Cost-effectiveness of guideline-based care provision for patients with diabetes-related foot ulcers: A modelled analysis using discrete event simulation.

AIMS: The provision of guideline-based care for patients with diabetes-related foot ulcers (DFU) in clinical practice is suboptimal. We estimated the cost-effectiveness of higher rates of guideline-based care, compared with current practice. METHODS: The costs and quality-adjusted life-years (QALYs) associated with current practice (30% of patients receiving guideline-based care) were compared with seven hypothetical scenarios with increasing proportion of guideline-based care (40%, 50%, 60%, 70%, 80%, 90% and 100%). Comparisons were made using discrete event simulations reflecting the natural history of DFU over a 3-year time horizon from the Australian healthcare perspective. Incremental cost-effectiveness ratios were calculated for each scenario and compared to a willingness-to-pay of AUD 28,000 per QALY. Probabilistic sensitivity analyses were conducted to incorporate joint parameter uncertainty. RESULTS: All seven scenarios with higher rates of guideline-based care were likely cheaper and more effective than current practice. Increased proportions compared with current practice resulted in between AUD 0.28 and 1.84 million in cost savings and 11-56 additional QALYs per 1000 patients. Probabilistic sensitivity analyses indicated that the finding is robust to parameter uncertainty. CONCLUSIONS: Higher proportions of patients receiving guideline-based care are less costly and improve patient outcomes. Strategies to increase the proportion of patients receiving guideline-based care are warranted.

Multiple factors predict longer and shorter time-to-ulcer-free in people with diabetes-related foot ulcers: Survival analyses of a large prospective cohort followed-up for 24-months.

AIMS: To investigate factors independently associated with time-to-(being)-ulcer-free, time-varying effects and predict adjusted ulcer-free probabilities, in a large prospective cohort with diabetes-related foot ulcers (DFU) followed-up for 24 months. METHODS: Patients presenting with DFU(s) to 65 Diabetic Foot Services across Queensland, Australia, between July-2011 and December-2017 were included. Demographic, comorbidity, limb, ulcer, and treatment factors were captured at presentation. Patients were followed-up until ulcer-free (all DFU(s) healed), amputation, death or two years. Factors associated with time-to-ulcer-free were investigated using both Cox proportional hazards and flexible parametric survival models to explore time-varying effects and plot predicted adjusted ulcer-free probability graphs. RESULTS: Of 4,709 included patients (median age 63 years, 69.5% male), median time-to-ulcer-free was 112 days (IQR:40->730), with 68.4% ulcer-free within two years. Factors independently associated with longer time-to-ulcer-free were each year of age younger than 60 years, living in a regional or remote area, smoking, neuropathy, peripheral artery disease (PAD), ulcer size >1 cm2, deep ulcer and mild infection (all p < 0.05). Time-varying effects were found for PAD and ulcer size limiting their association to six months only. Shorter time-to-ulcer-free was associated with recent DFU treatment by a podiatrist and receiving knee-high offloading treatment (both p < 0.05). Predicted adjusted ulcer-free probability graphs reported largest differences in time-to-ulcer-free over 24-months for geographical remoteness and PAD factors. CONCLUSIONS: Multiple factors predicted longer and shorter time-to-ulcer-free in people presenting with DFUs. Considering these factors, their time-varying effects and adjusted ulcer-free probability graphs, should aid the prediction of the likely time-to-(being)-ulcer-free for DFU patients.

Foot Complications in a Representative Australian Inpatient Population.

We investigated the prevalence and factors independently associated with foot complications in a representative inpatient population (adults admitted for any reason with and without diabetes). We analysed data from the Foot disease in inpatients study, a sample of 733 representative inpatients. Previous amputation, previous foot ulceration, peripheral arterial disease (PAD), peripheral neuropathy (PN), and foot deformity were the foot complications assessed. Sociodemographic, medical, and foot treatment history were collected. Overall, 46.0% had a foot complication with 23.9% having multiple; those with diabetes had higher prevalence of foot complications than those without diabetes (p < 0.01). Previous amputation (4.1%) was independently associated with previous foot ulceration, foot deformity, cerebrovascular accident, and past surgeon treatment (p < 0.01). Previous foot ulceration (9.8%) was associated with PN, PAD, past podiatry, and past nurse treatment (p < 0.02). PAD (21.0%) was associated with older age, males, indigenous people, cancer, PN, and past surgeon treatment (p < 0.02). PN (22.0%) was associated with older age, diabetes, mobility impairment, and PAD (p < 0.05). Foot deformity (22.4%) was associated with older age, mobility impairment, past podiatry treatment, and PN (p < 0.01). Nearly half of all inpatients had a foot complication. Those with foot complications were older, male, indigenous, had diabetes, cerebrovascular accident, mobility impairment, and other foot complications or past foot treatment.

Differences in the daily activity of patients with diabetic foot ulcers compared to controls in their free-living environments.

The aims of our study were to investigate multiple daily activity outcomes in patients with diabetic foot ulcers (DFU) compared to diabetic peripheral neuropathy (DPN) and diabetes (DM) controls in their free-living environments. We examined daily activity outcomes of 30 patients with DFU, 23 DPN and 20 DM. All patients wore a validated multi-sensor device for > 5 days (>22 hours per day) to measure their daily activity outcomes: steps, energy expenditure (kJ), average metabolic equivalent tasks (METs), physical activity (>3·0 METs) duration and energy expenditure, lying duration, sleep duration and sleep quality. We found that DFU patients recorded fewer median (interquartile ranges, IQR) daily steps [2154 (1621-4324)] than DPN [3660 (2742-7705)] and DM [5102 (4011-7408)] controls (P < 0·05). In contrast, DFU patients recorded more mean ± SD daily energy expenditure (kJ) (13 006 ± 3559) than DPN (11 085 ± 1876) and DM (11 491 ± 1559) controls (P < 0·05). We found no other differences in daily activity outcomes (P > 0·1). We conclude that DFU patients typically take fewer steps but expend more energy during their normal daily activity than DPN and DM controls. We hypothesise that the increased energy expenditure for DFU patients may be due to wound healing or an inefficient gait strategy. Further investigations into this energy imbalance in DFU patients may improve healing in future.

Incidence and risk factors for developing infection in patients presenting with uninfected diabetic foot ulcers.

OBJECTIVE: There is a paucity of research on patients presenting with uninfected diabetic foot ulcers (DFU) that go on to develop infection. We aimed to investigate the incidence and risk factors for developing infection in a large regional cohort of patients presenting with uninfected DFUs. METHODS: We performed a secondary analysis of data collected from a validated prospective state-wide clinical diabetic foot database in Queensland (Australia). Patients presenting for their first visit with an uninfected DFU to a Diabetic Foot Service in one of thirteen Queensland regions between January 2012 and December 2013 were included. Socio-demographic, medical history, foot disease history, DFU characteristics and treatment variables were captured at the first visit. Patients were followed until their DFU healed, or if their DFU did not heal for 12-months, to determine if they developed a foot infection in that period. RESULTS: Overall, 853 patients were included; mean(standard deviation) age 62.9(12.8) years, 68.0% male, 90.9% type 2 diabetes, 13.6% indigenous Australians. Foot infection developed in 342 patients for an overall incidence of 40.1%; 32.4% incidence in DFUs healed <3 months, 55.9% in DFUs healed between 3-12 months (p<0.05). Independent risk factors (Odds Ratio (95% confidence interval)) for developing infection were: DFUs healed between 3-12 months (2.3 (1.6-3.3)), deep DFUs (2.2 (1.2-3.9)), peripheral neuropathy (1.8 (1.1-2.9)), previous DFU history (1.7 (1.2-2.4)), foot deformity (1.4 (1.0-2.0)), female gender (1.5 (1.1-2.1)) and years of age (0.98 (0.97-0.99)) (all p<0.05). CONCLUSIONS: A considerable proportion of patients presenting with an uninfected DFU will develop an infection prior to healing. To prevent infection clinicians treating patients with uninfected DFUs should be particularly vigilant with those presenting with deep DFUs, previous DFU history, peripheral neuropathy, foot deformity, younger age, female gender and DFUs that have not healed by 3 months after presentation.

A cost-effectiveness analysis of optimal care for diabetic foot ulcers in Australia.

In addition to affecting quality of life, diabetic foot ulcers (DFUs) impose an economic burden on both patients and the health system. This study developed a Markov model to analyse the cost-effectiveness of implementing optimal care in comparison with the continuation of usual care for diabetic patients at high risk of DFUs in the Australian setting. The model results demonstrated overall 5-year cost savings (AUD 9100·11 for those aged 35-54, $9391·60 for those aged 55-74 and $12 394·97 for those aged 75 or older) and improved health benefits measured in quality-adjusted life years (QALYs) (0·13 QALYs, 0·13 QALYs and 0·16 QALYs, respectively) for high-risk patients receiving optimal care for DFUs compared with usual care. Total cost savings for Australia were estimated at AUD 2·7 billion over 5 years. Probabilistic sensitivity analysis showed that optimal care always had a higher probability of costing less and generating more health benefits. This study provides important evidence to inform Australian policy decisions on the efficient use of health resources and supports the implementation of evidence-based optimal care in Australia. Furthermore, this information is of great importance for comparable developed countries that could reap similar benefits from investing in these well-known evidence-based strategies.

The silent overall burden of foot disease in a representative hospitalised population.

The aims of this study were to investigate the point prevalence, and associated independent factors, for foot disease (ulcers, infections and ischaemia) in a representative hospitalised population. We included 733 (83%) of 883 eligible adult inpatients across five representative Australian hospitals on one day. We collected an extensive range of self-reported characteristics from participants. We examined all participants to clinically diagnose foot disease (ulcers, infections and ischaemia) and amputation procedures. Overall, 72 participants (9·8%) [95% confidence interval (CI):7·2-11·3%] had foot disease. Foot ulcers, in 49 participants (6·7%), were independently associated with peripheral neuropathy, peripheral arterial disease, previous foot ulcers, trauma and past surgeon treatment (P < 0·05). Foot infections, in 24 (3·3%), were independently associated with previous foot ulcers, trauma and past surgeon treatment (P < 0·01). Ischaemia, in 33 (4·5%), was independently associated with older age, smokers and past surgeon treatment (P < 0·01). Amputation procedures, in 14 (1·9%), were independently associated with foot infections (P < 0·01). We found that one in every ten inpatients had foot disease, and less than half of those had diabetes. After adjusting for diabetes, factors linked with foot disease were similar to those identified in diabetes-related literature. The overall inpatient foot disease burden is similar in size to well-known medical conditions and should receive similar attention.

Direct inpatient burden caused by foot-related conditions: a multisite point-prevalence study.

OBJECTIVE: The aims of this point-prevalence study were to investigate a representative inpatient population to determine the prevalence of people admitted to hospital for the reason of a foot-related condition, and identify associated independent factors. METHODS: Participants were adult inpatients in 5 different representative hospitals, admitted for any reason on the day of data collection. Maternity, mental health and cognitively impaired inpatients were excluded. Participants were surveyed on a range of self-reported demographic, social determinant, medical history, foot disease history, self-care, footwear, past foot treatment prior to hospitalisation and reason for admission variables. Physical examinations were performed to clinically diagnose a range of foot disease and foot risk factor variables. Independent factors associated with being admitted to hospital for the primary or secondary reason of a foot-related condition were analysed using multivariate logistic regression. RESULTS: Overall, 733 participants were included; mean (SD) age 62 (19) years, male 55.8%. Foot-related conditions were the primary reason for admission in 54 participants (7.4% (95% CI 5.7% to 9.5%)); 36 for foot disease (4.9%), 15 foot trauma (2.1%). Being admitted for the primary reason of a foot-related condition was independently associated with foot infection, critical peripheral arterial disease, foot trauma and past foot treatment by a general practitioner and surgeon (p<0.01). Foot-related conditions were a secondary reason for admission in 28 participants (3.8% (2.6% to 5.6%)), and were independently associated with diabetes and current foot ulcer (p<0.01). CONCLUSIONS: This study, the first in a representative inpatient population, suggests the direct inpatient burden caused by foot-related conditions is significantly higher than previously appreciated. Findings indicate 1 in every 13 inpatients was primarily admitted because of a foot-related condition with most due to foot disease or foot trauma. Future strategies are recommended to investigate and intervene in the considerable inpatient burden caused by foot-related conditions.

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

BACKGROUND: Australian subacute inpatient rehabilitation facilities face significant challenges from the ageing population and the increasing burden of chronic disease. Foot disease complications are a negative consequence of many chronic diseases. With the rapid expansion of subacute rehabilitation inpatient services, it seems imperative to investigate the prevalence of foot disease and foot disease risk factors in this population. The primary aim of this cross-sectional study was to determine the prevalence of active foot disease and foot disease risk factors in a subacute inpatient rehabilitation facility. METHODS: Eligible participants were all adults admitted at least overnight into a large Australian subacute inpatient rehabilitation facility over two different four week periods. Consenting participants underwent a short non-invasive foot examination by a podiatrist utilising the validated Queensland Health High Risk Foot Form to collect data on age, sex, medical co-morbidity history, foot disease risk factor history and clinically diagnosed foot disease complications and foot disease risk factors. Descriptive statistics were used to determine the prevalence of clinically diagnosed foot disease complications, foot disease risk factors and groups of foot disease risk factors. Logistic regression analyses were used to investigate any associations between defined explanatory variables and appropriate foot disease outcome variables. RESULTS: Overall, 85 (88%) of 97 people admitted to the facility during the study periods consented; mean age 80 (±9) years and 71% were female. The prevalence (95% confidence interval) of participants with active foot disease was 11.8% (6.3 - 20.5), 32.9% (23.9 - 43.5) had multiple foot disease risk factors, and overall, 56.5% (45.9 - 66.5) had at least one foot disease risk factor. A self-reported history of peripheral neuropathy diagnosis was independently associated with having multiple foot disease risk factors (OR 13.504, p = 0.001). CONCLUSION: This study highlights the potential significance of the burden of foot disease in subacute inpatient rehabilitation facilities. One in eight subacute inpatients were admitted with active foot disease and one in two with at least one foot disease risk factor in this study. It is recommended that further multi-site studies and management guidelines are required to address the foot disease burden in subacute inpatient rehabilitation facilities.

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

BACKGROUND: Foot 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. METHODS: The 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. RESULTS: A 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. CONCLUSIONS: The 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.

Developing an evidence-based clinical pathway for the assessment, diagnosis and management of acute Charcot Neuro-Arthropathy: a systematic review.

BACKGROUND: Charcot Neuro-Arthropathy (CN) is one of the more devastating complications of diabetes. To the best of the authors' knowledge, it appears that no clinical tools based on a systematic review of existing literature have been developed to manage acute CN. Thus, the aim of this paper was to systematically review existing literature and develop an evidence-based clinical pathway for the assessment, diagnosis and management of acute CN in patients with diabetes. METHODS: Electronic databases (Medline, PubMed, CINAHL, Embase and Cochrane Library), reference lists, and relevant key websites were systematically searched for literature discussing the assessment, diagnosis and/or management of acute CN published between 2002-2012. At least two independent investigators then quality rated and graded the evidence of each included paper. Consistent recommendations emanating from the included papers were then fashioned in a clinical pathway. RESULTS: The systematic search identified 267 manuscripts, of which 117 (44%) met the inclusion criteria for this study. Most manuscripts discussing the assessment, diagnosis and/or management of acute CN constituted level IV (case series) or EO (expert opinion) evidence. The included literature was used to develop an evidence-based clinical pathway for the assessment, investigations, diagnosis and management of acute CN. CONCLUSIONS: This research has assisted in developing a comprehensive, evidence-based clinical pathway to promote consistent and optimal practice in the assessment, diagnosis and management of acute CN. The pathway aims to support health professionals in making early diagnosis and providing appropriate immediate management of acute CN, ultimately reducing its associated complications such as amputations and hospitalisations.

Research capacity and culture in podiatry: early observations within Queensland Health.

BACKGROUND: Research is a major driver of health care improvement and evidence-based practice is becoming the foundation of health care delivery. For health professions to develop within emerging models of health care delivery, it would seem imperative to develop and monitor the research capacity and evidence-based literacy of the health care workforce. This observational paper aims to report the research capacity levels of statewide populations of public-sector podiatrists at two different time points twelve-months apart. METHODS: The Research Capacity & Culture (RCC) survey was electronically distributed to all Queensland Health (Australia) employed podiatrists in January 2011 (n = 58) and January 2012 (n = 60). The RCC is a validated tool designed to measure indicators of research skill in health professionals. Participants rate skill levels against each individual, team and organisation statement on a 10-point scale (one = lowest, ten = highest). Chi-squared and Mann Whitney U tests were used to determine any differences between the results of the two survey samples. A minimum significance of p < 0.05 was used throughout. RESULTS: Thirty-seven (64%) podiatrists responded to the 2011 survey and 33 (55%) the 2012 survey. The 2011 survey respondents reported low skill levels (Median < 4) on most aspects of individual research aspects, except for their ability to locate and critically review research literature (Median > 6). Whereas, most reported their organisation's skills to perform and support research at much higher levels (Median > 6). The 2012 survey respondents reported significantly higher skill ratings compared to the 2011 survey in individuals' ability to secure research funding, submit ethics applications, and provide research advice, plus, in their organisation's skills to support, fund, monitor, mentor and engage universities to partner their research (p < 0.05). CONCLUSIONS: This study appears to report the research capacity levels of the largest populations of podiatrists published. The 2011 survey findings indicate podiatrists have similarly low research capacity skill levels to those reported in the allied health literature. The 2012 survey, compared to the 2011 survey, suggests podiatrists perceived higher skills and support to initiate research in 2012. This improvement coincided with the implementation of research capacity building strategies.

Is simulation training effective in increasing podiatrists' confidence in foot ulcer management?

BACKGROUND: Foot ulcers are a frequent reason for diabetes-related hospitalisation. Clinical training is known to have a beneficial impact on foot ulcer outcomes. Clinical training using simulation techniques has rarely been used in the management of diabetes-related foot complications or chronic wounds. Simulation can be defined as a device or environment that attempts to replicate the real world. The few non-web-based foot-related simulation courses have focused solely on training for a single skill or "part task" (for example, practicing ingrown toenail procedures on models). This pilot study aimed to primarily investigate the effect of a training program using multiple methods of simulation on participants' clinical confidence in the management of foot ulcers. METHODS: Sixteen podiatrists participated in a two-day Foot Ulcer Simulation Training (FUST) course. The course included pre-requisite web-based learning modules, practicing individual foot ulcer management part tasks (for example, debriding a model foot ulcer), and participating in replicated clinical consultation scenarios (for example, treating a standardised patient (actor) with a model foot ulcer). The primary outcome measure of the course was participants' pre- and post completion of confidence surveys, using a five-point Likert scale (1 = Unacceptable-5 = Proficient). Participants' knowledge, satisfaction and their perception of the relevance and fidelity (realism) of a range of course elements were also investigated. Parametric statistics were used to analyse the data. Pearson's r was used for correlation, ANOVA for testing the differences between groups, and a paired-sample t-test to determine the significance between pre- and post-workshop scores. A minimum significance level of p < 0.05 was used. RESULTS: An overall 42% improvement in clinical confidence was observed following completion of FUST (mean scores 3.10 compared to 4.40, p < 0.05). The lack of an overall significant change in knowledge scores reflected the participant populations' high baseline knowledge and pre-requisite completion of web-based modules. Satisfaction, relevance and fidelity of all course elements were rated highly. CONCLUSIONS: This pilot study suggests simulation training programs can improve participants' clinical confidence in the management of foot ulcers. The approach has the potential to enhance clinical training in diabetes-related foot complications and chronic wounds in general.