Background/Objectives: Patient and public involvement (PPI) in the design, conduct, and dissemination of pragmatic trials may make trial results more relevant and meaningful. The nature of PPI in paediatric pragmatic trials has been poorly characterized in the literature. This study examined the prevalence and nature of PPI in paediatric pragmatic trials and lessons learned from researchers’ experiences. Methods: For this mixed methods study, we conducted an online survey and semi-structured interviews with corresponding authors of published paediatric pragmatic trials, identified using an online search filter in MEDLINE. Descriptive statistics and qualitative thematic analysis were used to analyse the data. Results: PPI was reported by 71/127 (56%) survey respondents. Reported impacts of PPI in the survey included the following: more feasible interventions (71%), higher-quality research (57%), improved recruitment and retention (57%), and increased applicability of research findings (57%). Both survey and interview participants identified that insufficient resources, time, and training for relationship development were challenges to PPI in paediatric trials. Three themes were identified from the semi-structured interview data (recruitment and engagement, sustaining PPI relationships, and PPI value added). Conclusions: PPI aligns with the purpose and intended impact of pragmatic trials, and paediatric researchers perceive that PPI leads to increased research relevance, quality, and dissemination. There is, however, a need for institutional and funding bodies to invest in PPI partnership, including offering support for researchers and providing opportunities for children, youth, and parents as PPI partners.
Vanderhout et al. (Tue,) studied this question.