
Translational Research and Patient Safety in Europe
Functional eCRF tool
Web questionnaire
eHR
Other databases
Data extraction
Database (personal)
CRF
GP
Database (anonymous)
Researcher
Translational Research and Patient Safety in Europe
Subject portal for PROM
Patient
GP
reminders
Web
questionnaire
alarm
eHR
alarm
a
l
a
r
m
eCRF
Data extraction
Database
Researcher
Translational Research and Patient Safety in Europe
Database
manager
Other databases
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
Translational Research and Patient Safety in Europe
Translational Research and Patient Safety in Europe