A core outcome set for future research in ectopic pregnancy: an international consensus development study

Fertil Steril. 2023 May;119(5):804-812. doi: 10.1016/j.fertnstert.2023.01.042. Epub 2023 Feb 1.

Abstract

Objective: To address methodological deficiencies in published randomized controlled trials and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy (EP).

Design: To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in EP. Potential core outcomes were then entered into a 3-round Delphi survey. A total of 154 participants from 6 continents, comprising health care professionals, researchers, and individuals with lived experience in EP, completed all 3 rounds of the Delphi survey. Outcomes were prioritized at 3 consensus development meetings, and recommendations were developed on how to report these outcomes where possible.

Setting: Not applicable.

Patient(s): Health care professionals, researchers, and individuals with lived experience in EP.

Intervention(s): Not applicable.

Main outcome measure(s): Consensus for inclusion in core outcome set.

Result(s): Six outcomes reached full consensus, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction.

Conclusion(s): The core outcome set with 6 outcomes for EP will help standardize reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient-centered care.

Keywords: Core outcome set; consensus methods; ectopic pregnancy.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Consensus
  • Delphi Technique
  • Female
  • Humans
  • Pregnancy
  • Pregnancy, Ectopic* / diagnosis
  • Pregnancy, Ectopic* / epidemiology
  • Pregnancy, Ectopic* / therapy
  • Randomized Controlled Trials as Topic
  • Research Design*
  • Treatment Outcome