Evidence map›Paper›PMID 28847877›Full record

Trial reportArchives of disease in childhood2018

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

Caitlin B O'Hara, Ruth R Canter, Paul R Mouncey, Anjali Carter, Nicola Jones, Simon Nadel, Mark J Peters, Mark D Lyttle, David A Harrison, Kathryn M Rowan and 2 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Archives of disease in childhood, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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  15. Timing of Stoma Closure in Neonates: the ToSCiN mixed-methods study.Health technology assessment (Winchester, England) · 2024
    Observational
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  20. Priorities for paediatric critical care research: a modified Delphi study by the Australian and New Zealand Intensive Care Society Paediatric Study Group.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Caitlin B O'HaraInstitute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Ruth R CanterClinical Trials Unit, Intensive Care National Audit and Research Centre (ICNARC), London, UK.
Paul R MounceyClinical Trials Unit, Intensive Care National Audit and Research Centre (ICNARC), London, UK.
Anjali CarterPatient and Public Involvement Partner, Watford, UK.
Nicola JonesPatient and Public Involvement Partner, Watford, UK.
Simon NadelPaediatric Intensive Care Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.
Mark J PetersInstitute of Child Health, University College London, UK and Great Ormond Street Hospital NHS Foundation Trust, London, UK.
Mark D LyttleFaculty of Health and Applied Sciences, University of the West of England, Bristol, UK.
David A HarrisonClinical Trials Unit, Intensive Care National Audit and Research Centre (ICNARC), London, UK.
Kathryn M RowanClinical Trials Unit, Intensive Care National Audit and Research Centre (ICNARC), London, UK.
David InwaldPaediatric Intensive Care Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.
Kerry WoolfallInstitute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Intensive Care National Audit & Research Centre · GBUniversity of Liverpool · GBWatford General Hospital · GBGreat Ormond Street Hospital for Children NHS Foundation Trust · GBSt Mary's Hospital · GBSt. Mary's Hospital · GBUniversity of the West of England · GB

Funding

Department of Health 15/44/01Department of Health HTA/13/04/105
6 · The paper itself

Abstract

objectiveThe 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.

designQualitative 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.

participantsTwenty-one parents (seven bereaved) were interviewed 16 (median) months since their child's hospital admission (range: 1-41).

resultsAll 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.

conclusionsFindings 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.

Indexed as

Ethics, ResearchChildChild, PreschoolEmergency Service, HospitalFeasibility StudiesFemaleFluid TherapyHumansIntensive Care Units, PediatricMaleParentsQualitative ResearchRandomized Controlled Trials as TopicShock, SepticSurveys and QuestionnairesUnited Kingdomethicsintensive carequalitative researchsepsis

Identifiers

PMID28847877
PMCPMC5754873
OpenAlexW2749485654

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.