New resource informs improved outcome reporting in neonatal clinical trials

An international review of outcome reporting in neonatal clinical trials led by researchers at The Hospital for Sick Children (SickKids) has uncovered a lack of consistency in outcome reporting and provided a roadmap to inform future research.

Clinical trials have the potential to change care and improve outcomes for children around the world, but when outcomes are poorly defined and reported, it can be difficult for clinicians and scientists to apply learnings from a trial to a new population. This is especially true for children and youth, who make up only 25 per cent of the population and rely on clear, consistent child health outcome reporting to make trials relevant to their needs.

In two new papers published in Pediatrics, the research team reviewed how well items are being reported in neonatal clinical trials and presented examples for future outcome reporting.

The studies, led by Dr. Martin Offringa, neonatologist and Senior Scientist in in the Child Health Evaluative Sciences (CHES) program, build on previous research updating clinical trial reporting guidelines and are part of a growing push to improve the comprehensiveness and quality of trial reporting in the paediatric research community. 

Read more from Offringa and Ami Baba, Senior Project Manager in the EnRICH Research Group and Network and co-first author on the papers:

What did your research uncover?

Baba: In our first study (Heterogeneity and gaps in reporting primary outcomes from neonatal trials), we found quite variable and inconsistent reporting of the same outcomes in the 36 recently published neonatal trials that we assessed. Many important trial outcome features were not adequately described in the trial report, to the extent that can change the interpretation of the trial’s result.  

Our findings really highlighted the need for a larger uptake and use of existing reporting guidelines, and so our second paper (Strengthening reporting of neonatal trials) compiled good reporting examples for each standard reporting item for the top 12 most important neonatal trial outcomes to help guide research teams.   

Why is outcome reporting important?

Offringa: When other researchers and stakeholders are not able to fully understand what the trial was about, what was found and the implications of its results, the study can no longer inform clinical practice. As researchers, we all need to be aware of the most modern concepts in health outcomes, apply these concepts where needed, and make sure our important findings and messages do not get lost because of preventable reporting oversights. 

Baba: Beyond academic circles, increased awareness of suboptimal reporting in research is critical, as it encourages readers to be critical of their source of information and how it is reported. We believe these papers are an important step towards the standardization of outcome reporting in neonatal clinical trials, and subsequently an essential component of improving child health outcomes. 

What are the next steps for this research? 

Offringa: Well-reported clinical research will be the foundation for SickKids vision of Precision Child Health, providing individualized care to each patient. We need to clearly establish and report on the outcomes for each child in detail, so that the approach for one child may be used to inform and transform care for others in the future. 

Baba: While these two papers looked specifically at outcome reporting in paediatric randomized clinical trials (RCTs), there is room for improved reporting in all aspects of paediatric RCTs, from consent processes, social determinants of health, and to tailored treatments for young children. We are currently developing reporting guideline extensions for paediatric clinical trial protocols and trial reports that will inform this work.