Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department-led paediatric trial.
Anticonvulsants
/ therapeutic use
Child
Data Collection
/ methods
Emergency Service, Hospital
England
Female
Humans
Levetiracetam
/ therapeutic use
Male
Multicenter Studies as Topic
Parents
/ psychology
Phenytoin
/ therapeutic use
Pragmatic Clinical Trials as Topic
Randomized Controlled Trials as Topic
Research Design
Status Epilepticus
/ drug therapy
clinical
epilepsy
operational
paediatric emergency med
qualitative research
research
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:
03
08
2020
accepted:
01
09
2020
pubmed:
15
10
2020
medline:
13
7
2021
entrez:
14
10
2020
Statut:
ppublish
Résumé
Key challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials. A mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate. A total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target. Successful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.
Sections du résumé
BACKGROUND
BACKGROUND
Key challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials.
METHODS
METHODS
A mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate.
RESULTS
RESULTS
A total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target.
CONCLUSIONS
CONCLUSIONS
Successful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.
Identifiants
pubmed: 33051276
pii: emermed-2020-209487
doi: 10.1136/emermed-2020-209487
pmc: PMC7907583
doi:
Substances chimiques
Anticonvulsants
0
Levetiracetam
44YRR34555
Phenytoin
6158TKW0C5
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
191-197Subventions
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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