Repository logo
  • Log In
    Log in via Symplectic to deposit your publication(s).
Repository logo
  • Communities & Collections
  • Research Outputs
  • Statistics
  • Log In
    Log in via Symplectic to deposit your publication(s).
  1. Home
  2. Faculty of Medicine
  3. Faculty of Medicine
  4. A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock
 
  • Details
A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock
File(s)
A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock.pdf (468.14 KB)
Published version
Author(s)
O'Hara, Caitlin B
Canter, Ruth R
Mouncey, Paul R
Carter, Anjali
Jones, Nicola
more
Type
Journal Article
Abstract
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.
Date Issued
2017-08-28
Date Acceptance
2017-06-12
Citation
Archives of Disease in Childhood, 2017, 103, pp.28-32
URI
http://hdl.handle.net/10044/1/70249
DOI
https://www.dx.doi.org/10.1136/archdischild-2016-312515
ISSN
1468-2044
Publisher
BMJ Publishing Group
Start Page
28
End Page
32
Journal / Book Title
Archives of Disease in Childhood
Volume
103
Copyright Statement
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
Sponsor
NIHR Health Technology Assessment programme
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000417928700012&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Grant Number
HTA Project: 13/04/105
Subjects
Science & Technology
Life Sciences & Biomedicine
Pediatrics
EMERGENCY RESEARCH
DEFERRED CONSENT
MEDICAL-RESEARCH
CARE RESEARCH
CHILDREN
PATIENT
HEALTH
PARTICIPATION
CONSULTATION
INTERVIEWS
Publication Status
Published
Date Publish Online
2017-08-28
About
Spiral Depositing with Spiral Publishing with Spiral Symplectic
Contact us
Open access team Report an issue
Other Services
Scholarly Communications Library Services
logo

Imperial College London

South Kensington Campus

London SW7 2AZ, UK

tel: +44 (0)20 7589 5111

Accessibility Modern slavery statement Cookie Policy

Built with DSpace-CRIS software - Extension maintained and optimized by 4Science

  • Cookie settings
  • Privacy policy
  • End User Agreement
  • Send Feedback