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

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.

Contributors

Supervisor: Prof Ben W. Mol
Monash Womens, Monash Health, Clayton, Victoria, AUS
Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, AUS

Krystle Chong, Monash Health

Publication

Journal: Fertility and Sterility
Volume:
Issue:
Pages: -
Year: 2023
DOI: 10.1016/j.fertnstert.2023.01.042

Further Study Information

Current Stage: Completed
Date: January 2021 - December 2021
Funding source(s): None


Health Area

Disease Category: Gynaecology, Pregnancy & childbirth

Disease Name: Ectopic pregnancy

Target Population

Age Range: Unknown

Sex: Female

Nature of Intervention: Not specified

Stakeholders Involved

- Clinical experts
- Patient/ support group representatives
- Researchers
- Service providers

Study Type

- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Literature review

International steering group of key stakeholders has been established, including healthcare professionals, researchers, and patients with lived experience with ectopic pregnancy. Potential outcomes from ectopic pregnancies have been identified from a comprehensive literature review of published randomised controlled trials, and will be entered into a modified Delphi method. Key stakeholders will then be invited to score
potential core outcomes non a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring shoulder promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes.

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