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

Title: A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock
Authors: O'Hara, CB
Canter, RR
Mouncey, PR
Carter, A
Jones, N
Nadel, S
Peters, MJ
Lyttle, MD
Harrison, DA
Rowan, KM
Inwald, D
Woolfall, K
Item 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.
Issue Date: 28-Aug-2017
Date of Acceptance: 12-Jun-2017
URI: http://hdl.handle.net/10044/1/70249
DOI: https://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/Funder: NIHR Health Technology Assessment programme
Funder's Grant Number: HTA Project: 13/04/105
Keywords: Science & Technology
Life Sciences & Biomedicine
Pediatrics
EMERGENCY RESEARCH
DEFERRED CONSENT
MEDICAL-RESEARCH
CARE RESEARCH
CHILDREN
PATIENT
HEALTH
PARTICIPATION
CONSULTATION
INTERVIEWS
ethics
intensive care
qualitative research
sepsis
Child
Child, Preschool
Emergency Service, Hospital
Ethics, Research
Feasibility Studies
Female
Fluid Therapy
Humans
Intensive Care Units, Pediatric
Male
Parents
Qualitative Research
Randomized Controlled Trials as Topic
Shock, Septic
Surveys and Questionnaires
United Kingdom
Humans
Shock, Septic
Fluid Therapy
Feasibility Studies
Parents
Qualitative Research
Ethics, Research
Child
Child, Preschool
Emergency Service, Hospital
Intensive Care Units, Pediatric
Female
Male
Randomized Controlled Trials as Topic
Surveys and Questionnaires
United Kingdom
Science & Technology
Life Sciences & Biomedicine
Pediatrics
EMERGENCY RESEARCH
DEFERRED CONSENT
MEDICAL-RESEARCH
CARE RESEARCH
CHILDREN
PATIENT
HEALTH
PARTICIPATION
CONSULTATION
INTERVIEWS
Pediatrics
1103 Clinical Sciences
1114 Paediatrics and Reproductive Medicine
1117 Public Health and Health Services
Publication Status: Published
Online Publication Date: 2017-08-28
Appears in Collections:Department of Medicine
Faculty of Medicine



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