The Queensland high risk foot form (QHRFF) – is it a reliable and valid clinical research tool for foot disease?

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.

Prevalence of active foot disease and foot disease risk factors in a subacute inpatient rehabilitation facility: a cross-sectional prevalence study

“…Each examination used the validated Queensland Health High Risk Foot Form (QHRFF) to collect age, sex, co-morbidity and foot disease data [14]. The QHRFF data collection procedures, methods and definitions have been previously reported [14].…”

“…In brief the QHRFF collects 46-items of data across seven broad domains via a survey of the patient's medical history and a physical clinical assessment for foot disease complications and foot disease risk factors [14]. The seven domains include identifying general demographics, different health professionals attending (data not utilised for this study), medical comorbidity history, foot disease risk factor history, clinical diagnoses of foot disease risk factors, clinical diagnoses of foot disease complications, and clinical management principles performed (data not utilised for this study) [14]. The domains of medical co-morbidity history and foot disease risk factor history were defined as the participant self-reporting being previously diagnosed by a health professional [14].…”

“…All foot disease complications and foot disease risk factors were clinically diagnosed by the podiatrist for the purposes of this study using definitions from the national diabetic foot guidelines and adopted by the validated QHRFF [14,19]. Foot ulceration was defined as a current full thickness wound beneath the ankle on a person with clinically diagnosed peripheral neuropathy or PAD [13,14].…”

“…Foot disease is generally the end result of chronic disease [13][14][15]. 'Foot disease complications', including foot ulcerations and foot infections, consume significant inpatient acute hospital resources in Australia [15][16][17][18][19].…”

“…Amputations typically have a preceding foot disease complication that is the result of trauma and 'foot disease risk factors'; including peripheral neuropathy, peripheral arterial disease (PAD) and orthopaedic foot deformity [15][16][17][18][19][20][21]. ' At risk populations' for foot disease are those populations more predisposed to developing foot disease risk factors and in turn foot disease complications that often progress to lower limb amputation [14]. Whilst people with diabetes are widely acknowledged as the primary at risk population for foot disease [15][16][17][18][19], there is growing evidence that other chronic disease patient groups, including those with cardiovascular disease (CVD) and chronic kidney disease (CKD), are also at risk populations with similar degrees of risk factors and foot disease to diabetes [20,21].…”