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-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-Children 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.
Current status
An international advisory group has been assembled. Youth workshops have been conducted in Canada, England, Spain, France, and Scotland. The Delphi Study launched in January 2024 and is currently ongoing. The registration for the development of CONSORT-C can be found here.
Publications
Systematic review: Clyburne-Sherin AV, Thurairajah P, Kapadia MZ, Sampson M, Chan WW, Offringa M. Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews. Trials. 2015 Sep 18;16:417. doi: 10.1186/s13063-015-0954-0. PMID: 26385379; PMCID: PMC4574457.
Viewpoint: Baba A, Offringa M. Transparent Reporting-SPIRIT-C/CONSORT-C Pediatric Updates. JAMA Pediatr. 2023 Dec 26. doi: 10.1001/jamapediatrics.2023.5740. Epub ahead of print. PMID: 38147343.
Protocol: Baba A, Smith M, Potter BK, Chan AW, Moher D, Offringa M. Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children. Trials. 2024 Jan 30;25(1):96. doi: 10.1186/s13063-024-07948-7. PMID: 38287439.
Updated January 2024
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