Rick Jones, Yorkshire Centre of Health Informatics, University of Leeds

1. EPSRC – Pathways to Impact Grant.Training and education for the developers of databases in research and clinical practice. Rick Jones, Yorkshire Centre of Health Informatics, University of Leeds

2. Context • The UK can significantly enhance its clinical research capability by using, strictly within the bounds of patient confidentiality, the electronic patient data that the UK’s National Programmes for IT in the NHS have the potential to allow. This will have enormous benefits for all types of clinical, public health and health services research and for many aspects of patient care.

3. Context: Simulations • 4.1 Surveillance (Pharmacovigilance) • The vision for an ideal surveillance system is of a nationwide “active” system for tracking patients’ responses to medical interventions (POMS, immunisations and OTC drugs as well as Devices) and of disease and other incidents requiring reporting. • 4.2 Clinical Trials • Within the range of activities involved in running a successful clinical trial in the future, there will be a need to access and process data from electronic records at a number of stages before, during and after the trial. • 4.3 Prospective tracking of a known cohort • This simulation team concluded that in order for UK Biobank (which is a resource for prospective studies) to be able to provide benefits access to data will have to be at patient level data (identifiable) both coded and textual. • 4.4 Observational epidemiology • The construction of retrospective observational epidemiological studies based on routine data sources requires access to data from a very wide range of electronic records, both within and without the health services.

4. Context: The NHS Research Capability Programme • Six work streams: • Technical Architecture • Functional Scope • Data Quality, Standards and Linkage • Information Governance and Threat Assessment • Infrastructure • Communications and Stakeholder Engagement

5. Harvesting research outcomes from clinical databases - demonstrating the potential of TPP SystmOne. Richard Gillott, Cardiovascular Database Developer, LTHT Rick Jones, Yorkshire Centre of Health Informatics, University of Leeds

6. Aims & objectives • Based on the work of the RCP could a practical trial be carried out as proof of concept to: • Prove the feasibility of extracting identifiable patient data from GP systems for use in research • Construct an architecture to enable the rapid, repeatable, and secure query & collection of data.

7. Pilot trial • A small trial was planned with the aid of 2 research groups based in Leeds • The pilot aimed to demonstrate the value of the information contained in the patient record, and prove whether the data was sufficient in its coverage of the population and its completeness

8. Results: Yields of Records 81% Cardiovascular 66% Oncology

9. For linked records… We need: • Granulated consent – all or part of record • A model to allow selective searching by: • Clinical relevance • Administrative components • Therapeutics • Diagnostics • An understanding of when and how frequently to conduct searches • A business model to reimburse GP systems suppliers / data guardians for their search time

10. Workshop 1. Headlines • Specificity of Consent Statements • Baseline Knowledge of Electronic Record Systems • Videos of Consent Process • Consent to approach relatives • Trial Designs for Long-term outcomes • Knowledge of Accountable Parties • Specimen Consent Forms and Information Sheets

11. Today: Architecture

12. Background • Building upon the work undertaken by the RCP • Proposed a number of high level architectures • Centralized vs federated data • Concentrates on Secondary Care • Honest broker • The RCPs work and its database of documents was reviewed. • The aim was not to provide a conclusive model for implementation, but to discuss some of the important considerations that need to be made.

13. About the model • Uses the Service Orientated Architecture (SOA) paradigm, in a format that ties in with the work being conducted by the Research Capability Program to link data from Primary, Secondary and Tertiary sites across the NHS. • Adopts the hybrid model of centralized & federated data storage and processing • Recognises the mechanisms necessary for the querying of data are already available in some systems, such as SystmOne, thanks to the GPES initiative. However, this scheme will need to be extended, to support both the push and the pull methods required by a scalable solution.

14. Centralized vs distributed

15. Overview diagram

16. Deployment diagram

17. In this workshop…… • Can we explore and determine an architecture? • Can we consider the metrics of use of a linked search service? • Numbers of patients • Frequency of searches • At what scale should this be developed? • Local pilot • Employ National infrastructure

18. Exercise 1 • What are the main use-cases of a system? • Use simple UML notation • High level view • Identify as many actors as possible

19. UML Use Cases • Keep it simple • Identify actors • Patient • Researcher • Clinician • Sys Admin • Key tasks • Don’t worry about syntax

20. Intermission & Food for thought Tony Solomonides et al, Privacy compliance and enforcement on Europeanhealthgrids: an approach through ontology • Phil. Trans. R. Soc. A 2010 368, 4057-4072

21. Exercise 2 • Can we identify the components needed to meet the requirement? • Systems • Processes • Connections • We’ll sort out the UML later!

22. It doesn’t need to be pretty…

23. Next steps… • Workshop output will be synthesised and circulated for validation • Overview of work to date will be prepared for 31st March Workshop • Concept is that the overview will be presented and critiqued by participants and prepared for a final white paper report • We are expecting a number of patients at the final session

24. At 1pm.. • Free Text in GP Patient Records: How much extra information is there and how can we extract it? Rob Koeling, University of Sussex. • The UK General Practice Research Database provides a valuable source of information for health services research. Coded data is supplemented by free text (physicians' notes or letters). However, due to the difficulty of extracting information, and the cost of anonymisation, free text is seldom utilised in research. One of the goals of the PREP (Patient Record Enhancement Project) project at the University of Sussex and the Brighton and Sussex Medical School, is to explore how much extra information (i.e. on top of the coded data) is concealed in the free text fields of GP patient records. I will present some results of an annotation effort in which a corpus containing text records of 344 women in the year prior to a diagnosis of ovarian cancer were marked up with 5 commonly presenting symptoms. I will also report on a simple method we developed for automatically extracting these symptoms using string matching. I will talk about what this means for the estimates of the incidence of these symptoms and what we can do to extract this information. How far can simple, readily available, methods take us and what is the scope for more complex information extraction techniques.

25. Yorkshire Centre for Health Informatics Director Dr Susan Clamp +44 (0)113 343 4960 s.clamp@leeds.ac.uk www.ychi.leeds.ac.uk