Two New Child Health Reporting Guidelines: SPIRIT/CONSORT-Children

Comprehensive reporting in published trial protocols and reports is vital to readers to have the proper context to understand how a trial was designed, conducted, and what the findings may mean. To inform health decisions. The omission of key details in trial publications has a substantial impact on trial end-users, i.e., patients, their families, clinicians, and scientists.

This is an ongoing issue within medical research. For over a decade, there has been a push to improve transparency and reporting. This effort has not gone unnoticed, and has gained significant traction: as of November 2023, the Enhancing the Quality of and Transparency of Health Research (EQUATOR) network database curates a record of 600 reporting guidelines.

Notably, for trial protocols and trial reports, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, and the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement, provide guidance on the minimum set of information that should be reported. As highlighted by Hopewell et al. (2022), these guidelines have been endorsed and cited extensively. An updated version of both SPIRIT and CONSORT are expected in early 2024. These updates will factor several changes reflecting developments in the clinical trial field and will harmonize reporting guidance between these checklists.

Yet, despite growing endorsement, awareness, and a surge in the number of reporting guidelines, there is a paucity of pediatric-specific reporting guidelines. Specifically, a recent empirical study published by Li et al. (2023) found only four guidelines for research conducted with the pediatric population but none of them were dedicated to pediatrics/child health clinical trials. Relatedly, large variability in reporting continue to persist in pediatric/child health clinical trials, as seen in adolescent depression trials and neonatal trials. As highlighted in a systematic review published in 2015, there are several unique considerations in reporting pediatric/child health clinical trials comprehensively. At the end of 2023, there is an urgent need for reporting guidance that considers pediatric-specific issues like sources for drug doses based on a participant’s age and development, age-appropriate trial outcome selection and measurement, to name a few.

Building on the updated SPIRIT and CONSORT guidelines, a Canadian team has started developing guidance specific to pediatric/child health clinical trials: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C). Their development will harness the voices of an international group of stakeholders, including young people (ages 12-24) and family caregivers (e.g., parents, guardians). The aim is to identify the minimum information set – items that should be reported in all published pediatric/child health clinical trials to improve the interpretability and usability of trial protocols and reports. Established research methods will be used to reach consensus on the final reporting items in the checklists.

We invite those who are involved with and are stakeholders of pediatric/child health clinical trials to get involved in this global initiative. We are looking for Delphi panelists globally to contribute to this effort between January and April 2024. Express your interest through this form – and become a part of this global initiative to foster transparent reporting in pediatric/child health clinical trials!