Evidence map›Paper›PMID 39240785›Full record

SynthesisDiabetes care2024

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

Aleksandra Staniszewska, Frances Game, Jane Nixon, David Russell, David G Armstrong, Christopher Ashmore, Sicco A Bus, Jayer Chung, Vivienne Chuter, Ketan Dhatariya and 16 more

Abstract readSystematic Review
In one paragraph

Synthesis in Diabetes care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Immunomodulatory Tissue-Engineering Strategies for Diabetic Foot Ulcer Management: A Systematic Review.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
    Pooled it
  5. Review
  6. Benefits of Multi-Disciplinary Limb Preservation Teams.Clinics in podiatric medicine and surgery · 2026
    Review
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Effect of Digital Intervention on Nurses' Knowledge About Diabetic Foot Ulcer: A Quasi-Experimental Study.International journal of environmental research and public health · 2025
    Article
  17. Review
  18. Article
  19. Global Trends in Diabetic Foot Research (2004-2023): A Bibliometric Study Based on the Scopus Database.International journal of environmental research and public health · 2025
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Aleksandra StaniszewskaTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K.ORCID 0000-0002-8917-1281
Frances GameUniversity Hospitals of Derby and Burton NHS Foundation Trust, Derby, U.K.
Jane NixonLeeds Institute of Health Sciences, University of Leeds, Leeds, U.K.
David RussellLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, U.K.
David G ArmstrongSouthwestern Academic Limb Salvage Alliance, Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, CA.
Christopher AshmoreFaculty of Medicine and Health, University of Leeds, Leeds, U.K.
Sicco A BusDepartment of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam University Medical Center and University of Amsterdam, Amsterdam, the Netherlands.
Jayer ChungDivision of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX.
Vivienne ChuterSchool of Health Sciences, Western Sydney University, Campbelltown, Australia.
Ketan DhatariyaElsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.ORCID 0000-0003-3619-9579
George DovellTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K.
Michael EdmondsDiabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, U.K.ORCID 0000-0002-8931-0069
Robert FitridgeDiscipline of Surgery, The University of Adelaide, Adelaide, Australia.
Catherine GoodayNorfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.
Emma J HamiltonMedical School, University of Western Australia, Murdoch, Australia.
Amy JonesNorth Bristol NHS Trust, Bristol, U.K.
Venu KavarthapuDepartment of Trauma and Orthopaedics, King's College Hospital, London, U.K.
Lawrence A LaveryDepartment of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX.
Joseph L MillsDivision of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX.
Matilde Monteiro-SoaresPortuguese Red Cross Health School Lisbon, Lisbon, Portugal.
Maia Osborne-GrinterTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K.
Edgar J G PetersAmsterdam Infection & Immunity, Infectious Diseases and Amsterdam Movement Sciences, Rehabilitation and Development, Amsterdam University Medical Center, Amsterdam, the Netherlands.
Joseph ShalhoubImperial Vascular Unit and Department of Surgery & Cancer, Imperial College Healthcare NHS Trust, London, U.K.
Jaap van NettenDepartment of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam University Medical Center and University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-6420-6046
Dane K WukichDepartment of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, TX.ORCID 0000-0002-3637-6208
Robert J HinchliffeTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDiabetes 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

methodsThe 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.

resultsThe 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.

conclusionsThe 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.

Indexed as

Delphi TechniqueDiabetic FootHumansOutcome Assessment, Health Care

Identifiers

PMID39240785
PMCPMC11502534

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.