COSCAR 1.0
Research type
Research Study
Full title
Developing, disseminating and implementing a Core Outcome Set for Caesarean Scar Ectopic Pregnancy Research (COSCAR)
IRAS ID
334576
Contact name
Simrit Nijjar
Contact email
Sponsor organisation
UCLH/UCL Joint Research Office, part of the Research Directorate
Clinicaltrials.gov Identifier
Z6364106/2023/12/71, UCL Data Protection Registration number; 2903, COMET
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Studies evaluating caesarean scar ectopic pregnancy (CSEP) report many different outcomes and often define and measure success or complications of various treatments in different ways. This variation in reporting of results leads to heterogeneity and an inability to directly or reliably compare results of studies, which means the optimal treatment option remains unknown.
A core outcome set (COS) is a consensus-based agreed minimum set of outcomes that should be reported and measured in all clinical trials of a specific disease or study population. An outcome refers to what is being measured. We intend to develop a COS to ensure outcomes important to all stakeholders are collected in all subsequent research studies to ensure future research in CSEP is consistent, which will allow for a more reliable head-to-head comparison of the different treatment modalities and their outcomes. This will then enable synthesis of high-quality evidence to inform evidence-based treatment guidelines for CSEP.
The COS will be defined for all treatment options for CSEP, including expectant, medical, and surgical management.
A mixed-method consensus approach will be used as informed by the COMET handbook to develop this COS. Potential core outcomes will be identified through a comprehensive literature review and semi-structured interviews with individuals with a lived experience of CSEP. 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 stakeholders to develop the final COS, which will then be disseminated through publication in a peer reviewed scientific journal to ensure its uptake by the gynaecology research community.
REC name
London - Surrey Research Ethics Committee
REC reference
24/LO/0190
Date of REC Opinion
8 Apr 2024
REC opinion
Further Information Favourable Opinion