Changes In Scores Research Articles

Patient-Determined Important Change for the Neck Disability Index With Application of Credibility Analysis: An Exploratory Study

ObjectiveThe purposes of this study were to preliminarily report patient-identified change for the neck disability index (NDI) as either important or not important with time between follow-up of approximately 7 to 10 days and assess the credibility of the preliminary results with the use of a recently established credibility instrument. MethodsThis study was a secondary analysis from a primary randomized clinical trial assessing short-term physical therapist care for individuals with mechanical neck pain. Neck disability index scores and participant-reported importance of global rating of change scores from 42 participants were analyzed from a randomized clinical trial assessing short-term responses to thoracic manipulation and dry needling for neck pain. Patient-important change was computed using receiver operating characteristic curves, and statistical error of the measurement was calculated using (SD × [1 − r]1/2) × 1.96 to assess measurement error at the 95% CI. ResultsThirty-six participants rated global rating of change as important, and 6 rated it as not important. Patient-important change was calculated at 3.5 NDI points on a 0 to 50 NDI scoring scale. This value exceeded the statistical error, which was calculated at 2.16 NDI points. The credibility analysis revealed that 4 of 5 criteria showed strong credibility for the patient-important change estimate. ConclusionUsing patient-determined importance to dichotomize improvement may yield a lower threshold than current researcher-defined methods. Clinically, these results may be more responsive to patient-centric change than using previously reported minimal clinically important difference data.

Change processes associated with functional improvement in a web-based version of Skills Training in Affective and Interpersonal Regulation (webSTAIR) for trauma-exposed veterans.

In spite of the evidence that both symptom reduction and functional improvement are important for supporting recovery from trauma, psychotherapy process research has largely focused on mechanisms of symptom reduction. A better understanding of how change occurs in treatments that emphasize functional improvement rather than trauma processing is critical for optimizing effective, patient-centered care. This study involved secondary analysis of data collected in three multisite trials of a 10-module web-based version of Skills Training in Affective and Interpersonal Regulation, a skills-focused transdiagnostic intervention. The sample included 314 trauma-exposed veterans (38% male; 64% non-Hispanic White) who screened positive for elevated symptoms of posttraumatic stress disorder and/or depression. Latent change score modeling examined prospective relationships between changes from pre-to-mid and mid-to-post treatment in four potential mechanisms (emotion regulation, interpersonal problems, posttraumatic stress disorder symptoms, and depression symptoms) and the association of these changes with overall functional improvement (at posttreatment and follow-up). Emotion regulation change during the first half of treatment predicted interpersonal and symptom improvements during the second half of treatment, but not vice versa. Changes in each potential mechanism were uniquely associated with functional improvement and together statistically accounted for 78% additional variance in functional improvement beyond what was associated with baseline functioning and covariates. Results support emotion regulation as an early mechanism of transdiagnostic therapeutic change in web-based version of Skills Training in Affective and Interpersonal Regulation and highlight the relevance of all four potential mechanisms to functional improvement. The study contributes to an understanding of how change occurs in skills-focused interventions for trauma-exposed individuals. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Development and psychometric properties of the Health Anxiety Behavior Inventory (HABI)

Abstract Background: Mainstream cognitive behavioural theory stipulates that clinically significant health anxiety persists over time at least partially due to negatively reinforced health-related behaviours, but there exists no broad and psychometrically valid measure of such behaviours. Aims: To draft and evaluate a new self-report scale – the Health Anxiety Behavior Inventory (HABI) – for the measurement of negatively reinforced health anxiety behaviours. Method: We drafted the HABI from a pool of 20 candidate items administered in a clinical trial at screening, and before and after cognitive behaviour therapy (n=204). A psychometric evaluation focused on factor structure, internal consistency, convergent and discriminant validity, test–retest reliability, and sensitivity to change. Results: Based on factor analysis, the HABI was completed as a 12-item instrument with a four-dimensional factor structure corresponding to the following scales: (i) bodily preoccupation and checking, (ii) information- and reassurance-seeking, (iii) prevention and planning, and (iv) overt avoidance. Factor inter-correlations were modest. The internal consistency (α=.73–.87) and 2-week test–retest reliability (r=.75–.90) of the scales was adequate. The bodily preoccupation and checking, and information- and reassurance-seeking scales were most strongly correlated with the cognitive and emotional components of health anxiety (r=0.41, 0.48), and to a lower extent correlated to depressive symptoms and disability. Change scores in all HABI scales correlated with improvement in the cognitive and emotional components of health anxiety during cognitive behaviour therapy. Conclusions: The HABI appears to reliably measure negatively reinforced behaviours commonly seen in clinically significant health anxiety, and might be clinically useful in the treatment of health anxiety.

Efficacy of Posterior Pharyngeal Wall Injection for Velopharyngeal Dysfunction in Adults.

Posterior pharyngeal wall (PPW) injection is often employed to treat velopharyngeal deficiency (VPD). We sought to analyze the impact of PPW injection on severity of dysphagia and dysphonia. Retrospective chart review was conducted of patients undergoing PPW injection from 2018 to 2023 at a tertiary laryngology center. Effects on Voice Handicap Index-10 (VHI-10), Eating Assessment Tool-10 (EAT-10), soft palate closure on modified barium swallow, and auditory-perceptual measures of hypernasality and audible nasal air emission were analyzed. 67 PPW injections were performed in 29 patients (11 female). Mean age was 59.4 ± 17.0 years. Etiologies were head and neck cancer (n = 23) and neurologic conditions (n = 6). 30 PPW injections were performed concurrent with intervention on the upper esophageal sphincter (25 dilations, 3 myotomies, 2 botulinum toxin injections), and 8 with a glottic procedure (6 vocal fold injections, 2 thyroplasties). Change scores were 3.87 (-6.85 to -0.89, p = .012) for VHI-10 and -3.00 (-4.75 to -1.25, p = 0.001) for EAT-10. These were statistically different from 0 for the whole cohort but not in the subset of patients undergoing concurrent voice and/or swallow surgery. Soft palate closure scores tended to be better (but not statistically significant) on MBS after PPW injection. Hypernasality and audible nasal air emission both improved after injection. PPW injection appears to have a therapeutic effect on dysphagia/dysphonia in patients with VPD; however, many patients have multifactorial impairment. Additional study is needed to determine benefit of PPW when performed in conjunction with other procedures in this complex patient population. Level 4 (Case series) Laryngoscope, 2024.

Uncovering conserved networks and global conformational changes in G protein-coupled receptor kinases

G protein-coupled receptor kinases (GRKs) are essential regulators of signaling pathways mediated by G protein-coupled receptors. Recent research suggests that GRK-mediated phosphorylation patterns dictate functional selectivity, leading to biased cellular responses. However, a comprehensive understanding of the structural mechanisms at the single-residue level remains elusive. This study aims to define the general conformational dynamics of GRKs with a particular focus on quantifying the transitions between the closed and open states. Specifically, we examined these transitions, classified based on the ionic lock between the regulatory G protein signaling homology domain and kinase domain. To facilitate a precise structural comparison, we assigned common labels to topologically identical positions across the 47 GRK structures retrieved from the Protein Data Bank. Our analysis identified both general and subfamily-specific dynamic movements within the networks and measured the conformational change scores between the two states. Elucidating these structural dynamics could provide significant insights into the regulatory mechanisms of GRK.

Variability in forced expiratory volume in 1 s in children with symptomatically well-controlled asthma

AimsSpirometry is used by many clinicians to monitor asthma in children but relatively little is understood about its variability over time. The aim of this study was to determine the...

Advancing readiness for change in substance use for people with substance use disorders using the Kawa model based intervention program: A quasi-experimental study.

Substance use disorders (SUDs) may cause severe social and health problems. Therefore, providing adequate treatments for people with SUDs to change their drug use behaviors is important. This study examined the effectiveness of Kawa Model based therapy among people with SUDs in Taiwan. Participants were recruited from people with SUDs who violated the Controlled Drugs Act in Taiwan were mandated to abstinence services by law from January 2016 through October 2021 in Southern Taiwan. Each participant selected a 2-hour for 4 times or 8-hour for one day compulsory treatments and received either the Kawa model based treatment (n = 55; 9 women; mean ± SD age = 36.73 ± 10.42years) or psychoeducation courses (n = 42; 8 women; mean ± SD age = 27.57 ± 5.78years), respectively. Stages of change was assessed using the University of Rhode Island Change Assessment before and after treatments. There were no significant differences in the stages of change scores at baselines between the 2 groups (p = .06-0.20). After treatments, participants who received the Kawa Model based treatment had higher scores in specific stages of change than did those who received the psychoeducation course in the domains of 'contemplation' (p = .001), 'action' (p = .001), and 'readiness' (p = .002). The present study demonstrated initial and preliminary findings that the Kawa Model based therapy may improve readiness for changing drug use behaviors in people with SUDs.

Outcomes of Charcot-Marie-Tooth Disease Cavovarus Surgical Reconstruction.

Charcot-Marie-Tooth (CMT) disease is a progressive inherited neurologic disorder causing muscle weakness and lower extremity deformity. The goal of foot and ankle surgical treatment is to create a stable, plantigrade foot, with the potential elimination of brace-wear for ambulation. The aim of this study was to report baseline CMT patient function and subsequent outcome improvement from surgical treatment, as determined by PROMIS physical function (PF), pain interference (PI), and mental health/depression (D) scores. Retrospective data were collected on consecutive CMT patients older than 18 years receiving surgical treatment by a single surgeon from 2018 to 2022 with minimum 1-year follow-up. Each patient prospectively completed PROMIS preoperatively and postoperatively after all planned surgical treatment was completed. Prospective clinical and radiographic data were collected to describe complications and correlation to outcome. Ninety-five feet in 64 patients older than 18 years were included for analysis. Mean follow-up was 21 months (range, 12-31) with 100% minimum 1-year follow-up. CMT patients had worse preoperative and baseline scores in all domains except PROMIS-D compared with population normal PROMIS scores. Significant improvements were identified in all PROMIS domains following surgical treatment. The mean PROMIS-PF score increased (40 to 45, delta = 4.9, P < .001), the mean PROMIS-PI score decreased (59 to 52, delta = 7.1, P < .001), and the mean PROMIS-D score decreased (50 to 47, delta = 3.0, P = .004). Subgroup analysis was performed for patients with severe radiographic deformity and those treated with arthrodesis in an attempt to demonstrate the impact of disease severity on outcome. Subgroup analysis demonstrated that arthrodesis led to worse overall PROMIS-PF outcome with the same change score. Surgical treatment for CMT patients provides significant clinical improvement in all measured outcome domains. CMT patients can be restored to normal population physical function and pain interference outcome scores. Patients with more severe deformity have similar improvement from surgical treatment, although their ultimate functional improvement is blunted due to a lower baseline.

Subthalamic Stimulation Improves Short-Term Satisfaction with Life and Treatment in Parkinson's Disease.

The effect of subthalamic stimulation (STN-DBS) on patients' personal satisfaction with life and their Parkinson's disease (PD) treatment is understudied, as is its correlation with quality of life (QoL). Therefore, we tested the hypothesis that STN-DBS for PD enhances satisfaction with life and treatment. In a prospective, multicenter study with a 6-month follow-up involving 121 patients, we measured the main outcomes using the Satisfaction with Life and Treatment Scale (SLTS-7). Secondary outcomes included the eight-item PD Questionnaire (PDQ-8), European QoL Questionnaire (EQ-5D-3L), EQ-Visual Analogue Scale (VAS), Non-Motor Symptom Scale (NMSS), Hospital Anxiety and Depression Scale (HADS), and Unified PD Rating Scale (UPDRS). Longitudinal outcome changes, effect sizes (Cohen's d), and correlations between outcome changes were analyzed. SLTS-7 scores improved at the 6-month follow-up, particularly in the domains of 'satisfaction with physical health' and 'satisfaction with treatment'. Change scores correlated strongly (EQ-VAS), moderately (PDQ-8 SI and HADS), and weakly (UPDRS-activities of daily living and EQ-5D-3L) with other scales. Satisfaction with physical health, psychosocial well-being, or treatment was not related to UPDRS-motor examination. This study provides evidence that STN-DBS enhances patients' personal satisfaction with life and treatment. This satisfaction is associated with improvements in the QoL, daily activities, and neuropsychiatric aspects of PD rather than its motor aspects.

Enhancing upper extremity muscle strength in individuals with spinal cord injury using low-intensity blood flow restriction exercise.

This study explores the feasibility and effects of low-intensity blood flow restriction exercise on forearm muscle strength and function in individuals with spinal cord injury. Pilot randomized clinical trial. Ten male and female adult participants with chronic cervical and thoracic spinal cord injury underwent an 8-week low-intensity blood flow restriction exercise programme that targeted forearm muscles. Each participant's contralateral forearm served as the control. Grip strength was the primary outcome measure, and participants also provided qualitative feedback on their experiences. The study revealed a significant increase in participants' forearm muscle strength on the experimental side engaged in low-intensity blood flow restriction training, with an average strength gain of 7.5 ± 0.36 kg after 16 exercise sessions (Cohen's d = -6.32, 95% CI -8.34, -6.68). In comparison, the control side, following a conventional high- intensity exercise regimen without BFR, showed a more modest strength increase of 4.4 ± 0.67 kg. A mean Patient's Global Impression of Change score of 2.2 reflected overall improvements in participants' daily activities and health status. This study highlights the feasibility and effectiveness of low-intensity blood flow restriction exercise as a safe and promising approach to enhancing forearm muscle strength in individuals with spinal cord injury. The observed positive outcomes, coupled with a high level of participant satisfaction, underscore the potential of this innovative method to significantly improve limb muscle strength, thereby contributing to greater functional independence in this population.

Improving the Training Process for Student Providers in a Student-Run Free Clinic: Assessing the Impact of a Small Group, Peer-Led Training Process

Background: Student-run free clinics give students crucial opportunities to improve their skills as future medical professionals. However, many students at our institution feel unprepared to take on student provider roles despite completing a training curriculum. This study describes an improved way to train student providers using a small group, peer-led training process. Methods: Participants in the control group completed our institution’s current training process consisting of viewing e-modules and observing a clinic visit. Participants in the experimental group took part in small group, peer-led training sessions. All study participants completed pre- and post-training surveys to assess their confidence in navigating the electronic health record, performing physical exams, and patient interviewing and in their sense of overall preparedness. Participants’ pre-training to post-training confidence change scores were calculated for each question, and the two groups’ results were compared using Mann-Whitney-U tests. Results: Results revealed a statistically significant increase in confidence in performing physical exams and navigating the electronic health record for students in the experimental group compared to the control group. While both groups saw an increase in confidence in overall preparedness to serve as a student provider and in patient interviewing, no significant differences were observed between the two groups. Conclusions: While both groups showed increases in confidence change scores for all components surveyed, participants in the small group, peer-led training process reported a larger increase in their confidence to perform physical exam and electronic health record navigation skills after the training intervention than the control group participants. Small-group, peer-led training sessions give students opportunities to receive early hands-on exposure to technical skills. The findings of this study can lead to lasting improvement in our institution’s provider training process while serving as a model for other student-run clinic programs to better prepare student providers to care for at-risk populations.

Modafinil Versus Amphetamine-Dextroamphetamine For Idiopathic Hypersomnia and Narcolepsy Type 2: A Randomized, Blinded, Non-inferiority Trial.

Although there are several treatments for narcolepsy type 2 and idiopathic hypersomnia, studies that assess amphetamines, symptoms beyond sleepiness, and comparative effectiveness are needed. We performed a randomized, fully blinded, noninferiority trial of modafinil versus amphetamine-dextroamphetamine in these disorders. Forty-four adults were randomized to modafinil or amphetamine-dextroamphetamine, individually titrated to a maximum of modafinil 200 mg twice daily or amphetamine-dextroamphetamine 20 mg twice daily, for 12 weeks. Primary outcome was change in Epworth from baseline to week 12, with a noninferiority threshold of 2 points. Secondary outcomes were (1) patient global impression of change measures of disease severity, sleepiness, sleep inertia, and cognition; (2) change from baseline in Hypersomnia Severity Index; and (3) change from baseline in Sleep Inertia Questionnaire. Adverse events were compared between groups. Epworth improved 5.0 [± standard deviation (SD) 2.7] points with modafinil and 4.4 (± SD 4.7) with amphetamine-dextroamphetamine; noninferiority of amphetamine-dextroamphetamine was not demonstrated (P = 0.11). Noninferiority of amphetamine-dextroamphetamine was demonstrated for change scores of severity, sleepiness, sleep inertia, Hypersomnia Severity Index, and Sleep Inertia Questionnaire. Dropouts due to adverse events were 31.8% for modafinil (including two severe events) and 9.1% for amphetamine-dextroamphetamine, P = 0.13. Anxiety was more common with modafinil and appetite suppression with amphetamine-dextroamphetamine. Noninferiority of amphetamine-dextroamphetamine to modafinil was not demonstrated for the primary outcome. However, amphetamine-dextroamphetamine was noninferior on multiple secondary measures of disease severity and symptomatology. These data may inform shared decision-making regarding treatment for idiopathic hypersomnia and narcolepsy type 2. Clinicaltrials.gov Registration (NCT03772314) 12/10/18. .

Fusion versus decompression alone for lumbar degenerative spondylolisthesis and spinal stenosis: a target trial emulation with index trial benchmarking

PurposeThe value of adding fusion to decompression surgery for lumbar degenerative spondylolisthesis and spinal canal stenosis remains debated. Therefore, the comparative effectiveness and selected healthcare resource utilization of patients undergoing decompression with or without fusion surgery at 3 years follow-up was assessed.MethodsUsing observational data from the Lumbar Stenosis Outcome Study and a target trial emulation with index trial benchmarking approach, our study assessed the comparative effectiveness of the two main surgical interventions for lumbar degenerative spondylolisthesis—fusion and decompression alone in patients with lumbar degenerative spondylolisthesis and spinal canal stenosis. The primary outcome-measure was change in health-related quality of life (EuroQol Health Related Quality of Life 5-Dimension 3-Level questionnaire [EQ-5D-3L]); secondary outcome measures were change in back/leg pain intensity (Numeric Rating Scale), change in satisfaction (Spinal Stenosis Measure satisfaction subscale), physical therapy and oral analgesic use (healthcare utilization).Results153 patients underwent decompression alone and 62 had decompression plus fusion. After inverse probability weighting, 137 patients were included in the decompression alone group (mean age, 73.9 [7.5] years; 77 female [56%]) and 36 in the decompression plus fusion group (mean age, 70.1 [6.7] years; 18 female [50%]). Our findings were compatible with no standardized mean differences in EQ-5D-3L summary index change score at 3 years (EQ-5D-3L German: 0.07 [95% confidence interval (CI), − 0.25 to 0.39]; EQ-5D-3L French: 0.18 [95% CI, − 0.14 to 0.50]). No between-group differences in change in back/leg pain intensity or satisfaction were found. Decompression plus fusion was associated with greater physical therapy utilization at 3 years follow-up.ConclusionDecompression alone should be considered the primary option for patients with lumbar degenerative spondylolisthesis and spinal stenosis.

Precision in Progress: Unraveling the Clinimetric Properties of Beery-Buktenica Developmental Test of Visual-Motor Integration in Children With Cerebral Palsy Across Diverse Motor Severities

BackgroundIn the realm of pediatric cerebral palsy (CP), visual motor challenges often overshadow a child's developmental journey. This study delves into the responsiveness and crucial benchmarks, specifically the minimal clinically important difference (MCID), of the Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) among children with varying motor severities. MethodEighty-eight children with CP (50 males, 38 females; aged three to 12 years) with Gross Motor Function Classification System (GMFCS) levels I to III were recruited from the rehabilitation department of Chang Gung Memorial Hospital in Taiwan. Each participant received the Beery VMI tests at baseline and at one-year follow-up. The standardized response mean (SRM) was calculated to determine the responsiveness of Beery VMI, and a distribution-based approach was used to estimate MCID. ResultsThe Beery VMI exhibited remarkable responsiveness across GMFCS levels I to III (SRM = 0.98-2.36). MCIDs for Beery VMI varied across severities, with ranges of 2.93 to 4.41 (0.2 S.D.), 7.31 to 11.49 (0.5 S.D.), and 11.70 to 18.38 (0.8 S.D.). Notably, in the visual perception subset, MCIDs were 3.93 to 4.03 (0.2 S.D.), 9.83 to 10.07 (0.5 S.D.), and 15.73 to 16.11 (0.8 S.D.). In the supplemental motor coordination subtest, MCIDs spanned 1.67 to 4.87 (0.2 S.D.), 4.18 to 12.17 (0.5 S.D.), and 6.68 to 19.47 (0.8 S.D.). ConclusionsBeery VMI demonstrates robust responsiveness in children with CP. Motor-severity-tailored MCIDs offer a guide for clinicians and researchers, hinting at treatment efficacy. Particularly, lower change scores in VMI and motor coordination subtests may signal effective interventions for moderate motor disability over mild cases.

A Patient-Centered Perspective on Changes in Personal Characteristics After Deep Brain Stimulation

Deep brain stimulation (DBS) results in improvements in motor function and quality of life in patients with Parkinson disease (PD), which might impact a patient's perception of valued personal characteristics. Prior studies investigating whether DBS causes unwanted changes to oneself or one's personality have methodological limitations that should be addressed. To determine whether DBS is associated with changes in characteristics that patients with PD identify as personally meaningful. This cohort study assessed changes in visual analog scale (VAS) ratings reflecting the extent to which patients with PD manifested individually identified personal characteristics before and 6 and 12 months after DBS at a large academic medical center from February 21, 2018, to December 9, 2021. The VAS findings were tailored to reflect the top 3 individually identified personal characteristics the patient most feared losing. The VASs were scored from 0 to 10, with 0 representing the least and 10 the most extreme manifestation of the trait. Change scores were examined at the individual level. Content analysis was used to code the qualitative data. Qualitative and quantitative analyses were performed from January 12, 2019 (initial qualitative coding), to December 15, 2023. Deep brain stimulation. The primary outcome variable was the mean VAS score for the top 3 personal characteristics. The secondary outcome was the incidence of meaningful changes on the patients' top 3 characteristics at the individual level. Fifty-two of 54 dyads of patients with PD and their care partners (96.3%) were recruited from a consecutive series approved for DBS (36 patients [69.2%] were male and 45 care partners [86.5%] were female; mean [SD] age of patients, 61.98 [8.55] years). Two patients and 1 care partner were lost to follow-up. Increases in the mean VAS score (indicative of greater manifestation of [ie, positive changes in] specific characteristics) were apparent following DBS for ratings of both the patients (Wald χ2 = 16.104; P < .001) and care partners (Wald χ2 = 6.746; P < .001) over time. The slopes of the changes for both the patient and care partners were correlated, indicating agreement in observed changes over time. The individual level analyses indicated that scores for most patients and care partners remained the same or increased. In this cohort study, participants reported greater (more positive) manifestations of individually identified, valued characteristics after DBS. These findings may be relevant to informing decision-making for patients with advanced PD who are considering DBS.

Efficacy and safety of SKCPT in patients with knee osteoarthritis: A multicenter, randomized, double-blinded, active-controlled phase III clinical trial

Ethnopharmacological relevanceOsteoarthritis (OA) is the most prevalent type of arthritis worldwide and a leading cause of years lost to pain and disability. Among the current pharmacological treatments for OA, symptomatic slow-acting drugs for OA (SYSADOA) induce pain relief and aim to improve joint function by relieving inflammation while causing fewer gastrointestinal and cardiovascular adverse events than non-steroidal anti-inflammatory drugs (NSAIDs). SKCPT is a herbal SYSADOA formulated from Clematis mandshurica, Trichosanthes kirilowii, and Prunella vulgaris powdered extracts. This preparation has been shown to induce cartilage protection and anti-inflammatory effects in preclinical studies and inhibit glycosaminoglycan degradation and catabolic gene expression in human OA chondrocytes and cartilage. Aim of the studyWe aimed to evaluate the non-inferiority of SKCPT to celecoxib and safety for treating knee OA. Materials and methodsThis multicenter, randomized, double-blind, phase III clinical trial enrolled adults with primary knee OA who were randomized (1:1) to SKCPT 300 mg twice daily or celecoxib 200 mg once daily for 12 weeks. ResultsIn total, 278 patients were assigned to treatment (SKCPT, 136; celecoxib, 142) for approximately 12 weeks. The primary endpoint was the mean change of Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) pain subscale scores from baseline to Day 84. The mean change (least squares [LS] mean ± standard error) from baseline to Day 84 was −23.74 ± 1.48 for SKCPT and −25.88 ± 1.44 for celecoxib. The two-sided 95% confidence interval of the difference (LS mean) between groups was [−1.94, 6.20], confirming that the upper limit was less than the non-inferiority margin of 10. Additionally, there were no significant differences in the secondary endpoints (mean changes of K-WOMAC pain, physical, stiffness subscale, and total score, and the frequency and number of doses of rescue medications) between groups at all time points. Differences between groups in adverse events and adverse drug reactions were not significant, and no serious adverse events occurred. ConclusionsSKCPT efficacy was non-inferior, and its safety profile was similar, to celecoxib. Building on previous results showing that SYSADOA reduce NSAID intake, the present results suggest that the SYSADOA SKCPT could effectively replace NSAIDs in knee OA treatment while avoiding long-term side effects.

Development of a General Composite Scale (GENCOMS) for Progressive Neurodegenerative Diseases and Implications for the Assessment of Disease-Modifying Therapies.

The reliable assessment of treatment outcomes for disease-modifying therapies (DMT) in neurodegenerative disease is challenging. The objective of this paper is to describe a generalized framework for developing composite scales that can be applied in diverse, degenerative conditions, termed "GENCOMS." Composite scales optimize the sensitivity for detecting clinically meaningful effects that slow disease progression. The GENCOMS method relies on robust natural history data and/or placebo arm data from DMT trials. Validated scales that are core to the disease process have been identified, and item level data obtained to standardize the response outcomes from 0 (best possible score) to 1 (worst possible score). A partial least squares regression analysis was conducted with temporal change as the dependent variable and change scores in standardized items as the explanatory variables. The derived model coefficients constitute a weighted sum of items that most effectively measure disease progression. The resultant composite scale was optimized to detect disease progression and can be examined in a range of slow or fast progressing populations. The scale can be used in studies with comparable patient populations as an endpoint optimized to measure disease progression and therefore ideally suited to assess treatment effects in DMTs. The methodology presented here provides a generalizable framework for developing composite scales in the assessment of neurodegenerative disease progression and evaluation of DMT effects. By objectively selecting and weighting items from previously validated measures based solely on their sensitivity to disease progression, this methodology allows for the creation of a more responsive measurement of clinical decline. This heightened sensitivity to clinical decline can be utilized to detect modest yet meaningful treatment effects in the early stages of neurogenerative diseases, when it is optimal to begin a DMT.

Effectiveness of a psychoeducational program for caregivers of persons with acquired brain injury: a randomized controlled trial (EDUCA-V)

ABSTRACT Objective To assess the effectiveness of a psychoeducational intervention program (PIP) compared to standard attention in reducing caregiver burden after the intervention (at 4 months) and at follow-up (at 8 months). Methods A multicenter, evaluator-blind, randomized controlled trial. The experimental group received a PIP intervention consisting of 10 weekly group sessions, while the control group received standard attention. The primary outcome was measured as the change scores from baseline on the caregiver’s burden (ZBI). The secondary outcomes evaluated included caregiver mental health (GHQ-28), anxiety (STAI), and depression (CES-D). Trial registration: ISRCTN16513116. Results The sample comprised 76 informal caregivers (41 allocated in the intervention condition and 35 in the control). The caregiver’s burden (ZBI) did not show significant differences between groups at 4 months or 8 months. There were favorable and significant changes in the caregiver’s mental health (GHQ) and depression (CES-D) at 4 months in the PIP group. There were no significant differences between groups in anxiety during the trial. Conclusions The PIP intervention group reported positive effects on general mental health and depression after the intervention but not at follow-up. We need more studies which interventions follow expert recommendations and can sustain positive results over time.

Enhancing risk assessment in Chagas cardiomyopathy: Electrophysiology study stratified by Rassi score

BackgroundChagas cardiomyopathy (CCM) is increasingly prevalent in developed countries due to migration from endemic areas. Accurate risk stratification is crucial due to the variable clinical course of CCM. ObjectiveTo analyze the association between Rassi score progression and electrophysiology study (EPS) changes in CCM patients. MethodsThis prospective, observational cohort study involved CCM patients from two tertiary hospitals. Patients were classified as low, intermediate, or high risk based on the Rassi score. Data collected included demographics, clinical history, and diagnostic tests. EPS assessed AH, HH, and HV intervals, and inducibility of ventricular arrhythmias. Follow-ups were at 30 days and six-month intervals, with individualized discussions for cardiac implantable electric devices (CIED) based on EPS results. ResultsOf 67 screened CCM patients, 59 underwent EPS. The mean Rassi score was 8.7 ± 4.5 points, with 33.8 % low, 38.9 % intermediate, and 27.1 % high risk. EPS abnormalities were found in 57.6 % of patients, mainly VT/VF (52.5 %). Most induced ventricular arrhythmias were monomorphic VT (80.7 %). A significant association was found between Rassi score risk classification and EPS changes (OR = 1.88 95 %CI: 1.15–3.06 p = 0.02). Higher Rassi scores correlated with VT presence on EPS (p = 0.0036). Syncope/pre-syncope had an OR 2.45 95 %CI:1.21–4.94; p = 0.012, independent of Rassi risk. Decreased ejection fraction was linked to EPS changes (p = 0.04). ConclusionEPS changes among CCM was associated with progression of the Rassi score, indicating its utility as a stratification tool. Factors such as the presence of syncope/pre-syncope, decreased LVEF and wall motion abnormalities emerged as independent predictors within Rassi scores for changes in EPS.

67 Precision identification and weight assessment of cattle using supervised machine learning on body surface keypoints

Abstract Computer vision systems (CVS) offer identification solutions for animals with distinct coat patterns, but are less effective for solid-colored herds. In addition, they can be used to measure critical phenotypes, such as body weight (BW). Providing both BW and identification for solid-colored animals can help farmers make decisions. This study aimed to 1) develop an automatic CVS capable of identifying using the Euclidean distance between keypoints located at specific anatomical landmarks (e.g., bony prominences), and 2) predict the BW using features extracted from these keypoints. The keypoint model was trained to identify seven keypoints per cow, located at the left and right hips, left and right pin bones, tail head, sacral, and cervical vertebrae. These locations remain constant as body condition score of a cow changes. The Euclidean distance between these keypoints was used to generate biometric features for each cow. The keypoint detection model was trained using 3,928 images over 900 epochs with a batch size of 14 and validated using 391 images. This trained model was used to predict keypoints on a different set of 41 cows over 5 d, resulting in a total of 6,944 images which correspond to the dataset for cow identification. The Random Forest (RF) algorithm for cow identification was trained with the first 4 d (5,376 images), and the last day served as the test set (1,568 images). For the cow identification, a RF algorithm was employed on the Euclidean distance of the keypoints. The hyperparameters were determined through a grid search on the training set, utilizing 5-fold cross-validation. The hyperparameters ‘mtry’ (which ranged from 1 to 10) and ‘ntree’ (which ranged from 250 to 500, in increments of 50) were optimized. For the second objective, due to the completely new environment, the keypoint model was fine-tuned using transfer learning for 240 epochs with a batch size of 14, utilizing 310 images. The model predicted keypoints in 1,593 images from different beef-on-dairy animals. This dataset was used to train the BW prediction model. The Euclidean distances from the predicted images and sex were used as features. A RF model was trained using a leave-one-animal-out cross-validation approach. The hyperparameters were determined through a grid search on the training set, using 10-fold cross-validation. The ‘mtry’ parameter ranged from 2 to 16, in increments of 2. For animal identification, the model achieved an accuracy, precision, recall, and F1-score of 92.7%, 89.0%, 90.2%, and 92.7%, respectively. To predict BW, the RF model achieved an R² of 0.86 and a root mean squared prediction error of 36.9 kg, representing 6.7% of the observed values average. These results suggest that keypoints located on the dorsal body surface can identify and weigh individual animals, even those lacking distinct coat color patterns.