The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index; none of the 21 sources its claims cite is checked for support yet.
Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration
Open accessAbstract
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.
Overview
CoChat Summary
TL;DR
This study developed a core outcome set (COS) for studies assessing interventions for diabetes-related foot ulceration using COMET methodology. The final COS comprises eight outcomes: wound healing, time to healing, new/recurrent ulceration, infection, major amputation, minor amputation, health-related quality of life, and mortality.
Key findings
- The systematic review generated 714 unique outcomes merged into 95, and 18 patient interviews yielded 8 additional outcomes, producing 103 candidate outcomes for the Delphi survey.
- The two Delphi rounds were completed by 336 respondents (281 health care professionals, 55 patients) and 176 respondents (152 health care professionals, 24 patients), with a 52% second-round response rate; 63 outcomes were rated critical and 40 remained without consensus.
- After steering group rationalization excluded 41 of 63 critical outcomes (65%) and 25 of 40 no-consensus outcomes (63%), 37 outcomes were discussed at the consensus meeting, which was attended by 23 health care professionals and 5 patient representatives.
- The consensus meeting ratified 8 COS outcomes: wound healing, time to healing, new/recurrent ulceration, infection, major amputation, minor amputation, health-related quality of life, and mortality.
Methods
- COS development followed four COMET phases: systematic review and patient interviews to generate a long list; two-round Delphi survey; steering group meeting; and online consensus meeting.
- The Delphi survey used REDCap, presented outcomes in five COMET taxonomy areas, and scored each on a 9-point Likert scale from 1 (not important) to 9 (critically important).
- Consensus criteria defined critical outcomes as rated 7–9 by ≥70% of respondents and 1–3 by ≤15%; exclusion as rated 1–3 by ≥70% and 7–9 by ≤15%; outcomes meeting neither were considered without consensus and taken to the second round.
Limitations
- Stated: the Delphi survey had a moderate 52% response rate, and patient participation was relatively low despite active engagement across COS stages.
- Stated: the patient population is very heterogeneous, leading to an unexpectedly high number of critical outcomes (n = 63) and necessitating deviation from standard COS protocol via steering group rationalization before the consensus meeting.
- Evident from the text: only U.K. patients could participate in the Delphi survey because of ethical approval arrangements, and the final COS is not intended to provide guidance on how each outcome should be measured.
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0 Valid · 0 Not valid · 21 Not checked · 35 Own results and interpretations
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In the paper
“Following review of the critical outcomes, 41 out of 63 (65%) were excluded from discussion in the subsequent consensus meeting”
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Results > Phase III: Steering Group Meeting
plainn = 63- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Despite 22 outcomes being considered as critical in the Delphi process, the final 8 included in the COS captured most of these measures”
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Conclusions > Ratification of the Final COS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Following the Delphi process and steering committee review, 37 out of 103 long-listed outcomes (22 ranked as critical and 15 without consensus) were discussed and voted on in the consensus meeting”
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Results > Phase IV: Consensus Meeting
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Patient interviews yielded eight additional outcomes, which included wound bleeding, foot swelling, weight loss, requirement for foot elevation, reduction in cigarette smoking, psychological impact on partner, complications of debridement, and complications of plaster casting.”
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Results > Phase I: Generation of the Long List of Outcomes
plainn = 18- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“The systematic review generated 714 unique outcomes that were subsequently merged into 95 outcomes following application of the COMET taxonomy (8).”
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Results > Phase I: Generation of the Long List of Outcomes
What the sources say
- Not checked yetcites [8] Dovell, 2021, A systematic review of outcome reporting for interventions to treat people with diabetic foot ulceration, Diabet Med source
plainstates a cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
19 more claims
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Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Results > Phase IV: Consensus Meeting
“Outcomes with consensus are defined as not meeting criteria for inclusion or exclusion.”
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Research Design and Methods > Phase II: Delphi Process (May–December 2023)
“The outcomes not fulfilling the criteria for inclusion or exclusion were considered to lack consensus and were taken forward to the second round of the Delphi survey.”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Results > Phase II: Delphi Process
“| Pain | 3 | | 72 | | Critical |”
§ Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration > Results > Phase IV: Consensus Meeting
“| Pain | 2 | 15 | 25 | 42 | 73 | 42 |”
Citations
Cites
Harris, P. A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., & Conde, J. G. (2009) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2008.08.010 · Cited by 51,384
Diabetic foot ulcers and their recurrence
Armstrong, D. G., Boulton, A. J. M., & Bus, S. A. (2017) · New England Journal of Medicine · doi:10.1056/nejmra1615439 · Cited by 4,376
Self-citationEpidemiology of Type 2 Diabetes – Global Burden of Disease and Forecasted Trends
Khan, M. A., Hashim, M. J., King, J., Govender, R. D., Mustafa, H., & Alkaabi, J. (2019) · Journal of Epidemiology and Global Health · doi:10.2991/jegh.k.191028.001 · Cited by 3,577
The COMET Handbook: version 1.0
Williamson, P. R., Altman, D. G., Bagley, H., Barnes, K. L., Blazeby, J. M., Brookes, S. T., Clarke, M., Gargon, E., Gorst, S., Harman, N., et al. (2017) · Trials · doi:10.1186/s13063-017-1978-4 · Cited by 2,011
Developing core outcome sets for clinical trials: issues to consider
Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012) · Trials · doi:10.1186/1745-6215-13-132 · Cited by 1,661
Abbott, C. A., Malik, R. A., van Ross, E. R. E., Kulkarni, J., & Boulton, A. J. M. (2011) · Diabetes Care · doi:10.2337/dc11-1108 · Cited by 868
Core outcome set–STAndards for reporting: the COS-STAR statement
Kirkham, J. J., Gorst, S., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., Moher, D., Schmitt, J., Tugwell, P., et al. (2016) · PLOS Medicine · doi:10.1371/journal.pmed.1002148 · Cited by 650
The cost of diabetic foot ulcers and amputations to the National Health Service in England
Kerr, M., Barron, E., Chadwick, P., Evans, T., Kong, W. M., Rayman, G., Sutton‐Smith, M., Todd, G., Young, B., & Jeffcoate, W. J. (2019) · Diabetic Medicine · doi:10.1111/dme.13973 · Cited by 458
Pineda, C., Espinosa, R., & Pena, A. (2009) · Seminars in Plastic Surgery · doi:10.1055/s-0029-1214160 · Cited by 409
Definitions and criteria for diabetes‐related foot disease (IWGDF 2023 update)
van Netten, J. J., Bus, S. A., Apelqvist, J., Chen, P., Chuter, V., Fitridge, R., Game, F. L., Hinchliffe, R. J., Lazzarini, P. A., Mills, J. L., et al. (2023) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3654 · Cited by 258
Self-citation
Cited by
Wassif, R. K., Shamma, R. N., Hoffy, N. M. E., & El-Kayal, M. (2025) · AAPS PharmSciTech · doi:10.1208/s12249-025-03172-x · Cited by 35
Silva, M. A., Hamilton, E. J., Russell, D., Game, F. L., Wang, S. C., Baptista, S., & Monteiro‐Soares, M. (2025) · Journal of Medical Internet Research · doi:10.2196/69408 · Cited by 26
Self-citationPeñaranda, Y. F., Labarta-González-Vallarino, A., Arroyo-Bello, E., & Córdoba, M. G. D. Q. (2025) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph22040463 · Cited by 15
Alasfour, L., Alboloushi, A., Kirwan, E., McIntosh, C. D., MacGilchrist, C., & Hurst, J. E. (2025) · Journal of Tissue Viability · doi:10.1016/j.jtv.2025.100935 · Cited by 9
Ferguson, K. R., Alam, S., Phillips, C., Spencer, L., Goodeve, M., Begum, S., Travis, H., Tang, J., Feinn, R., McHugh, D., et al. (2025) · Complications · doi:10.3390/complications2040026 · Cited by 6
Metadata
- Authors
- Staniszewska, A., Game, F., Nixon, J., Russell, D., Armstrong, D. G., Ashmore, C., Bus, S. A., Chung, J., Chuter, V., Dhatariya, K., Dovell, G., Edmonds, M., Fitridge, R., Gooday, C., Hamilton, E. J., Jones, A., Kavarthapu, V., Lavery, L. A., Mills, J. L., Monteiro-Soares, M., Osborne-Grinter, M., Peters, E. J. G., Shalhoub, J., van Netten, J., Wukich, D. K., & Hinchliffe, R. J.
- Affiliations
- North Bristol NHS Trust (GB)
- University Hospitals of Derby and Burton NHS Foundation Trust (GB)
- University of Leeds (GB)
- University of Southern California (US)
- Amsterdam University Medical Centers (NL)
- Baylor College of Medicine (US)
- Western Sydney University (AU)
- University of East Anglia (GB)
- University of Bristol (GB)
- King's College Hospital NHS Foundation Trust (GB)
- Royal Adelaide Hospital (AU)
- Norfolk and Norwich University Hospitals NHS Foundation Trust (GB)
- The University of Western Australia (AU)
- King's College Hospital (GB)
- The University of Texas Southwestern Medical Center (US)
- 21Portuguese Red Cross Health School Lisbon, Lisbon, Portugal
- Imperial College Healthcare NHS Trust (GB)
- Corresponding author
- Staniszewska, Aleksandra
- ORCID
- Staniszewska, Aleksandra
- Game, Frances
- Nixon, Jane
- Russell, David
- Armstrong, David G.
- Ashmore, Christopher
- Bus, Sicco A.
- Chung, Jayer
- Chuter, Vivienne
- Dhatariya, Ketan
- Dovell, George
- Edmonds, Michael
- Fitridge, Robert
- Gooday, Catherine
- Hamilton, Emma J.
- Kavarthapu, Venu
- Lavery, Lawrence A.
- Mills, Joseph L.
- Osborne-Grinter, Maia
- Peters, Edgar J.G.
- Shalhoub, Joseph
- van Netten, Jaap
- Wukich, Dane K.
- Hinchliffe, Robert J.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2024-09-06
- Volume
- 47
- Issue
- 11
- Pages
- 1958-1968
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC11502534
- OpenAlex
- W4402305119
- Cited by
- 45
- References
- 27
- Citations by year
- 2026: 27 · 2025: 18
- FWCI
- 2.89
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Explore Bristol Research (publishedVersion, cc-by)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Funders
- University of Bristol
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- core outcome set, wound healing, ulcer recurrence, infection, amputation, health-related quality of life, mortality, Delphi consensus, outcome standardization, comparative effectiveness
- MeSH terms
- Delphi Technique, Humans, Outcome Assessment, Health Care, Diabetic Foot
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