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.

Original languageEnglish
Pages (from-to)804-812
Number of pages9
JournalFertility and Sterility
Volume119
Issue number5
Early online date1 Feb 2023
DOIs
Publication statusPublished - May 2023

Bibliographical note

Funding Information:
K.Y.C. has nothing to disclose. S.S. has nothing to disclose. K.B. has nothing to disclose. P.C.-A. reports grants from the National Institutes of Health / National Cancer Institute Cancer Centre Support Grant P30 CA008748. P.C. has nothing to disclose. G.C. has nothing to disclose. L.d.W. has nothing to disclose. J.M.N.D. has nothing to disclose. A.W.H. has received honoraria for consultancy for Ferring , Roche , Nordic Pharma , and AbbVie . M.M. has nothing to disclose. F.M. has nothing to disclose. M.O. has nothing to disclose. R.P. has nothing to disclose. A.S. has nothing to disclose. M.v.W. reports leading the Netherlands Satellite of the Cochrane Gynaecology and Fertility Group. J.v.H. has nothing to disclose. L.N.V. reports other from Merck , grants and other from Merck Sharp and Dohme , and grants and other from Ferring , outside the submitted work. J.Z. has nothing to disclose. D.J. has nothing to disclose. B.W.M. reports grants from the National Health and National Health and Medical Research Council , other from ObsEva, and grants from Guerbet and Merck , outside the submitted work.

Keywords

  • consensus methods
  • Core outcome set
  • ectopic pregnancy

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