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A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock
  1. Caitlin B O’Hara1,
  2. Ruth R Canter2,
  3. Paul R Mouncey2,
  4. Anjali Carter3,
  5. Nicola Jones3,
  6. Simon Nadel4,
  7. Mark J Peters5,
  8. Mark D Lyttle6,7,
  9. David A Harrison2,
  10. Kathryn M Rowan2,
  11. David Inwald4,
  12. Kerry Woolfall1
  1. 1 Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK
  2. 2 Clinical Trials Unit, Intensive Care National Audit and Research Centre (ICNARC), London, UK
  3. 3 Patient and Public Involvement Partner, Watford, UK
  4. 4 Paediatric Intensive Care Unit, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK
  5. 5 Institute of Child Health, University College London, UK and Great Ormond Street Hospital NHS Foundation Trust, London, UK
  6. 6 Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK
  7. 7 Emergency Department, Bristol Royal Hospital for Children, Upper Maudlin Street, Bristol, UK
  1. Correspondence to Dr Kerry Woolfall, Institute of Psychology, Health and Society, The University of Liverpool, Block B, Room B112, Waterhouse Building, Liverpool L69 3GL, UK; K.Woolfall{at}liverpool.ac.uk

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.

  • qualitative research
  • ethics
  • intensive care
  • sepsis

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/

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Footnotes

  • Contributors KW, DI, PRM, MDL, SN, MJP, DAH, AC, NJ and KMR conceived and designed the research. CBO, KW, DI, AC, NJ, RRC, PRM and KMR contributed to the design of recruitment materials and topic guide. CBO conducted the interviews. CBO and KW analysed the data. CBO, KW and DI wrote the paper. MDL, RRC, MJP and PRM critically revised the manuscript. All authors reviewed and approved the final manuscript.

  • Funding This study was funded by the National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (Project: 13/04/105). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health. The researchers are independent from the funders. The funders had no role in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

  • Competing interests None declared.

  • Ethics approval North West – Liverpool Central Research Ethics Committee (15/NW/0913).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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