Inconsistent outcome reporting in large neonatal trials: a systematic review

Area of Science:

• Neonatal research
• Clinical trial methodology
• Evidence-based medicine

Background:

• Inconsistent outcome selection and reporting in clinical trials contribute to research waste.
• The prevalence of this issue in neonatal trials is not well-documented.
• Standardized outcome reporting is crucial for reliable research findings.

Purpose of the Study:

• To assess outcome reporting consistency in large neonatal clinical trials.
• To examine the use of composite outcomes in these trials.
• To determine the extent of parent or former patient involvement in outcome selection.

Main Methods:

• A systematic literature search was performed across major databases (CENTRAL, CINAHL, EMBASE, MEDLINE).
• Randomized trials involving at least 100 infants per arm, published between July 2012 and July 2017, were included.
• Outcomes, outcome measures, and parent/former patient involvement were extracted and categorized.

Main Results:

• Seventy-six trials with 43,126 infants were analyzed, reporting 216 distinct outcomes and 889 measures.
• Outcome reporting was highly variable; only 88% reported survival, and most outcome measures appeared in single trials.
• Thirty-three composite outcomes were used, but no trials reported parent or former patient involvement in outcome selection.

Conclusions:

• Inconsistent outcome reporting and lack of stakeholder involvement in neonatal trials hinder clinically meaningful research.
• Establishing a core outcome set for neonatal trials, with multi-stakeholder input, is essential.
• This initiative aims to enhance the quality and relevance of future neonatal research.