Inter-observer variability in the assessment of diabetic foot ulcers
Research type
Research Study
Full title
Inter-observer variability when using validated scoring systems in the assessment of diabetic foot ulcers
IRAS ID
133879
Contact name
Baris Ozdemir
Contact email
Sponsor organisation
Joint Research and Enterprise Office (JREO), St George's University of London
Research summary
Diabetic foot ulcers (DFU) are a serious complication of diabetes, leading to significant morbidity. It is estimated that up to 15% of patients with diabetes may develop a foot ulcer during their lifetime; the majority of patients requiring major lower limb amputation have had a preceding foot ulcer. The development of a DFU is a complex multi-factorial pathological process and there is wide variation in the presentation, response to treatment and eventual outcomes of DFU amongst individual patients.
A number of validated and non-validated scoring systems have been developed in order to help clinicians and researchers classify DFU and monitor progress or record response to treatment. These vary in their complexity and popularity. Whilst it may be accepted that detailed validated scoring systems may be a useful tool to compare DFU data between centres, it is unclear whether current use of scoring systems is reliable when used by different clinicians across multiple sites and this may preclude meaningful multi-centre analysis.
There is therefore a need to assess inter-observer variability when assessing DFU to ensure that assimilation of data across multiple sites can be meaningfully interpreted. There have been no studies to date that directly address this issue.
This will be a prospective study of patients with DFU who are already engaged with multi-disciplinary diabetic foot services at the participating centre. We will use three validated scoring systems currently in use. We aim to include a range of clinician assessors to reflect the typical multi-disciplinary approach to treating patients with DFU. This should include vascular surgeons and trainees, podiatrists, diabetologists, tissue viability nurses and physicians. Training in the use of the scoring systems will be administered to assessors before the assessment sessions.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1431
Date of REC Opinion
18 Dec 2013
REC opinion
Further Information Favourable Opinion