Developing and Implementing a Core Outcome Set for Ectopic Pregnancy

Abstract

Background: Diagnosis of ectopic pregnancy (EP) has improved significantly in the last few decades, and RCTs remain the mainstay of assessing the effectiveness and safety of treatments. The pooling of individual RCT data is likely to provide the best evidence to inform clinical practice. However, currently published data in ectopic pregnancy has reported many different outcomes, which are themselves often defined and measured in distinct ways. The lack of consensus and level of variation results in an inability to compare the results of individual RCTs, and consequently directly impacts the usefulness of research to inform patients and clinicians in clinical practice. Aim: The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Methods and Analysis: We have established an international steering group of stakeholders, including healthcare professionals, researchers, and individuals with lived experience with EP. We have identified potential outcomes from a comprehensive literature review of published randomised controlled trials. We have utilised a modified Delphi method to prioritize outcomes. Results: Key stakeholders have been invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). 424 enrolled participants, with 86% completing round 1, comprising of 117 (32%) healthcare professionals, 237(64%) individuals with lived experience, 14(4%) researchers. Highly rates outcomes included the resolution of EP, psychological impact, and future fertility outcomes. Conclusion: Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes over 3 rounds. Implementation of a core outcome set will enable collection and reporting of data in a standardised fashion. This will allow standardisation of research to guide and inform clinical practice and enhance patient centred care.