Pragmatic use of data for research, audit and revalidation

1. Pragmatic use of data for research, audit and revalidation Will Dixon Health Informatics Unit 10th anniversary Royal College of Physicians, 15th Sept 2011

2. Outline • Sources of information • Clinical care, audit & research • eHealth observational research • Potential • Barriers • Harmonised data collection • Arthritis Research UK’s INBANK project • DANBIO

3. Information sources Clinical care Research Audit & Revalidation

4. Clinical care Rheumatology new patient • Demographics • Symptoms • onset; site; severity; disability • Co-morbidity • Family history • Social history • Medication • Examination http://www.medicaltextbooksrevealed.com/files/11153-53.pdf

5. Research BSR Biologics Register Incidence of serious adverse events VS • Anti-TNF treated RA cohort (n=4000) • Infliximab • Etanercept • Adalimimab Biologic-naïve active RA cohort (n=4000)

6. Research BSR Biologics Register • Demographics • Symptoms • onset; site; severity; disability • Co-morbidity; adverse events • Social history (occupation) • Medication • Examination (DAS28 score)

7. Audit BSR National Audit 2010Early RA: NICE CG79 • Demographics • Symptoms • onset; severity; disability • Medication • Access to MDT

9. Clinical Research Audit

10. Clinical Research Audit

11. Information sources Clinical care Research Audit & Revalidation Structure clinical information systems to generate high-quality data for audit and research

12. Opportunity in UK • Universal access to healthcare • ‘Cradle to grave’ records • Electronic patient records in primary care • Other eData e.g. PACS • EPR in secondary care coming… • Huge potential for eHealth observational research

13. Observational researchWhat data is needed? Shallow & wide ‘Wholehealth experience’ e.g. GPRD HES Deep and narrow Disease-specific e.g. Secondary care recordsNational registers Research databases “T-shaped data”

14. Observational researchSteroid safety in patients with RA Disease severity Confounder Outcome Serious infection Exposure Steroid therapy

15. Observational researchSteroid safety in patients with RA Shallow & wide GPRD HES Prescriptions GP visits / HES data Steroid therapy ? • GP prescriptions • Hospital administration Serious infection Disease activity ? Deep and narrow National registers Research databases Secondary care records Problem

16. Research & audit using eHealth data Obstacles • Secondary care records often paper-based • EPRs not structured to collect information for research Solutions • Include research and audit requirements in EPR architecture • Need to harmonise research data

17. Studies in rheumatoid arthritis n=100 n=400 Prospective study of RA-associated interstitial lung disease Synovial predictors of EIA outcome • For all future studies in RA • Define minimum core dataset • Collect in harmonised way n=1000 Pharmacogenetics of methotrexate therapy Disease characteristics Disease severity Drug therapy n=500 Question Predictors of drug response

18. Harmonised data Osteoarthritis SLE Common minimum core Clinical care Vasculitis MSk pain Min.Core Min.Core Min.Core Min.Core Research Min.Core Rheumatoid arthritis Audit & Revalidation

19. INBANK A national research infrastructure to facilitate musculoskeletal research, including • a searchable catalogue of extant studies and • a prospective research database of clinician- and patient-reported outcomes with linked biological samples http://www.arthritisresearchuk.org/research/inbank.aspx

20. Disease hubs Sys sclerosis Others… RA Vasculitis Centralised informatics platform Centralised biobanking

21. Disease hubs Sys sclerosis Others… RA Vasculitis Centralised informatics platform Data collection Data linkage Data provision • INBANK Extant • Inventory of extant collections • Meta-data about studies • Clinical • Samples Link to national datasets GPRD National joint register etc. Datasets to researchers Clinical reports Patient identification for trials INBANK Prospective Web-based data collection Minimum core dataset + ‘bolt-on’ sub-studies Tracking biological samples Tracking of study progress National audit ADRs to MHRA Centralised biobanking

22. Research data collection in NHS practice Opportunities • ‘Real-world’ data across UK • Single data entry for clinical, research and audit purposes • National audit using INBANK platform • Automation of O/P letters • Augments clinical record • Patient-reported outcomes • Longitudinal record

23. DANBIO Courtesy of Merete Hetland

24. DANBIO Courtesy of Merete Hetland

25. Data collection in NHS practice Opportunities Threats Time not greater than current paper Existing databases Administrative burden NHS IT; R&D departments Integration with NHS systems • ‘Real-world’ data across UK • Single data entry for clinical, research and audit purposes • National audit using INBANK platform • Automation of O/P letters • Augments clinical record • Patient-reported outcomes • Longitudinal record

26. INBANK A national research infrastructure to facilitate musculoskeletal research, including • a searchable catalogue of extant studies and • a prospective research database of clinician- and patient-reported outcomes with linked biological samples http://www.arthritisresearchuk.org/research/inbank.aspx

27. Patient-reported outcomes • Data from the source • Informs consultation • Collect outcomes important to patients • Quality of care • Reduces burden of clinician data entry • Two-way communication • Data collection • Dissemination of knowledge

28. DANBIO Courtesy of Merete Hetland

29. INBANKLong-term vision • Engagement of the clinical and research communities • Proof of clinical, research and audit benefits from single data entry • High-quality data becomes standard of care • Influence disease-specific EPRs in secondary care Structure clinical information systems to generate high-quality data for audit and research

30. Outline • Sources of information • Clinical care, audit & research • Overlap • eHealth observational research • Potential • Barriers • Harmonised data collection • Arthritis Research UK’s INBANK project