Citation: BMJ Open. 2020, 10(4), e035516
Author: Noble AJ, Snape D, Nevitt S, Holmes EA, Morgan M, Tudur-Smith C, Hughes DA, Buchanan M, McVicar J, MacCallum E, Goodacre S, Ridsdale L, Marson AG
Abstract: OBJECTIVE: To determine the feasibility and optimal design of a randomised controlled trial (RCT) of Seizure First Aid Training For Epilepsy (SAFE).
DESIGN: Pilot RCT with embedded microcosting.
SETTING: Three English hospital emergency departments (EDs).
PARTICIPANTS: Patients aged ≥16 with established epilepsy reporting ≥2 ED visits in the prior 12 months and their significant others (SOs).
INTERVENTIONS: Patients (and their SOs) were randomly allocated (1:1) to SAFE plus treatment-as-usual (TAU) or TAU alone. SAFE is a 4-hour group course.
MAIN OUTCOME MEASURES: Two criteria evaluated a definitive RCT's feasibility: (1) ≥20% of eligible patients needed to be consented into the pilot trial; (2) routine data on use of ED over the 12 months postrandomisation needed securing for ≥75%. Other measures included eligibility, ease of obtaining routine data, availability of self-report ED data and comparability, SAFE's effect and intervention cost.
RESULTS: Of ED attendees with a suspected seizure, 424 (10.6%) patients were eligible; 53 (12.5%) patients and 38 SOs consented. Fifty-one patients (and 37 SOs) were randomised. Routine data on ED use at 12 months were secured for 94.1% patients. Self-report ED data were available for 66.7% patients. Patients reported more visits compared with routine data. Most (76.9%) patients randomised to SAFE received it and no related serious adverse events occurred. ED use at 12 months was lower in the SAFE+TAU arm compared with TAU alone, but not significantly (rate ratio=0.62, 95% CI 0.33 to 1.17). A definitive trial would need ~674 patient participants and ~39 recruitment sites. Obtaining routine data was challenging, taking ~8.5 months.
CONCLUSIONS: In satisfying only one predetermined 'stop/go' criterion, a definitive RCT is not feasible. The low consent rate in the pilot trial raises concerns about a definitive trial's finding's external validity and means it would be expensive to conduct. Research is required into how to optimise recruitment from the target population.
TRIAL REGISTRATION NUMBER:
ISRCTN13871327.
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
KEYWORDS: accident & emergency medicine; clinical trials; epilepsy; health economics; organisation of health services
Link to PubMed record
