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

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

SUBMITTER: Deja E 

PROVIDER: S-EPMC10773389 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature