Background: Foot disease complications, such as foot ulcers and infection, contribute to considerable morbidity\r\nand mortality. These complications are typically precipitated by ââ?¬Å?high-risk factorsââ?¬Â, such as peripheral neuropathy\r\nand peripheral arterial disease. High-risk factors are more prevalent in specific ââ?¬Å?at riskââ?¬Â populations such as diabetes,\r\nkidney disease and cardiovascular disease. To the best of the authorsââ?¬â?¢ knowledge a tool capturing multiple high-risk\r\nfactors and foot disease complications in multiple at risk populations has yet to be tested. This study aimed to\r\ndevelop and test the validity and reliability of a Queensland High Risk Foot Form (QHRFF) tool.\r\nMethods: The study was conducted in two phases. Phase one developed a QHRFF using an existing diabetes foot\r\ndisease tool, literature searches, stakeholder groups and expert panel. Phase two tested the QHRFF for validity and\r\nreliability. Four clinicians, representing different levels of expertise, were recruited to test validity and reliability.\r\nThree cohorts of patients were recruited; one tested criterion measure reliability (n = 32), another tested criterion\r\nvalidity and inter-rater reliability (n = 43), and another tested intra-rater reliability (n = 19). Validity was determined\r\nusing sensitivity, specificity and positive predictive values (PPV). Reliability was determined using Kappa, weighted\r\nKappa and intra-class correlation (ICC) statistics.\r\nResults: A QHRFF tool containing 46 items across seven domains was developed. Criterion measure reliability of at\r\nleast moderate categories of agreement (Kappa > 0.4; ICC > 0.75) was seen in 91% (29 of 32) tested items. Criterion\r\nvalidity of at least moderate categories (PPV > 0.7) was seen in 83% (60 of 72) tested items. Inter- and intra-rater\r\nreliability of at least moderate categories (Kappa > 0.4; ICC > 0.75) was seen in 88% (84 of 96) and 87% (20 of 23)\r\ntested items respectively.\r\nConclusions: The QHRFF had acceptable validity and reliability across the majority of items; particularly items\r\nidentifying relevant co-morbidities, high-risk factors and foot disease complications. Recommendations have been\r\nmade to improve or remove identified weaker items for future QHRFF versions. Overall, the QHRFF possesses\r\nsuitable practicality, validity and reliability to assess and capture relevant foot disease items across multiple at risk\r\npopulation.
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