Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration
Authors' conclusion
The proposed COS for studies assessing treatments for diabetes-related foot ulceration was developed using COMET methodology. Its adoption by the research community will facilitate assessment of comparative effectiveness of current and evolving interventions.
Study context
- Population
- Patients and experts rating outcomes for studies assessing treatments for diabetes-related foot ulceration336 and 176 respondents
- Outcome
- Core outcome set
Methodological detailsDelphi consensus, Core Outcome Measures in Effectiveness Trials (COMET) methodology, systematic review, patient interviews, two-round Delphi survey, consensus meeting
- Delphi consensus
- COMET methodology
- Systematic review
- Patient interviews
- Two-round Delphi survey
- Consensus meeting
Recommendations
As reported in the abstract
Candidate outcomes generated
103
Outcomes discussed in consensus meeting (22 critical, 15 without consensus)
37
Outcomes in the core outcome set (COS): wound healing, time to healing, new/recurrent ulceration, infection, major amputation, minor amputation, health-related quality of life, mortality
8
Further findings
Delphi participation
- Respondents completing round 1
- 336
- Respondents completing round 2
- 176
- Overall second round response rate
- 52%
Original publication
Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration. Diabetes Care. Published 6 September 2024. doi:10.
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