A Core Outcome Set to Guide Future Research on Caesarean Scar Ectopic Pregnancy: COSCAR Consensus Study

Area of Science:

• Reproductive Medicine
• Gynecological Surgery
• Clinical Trial Methodology

Background:

• Caesarean scar ectopic pregnancy (CSEP) presents unique challenges in diagnosis and management.
• Existing research lacks standardized outcome measures, hindering comparative analysis and evidence synthesis.
• A consensus-driven core outcome set (COS) is crucial for advancing CSEP research quality.

Purpose of the Study:

• To establish a universally accepted core outcome set (COS) for research concerning caesarean scar ectopic pregnancy (CSEP) treatment.
• To ensure consistency and comparability in clinical trials and observational studies investigating CSEP.

Main Methods:

• A Delphi consensus development study was conducted internationally, adhering to COMET guidelines.
• Potential outcomes were identified through systematic review and patient interviews, followed by two rounds of online Delphi surveys involving diverse stakeholders.
• A final consensus meeting of the steering committee, including healthcare professionals, researchers, and patient advocates, finalized the COS.

Main Results:

• An initial 346 outcomes were systematically reduced to 19 core outcomes across seven key domains, including treatment success, complications, mortality, future reproductive health, and patient experience.
• The developed COS includes clear definitions for each core outcome.
• Additionally, 15 non-mandatory outcomes and four essential reporting items were recommended.

Conclusions:

• An international consensus-driven core outcome set (COS) for CSEP research has been successfully developed.
• This COS standardizes outcome reporting, facilitating higher-quality evidence generation.
• The implementation of this COS is expected to inform clinical guidelines and enhance patient care for CSEP.