A protocol for developing, disseminating, and implementing a core outcome set for adenomyosis research.

Area of Science:

• Gynecology
• Reproductive Medicine
• Clinical Trials

Background:

• Adenomyosis is a common gynecological condition linked to heavy/painful periods, infertility, and adverse pregnancy outcomes.
• Current adenomyosis treatment studies report varied outcomes and measures, hindering data synthesis and clinical practice.
• This heterogeneity prevents effective meta-analyses and the development of evidence-based guidelines.

Purpose of the Study:

• To establish a minimum set of core outcomes for all future studies on uterus-sparing interventions for adenomyosis.
• To reduce heterogeneity in research and facilitate easier data synthesis.
• To enable comparable, prioritized, and patient-centered conclusions from meta-analyses and guidelines.

Main Methods:

• A systematic literature review identified potential outcomes.
• An international steering group of stakeholders agreed on a long list of outcomes.
• A modified Delphi process involving key stakeholders refined the outcome set.
• Recommendations for high-quality outcome measures will be developed.

Main Results:

• A core outcome set for adenomyosis research is being developed.
• The process involves systematic review, stakeholder consensus, and a Delphi methodology.
• The refined set will guide future research and improve data comparability.

Conclusions:

• Implementing this core outcome set will enhance comparable data availability in adenomyosis trials.
• This facilitates more patient-centered, evidence-based care for individuals with adenomyosis.
• The core outcome set will generate clinically significant and patient-centered results for treatment studies.