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Reliability and Validity of a Point-of-Care Sural Nerve Conduction Device for Identification of Diabetic Neuropathy
Confirmation of diabetic sensorimotor polyneuropathy (DSP) relies on standard nerve conduction studies (NCS) performed in specialized clinics. We explored the utility of a point-of-care device (POCD) for DSP detection by nontechnical personnel and a validation of diagnostic thresholds with those observed in a normative database.
44 subjects with type 1 and type 2 diabetes underwent standard NCS (reference method). Two nontechnical examiners measured sural nerve amplitude potential (SNAP) and conduction velocity (SNCV) using the POCD. Reliability was determined by intraclass correlation coefficients (ICC [2], [1]). Validity was determined by Bland-Altman analysis and receiver operating characteristic curves.
The 44 subjects (50% female) with mean age 56 ± 18 years had mean SNAP and SNCV of 8.0 ± 8.6 µV and 41.5 ± 8.2 m/s using standard NCS and 8.0 ± 8.2 µV and 49.9 ± 11.1 m/s using the POCD. Intrarater reproducibility ICC values were 0.97 for SNAP and 0.94 for SNCV while interrater reproducibility values were 0.83 and 0.79, respectively. Mean bias of the POCD was -0.1 ± 3.6 µV for SNAP and +8.4 ± 6.4 m/s for SNCV. A SNAP of ≤6 µV had 88% sensitivity and 94% specificity for identifying age-and height-standardized reference NCS values, while a SNCV of ≤48 m/s had 94% sensitivity and 82% specificity [corrected].. Abnormality in one or more of these thresholds was associated with 95% sensitivity and 71% specificity for identification of DSP according to electrophysiological criteria.
The POCD demonstrated excellent reliability and acceptable accuracy. Threshold values for DSP identification validated those of published POCD normative values. We emphasize the presence of measurement bias--particularly for SNCV--that requires adjustment of threshold values to reflect those of standard NCS.
Journal Article
Identification and Prediction of Diabetic Sensorimotor Polyneuropathy Using Individual and Simple Combinations of Nerve Conduction Study Parameters
Evaluation of diabetic sensorimotor polyneuropathy (DSP) is hindered by the need for complex nerve conduction study (NCS) protocols and lack of predictive biomarkers. We aimed to determine the performance of single and simple combinations of NCS parameters for identification and future prediction of DSP.
406 participants (61 with type 1 diabetes and 345 with type 2 diabetes) with a broad spectrum of neuropathy, from none to severe, underwent NCS to determine presence or absence of DSP for cross-sectional (concurrent validity) analysis. The 109 participants without baseline DSP were re-evaluated for its future onset (predictive validity). Performance of NCS parameters was compared by area under the receiver operating characteristic curve (AROC).
At baseline there were 246 (60%) Prevalent Cases. After 3.9 years mean follow-up, 25 (23%) of the 109 Prevalent Controls that were followed became Incident DSP Cases. Threshold values for peroneal conduction velocity and sural amplitude potential best identified Prevalent Cases (AROC 0.90 and 0.83, sensitivity 80 and 83%, specificity 89 and 72%, respectively). Baseline tibial F-wave latency, peroneal conduction velocity and the sum of three lower limb nerve conduction velocities (sural, peroneal, and tibial) best predicted 4-year incidence (AROC 0.79, 0.79, and 0.85; sensitivity 79, 70, and 81%; specificity 63, 74 and 77%, respectively).
Individual NCS parameters or their simple combinations are valid measures for identification and future prediction of DSP. Further research into the predictive roles of tibial F-wave latencies, peroneal conduction velocity, and sum of conduction velocities as markers of incipient nerve injury is needed to risk-stratify individuals for clinical and research protocols.
Journal Article
Reproducibility of In Vivo Corneal Confocal Microscopy Using an Automated Analysis Program for Detection of Diabetic Sensorimotor Polyneuropathy
In vivo Corneal Confocal Microscopy (IVCCM) is a validated, non-invasive test for diabetic sensorimotor polyneuropathy (DSP) detection, but its utility is limited by the image analysis time and expertise required. We aimed to determine the inter- and intra-observer reproducibility of a novel automated analysis program compared to manual analysis.
In a cross-sectional diagnostic study, 20 non-diabetes controls (mean age 41.4±17.3y, HbA1c 5.5±0.4%) and 26 participants with type 1 diabetes (42.8±16.9y, 8.0±1.9%) underwent two separate IVCCM examinations by one observer and a third by an independent observer. Along with nerve density and branch density, corneal nerve fibre length (CNFL) was obtained by manual analysis (CNFLMANUAL), a protocol in which images were manually selected for automated analysis (CNFLSEMI-AUTOMATED), and one in which selection and analysis were performed electronically (CNFLFULLY-AUTOMATED). Reproducibility of each protocol was determined using intraclass correlation coefficients (ICC) and, as a secondary objective, the method of Bland and Altman was used to explore agreement between protocols.
Mean CNFLManual was 16.7±4.0, 13.9±4.2 mm/mm2 for non-diabetes controls and diabetes participants, while CNFLSemi-Automated was 10.2±3.3, 8.6±3.0 mm/mm2 and CNFLFully-Automated was 12.5±2.8, 10.9 ± 2.9 mm/mm2. Inter-observer ICC and 95% confidence intervals (95%CI) were 0.73(0.56, 0.84), 0.75(0.59, 0.85), and 0.78(0.63, 0.87), respectively (p = NS for all comparisons). Intra-observer ICC and 95%CI were 0.72(0.55, 0.83), 0.74(0.57, 0.85), and 0.84(0.73, 0.91), respectively (p<0.05 for CNFLFully-Automated compared to others). The other IVCCM parameters had substantially lower ICC compared to those for CNFL. CNFLSemi-Automated and CNFLFully-Automated underestimated CNFLManual by mean and 95%CI of 35.1(-4.5, 67.5)% and 21.0(-21.6, 46.1)%, respectively.
Despite an apparent measurement (underestimation) bias in comparison to the manual strategy of image analysis, fully-automated analysis preserves CNFL reproducibility. Future work must determine the diagnostic thresholds specific to the fully-automated measure of CNFL.
Journal Article
The CLASS 150/220 GHz Polarimeter Array: Design, Assembly, and Characterization
We report on the development of a polarization-sensitive dichroic (150/220 GHz) detector array for the Cosmology Large Angular Scale Surveyor (CLASS) delivered to the telescope site in June 2019. In concert with existing 40 and 90 GHz telescopes, the 150/220 GHz telescope will make observations of the cosmic microwave background over large angular scales aimed at measuring the primordial B-mode signal, the optical depth to reionization, and other fundamental physics and cosmology. The 150/220 GHz focal plane array consists of three detector modules with 1020 transition edge sensor bolometers in total. Each dual-polarization pixel on the focal plane contains four bolometers to measure the two linear polarization states at 150 and 220 GHz. Light is coupled through a planar orthomode transducer fed by a smooth-walled feedhorn array made from an aluminum–silicon alloy (CE7). In this work, we discuss the design, assembly, and in-laboratory characterization of the 150/220 GHz detector array. The detectors are photon-noise limited, and we estimate the total array noise-equivalent power to be 2.5 and 4
aW
s
for 150 and 220 GHz arrays, respectively.
Journal Article
Lack of association between body mass index and plasma adiponectin levels in healthy adults
Objectives: To test the hypothesis that obesity (increase in fat mass) independently affects the level of adipokines: adiponectin, tumor necrosis factor-α (TNFα) and interleukin (IL)-6. Methods: Publications in the past decade reporting adult plasma adiponectin, leptin, TNFα and/or IL-6 levels were compiled. Mean gender-specific values were extracted from studies that included medical screening to confirm physical health (43 groups, total 4852 subjects). Correlation analysis was conducted between adipokine levels and body mass index (BMI), a widely used estimate of adiposity. Results: For healthy lean to obese adults of both genders, no significant correlation between plasma adiponectin and BMI was detected. There was also no gender difference in plasma adiponectin level. In contrast, leptin levels showed a positive correlation with BMI in both genders, and women had significantly higher levels of plasma leptin consistent with a higher percentage of body fat. The proinflammatory cytokine TNFα failed to show correlation with BMI. Although IL-6 showed a positive correlation with BMI in women, the obesity-related increase was very limited. Conclusions: Data analysis based on studies performed on healthy adults did not support the hypothesis that obesity independently affects the plasma level of adiponectin and TNFα. Reported obesity-related changes in plasma adipokine levels may be a consequence of obesity-related metabolic disorders. Future studies are especially needed to understand the homeostasis of adiponectin.
Journal Article
The emergence of psychoanalytical electrochemistry: the translation of MDD biomarker discovery to diagnosis with electrochemical sensing
The disease burden and healthcare costs of psychiatric diseases along with the pursuit to understand their underlying biochemical mechanisms have led to psychiatric biomarker investigations. Current advances in evaluating candidate biomarkers for psychiatric diseases, such as major depressive disorder (MDD), focus on determining a specific biomarker signature or profile. The origins of candidate biomarkers are heterogenous, ranging from genomics, proteomics, and metabolomics, while incorporating associations with clinical characterization. Prior to clinical use, candidate biomarkers must be validated by large multi-site clinical studies, which can be used to determine the ideal MDD biomarker signature. Therefore, identifying valid biomarkers has been challenging, suggesting the need for alternative approaches. Following validation studies, new technology must be employed to transition from biomarker discovery to diagnostic biomolecular profiling. Current technologies used in discovery and validation, such as mass spectroscopy, are currently limited to clinical research due to the cost or complexity of equipment, sample preparation, or measurement analysis. Thus, other technologies such as electrochemical detection must be considered for point-of-care (POC) testing with the needed characteristics for physicians’ offices. This review evaluates the advantages of using electrochemical sensing as a primary diagnostic platform due to its rapidity, accuracy, low cost, biomolecular detection diversity, multiplexed capacity, and instrument flexibility. We evaluate the capabilities of electrochemical methods in evaluating current candidate MDD biomarkers, individually and through multiplexed sensing, for promising applications in detecting MDD biosignatures in the POC setting.
Journal Article
Analysis of Polarized Dust Emission Using Data from the First Flight of SPIDER
Using data from the first flight of Spider and from the Planck High Frequency Instrument, we probe the properties of polarized emission from interstellar dust in the Spider observing region. Component-separation algorithms operating in both the spatial and harmonic domains are applied to probe their consistency and to quantify modeling errors associated with their assumptions. Analyses of diffuse Galactic dust emission spanning the full Spider region demonstrate (i) a spectral energy distribution that is broadly consistent with a modified-blackbody (MBB) model with a spectral index of β d = 1.45 ± 0.05 (1.47 ± 0.06) for E (B)-mode polarization, slightly lower than that reported by Planck for the full sky; (ii) an angular power spectrum broadly consistent with a power law; and (iii) no significant detection of line-of-sight polarization decorrelation. Tests of several modeling uncertainties find only a modest impact (∼10% in σ r ) on Spider’s sensitivity to the cosmological tensor-to-scalar ratio. The size of the Spider region further allows for a statistically meaningful analysis of the variation in foreground properties within it. Assuming a fixed dust temperature T d = 19.6 K, an analysis of two independent subregions of that field results in inferred values of β d = 1.52 ± 0.06 and β d = 1.09 ± 0.09, which are inconsistent at the 3.9σ level. Furthermore, a joint analysis of Spider and Planck 217 and 353 GHz data within one subregion is inconsistent with a simple MBB at more than 3σ, assuming a common morphology of polarized dust emission over the full range of frequencies. This evidence of variation may inform the component-separation approaches of future cosmic microwave background polarization experiments.
Journal Article
Continuous Suprainguinal Fascia Iliaca Block vs Epidural Analgesia for Pediatric Hip Surgery: A Retrospective Cohort Study
The primary aim of this study was to compare the continuous suprainguinal fascia iliaca block (CSFI) and continuous epidural analgesia (CEA) for procedures of the proximal femur and acetabulum in children. We hypothesized that CSFI would provide equivalent opioid requirements while both blocks were in place, reduced opioid requirements after epidural removal, earlier mobilization, and decreased length of stay compared to CEA.
We retrospectively examined all pediatric patients who underwent a procedure of the proximal femur or acetabulum between January 1, 2013, and December 31, 2023. Outcome measures included opioid usage, verbal pain scores (0-10), sedation scores, time to ambulation and length of hospital stay. The primary endpoint was daily opioid requirements.
There were 82 patients in the cohort, 35 patients in the CEA group and 47 patients in the CSFI group. We found no evidence for differences in daily mean opioid requirements (parenteral and oral) for the two groups on the day of surgery (DOS) and POD 1 when both blocks were in place. CSFI was strongly associated with lower mean opioid requirements on POD 2 and POD 3 following removal of the epidural catheter, earlier time to ambulation, shorter length of stay and less sedation on the DOS, POD 1, and 2. Four patients reported persistent anterior thigh numbness 6 weeks after the procedure, all in the CSFI group. (8.5%).
CSFI was associated with similar parenteral and oral opioid requirements compared to CEA while both blocks were in place, earlier mobilization, reduced length of stay, less sedation and reduced opioid usage after epidural removal. CSFI appears to offer significant advantages over CEA for procedures of the proximal femur and acetabulum in pediatric patients, but persistent thigh numbness in the CSFI group warrants further investigation.
Journal Article
Discrimination of GutCheck(NEC): a clinical risk index for necrotizing enterocolitis
Better measures are needed to identify infants at risk for developing necrotizing enterocolitis (NEC) and facilitate communication about risk across transitions. Although NEC is multi-factorial, quantification of composite risk for NEC in an individual infant is not clearly defined. The objective of this study was to describe the derivation, validation and calibration testing of a novel clinical NEC risk index, GutCheck(NEC). Individual risk factors were weighted to assess composite odds of developing NEC. GutCheck(NEC) is designed to improve communication about NEC risk and coordination of care among clinicians across an infant's clinical course.
On the basis of a synthesis of research evidence about NEC risk and an e-Delphi study including 35 neonatal experts, we identified NEC risk factors believed by the experts to be most relevant for a NEC risk index, then applied a logistic model building process to derive and validate GutCheck(NEC). De-identified data from the Pediatrix BabySteps Clinical Data Warehouse (discharge date 2007 to 2011) were split into three samples for derivation, validation and calibration. By comparing infants with medical NEC, surgical NEC and those who died to infants without NEC, we derived the logistic model using the un-matched derivation set. Discrimination was then tested in a case-control matched validation set and an un-matched calibration set using receiver operating characteristic curves.
Sampled from a cohort of 58 820 infants, the randomly selected derivation set (n=35 013) revealed nine independent risk factors (gestational age, history of packed red blood cell transfusion, unit NEC rate, late-onset sepsis, multiple infections, hypotension treated with inotropic medications, Black or Hispanic race, outborn status and metabolic acidosis) and two risk reducers (human milk feeding on both days 7 and 14 of life, and probiotics). Unit NEC rate carried the most weight in the summed score. Validation using a 2:1 matched case-control sample (n=360) demonstrated fair to good discrimination. In the calibration set (n=23 447), GutCheck(NEC) scores (range 0 to 58) discriminated those infants who developed surgical NEC (area under the curve (AUC)=0.84, 95% confidence interval (CI) 0.82 to 0.84) and NEC leading to death (AUC=0.83, 95% CI 0.81 to 0.85), more accurately than medical NEC (AUC= 0.72, 95% CI 0.70 to 0.74).
GutCheck(NEC) represents weighted composite risk for NEC and discriminated infants who developed NEC from those who did not with very good accuracy. We speculate that targeting modifiable NEC risk factors could reduce national NEC prevalence.
Journal Article