COSMIC: a core outcome set for intravenous maintenance fluid therapy trials in children
Abstract
Background: Intravenous maintenance fluid therapy is one of the most common therapies for hospitalized children, yet the field lacks standardized outcomes to evaluate its effectiveness. Although intravenous maintenance fluid therapy has been used for nearly two centuries, existing studies show wide heterogeneity in reported endpoints, limiting the ability to perform meta-analyses and generate robust evidence. No core outcome set specific to pediatric intravenous maintenance fluid therapy currently exists, and previous initiatives have focused narrowly on fluid accumulation rather than the five components of intravenous maintenance fluid therapy prescription. This study aimed to create a comprehensive core outcome set-COSMIC-to standardize outcome reporting across research involving indications, tonicity, balanced solutions, composition, and volume of intravenous maintenance fluid therapy in children.
Methods: The study followed the core outcome measures in effectiveness trials and core outcome set-standards for development guidelines and was prospectively registered. Four phases were undertaken: a systematic literature review (1960-2023), the extraction and classification of all reported intravenous maintenance fluid therapy-related outcomes, a two-round modified Delphi process involving international experts and non-experts, and two online consensus meetings to finalize the cost. Eligible participants included authors of intravenous maintenance fluid therapy publications…
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