Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration

Aleksandra Staniszewska^{1

2}, Frances Game³, Jane Nixon⁴, David Russell⁵, David G Armstrong⁶, Christopher Ashmore⁷, Sicco A Bus⁸, Jayer Chung⁹, Vivienne Chuter¹⁰, Ketan Dhatariya^{11

12}, George Dovell¹, Michael Edmonds¹³, Robert Fitridge^{14

15}, Catherine Gooday¹⁶, Emma J Hamilton^{17

18}, Amy Jones², Venu Kavarthapu¹⁹, Lawrence A Lavery²⁰, Joseph L Mills⁹, Matilde Monteiro-Soares^{21

22

23

24}, Maia Osborne-Grinter¹, Edgar J G Peters²⁵, Joseph Shalhoub²⁶, Jaap van Netten⁸, Dane K Wukich²⁷, Robert J Hinchliffe^{1

2}

Affiliations

¹ Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K.
² North Bristol NHS Trust, Bristol, U.K.
³ University Hospitals of Derby and Burton NHS Foundation Trust, Derby, U.K.
⁴ Leeds Institute of Health Sciences, University of Leeds, Leeds, U.K.
⁵ Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, U.K.
⁶ Southwestern Academic Limb Salvage Alliance, Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, CA.
⁷ Faculty of Medicine and Health, University of Leeds, Leeds, U.K.
⁸ Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam University Medical Center and University of Amsterdam, Amsterdam, the Netherlands.
⁹ Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX.
¹⁰ School of Health Sciences, Western Sydney University, Campbelltown, Australia.
¹¹ Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.
¹² Norwich Medical School, University of East Anglia, Norwich, U.K.
¹³ Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.
¹⁴ Discipline of Surgery, The University of Adelaide, Adelaide, Australia.
¹⁵ Vascular and Endovascular Surgery Service, Royal Adelaide Hospital, Adelaide, Australia.
¹⁶ Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.
¹⁷ Medical School, University of Western Australia, Murdoch, Australia.
¹⁸ Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Murdoch, Australia.
¹⁹ Department of Trauma and Orthopaedics, King's College Hospital, London, U.K.
²⁰ Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX.
²¹ Portuguese Red Cross Health School Lisbon, Lisbon, Portugal.
²² Cross Investigação e Desenvolvimento, Lisbon, Portugal.
²³ Departamento de Medicina da Comunidade Informação e Decisão em Saúde, Faculty of Medicine, University of Porto, Porto, Portugal.
²⁴ Center for Health Technology and Services Research, Faculty of Medicine, University of Porto, Porto, Portugal.
²⁵ Amsterdam Infection & Immunity, Infectious Diseases and Amsterdam Movement Sciences, Rehabilitation and Development, Amsterdam University Medical Center, Amsterdam, the Netherlands.
²⁶ Imperial Vascular Unit and Department of Surgery & Cancer, Imperial College Healthcare NHS Trust, London, U.K.
²⁷ Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, TX.

PMID: 39240785
PMCID: PMC11502534
DOI: 10.2337/dc24-1112

Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration

Aleksandra Staniszewska et al. Diabetes Care. 2024.

. 2024 Nov 1;47(11):1958-1968.

doi: 10.2337/dc24-1112.

Authors

Affiliations

¹ Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K.
² North Bristol NHS Trust, Bristol, U.K.
³ University Hospitals of Derby and Burton NHS Foundation Trust, Derby, U.K.
⁴ Leeds Institute of Health Sciences, University of Leeds, Leeds, U.K.
⁵ Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, U.K.
⁶ Southwestern Academic Limb Salvage Alliance, Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, CA.
⁷ Faculty of Medicine and Health, University of Leeds, Leeds, U.K.
⁸ Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam University Medical Center and University of Amsterdam, Amsterdam, the Netherlands.
⁹ Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX.
¹⁰ School of Health Sciences, Western Sydney University, Campbelltown, Australia.
¹¹ Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.
¹² Norwich Medical School, University of East Anglia, Norwich, U.K.
¹³ Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.
¹⁴ Discipline of Surgery, The University of Adelaide, Adelaide, Australia.
¹⁵ Vascular and Endovascular Surgery Service, Royal Adelaide Hospital, Adelaide, Australia.
¹⁶ Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.
¹⁷ Medical School, University of Western Australia, Murdoch, Australia.
¹⁸ Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Murdoch, Australia.
¹⁹ Department of Trauma and Orthopaedics, King's College Hospital, London, U.K.
²⁰ Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX.
²¹ Portuguese Red Cross Health School Lisbon, Lisbon, Portugal.
²² Cross Investigação e Desenvolvimento, Lisbon, Portugal.
²³ Departamento de Medicina da Comunidade Informação e Decisão em Saúde, Faculty of Medicine, University of Porto, Porto, Portugal.
²⁴ Center for Health Technology and Services Research, Faculty of Medicine, University of Porto, Porto, Portugal.
²⁵ Amsterdam Infection & Immunity, Infectious Diseases and Amsterdam Movement Sciences, Rehabilitation and Development, Amsterdam University Medical Center, Amsterdam, the Netherlands.
²⁶ Imperial Vascular Unit and Department of Surgery & Cancer, Imperial College Healthcare NHS Trust, London, U.K.
²⁷ Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, TX.

PMID: 39240785
PMCID: PMC11502534
DOI: 10.2337/dc24-1112

Abstract

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.

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Conflict of interest statement

Duality of Interest. No potential conflicts of interest relevant to this article were reported.

Figures

**Figure 1**
The four phases of COS development. Critical outcomes indicate items that have been rated as 7–9 by at least 70% of respondents at a given stage. Outcomes without consensus are those that have not been rated as either critical or not important by enough respondents.

See this image and copyright information in PMC

References

1. International Diabetes Association . IDF Diabetes Atlas. 10th ed. Accessed 11 April 2024. Available from https://www.diabetesatlas.org
1. Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of type 2 diabetes - global burden of disease and forecasted trends. J Epidemiol Glob Health 2020;10:107–111 - PMC - PubMed
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1. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med 2017;376:2367–2375 - PubMed
1. Kerr M, Barron E, Chadwick P, et al. The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabet Med 2019;36:995–1002 - PubMed

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Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration

Affiliations

Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical