Modern standards for research reporting and practices to advance paediatric trials and systematic reviews

Abstract

Paediatric randomized controlled trials (RCTs) and systematic reviews are critical in informing healthcare decisions and clinical practice. However, deficiencies in reporting preclude their impact, as key details on what was done, what was found, and what the results mean are not always described. First, we explore suboptimal reporting in paediatric reporting. Second, as a proposed solution, this thesis presents paediatric-specific reporting guideline extensions for trial protocols (SPIRIT-C 2026), final reports (CONSORT-C 2026), trial interventions (TIDieR-C), and systematic reviews of intervention studies in paediatrics (PRISMA-C 2026). The development of these guidelines is described, and the reporting guideline checklists, as well as explanations and elaborations for new reporting items, are presented. Third, we address the meaningful involvement of children, young people, and families. We identify key enablers of meaningful involvement of young people and family caregivers in reporting guideline development. Furthermore, we describe responsible research practices such as the return of trial results to participants, and developed a template co-designed with young people and family caregivers to facilitate the return of trial results. Finally, we place the work presented in this thesis within the wider context of the paediatric research ecosystem, and describe how consideration of the research process as a whole, and implementation of the research reporting standards presented in this thesis, can improve the paediatric-specific evidence base.