Abstract
BackgroundEcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediately administer an intervention without informed consent and changes in staffing during trial conduct, mainly due to physician rotations. Using literature on parents’ perspectives and research without prior consent (RWPC) guidance, we developed an interactive training package (including videos, simulation and question and answer sessions) and evaluated its dissemination and impact upon on practitioners’ confidence in recruitment and consent.MethodsQuestionnaires were administered before and immediately after training followed by telephone interviews (mean 11 months later), focus groups (mean 14 months later) and an online questionnaire (8 months before trial closure).ResultsOne hundred and twenty-five practitioners from 26/30 (87%) participating hospitals completed a questionnaire before and after training. We conducted 10 interviews and six focus groups (comprising 36 practitioners); 199 practitioners working in all recruiting hospitals completed the online questionnaire. Before training, practitioners were concerned about recruitment and consent. Confidence increased after training for explaining (all scale 0–5, 95% CIs above 0 and p values < 0.05): the study (66% improved mean score before 3.28 and after 4.52), randomisation (47% improvement, 3.86 to 4.63), RWPC (72% improvement, 2.98 to 4.39), and addressing parents’ objections to randomisation (51% improvement, 3.37 to 4.25). Practitioners rated highly the content and clarity of the training, which was successfully disseminated. Some concerns about staff availability for training and consent discussions remained.ConclusionsTraining improved practitioners’ confidence in recruitment and RWPC. Our findings highlight the value of using parents’ perspectives to inform training and to engage practitioners in trials that are at high risk of being too challenging to conduct.
Highlights
EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom
Emergency Treatment with Levetiracetam or Phenytoin in Status Epilepticus in Children (EcLiPSE) was a 30-site, un-blinded, pragmatic and randomised controlled trial that explored second-line treatment of convulsive status epilepticus in children [6]
Challenges to the success of EcLiPSE included: practitioner concerns and inexperience in research without prior consent (RWPC); trained staff leaving due to junior physician rotations; use of an anti-epileptic medication that is not the standard anticonvulsant used in this clinical setting; and the likelihood that randomised patients are moved between departments or hospitals, which increases the size of trial team and complexity of trial set up
Summary
EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Trials involving time-critical interventions in paediatric emergency and critical care have additional practical and ethical challenges These include, high staff turnover due to junior physician rotations, no time to seek prior informed consent, and practitioner anxiety about approaching families for consent after a trial intervention has already been administered [5]. As there is no time to seek written informed consent in a life-threatening situation, practitioners approached parents as soon as possible after the child has stabilised to inform them that their child has already been entered into a clinical trial and discuss the use of their child’s data and continued follow-up [7, 8] This is research without prior consent (RWPC, known as deferred consent). Challenges to the success of EcLiPSE included: practitioner concerns and inexperience in RWPC; trained staff leaving due to junior physician rotations; use of an anti-epileptic medication (levetiracetam) that is not the standard anticonvulsant used in this clinical setting; and the likelihood that randomised patients are moved between departments or hospitals, which increases the size of trial team and complexity of trial set up
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