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Randomized Controlled Trial
. 2024 Jan 2;14(1):e077023.
doi: 10.1136/bmjopen-2023-077023.

Stakeholders' perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Elizabeth Deja  1 , Chloe Donohue  2 , Malcolm G Semple  3   4 , Kerry Woolfall  5 ; BESS Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Stakeholders' perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Elizabeth Deja et al. BMJ Open. .

Abstract

Objectives: 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.

Design: A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.

Setting: Fourteen UK paediatric intensive care units.

Participants: 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.

Results: 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.

Conclusion: 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.

Trial registration number: ISRCTN11746266.

Keywords: ETHICS (see Medical Ethics); Feasibility Studies; Paediatric intensive & critical care; QUALITATIVE RESEARCH; Randomized Controlled Trial; Respiratory infections.

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Conflict of interest statement

Competing interests: MGS: Independent external and non-remunerated member of Pfizer’s External Data Monitoring Committee for their mRNA vaccine program(s); HMG UK Scientific Advisory Group for Emergencies (SAGE), COVID-19 Response, Non-remunerated independent member March 2020 to March 2022. HMG UK New Emerging Respiratory Virus Threats Advisory Group (NERVTAG), Non-remunerated independent member since 2014; Integrum Scientific LLC, Greensboro, NC, USA, Chair of Infectious Disease Scientific Advisory Board; MedEx Solutions Ltd, Director; Integrum Scientific LLC, Greensboro, NC, USA, Minority Owner: MedEx Solutions Ltd, Majority Owner.

Figures

Figure 1
Figure 1
Parent recruitment. BESS, Bronchiolitis Endotracheal Surfactant Study.
Figure 2
Figure 2
Description of research without prior consent (RWPC) read to participants during interview.
See this image and copyright information in PMC

References

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