1. 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 .

2. 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

3. 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

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

5. 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

6. 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

7. 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

8. 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 .

9. 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

10. 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 )
The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health :

11. Questions?