Clinical Trials Research Unit, University of Leeds, UK Using electronic health records in clinical trials: rising to the challenge of developing a data linkage pipeline – experience from the ISCOMAT programme. Suzanne Hartley Clinical Trials Research Unit, University of Leeds, UK On behalf of the ISCOMAT team .

UK cardiology patients carry a significant burden of disease Improving the safety and continuity of medicines management at care transitions (ISCOMAT) UK cardiology patients carry a significant burden of disease Heart failure is responsible for ~ 5% of medical admissions and the re-admission within 3 months of discharge may be as high as 50% Half of patients discharged from cardiology wards not taking the correct medicines 2-3 days after discharge

ISCOMAT programme WP2: Intervention development March ‘16 – June ‘17 Aug ‘16 – June ‘17 June ‘17 – March ‘18 June ‘17 – Nov ‘21 WP1: Whole pathway analysis 16 pts at 4 hospitals Data linkage, 60 pts at 4 hospitals) WP2: Intervention development Experience-Based Co-Design Medicines at Transitions Toolkit (MaTT) WP3: Feasibility 30 patients at 3 hospital usability/ acceptability WP4: cluster RCT 2,100 patients, 42 hospitals Primary outcome: HF re-hospitalisation & all cause mortality Key secondary - Continuity of evidence based care . Data linkage algorithm for evaluation of medicines management in a (cardiology) patient pathway

Why are we using routine data? Efficient Remote access Data from different care settings can be linked Know data providers Cohort of consenting participants

Why do we need to develop a data linkage pipeline? Heart Failure Audit: Diagnosis; co-morbidities; medication on admission; medication on discharge; admission details; discharge details. Secondary Care (Hospital Episode Statistics): Diagnosis; co-morbidities; admission details; discharge details Primary Care: Diagnosis; co-morbidities; medication profile Office for National Statistics: Date & cause of death

Overview of the data linkage pipeline Recruit HF patients Data Access Requests CTRU provide patient identifiers Secure File Transfer to CTRU HF Audit Secure Network 4 Hospitals Clean Outputs HES Linkage Data linkage algorithm GP records Analysis Process to access data GP records CTRU Patient Performa ONS March ‘16 June ‘17

Key findings Data dictionaries Number of providers HF Audit Secondary Care / ONS Primary Care Data dictionaries  Number of providers 1 2 Bespoke data extraction ? Data Access Request Process Request changes to ethically approved documents Number of contracts / Data Sharing Agreements 4 >50* Dummy / anonymised data available Cost ££ Time lag (from event to data being available) Variable ~3 mths *DSA required for each GP practice

What have we learned? Feasibility work is important Access to data is complex Cost and lengthy process Not an option for all studies Building relationships is important Align requirements Inform guidance Support future data access request .

What have we learned? Data Sharing Contracts / DSA vary across providers Data is provided for use outlined in application Consider data sharing upfront Cost / process / analysis / communication with participants Be prepared for ‘constant’ change Regulations & legislation Data provider processes Multiple ways to keep participants informed Annual renewal / review

Acknowledgements ISCOMAT Data linkage team Professor Gerry Armitage Professor Alison Blenkinsopp Dr Peter Gardner Professor Chris Gale Dr Beth Fylan Gwynn Mrs Ivana Holloway Professor Claire Hulme Dr Hanif Ismail Mr Duncan Petty Professor Mohamed Amin Mohammed Dr Roberta Longo Dr Sarah Alderson Professor Amanda Farrin This presentation summarises independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (Grant Reference Number RP-PG-0514-20009) The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health :

Questions? Email: s.hartley@leeds.ac.uk