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

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.

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.

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).