1. E trials: opportunities and issues
Professor Helen Snooks
Swansea University

2. CIPHER methodological strand: Improving efficiency in trials and natural experiments
Case study - SAFER 2:
HTA funded Cluster RCT in South Wales, Nottingham and London
Intervention: Protocols for paramedics to assess and refer older people who have fallen to community based falls service instead of conveyance to ED
Outcomes
Further emergency events
999 calls
ED attendances
Emergency admissions
Deaths
Quality of life and satisfaction
SAIL databank used for Welsh patients (ED, admissions, deaths); identifiable data collected for English patients from individual Trusts AND from HSCIC
Questionnaires to patients
All data linked anonymously and analysed in SAIL gateway

3. Progress: SAFER 2 (n = 4800)
SAIL and HSCIC outcomes now all retrieved and linked. Matching rate > 98%
Analysable outcomes for 80% of eligible patients
Identifiable outcomes for consented patients from English sites all retrieved, matched and linked (<40%)
Self reported outcomes for those that returned questionnaires (35%)
Routine data outcomes on non-responders allowed reliable imputation of quality of life outcomes

4. Advantages
Encouraging early experience with incorporation of linked anonymised routine data outcomes in cluster trial
Much higher inclusion than traditional trials
Very high matching rate
Potentially efficient

5. Challenges consent Permissions Data quality Management of SUSARs
Use of routine data outcomes rather than patient reported outcomes