Gastrointestinal symptom burden in diabetic autonomic and peripheral neuropathy - A Danes cohort study.

OBJECTIVE: We investigated associations between gastrointestinal symptoms - evaluated as a combined weighted symptom score (CWSS) - Diabetic autonomic neuropathy (DAN), and distal symmetrical polyneuropathy (DSPN) in type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS: Cross-sectional study in a tertiary outpatient clinic. CWSS was calculated based on questionnaires: gastroparesis composite symptom index (GCSI) and gastrointestinal symptom rating score (GSRS). DAN and DSPN were addressed using the composite autonomic symptom score 31 (COMPASS-31) questionnaire, cardiac autonomic reflex tests (CARTs), electrochemical skin conductance (ESC), vibration perception threshold (VPT), Michigan Neuropathy Screening Instrument (MNSI), pain- and thermal sensation. Analyses were adjusted for age, sex, diabetes duration, smoking, LDL-cholesterol, HbA1C and systolic blood pressure. Type 1 and type 2 diabetes were evaluated separately. RESULTS: We included 566 with type 1 diabetes and 377 with type 2 diabetes. Mean ± SD age was 58 ± 15 years and 565 (59.9 %) were women. A high CWSS was present in 143 (25 %) with type 1 and 142 (38 %) with type 2 diabetes. The odds of DAN by COMPASS-31 (p < 0.001) were higher in the high score group. For type 1 diabetes, odds of cardiac autonomic neuropathy were higher in the high CWSS group. The odds of DSPN by VPT and MNSI in type 1 diabetes, and by ESC, VPT and pain sensation in type 2 diabetes were higher in the high CWSS group. CONCLUSIONS: A high symptom score was associated with neuropathy by COMPASS-31 and vibration perception. Gastrointestinal symptom burden associated inconsistently with other neuropathy tests between diabetes types.

Assessment of the severity of diabetic polyneuropathy aids in predicting the risk of developing diabetic complications in patients with untreated diabetes.

This study aimed to determine the efficacy of assessing the severity of diabetic polyneuropathy (DPN) in patients with untreated diabetes. Seventy-two patients with untreated type 2 diabetes who were hospitalized for glycemic control were enrolled and divided into the following two groups: patients who had no prior diagnosis and patients who were unattended or had discontinued treatment. Electrophysiological criteria consistent with Baba's classification were used to diagnose and assess the severity of DPN. The patients were divided into three subgroups: no DPN (stage 0), mild DPN (stage 1), and moderate or more-severe DPN (stages 2-4). Intergroup comparisons were performed for the clinical characteristics and the results of the nerve conduction studies. Twenty-two (30%), 25 (35%), and 25 (35%) patients were categorized into the no DPN, mild DPN, and moderate or more-severe DPN subgroups, respectively. The number of patients who were unattended or had discontinued treatment in the moderate or more-severe DPN subgroup was significantly higher than that in the no DPN subgroup. The patients in the moderate or more-severe DPN subgroup had an increased risk of developing diabetic retinopathy and nephropathy, with odds ratios of 19.5 and 11.0 for advanced stages of retinopathy and nephropathy, respectively. Thus, the assessment of the severity of DPN could aid in the prediction of the risk of developing diabetic complications in patients with untreated diabetes.

Skin microcirculatory responses: A potential marker for early diabetic neuropathy assessment using a low-cost portable diffuse optical spectrometry device.

Diffuse optical measurement is an evolving optical modality providing a fast and portable solution for microcirculation assessment. Diffuse optics in static and dynamic modalities are combined here in a system to assess hemodynamics in skin tissues of control and diabetic subjects. The in-house developed system consists of a laser source, fiber optic probe, a low-cost avalanche photodiode, a finite element model (FEM) derived static optical property estimator, and a software correlator for continuous flow monitoring through microvasculature. The studies demonstrated that the system quantifies the changes in blood flow rate in the immediate skin subsurface. The system is calibrated with in vitro flow models and a proof-of-concept was demonstrated on a limited number of subjects in a clinical environment. The flow changes in response to vasoconstrictive and vasodilative stimuli were analyzed and used to classify different stages of diabetes, including diabetic neuropathy.

Corneal characteristics of Mongolian population with type 2 diabetic peripheral neuropathy in inner Mongolia, China: an assessment using corneal confocal microscopy.

OBJECTIVE: To quantify corneal nerve fiber parameters in a Mongolian population with diabetic peripheral neuropathy (DPN) by corneal confocal microscopy. METHODS: This study conducted a comprehensive evaluation of 114 participants from Hulunbuir between January 2020 and December 2021. The participants included healthy controls, Mongolian and Han patients with type 2 diabetes mellitus. Demographic, medical, and laboratory data were collected, and neuropathy was evaluated by confocal corneal microscopy. And compare various parameters between Han and Mongolian were performed using SPSS software. RESULTS: The average waist circumference of Mongolian diabetic patients was larger than that of Han diabetic patients (P < 0.05). The mean HbA1c of Mongolian was 9.30 (8.15, 10.30) %, and that of Han was 8.30 (7.20, 9.40) % (P = 0.023). The average values of Corneal Nerve Fiber Density (CNFD), Corneal Nerve Fiber Length (CNFL) and corneal nerve branch density (CNBD) in Mongolian diabetic patients were significantly lower than those in Han diabetic patients (P < 0.05). The correlation coefficient between CNFL and age was - 0.368. ROC results show that CNBD has a certain diagnostic value for DPN in Mongolian patients with type 2 diabetes and the optimal cut-off point value is 24.99(no./mm2), the sensitivity is 80.0%, and the specificity is 77.8%. CONCLUSION: The corneal confocal microscopy could possibly represent a promising adjuvant technique for the early diagnosis and assessment of PDN in Mongolian T2DM patients.

Wearable sensors-based postural analysis and fall risk assessment among patients with diabetic foot neuropathy.

AIMS: To investigate the cross-sectional association between deep and superficial diabetic neuropathy, postural impairment assessed by wearable inertial sensors, and the risk of fall among patients with diabetic foot. METHODS: Diabetic patients attending a University Podiatric Clinic were evaluated for the presence of deep and superficial peripheral neuropathy in sensory tests. Postural impairment was assessed using a wearable inertial sensor, and the evaluation of balance/gait and risk of fall was determined by the Tinetti Scale and Downton Index, respectively. Glycemic control was measured by glycated haemoglobin concentration and fasting glycaemia. The postural parameters measured were the anteroposterior and medio-lateral sway of the center of mass (CoM) and the sway area (area traveled by the CoM per second). The results were analyzed through a logistic regression model to assess those posture variables mostly significantly associated with neuropathy and risk of fall scales. RESULTS: A total of 85 patients were evaluated. Spearman's rank correlation coefficients showed a strong and significant relationship (p < 0.05) between deep diabetic neuropathy assessed by Semmes-Weinstein monofilament, diapason and biothensiometer and postural alterations, whereas no significant correlations between superficial (painful sensitivity) neuropathy and the postural parameters. The sway path of the displacement along the anterior-posterior axis recorded during tests performed with eyes open and feet close together were significantly (p < 0.05) correlated with a poor glycemic (glycated haemoglobin concentration) control and each other with all diabetic neuropathy tests, fall risk scales, muscular weakness, ankle joint limitation and history of ulcers. CONCLUSIONS: The results support the existence of a strong association between alterations of the deep somato-sensitive pathway (although depending on the tool used to measure peripheral neuropathy), glycemic control and balance impairments assessed using a wearable sensors. Wearable-based postural analysis might be part of the clinical assessment that enables the detection of balance impairments and the risk of fall in diabetic patients with diabetic peripheral neuropathy.

Quantitative assessment of painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation: a pilot study.

OBJECTIVE: Randomized trials have demonstrated efficacy of spinal cord stimulation (SCS) for treatment of painful diabetic neuropathy (PDN). Preliminary data suggested that treatment of PDN with high-frequency SCS resulted in improvements on neurological examination. The purpose of the present study was to explore whether patients with PDN treated with high-frequency SCS would have improvements in lower-extremity peripheral nerve function. DESIGN: Prospective cohort study in an outpatient clinical practice at a tertiary care center. METHODS: Patients with PDN were treated with high-frequency SCS and followed up for 12 months after SCS implantation with clinical outcomes assessments of pain intensity, neuropathic symptoms, and neurological function. Small-fiber sudomotor function was assessed with the quantitative sudomotor axon reflex test (QSART), and large-fiber function was assessed with nerve conduction studies (NCS). Lower-extremity perfusion was assessed with laser Doppler flowmetry. RESULTS: Nine patients completed 12-month follow-up visits and were observed to have improvements in lower-extremity pain, weakness, and positive sensory symptoms. Neuropathy impairment scores were improved, and 2 patients had recovery of sensory responses on NCS. A reduction in sweat volume on QSART was observed in the proximal leg but not at other sites. No significant differences were noted in lower-extremity perfusion or NCS as compared with baseline. CONCLUSIONS: The improvement in pain relief was concordant with improvement in neuropathy symptoms. The findings from this study provide encouraging preliminary data in support of the hypothesis of a positive effect of SCS on peripheral neuropathy, but the findings are based on small numbers and require further evaluation. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT03769675.

Plantar threshold sensitivity assessment using an automated tool-Clinical assessment comparison between a control population without type 2 diabetes mellitus, and populations with type 2 diabetes mellitus, with and without neuropathy symptoms.

Diabetic peripheral neuropathy is often classified as a loss of sensation in the extremities, particularly in elderly populations. The most common diagnosis technique is with the use of the hand-applied Semmes-Weinstein monofilament. This study's first aim was to quantify and compare sensation on the plantar surface in healthy and type 2 diabetes mellitus populations with the standard Semmes-Weinstein hand-applied methodology and a tool that automates this approach. The second was to evaluate correlations between sensation and the subjects' medical characteristics. Sensation was quantified by both tools, at thirteen locations per foot, in three populations: Group 1-control subjects without type 2 diabetes, Group 2-subjects with type 2 diabetes and with neuropathy symptoms, and Group 3-subjects with type 2 diabetes without neuropathy symptoms. The percentage of locations sensitive to the hand-applied monofilament, yet insensitive to the automated tool was calculated. Linear regression analyses between sensation and the subject's age, body mass index, ankle brachial index, and hyperglycemia metrics were performed per group. ANOVAs determined differences between populations. Approximately 22.5% of locations assessed were sensitive to the hand-applied monofilament, yet insensitive to the automated tool. Age and sensation were only significantly correlated in Group 1 (R2 = 0.3422, P = 0.004). Sensation was not significantly correlated with the other medical characteristics per group. Differences in sensation between the groups were not significant (P = 0.063). Caution is recommended when using hand-applied monofilaments. Group 1's sensation was correlated to age. The other medical characteristics failed to corelate with sensation, despite group.

Accuracy and Cost-effectiveness of the Diabetic Foot Screen Proforma in Detection of Diabetic Peripheral Neuropathy in Myanmar.

Objective: Proper foot assessment is important for early detection and treatment of diabetic peripheral neuropathy (DPN), the main cause of diabetic foot ulcers (DFUs). This study aimed to determine the accuracy and cost-effectiveness of the locally developed Diabetic Foot Screen (DFS) proforma in detecting DPN among diabetic patients at 10 selected clinics in Yangon, Myanmar. Methodology: The study included 625 type 2 diabetics from 10 primary care clinics who participated in the diagnostic accuracy and cost-effectiveness analysis. They were assessed with DFS proforma and biothesiometry by two examiners independently. The cost-effectiveness analysis was conducted based on available data in the local primary care setting. Results: The overall accuracy of the DFS proforma assessment was 74.76% (95% CI: 70.46%- 79.06%). The optimal cut-off DFS score was ≥1.5 (sensitivity 62%; specificity 76%) in detecting DPN. Compared to biothesiometry, the cost-effectiveness of DFS proforma assessment in DPN detection was 41.79 USD per DPN case detected. Conclusion: This study supported the use of DFS proforma for DPN detection in primary care clinics. It also provided new information on the estimated costs per patient with DPN detected in Myanmar.

Small fiber neuropathy for assessment of disease severity in amyotrophic lateral sclerosis: corneal confocal microscopy findings.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder with progressive motor system impairment, and recent evidence has identified the extra-motor involvement. Small fiber neuropathy reflecting by sensory and autonomic disturbances in ALS has been reported to accompany the motor damage. However, non-invasive assessment of this impairment and its application in disease evaluation of ALS is scarce. We aim to evaluate the use of corneal confocal microscopy (CCM) to non-invasively quantify the corneal small fiber neuropathy in ALS and explore its clinical value in assessing disease severity of ALS. METHODS: Sixty-six patients with ALS and 64 healthy controls were included in this cross-sectional study. Participants underwent detailed clinical assessments and corneal imaging with in vivo CCM. Using ImageJ, the following parameters were quantified: corneal nerve length (IWL) and dendritic cell density (IWDC) in the inferior whorl region and corneal nerve fiber length (CNFL), nerve fiber density (CNFD), nerve branch density (CNBD), and dendritic cell density (CDC) in the peripheral region. Disease severity was evaluated using recognized scales. RESULTS: Corneal nerve lengths (IWL and CNFL) were lower while dendritic cell densities (IWDC and CDC) were higher in patients with ALS than controls in peripheral and inferior whorl regions (p < 0.05). Additionally, corneal nerve complexity in the peripheral region was greater in patients than controls with higher CNBD (p = 0.040) and lower CNFD (p = 0.011). IWL was significantly associated with disease severity (p < 0.001) and progression (p = 0.002) in patients with ALS. Patients with bulbar involvement showed significantly lower IWL (p = 0.014) and higher IWDC (p = 0.043) than patients without bulbar involvement. CONCLUSIONS: CCM quantified significant corneal neuropathy in ALS, and alterations in the inferior whorl region were closely associated with disease severity. CCM could serve as a noninvasive, objective imaging tool to detect corneal small fiber neuropathy for clinical evaluation in ALS.

Corneal nerves in diabetes-The role of the in vivo corneal confocal microscopy of the subbasal nerve plexus in the assessment of peripheral small fiber neuropathy.

The cornea's intense innervation is responsible for corneal trophism and ocular surface hemostasis maintenance. Corneal diabetic neuropathy affects subbasal nerve plexus, with progressive alteration of nerves' morphology and density. The quantitative analysis of nerve fibers can be performed with in vivo corneal confocal microscopy considering the main parameters such as corneal nerve fibers length, corneal nerve fibers density, corneal nerve branching density, tortuosity coefficient, and beadings frequency. As the nerve examination permits the detection of early changes occurring in diabetes, the invivo corneal confocal microscopy becomes, over time, an important tool for diabetic polyneuropathy assessment and follow-up. In this review, we summarize the actual evidence about corneal nerve changes in diabetes and the relationship between the grade of alterations and the duration and severity of the disease. We aim at understanding how diabetes impacts corneal nerves and how it correlates with sensorimotor peripheral polyneuropathy and retinal complications. We also attempt to analyze the safety of the most common surgical procedures such as cataract and refractive surgery in diabetic patients and to highlight the specific risk factors. We believe that information about the corneal nerve fibers' condition obtained from the in vivo subbasal nerve plexus investigation may be crucial in monitoring peripheral small fiber polyneuropathy and that it will help with decision-making in ophthalmic surgery in diabetic patients.

Performance analysis of noninvasive electrophysiological methods for the assessment of diabetic sensorimotor polyneuropathy in clinical research: a systematic review and meta-analysis with trial sequential analysis.

Despite the availability of various clinical trials that used different diagnostic methods to identify diabetic sensorimotor polyneuropathy (DSPN), no reliable studies that prove the associations among diagnostic parameters from two different methods are available. Statistically significant diagnostic parameters from various methods can help determine if two different methods can be incorporated together for diagnosing DSPN. In this study, a systematic review, meta-analysis, and trial sequential analysis (TSA) were performed to determine the associations among the different parameters from the most commonly used electrophysiological screening methods in clinical research for DSPN, namely, nerve conduction study (NCS), corneal confocal microscopy (CCM), and electromyography (EMG), for different experimental groups. Electronic databases (e.g., Web of Science, PubMed, and Google Scholar) were searched systematically for articles reporting different screening tools for diabetic peripheral neuropathy. A total of 22 studies involving 2394 participants (801 patients with DSPN, 702 controls, and 891 non-DSPN patients) were reviewed systematically. Meta-analysis was performed to determine statistical significance of difference among four NCS parameters, i.e., peroneal motor nerve conduction velocity, peroneal motor nerve amplitude, sural sensory nerve conduction velocity, and sural sensory nerve amplitude (all p < 0.001); among three CCM parameters, including nerve fiber density, nerve branch density, and nerve fiber length (all p < 0.001); and among four EMG parameters, namely, time to peak occurrence (from 0 to 100% of the stance phase) of four lower limb muscles, including the vastus lateralis (p < 0.001), tibialis anterior (p = 0.63), lateral gastrocnemius (p = 0.01), and gastrocnemius medialis (p = 0.004), and the vibration perception threshold (p < 0.001). Moreover, TSA was conducted to estimate the robustness of the meta-analysis. Most of the parameters showed statistical significance between each other, whereas some were statistically nonsignificant. This meta-analysis and TSA concluded that studies including NCS and CCM parameters were conclusive and robust. However, the included studies on EMG were inconclusive, and additional clinical trials are required.

Diabetic Peripheral Neuropathy Risk Assessment using Digital Fundus Photographs and Machine Learning.

In this work, we demonstrate a novel approach to assessing the risk of Diabetic Peripheral Neuropathy (DPN) using only the retinal images of the patients. Our methodology consists of convolutional neural network feature extraction, dimensionality reduction and feature selection with random projections, combination of image features to case-level representations, and the training and testing of a support vector machine classifier. Using clinical diagnosis as ground truth for DPN, we achieve an overall accuracy of 89% on a held-out test set, with sensitivity reaching 78% and specificity reaching 95%.

Risk assessment for foot ulcers among Tunisian subjects with diabetes: a cross sectional outpatient study.

BACKGROUND: Diabetic foot is an underestimated and redoubtable diabetes complication. The aims of our study were to assess diabetic foot ulcer risk factors according to International Working Group on the Diabetic Foot (IWGDF) classification, stratify patients into risk categories and identify factors associated with higher-risk grade. METHODS: Cross-sectional setting over a period of 07 months, patients were randomly selected from the diabetic outpatients attending our unit of diabetology. Questionnaire and clinical examination were made by the same physician. Patients free of active foot ulcer were included. RESULTS: Among 230 patients evaluated, 10 had an active foot ulcer and were excluded. Five patients (2.27%) had a history of foot ulcer and 3(1.36%) had a lower-limb amputation. Sensory neuropathy, as measured by the 5.07(10 g) Semmes-Weinstein monofilament testing, was present in 23.63% of patients, whereas 36.82% had a peripheral arterial disease based on clinical findings, and 43.63% had foot deformities. According to the IWGDF classification, Group 0: 72.72%, Group 1: 5.9%, Group 2: 17.73% and Group 3: 3.63%. After univariate analysis, patients in higher-risk groups were significantly more often female, had higher age and BMI, longer diabetes duration, elevated waist circumference, low school level, retinopathy and hyperkeratosis. Multivariate logistic regression analysis identified 3 significant independent factors associated with high-risk groups: retinopathy (OR = 2.529, CI95 [1.131-5.655], p = 0.024), hyperkeratosis (OR = 2.658, CI95 [1.222-5.783], p = 0.014) and school level (OR = 0.489, CI95 [0.253-9.44], p = 0.033). CONCLUSIONS: Risk factors for foot ulceration were rather common in outpatients with diabetes. The screening of patients at risk for foot ulceration should start early, integrated with sustainable patient education.

Bioengineered Polymer/Composites as Advanced Biological Detection of Sorbitol: An Application in Healthcare Sector.

Bioengineered polymers and nanomaterials have emerged as promising and advanced materials for the fabrication and development of novel biosensors. Nanotechnology-enabled biosensor methods have high sensitivity, selectivity and more rapid detection of an analyte. Biosensor based methods are more rapid and simple with higher sensitivity and selectivity and can be developed for point-of-care diagnostic testing. Development of a simple, sensitive and rapid method for sorbitol detection is of considerable significance to efficient monitoring of diabetes-associated disorders like cataract, neuropathy, and nephropathy at initial stages. This issue encourages us to write a review that highlights recent advancements in the field of sorbitol detection as no such reports have been published till the date. The first section of this review will be dedicated to the conventional approaches or methods that had been playing a role in detection. The second part focused on the emerging field i.e. biosensors with optical, electrochemical, piezoelectric, etc. approaches for sorbitol detection and the importance of its detection in healthcare application. It is expected that this review will be very helpful for readers to know the different conventional and recent detection techniques for sorbitol at a glance.

Item reduction of the 39-item Rotterdam Diabetic Foot Study Test Battery using decision tree modelling.

AIMS: Pedal sensory loss due to diabetes-related neuropathy can be graded by testing static two-point discrimination (S2PD), moving two-point discrimination (M2PD), static one-point discrimination (S1PD; eg, 10-g monofilament), and vibration sense and is included in the Rotterdam Diabetic Foot (RDF) Study Test Battery. The aim of this study is to investigate if decision tree modelling is able to reduce the number of tests needed in estimating pedal sensation. METHODS: The 39-item RDF Study Test Battery (RDF-39) scores were collected from the prospective RDF study and included baseline (n = 416), first follow-up (n = 364), and second follow-up (n = 135) measurements, supplemented with cross-sectional control data from a previous study (n = 196). Decision tree analysis was used to predict total RDF-39 scores using individual test item data. The tree was developed using baseline RDF study data and validated in follow-up and control data. Spearman correlation coefficients assessed the reliability between the decision tree and original RDF-39. RESULTS: The tree reduced the number of items from 39 to 3 in estimating the RDF-39 sum score. M2PD (hallux), S2PD (first dorsal web, fifth toe), vibration sense (interphalangeal joint), and S1PD (first dorsal web, fifth toe) measurements proved to be predictive. The correlation coefficients to original scores were high (0.76 to 0.91). CONCLUSIONS: The decision tree was successful at reducing the number of RDF Test Battery items to only 3, with high correlation coefficients to the scores of the full test battery. The findings of this study aids medical decision making by time efficiently estimating pedal sensory status with fewer tests needed.

Validation of Neuropad in the Assessment of Peripheral Diabetic Neuropathy in Patients with Diabetes Mellitus Versus the Michigan Neuropathy Screening Instrument, 10g Monofilament Application and Biothesiometer Measurement.

OBJECTIVE: Sudomotor dysfunction is a feature of Diabetic Peripheral Neuropathy (DPN). The indicator plaster Neuropad can provide an easy and accurate way to diagnose DPN. The aim of the present study was to evaluate Neuropad's specificity, sensitivity and accuracy in detecting DPN in patients with Diabetes Mellitus (DM). METHODS: A total of 174 patients with DM (79 with type 1 DM, 88 women), mean age 49.8 ± 16.1 years and mean DM duration 17.3 ± 7.7 years were included in the present study. The following methods were used to diagnose DPN: the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively), application of 10 g monofilament (MONO) and measurement of vibration perception threshold with biothesiometer (BIO). Neuropad was applied to both feet in all patients and according to the presence or absence of color change of the sticker, patients were divided in two groups: group A (n = 82, complete change in color from blue to pink, depicting normal perspiration) and group B (n = 92, incomplete or no change, depicting abnormal perspiration). RESULTS: MNSIQ and MNSIE were positive for DPN in 111 and 119 patients, respectively. BIO was abnormal in 109 and MONO in 59 patients. Sensitivity of Neuropad testing was 95% vs. MONO, 73% vs. BIO, 73% vs. MNSIE and 75% vs. ΜNSIQ. Specificity was 69, 81, 90 and 92%, respectively and accuracy of the test was 78, 76, 78 and 83%, respectively. CONCLUSION: Neuropad has a high sensitivity and specificity in detecting DPN vs. MNSIQ, MNSIE and BIO. Neuropad has a high sensitivity but moderate specificity vs. MONO. The accuracy of the test was high in all measurements.

Cost-effectiveness analysis of the Neuropad device as a screening tool for early diabetic peripheral neuropathy.

OBJECTIVE: To carry out a cost-effectiveness analysis of the use of Neuropad as a screening test for diabetic neuropathy together with the standard care tool, the 10-g monofilament, in people with diabetes. RESEARCH DESIGN AND METHODS: A cost-effectiveness analysis using a Markov model was developed to assess the impact on costs and outcomes of using Neuropad as a test for diabetic neuropathy (1) as a complement to the standard test, the 10-g monofilament (Neuropad + monofilament vs. monofilament); and (2) as a substitute for the monofilament (Neuropad vs. monofilament); from the healthcare provider perspective. The time horizon was 3 years. Data on costs and health gains were extracted from the literature. The incremental cost-utility ratio was calculated. Deterministic and probabilistic sensitivity analyses were also performed. RESULTS: Compared with standard care, Neuropad, in combination with the 10-g monofilament tool, is the dominant strategy as it leads to higher health gains and lower costs. In practice, compared with using the monofilament alone, performing both tests would lead to a savings of £1049.26 per patient and 0.044 QALY gain. Results were found to be consistent across the sensitivity analyses. CONCLUSIONS: Using both screening tools (Neuropad + monofilament) is a cost-effective strategy and the dominant alternative, when compared against using the 10-g monofilament alone. The results would be of special relevance in the early detection of diabetic peripheral neuropathy and to ensure the efficient allocation of resources and, thus, the sustainability of healthcare systems.

Evaluation of the risk of diabetic peripheral neuropathy: Design and validation of the NeuDiaCan nursing screening procedure. / Valoración del riesgo de neuropatía periférica diabética: diseño y validación del procedimiento para cribado enfermero NeuDiaCan.

OBJECTIVE: To design and validate a nursing screening procedure for diabetic peripheral neuropathy in primary care. METHODS: The study was carried out in three phases. 1)Construction of an item bank to form the procedure with an exit score describing the patient's clinical situation. 2)Test and reduction of the initial tentative procedure on a sample of 50 patients using community nurse consultations, eliminating the components with low inter-intra nurse reliability. 3)Validation of the version of the procedure obtained in the previous step on a sample of 106 patients. Calculation of validity and reliability by eliminating components with low criterion validity with respect to the results of the diagnostic electromyography used as a reference standard. Cut-off points were estimated for the use of the procedure as a screening tool, predictive values, performance, internal consistency and inter-nurse reliability. RESULTS: The initial tentative procedure consisted of 12 components that were reduced to 10. In the process of validation of this second version the procedure was simplified again, eventually comprising 6 components, with a cut-off point of 2.5 in its output scale, the point at which it reaches adequate values of sensitivity and negative predictors to be used as a screening instrument. For this cut-off point the inter-intra nurse reliability, criterion validity and predictive validity reached acceptable values. CONCLUSIONS: NeuDiaCan as a nursing screening procedure for diabetic peripheral neuropathy in primary care is valid, reliable and easy to use.