Escolar Documentos
Profissional Documentos
Cultura Documentos
Gokce B. Laleci Erturkmen, PhD A. Anil Sinaci, MSc SRDC Software Research, Development and Consultancy Ankara, Turkey
SALUS: Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety Studies (http://www.salusproject.eu/)
A STREP funded under Objective ICT-2011.5.3b Tools and environments enabling the re-use of electronic health records which aims to
Enable effective integration and utilization of electronic health record (EHR) data to improve post-market safety activities on a proactive basis Pilots in Lombardia Region (Italy) and Eastern Saxony (Germany)
WHO-UMC and ROCHE are actively involved in pilot studies
Partners
SRDC Ltd, Turkey (coordinator) EUROREC, France WHO- UMC, Sweden OFFIS, Germany AGFA Healthcare, Belgium
ERS, Netherlands LISPA, Italy INSERM, France TUD, Germany ROCHE, Switzerland
How SALUS extends current spontaneous reporting system to seamlessly exploit the already existing clinical data at EHRs
An ideal system for ADR surveillance would combine the strengths of case reports with those of EHRs
2013 Joint Summits on Translational Science 3
Use Cases
Enabling Semi-automatic Notification of Suspected ADEs and Reporting ADEs within a Hospital
Enabling Notification of Suspected ADEs Enabling Semi-automatic ADE Reporting
Temporal pattern characterisation Is there a temporal association between a drug of interest and a medical event of interest
By comparing the actual and expected counts of events in different time periods relative to the first prescription of a drug Can be used for evaluating ADEs Can be used to assess positive impacts of drugs
2013 Joint Summits on Translational Science 4
Use Cases
Running Exploratory Analysis Studies over EHRs for Signal Detection
Temporal association screening on EHRs
What does the Medical Event profile look like for Nifedipine? Are there any drugs that might be associated with causing Myocardial Infarction? Open ended analysis, no prior hypothesis Generates associations that might become signals
Using EHRs as secondary use data sources for Post Marketing safety studies Estimate incidence rates of congestive heart failure (CHF) in diabetic patients with a recent acute coronary syndrome (ACS) event on different diabetic medications
From ITI: IHE XDS (MS), From PCC: IHE QED, IHE CM
Subscription/query based, yet not specialized for population based queries Not only HL7 CCD, SALUS would support patient summaries expressed in EN13606 artefacts
IHE DEX
For the reuse of EHRs for clinical research
E.g. CCD CDASH annotated ODM
Power of an MDR
apply mappings earlier in the process
During the form design, data elements of the form have already been mapped to the corresponding elements in the EHR export
The MDR to maintain the exact correspondences between the research and healthcare data elements
DEX is to support study feasibility, patient eligibility and recruiting, adverse event reporting, retrospective observational studies as well as case report form pre-population
existing standards for patient summaries ASTM/HL7 CCD
2013 Joint Summits on Translational Science 9
DEX Volume 1 is complete Volume 2 is underway Release for Public comment in May Trial Implementation in July
10
MDR
ISO/IEC 11179
11
There are many different efforts to define Data Elements, and binding them to actual data sources (like CCD documents) Examples:
Health Information Technology Standards Panel (HITSP) has defined the C154: Data Dictionary Component
HITSP C83 marks the elements in CCD document with the corresponding HITSP C154 data elements
The Federal Health Information Model (FHIM) develops a common Computationally Independent Model (CIM) for EHRs GE/Intermountain Healthcare Clinical Element Models (CEM) The Transitions of Care Initiative (ToC) maintains the S&I Clinical Element Data Dictionary (CEDD)
Mappings to I2B2, PopMedNet, HQuery implementations, FHIM Model, HITSP C154 when possible
available in separate excel sheets, PDFs
CDISC SDTM, CDASH Mini Sentinel Common Data Model (CDM) I2B2 data model Observational Medical Outcomes Project (OMOP) Common Data Model (CDM)
12
13
BRIDG Semantic MDR maintains a skos:exactMatch mapping from LBORRES to Result.Value through PerformedObservationResult.val ue.Any
Metadata Consumer
2
ODM is annotated with SDTM
7 6
14
15
DEX Interface
Conclusion Standard-based IHE profiles for TRANSFoRm, EHR4CR, SALUS use cases
Collaborating to test IHE profiles during a joint projectathon will be a first step towards global interoperability between EHR4CR, TRANSFoRM and SALUS platforms and towards a pan-EU capability for clinical research and patient safety.
16
Use case #3: Extraction of sets of individual clinical Security & confidentiality Standards : CDISC (CDASH, Operational Design Model (ODM), Study Design Model (SDM), CSHARE, BRIDG) - HL7 (RIM, DCM, Clinical Statement model, CDA (templates e.g. CCD), 2013 Joint Summits on Translational Science 17 Vocabulary) ISO (ISO 21090, ISO 11179)
EHR4CR / TrRANSFoRM use cases SALUS use cases Clinical Research Patient Safety Protocol feasibility study Signal detection Patient recruitment IHE QRPH:Retrieve Process for Execution [RPE], Clinical Research Process Content [CRPC], Data Element Exchange [DEX] (under development) IHE PCC Query for Existing Data [QED], Care Management [CM] Case Report Form (CRF) preIndividual case safety report population (ICSR) form pre-population IHE ITI: Retrieve Form for Data Capture [RFD], IHE QRPH: Retrieve Process for Execution [RPE], Clinical Clinical Research Process Content [CRPC], Data Element Exchange [DEX] (under development) Research Document [CRD] Drug Safety Content [DSC] Retrospective observational study Use case #1+ Use case #2 Data Element Exchange [DEX] (under development) IHE ITI: XUS, CT, ATNA
Questions ?
18