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Abstract
Background
Randomised controlled trials (RCTs) evaluating ectopic pregnancy have different outcomes which are defined and measured in diverse ways, which limits their ability to inform evidence-based clinical practice.
Objective
To address methodological deficiencies in published RCTs and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy.
Design
To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in ectopic pregnancy. Potential core outcomes were then entered into a three-round Delphi survey. 154 participants from six continents, comprising healthcare professionals, researchers, and individuals with lived experience in ectopic pregnancy, completed all three rounds of the Delphi survey. Outcomes were prioritised at three consensus development meetings and recommendations were developed on how to report these outcomes where possible.
Subjects
Healthcare professionals, researchers, and individuals with lived experience in ectopic pregnancy
Results
Six outcomes reached full consensus, including treatment success, resolution time, number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction.
Conclusion
The core outcome set with six outcomes for ectopic pregnancy will help standardise reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient centred care.
Randomised controlled trials (RCTs) evaluating ectopic pregnancy have different outcomes which are defined and measured in diverse ways, which limits their ability to inform evidence-based clinical practice.
Objective
To address methodological deficiencies in published RCTs and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy.
Design
To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in ectopic pregnancy. Potential core outcomes were then entered into a three-round Delphi survey. 154 participants from six continents, comprising healthcare professionals, researchers, and individuals with lived experience in ectopic pregnancy, completed all three rounds of the Delphi survey. Outcomes were prioritised at three consensus development meetings and recommendations were developed on how to report these outcomes where possible.
Subjects
Healthcare professionals, researchers, and individuals with lived experience in ectopic pregnancy
Results
Six outcomes reached full consensus, including treatment success, resolution time, number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction.
Conclusion
The core outcome set with six outcomes for ectopic pregnancy will help standardise reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient centred care.
Original language | English |
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Pages (from-to) | 804-812 |
Journal | Fertility and Sterility |
Volume | 119 |
Issue number | 5 |
Early online date | 1 Feb 2023 |
DOIs | |
Publication status | Published - May 2023 |
Keywords / Materials (for Non-textual outputs)
- Core outcome set
- consensus methods
- ectopic pregnancy
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- 1 Finished
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MRC Centre for Reproductive Health at the University of Edinburgh
Pollard, J.
12/09/16 → 11/09/22
Project: Research