Development of a core outcome set for diabetic foot ulceration. Ver 1.
Research type
Research Study
Full title
Development of a core outcome set for diabetic foot ulceration.
IRAS ID
245732
Contact name
Robert Hinchliffe
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background.
Patients with diabetes are at high risk of developing foot ulcers and if they become infected or fail to heal they are at risk of losing their foot or even their entire leg. This significantly affects a patient’s health, quality of life and may even lead to premature death. There are myriad treatments for Diabetic Foot Ulcers (DFU), but the best treatment option is still an area of active research. Trials assessing the treatment of DFU report different and varying outcomes. This means that different treatments for DFU are not easily compared. One solution to this problem is developing a Core Outcome Set (COS). A COS aims to establish a set of results or outcomes that investigators should report when investigating a treatment for a certain condition. This permits easy comparison of different treatments for the same condition and allows pooling of results for large scale analysis.Methods
A COS is developed in three phases. Firstly, by identifying all the possible results or outcomes for the treatment of DFU. This is done by firstly, interviewing patients, secondly reviewing the published literature and thirdly by consulting a panel of experts. This will create a long list of outcomes which is then sent to healthcare professionals and patients in the second phase in the form of a Delphi survey. In each survey round patients and healthcare professionals rank the outcomes from most important to least important. The results are collected, and the least important outcomes removed. This process is repeated until a list of important outcomes is identified. These are then taken to a face to face consensus meeting of patients and healthcare professionals and the final COS is created by anonymous voting. Patients and health professionals are involved throughout the process to ensure that the core outcome set developed has outcomes relevant to both groups.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0478
Date of REC Opinion
17 Sep 2018
REC opinion
Further Information Favourable Opinion