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Parents’ prioritised outcomes for trials investigating treatments for paediatric severe infection: a qualitative synthesis
  1. Kerry Woolfall1,
  2. Caitlin O’Hara1,
  3. Elizabeth Deja1,
  4. Ruth Canter2,
  5. Imran Khan3,
  6. Paul Mouncey2,
  7. Anjali Carter4,
  8. Nicola Jones4,
  9. Jason Watkins4,
  10. Mark David Lyttle5,6,
  11. Lyvonne Tume5,
  12. Rachel Agbeko7,
  13. Shane M Tibby8,
  14. John Pappachan9,
  15. Kent Thorburn10,
  16. Kathryn M Rowan2,
  17. Mark John Peters11,
  18. David Inwald12
  19. on behalf of PERUKI (Paediatric Emergency Research in the UK and Ireland) and PICS (Paediatric Intensive Care Society)
  1. 1 Health Services Research, University of Liverpool, Liverpool, UK
  2. 2 Intensive Care National Audit & Research Centre (ICNARC), London, UK
  3. 3 Centre of Primary Care and Public Health, Queen Mary University of London, London, UK
  4. 4 Patient partner, London, UK
  5. 5 Emergency Department, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
  6. 6 Health and Applied Sciences, University of the West of England, Bristol, UK
  7. 7 Paediatric Intensive Care, Great North Children’s Hospital, Newcastle upon Tyne, UK
  8. 8 Department of Paediatric Intensive Care, Evelina Childrens Hospital, Guys St Thomas NHS Foundation Trust, London, UK
  9. 9 Paediatric Intensive Care, Southampton Children’s Hospital, Southampton, UK
  10. 10 Paediatric Intensive Care, Royal Liverpool Childrens Hospital Alder Hey, Liverpool, UK
  11. 11 Paediatric Intensive Care, Great Ormond St Hospital NHS Trust, London, UK
  12. 12 Paediatric Intensive Care Unit, Imperial College Healthcare NHS Trust, London, UK
  1. Correspondence to Dr Kerry Woolfall, Institute of Population Health Sciences, University of Liverpool, Liverpool L69 3BX, UK; K.Woolfall{at}liverpool.ac.uk

Abstract

Objective To identify parents’ prioritised outcomes by combining qualitative findings from two trial feasibility studies of interventions for paediatric suspected severe infection.

Design Qualitative synthesis combining parent interview data from the Fluids in Shock (FiSh) and Fever feasibility studies. Parents had experience of their child being admitted to a UK emergency department or intensive care unit with a suspected infection.

Participants n=: 85 parents. FiSh study: n=41 parents, 37 mothers, 4 fathers, 7 were bereaved. Fever study: n=44 parents, 33 mothers, 11 fathers, 7 were bereaved.

Results In addition to survival, parents prioritised short-term outcomes including: organ and physiological functioning (eg, heart rate, breathing rate and temperature); their child looking and/or behaving more like their normal self; and length of time on treatments or mechanical support. Longer term prioritised outcomes included effects of illness on child health and development. We found that parents’ prioritisation of outcomes was influenced by their experience of their child’s illness, survival and the point at which they are asked about outcomes of importance in the course of their child’s illness.

Conclusions Findings provide insight into parent prioritised outcomes to inform the design of future trials investigating treatments for paediatric suspected or proven severe infection as well as core outcome set development work.

  • paediatrics
  • outcomes research
  • severe infection
  • clinical trials
  • parents

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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http://dx.doi.org/10.1136/archdischild-2019-316807

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    Footnotes

    • Contributors DI, MJP, KW, PM, RC, IK and KMR conceived and designed the research. All authors contributed to the study design of recruitment materials and topic guides. CBO, ED and KW conducted the interviews. CBO, ED and KW analysed the data. CBO, KW, ED, DI and MP wrote the paper. MDL, PM, LT, RA, and KT 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 programme (Fluids in Shock (FiSh): 13/04/105, Fever: 15/44/01) and supported by the NIHR Great Ormond Street Hospital Biomedical Research Centre.

    • Disclaimer The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care. 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.

    • Competing interests None declared.

    • Ethics approval The FiSh feasibility study (phase 1) was approved by the North West – Liverpool Central Research Ethics Committee (15/NW/0913). The FiSh external pilot study (phase 2) received full ethical approval from the Health Research Authority (HRA) and was approved by London Stanmore NHS Research Ethics Committee (16/LO/0854). The Fever qualitative study (phase 1) was approved by North West – Liverpool East Research Ethics Committee (16/NW/0826). The Fever pilot trial received full ethical approval from the Health Research Authority and was approved by Hampstead NHS Research Ethics Committee (Reference number: 17/LO/1139).

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

    • Collaborators Conducted on behalf of PERUKI and PICS.

    • Patient consent for publication Not required.

    • Patient and public involvement Patient partners AC, NJ and JW were involved in study design, oversight, review and interpretation of FiSh (AC and NJ) and Fever (JW) findings. All reviewed and approved the final manuscript.

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    © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.