Ontology highlight
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.
SUBMITTER: Noble AJ
PROVIDER: S-EPMC7201300 | biostudies-literature | 2020 Apr
REPOSITORIES: biostudies-literature
BMJ open 20200416 4
<h4>Objective</h4>To determine the feasibility and optimal design of a randomised controlled trial (RCT) of Seizure First Aid Training For Epilepsy (SAFE).<h4>Design</h4>Pilot RCT with embedded microcosting.<h4>Setting</h4>Three English hospital emergency departments (EDs).<h4>Participants</h4>Patients aged ≥16 with established epilepsy reporting ≥2 ED visits in the prior 12 months and their significant others (SOs).<h4>Interventions</h4>Patients (and their SOs) were randomly allocated (1:1) to ...[more]