Translational Medicine and Patient Safety in Europe

Transcription

1 TRANSFoRm Translational Medicine and Patient Safety in Europe Prof Brendan Delaney King s College London, Co-ordinator and Scientific Director, on behalf of the project steering ctte This project is partially funded by the European Commission under the 7th Framework Programme. Grant Agreement No (TRANSFoRm) 1

2 7.5M EU Framework 7 Project March 2010-May 2015* Funded under the Patient Safety Work program of FP7 To support decision making To support clinical trials As part of a Rapid Learning Healthcare System *Nov 15? 2

3 21 Partners from 10 Member States

4 Aims of TRANSFoRm To develop methods, models, services, validated architectures and demonstrations to support the learning health system, specifically: Epidemiological research using primary care records, including genotype-phenotype studies and other record linkages Research workflow embedded in the EHR Decision support for diagnosis

5 Use case 1: Type 2 Diabetes Research Question: In type 2 diabetic patients, are selected single nucleotide polymorphisms (SNPs) associated with variations in drug response to oral antidiabetic drugs (Sulfonylurea)? Design: Case-control study Data: primary care databases (phenotype data) pre-linked to genomic databases (genetic risk factors) data federation

6 Use case 2: Gastro-oesophageal reflux disease (GORD) Research Question: What gives the best symptom relief and improvement in QoL: continuous or on demand PPI use? Design: Randomised Controlled Trial (RCT) Data: Collection through ehr & web based questionnaire ecrf AND mobile PROMS Provenance and security

7 Use case 3: Diagnostic Decision Support Alerting v prompting (assisting v correcting) in chest pain, abdominal pain and shortness of breath Clinical Prediction rule web service (with underlying ontology) Prototype DSS integrated with InPS EHR system Translational Research and Patient Safety Translational in Europe Research and Patient Safety in Europe

8 Clinical Data Integration Model: Upper ontology: Basic Formal Ontology (BFO) Middle (domain) ontologies: Ontology-based OGMS (Ontology of General Medical Science) IAO (Information Artefact Ontology) VSO (Vital Signs Ontology) Forms the core concept integration across the project. Relatively high level to reduce complexity and enable fine granularity mapping to be achieved at terminology level. J-F Ethier et al JAMIA 2013 and Meth Inf Med 2014

9 Study/Trial CRIM Reference Terminologies and mappings used by Workbench used by CDIM used by Middleware Provenance and security models used by Data node connector used by CDIM-DSM mappings db DS model (DSM)

10 Data Standards Data Elements ISO11179, IHE Profiles CRPC, RPE, RFDC Core Standards, CDISC, HL7, UMLS Brendan Delaney 10

11 The Archetype Dual-Model Approach The archetype approach is a two-level modelling paradigm and uses a constraint model to define detailed clinical data elements. The higher level uses a generic reference model to define the basic data types and data structures which are independent of specific clinical data elements. The lower level applies archetypes (constraints) to the reference model to define detailed clinical contents. A similar approach is available in HL7 to define HL7 CSP (Clinical Statement Pattern).

12 TRANSFoRm Archetypes Reference model is based on CRIM which is based on BRIDG. Data elements retrieved from EHR sources are considered as PerformedObservationResult (BRIDG class) PerformedObservationResult is extended so an attribute in PerformedObservationResult is of type Element (openehr class) which represents a single data item of primitive types.

13 Extending ODM with Archetypes ODM FormDef * ItemGroupDef * ItemDef Map to map to RM PerformedObser vationresult * Element Archetype

14 Platform components and their interconnection Vendor Authoring Tools Web Services Listener SS (Study System) HTML forms, ODM transport files, varqs (varqs are the form variables expressed using the TRANSFoRm query model) Web Services Client/Listener DNC Data query logic Web Server (html forms) Web Client Operates on XML documents only DNC Helper PC EHR Client Web Services Client/Listener EHR (HTML) forms, ODM transport files, varqs

15 Semantic Mediator With the help of the local LexEVS service which provides CDIM-DSM, DSM and local terminology mappings, semantic mediator translates archetype-based user query requests into sql or xquery statements.

16 Patient Related Outcome Measures Triggered via the system and linked to a research subject (with consent) QoL EQ5D Symptoms score for GORD Collected via web Android/iOS device 16

17 17

18 Diagnostic Decision Support Tool The Decision Support Tool will provide patient-specific advice at the moment of consultation so that clinicians are able to access and quantify likely differential diagnoses framed in terms of diagnostic probabilityand alternative diagnostic possibilities. Decision Support Tool Characteristics: Connectivity to different EHRs via CDIM Triggered by a patient expressed reason for encounter Suggests/alerts for potential missed diagnoses Can use evidence based on both literature and data mining of primary care coded data

19 Family Practice EHR Decision Support Tools CDIM based Data Connector Decision Support Tool Decision Support Components Query Interface Diagnostic Evidence Models Clinical Evidence Service Clinical Evidence Ontology Literature Update Interface Data Mining Tools Data Mining Tools Analysis Research Repository TRANSHIS Project

20 Eliciting User Decision Requirements Experimental study (Kostopoulou et al. BJGP 2014) A range of methods & data types/sources In situ observations of 104 clinical consultations and follow-up GP interviews; HTA of the diagnostic task; CTA analysis 34 think-aloud protocols 24 interview transcripts (CDM) HTA: Hierarchical Task Analysis CTA: Cognitive Task Analysis CDM: Critical Decision Method

21 Initial list of diagnoses

22 Status Jan 2015 DSS working prototype being evaluated with 34 clinicians in a CBA using simulated patients (actors) Epidemiology Validation in Belgium complete Jan. Evaluation in England, Scotland, Greece, Netherlands April-May RCT- Validation in Poland in February. Evaluation in UK (2 vendors), Greece, Netherlands. April-Sept. (Nested cluster RCT) EU LHS Conference in September

23 An LHS that is trusted and valued Building confidence and trust in the data inputs. PROVENANCE model Model for collecting meta-data for data quality PROMs via mobile and web Building confidence and trust in the process Analysis of EU data protection policies using a graphical approach and a zone model (Kuchinke et al Int J Med Inf 214) Approach to privacy based on existing processes of data owners and processors 23

24 An LHS that is economically sustainable Conceptualizing value in the context of the LHS Business model development Involvement of five EU member states with networks and vendors in each Founding member of the European Institute for Innovation through Health Data 24

25 An LHS that is stable, certifiable, adaptable and self-improving An adaptable LHS Four models (CRIM, CDIM, Diagnosis and Provenance) CRIM Kuchinke et al BMC Med Inf Dec Making in press A certifiable LHS Use of standards (CDISC ODM SDM, ISO13606 A stable LHS Architecture for data representation and data standards (Archetypes) Provenance 25

26 An LHS that is capable of generating valid knowledge Rapidly creating knowledge that engenders learning Data mining of diagnostic data (Lift, support) Diagnostic ontology underpins entire learning cycle Communication Full integration within the EHR Evaluation 26

27 TRANSFoRm and the RCT A special case of the LHS The RCT remains the gold standard for research evidence and we need more not LESS RCTs The LHS must enable rapid pragmatic RCTs embedded within the healthcare system Standards, model based data node connector to EHRs, Baseline for research within research to explore value of big data 27

28 Challenges for the LHS To embrace and encompass the whole research paradigm, not replace it To make decision support routine in practice To place patients at the heart of the LHS To place INTERNATIONALLY ADOPTED open standards and open certifiable models at the heart of LHS adoption [The www NOT AOL!] 28