A growing number of pediatric core outcome sets have been developed in the past 20 years. Previous studies have provided many useful insights into the uptake of core outcome sets (COS). In addition to the awareness of COS among clinical trial investigators, some methodology of COS development (especially patient involvement) is a factor that promotes COS uptake. However, the uptake of COS in pediatric clinical trials needs to be further explored. Therefore, the aim of this study is to provide information on the rationale and use of pediatric COS in clinical trials, and to analyze in depth the awareness and views of COS developers and clinical trialists about COS development and use.
ContributorsRuobing Lei, Chevidence Lab of Child & Adolescent Health, Children’s Hospital of Chongqing Medical University, Chongqing, China
Yaolong Chen, Chevidence Lab of Child & Adolescent Health, Children’s Hospital of Chongqing Medical University, Chongqing, China
Paula Williamson, MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK
Disease Category: Child health
Disease Name: N/A
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Any
- Clinical experts
- COS uptake study
- Interview
- Literature review
- Survey
We will include all pediatric COS identified in our previous systematic review and those subsequently included in the COMET database and extract the data including condition, target population, intervention, list of core outcomes, and the details of patient involvement. We will search Clinicaltrials.gov for trials on health conditions addressed by the included COS. The comparability of the scopes in each COS-trial pair and for the outcomes in each clinical trial that are exact matches, general matches, and non-matches with outcomes in each relevant COS will be assessed. Then we will conduct survey and semi-structured interviews among COS developers and clinical trial investigators to examine their views.