Change In Total Score Research Articles

Warrick score in rheumatoid-arthritis interstitial lung disease: a promising tool for assessing the extent and progression of lung involvement

BackgroundThe clinical manifestations and course of rheumatoid arthritis-associated interstitial lung disease (RA-ILD) exhibits considerable heterogeneity. In this study, we aimed to explore radiographic progression over a defined period, employing the Warrick score as a semi-quantitative measure in early RA-ILD, and to assess the associated risk factors for progression.MethodsRA-ILD patients underwent consecutive Warrick scoring based on initial high-resolution computed tomography (HRCT) at diagnosis and the first follow-up. Associations between Warrick scores, pulmonary function tests, and patient characteristics were analyzed. The ROC curve assessed the predictive performance of the Warrick score change rate for ILD progression, while multivariable logistic regression analysis identified risk factors for progression.ResultsSignificant correlations were found between Warrick scores and age at RA-ILD diagnosis, age at ILD diagnosis, and baseline DAS28-ESR. For the severity score, correlations were r = 0.359, r = 0.372, and r = 0.298 (p = 0.001, p < 0.001, p = 0.014, respectively); for the extent score, r = 0.364, r = 0.318, and r = 0.255 (p = 0.001, p = 0.005, p = 0.038, respectively); and for the total score, r = 0.376, r = 0.367, and r = 0.280 (p < 0.001, p = 0.001, p = 0.022, respectively). Annual changes in severity, extent, and total Warrick scores showed sensitivities of 91–97% and specificities of 98% for predicting progression over a 5-year follow-up. Cut-off values were 0.0278 for the severity score (AUC 0.954), 0.0227 for extent score (AUC 0.976), and 0.0694 for total score (AUC 0.946). Warrick severity, extent, and total scores increased significantly during follow-up. Age > 50 years (OR 7.7; p = 0.028) and baseline usual interstitial pneumonia (UIP) pattern (OR 3.1, p = 0.041) were identified as risk factors for progression.ConclusionsAdvanced age and UIP pattern were significant risk factors for progression. Warrick scoring may may help predict progression in RA-ILD, particularly through changes in severity, extent, and total scores. Due to the retrospective design and small sample size, further prospective studies with larger cohorts are needed to confirm these findings and validate Warrick scoring as a reliable marker for RA-ILD progression.

Efficacy and safety of Matricaria chamomilla intervention in managing menopausal symptoms: a triple-blind clinical trial.

Menopausal symptoms can significantly impact women's quality of life. Herbal interventions like Matricaria chamomilla (chamomile) have been suggested as potential remedies. However, their efficacy and safety remain underexplored. This triple-blind clinical trial enrolled 80 postmenopausal women meeting specific criteria. Inclusion criteria included participants in early or late perimenopause, defined by a symptom score >15, FSH levels >40, or 2 years since menopause, with no significant comorbidities. Participants were randomly assigned to intervention and placebo groups. In a triple-blind clinical trial with 80 postmenopausal women (aged 47-62) from Babol City Health Center, participants were randomly assigned to receive either chamomile (100 mg capsules with 1.2% apigenin, four times daily) or a placebo over 12 weeks. Symptoms of menopause were assessed using the Australian Menopause Association's Scorecard Symptom Questionnaire. Over 12 weeks, they received either chamomile or placebo capsules, with side effect assessments every 4 weeks. Notable differences were found between the intervention and control groups in the overall scores on the symptom scorecard from baseline to 12 weeks' postintervention (-10.36; 95% confidence interval [CI], -13.84 to -6.92; P < 0.001). Specific subscores also improved in the intervention group: vasomotor (-2.25; 95% CI, -3.09 to -1.42; P < 0.001), psychological (-3.74; 95% CI, -5.29 to -2.20; P < 0.001), locomotor (-2.70; 95% CI, -3.63 to -1.77; P < 0.001), and urological (-1.89; 95% CI, -2.77 to -1.00; P < 0.001). Both groups showed significant changes in total symptom scores over time (P < 0.001). Two participants experienced side effects, including mouth sores, skin spots, and itching, in the chamomile group, which led to their dropping out of the study. Chamomile intervention shows promise in alleviating menopausal symptoms, but its use warrants caution due to associated side effects. Further research is necessary to optimize dosage and mitigate adverse reactions for safer and more effective management of menopausal symptoms.

Correlation of King-Devick Test and Helmet Impact Exposures Over a Youth Football Season.

The cumulative effect of repetitive subconcussive head impacts on neurocognitive function during youth contact sports remains largely unknown. There is a paucity of literature evaluating cumulative helmet forces over a season and their correlation with preseason and postseason cognitive performance tasks such as the King-Devick test (KDT). Higher helmet forces recorded throughout a 10-week, 10-game youth football season would correlate with slower performance on postseason KDT. Prospective cohort study. Level 3. A cohort of 58 youth football players (ages 9-13 years) underwent pre- and postseason KDT. Players wore SpeedFlex helmets (Riddell) fitted with InSite Impact Response System helmet accelerometers (Riddell) which recorded impacts of ≥15g. Head impacts were tallied over a season and assigned a score of 1, 2, or 3 based on magnitude of g forces. Suspected concussions were correlated with KDT times and recorded instances of head impact. Pre- and postseason KDT scores were compared. During the season, 2013 head impacts were recorded. Median (range) total cumulative force score was 24 (5-476); 6 players sustained head impacts concerning for concussion, and 4 were clinically diagnosed with concussions. Overall, postseason KDT times improved compared with preseason, with a median (range) change of -4.8 seconds (-7.6, -1.1). Analysis showed no correlation between changes in KDT time and total cumulative force score over the season. KDT times in youth football players did not change significantly based on head impact exposure over a single youth football season; most players' KDT times improved from preseason to postseason. Although our study did not show significant cognitive impact as measured by KDT over a single youth football season, the long-term effects of concussion on the immature brain and how it can impact cognitive development remains largely unknown and should be an area of ongoing study.

Effect of Climate Change and Health Course on Global Warming Knowledge and Attitudes, Environmental Literacy, and Eco-Anxiety Level of Nursing Students: A Quasi-Experimental Study.

Climate change is the most important problem that threatens the health of individuals, public health, and health systems on a global scale. The International Council of Nurses emphasizes that nurses should strive to reduce the effects of climate change and help individuals and systems adapt. In addition, it is stated that climate change should be integrated into nursing education curricula and nursing students, who are future healthcare providers, should be prepared to reduce the effects of climate change and promote a healthier environment. The aim of this study is to examine the effect of the Climate Change and Health course on global warming knowledge and attitude, environmental literacy, and eco-anxiety levels in nursing students. In this study, a pretest-posttest comparative quasi-experimental design type was used. The research was conducted with 117 students taking the "Climate Change and Health" course added to the curriculum at the Nursing Department of a private university in Istanbul between February 2023 and June 2023. Data were collected before and after the intervention using the Descriptive Characteristics Form, Global Warming Knowledge Questionnaire, Global Warming Attitude Scale, Environmental Literacy Scale for Adults, and Eco-Anxiety Scale. After taking the Climate Change and Health course, nursing students' global warming knowledge and attitude total scores increased, and a statistically significant increase was detected in the eco anxiety total and behavioral symptoms subscale mean scores. There was no statistically significant change in the Environmental Literacy Scale total and subscale mean scores. It can be stated that the Climate Change and Health course positively improved nursing students' knowledge and attitudes toward global warming and increased their sensitivity about climate change. Nurses, who constitute the most important part of the healthcare workforce worldwide, have an important role in creating a healthy and safe environment and in combating the effects of global warming and climate change. For this reason, in order to train knowledgeable and equipped health professionals on this subject, it is recommended that courses on the effects of climate change, adaptation, and coping with it be added to the nursing curriculum and integrated into all subjects every year to ensure continuity.

Content Validity of the Friedreich Ataxia Rating Scale in Patients with Spinocerebellar Ataxia.

The Friedreich Ataxia Rating Scale-Activities of Daily Living (FARS-ADL) is a validated and highly utilized measure for evaluating patients with Friedreich Ataxia. While construct validity of FARS-ADL has been shown for spinocerebellar ataxia (SCA), content validity has not been established. Individuals with SCA1 or SCA3 (n=7) and healthcare professionals (HCPs) with SCA expertise (n=8) participated in qualitative interviews evaluating the relevance, clarity, and clinical meaningfulness of FARS-ADL for assessment of individuals with SCA. Interviews were recorded, transcribed, coded, and analyzed by ATLAS.Ti v22 software. FARS-ADL concepts most frequently reported by individuals with SCA were difficulty walking (n=7/7), falls (n=6/7), speech difficulties (n=4/7), and swallowing (n=3/7). Individuals with SCA reported that all FARS-ADL items were relevant; Gait and Walking (n=7/7), Bladder Function (n=6/7), and Falling (n=6/7) were considered extremely relevant. All HCPs (n=8/8) reported that most FARS-ADL items were relevant to individuals with SCA; Quality of Sitting Position was considered least relevant. HCPs reported meaningful change as 1-2 point score change in individual FARS-ADL items (n=7/7), 1-3 point change in total score (n=6/6), and stability on any item and/or total score over≥1year, depending on SCA subtype (n=5/8). Cognitive debriefing supported clarity and comprehension of FARS-ADL. Suggested improvements included refining response options for Dressing, Falling, Walking, and Bladder Function items. The findings confirm the content validity of most FARS-ADL items for use in individuals with mild-to-moderate SCA1 and SCA3, and offer suggested improvements for response options.

Effectiveness of a Videoconference-Based Cognitive Behavioral Therapy Program for Patients with Schizophrenia: Pilot Randomized Controlled Trial.

Cognitive behavioral therapy for psychosis (CBTp) is not sufficiently widespread in clinical practice, although evidence has been presented. The purpose of this study was to explore whether one-on-one videoconference-based CBTp (vCBTp) is more effective than usual care (UC) alone for improving psychiatric symptoms in patients with schizophrenia attending outpatient clinics. In this exploratory randomized controlled trial, patients with schizophrenia and schizoaffective disorders who were still taking medication in an outpatient clinic were randomly assigned to either the vCBTp plus UC group (n=12) or the UC group (n=12). The vCBTp program was conducted once a week, with each session lasting for 50 minutes, for a total of 7 sessions conducted in real-time and in a one-on-one format remotely using a loaned tablet computer (iPad). The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score, which measures the difference in the mean change from baseline (week 0) to posttest (week 8). The study included 24 participants. There were no significant differences between the 2 groups at baseline. With regard to significant differences between the 2 groups in terms of the primary outcome, the mean change in the PANSS total score from baseline to week 8 in the vCBTp plus UC group was -9.5 (95% CI -12.09 to -6.91) and the mean change in the UC alone group was 6.9 (95% CI 1.54-12.30). The difference between the 2 groups was significant (P<.001). In addition, significant improvements were observed in the subscales of positive (P<.001) and negative (P=.004) symptoms and general psychopathology (P<.001). Significant differences were also observed in the secondary outcomes of the General Anxiety Disorder-7 (GAD-7; P=.04) and EQ-5D-5L (P=.005). There were no dropouts and no serious adverse events in this study. A total of 7 remote vCBTp sessions conducted in the vCBTp plus UC group could be safely administered to patients with schizophrenia. They were also observed to be effective for psychiatric symptoms, general anxiety, and quality of life. However, because of the observed worsening of scores in the UC group, caution is required in interpreting significant differences between the 2 groups. This approach is expected to improve accessibility to CBTp for outpatients with schizophrenia and social anxiety regarding transportation use and financial and physical burdens related to transportation, and to contribute to promoting CBTp acceptability by compensating for the shortage of implementers. University Hospital Medical Information Network Clinical Trials Registry UMIN000043396; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049544. RR2-10.1136/bmjopen-2022-069734.

A Concussion Management Policy Change Promoted Earlier Initiation of Rehabilitation Services and Improved Clinical Recovery Outcomes in Concussion.

In line with emerging research, an interprofessional specialty concussion clinic instituted a policy change permitting earlier physiotherapy-based treatment entry. Our objective was to determine the effect of this policy change on concussion recovery outcomes. Secondary analysis of prospectively collected clinical data. 600 youth with concussion were included. Active rehabilitation was initiated ≥4 weeks (prepolicy) or ≥2 weeks (postpolicy) postconcussion based on institutional policy. Cox proportional hazard models, linear mixed models, and chi-square analyses were conducted. The postpolicy group (median = 22 d [interquartile range: 17-27]) started treatment earlier than the prepolicy group (median = 26d [interquartile range: 24-30], P < .001). Length of episode of care (χ2(1) = 11.55, P < .001, odds ratios = 1.49; 95% confidence interval, 1.19-1.88); rehabilitation (χ2(1) = 9.47, P = .002, odds ratios = 1.73, 95% confidence interval, 1.22-2.45]); and total recovery (χ2(1) = 11.53, P < .001, odds ratios = 1.49; 95% confidence interval, 1.18-1.88) were reduced in patients postpolicy change. A significant interaction effect was found for total postinjury symptom (F2,320 = 3.59, P = .03) and symptom change scores (F2,315 = 5.17, P = .006), with the postpolicy group having faster symptom resolution over time. No group differences were observed for persisting symptoms. Earlier rehabilitation initiation occurred as intended following an institutional policy change, which had small, but significant, effects on recovery outcomes in youth with concussion. Health care providers should adopt policies to encourage early active rehabilitation services after concussion.

The Chinese version of the immediate mood scaler (IMS): a study evaluating its validity, reliability, and responsiveness in patients with MDD in China

BackgroundIt is important to timely capture the fluctuation of the symptoms related to major depressive disorder (MDD). However, most conventionally used assessment tools for MDD symptoms are not designed for real-time assessment. The Immediate Mood Scaler (IMS) is suitable for the real-time evaluation of the mood of patients with MDD.MethodsThe original IMS was translated into Chinese and back-translated. At baseline, data from 368 patients with MDD, including demographic information and scores on the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and IMS, were collected. In total, 185 participants completed the retest at Week 2 which included the PHQ-9, GAD-7, and IMS. Internal structural validity, construct validity, and internal consistency were evaluated with the confirmatory factor analysis (CFA), the Pearson correlation, and Cronbach’s α, respectively. Responsiveness was anchored by the change of the PHQ-9 total scores from baseline to Week 2 and predictability was tested using the multivariate linear mixed model for repeated measures (MMRM).ResultsTwo factors with an eigenvalue greater than 1, corresponding to IMS-Depression and IMS-Anxiety subscales, were identified using CFA. The Cronbach’s α that evaluated internal consistency was 0.96, 0.95, and 0.92 for the scores of the IMS, IMS-Depression subscale, and IMS-Anxiety subscale at baseline, respectively. The depression and anxiety subscales at baseline showed high subscale-total correlations (r = 0.96 for the depression subscale; r = 0.89 for the anxiety subscale). The test-retest ICC (0.65, 95%CI: 0.53–0.73) of the IMS at baseline and Week 2 show high reliability. The total score of IMS had significant correlations with that of the PHQ-9 (r = 0.52, P < 0.001) and GAD-7(r = 0.43, P < 0.001), indicating good construct validity. In patients with MDD who showed changes in mood, the changes in total scores of the IMS from baseline to the retest were statistically significant with a mean difference of 13.3 (SD: 20.1), an ES of 0.66, and an SRM of 0.3, showing good responsiveness. Also, the baseline IMS-Depression subscale score could predict the change in the PHQ-9 score over the two weeks (t = 2.19, P = 0.029).ConclusionsStudy findings suggest that the Chinese version of the IMS is a valid and reliable tool for assessing mood symptoms in patients with MDD in China. Further validation studies of the Chinese version IMS in different regions and at various levels of medical institutions are needed to further confirm the current findings.

Efficacy and tolerability of antidepressants monotherapy for behavioral and psychological symptoms of dementia: A meta-analysis of randomized controlled trials

Behavioral and psychological symptoms of dementia (BPSD) are common and difficult to manage. Although experimental data suggest that antidepressants may reduce BPSD, the results are inconclusive. To evaluate the efficacy and tolerability of antidepressants monotherapy for treating BPSD. We searched 10 cross-disciplinary electronic databases from inception to October 2023.Randomized controlled trials (RCTs) comparing antidepressants versus placebo for treating BPSD were included. The primary outcome was change in total neuropsychiatric symptom scale scores. Secondary outcomes included changes on agitation and psychosis subscale scores, change in total score of Mini-mental State Examination (MMSE). Tolerability outcomes included incidences and discontinuations due to adverse events. Finally, 8 RCTs including 676 patients were identified. We found a small beneficial effect of antidepressants on overall BPSD However, when trials with potential high-dose citalopram were excluded, no improvement was observed. No significant effects were detected on agitation and cognition. Currently there is no clear evidence of a beneficial effect of currently available antidepressants on overall BPSD and in particular agitation. Notably, clinician should be cautious of the potential risk of arrhythmias, dizziness and diarrhea when prescribing an antidepressant.

Efficacy and safety of perfluorohexyloctane eye drops in ametropic patients with dry eye disease associated with meibomian gland dysfunction: A subgroup analysis from a phase 3 clinical trial

Aims/Purpose: The randomized clinical trial demonstrated the efficacy and safety of perfluorohexyloctane (SHR8058) eye drops for dry eye disease (DED) associated with meibomian gland dysfunction (MGD). This post‐hoc analysis aimed to evaluate the efficacy and safety of perfluorohexyloctane eye drops in ametropic patients with DED associated with MGD.Methods: This subgroup analysis based on a randomized, double‐masked, saline‐controlled, phase 3 trial included ametropic patients with DED and MGD. In the original study, participants were randomized to receive either perfluorohexyloctane or 0.6% sodium chloride (NaCl) drops four times daily for 57 days. Primary endpoints were changes in total corneal fluorescein staining (tCFS) and eye dryness score at day 57.Results: A total of 121 ametropic patients were included (57 in the perfluorohexyloctane group, 64 in the NaCl group). At day 57, the perfluorohexyloctane group showed a significant improvement in tCFS score (mean reduction: −5.2) vs. NaCl (mean reduction: −3.3), with an estimated least squares mean (LSmean) difference of −1.9 (95% CI: −2.7 to −1.1). Eye dryness score improved significantly in the perfluorohexyloctane group (mean reduction: −42.4) vs. NaCl (mean reduction: −26.9), with an estimated LSmean difference of −15.5 (95% CI: −22.1 to −8.8). Additionally, perfluorohexyloctane eye drops alleviated symptoms including pain, awareness of DED symptoms, and frequency of dryness compared to the control. Ocular treatment‐emergent adverse events were similar between groups (15.8% in the perfluorohexyloctane group vs. 14.1% in the NaCl group).Conclusions: Perfluorohexyloctane eye drops significantly improved both objective signs and subjective symptoms of DED in ametropy patients with MGD, demonstrating favorable efficacy and safety.

Changes in quality of life (QoL) following treatment entry in a drug-free therapeutic community in Belgium

ABSTRACT Background Several studies have demonstrated the effectiveness of drug-free therapeutic communities (TCs) in terms of improved mental health and reduced drug use. However, there is limited research on the effectiveness of TCs using patient-reported outcome measures (PROMs) such as quality of life (QoL). Methods The study included a baseline sample of 145 participants starting treatment in a TC for addictions in Belgium. Subsequent assessments followed 3, 6, and 12 months after baseline assessment. Changes in total QoL (MANSA) and domain scores were analyzed. Additionally, differences in QoL baseline scores were analyzed between early dropouts and those who completed the program. Results Results showed significant improvements in all QoL domains (except for satisfaction with sexual life). The degree of improvement of total QoL scores, however, depended on the initial level of QoL. Additionally, participants who were still in TC after 3 months were younger and had higher scores for satisfaction with treatment and mental health during the first weeks of treatment than drop-outs, which could reflect their motivation and readiness to change. Conclusion Therapeutic communities have the potential to enhance the QoL for individuals with substance use disorders. Focusing on satisfaction with treatment and mental health during the first weeks of the program could potentially increase treatment retention and patient-reported outcomes (PROM).

Randomized, Double-Blind, Placebo-Controlled Trial on the Efficacy, Safety and Tolerability of Modified-Release Methylphenidate (MPH-MR) in Chinese Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

The efficacy and safety of modified-release methylphenidate (MPH-MR) in the treatment of attention-deficit/hyperactivity disorder (ADHD) have been shown in both pediatric and adult Caucasian patients. The objective of this study was to assess the efficacy and safety of MPH-MR in Chinese children and adolescents with ADHD. MICCA was a randomized, double-blind, placebo-controlled trial conducted at 19 sites in China from September 2018 to July 2021. The study enrolled children and adolescents aged 6 to <18 years with a primary diagnosis of ADHD according to the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition (DSM-5). Patients were randomized 1:1 to once-daily MPH-MR (10-60 mg) or placebo. The study included an up-titration phase of up to 5 weeks and a dose maintenance phase of 4 weeks. The primary efficacy endpoint was the change in the ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to the end of the maintenance phase (EoM). Secondary endpoints included the change from baseline to EoM in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) total score, and Clinical Global Impression-Improvement (CGI-I) scores at EoM. Safety assessments included treatment-emergent adverse events (TEAEs) and vital signs. A total of 221 patients were randomized (MPH-MR: n = 110; placebo: n = 111). The change in the ADHD-RS-IV total score from baseline to EoM was significantly greater for MPH-MR versus placebo, with a least squares (LS) mean (95% confidence interval [CI]) treatment difference of -4.6 (-6.92, -2.30) (p < 0.001). The mean (95% CI) treatment difference for the WFIRS-P total score change from baseline to EoM also significantly favored MPH-MR over placebo (-6.46 [-10.57, -2.34]; p = 0.002). The CGI-I score at EoM was significantly lower in the MPH-MR group compared to the placebo group (2.2 vs 2.5; p = 0.002). Treatment-emergent adverse events were reported for 74 (67.3%) patients in the MPH-MR group and 55 (49.1%) patients in the placebo group. Most TEAEs were mild to moderate in severity. The most common TEAEs for MPH-MR were decreased appetite, nausea and upper respiratory tract infection. Treatment-emergent adverse events leading to study drug discontinuation/study withdrawal were reported in 4 (3.6%) patients in the MPH-MR group and 1 (0.9%) patient in the placebo group. No clinically relevant changes in vital signs were observed during the study. Modified-release methylphenidate was superior to placebo in improving ADHD symptoms and functioning in Chinese pediatric patients with ADHD. Modified-release methylphenidate had a good safety and tolerability profile. Trial Registration http://www.chinadrugtrials.org.cn/ Identifier: CTR20180056 (registered on 21 May 2018).

Brief Video-Delivered Intervention to Reduce Anxiety and Improve Functioning in Older Veterans: Pilot Randomized Controlled Trial.

Older veterans with anxiety disorders encounter multiple barriers to receiving mental health services, including transportation difficulties, physical limitations, and limited access to providers trained to work with older persons. To address both accessibility and the shortage of available providers, evidence-based treatments that can be delivered via guided self-management modalities are a potential solution. This study aims to determine the feasibility and acceptability of a randomized controlled trial of 2 guided self-management interventions. This study compared the treatment effects of these 2 interventions (relaxation and health psychoeducation) on anxiety symptom severity and functioning in older veterans with anxiety disorders. Our exploratory aims examined factors related to home practices and treatment engagement and perceptions of the practices. Participants were randomized to one of two video-delivered interventions: (1) Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE)-breathing and progressive relaxation or (2) Healthy Living for Reduced Anxiety-psychoeducation about lifestyle changes. Telephone coaching calls were conducted weekly. Measures of anxiety, depression, and functioning were obtained at baseline, week 4 (end of treatment), week 8, and week 12. Participants completed a semistructured interview at week 12. Analyses included descriptive statistics to summarize measures of intervention engagement; mixed-effects models to characterize symptom change, and qualitative analyses. Overall, 56 participants (n=48, 86% men; n=23, 41% from ethnic or racial minority groups; mean age 71.36, SD 6.19 y) were randomized. No difference in retention between study arms was found. The Healthy Living group (29/56, 52%) completed significantly more lessons (mean 3.68, SD 0.86) than the BREATHE group (27/56, 48%; mean 2.85, SD 1.43; t53=2.60; P=.01) but did not differ in completion of coaching calls. In the BREATHE group, greater baseline anxiety scores (r=-0.41; P=.03) and greater severity of medical comorbidity (r=-0.50; P=.009) were associated with fewer completed practices. There was no effect of intervention on change in total anxiety scores or functioning. For specific anxiety subtypes, Healthy Living produced a greater decline in somatic anxiety compared with BREATHE. Qualitative analyses found barriers to practicing, including difficulty setting time aside to practice, forgetting, or having other activities that interfered with BREATHE practices. Some participants described adapting their practice routine to fit their daily lives; some also used relaxation skills in everyday situations. These findings suggest that a larger randomized controlled trial of guided self-management approaches to treating late-life anxiety is feasible; however, BREATHE was not effective in reducing anxiety compared with Healthy Living. Possible contributing factors may have been the reliance on a single technique. Progressive relaxation was reported to be enjoyable for most participants, but maintaining home practices was challenging. Those with milder anxiety severity and fewer health problems were better able to adhere to practices. ClinicalTrials.gov NCT02400723; https://clinicaltrials.gov/study/NCT02400723.

Impact of a health literacy sensitive model of care in outpatient nephrology dietetic clinics.

Inadequate health literacy in people with chronic kidney disease is associated with poorer disease management and greater complications. Adherence to the renal diet is known to be suboptimal and patient feedback about the renal diet suggests that patients leave nephrology clinics feeling confused. The present study aimed to evaluate the impact of a health literacy sensitive model of care (MOC) in outpatient nephrology dietetic clinics. This quasi-experimental non-randomised pre-post study recruited adults attending three renal dietitian clinics. The revised MOC consisted of a renal diet question prompt sheet, teachback, and plain language materials and instructions. Outcomes assessed included clinical, dietary, patient-reported satisfaction and quality of life. Differences between and within groups were analysed using paired t-tests, independent sample t-tests (or non-parametric equivalent), chi-squared and McNemar's tests. Linear mixed models evaluated change in total diet quality score, fruit, vegetable, protein and dairy intake with time as a fixed effect and a random subject specific effect. Fail to attend rates at the initial appointments were lower in the revised MOC (21.5% vs. 9.1%). The revised MOC was associated with significantly improved fruit (p = 0.03) and vegetable (p = 0.003) intake and an improved proportion with adequate diet quality (p = 0.03). These impacts were of moderate effect size (d = 0.5, 95% confidence interval = 0.0-1.0). The revised MOC was also associated with greater satisfaction at baseline (p = 0.04) and higher acceptability scores for all questions at the review appointments. Quality of life improved clinically but not significantly in the revised MOC (p = 0.92). This low-cost health literacy sensitive intervention is a promising strategy to improve fruit and vegetable intake in adults attending renal dietitian clinics. Further research to determine fidelity of teachback use and cost utility analysis would be beneficial. Larger scale trials powered to detect changes in quality of life would also be informative.

Samelisant (SUVN-G3031), A Histamine 3 Receptor Inverse Agonist: Results from The Phase 2 Double-Blind Randomized Placebo-Controlled Study for The Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy

Narcolepsy is a rare, chronic neurological disorder characterized by a dysregulated sleep-wake cycle, with core clinical features including excessive daytime sleepiness (EDS), cataplexy, hypnopompic/hypnagogic hallucinations, and sleep paralysis. Several treatment options are available for the symptomatic management of narcolepsy, but they have limitations. Comorbidities of narcolepsy further limit the treatment choices. Blocking of histamine 3 (H3) receptors has been demonstrated to be a viable approach for the management of symptoms of narcolepsy. Samelisant (SUVN-G3031) is a new H3 receptor inverse agonist. The efficacy, safety, tolerability, and pharmacokinetics of Samelisant in narcolepsy patients were evaluated in a phase 2, double-blind, placebo-controlled study (ClinicalTrials.gov identifier: NCT04072380). Patients diagnosed with narcolepsy according to the International Classification of Sleep Disorders criteria and having an Epworth Sleepiness Scale (ESS) score of ≥12 and a mean Maintenance of Wakefulness Test (MWT) time of <12min across the 4 sessions at baseline were enrolled. The total study duration was up to 7 weeks, which included a screening period of 4 weeks, a treatment period of 2 weeks, and a safety follow-up 1 week after the last study drug administration. The primary efficacy measure was the change in total ESS score compared to placebo. Secondary and exploratory assessments included the Clinical Global Impression of Severity, MWT, Clinical Global Impression of Change, Patient Global Impression of Change and cataplexy rate. Safety assessments included monitoring adverse events (AEs) and laboratory assessments. Of the 426 patients screened, 190 were randomized. The safety and intention-to-treat population included 188 and 164 patients, respectively. A statistically significant treatment effect of Samelisant was observed on the primary endpoint, indicating improvements in EDS. The treatment's impact on EDS was also evident on the other patients' and clinicians' perspectives scales. The AEs reported in ≥5% patients in any treatment groups were insomnia, abnormal dreams, nausea, and hot flush. Global phase 3 studies and long-term safety and efficacy assessments of Samelisant are planned to reaffirm the current findings.

Comparison of hearing-aid effectiveness based on user-operated versus traditional audiometry: a randomised clinical trial

Objective To investigate whether hearing-aid fitting based on user-operated audiometry is non-inferior to hearing-aid fitting based on traditional audiometry. Design This non-inferiority randomised clinical trial, took place at Odense University Hospital, Odense, Denmark. In a first visit, participants were tested with traditional audiometry as well as user-operated audiometry and filled in the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at baseline. Next, they were randomly divided to receive hearing aids fitted based on either the user-operated (UAud group) or the traditional audiometry (control group) hearing thresholds. After three months of hearing-aid use, participants underwent an aided hearing-in-noise test and completed the SSQ12 again, as well as an additional battery of outcome measures. Study sample A total of 215 adults with sensorineural hearing impairment referred for bilateral hearing-aid fitting. Results The before-after change in SSQ12 total scores was not different between the groups as the interaction between test times and groups was −0.06 (95% CI −0.56 to 0.44, p = 0.811). Conclusions The findings suggest that the HA effectiveness in the UAud group was non-inferior to those observed in the control group. This implies that integrating user-operated audiometry into the clinical system is feasible, offering potential personnel time savings without compromising patient outcomes. Trial Registration The trial was registered at ClinicalTrials.gov (NCT05043207).

Biphasic cartilage repair implant versus microfracture in the treatment of focal chondral and osteochondral lesions of the knee: a prospective, multi-center, randomized clinical trial

BackgroundAutologous minced cartilage is a method for cartilage defect repair, and our study focuses on a newly developed biphasic cylindrical osteochondral construct designed for use in human knees. We aimed to compare its clinical effectiveness and safety with microfracture, the commonly utilized reparative treatment for knee chondral or osteochondral defects.Materials and methodsConducted as a prospective multicenter, randomized controlled, non-inferiority trial across nine hospitals, the study involved 92 patients with International Cartilage Repair Society (ICRS) grade 3 to 4 chondral or osteochondral lesions on femoral condyles. Patients were evenly randomized to receive either the biphasic cartilage-repair implant (BiCRI) or microfracture. Functional outcomes and safety assessments were conducted at postoperative intervals of 6 weeks and 3, 6, and 12 months. Primary and secondary endpoints included International Knee Documentation Committee (IKDC) 2000 Subjective Knee Evaluation Form score improvement, the grade distribution in the IKDC 2000 Knee Examination Form, and various assessments, such as the Knee Injury and Osteoarthritis Outcome Score (KOOS), visual analog scales (VASs) for pain, MRI findings, and arthroscopic findings at 12 months.ResultsOut of the initial participants, 47 in the BiCRI group and 45 in the microfracture group completed the follow-up. At 12 months, the mean change in IKDC total score was 25.56 ± 18.48 for BiCRI and 27.51 ± 23.65 for microfracture. The 95% confidence interval (CI) for the score difference (BiCRI minus microfracture) was − 6.95, exceeding the non-inferiority margin of − 12. Secondary endpoints indicated comparable functional outcomes, and arthroscopic findings demonstrated more fully regenerated cartilage in the BiCRI group.ConclusionBased on the IKDC 2000 Subjective Knee Evaluation Form score, BiCRI proved non-inferior to microfracture at 12 months. Short-term functional outcomes were comparable to those with microfracture, while arthroscopic findings showed more complete cartilage regeneration in the BiCRI group. Consequently, BiCRI emerges as a viable alternative for treating chondral or osteochondral defects.Level of evidenceLevel 2, multi-center, randomized clinical trial.Trial registration: Name of the registry: ClinicalTrials.gov. Trial registration number: NCT01477008. Date of registration: 11/14/2011. URL of trial registry record: clinicaltrials.gov/study/NCT01477008

Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 (TYK2) Inhibitor, in Patients With Moderate to Severe Scalp Psoriasis: Improvement in Scalp-Related Quality of Life and Symptoms in the Phase 3b/4 Multicenter, Randomized, Double-Blinded, Placebo-Controlled PSORIATYK SCALP Trial

Introduction: PSORIATYK SCALP (NCT05478499)—an ongoing 52-week, phase 3b/4, multicenter, randomized, double-blinded, placebo-controlled trial—assesses the efficacy and safety of deucravacitinib in patients aged ≥18 years with moderate to severe scalp psoriasis (Psoriasis Scalp Severity Index ≥12, scalp-specific Physician Global Assessment ≥3, scalp surface area involvement ≥20%, and body surface area [BSA] involvement ≥3%). We assessed Week 16 patient-reported outcomes using Scalpdex, a validated, scalp-specific quality-of-life instrument, and numeric rating scales (NRSs) for scalp-specific symptoms. Methods: Patients were randomized 1:2 to placebo or deucravacitinib 6 mg for 16 weeks, stratified by previous biologic use (yes or no) and body weight (&lt;90 or ≥90 kg). Changes from baseline in Scalpdex total score and NRS scores for scalp-specific itch, pain, and flaking were assessed with an analysis of covariance (ANCOVA) model with treatment and randomization stratification factors as fixed effects and the baseline value as a covariate. Scalpdex total score change from baseline was further assessed in BSA subgroups (BSA 3–10%, BSA &gt;10%), using an ANCOVA model with treatment as a fixed effect and the baseline value as a covariate. P values are nominal. Results: Mean baseline scores (placebo: n=51; deucravacitinib: n=103) indicated severe impact on quality of life (Scalpdex total score &gt;44.0) and moderate to severe symptoms (NRS ≥4.0). At Week 16, adjusted mean change from baseline (95% CI) in Scalpdex total score was greater in patients receiving deucravacitinib versus placebo (−22.3 [−26.1, −18.6] vs −10.5 [−15.7, −5.2]; P=0.0003). Changes from baseline (95% CI) in scalp-specific NRS measures were greater in patients receiving deucravacitinib versus placebo (itch: −3.2 [−3.7, −2.7] vs −0.7 [−1.4, 0.0]; pain: −2.1 [−2.6, −1.6] vs −0.1 [−0.8, 0.5]; flaking: −3.9 [−4.5, −3.4] vs −1.0 [−1.8, −0.2]; all P&lt;0.0001). In each BSA subgroup, patients receiving deucravacitinib versus placebo reported greater Week 16 change from baseline in Scalpdex total score (BSA 3–10%: −19.8 [−23.9, −15.6] vs −10.5 [−16.1, −4.9]; P=0.0096; BSA &gt;10%: −26.2 [−33.2, −19.3] vs −11.2 [−22.3, 0.0]; P=0.0263). Conclusion: Deucravacitinib was efficacious in improving scalp-specific psoriasis symptoms and quality of life. Furthermore, scalp-related quality of life was improved in patients receiving deucravacitinib in both BSA subgroups.

The impact of preoperative treatment on mismatch repair protein and HER2 expression in colorectal cancer: an analysis of paired samples

BackgroundColorectal cancer (CRC) is a leading cause of cancer-related mortality, highlighting the necessity for multifaceted treatment strategies, including preoperative treatment (PT), which can enhance surgical outcomes and provide prognostic insights. This study aims to clarify the impact of PT-induced changes in mismatch repair (MMR) and human epidermal growth factor receptor 2 (HER2) expression, potentially informing tailored treatment strategies and improving clinical outcomes for CRC patients.MethodsThis retrospective study analyzed 120 paired samples from CRC patients who underwent preoperative treatment, comparing pre- and post-treatment specimens. A control group of 60 untreated surgical specimens was also included. Immunohistochemistry assessed MMR proteins (MSH6, MSH2, MLH1, PMS2) and HER2 expression. MSI status was determined in samples with low MMR expression.ResultsCompared to pre-treatment samples, post-treatment samples exhibited lower levels of MSH6, MSH2, and total MMR expression, along with higher levels of HER2 expression. However, when compared to the untreated control group, there were no significant differences in the expression of MSH6, total MMR, and HER2. All samples that exhibited weak MMR expression and those that shifted to deficient mismatch repair (dMMR) status following treatment had stable microsatellite status. No clear clinicopathological characteristics or prognostic factors were found to be associated with changes in MMR and HER2 expression, except for the use of fluorouracil or capecitabine, which was related to changes in total MMR scores. ypTNM stage and TRG scores were identified as independent factors affecting disease progression in our study.ConclusionsPT is associated with a reduction in MMR expression, notably for the MSH2 protein, while it does not appear to influence HER2 expression.

Efficacy and safety of YOXINTINE for depression: A double-blinded, randomized, placebo-controlled, phase 2 clinical trial

BackgroundYOXINTINE contains >98 % of 20(S)-protopanaxadial (PPD), a metabolic product of ginsenosides with pre-clinical neuroprotective activity. Animal experiments and previous studies have shown that PPD has good antidepressant effect and safety. PurposeTo evaluate YOXINTINE in treating depression compared with a placebo in Chinese patients. Study DesignThis was a multicenter, double-blinded, randomized, placebo-controlled, phase 2 clinical trial. MethodsThe study included 178 randomized (1:1:1) Chinese patients with depression. Patients were randomly assigned to receive oral YOXINTINE at doses of 200 or 400 mg or a placebo administered twice daily for 8 weeks. The primary outcome was assessed by measuring changes in the Montgomery–Asberg Depression Rating Scale (MADRS) total score. All adverse reactions were recorded. All demographic and baseline characteristics were comparable. ResultsThe changes in MADRS total scores from baseline were −10.43 for the placebo group, −16.24 for the 200 mg YOXINTINE group, and −13.60 for the 400 mg YOXINTINE group. The differences in MADRS total score changes compared with the placebo were −5.81 (95 % CI: −7.69, −3.92; P < 0.0001) and −3.17 (95 % CI: −5.08, −1.25; P = 0.0013) for the 200 mg and 400 mg groups, respectively. The results indicated a significantly greater MADRS score reduction in the 200 mg group (P = 0.0058, 95 % CI: 0.78, 4.51). Adverse event incidence was comparable among all groups. ConclusionOral YOXINTINE is safe and significantly improves depressive symptoms. PPD may exhibit antidepressant properties through mechanisms distinct from monoamine reuptake inhibition. Registration numberChiCTR2300070568