Standardising definitions for the pre-eclampsia core outcome set: A consensus development study

Area of Science:

• Obstetrics and Gynecology
• Clinical Trial Methodology
• Global Health

Background:

• Pre-eclampsia research lacks standardized outcome definitions, hindering evidence synthesis and clinical application.
• Existing definitions vary across guidelines and trials, leading to inconsistencies in research findings.
• Standardized definitions are crucial for improving the quality and comparability of pre-eclampsia research.

Purpose of the Study:

• To develop consensus definitions for the core outcome set in pre-eclampsia research.
• To ensure consistency in outcome measurement across studies.
• To facilitate the translation of research findings into clinical practice.

Main Methods:

• A comprehensive review of existing definitions from initiatives, guidelines, systematic reviews, and randomized trials.
• A consensus development meeting involving healthcare professionals and researchers, with representation from low- and middle-income countries.
• International steering group approval of the final core outcome set.

Main Results:

• Consensus definitions were successfully developed for all core outcomes related to pre-eclampsia.
• Specific definitions were created for stroke, pulmonary edema, acute kidney injury, elevated liver enzymes, low platelet count, birth weight, and neonatal seizures.
• Definitions were tailored for low- and middle-income countries, considering limitations in diagnostic interventions.

Conclusions:

• The established consensus definitions will standardize measurements in pre-eclampsia core outcome sets.
• This standardization is expected to enhance consistency in future randomized trials and systematic reviews.
• Improved research accessibility and translation into clinical practice are anticipated outcomes.