A protocol for developing and implementing a core outcome set in ectopic pregnancy

Study Question:
To develop and implement a core outcome set to guide future ectopic pregnancy research

What is Known:
RCTs evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently to guide future research in ectopic pregnancy.

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

Further Study Information

Current Stage: Ongoing
Date: November 2019 - April 2020
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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