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Strengthening outcome reporting in neonatal trials

By Ami Baba and Dr. Martin Offringa


Suboptimal reporting is a widespread issue in paediatric research. The omission of key details in clinical trial reporting has a massive (if often invisible) impact on trial end-users, from patients and families, to clinicians, scientists and other stakeholders.


In many fields, like adult rheumatology, transparent clinical trial outcome reporting has become integral in the improvement of health outcomes, as it increases the availability of the “minimal” information that informs treatment choices.


While inadequate reporting is known to be an issue in medical research in general and is a significant contributor to “research waste”, its negative effects are magnified in paediatrics because there still are few well-conducted paediatric randomized clinical trials (RCTs).


Our papers set new standards for high quality reporting of outcome reporting in neonatal trials, so valuable research doesn’t get wasted.


We know that comprehensiveness and quality of trial reporting has been of interest within the paediatric research community for years, to expand the pool evidence that is invaluable to advancing child health. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, and the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement, provide checklists for the development of clinical trial protocols and reporting of randomized controlled trials, respectively.


However, before the SPIRIT-Outcomes 2022 and CONSORT-Outcomes 2022 reporting extensions were published by our team in December 2022, consensus-based guidance on what information about outcome reporting should be included was not available in the research community.


In examining how well current standard items are reported in published neonatal trials, our latest research in Pediatrics identified that, while trial authors generally reported most CONSORT 2010 items, many important trial outcome features were not adequately described in their trial report, to a degree that can change the interpretation of the trial’s results (1).


Our review rated 36 neonatal trials’ primary outcome reporting quality. These trials were the main “decision changing” trials in the field from the last seven years and were in nine journals highly relevant to neonatology, including the New England Journal of Medicine, JAMA Pediatrics, The Lancet Child and Adolescent Health, JAMA, and Pediatrics.


Inconsistent outcome reporting can have massive downstream impacts on the development of future clinical trials and patient care, so why does this problem continue exist? In speaking with clinical trial experts from around the world, our research uncovered that many research teams did not understand key outcome concepts.


To help address this issue, we compiled good reporting examples for each standard reporting item for the top 12 most important neonatal trial outcomes for research teams to reference in their own work. This guide, also published in Pediatrics (2), will serve as a resource for research teams around the world, to help inform standardization of the design, conduct, and eventual reporting of child health trials.


As researchers, we are supported by a myriad of tools and resources that can inform out trial design and reporting. We encourage all research teams to familiarize themselves with the exceptional outcome reporting and to work towards a future where no research is wasted.


Dr. Martin Offringa is a neonatologist and Senior Scientist in in the Child Health Evaluative Sciences (CHES) program at The Hospital for Sick Children (SickKids) in Toronto, Canada.


Ami Baba is a Senior Project Manager in the EnRICH Research Group and Network at The Hospital for Sick Children (SickKids) in Toronto, Canada.


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