1. Research Developments in the Registry
Phil Clayton

2. Outline New ANZDATA database Historic uses of ANZDATA for trial work
Registry RCTs
Data linkage

3. Original database Established in 1970s Oracle based system
Special software required
Clunky user interface
Expensive maintenance
Designed around regular surveys

4. “Real-time” system 2004 Ability to submit event-based data
New patients
Deaths
Transfers between hospitals
Etc
Data submitted by fax or online
+/- manual checks by senior staff before incorporation into main database

5. Limitations of old system
Clunky
Out of support
Limited support for truly real-time data entry

7. New database Modern MS SQL based database with web front-end
ANZOD and living kidney donor components complete
ANZDATA component due to launch end 2016
Being used for 2015 survey data entry, ironing out bugs

8. Features of new database
Web front-end
Same front-end for end users and ANZDATA staff
All data elements can be entered real-time from anywhere with web access
Real-time validation of data at time of entry
Web services (communication with external databases)
Data extraction directly by users

13. Previous uses of ANZDATA for trial work
Long term follow-up of trials

14. Previous uses of ANZDATA for trial work
Long term follow-up of trials

15. Previous uses of ANZDATA for trial work
Long term follow-up of trials

16. Previous uses of ANZDATA for trial work
Long term follow-up of trials

17. Previous uses of ANZDATA for trial work
Long term follow-up of trials

18. Previous uses of ANZDATA for trial work
Long term follow-up of trials

19. Problems with traditional RCTs
Highly selected population
Inadequate power (especially for rare outcomes or those that take a long time to occur)
Expensive
Often seen as separate from core clinical activity

20. Registry RCTs
Submission of data to registries already embedded in clinical practice
Therefore pre-existing mechanism for following patients up
Opportunity to extend this to include randomised interventions

22. TASTE study
Compared intracoronary thrombus aspiration before primary PCI vs PCI alone in patients with STEMI
Used online registry modules for randomisation at the time of intervention
Linked to data capture within already-existing national comprehensive registries in Sweden, Iceland and Denmark
Cost little more than 1% of a standard RCT
Recruited over 7000 patients within 33 months
Carried out by clinicians during acute cardiology care

23. Support for registry RCTs
Inherent in new database
Real-time data entry
Web front-end
Web services
Under development (funded by BEAT-CKD)
Trials module

24. Trials module Common components Trial-specific
Trial registration, enrolment arm, identification etc
Randomisation support
Trial-specific
Data collection
Baseline
Study visits
Enhanced survey data
Event-based data

26. First cabs off the rank
BEST-Fluids
RESOLVE

27. Data linkage Enrich dataset using external data
Time consuming, expensive
Existing link with NOMS
Master linkage keys
SA/NT Datalink
Others underway

28. Conclusions New database will be up and running soon
Will allow ANZDATA to support:
Real-time data entry by end users
Real-time data extraction by users
Communication with external databases
Direct support for registry trials is coming soon
Enhancing value of Registry by linking with external data

29. Acknowledgements
Australian and New Zealand patients and staff for their cooperation and contributions to ANZDATA
AKTN Methodology Working Group
Suetonia Palmer