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Uptake of core outcome sets in paediatric clinical trials: a protocol

Ruobing Lei1,2,3, Janne Estill4,5, Ivan D Florez6,7,8

  • 1Chevidence Lab of Child & Adolescent Health, Children's Hospital of Chongqing Medical University, Chongqing, China.

BMJ Paediatrics Open
|March 3, 2025
PubMed

Insights

This study examines the use of paediatric core outcome sets (COS) in clinical trials. It analyzes COS development, patient involvement, and trialist awareness to improve the application of these crucial pediatric research tools.

Area of Science:

  • Paediatric research methodology
  • Clinical trial design and conduct
  • Health outcomes research

Background:

  • Numerous paediatric core outcome sets (COS) have been developed, yet their uptake in clinical trials requires further investigation.
  • Previous research highlights the importance of COS awareness, development processes (including patient participation), and developer actions in promoting COS adoption.
  • Understanding the rationale and practical application of paediatric COS is essential for improving evidence synthesis and clinical decision-making.

Purpose of the Study:

  • To investigate the rationale and utilization of paediatric core outcome sets (COS) within clinical trials.
  • To analyze the awareness and perspectives of both COS developers and clinical trialists regarding COS development and implementation.
  • To identify factors influencing the uptake and effective use of paediatric COS in research.

Main Methods:

  • Systematic review of identified paediatric COS, including target condition, population, intervention, core outcomes, and patient involvement.
  • Registry searches (ClinicalTrials.gov, WHO ICTRP) to identify relevant paediatric clinical trials.
  • Comparative analysis of COS-trial outcome scope matching and qualitative data collection via surveys and interviews with COS developers and trialists.

Main Results:

  • Identification and characterization of paediatric COS and their corresponding clinical trials.
  • Assessment of the degree of outcome matching between COS and clinical trials.
  • In-depth examination of the views and experiences of COS developers and clinical trialists.

Conclusions:

  • The study will provide critical insights into the current use and perceived barriers to paediatric COS adoption in clinical trials.
  • Findings will inform strategies to enhance the development and implementation of COS, ultimately improving the quality and comparability of paediatric research.
  • Recommendations will be formulated to optimize the integration of COS into paediatric clinical trial design and reporting.
Abstract

Keywords:
Child HealthData CollectionQualitative research

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