Abstract
BackgroundFoot disease complications, such as foot ulcers and infection, contribute to considerable morbidity and mortality. These complications are typically precipitated by “high-risk factors”, such as peripheral neuropathy and peripheral arterial disease. High-risk factors are more prevalent in specific “at risk” populations such as diabetes, kidney disease and cardiovascular disease. To the best of the authors’ knowledge a tool capturing multiple high-risk factors and foot disease complications in multiple at risk populations has yet to be tested. This study aimed to develop and test the validity and reliability of a Queensland High Risk Foot Form (QHRFF) tool.MethodsThe study was conducted in two phases. Phase one developed a QHRFF using an existing diabetes foot disease tool, literature searches, stakeholder groups and expert panel. Phase two tested the QHRFF for validity and reliability. Four clinicians, representing different levels of expertise, were recruited to test validity and reliability. Three cohorts of patients were recruited; one tested criterion measure reliability (n = 32), another tested criterion validity and inter-rater reliability (n = 43), and another tested intra-rater reliability (n = 19). Validity was determined using sensitivity, specificity and positive predictive values (PPV). Reliability was determined using Kappa, weighted Kappa and intra-class correlation (ICC) statistics.ResultsA QHRFF tool containing 46 items across seven domains was developed. Criterion measure reliability of at least moderate categories of agreement (Kappa > 0.4; ICC > 0.75) was seen in 91% (29 of 32) tested items. Criterion validity of at least moderate categories (PPV > 0.7) was seen in 83% (60 of 72) tested items. Inter- and intra-rater reliability of at least moderate categories (Kappa > 0.4; ICC > 0.75) was seen in 88% (84 of 96) and 87% (20 of 23) tested items respectively.ConclusionsThe QHRFF had acceptable validity and reliability across the majority of items; particularly items identifying relevant co-morbidities, high-risk factors and foot disease complications. Recommendations have been made to improve or remove identified weaker items for future QHRFF versions. Overall, the QHRFF possesses suitable practicality, validity and reliability to assess and capture relevant foot disease items across multiple at risk populations.
Highlights
Foot disease complications, such as foot ulcers and infection, contribute to considerable morbidity and mortality
Phase one – development of the tool The literature search identified 174 papers that reported on tools to identify or measure foot disease complications and/or high-risk factors, with the majority of papers relating to diabetes populations (90 (52%))
Fifty-nine individual tools were identified from the literature search; 23 were considered to have adequate practicality, face validity and applicability to an Australian clinical context to be considered for the Queensland High Risk Foot Form (QHRFF)
Summary
Foot disease complications, such as foot ulcers and infection, contribute to considerable morbidity and mortality. Best practice foot disease management has been shown to significantly reduce hospitalisation, amputation, mortality and overall costs within different at risk populations [5,12,13,20]. These multi-faceted best practice interventions commonly include screening for high-risk factors, multi-disciplinary management of foot disease complications, clinical training, evidence-based clinical pathway utilisation and regular capture and analysis of foot disease clinical data [5,6,12,13,20]. In consideration of the growing problem of foot disease, and the potential future improvements observed with best practice clinical management and research, it is imperative that any clinical tools to assess, capture, measure or analyse patient outcomes in at risk populations are valid and reliable
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