Development of a Core Outcome Set for studies assessing interventions for Diabetes- related Foot Ulceration

• DOI: 10.2337/figshare.26792704.v1
• Publication Date: 2024-09-06T17:08:22Z
• Authors: Aleksandra Stanis...; 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-...; Maia Osborne-Grinter; Edgar J.G. Peters; Joseph Shalhoub; Dane K. Wukich; Robert J. Hinchliffe
• Keywords: Foot (prosody)

<p dir="ltr"><b>Objective:</b></p><p dir="ltr">Diabetes mellitus affects 537 million people globally, with 34% expected to develop foot ulceration in their lifetime. Diabetes-related cause strain on healthcare systems worldwide, necessitating provision of high-quality evidence guide management. Given heterogeneity reported outcomes, a Core Outcome Set (COS) was developed standardize outcome measures studies assessing treatments for diabetes-related ulceration.</p><p dir="ltr"><b>Research Design and Methods:</b></p><p dir="ltr">The COS using COMET methodology. A systematic review patient interviews generated long-list outcomes that were rated by patients experts 9-point Likert scale (from 1-not important 9-critical) the first round Delphi survey. Based predefined criteria, without consensus reprioritized second round. Critical those after two rounds discussed meeting where ratified.</p><p><b>Results:</b></p><p 103 candidate outcomes. The consecutive completed 336 176 respondents, resulting an overall response rate 52%. Of 37 (22 critical 15 round), eight formed COS: wound healing, time new/recurrent ulceration, infection, major amputation, minor health-related quality life mortality</p><p dir="ltr"><b>Conclusions:</b></p><p proposed Its adoption research community will facilitate assessment comparative effectiveness current evolving interventions.</p>