Coming soon: A taxonomy has been developing for core outcomes in pediatric clinical trials
2National Institute of Health Data Science at Peking University, Beijing, China., China
3Oregon Health & Science University, USA
A standard taxonomy can help improve the standardization of databases or registry platforms, which can facilitate knowledge discovery and improve efficiency, reduce study waste, and increase the association of findings. The Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed a taxonomy for outcomes in medical research, but we found some limitations in it, such as the inability to categorize child growth and development, neonatal, and caregiver-related outcomes.
Objectives: We aim to develop a taxonomy of core outcomes applicable to child health.
Methods: Using systematic review to collate the core outcomes proposed by published pediatric core outcome set (COS) studies, based on which initial draft of the outcome’s taxonomy was applicable to children, will be formed using k-means clustering. Secondly, based on the clustering results, items of the taxonomy will be merged, deleted, or modified using the focus group discussion, and each item will be given a clear definition. Third, we will use a two-round Delphi survey with a consensus discussion to determine the final version of taxonomy. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. Finally, the newly developed taxonomy will be used to classify the pediatric core outcomes, and inter-rater reliability and content validity were calculated.
Results: A total of 906 pediatric core outcomes was collated. Forty-three categories were initially obtained by k-means clustering. A focus group discussion is in progress.
Conclusions: Implementation of this standard, pediatric-applicable taxonomy in clinical trials and systematic review databases and registry platforms will further facilitate effective searching, reporting, and classification of pediatric trial results. Patient, public, and/or healthcare consumer involvement: None.