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Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial
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), inex...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907583/ https://www.ncbi.nlm.nih.gov/pubmed/33051276 http://dx.doi.org/10.1136/emermed-2020-209487 |
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author | Roper, Louise Lyttle, Mark D Gamble, Carrol Humphreys, Amy Messahel, Shrouk Lee, Elizabeth D Noblet, Joanne Hickey, Helen Rainford, Naomi Iyer, Anand Appleton, Richard Woolfall, Kerry |
author_facet | Roper, Louise Lyttle, Mark D Gamble, Carrol Humphreys, Amy Messahel, Shrouk Lee, Elizabeth D Noblet, Joanne Hickey, Helen Rainford, Naomi Iyer, Anand Appleton, Richard Woolfall, Kerry |
author_sort | Roper, Louise |
collection | PubMed |
description | 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: 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: 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: 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. |
format | Online Article Text |
id | pubmed-7907583 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-79075832021-03-11 Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial Roper, Louise Lyttle, Mark D Gamble, Carrol Humphreys, Amy Messahel, Shrouk Lee, Elizabeth D Noblet, Joanne Hickey, Helen Rainford, Naomi Iyer, Anand Appleton, Richard Woolfall, Kerry Emerg Med J Original Research 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: 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: 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: 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. BMJ Publishing Group 2021-03 2020-10-13 /pmc/articles/PMC7907583/ /pubmed/33051276 http://dx.doi.org/10.1136/emermed-2020-209487 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Original Research Roper, Louise Lyttle, Mark D Gamble, Carrol Humphreys, Amy Messahel, Shrouk Lee, Elizabeth D Noblet, Joanne Hickey, Helen Rainford, Naomi Iyer, Anand Appleton, Richard Woolfall, Kerry Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial |
title | Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial |
title_full | Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial |
title_fullStr | Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial |
title_full_unstemmed | Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial |
title_short | Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial |
title_sort | planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907583/ https://www.ncbi.nlm.nih.gov/pubmed/33051276 http://dx.doi.org/10.1136/emermed-2020-209487 |
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