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Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE).

Patricia Healy^1,2, Sanne Gordijn³, Wessel Ganzevoort⁴

¹Health Research Board - Trials Methodology Research Network, Galway, Ireland. patricia.healy@nuigalway.ie.

|August 24, 2018

Summary

This study is developing core outcome sets (COS) for fetal growth restriction (FGR) prevention and treatment. Standardizing outcomes will improve research synthesis and clinical practice for better patient care.

Keywords:

Core outcome sets Delphi Foetal growth restriction Methodology Pregnancy

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Area of Science:

Obstetrics and Gynecology
Perinatology
Clinical Trial Methodology

Background:

Fetal growth restriction (FGR) poses significant risks for stillbirth, neonatal complications, and long-term health issues like cardiovascular disease and neurodevelopmental disorders.
Current research on FGR interventions is hindered by inconsistent outcome definitions and reporting, making evidence synthesis challenging.
Developing standardized Core Outcome Sets (COS) is crucial for improving the quality and comparability of FGR research.

Framework:

A systematic literature review will identify existing outcomes reported in FGR studies.
An international Delphi study involving diverse stakeholders (parents, healthcare professionals, researchers) will prioritize and refine outcome importance.
A face-to-face consensus meeting will finalize the agreed-upon outcomes for the COS.

Implementation:

The Delphi study will involve three sequential online rounds for rating outcome importance.
Stakeholders can propose additional outcomes during the initial round of the Delphi study.
The process culminates in a consensus meeting to agree on the final list of outcomes for the FGR COS.

Implications:

The developed COS will ensure consistent data collection and reporting in FGR trials, reducing heterogeneity.
Standardized outcomes will enhance the synthesis of evidence through systematic reviews and meta-analyses.
Ultimately, this initiative aims to improve evidence-based clinical practice, patient care, and research quality in FGR.