E trials: opportunities and issues Professor Helen Snooks Swansea University

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

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

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

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