Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study
Objectives Platform trials were used successfully in adult populations during the COVID-19 pandemic. By testing multiple treatments within a single trial, platform trials can help identify the most effective treatments (and any interactions between treatments) for patients more quickly and with less...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e085142.full |
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| author | Kerry Woolfall Mark J Peters Padmanabhan Ramnarayan Elizabeth Deja Jennifer Preston Paul R Mouncey Julie C Menzies Doug William Gould Tracy Karen Mitchell Shelley Marsh Jennifer Ainsworth Hannah Sedgwick Carly Tibbins |
| author_facet | Kerry Woolfall Mark J Peters Padmanabhan Ramnarayan Elizabeth Deja Jennifer Preston Paul R Mouncey Julie C Menzies Doug William Gould Tracy Karen Mitchell Shelley Marsh Jennifer Ainsworth Hannah Sedgwick Carly Tibbins |
| author_sort | Kerry Woolfall |
| collection | DOAJ |
| description | Objectives Platform trials were used successfully in adult populations during the COVID-19 pandemic. By testing multiple treatments within a single trial, platform trials can help identify the most effective treatments (and any interactions between treatments) for patients more quickly and with less burden for patients and their families. The aim of this qualitative research was to inform the design of the first adaptive platform trial for paediatric intensive care in the UK with young people, parents/carers and paediatric intensive care unit (PICU) staff.Design Qualitative semistructured focus group study. Data were analysed using reflexive thematic analysis.Participants Young people, parents/carers, and PICU medical, nursing and research staff.Setting The UK.Results A total of 86 participants (18 young people; 15 parents/carers; 53 PICU staff) took part in 1 of 10 focus groups between May and September 2023. Participants viewed the proposed PICU platform trial and use of research without prior consent to be acceptable. Findings provide insight into how the PICU platform trial should be designed and operationalised, including having a broad and inclusive population eligible for inclusion onto the platform trial, with different inclusion and exclusion criteria for each domain; starting the trial with no more than three domains and prioritising the outcomes of Child quality of life and Survival (all participants). Optimal governance structure and suggestions about how any challenges to the success of the full trial can be overcome are also presented.Conclusions Young people, parents/carers and PICU staff viewed the proposed PICU platform trial to be acceptable. These key stakeholders supported us with the design of an adaptive platform trial for PICU that has a rigorous methodology, yet can be operationalised in a family-centred way, to provide high-quality evidence that can support clinical decision-making and guide the treatment of critically ill children. Our findings have informed the PICU platform trial protocol. |
| format | Article |
| id | doaj-art-f434fb78964140cea9303ed67554d862 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f434fb78964140cea9303ed67554d8622025-01-09T15:45:10ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-085142Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative studyKerry Woolfall0Mark J Peters1Padmanabhan Ramnarayan2Elizabeth Deja3Jennifer Preston4Paul R Mouncey5Julie C Menzies6Doug William Gould7Tracy Karen Mitchell8Shelley Marsh9Jennifer Ainsworth10Hannah Sedgwick11Carly Tibbins125 Institute of Population Health, Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK9 NIHR Biomedical Research Centre, Great Ormond Street Hospital For Children NHS Trust, London, UK3 Department of Surgery and Cancer, Imperial College London, London, UK5 Institute of Population Health, Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK7 GenerationR Liverpool Young Person’s Advisory Group, Alder Hey Children`s Hospital Clinical Research Facility, Liverpool, UK4 Intensive Care National Audit and Research Centre, London, UK2 Paediatric Intensive Care Unit, Bristol Royal Hospital for Children, Bristol, UK4 Intensive Care National Audit and Research Centre, London, UK1 Public Health, Policy and Systems, University of Liverpool, Liverpool, UK6 Patient and Public Partner, London, UK7 GenerationR Liverpool Young Person’s Advisory Group, Alder Hey Children`s Hospital Clinical Research Facility, Liverpool, UK4 Intensive Care National Audit and Research Centre, London, UK8 NIHR Clinical Research Network West Midlands, Birmingham, West Midlands, UKObjectives Platform trials were used successfully in adult populations during the COVID-19 pandemic. By testing multiple treatments within a single trial, platform trials can help identify the most effective treatments (and any interactions between treatments) for patients more quickly and with less burden for patients and their families. The aim of this qualitative research was to inform the design of the first adaptive platform trial for paediatric intensive care in the UK with young people, parents/carers and paediatric intensive care unit (PICU) staff.Design Qualitative semistructured focus group study. Data were analysed using reflexive thematic analysis.Participants Young people, parents/carers, and PICU medical, nursing and research staff.Setting The UK.Results A total of 86 participants (18 young people; 15 parents/carers; 53 PICU staff) took part in 1 of 10 focus groups between May and September 2023. Participants viewed the proposed PICU platform trial and use of research without prior consent to be acceptable. Findings provide insight into how the PICU platform trial should be designed and operationalised, including having a broad and inclusive population eligible for inclusion onto the platform trial, with different inclusion and exclusion criteria for each domain; starting the trial with no more than three domains and prioritising the outcomes of Child quality of life and Survival (all participants). Optimal governance structure and suggestions about how any challenges to the success of the full trial can be overcome are also presented.Conclusions Young people, parents/carers and PICU staff viewed the proposed PICU platform trial to be acceptable. These key stakeholders supported us with the design of an adaptive platform trial for PICU that has a rigorous methodology, yet can be operationalised in a family-centred way, to provide high-quality evidence that can support clinical decision-making and guide the treatment of critically ill children. Our findings have informed the PICU platform trial protocol.https://bmjopen.bmj.com/content/15/1/e085142.full |
| spellingShingle | Kerry Woolfall Mark J Peters Padmanabhan Ramnarayan Elizabeth Deja Jennifer Preston Paul R Mouncey Julie C Menzies Doug William Gould Tracy Karen Mitchell Shelley Marsh Jennifer Ainsworth Hannah Sedgwick Carly Tibbins Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study BMJ Open |
| title | Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study |
| title_full | Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study |
| title_fullStr | Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study |
| title_full_unstemmed | Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study |
| title_short | Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study |
| title_sort | developing an adaptive paediatric intensive care unit platform trial with key stakeholders a qualitative study |
| url | https://bmjopen.bmj.com/content/15/1/e085142.full |
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