Deja, Elizabeth 
ORCID: 0000-0002-3626-4927, Donohue, Chloe, Semple, Malcolm G ORCID: 0000-0001-9700-0418, Woolfall, Kerry ORCID: 0000-0002-5726-5304 and BESS Investigators,
(2024)
Stakeholders' perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study.
BMJ open, 14 (1).
e077023-.
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Deja et al 2024 Stakeholders perspectives on clinical trial acceptability and approach to consent within a limited timeframe BMJ Open e077023.full.pdf - Open Access published version Download (744kB) | Preview |
Abstract
<h4>Objectives</h4>The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.<h4>Design</h4>A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.<h4>Setting</h4>Fourteen UK paediatric intensive care units.<h4>Participants</h4>Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.<h4>Results</h4>Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child's participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be 'streamlined' to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.<h4>Conclusion</h4>Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.<h4>Trial registration number</h4>ISRCTN11746266.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | BESS Investigators, Humans, Bronchiolitis, Surface-Active Agents, Feasibility Studies, Research Design, Informed Consent, Child, Infant, Surveys and Questionnaires |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Population Health |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 05 Jan 2024 16:58 |
| Last Modified: | 02 Feb 2024 07:11 |
| DOI: | 10.1136/bmjopen-2023-077023 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3177732 |
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