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

Deja, E, Donohue, C, Semple, MG, Woolfall, K, BESS Investigators and van Miert, C (2024) Stakeholders' perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study. BMJ Open, 14 (1).

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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.

Item Type:	Article
Uncontrolled Keywords:	BESS Investigators; Humans; Bronchiolitis; Surface-Active Agents; Feasibility Studies; Research Design; Informed Consent; Child; Infant; Surveys and Questionnaires; ETHICS (see Medical Ethics); Feasibility Studies; Paediatric intensive & critical care; QUALITATIVE RESEARCH; Randomized Controlled Trial; Respiratory infections; Infant; Humans; Child; Informed Consent; Research Design; Surveys and Questionnaires; Surface-Active Agents; Bronchiolitis; Feasibility Studies; 4203 Health Services and Systems; 42 Health Sciences; Pediatric; Clinical Trials and Supportive Activities; Clinical Research; Infant; Humans; Child; Informed Consent; Research Design; Surveys and Questionnaires; Surface-Active Agents; Bronchiolitis; Feasibility Studies; 1103 Clinical Sciences; 1117 Public Health and Health Services; 1199 Other Medical and Health Sciences; 32 Biomedical and clinical sciences; 42 Health sciences; 52 Psychology
Subjects:	R Medicine > RT Nursing
Divisions:	Nursing and Advanced Practice
Publisher:	BMJ Publishing Group
Date of acceptance:	24 November 2023
Date of first compliant Open Access:	29 April 2025
Date Deposited:	29 Apr 2025 12:44
Last Modified:	29 Apr 2025 12:44
DOI or ID number:	10.1136/bmjopen-2023-077023
URI:	https://researchonline.ljmu.ac.uk/id/eprint/26282

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