학술논문
Stakeholders’ perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study
Document Type
article
Author
Matthew Peak; Kerry Woolfall; Michael Griksaitis; Clare Fowler; Simon Gates; Christopher Lamb; Elizabeth Deja; Rachel Agbeko; John Pappachan; Helen Parker; Jennifer Preston; Ahmed Osman; Paula Williamson; Paul S McNamara; Mark Turner; David Armstrong; Tracy Moitt; Ramesh Kumar; John Alexander; Kevin P Morris; Roger Parslow; Steve Cunningham; Craig Knott; Chloe Donohue; Catrin Barker; Julie Richardson; Ashley Jones; Stephanie Clarke; Malcolm G Semple; Richard Levin; James Weitz; Natasha Roberts; Vanessa Compton; Kentigern Thorburn; PHILIP MILNER; Howard W Clark; Bessie Cipriano; Nosheen Khalid; Nicolene Plaatjies; Avishay Sarfatti; Mark Terris; Santosh Sundararajan; Edgar Brincat; Natasha Thorn; Ramiya Kirupananthan; Peter J Davis; Samantha Owen; Pavanasam Ramesh; Sarah Fox; Laura Price; Hannah Clarke; Charlotte Thompson; Wendy Browne; Constantinos Kanaris; Christine Mackerness; Laura Rad; Grace Williamson; Simone Paulson; Laura O'Malley; Zoe Oliver; Evette Allen; Clare van Miert; Ashley Best; Jens Madsen; Anne Dawson; Colin Summers; Blessing Osaghae; Madhuri Panchal; Anthony Postle; Peter Jirasek; Dawn Jones; Michael Mander; Laura Rimmer; Paul C Ritson; Chris Simons; Afeda Mohamed Ali; Cara Alexander; Hannah Child; Natalie Milburn; Holly Parkin; Harriet Payne; Carly Tooke; Helen Winmill; Katherine Baptiste; Sophie Coles; Sarah-Jayne Eames; Christina Linton; Helen Marley; Sarah Mogan; Alvin Schadenberg; John Stiven; Rob Claydon; Anna Stancombe; Kate Teeley; Kathryn Reeves; Emily Scriven; Raghu N Ramaiah; Rekha Patel; Patrick E Davies; Lindsay Crate; Kirsten Beadon; Rachel McMinnis; Frances Sinfield; Hilary Callaghan; Vicki Linton; Jeremy Lyons; Clara Nelson; Tsz-YanMilly Lo; Jackie McCormick; Andrea Wood; Ross Marscheider; Stephen D Playfor; Bernadette C Gavin; Dave J Morgan; Lara T Bunni; Claire F Jennings; Rebecca Marshall; Emma K Riley; Lorena Caruana; Amber Cook; Tracey Curtis; Nichola Etherington; Jenni McCorkell; Christie Mellish; Jenny Pond; Catherine Postlethwaite; Nicola McClelland; Holly Minchin; Joanne Tomlinson; Simona Lampariello; Tara Murray; Olivia Nugent; Samantha Reed; Christa Ronan; Salman Siddiqi
Source
BMJ Open, Vol 14, Iss 1 (2024)
Subject
Language
English
ISSN
2044-6055
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.