Trial reportBMJ open2014
Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting.
Trial report in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
47 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Views on consent approaches used in emergency and critical care research: a rapid, systematic review.Trials · 2026Pooled it
- Pooled it
- A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research.BMC medical ethics · 2018Pooled it
- Pooled it
- Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study.BMJ open · 2024Trial
- Children's, parents', and teachers' experiences of the feasibility of a telerehabilitation intervention for children with acquired brain injury in the chronic phase - a qualitative study of acceptability and participation in the Child In Context Intervention (CICI).BMC health services research · 2023Trial
- Continuous local anaesthetic wound infusion of bupivacaine for postoperative analgesia in neonates: a randomised control trial (CANWIN Study).BMJ paediatrics open · 2022Trial
- How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme.Trials · 2022Trial
- Levetiracetam as an alternative to phenytoin for second-line emergency treatment of children with convulsive status epilepticus: the EcLiPSE RCT.Health technology assessment (Winchester, England) · 2020Trial
- Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial.Lancet (London, England) · 2019Trial
- Trial
- A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock.Archives of disease in childhood · 2018Trial
- Trial
- Trial
- The Paediatric Intensive Care Adaptive Platform Trial (PIVOTAL): Turning Pediatric Critical Care Practice Into Clinical Research.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2026Article
- Current Consent Models Perpetuate Ignorance in Pediatric Critical Care.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2025Article
- Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study.BMJ open · 2025Article
- Article
- A survey of caregiver preferences regarding research participation in the paediatric emergency department.Paediatrics & child health · 2024Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
objectiveTo inform the design of a randomised controlled trial (called EcLiPSE) to improve the treatment of children with convulsive status epilepticus (CSE). EcLiPSE requires the use of a controversial deferred consent process.
designQualitative interview and focus group study.
setting8 UK support groups for parents of children who have chronic or acute health conditions and experience of paediatric emergency care.
participants17 parents, of whom 11 participated in telephone interviews (10 mothers, 1 father) and 6 in a focus group (5 mothers, 1 father). 6 parents (35%) were bereaved and 7 (41%) had children who had experienced seizures, including CSE.
resultsMost parents had not heard of deferred consent, yet they supported its use to enable the progress of emergency care research providing a child's safety was not compromised by the research. Parents were reassured by tailored explanation, which focused their attention on aspects of EcLiPSE that addressed their priorities and concerns. These aspects included the safety of the interventions under investigation and how both EcLiPSE interventions are used in routine clinical practice. Parents made recommendations about the appropriate timing of a recruitment discussion, the need to individualise approaches to recruiting bereaved parents and the use of clear written information.
conclusionsOur study provided information to help ensure that a challenging trial was patient centred in its design. We will use our findings to help EcLiPSE practitioners to: discuss potentially threatening trial safety information with parents, use open-ended questions and prompts to identify their priorities and concerns and clarify related aspects of written trial information to assist understanding and decision-making.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.