A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock

Jones, Nicola; Nadel, Simon; Peters, Mark J.; Harrison, David A.; Rowan, Kathryn M.; O'Hara, CB; Inwald, David; Canter, Ruth R.; Mouncey, Paul R.; Carter, Anjali; Lyttle, Mark D.; Woolfall, Kerry

Abstract

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. Objective The Fluids in Shock (FiSh) Trial proposes to evaluate whether restrictive fluid bolus therapy (10 mL/ kg) is more beneficial than current recommended practice (20 mL/kg) in the resuscitation of children with septic shock in the UK. This qualitative feasibility study aimed to explore acceptability of the FiSh Trial, including research without prior consent (RWPC), potential barriers to recruitment and participant information for a pilot trial. Design Qualitative interview study involving parents of children who had presented to a UK emergency department or been admitted to a paediatric intensive care unit with severe infection in the previous 3 years. Participants Twenty-one parents (seven bereaved) were interviewed 16 (median) months since their child’s hospital admission (range: 1–41). results All parents said they would have provided consent for the use of their child’s data in the FiSh Trial. The majority were unfamiliar with RWPC, yet supported its use. Parents were initially concerned about the change from currently recommended treatment, yet were reassured by explanations of the current evidence base, fluid bolus therapy and monitoring procedures. Parents made recommendations about the timing of the research discussion and content of participant information. Bereaved parents stated that recruiters should not discuss research immediately after a child’s death, but supported a personalised postal’opt-out’ approach to consent. conclusions Findings show that parents whose child has experienced severe infection supported the proposed FiSh Trial, including the use of RWPC. Parents’ views informed the development of the pilot trial protocol and site staff training. trial registration number ISRCTN15244462—results.

• Journal Article Type: Article
• Acceptance Date: Jun 12, 2017
• Online Publication Date: Aug 29, 2017
• Publication Date: Jan 1, 2018
• Deposit Date: Aug 14, 2017
• Publicly Available Date: Aug 29, 2017
• Journal: Archives of Disease in Childhood
• Print ISSN: 0003-9888
• Electronic ISSN: 1468-2044
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 103
• Issue: 1
• Pages: 28-32
• DOI: https://doi.org/10.1136/archdischild-2016-312515
• Keywords: children, critical illness, medical ethics, qualitative research, sepsis
• Public URL: https://uwe-repository.worktribe.com/output/871940
• Publisher URL: http://dx.doi.org/10.1136/archdischild-2016-312515
• Contract Date: Aug 14, 2017