Objective: To develop a core outcome set (COS) for research on caesarean scar ectopic pregnancy (CSEP) treatment.
Design: Consensus development study.
Setting:
International.
Population:
Healthcare professionals, researchers, patient advocates, or individuals with lived experience of CSEP.
Methods:
The Delphi process was conducted from July to November 2024 following a systematic review and interviews with individuals with lived experience of CSEP, which identified potential outcomes. This process followed COMET guidance. Outcomes were presented in a two-round online Delphi survey. Round one included 287 healthcare professionals, 50 researchers, and 69 patient advocates and individuals with lived experience from 51 countries. In round two, 281 participants from 43 countries contributed. The final COS was developed at a consensus meeting of the steering committee, comprising all key stakeholders.
Results:
346 outcomes were initially identified, reduced to 62 in round one, then 40 in round two of the Delphi survey. The final COS comprises 19 core outcomes across seven domains: (1) Treatment success in early CSEP; (2) Complications in early treated CSEP; (3) Success of expectantly managed advanced live CSEP; (4) Complications of expectantly managed advanced live CSEP; (5) Mortality and severe morbidity; (6) Future reproductive health; and (7) Patient experience. Additionally, 15 non-mandatory outcomes and four essential reporting items were recommended. Clear definitions were provided for each core outcome.
Conclusion:
Through international consensus, we have developed a COS that reflects the perspectives of healthcare professionals, researchers, and individuals with lived experience of CSEP. This COS allows for standardised outcome reporting in future research, fostering a new generation of high-quality evidence that can inform clinical guidelines and ultimately improve patient outcomes.
Keywords:
Delphi; caesarean scar; consensus development study; core outcome set development; ectopic pregnancy; stakeholder engagement.
Simrit Nijjar, Ilan E Timor-Tritsch, Andrea Kaelin Agten, Jin Li, Krystle Y Chong, Munira Oza, Rosanna Acklom, Francesco D'antonio, Lan N Vuong, Ben Mol, Cecilia Bottomley, Davor Jurkovic
Disease Category: Gynaecology
Disease Name: Ectopic pregnancy
Age Range: 18 - 50
Sex: Female
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Systematic review
A mixed-method consensus approach will be used as informed by the COMET handbook. Potential core outcomes will be identified through a comprehensive literature review and semi-structured interviews with individuals with a lived experience of caesarean scar ectopic pregnancy. We will establish an international steering group of key stakeholders, including healthcare professionals, researchers, patients and patient representatives. The resulting list of potential outcomes will be entered into a 2-round modified Delphi process. Finally, the resulting core outcomes will be presented to a consensus meeting of key to develop the final core outcome set.