Children's and caregivers' participation in the development of paediatric core outcome sets: a cross-sectional analysis.

Abstract

Objectives: This study aims to address the status of children's and caregivers' participation in the development of paediatric core outcome sets (COS).

Methods: We included all paediatric COS from a previous systematic review and searched the Core Outcome Measures in Effectiveness Trials database to 26 February 2024 for recent paediatric COS. We used descriptive and thematic analysis methods to present the characteristics of the included COS and to describe children's and caregivers' participation in the development, including any facilitators and barriers. We assessed the degree of participation of children and caregivers in two steps: by rating whether their views were considered in forming the outcome list (yes/no) and then whether their views were integrated in determining the most important outcomes (fully integrated/partially integrated/not integrated).

Results: A total of 114 paediatric COS were included. 60 (53%) COS involved children and caregivers in the development process. 29 (48%) of the 60 COS considered children's and caregivers' views in forming the initial outcome list, which was most often conducted by interview (n=12 of 29, 41%). Regarding determining the most important outcomes, 35 (58%) of the 60 COS fully integrated children's and caregivers' views, and the most common method was the Delphi survey with consensus meeting (n=29 of 35, 83%); the youngest child participants were aged 7 years. The most frequently mentioned facilitator of children's and caregivers' participation was the engagement of patient groups or organisations.

Conclusion and relevance: We evaluated the degree of children's and caregivers' participation in the development of COS and found that strategies to promote children's and caregivers' participation should be constructed.