Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration Article Swipe
Aleksandra Staniszewska
,
Frances L. Game
,
Jane Nixon
,
David Russell
,
David G. Armstrong
,
Christopher Ashmore
,
Sicco A. Bus
,
Jayer Chung
,
Vivienne Chuter
,
Ketan Dhatariya
,
George Dovell
,
Michael Edmonds
,
Robert Fitridge
,
Catherine Gooday
,
Emma Hamilton
,
Amy Jones
,
Venu Kavarthapu
,
Lawrence A. Lavery
,
Joseph L. Mills
,
Matilde Monteiro‐Soares
,
Maia Osborne-Grinter
,
Edgar J.G. Peters
,
Joseph Shalhoub
,
Jaap J. van Netten
,
Dane K. Wukich
,
Robert J. Hinchliffe
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.2337/dc24-1112
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.2337/dc24-1112
OBJECTIVE Diabetes affects 537 million people globally, with 34% expected to develop foot ulceration in their lifetime. Diabetes-related foot ulceration causes strain on health care systems worldwide, necessitating provision of high-quality evidence to guide their management. Given heterogeneity of reported outcomes, a core outcome set (COS) was developed to standardize outcome measures in studies assessing treatments for diabetes-related foot ulceration. RESEARCH DESIGN AND METHODS The COS was developed using Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and patient interviews generated a long list of outcomes that were rated by patients and experts using a nine-point Likert scale (from 1 [not important] to 9 [critical]) in the first round of the Delphi survey. Based on predefined criteria, outcomes without consensus were reprioritized in a second Delphi round. Critical outcomes and those without consensus after two Delphi rounds were discussed in the consensus meeting where the COS was ratified. RESULTS The systematic review and patient interviews generated 103 candidate outcomes. The two consecutive Delphi rounds were completed by 336 and 176 respondents, resulting in an overall second round response rate of 52%. Of 37 outcomes discussed in the consensus meeting (22 critical and 15 without consensus after the second round), 8 formed the COS: wound healing, time to healing, new/recurrent ulceration, infection, major amputation, minor amputation, health-related quality of life, and mortality. CONCLUSIONS 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.
Related Topics
Concepts
Medicine
Delphi method
Diabetic foot
Amputation
Psychological intervention
Systematic review
Likert scale
Delphi
Foot (prosody)
Quality of life (healthcare)
Outcomes research
Physical therapy
Diabetes mellitus
MEDLINE
Diabetic foot ulcer
Evidence-based medicine
Intensive care medicine
Surgery
Alternative medicine
Nursing
Pathology
Computer science
Philosophy
Operating system
Mathematics
Statistics
Law
Endocrinology
Linguistics
Political science
Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.2337/dc24-1112
- OA Status
- green
- Cited By
- 14
- References
- 27
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4402305119
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4402305119Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.2337/dc24-1112Digital Object Identifier
- Title
-
Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot UlcerationWork title
- Type
-
reviewOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-09-06Full publication date if available
- Authors
-
Aleksandra Staniszewska, Frances L. Game, Jane Nixon, David Russell, David G. Armstrong, Christopher Ashmore, Sicco A. Bus, Jayer Chung, Vivienne Chuter, Ketan Dhatariya, George Dovell, Michael Edmonds, Robert Fitridge, Catherine Gooday, Emma Hamilton, Amy Jones, Venu Kavarthapu, Lawrence A. Lavery, Joseph L. Mills, Matilde Monteiro‐Soares, Maia Osborne-Grinter, Edgar J.G. Peters, Joseph Shalhoub, Jaap J. van Netten, Dane K. Wukich, Robert J. HinchliffeList of authors in order
- Landing page
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https://doi.org/10.2337/dc24-1112Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
-
greenOpen access status per OpenAlex
- OA URL
-
https://www.ncbi.nlm.nih.gov/pmc/articles/11502534Direct OA link when available
- Concepts
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Medicine, Delphi method, Diabetic foot, Amputation, Psychological intervention, Systematic review, Likert scale, Delphi, Foot (prosody), Quality of life (healthcare), Outcomes research, Physical therapy, Diabetes mellitus, MEDLINE, Diabetic foot ulcer, Evidence-based medicine, Intensive care medicine, Surgery, Alternative medicine, Nursing, Pathology, Computer science, Philosophy, Operating system, Mathematics, Statistics, Law, Endocrinology, Linguistics, Political scienceTop concepts (fields/topics) attached by OpenAlex
- Cited by
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14Total citation count in OpenAlex
- Citations by year (recent)
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2025: 14Per-year citation counts (last 5 years)
- References (count)
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27Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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