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

Lei, Ruobing, Estill, Janne, Florez, Ivan D, Li, Qiu, Chen, Yaolong and Williamson, Paula ORCID: 0000-0001-9802-6636 (2025) Uptake of core outcome sets in paediatric clinical trials: a protocol BMJ PAEDIATRICS OPEN, 9 (1). e003054-. ISSN 2399-9772, 2399-9772

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Abstract

Introduction A growing number of paediatric core outcome sets (COS) have been developed in the past 20 years. Previous studies have provided many useful insights into the uptake of COS. In addition to the awareness of COS among clinical trialists, the COS development process (especially patient participation) and the actions of the developers can promote COS uptake. However, the uptake of COS in paediatric clinical trials needs to be further explored. The aim of this study is to provide information on the rationale and use of paediatric COS in clinical trials, and to analyse in depth the awareness and views of COS developers and clinical trialists about the development and use of COS. Methods and analysis We will include all paediatric COS identified in our previous systematic review and those subsequently included in the Core Outcome Measures in Effectiveness Trials (COMET) database. We will extract the target condition, population, intervention, list of core outcomes and the details of patient involvement. Next, we will search the Clinicaltrials.gov and WHO International Clinical Trials Registry Platform for trials on health conditions addressed by the identified COS. We will assess the comparability of the scopes in each COS-trial pair and determine for the outcomes in each clinical trial if they match exactly or generally, or if they do not match, with the outcomes of their respective COS. Finally, we will conduct a survey and semistructured interviews among COS developers and clinical trialists to examine their views. Ethics and dissemination Ethical approval for the study has been granted by the ethics committee of the Institute of Health Data Science, Lanzhou University (No. HDS-202405-01). This study was registered on COMET (https://www.comet-initiative.org/Studies/Details/3122).

Item Type:	Article
Uncontrolled Keywords:	Child Health, Data Collection, Qualitative research
Divisions:	Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Population Health
Depositing User:	Symplectic Admin
Date Deposited:	24 Apr 2025 08:53
Last Modified:	16 Jun 2026 20:12
DOI:	10.1136/bmjpo-2024-003054
Open Access URL:	https://bmjpaedsopen.bmj.com/content/9/1/e003054
Related Websites:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3191589
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