Core Outcome Sets Relevant to Maternity Service Users: A Scoping Review

Area of Science:

• Obstetrics and Gynecology
• Neonatal Medicine
• Clinical Trial Methodology

Background:

• Variation in reported outcomes in maternity clinical trials complicates data synthesis and can lead to suboptimal interventions.
• Core outcome sets (COSs) are crucial for standardizing outcome measurement in research.
• This review addresses the need for standardized outcomes in maternity and neonatal care.

Purpose of the Study:

• To identify studies developing maternity-related COSs.
• To evaluate the scope, quality, and consistency of these COSs.
• To identify gaps in current evidence for COS development and application.

Main Methods:

• A comprehensive search was conducted across multiple databases and COS registers.
• Included studies published in English from inception to January 2020, focusing on maternal and neonatal COSs.
• COS development processes were assessed against established standards.

Main Results:

• Thirty-two articles on 26 COSs (17 maternal, 9 neonatal) were included, with a significant increase in publications since 2017.
• Maternal COSs generally included more outcomes than neonatal COSs.
• No COS met all minimum development standards; overlap and inconsistency in outcomes were common, though two COSs offered measurement guidance.

Conclusions:

• The increasing number of COSs indicates a growing commitment to standardizing outcomes.
• Despite improvements, the quality of COS development requires enhancement.
• Standardizing outcome measurement, definitions, and timing across COSs is urgently needed to improve data synthesis and clinical practice.