Real-World Assessment of Routine Diabetic foot Screening – REWARDS Study

Background: Diabetes mellitus affects 4.9 million individuals in the United Kingdom.

Approximately 25% of people with diabetes develop foot ulceration during their life and 80% of amputations are preceded by a foot ulcer.

Since 2004, General Practitioners in England have been contractually encouraged to perform annual foot screening for patients with diabetes. A comprehensive Diabetes Foot Action plan was introduced in Scotland in 2006. Data from the Scottish Diabetes Registry demonstrated a 30% reduction in the amputation rate between 2003 and 2009.

However, it remains unclear whether the introduction of foot screening has affected patient outcomes in England. Aims and objectives: The aims of this study are to investigate: 1. The effectiveness of screening for the early signs of foot disease in diabetes in primary care 2. The predictive performance of the screening tests 3.

The equity of uptake to identify opportunities for optimising care The specific objectives are to: 1.

Describe the risk of amputation in patients with diabetes in England between 2000 and 2019 and determine whether the introduction of screening tests in primary care in 2004 were associated with a decrease in the risk of amputation 2.

Assess the predictive performance of primary care screening tests to identify those at high risk of amputation and determine whether a risk model using routine primary care data is as effective as, or additively improves, the performance of primary care screening 3.

Examine the equity of uptake of screening tests in primary care Methods: Linked Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases will be used to address the study objectives. A patient advisory group will help identify any additional factors for inclusion in the analysis throughout the study.

Objective 1 will be addressed using a controlled interrupted timeseries analysis to examine amputation rates in populations with and without diabetes and the effect of the introduction of primary care incentives in 2004 on these trends.

A sensitivity analysis will be performed for 2004-2010 and 2011-2019 periods to reflect the modification of the screening criteria.

Objective 2 will be achieved using a retrospective cohort design with the outcome of screening tests among people with diabetes as the main exposure and amputation as the main outcome.

Objective 3 will be addressed using a repeat cross-sectional design to examine the relationship between uptake of screening and demographic and clinical characteristics.

A multidisciplinary panel meeting composed of patients and relevant stakeholders will be held to review the data from the analyses and discuss current issues with foot screening and formulate recommendations for future improvements.

Timeline: The study will be finalised by November 2026 with recommendations available to the key stakeholders by January 2027.

The results of the study will be presented at national and international vascular and diabetes meetings and published in leading peer-review journals by the end of 2027.

The findings will provide good quality evidence to either support ongoing foot screening in the community or encourage development of alternative interventions to improve outcomes in patients with diabetic foot disease.