1. # SCIMP2013

2. Data Wizards Frank Sullivan FRSE, FRCP, FRCGP GP Nethergate Health Centre, Dundee NHSTayside Prof of R&D in GP &1y care Director Health Informatics Centre, University of Dundee Privacy Advisory Committee Member Director 2 Scotland has world-leading opportunities for eHealth Record Research

3. Clinical records 1983

4. Prendergast v Sam and Dee Ltd High Court 1983

5. Clinical records 2013

6. At the Health eResearch Centre launch on 1 st May Minister for Universities and Science David Willetts said: “Thanks to the NHS and the UK’s world-leading research base, we are uniquely positioned to use patient data to study disease and develop better treatments. The e-health centres are the first of their kind and have the potential to revolutionise health research. They will provide a vital insight into conditions affecting millions of people and ultimately bring benefits for patients.”

7. A&EA&E BIRTH DEATH Neonatal Record SMR11 Child health surveillance Immunisation GP consultations Dental SMR13 Outpatients SMR00 Hospital Admissions SMR01 Mental Health SMR04 Prescribing Screening Community care SMR50 Cancer registrations SMR06 Cancer Registry Scotland has excellent, linkable databases Laboratory Maternity

8. The next half hour New data for old –Benefits to patients –SHIP/SPIRE/SHARE –The Farr institute –TRANSFoRm/EHR4CR Why should we share data? –Benefits>>>Effort –Secure and confidential –Data quality –Recompense

9. Benefits to patients Established –ECS –Priority Amend –Diabetes –WOSCOPS Emergent –Multimorbidity –Polypharmacy –ECLS

10. Scottish Emergency Care Summary 2005-6 Out of Hours and A/E initially Provides –Current drugs –Adverse Drug reactions Information campaign – leaflets –2.5M households 174 (0.003%) patients opted out

11. Priority Amend Raschkes B MSc

12. DARTS SCI-DCNETWORK

13. Reducing amputation rates Diabetic Medicine Volume 26, Issue 8, pages 773-777, 30 MAY 2009 DOI: 10.1111/j.1464-5491.2009.02770.x http://onlinelibrary.wiley.com/doi/10.1111/j.1464-5491.2009.02770.x/full#f1 Volume 26, Issue 8, http://onlinelibrary.wiley.com/doi/10.1111/j.1464-5491.2009.02770.x/full#f1 per 1000 patients with diabetes. adjusted for age and sex. Total Major

14. Predicting progressive retinopathy: T1DM R0M0 at last exam R1M0 then R0M0 at last exam Red = women, Blue = Men Filled = 1 year screens, Open = 2 year screens

15. If all people with T1DM and 2 previous screens showing R0M0 in 2008 switched to 2 yearly screens 40% reduction in number of screening exams done in 2009 What is an acceptable level of interval disease? Policy level implications of changing strategy

16. Trial £20M 15 year follow-up £20K

17. Image showing the management of Bell's palsy in the UK according to treatment. Morales D R Sullivan F et al. BMJ Open 2013;3:e003121 ©2013 by British Medical Journal Publishing Group 2004 Cochrane SRs SBPS

18. Image showing the trends in referral to secondary care for Bell's palsy in the UK from 2001 to 2012. Morales D R et al. BMJ Open 2013;3:e003121 ©2013 by British Medical Journal Publishing Group

19. Population-based study using PCCIU data 1.75M people in Scotland 42.2% one or more long-term condition. “Management of patients with several chronic diseases is now the most important task facing health services in developed countries, which presents a fundamental challenge to the single- disease focus that pervades medicine” Lancet May 15 th 2012

20. Significant association with Deprivation

21. Remote Queries on GP records

22. GP-POLY £1.7M HTA General practitioner led medication review of older people with polypharmacy : a large, cluster randomised, stepped-wedge trial of a complex intervention to incentivise and facilitate medication review in older people with multimorbidity.

23. Recruitment using GP records Awareness raising Practice letters & Calls GP computer based reminders Public spaces

24. Identifying patients at practice level n=5 437 3 837 960 640

25. New data for Old SHIP- The Scottish Health Informatics Program (and Farr) SPIRE - Scottish Primary Care Information Resource SHARE - The Scottish Health Research Register

26. £3.8M over 4 years MRC ESRC EPSRC Chief Scientist Office

27. SHIP Linkage part 1 Local IDs Study numbers Local IDs Study numbers Indexing Service Datasource 1 Local IDs Names Addresses Dates of birth Datasource 2 Local IDs Names Addresses Dates of birth

28. SHIP Linkage part 2 Study numbers Payload data Study numbers Payload data Safe Haven Study numbers PayloaddataPay loaddata Datasource 1Datasource 2

29. Proportionate governance

30. The eData, Research and Innovation Service eDRIS Service Help with study design Provide expert advice on coding, terminology, meta data and study feasibility Agree deliverables and timelines Facilitate completion of required permissions Liaison with technical infrastructur e (safe havens) Liaison with data suppliers to secure data Provide analyses, interpretation and intelligence about data (where required) Support projects from start to finish Build relationship between data suppliers and customers Single point of entry for health research A named Person from start to finish 1 2 3 4 5 6 7 8

31. Grampian Tayside Glasgow Lothian NSS National eDRIS portal NRS East Node NRS West Node NRS South East Node Scottish Morbidity Record Community prescribing Clinical speciality Laboratory Imaging Research datasets National Datasets “Phenotypically-rich” Datasets Treatment outcomes in stratified populations Care-integration Biomarkers Clinical trial Feasibility Pharmaco- vigilance Health Intelligence Epidemiology NRS North Node

32. ++ + Source Systems Identifiable Information National Safe Haven – Secure Network ISD Storage of keys to map pseudo- identifiers to identifiers An Instance of this exists for each local area Linking – ATOS Indexing eDRIS Add-on Researcher’s Choice Each Local Safe Havens chooses the software and service they provide as eDRIS Add-On Local Safe Havens – NHS Network eDRIS Only – No Local Safe Haven Involvement Local Data Sets Regional Subsets of National Health Resources provided to Local Safe Havens Provided only by agreement between local safe haven and their health boards or other relevant data custodian Local Safe Havens - University Network Local Linked Data – Project/Pseudo Identifiers Project Specific National Linked Data – Project Identifiers Data sets released to local safe haven as per local agreements with relevant governing body Primary Care Images SMR SCI- Store Other Persistent National Data Sets Project Identifiers One off Projects Personal Identifiers Project Identifiers Project Identifiers and Data DBs provided by agreement with local health board API access by local safe havens to these health data sets providing approval and add on service agreed API access by eDRIS to these health data sets providing governance approval Pseudo identifiers converted to Project identifiers SMR ? + + + ++ Project Identifiers Personal Identifiers Project Identifiers and Data + + + + + + + + + National Safe Haven Researcher Interface Persistent National Health Datasets Historical Information Stored Linkable using Pseudo Identifiers

33. HeRC UK HeRC - Scotland HeRC - Wales HeRC - UCL HeRC - Manchester HeRC – St AndrewsHeRC - Glasgow HeRC - Dundee HeRC - Edinburgh HeRC - ISD HeRC - Aberdeen £19M funding for eHealth records research Call led by MRC Arthritis Research UK, the British Heart Foundation, Cancer Research UK, the Chief Scientist Office (Scottish Government Health Directorates), the Economic and Social Research Council, the Engineering and Physical Sciences Research Council, the Medical Research Council, the National Institute for Health Research, the National Institute for Social Care and Health Research (Welsh Government) and the Wellcome Trust Department Of business Innovation & Skills £20M

35. Electronic Clincal File Dual- Source Routine Healthcare Clinical Research Electronic Health Record Single-Source TRANSFoRm

36. Diabetes use case: In 5 countries link phenotypic data from GP to genomic data TRANSFoRm

37. Scottish Primary Care Information Resource (SPIRE) Planned Uses At National / NHS Board level: Informing national policy QOF / Data for payment purposes Local ‘whole system’ analysis & planning Research, including data linkage Public Health Surveillance National primary care publications & reports

38. What is SPIRE? Objective: To ensure a consistent national approach to the appropriate and safe use of data extracted from General Practice Clinical IT systems in Scotland. Aim: To fill a known gap in national data sources relating to primary care. Scope: Develop an extract mechanism to transfer data securely from GP systems to a safe haven in NSS. –Demonstrate robust Information Governance –Maintain a national dataset –Perform bespoke extracts (e.g. approved research) –Provide routine extracts to support e.g. QOF payments –Provide a National Analysis & Intelligence Service

39. GP Participation Options GP practice consent sought prior to any data extract –Case-by-case basis –Consent may be to recurring data extraction (e.g. National dataset) –Prior notification –No response = opt out –Right to opt out after opting in (data erasure) –Ability to view content of extracts –Patient opt-out respect even if GP opts in.

41. Data Linkage Only if approved by IAG & PAC Any linkage required will utilise the NSS Electronic Data Research & Innovation Service (eDRIS) –Separation of patient identifiers and payload data in linkage process –Production of anonymised data at individual level –In the very rare occasions where patient identifiable data are needed for research, explicit patient consent will be required –Provision of safe & secure access for researchers

42. How can GPs Benefit? Participation is voluntary; no payment from NSS Initial thoughts on GP intelligence needs: –Direct access to information on practice workload, activity & demographics –Access to comparative information about e.g. referral rates –QOF / drill-down analysis –Risk stratification Potential solution options: –Reporting/querying functionality in extract tool –Create/develop bespoke tools e.g. QOF dashboard Reduced workload associated with data extraction Funding for research quality data available from studies

43. Funding Options Improving data quality –Training –Research incentive scheme –£500-6 000 per annum Observational research –0.Xp per patient Y 000s patients Interventional research –£Z00 per patient recruited to trials

44. ….would you like your doctor to tell you about research that you would be able to take part in? If the research would involve… Allowing a researcher confidential access to your medical records but no other involvement

47. What is SHARE? A register of people aged 16 or over and living in Scotland who have said they are interested in helping with medical research. With permission to link to their NHS Datasets to establish their eligibility for research projects. Builds upon Scotland’s excellent informatics –Databases –Record Linkage

48. Pilot use for Focus group ( Typical recruitment<5%) 12 adults, male and female required 86 invited 28 responded –12 said no –16(19%) interested in participating –12 attended

49. Why should we share data? Benefits>>>Effort Secure and confidential Data Quality Rewarded

50. Patient records Quality improvement Research Benefits>>>Effort GP records Patient Better informed decisions New knowledge Local insights Relevant patient data Patient data Grouped analysis Comparison with targets Retrieval High quality care In a Data Rich Environment Sullivan and Wyatt, ABC of Health Informatics 2006

52. Caldicott 2 recommendations 1.Justify the purpose(s) 2.Don’t use personal confidential data unless it is absolutely necessary. 3.Use the minimum necessary personal confidential data. 4.Access to personal confidential data should be on a strict need-to-know basis 5.Everyone with access to personal confidential data should be aware of their responsibilities 6.Comply with the law 7.The duty to share information can be as important as the duty to protect patient confidentiality.

53. In Summary Increasing availability of linked and novel eHealth records is enabling better clinical care and research. Methodologies to make use of the data safely have been established in Scotland. Limitations need to be acknowledged and addressed. eHealth records research is a world-leading opportunity for the Scotland and beyond.

54. # SCIMP2013