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Patient and Public Involvement in Paediatric Pragmatic Randomized Controlled Trials: A Mixed Methods Study
Shelley Vanderhout1,2, Shipra Taneja1, Pascale Nevins3
1Institute for Better Health, Trillium Health Partners, Mississauga, ON L5B 1B8, Canada.
Children (Basel, Switzerland)
|December 30, 2025
Summary
Patient and public involvement (PPI) in paediatric pragmatic trials enhances research relevance and quality. However, insufficient resources and time pose challenges, necessitating greater investment in PPI partnerships.
Area of Science:
- Clinical Trials
- Paediatric Research
- Health Services Research
Background:
- Patient and public involvement (PPI) can improve the relevance and impact of pragmatic trials.
- The extent and nature of PPI in paediatric pragmatic trials are not well understood.
- This study investigates PPI in paediatric pragmatic trials and researchers' experiences.
Purpose of the Study:
- To examine the prevalence and nature of PPI in paediatric pragmatic trials.
- To identify lessons learned from researchers involved in PPI in paediatric trials.
- To understand the perceived impacts and challenges of PPI in this context.
Main Methods:
- Mixed-methods study combining an online survey and semi-structured interviews.
- Targeted MEDLINE search to identify published paediatric pragmatic trials.
- Descriptive statistics and qualitative thematic analysis of collected data.
Main Results:
- 56% of surveyed authors reported PPI in their paediatric pragmatic trials.
- PPI was associated with more feasible interventions, higher research quality, and improved recruitment.
- Challenges included insufficient resources, time, and training for developing PPI relationships.
Conclusions:
- PPI is congruent with the goals of pragmatic trials, enhancing research quality and dissemination.
- Paediatric researchers recognize the value of PPI for trial impact.
- Increased institutional and funding support is crucial for successful PPI partnerships in paediatric research.
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