Multi-purpose use of patient data

Transcription

1 Multi-purpose use of patient data 13/05/2014 Athens Asst Prof Matic Meglic MD PhD MBA PARENT JA Coordinator

2 Disclaimer Examples from various clinical fields applicable also in RD I will be talking mainly about patient registries bridging PHR/EHR/HIS and public health and research

3 Seems very straightforward

4 Seems very straightforward Not.

5

6 Lost medical information Vast amounts of information; underutilised Patient Registries: only in EU? Valuable (future) source for secondary use, helping us with: HC&PH Policy (i.e. Indicators, Trends, Prediction) HTA, Ph. Vigil. & Safety, Post Marketing Authorisation, QoC Research, personalised medicine, future of clinical trials

7 Importance of Patient Registries Purpose: describe the natural history of disease determine clinical and/or cost-effectiveness assess safety or harm measure or improve quality of care public health surveillance disease control How is registry value created? Policies&Strategy Set-up Operations Use of data Data QGovernance Aim Modelling Security Processes Scope Semantics Privacy Data Q Population Development Funding etc. Security Privacy Primary use Secondary use

8 Patient registries are... an organized system that uses observational study methods to collect uniform data (clinical or other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s) (AHRQ definition)

9 Data sources for registries The Bad: Manual entry (paper) The Ugly: Online entry (patients, health care professionals) The Good: Electronically from primary source A number of EU projects to improve use of primary sources to populate registries: Recruitment, research data: SALUS, CDISC, BRIDG Semantics: SHN, EHR4CR, TRANSFORM, EMIF

10 PARENT OUTLINE Aim: provide MS with guidelines and recommendations on improving registry interoperability and use of data for secondary purposes (indicators, research, etc.) -cross-border setting May 2012 May 2015 Budget: 3.4 Mio (60% EC) 11 Associated partners 20+ Collaborating partners

11 PARENT Joint Action: improving reuse of patient registry data Questions: Where are the patient registries? Can we access their data for secondary use? Do we understand the data in the same way? Processes to exchange data? Need to improve: Patient registry discovery Setup and management aspects of registries Access, sharing of data

12 Key activities

13 Key activities

14 Findings Need for a single IT platform for discovery of data/registry sources? 85% YES Need for European platform providing common services for registries? 98% YES

15 What key services do we provide in Supporting two key use cases: Use case 1: PARENT? Help existing and new registries to be more interoperable (Guidelines, recommendations, best practices etc.) Assess Interoperability of these registries/data sources (Assessment Tool) Use case 2: Ability to identify registries/data sources (PARENT Registry of Registries) Provide search & retrieval and maintenance of (RoR) metadata from these registries

16 Scenarios Hands on work to ensure that policy reflects practice Very focused to solve a particular problem of one of our Associated Projects/Organizations To guide development of PARENT Framework and to create reusable best practices

17 Scenarios SAFETY: Analyzing EU hip implant registries data to assess risk of a particular implant type. HTA: Analysis of Atrial Fibrillation Registry to assess novel therapy LEGAL IOp: Best practice to tackle legal issues in international registries (EUReMS case) TECH IOp: Creating a new registry with high interoperability potential SEMANTIC IOp: Creating a repository of registry common data sets NICE UK: white paper on certification development for registries used in HTA

18 Common data set Pilot: Convert common datasets (RD, cancer, arthroplasty, cardio etc.) to ADL to create a common registry model repository (engage external expert support for modelling) Use OpenEHR Foundation s CKM environment for governance and accessibility PARENT & APG community to review models

19 PARENT-RoR.eu

20 PARENT Framework Guidelines, Recommendations, Methodologies Best practices Information models, ontologies, vocabularies Services, SW tools repository Registry of Registries, Assessment Tool Knowledge Management Platform PARENT Framework

21 Getting these services to registry holders Sustainable business model for PARENT Framework (part EC IOp assets; part service provision to MoH, registries, data users) 1. Partners adoption (MoHs, Public Health Institutes) 2. European Reference Network: intention to adopt PARENT Guidelines, services 3. ehn adoption 4. A stable organisation to provide and further develop the services

22 Relations to partially overlapping/bridging platforms EPIRARE RD platform & RD-Connect products JRC Cancer platform SemanticHealthNet SemanticHealth Institute & Network EMIF & EHR4CR ERICs & large scale research infrastructures

23 Future vision Focus: registries vs. data sources (broader) What PARENT aims to offer (growing complexity): Guidelines (development, improvement, re-use of data) RoR2, RoR3, registry development tools, mapping tools Assessment & Certification tools and services implementation support services Registry-As-A-Service Query & actual data brokerage; indicator calculation SW, merged data repository

24 Registry-as-a-service Providing small registry holders with an offthe-shelf registry in a cloud. Reduced risks (safety, audit, interoperability, etc.) Improved discovery of these registries

25 Who benefits? ERN Health Auth. EC MS JRC ERN ERN Registry holders Reducing barriers for data re-use Access to data Guidelines Comparison IT tools xxxxx xxxxx Access to data Quality of data Research organizat ions Pharma &Device Industry Insurers

26 Helping registries: Pay for data Very sensible topic Data recipient pays for data acquired from several registries; registries receive proportionate payment PARENT to act as intermediary to avoid conflict of interests between industry and registries Research organizat ions Pharma &Device Industry

27 Patient access & patient reported data Everyone talking about PROs/PROMs Goes further than that: The digitised self

28 Will we need patient registries in Not, if future? Availability of on demand querying of EHR, PHR, - omics databases. Available across organisations, borders. The same functionalities will still be needed, possibly solved in a different tech. manner.

29 Conclusions EU level services and knowledge exchange are needed to help data holders: improve their data quality and reduce cost of running the databases Reduce barriers in data availability (cost, time) Close collaboration with other ehealth initiatives required Collaboration on dataset, valueset definitions and governance

30 Thank you for your attention CONTACT: WEB: