Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set

Area of Science:

• Perinatal Medicine
• Clinical Trial Methodology
• Patient-Centered Outcomes Research

Background:

• Twin-Twin Transfusion Syndrome (TTTS) presents significant perinatal mortality and morbidity risks.
• Current treatment outcome reporting lacks standardization, hindering comparative effectiveness research.
• Fetoscopic laser surgery is the primary TTTS intervention, necessitating consistent outcome evaluation.

Framework:

• An international steering group, including patients, will guide core outcome set development.
• A systematic literature review will identify existing TTTS treatment outcomes.
• A modified Delphi method will achieve stakeholder consensus on core outcomes.

Implementation:

• Stakeholder consensus will be built via an international, multi-perspective online Delphi survey.
• A consensus meeting will finalize the core outcome set for TTTS.
• Future steps include defining measurement, dissemination, and international implementation strategies.

Implications:

• A standardized core outcome set will enhance TTTS clinical trials and systematic reviews.
• Improved research quality will better guide clinical practice and patient management.
• This initiative aims to advance maternal and perinatal outcomes, including long-term neurodevelopmental trajectories.