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Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study
Tracy Karen Mitchell1, Julie C Menzies2, Padmanabhan Ramnarayan3
1Public Health, Policy and Systems, University of Liverpool, Liverpool, UK Tracy.Mitchell@Liverpool.ac.uk.
Insights
This study found that young people, parents, and pediatric intensive care unit (PICU) staff found the proposed adaptive platform trial acceptable. Their input will help design a family-centered trial to improve critically ill children's treatment.
Area of Science:
- Pediatric Intensive Care
- Clinical Trial Design
- Qualitative Research
Background:
- Platform trials accelerate treatment discovery in adults, as seen during COVID-19.
- Adaptive platform trials offer efficient testing of multiple interventions.
- Paediatric intensive care (PICU) needs innovative trial designs.
Purpose of the Study:
- To inform the design of the UK's first adaptive platform trial in PICU.
- To incorporate perspectives of young patients, parents/carers, and PICU staff.
- To ensure a family-centered and operationalizable trial protocol.
Main Methods:
- Qualitative study using semistructured focus groups.
- Reflexive thematic analysis of collected data.
- Involved 86 participants: 18 young people, 15 parents/carers, 53 PICU staff.
Main Results:
- Stakeholders found the proposed PICU platform trial acceptable.
- Key design insights include broad eligibility, prioritizing child quality of life and survival outcomes.
- Recommendations provided for governance and overcoming trial challenges.
Conclusions:
- The proposed adaptive PICU platform trial is acceptable to key stakeholders.
- Stakeholder input ensures a rigorous yet family-centered design.
- Findings inform a protocol to generate high-quality evidence for critically ill children.
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.
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