Functional Scale Research Articles

Psychometric properties of a COVID-19 health literacy scale in a sample of German school principals applying Rasch analysis

Abstract Background During the COVID-19 pandemic, health literacy was found to be an asset to manage health-related information. The HLS-COVID-Q22 has been developed to measure COVID-19 health literacy. External validation needs to be assessed in different populations to verify the questionnaire’s functioning. The present study aimed to evaluate the psychometric properties of the HLS-COVID-Q22 in a sample of German school principals. Methods The sample consisted of 2187 German school principals who completed the HLS-COVID-Q22 online from April to March 2021. The data was analyzed using Rasch analysis, applying the Partial Credit Model for polytomous data. Dimensionality, item fit statistics and rating scale functioning was tested. Values for item difficulty and person ability as well as reliability indices were computed. Results Unidimensionality could be confirmed. The rating scale categories worked as intended, participants used every rating step category. Generally, item fit was verified. One item showed potential misfit but could remain in the questionnaire as excluding the item did not reduce reliability. A person separation index of 3.41 and person reliability of 0.92 showed excellent differentiation between COVID-19 health literacy levels. Furthermore, the values for item separation of 20.08 and item reliability of 1.0 indicate good construct validity. Conclusions The German version of the HLS-COVID-Q22 appears to be a reliable measurement tool for the target population. Evidence for construct, statistical and fit validity was collected. Future studies need to test additional types of validity like convergent and divergent validity to further evaluate the questionnaire. Moreover, the psychometric properties of the translated versions of the HLS-COVID-Q22 should be compared using Rasch analysis.

ETWST: An Extension to the Timed Water Swallow Test for Increased Dysphagia Screening Accuracy

AbstractWe aimed to fine-tuning the Timed Water Swallow Test (TWST) screening procedure to provide the most reliable prediction of the Flexible Endoscopic Evaluation of Swallowing (FEES) assessment outcomes, with age, sex, and the presence of clinical signs of dysphagia being considered in the assessment. Participants were healthy people and patients with suspected dysphagia. TWST performance and participants’ reported dysphagia symptoms were assessed in terms of their utility in predicting the outcome of a FEES assessment the same day. The FEES assessors were blinded to the nature of the TWST performance. The water swallowing capacity levels and clinical observations during a screening performance that were indicative of dysphagia/no symptoms in FEES were determined. Convergent validity was assessed as the agreement with the Functional Oral Intake Scale (FOIS) in the FEES assessment. TWST predicted FEES findings (aspiration and dysphagia) with a sensitivity of 72 and 45% and a specificity of 75% and 80%, respectively. Extended analysis of the TWST procedure (eTWST) identified aspiration (sensitivity = 92%, specificity = 62%) and dysphagia (sensitivity = 70%, and specificity = 72%) more accurately and showed a high correlation with FOIS (ɸ = 0.37). Excellent inter-rater reliability was further observed (Kw = 0.83). The extended evaluation of TWST performance has superior criterion validity to that of TWST. eTWST displayed high convergent validity and excellent interrater reliability. We therefore believe that eTWST can be highly relevant for clinical dysphagia screening.

Non-planar corrections in ABJM theory from quantum M2 branes

The quantization of semiclassical strings in AdS spacetimes yields predictions for the strong-coupling behaviour of the scaling dimensions of the corresponding operators in the planar limit of the dual gauge theory. Finding non-planar corrections requires computing string loops (corresponding to torus and higher genus surfaces), which is a challenging task. It turns out that in the case of the Uk(N) × U−k(N) ABJM theory there is an alternative approach: one may semiclassically quantize M2 branes in AdS4 × S7/ℤk which are wrapped around the 11d circle of radius 1/k = λ/N . Such M2 branes are the M-theory generalization of the strings in AdS × CP3. In this work, we show that by expanding in large M2 brane tension T2 ~ kN\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$ \\sqrt{kN} $$\\end{document} for fixed k, followed by an expansion in large k, we can predict the large λ asymptotics of the non-planar corrections to the dimensions of the dual ABJM operators. As a specific example, we consider the M2 brane configuration that generalizes the long folded string with large spin in AdS4, and compute the 1-loop correction to its energy. This calculation allows us to determine non-planar corrections to the universal scaling function or cusp anomalous dimension. We extend our analysis to the semiclassical M2 branes that generalize the “short” and “long” circular strings with two equal angular momenta in CP3. The “short” M2 brane corresponds to a dual operator whose dimension at strong coupling scales as ∆ ∼ λ1/4 + …, and we derive the leading non-planar correction to it.

Hindi version of the lower extremity functional scale: a study of translation, validation and cross-cultural adaptation

BACKGROUND: Lower Extremity Function Scale (LEFS) serves as a patient-reported outcome measure, used to evaluate the functional status of lower extremity in different musculoskeletal conditions. It was originally developed in English language (E-LEFS) and numerous translations in different languages are available to measure its usability among different cultures. OBJECTIVES: To translate the English version of the Lower Extremity Function Scale (E-LEFS) into Hindi language and to evaluate its content validity, cross-cultural adaptation along with the concurrent validity and reliability. METHOD: Process of forward and backward translation was carried out by two bilingual translators and a physiotherapist after obtaining developer’s approval, for which the Beaton guidelines were used. For the content validation, Delphi method of was employed in which 12 field experts of more than 5 years of experience participated. Cultural adaptation procedures were then carried out with 12 patients, who reported in out-patient department of the hospital through convenience sampling who were asked about whether the H-LEFS was well understood by the patients. Their responses were recorded as positive and negative responses. This process was followed by concurrent validation which was conducted by comparing the scores with the SF-36 scale, involving 30 patients with activity limitation in their daily life. Lastly, 50 patients were recruited for intra-rater reliability testing. RESULT: The scale was successfully translated and verified by the bi-lingual language experts. Content validity came out to be significant with each item scoring more than 0.92. Nearly all items, excluding item no. 8, 16, 17, 18, and 19 received universal agreement with a content validity ratio of 1. The average scale-level validity stood at 0.98, indicating excellent level of validity and the scale was found to be well adapted by the native people as out of 12 patients, 10 patients provided 100% positive response. Concurrent validation using Pearson’s correlation coefficient came out excellent with the values of 0.993 for E-LEFS and 0.890 for SF-36. Cronbach's alpha and ICC values were calculated as 1.00 for Intra-rater reliability. CONCLUSION: LEFS was well translated into Hindi language with an excellent content and concurrent validity and is found to be highly reliable. Hence, it is recommended for the usage of native Hindi speaking population.

The importance of stochasticity in determining galaxy emissivities and UV LFs during cosmic dawn and reionization

The stochastic nature of star formation and photon propagation in high-redshift galaxies can result in sizable galaxy-to-galaxy scatter in their properties. Ignoring this scatter by assuming mean quantities can bias estimates of their emissivity and corresponding observables. We constructed a flexible, semi-empirical model, sampling scatter around the following mean relations: (i) the conditional halo mass function (CHMF); (ii) the stellar-to-halo mass relation (SHMR); (iii) the galaxy star formation main sequence (SFMS); (iv) the fundamental metallicity relation (FMR); (v) the conditional intrinsic luminosity; and (vi) the photon escape fraction. In our fiducial model, ignoring scatter in these galaxy properties overestimates the duration of the Epoch of Reionization (EoR), delaying its completion by $ z 1--2. We quantified the relative importance of each of the above sources of scatter in determining the ionizing, soft-band X-ray, and Lyman Werner (LW) emissivities as a function of scale and redshift. We find that scatter around the SFMS is important for all bands, especially at the highest redshifts where the emissivity is dominated by the faintest, most "bursty" galaxies. Ignoring this scatter would underestimate the mean emissivity and its standard deviation computed over 5 cMpc regions by factors of up to sim 2--10 at $5 z 15$. The scatter around the X-ray luminosity to star formation rate and metallicity relation is important for determining X-ray emissivity, accounting for roughly half of its mean and standard deviation. The importance of scatter in the ionizing escape fraction depends on its functional form, while scatter around the SHMR contributes at the level of sim 10--20<!PCT!>. Other sources of scatter have a negligible contribution to the emissivities. Although scatter does flatten the UV luminosity functions, shifting the bright end by 1--2 magnitudes, the level of scatter in our fiducial model is insufficient to fully explain recent estimates from JWST photometry (consistent with previous studies). We conclude that models of the EoR should account for the burstiness of star formation, while models for the cosmic 21cm signal should additionally account for scatter in intrinsic X-ray production.

Correcting images for individual differences in color appearance

AbstractIndividual differences are a prominent feature of normal color vision and range from variations in sensitivity to perception and color naming. Corrections for differences in spectral sensitivity are common, and there is growing interest in calibrating displays for the sensitivity of an individual observer. In contrast, few studies have explored calibrations for aspects of color appearance. We developed a technique for adjusting images based directly on an individual's hue percepts and illustrate the principle of the approach using a set of hue scaling functions measured previously for a large sample of color‐normal observers (Emery et al. PNAS 2023). Colors in an image are mapped onto the average scaling function to define the hue perceived by the average “standard observer.” This hue is then mapped back to the chromaticity that would elicit the same response in any individual observer. With this correction, different observers – each looking at physically different images calibrated for their own hue percepts – should in principle agree on the perceived colors. Adjustments of this kind could be easily implemented on standard displays, because they require only measures of hue percepts and not spectral sensitivity, and could lead to greater consistency in the perception and communication about color across individuals with potentially widely different perceptual experiences of color.

OUTCOME MEASURES FOR CERVICOGENIC DIZZINESS: A META ANALYSIS.

Background: Cervicogenic dizziness (CGD) is a complex condition characterized by dizziness arising from cervical spine disorders. It affects approximately 40% of patients with chronic neck pain and can significantly impact daily activities, quality of life, and mental health. The involvement of cervical structure in vestibular function highlights the need for effective assessment tools. Outcome measures play a crucial role in diagnosing CGD, evaluating treatment effectiveness, and improving patient outcomes. This evolved, focusing on both subjective and objective assessments, including symptom questionnaires, functional scales, and vestibular function tests. Standardized outcome measures are essential for clinical making and guideline development. Objective: The objective of the study is to systematically evaluate and compare the reliability, validity and sensitivity data of various outcome measures of cervicogenic dizziness. Method: The systemic data were searched using PubMed, Scopus, Google scholar, Science direct, PEDro, Cochrane library to identify studies published from the year 2001 up to 2023. Study selection is reported according to PRISMA guidelines. A total of 50 review articles were collected on outcome measures for Cervicogenic Dizziness (CGD). Data extraction included Research, Evidence based study, Literature, Systematic reviews and Meta-analysis articles. Result: This meta-analysis states that outcomes measures for Cervicogenic Dizziness (CGD) show a highly significant difference. Conclusion: After analysis of various articles, it was concluded that diagnosing patients with outcome measures for Cervicogenic Dizziness shows highly significant and improving health care efficiency. This study identified reliable and valid outcome measures for assessing Cervicogenic Dizziness (CGD). Implication: This study findings have significant implication for clinical practice, research, and policy, enhancing diagnosis, treatment and patient outcomes, standardized use of validated outcome measures will inform evidence – based guidelines for Cervicogenic Dizziness.

The mentor attunement scale: a tool to measure a critical mentoring skill-set

ABSTRACT This article details a two-phase study of the development and validation of a mentor attunement scale (MAS). Phase 1 involved theory-driven generation of 20 items to measure four facets of attunement. Rasch analysis of data collected from 390 youth mentors indicated problematic reverse-coded items, which were eliminated to improve scale functioning. Exploratory Factor Analysis and reliability analysis applied to the same dataset supported this removal, and pointed to an internally consistent, 12-item, one-factor solution, then tested using Confirmatory Factor Analysis (CFA) in the second phase. CFA applied to a second cohort of 453 mentors produced a good fitting, single-factor, 5-item scale. A measurement model consisting of the five attunement items and an existing, 7-item empathy scale was then tested to confirm convergent and discriminant validity. The final solution supported a two-factor, 9-item MAS. Use of the MAS can advance the fragmented conceptualization and measurement of critical mentoring skills.

Probiotic Formulation for Patients With Bipolar or Schizophrenia Spectrum Disorder: A Double-Blind, Randomized Placebo-Controlled Trial.

Probiotic augmentation offers a promising treatment for bipolar disorder (BD) and schizophrenia spectrum disorder (SSD). By targeting microbiome deviations, they may improve both gut and brain health. In this double-blind, randomized, placebo-controlled trial with the multi-strain probiotic formulation Ecologic BARRIER, we aimed to improve psychiatric and cognitive symptoms, intestinal permeability, and gastrointestinal symptoms in patients with BD or SSD. A total of 131 patients were randomized 1:1 to receive either the probiotic supplement (n = 67) or a placebo (n = 64) for 3 months, in addition to treatment-as-usual. The primary outcomes were symptom severity assessed by the Brief Psychiatric Rating Scale and cognitive functioning by the Brief Assessment of Cognition in Schizophrenia. No significant effect of probiotics was observed on psychiatric symptoms, but borderline significant improvement was observed in the cognition category of verbal memory (Linear Mixed Model (LMM)0.33; adjusted P = .059). Probiotics beneficially affected markers of intestinal permeability and inflammation, including zonulin (LMMserum = -18.40; adjusted P = .002; LMMfecal = -10.47; adjusted P = .014) and alpha-1 antitrypsin (LMM 9.26; adjusted P = .025). Indigestion complaints significantly decreased in male participants in the probiotics group (LMM = -0.70; adjusted P = .010). Adverse events were similar between groups. Our study observed significant advantages of probiotics for gut health in BD and SSD, with excellent safety and tolerability. A borderline effect on verbal memory was also indicated. These results underscore the need for further research into microbiome-targeted interventions for patients with complex brain disorders.

Translate and cross-culturally adapt the original English version of the lower extremity functional scale into the Sinhalese version

Objectives: Functional ability is critical for quality of life (QOF), and its evaluation is vital in a clinical context. However, there is a deficiency of a universally recognized grading scale in Sinhala for assessing functional capacity in athletes with lower extremity musculoskeletal conditions. This research aimed to validate the linguistic and cross-cultural adaptation of a translated Sinhala version of the lower extremity functional scale (S-LEFS). Materials and Methods: A two-stage observational study was conducted. The lower extremity functional scale was cross-culturally adapted to Sinhala through independent, double forward, and backward translation. An experienced clinical researcher tested the translated version to establish the linguistic validation of S-LEFS. The finalized version was validated for construct, convergent, and criterion validity. A total of 112 participants, comprising 57 healthy (50.89%) and 55 unhealthy (49.11%) lower limb athletes, completed S-LEFS. Results: S-LEFS demonstrated excellent reliability with a Cronbach’s alpha of 0.952. Exploratory factor analysis revealed good factor loadings (>0.48) for all 20 items, with three components accounting for 70.63% of cumulative variance. Scale got a sensitivity of 87.5% and specificity of 81% at a cutoff point of 67.5. Kaiser-Meyer-Olkin (KMO) value was 0.918 (P < 0.0001), and Bartlett’s Test of Sphericity was significant (P < 0.01). No correlation was detected between S-LEFS and World Health Organization QOF-Bref (r = 0.281). Conclusion: S-LEFS is a reliable and valid tool for evaluating lower limb function in athletes.

Cepstrum-driven modulated empirical wavelet transform and its application in bearing fault diagnosis

Abstract Empirical wavelet transform (EWT) has a complete theoretical support and can adaptively separate modes with different characteristics from the frequency domain. Signal decomposition and mode extraction based on the empirical wavelet transform can obtain more accurate components. This paper proposes a modulated empirical wavelet transform driven by cepstrum under the basic framework of traditional EWT method. The most innovative point of this paper is to use the characteristics of cepstrum to update the waveform of trend spectrum and realize the function of separating different modes. The filtering process constructs filter banks covering the entire frequency band based on scaling functions and empirical wavelets. In order to enhance the fault characteristics from the filtering components, the amplitude of its spectrum was modulated based on the Fourier transform characteristics. Finally, the effectiveness of the algorithm is verified by using simulation signals and experimental signals provided by Case Western Reserve University. 
Keywords: Empirical wavelet transform, Rolling bearing, Cepstrum, Amplitude Modulation, Fault Diagnosis

Reliability, measurement error, and validity of the Arabic version of the Patient-Specific Functional Scale in patients with upper extremity musculoskeletal disorders.

To evaluate the measurement properties of the Arabic Patient-Specific Functional Scale (PSFS) in individuals with upper extremity musculoskeletal disorders. Participants with upper extremity musculoskeletal disorders (N = 139) completed the PSFS, Upper Extremity Functional Index (UEFI), the Disabilities of the Arm, Shoulder and Hand (DASH), Numeric Pain Rating Scale (NPRS) and the Global Assessment of Function scale (GAF). The same outcome measures were completed again with one week in addition to the Global Rating of Change Scale. The test-retest reliability, measurement error, floor and ceiling effects, and construct validity of the PSFS were examined. The PSFS demonstrated very good test-retest reliability (ICC2,1 = 0.82; 95% CI: 0.71-0.88), with no evidence of floor or ceiling effects. The standard error of measurement was determined to be 0.74 while the minimal detectable change was 1.73 points. The PSFS demonstrated significant negative correlation with DASH, NPRS (-0.58, -0.35), and significant positive correlation with the UEFI and GAF (0.56, 0.50). The PSFS demonstrated statistically higher correlation with the DASH and UEFI compared with the NPRS (p < 0.004) supporting our predefined construct validity hypotheses. The Arabic PSFS is an applicable, reliable, and valid outcome measure of upper-extremity activity limitations for patients with upper extremity musculoskeletal disorders.

Potential biomarkers of the effectiveness of pathogenetic therapy of spinal muscular atrophy in adults

The review summarizes and systematizes data on the prognostic significance of various biomarkers in determining the effectiveness of pathogenetic therapy for spinal muscular atrophy. The review includes a clinical case of a patient with type 3 spinal muscular atrophy. The case illustrates that a decrease in the level of heavy chains of neurofilaments in the cerebrospinal fluid of the patient during the use of pathogenetic therapy with nusinersen positively correlated with an improvement in motor function, assessed by standard functional scales.

Long-term outcomes and quality of life in congenital diaphragmatic hernia survivors treated with extracorporeal life support: A cross-sectional survey.

Few reports have shown Quality-of-Life long-term outcomes in children with congenital diaphragmatic hernia (CDH) who received extracorporeal membrane oxygenation (ECMO) support. We reviewed the short- and long-term outcomes in CDH patients that were supported with ECMO during their neonatal treatment. Telephone interviews of parents of CDH children were performed. The Functional Status Scale (FSS) and the Paediatric Quality of Life Inventory (PedQL, Version 4.0) were completed with the parents. All children with a CDH and supported with ECMO from 2010 to 2023 were included in the study. Twenty children were identified, with two having two ECMO runs. Birth weight was 3.2 kg (median). ECMO support lasted for (median) 13.6 days (range 3.8 to 39). Twelve patients were alive at the time of the survey. The age (median) at time of the interview was 6.3 years (range 1 to 12). The FSS score showed no impairment (FSS score 6) in any domain in eight patients. Two patients had a score of 7, and two patients had a score of 8 and 9, respectively. The PedQL showed a median score 84.5, with a physical health summary score of 92.5 and a psychosocial health summary score of 78.7. The cardiac specific PedQL inventory score was 77. ECMO support for CDH patients is associated with functional and Quality of Life outcomes that are similar to that in other PICU discharge populations. Denying ECMO support to CDH patients on the basis of predicted poor long-term outcomes does not appear to be justified.

Determination of Recovery by Total Restitution or Compensation Using Multifrequency Vestibular Tests and Subjective Functional Scales in a Human Model of Vestibular Neuritis

Background: Vestibular Neuritis (VN) can induce unilateral acute vestibular syndrome (AVS). This study aimed to identify predictive factors of recovery from vestibular neuritis considering total restitution and/or compensation. Methods: In this longitudinal study, 40 patients were included. The initial assessment, performed within 36 to 72 h from the onset (T0), included medical history taking (general and specific), including screening for cardiovascular risk factors (CVRFs), and a battery of diagnostic vestibular tests, comprising the bithermal caloric test (BCT), video head impulse test (VHIT), and skull vibration-induced nystagmus (SVIN) test. All patients also completed a Dizziness Handicap Inventory (DHI). All assessments were repeated 90 ± 15 days later (T3). Subjective compensation criteria were based on the DHI total score, and objective compensation criteria were based on laboratory test results. Four groups of patients (A, B, C, D) were delineated by combining patients with normal vs. abnormal vestibular tests and patients with normal vs. abnormal DHI. Results: CVRFs (but not age or body mass index (BMI)) were associated with a poorer recovery of symptoms. The BCT (lateral semicircular canal paresis %), VHIT (lateral semicircular canal gain), and SVINT (nystagmus slow phase velocity) recovered to normal values in 20%, 20%, and 27% of patients, respectively, at T3. Conclusions: Vascular risk factors (hypercholesterolemia) are correlated with patients who do not recover their symptoms via either total restitution or compensation. There was no significant difference between high- and low-frequency vestibular tests in patients recovering from their symptoms. Some patients with objective recovery may continue to have persistent subjective symptoms.

Prophylactic Swallowing Exercises in Patients with Laryngeal Cancer Who Underwent Total Laryngectomy—A Randomized Trial

Objectives: This study aims to determine the efficacy of prophylactic swallowing exercises on swallowing function in patients undergoing total laryngectomy for laryngeal cancer. Methods: The design was a randomized controlled trial set in one tertiary care academic medical center. A total of 92 patients undergoing total laryngectomy for stages III and IV laryngeal cancer performed five targeted swallowing exercises for a period of three months after their surgery, starting two weeks after the surgery. Weekly swallowing therapy sessions were held with the patients in order to encourage adherence and proper technique. The controls received no preventive exercise and were referred for swallowing treatment following the surgery, as well as radiation therapy if necessary. The Functional Oral Intake Scale (FOIS) and the Performance Status Scale for Head and Neck Cancer Patients (PSS-H&amp;N) were used to measure swallowing function at the baseline, one week following the surgery, and three, six, nine, and twelve months following the surgery. Results: Right after the surgery, there were no statistically significant variations between the intervention and control groups in the FOIS scores (p value = 0.64), the Eating in Public subscale scores (p value = 1) and Normalcy of Diet subscale scores (p = 0.33) of the PSS-H&amp;N. The scores were significantly better among the intervention patients at months 3, 6, 9, and 12 for all the scores, with p values smaller than 0.000. Conclusions: Although not immediately following the surgery, the patients who engaged in prophylactic swallowing exercises showed improvements in their ability to swallow at 3, 6, 9, and 12 months following their procedure.

Development and validation of the Forms and Functions of Aggressive Behavior Scale.

Preventing aggression is a global social issue that warrants additional research with up-to-date measures. Aggressive behaviors manifest in several ways, and the proper assessment should capture its multidimensional nature. We developed the Forms and Functions of Aggressive Behavior Scale (FFABS) to capture the field's current multidimensional understanding of aggression, including its forms (physical, verbal, and relational) and functions (proactive and reactive). Across three studies (N = 1388), we validated the factor structure of the FFABS, obtained partial scalar measurement invariance for males and females, and demonstrated consistent patterns with theoretically related stable constructs and with behavioral measures of inhibitory control and aggressive behaviors, establishing convergent and discriminant validity. We discuss the findings, limitations, practical implications, and future research directions.

Quantitative assessments of white matter hyperintensities and plasma biomarkers can predict cognitive impairment and cerebral microbleeds in cerebral small vessel disease patients

The objective of this study is to examine the efficacy of magnetic resonance imaging (MRI) features and peripheral blood biomarkers in assessing cognitive function in patients with cerebral small vessel disease (CSVD). A total of 58 CSVD patients were recruited. Six features of white matter hyperintensities (WMHs) were derived from MRI scans. Additionally, five neurodegenerative biomarkers (Aβ40, Aβ42, t-tau, p-tau181, NfL) and 13 serum inflammatory cytokines (VILIP-1, CCL2, IL-6, IL-18, TNF-α, CX3CL, sTREM-1/2, VEGF, s-RAGE, BNDF, TGF-β1, β-NGF) were quantified. Cognitive assessments were conducted using standardized neuropsychological scales. Spearman analysis revealed that the volumetric characteristics (absolute area, upper area, bottom area, absolute area percentage, upper percentage, and bottom percentage) of WMHs were negatively correlated with performance on all cognitive scale measures except the verbal fluency test (VFT) (r < -0.3, p > 0.05), while they were positively correlated with plasma neurofilament light (NFL) levels (r > 0.4, p < 0.05). Additionally, serum tumor necrosis factor-α (TNF-α) and soluble receptor for advanced glycation end-products (s-RAGE) showed significant correlations with scales of speech function. An integrated model incorporating WMHs features, neurodegenerative biomarkers, and neuroinflammatory markers was developed, demonstrating high predictive accuracy for cognitive impairment with an area under the curve (AUC) of 0.95 (accuracy 0.88, sensitivity 0.87, specificity 0.89). Another integrated model that includes features of WMHs and inflammatory cytokines for predicting cerebral microbleeds (CMBs) achieved an AUC of 0.95 (accuracy 0.88, sensitivity 0.82, specificity 0.92). Our findings suggest that these markers have the potential to be used for the early detection of cognitive decline and CMBs in patients with CSVD.

Effectiveness of Virtual Yoga for Chronic Low Back Pain

Chronic low back pain (CLBP) is a common condition with substantial impact on patients, in the form of physical and emotional suffering; health care costs; productivity; and health care professional burden. Although clinical guidelines recommend use of nonpharmacologic treatments first, such as yoga, there is a gap between guidelines and implementation in clinical practice. To compare the effects of virtual yoga classes vs a wait-list control on CLBP intensity, back-related function, sleep quality, and pain medication use. Single-blinded, 24-week, 2-arm, randomized clinical trial conducted from May 3, 2022, through May 23, 2023, comparing live streamed yoga classes (the yoga now group) with a wait-list control (the yoga later group, in which participants were offered the virtual intervention after the study but without assessments) among adults with CLBP. Adults 18 to 64 years of age with CLBP were recruited from the Cleveland Clinic Employee Health Plan, a large health system self-insured health plan. Inclusion criteria included a mean LBP intensity score of at least 4 on an 11-point numerical rating scale (scores ranged from 0 to 10, with higher scores indicating worse pain) and daily back pain interference about half or more of the days. Twelve consecutive weekly, 60-minute, virtual, live streamed hatha yoga group classes. Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire ([RMDQ], with higher scores reflecting poorer function) at 12 weeks. Secondary and exploratory outcomes included these measures at 24 weeks, pain medication use, and PROMIS sleep quality assessed using the Sleep Disturbance Short Form 8a, item 1 (scores ranged from 0 to 4, with higher scores reflecting better sleep quality). Analyses followed the intention-to-treat principle. Among 140 participants enrolled (yoga now = 71; yoga later = 69), the mean (SD) age was 47.8 (11.7) years and most were female (113 [80.7%]) and college-educated (103 [73.5%]). Mean (SD) baseline pain intensity (5.7 [1.5]) and RMDQ ([12.1 [4.4]) scores reflected moderate back pain and impairment. At week 12, yoga now compared with yoga later had greater reductions in mean pain intensity (-1.5 [95% CI, -2.2 to -0.7] points; P < .001) and mean RMDQ (-2.8 [95% CI, -4.3 to -1.3] points; P < .001) scores. At 24 weeks, the improvements in pain (mean change, -2.3 [95% CI, -3.1 to -1.6] points; P < .001) and RMDQ (mean change, -4.6 [95% CI, -6.1 to -3.1] points; P < .001) scores were sustained. At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the past week than yoga later participants and at 24 weeks, 21.2 absolute percentage points (95% CI, 5.2%-37.3%). Improvements in sleep quality were greater for participants in yoga now than among participants in yoga later at 12 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .008) and 24 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .005). Results of this randomized clinical trial of 140 adults with CLBP who were members of a large health system self-insured health plan suggest that virtual yoga classes may be a feasible, safe, and effective treatment option. ClinicalTrials.gov Identifier: NCT05319691.

Efficacy of Radicava® IV (intravenous edaravone) in subjects with differing trajectories of disease progression in amyotrophic lateral sclerosis: Use of a novel statistical approach for post hoc analysis of a pivotal phase 3 clinical trial

IntroductionSubjects with amyotrophic lateral sclerosis (ALS) treated with Radicava® (edaravone) IV (intravenous; Mitsubishi Tanabe Pharma America [MTPA], hereafter “MTPA IV edaravone”) in Study MCI186–19 had a significantly slower physical functional decline vs placebo-treated subjects as measured by the revised ALS Functional Rating Scale (ALSFRS-R) and analyzed by the linear mixed model for repeated measures (MMRM). This Study 19 post hoc analysis of MTPA IV edaravone–treated and placebo-treated subjects evaluated linear and nonlinear latent class mixed models defining trajectories based on identifying the model with the lowest Bayesian information criterion. The best model differentiated 4 nonlinear trajectories in ALS subjects. ALSFRS-R total score in MTPA IV edaravone–treated and placebo-treated subjects was evaluated for these 4 nonlinear latent class trajectory groups. MethodsDisease trajectories of MCI186–19 MTPA IV edaravone–treated or placebo-treated ALS subjects who completed the double-blind period were investigated using latent class analysis (LCA) statistical models to identify potential unique nonlinear ALSFRS-R disease trajectories. ResultsALSFRS-R trajectories revealed 4 unique nonlinear trajectory latent classes per treatment group in MTPA IV edaravone–treated and placebo-treated ALS subjects completing the MCI186–19 double-blind period. Latent classes 2–4 had statistically significant slowing of ALSFRS-R total score decline in the predicted nonlinear trajectories of MTPA IV edaravone–treated vs placebo-treated ALS subjects. ConclusionsThis post hoc analysis suggests MTPA IV edaravone treatment results in slower ALSFRS-R decline vs placebo in most predicted nonlinear trajectories. LCA is a novel approach that may benefit future trial analyses.