The CONSORT (Consolidated Standards of Reporting Trials) statement offers a standard way for authors to prepare reports of trial findings, thereby facilitating their complete and transparent reporting and aiding their critical appraisal and interpretation. The CONSORT statement has led to improved reporting and better implementation of trials. Yet, specific elements for trials with children (from newborn babies to adolescents, detailing the intervention, drug dose and delivery, validity of the outcomes studied, etc.) are not included. Paediatric trials require additional and modified items.
In collaboration with members of the CONSORT Group, we are extending the current CONSORT statement to develop a checklist of essential items that authors should include when reporting the main results of paediatric clinical trials. The CONSORT-C (Children) extension to the CONSORT statement aims to improve quality of information reported from paediatric trials by providing evidence-based recommendations on the core content that should be addressed in scientific literature. CONSORT-C will highlight the key elements in the reporting of paediatric trials that differ from adult trials by systematically evaluating current evidence from published guidelines and implementing expert, consumer, and knowledge user feedback to produce a checklist and supplementary explanation document to guide paediatric trial reports.
The evidence synthesis, Delphi survey and international consensus have been completed. The checklists have been finalized (available on request). CONSORT-C Statement and Explanation and Elaboration document will be published in Q2 2022.
Details from the systematic review can be found here: Clyburne-Sherin AVP, Thurairajah P, Kapadia M.Z, Sampson M, Chan WWY, Offringa M (2015). Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews – BMC Trials, 16: 417.
Updated February 2022