We will define a COS for studies that investigate any uterus-sparing intervention for treating uterine adenomyosis. The core outcomes will not be limited to a study type. All stages of adenomyosis will be included. The COS will be defined for a premenopausal population. Recommendations for the diagnosis of adenomyosis in clinical trials are not within the scope of COSAR. This should be in a separate process, including gynaecology imaging experts with special interest in adenomyosis.
ContributorsManaging group:
Dr. Joel Naftalin (University College London Hospital)
Dr. Tina Tellum (University Hospital Oslo)
Dr. Martin Hirsch (Oxford University Hospitals)
Disease Category: Gynaecology
Disease Name: Adenomyosis
Age Range: 18 - 60
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Device manufacturers
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Families
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion
- Systematic review
A long list of core outcomes was identified via a structured literature search and review.
The list will be presented to stakeholders via 2 rounds of Delphi-surveys. The participants will rate each item on a 9-point Likert scale.
All items that do not reach consensus in the first round, will be presented in the second round. In round 1, participants will have the possibility to suggest further outcomes, that will be presented in round 2.
Consensus that an outcome should not be included in the COS is defined as 70% or more scoring it as 1 to 3 and fewer than 15% scoring it as 7 to 9. Consensus that an outcome should automatically be included in the COS is defined as 70% or more scoring it as 7 to 9 and fewer than 15% scoring it as 1 to 3.
In round 3, the steering committee will discuss the items that did not reach consensus through previous rounds and agree on the final COS.
The steering committee will finally develop recommendations on outcome measures for each outcomes.