Tool for Rapid & Easy Identification of High Risk Diabetic Foot: Validation & Clinical Pilot of the Simplified 60 Second Diabetic Foot Screening Tool.
ABSTRACT: Most diabetic foot amputations are caused by ulcers on the skin of the foot i.e. diabetic foot ulcers. Early identification of patients at high risk for diabetic foot ulcers is crucial. The 'Simplified 60-Second Diabetic Foot Screening Tool' has been designed to rapidly detect high risk diabetic feet, allowing for timely identification and referral of patients needing treatment. This study aimed to determine the clinical performance and inter-rater reliability of 'Simplified 60 Second Diabetic Foot Screening Tool' in order to evaluate its applicability for routine screening.The tool was independently tested by n=12 assessors with n=18 Guyanese patients with diabetes. Inter-rater reliability was assessed by calculating Cronbach's alpha for each of the assessment items. A minimum value of 0.60 was considered acceptable. Reliability scores of the screening tool assessment items were: 'monofilament test' 0.98; 'active ulcer' 0.97; 'previous amputation' 0.97; 'previous ulcer' 0.97; 'fixed ankle' 0.91; 'deformity' 0.87; 'callus' 0.87; 'absent pulses' 0.87; 'fixed toe' 0.80; 'blisters' 0.77; 'ingrown nail' 0.72; and 'fissures' 0.55. The item 'stiffness in the toe or ankle' was removed as it was observed in only 1.3% of patients. The item 'fissures' was also removed due to low inter-rater reliability. Clinical performance was assessed via a pilot study utilizing the screening tool on n=1,266 patients in an acute care setting in Georgetown, Guyana. In total, 48% of patients either had existing diabetic foot ulcers or were found to be at high risk for developing ulcers.Clinicians in low and middle income countries such as Guyana can use the Simplified 60-Second Diabetic Screening Tool to facilitate early detection and appropriate treatment of diabetic foot ulcers. Implementation of this screening tool has the potential to decrease diabetes related disability and mortality.
Project description:Despite their potential for telemedicine in diabetic foot ulcer treatment, diagnostic accuracy of assessment of diabetic foot ulcers using mobile phone images is unknown. Our aim was to determine the validity and reliability of remote diabetic foot ulcer assessment using mobile phone images. Fifty diabetic foot ulcers were assessed live and photographed. Five independent observers remotely assessed the mobile phone images twice for presence of nine clinical characteristics and three treatment decisions. Positive likelihood (LLR+) and negative likelihood (LLR-) ratios were calculated for validity. Multirater Randolph's and bi-rater Bennet kappa values were calculated for reliability. LLR+ ranged from 1.3-4.2; LLR- ranged from 0.13-0.88; the treatment decision 'peri-wound debridement' was the only item with 'strong diagnostic evidence'. Inter-observer reliability kappa ranged from 0.09-0.71; test-retest reliability from 0.45-0.86; the treatment decision 'peri-wound debridement' was the only item with 'adequate agreement'. In conclusion, mobile phone images had low validity and reliability for remote assessment of diabetic foot ulcers and should not be used as a stand-alone diagnostic instrument. Clinicians who use mobile phone images in clinical practice should obtain as much additional information as possible when making treatment decisions based on these images, and be cautious of the low diagnostic accuracy.
Project description:BACKGROUND:Charcot neuroarthropathy (Charcot foot) is a serious limb-threatening complication most commonly seen in individuals with diabetic peripheral neuropathy. Although dermal thermometry is widely used by clinicians to assist in the diagnosis, monitoring, and management of the disease, there is limited high-quality evidence to support its reliability. Therefore, this study investigated the intra-rater and inter-rater reliability of infrared dermal thermometry in patients with Charcot neuroarthropathy. METHODS:We collected clinical, demographic, health status, and foot examination information on 32 adults with Charcot neuroarthropathy from a metropolitan high-risk foot service in Melbourne, Australia. Infrared dermal thermometry assessments were conducted by two independent raters at 10 anatomical sites of the Charcot foot using both a (i) touch and (ii) non-touch technique. Intra-rater and inter-rater reliability of the two assessment techniques were evaluated using intra-class correlation coefficients (ICCs), limits of agreement, standard error of measurement, and minimal detectable change statistics. RESULTS:Mean age was 59.9 (standard deviation [SD], 10.5) years, 68.8% were male, average duration of diabetes was 20.6 (SD, 15.1) years, 71.9% had type 2 diabetes, 93.8% had peripheral neuropathy, 43.8% had peripheral arterial disease, and 50% had previous foot ulceration. Charcot foot most commonly affected the tarsometatarsal joints (38.9%), had a median duration of 2.8 (interquartile range [IQR], 1.3 to 5.9) months, and a large proportion were being treated with total contact casting (69.4%). Overall, there was good to excellent intra-rater and inter-rater relative reliability for the 'touch' technique (ICC, 0.87 to 0.99; ICC, 0.83 to 0.98, respectively), and excellent intra-rater and inter-rater relative reliability for the 'non-touch' technique (ICC, 0.93 to 0.99; ICC, 0.91 to 0.99, respectively). In addition, measurement error was found to be relatively low across the 10 anatomical sites. CONCLUSIONS:Infrared dermal thermometry can now be used with confidence in clinical and research settings to provide a reliable assessment of skin temperature in patients with Charcot neuroarthropathy, using either a touch or non-touch technique at 10 commonly used testing sites. A non-touch technique, however, was observed to have slightly higher reliability indicating it may be associated with less measurement error than the touch technique.
Project description:BACKGROUND:One of the most common (and costly) complications of diabetes are diabetic foot ulcers, which often result in lower-extremity amputation. Regular foot care can reduce complications; however, roughly half of Canadians with diabetes do not participate in screening. We sought to evaluate the economic effects of using telemonitoring for diabetic foot ulcer prevention using mathematical modelling. METHODS:We used Markov modelling to compare current screening standards (standard care) to population-wide and targeted (high-risk) telemonitoring programs in a hypothetical cohort of Canadian patients aged 60 years. We varied the effectiveness (or outcome), defined as the proportion of diabetic foot ulcers prevented, to explore cost-effectiveness using model parameters from published literature and clinical experts. RESULTS:At 20%-40% effectiveness, population-based prevention resulted in 0.00399-0.00790 quality-adjusted life years (QALYs) gained per person over 5 years and an incremental cost of $479-$402 compared to standard care. At 15%-40% effectiveness, high-risk prevention resulted in a cost decrease per person over 5 years ($1.26-$25.55), with health benefits of 0.000207-0.00058 QALYs gained. INTERPRETATION:The use of telemonitoring in the diabetic lower extremity can offer patients better quality of life and can be cost-effective compared to current Canadian screening practices. Future work should focus on developing and validating technologies based on objective outcome measures for remote monitoring of the diabetic foot.
Project description:The Ankle Brachial Index is a useful clinical test for establishing blood supply to the foot. However, there are limitations to this method when conducted on people with diabetes. As an alternative to the Ankle Brachial Index, measuring Toe Systolic Pressures and the Toe Brachial Index have been recommended to assess the arterial blood supply to the foot. This study aimed to determine the intra and inter-rater reliability of the measurement of Toe Systolic Pressure and the Toe Brachial Index in patients with diabetes using a manual measurement system.This was a repeated measures, reliability study. Three raters measured Toe Systolic Pressure and the Toe Brachial Index in thirty participants with diabetes. Measurement sessions occurred on two occasions, one week apart, using a manual photoplethysmography unit (Hadeco Smartdop 45) and a standardised measurement protocol.The mean intra-class correlation for intra-rater reliability for toe systolic pressures was 0.87 (95% LOA: -25.97 to 26.06 mmHg) and the mean intra-class correlation for Toe Brachial Indices was 0.75 (95% LOA: -0.22 to 0.28). The intra-class correlation for inter-rater reliability was 0.88 for toe systolic pressures (95% LOA: -22.91 to 29.17.mmHg) and 0.77 for Toe Brachial Indices (95% LOA: -0.21 to 0.22).Despite the reasonable intra-class correlation results, the range of error (95% LOA) was broad. This raises questions regarding the reliability of using a manual sphygmomanometer and PPG for the Toe Systolic Pressure and Toe Brachial Indice.
Project description:The aim of this systematic review is to assess the peer-reviewed literature on the psychometric properties, feasibility, effectiveness, costs, and current limitations of using telehealth and telemedicine approaches for prevention and management of diabetic foot disease. MEDLINE/PubMed was searched for peer-reviewed studies on telehealth and telemedicine approaches for assessing, monitoring, preventing, or treating diabetic foot disease. Four modalities were formulated: dermal thermography, hyperspectral imaging, digital photographic imaging, and audio/video/online communication. Outcome measures were: validity, reliability, feasibility, effectiveness, and costs. Sixty-one studies were eligible for analysis. Three randomized controlled trials showed that handheld infrared dermal thermography as home-monitoring tool is effective in reducing ulcer recurrence risk, while one small trial showed no effect. Hyperspectral imaging has been tested in clinical settings to assess and monitor foot disease and conflicting results on its diagnostic use show that this method is still in an experimental stage. Digital photography is used to assess and monitor foot ulcers and pre-ulcerative lesions and was found to be a valid, reliable, and feasible method for telehealth purposes. Audio/video/online communication is mainly used for foot ulcer monitoring. Two randomized controlled trials show similar healing efficacy compared with regular outpatient clinic visits, but no benefit in costs. In conclusion, several technologies with good psychometric properties are available that may be of benefit in helping to assess, monitor, prevent, or treat diabetic foot disease, but in most cases, feasibility, effectiveness, and cost savings still need to be demonstrated to become accepted and used modalities in diabetic foot care.
Project description:Deciding if a diabetic foot ulcer is infected in a community setting is challenging without validated point-of-care tests. Four inflammatory biomarkers were investigated to develop a composite algorithm for mildly infected diabetic foot ulcers: venous white cell count, C-reactive protein (CRP) and procalcitonin, and a novel wound exudate calprotectin assay. Calprotectin is a marker of neutrophilic inflammation.In a prospective study, people with uninfected or mildly infected diabetic foot ulcers who had not received oral antibiotics in the preceding 2 weeks were recruited from community podiatry clinics for measurement of inflammatory biomarkers. Antibiotic prescribing decisions were based on clinicians' baseline assessments and participants were reviewed 1 week later; ulcer infection was defined by clinicians' overall impression from their two assessments.Some 363 potential participants were screened, of whom 67 were recruited, 29 with mildly infected diabetic foot ulcers and 38 with no infection. One participant withdrew early in each group. Ulcer area was 1.32 cm2 [interquartile range (IQR) 0.32-3.61 cm2 ] in infected ulcers and 0.22 cm2 (IQR 0.09-1.46 cm2 ) in uninfected ulcers. Baseline CRP for mild infection was 9.00 mg/ml and 6.00 mg/ml for uninfected ulcers; most procalcitonin levels were undetectable. Median calprotectin level in infected diabetic foot ulcers was 1437 ng/ml and 879 ng/ml in uninfected diabetic foot ulcers. Area under the receiver operating characteristic curve for a composite algorithm incorporating calprotectin, CRP, white cell count and ulcer area was 0.68 (95% confidence intervals 0.52-0.82), sensitivity 0.64, specificity 0.81.A composite algorithm including CRP, calprotectin, white cell count and ulcer area may help to distinguish uninfected from mildly infected diabetic foot ulcers. Venous procalcitonin is unhelpful for mild diabetic foot ulcer infection.
Project description:The purpose of this study was to assess the inter-rater reliability and intra-rater reliability of medical record review for the detection of hospital adverse events.We conducted two stages retrospective medical records review of a random sample of 96 patients from one acute-care general hospital. The first stage was an explicit patient record review by two nurses to detect the presence of 41 screening criteria (SC). The second stage was an implicit structured review by two physicians to identify the occurrence of adverse events from the positive cases on the SC. The inter-rater reliability of two nurses and that of two physicians were assessed. The intra-rater reliability was also evaluated by using test-retest method at approximately two weeks later.In 84.2% of the patient medical records, the nurses agreed as to the necessity for the second stage review (kappa, 0.68; 95% confidence interval [CI], 0.54 to 0.83). In 93.0% of the patient medical records screened by nurses, the physicians agreed about the absence or presence of adverse events (kappa, 0.71; 95% CI, 0.44 to 0.97). When assessing intra-rater reliability, the kappa indices of two nurses were 0.54 (95% CI, 0.31 to 0.77) and 0.67 (95% CI, 0.47 to 0.87), whereas those of two physicians were 0.87 (95% CI, 0.62 to 1.00) and 0.37 (95% CI, -0.16 to 0.89).In this study, the medical record review for detecting adverse events showed intermediate to good level of inter-rater and intra-rater reliability. Well organized training program for reviewers and clearly defining SC are required to get more reliable results in the hospital adverse event study.
Project description:To test whether depression is associated with an increased risk of incident diabetic foot ulcers.The Pathways Epidemiologic Study is a population-based prospective cohort study of 4839 patients with diabetes in 2000-2007. The present analysis included 3474 adults with type 2 diabetes and no prior diabetic foot ulcers or amputations. Mean follow-up was 4.1 years. Major and minor depression assessed by the Patient Health Questionnaire-9 were the exposures of interest. The outcome of interest was incident diabetic foot ulcers. We computed the hazard ratio and 95% confidence interval (CI) for incident diabetic foot ulcers, comparing patients with major and minor depression with those without depression and adjusting for sociodemographic characteristics, medical comorbidity, glycosylated hemoglobin, diabetes duration, insulin use, number of diabetes complications, body mass index, smoking status, and foot self-care. Sensitivity analyses also adjusted for peripheral neuropathy and peripheral arterial disease as defined by diagnosis codes.Compared with patients without depression, patients with major depression by Patient Health Questionnaire-9 had a 2-fold increase in the risk of incident diabetic foot ulcers (adjusted hazard ratio 2.00; 95% CI, 1.24-3.25). There was no statistically significant association between minor depression by Patient Health Questionnaire-9 and incident diabetic foot ulcers (adjusted hazard ratio 1.37; 95% CI, 0.77-2.44).Major depression by Patient Health Questionnaire-9 is associated with a 2-fold higher risk of incident diabetic foot ulcers. Future studies of this association should include better measures of peripheral neuropathy and peripheral arterial disease, which are possible confounders or mediators.
Project description:Diagnosing pediatric intensive care unit-acquired weakness (PICU-AW) is challenging. The Medical Research Council (MRC) score is a widely used screening method for muscle weakness in critically ill adults; however, its utility in critically ill children has not been established. Our objective was to determine the feasibility and interobserver reliability of muscle strength testing using MRC score in critically ill children. A prospective observational substudy of critically ill children aged 1 to 17 years and limited to bed rest during the first 48 hours of PICU admission was evaluated with weekly MRC exams independently performed by two clinical raters. MRC exams were attempted on all 33 participants, but could be completed in only 21 (64%), 9 of who (43%) received at least one exam while in the PICU, and in the remaining 12 (57%), MRC exams could only be completed after PICU discharge. Of the 95 attempted MRC exams, 55 (57%) could not be conducted or completed, most commonly due to patient sedation, and inability to comply due to cognitive ability, pain, or noncooperation. The inter-rater reliability for MRC sum score was excellent (intraclass correlation coefficient: 0.87). However, the inter-rater reliability was only moderate when used to determine PICU-AW (Cohen kappa: 0.48). MRC testing in the PICU was not feasible as an early screening tool for muscle weakness in the majority of critically ill children in this study. Further research is needed to find an appropriate screening tool that is both feasible and predicts clinically relevant outcomes in children, such as function and recovery following critical illness.
Project description:OBJECTIVE:The purpose of this study was to assess the virulence potential of Staphylococcus aureus strains isolated from diabetic foot ulcers and to discriminate noninfected from infected ulcers. RESEARCH DESIGN AND METHODS:Diabetic patients hospitalized in a diabetic foot department with a foot ulcer were prospectively enrolled if they had been free of antibiotic treatment over the previous 6 months. At admission, ulcers were classified as infected or noninfected on the basis of clinical examination, according to the International Working Group on the Diabetic Foot system. Only patients carrying S. aureus as the sole pathogen were included. In individuals with a grade 1 ulcer, a second bacterial specimen was obtained 1 month later. Using virulence genotyping markers, clonality tools, and an in vivo Caenorhabditis elegans model, we correlated the virulence of 132 S. aureus strains with grade, time of collection, and ulcer outcome. RESULTS:Among virulence genes, the most relevant combination derived from the logistic regression was the association of cap8, sea, sei, lukE, and hlgv (area under the curve 0.958). These markers were useful to distinguish noninfected (grade 1) from infected (grades 2-4) ulcers and to predict wound status at the follow-up. With use of the nematode model, S. aureus strains isolated from grade 1 ulcers were found to be significantly less virulent than strains from ulcers at or above grade 2 (P < 0.001). CONCLUSIONS:This study highlights the coexistence of two S. aureus populations on diabetic foot ulcers. A combination of five genes that may help distinguish colonized grade 1 from infected grade >or=2 wounds, predict ulcer outcome, and contribute to more appropriate use of antibiotics was discovered.