Reporting standards for child health research were few and poorly implemented

Transparent Reporting—SPIRIT-C/CONSORT-C Pediatric Updates

“…2 Reporting issues that are specifically related to pediatric RCTs include the following: (1) omission of key details on trial interventions and outcome measurements in children across age groups 3 ; (2) reporting of race, ethnicity, and various social determinants of health, such as sexual orientation and gender identity 4,5 ; (3) sample size calculations 6 ; and (4) describing consent and assent processes. 6 Certainly, awareness of research reporting has been increasing. For RCTs, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement and Consolidated Standards of Reporting Trials (CONSORT) statement have been widely cited and endorsed by journals for many years.…”

“…Notably, uptake of these guidelines is low, probably because these are specific to a particular subspecialty or condition and lack widespread dissemination and awareness in the pediatric community. 6 Evidently, reporting guidance that applies to all child health clinical trials is needed. Pediatric-specific reporting guidelines that feature reporting items that address common challenges in designing and conducting child health RCTs are needed to facilitate transparent and comprehensive reporting in pediatric trials, 6 as existing reporting standards do not provide adequate guidance on reporting of these pediatric-specific issues.…”

“…6 Evidently, reporting guidance that applies to all child health clinical trials is needed. Pediatric-specific reporting guidelines that feature reporting items that address common challenges in designing and conducting child health RCTs are needed to facilitate transparent and comprehensive reporting in pediatric trials, 6 as existing reporting standards do not provide adequate guidance on reporting of these pediatric-specific issues. 3,6 The perspectives of young people and family caregivers are needed to guide trialists in reporting key details that are important and relevant to trial end users.…”

“…Inadequate reporting on the design, conduct, and analysis of clinical trials prevents end users of research from being able to fully appreciate how the study was conducted, assess the reliability and validity of the trial findings, and understand the implications of the study’s findings in the context of their health management decisions and future research . Reporting issues that are specifically related to pediatric RCTs include the following: (1) omission of key details on trial interventions and outcome measurements in children across age groups; (2) reporting of race, ethnicity, and various social determinants of health, such as sexual orientation and gender identity; (3) sample size calculations; and (4) describing consent and assent processes …”

“…Although clear efforts have been made to improve reporting, at present, most research reporting guidelines are not pediatric specific. As of 2023, an empirical study found little guidance on reporting pediatric research: only 4 guidelines were published to date, and none of these guidelines were endorsed by pediatric journals listed in the Science Citation Index. Notably, uptake of these guidelines is low, probably because these are specific to a particular subspecialty or condition and lack widespread dissemination and awareness in the pediatric community .…”