Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials.
Anticonvulsants
/ therapeutic use
Child
Critical Care
Data Collection
/ methods
Emergency Service, Hospital
England
Female
Humans
Informed Consent
Levetiracetam
/ therapeutic use
Male
Multicenter Studies as Topic
Parents
/ psychology
Phenytoin
/ therapeutic use
Pragmatic Clinical Trials as Topic
Qualitative Research
Randomized Controlled Trials as Topic
Research Design
Status Epilepticus
/ drug therapy
paediatric emergency med
qualitative research
research, clinical
research, methods
Journal
Emergency medicine journal : EMJ
ISSN: 1472-0213
Titre abrégé: Emerg Med J
Pays: England
ID NLM: 100963089
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
29
01
2020
revised:
27
05
2020
accepted:
24
06
2020
pubmed:
31
8
2020
medline:
13
7
2021
entrez:
31
8
2020
Statut:
ppublish
Résumé
Alternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the 'Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children' (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC. Qualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner-parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe We analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC. This study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.
Sections du résumé
BACKGROUND
BACKGROUND
Alternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the 'Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children' (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC.
METHODS
METHODS
Qualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner-parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe
RESULTS
RESULTS
We analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC.
CONCLUSION
CONCLUSIONS
This study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.
Identifiants
pubmed: 32862140
pii: emermed-2020-209488
doi: 10.1136/emermed-2020-209488
pmc: PMC7907554
doi:
Substances chimiques
Anticonvulsants
0
Levetiracetam
44YRR34555
Phenytoin
6158TKW0C5
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
198-204Subventions
Organisme : Department of Health
ID : 12/127/134
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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