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.
Aleksandra Staniszewska, Frances 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 J. Hamilton, Amy Jones, Venu Kavarthapu, Lawrence A. Lavery, Joseph L. Mills, Matilde Monteiro-Soares, Maia Osborne-Grinter, Edgar J.G. Peters, Joseph Shalhoub, Jaap van Netten, Dane K. Wukich, and Robert J. Hinchliffe
Disease Category: Endocrine & metabolic, Wounds
Disease Name: Diabetic foot ulcer/ulceration, Diabetes mellitus
Age Range: 16 - 100
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (patients)
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- Consensus conference
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Systematic review
Long list of outcomes will be identified from 3 sources. Firstly a systematic review of the literature. Secondly patient interviews and thirdly from an international steering committee (made up of healthcare professionals and patient representatives).
A 3 round Delphi survey will then be undertaken to condense the long list of outcomes and the final core outcome set will be decided by a consensus meeting of the steering committee.