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Heterogeneity and Gaps in Reporting Primary Outcomes From Neonatal Trials
Ami Baba1, James Webbe2, Nancy J Butcher1,3
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Insights
Primary outcome reporting in neonatal trials is inconsistent. Key details like minimal important difference and missing data are often omitted, hindering interpretation and evidence-based decisions.
Area of Science:
- Neonatal research
- Clinical trial methodology
- Evidence-based medicine
Background:
- Clear outcome reporting is crucial for interpreting clinical trial findings and informing medical decisions.
- Standardized core outcomes for neonatal trials exist, but primary outcome reporting practices require further investigation.
- Identifying strengths and weaknesses in primary outcome reporting is essential for improving neonatal trial transparency.
Purpose of the Study:
- To evaluate the completeness of primary outcome reporting in recent neonatal clinical trials.
- To identify specific areas of strength and weakness in how primary outcomes are reported.
- To inform strategies for enhancing the quality and transparency of neonatal trial reporting.
Main Methods:
- A systematic evaluation of 36 neonatal trials published between 2015 and 2020 was conducted.
- Trials included at least 100 participants per arm and a primary outcome from a core outcome set.
- Trained raters assessed outcome reporting completeness using Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Main Results:
- Outcome reporting completeness varied significantly across the evaluated neonatal trials.
- While measurement, statistical methods, and participant flow were fully reported, other domains showed deficiencies.
- Key areas with incomplete reporting included minimal important difference (28%), missing data (24%), blinding of outcome assessors (66%), and handling multiplicity (42%).
Conclusions:
- Primary outcome reporting in neonatal trials frequently lacks essential information for result interpretation and knowledge synthesis.
- Inconsistent reporting hinders evidence-informed decision-making in neonatology.
- Adherence to existing outcome-reporting guidelines by researchers, journals, and reviewers is recommended to improve transparency.
Objectives:
Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials.
Methods:
Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.
Results:
Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.
Conclusions:
Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.
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