Characterization, hazard identification, and risk assessment of volatile organic compounds in Poly(butylene adipate-co-terephthalate)-based food contact articles.

The chemical safety of poly (butylene adipate-co-terephthalate) (PBAT) based food contact articles (FCAs) has aroused increasing toxicological concerns in recent years, but the chemical characterization and associated risk assessment still remain inadequate as it fails to elucidate the distribution pattern and discern the potential genotoxic and carcinogenic hazards of the identified substances. Herein, the volatile organic compounds (VOCs) in 50 batches of PBAT-based FCAs of representative categories and 10 batches of PLA and PBAT pellets were characterized, by which 237 VOCs of 10 chemical categories were identified and exhibited characteristic distribution patterns in the chemical spaces derived from their molecular descriptors. Chemical hazards associated with the identified VOCs were discerned by a hazard-driven classification scheme integrating hazard-related knowledge from multiple publicly available sources, and 34 VOCs were found to bear genotoxic or carcinogenic hazards and to feature higher average molecular weight than the other VOCs. Finally, the Risk and hazard quotient (HQ) calculated as the metrics of risk suggested that all identified VOCs posed acceptable risks (Risk<10-4 or HQ < 1), whereas oxolane, butyrolactone, N,N-dimethylacetamide, 2-butoxyethanol, benzyl alcohol, and 1,2,3-trichloropropane posed non-negligible (Risk>10-6) genotoxic or carcinogenic risk and thus should be of prioritized concern to promote the chemical safety of PBAT-based FCAs.

Contactless vital signs monitoring in macaques using a mm-wave FMCW radar.

Heart rate (HR) and respiration rate (RR) play an important role in the study of complex behaviors and their physiological correlations in non-human primates (NHPs). However, collecting HR and RR information is often challenging, involving either invasive implants or tedious behavioral training, and there are currently few established simple and non-invasive techniques for HR and RR measurement in NHPs owing to their stress response or indocility. In this study, we employed a frequency-modulated continuous wave (FMCW) radar to design a novel contactless HR and RR monitoring system. The designed system can estimate HR and RR in real time by placing the FMCW radar on the cage and facing the chest of both awake and anesthetized macaques, the NHP investigated in this study. Experimental results show that the proposed method outperforms existing methods, with averaged absolute errors between the reference monitor and radar estimates of 0.77 beats per minute (bpm) and 1.29 respirations per minute (rpm) for HR and RR, respectively. In summary, we believe that the proposed non-invasive and contactless estimation method could be generalized as a HR and RR monitoring tool for NHPs. Furthermore, after modifying the radar signal-processing algorithms, it also shows promise for applications in other experimental animals for animal welfare, behavioral, neurological, and ethological research.

Long-term impact of self-compassion training with core stability exercise on patients with nonspecific chronic low back pain: A randomized controlled trial.

OBJECTIVE: To compare the long-term effectiveness of self-compassion therapy (SCT) combined with core stability exercise (CSE) versus CSE alone in managing nonspecific chronic low back pain (NCLBP). METHODS: The combined group received SCT and CSE, while the exercise group only received CSE. Treatment was administered once weekly for four weeks, followed by one year of follow-up. The primary outcomes were changes in functional limitations (measured by Roland and Morris Disability Questionnaire scores[RMDQ]) and self-reported back pain (measured by the Numeric Pain Rating Scale[NRS]) at 52 weeks, with assessments also conducted at 2, 4, and 16 weeks. RESULTS: 52 (83.9%) completed the follow-up assessments and were included in the analysis (42 women [80.8%]; mean [SD] age,35.3 [10.0] years). In the combined group, the baseline mean (SD) RMDQ score was 9.3 (4.1),5.7 (5.8) at 2 weeks, 3.8 (3.4) at 4 weeks, 3.8 (3.7) at 16 weeks, and 2.4 (2.7) at 52 weeks. For the exercise group, the RMDQ scores were 8.2 (3.3) at baseline, 6.2 (4.2) at 2 weeks, 5.5 (4.7) at 4 weeks, 4.4 (4.5) at 16 weeks, and 5.2 (5.6) at 52 weeks. The estimated mean difference between the groups at 52 weeks was -3.356 points (95% CI, -5.835 to -0.878; P = 0.009), favoring the combined group. NRS scores showed similar changes. CONCLUSION: The addition of self-compassion therapy enhances the long-term efficacy of core stability training for NCLBP (Preregistered at chictr.org.cn:ChiCTR2100042810).

Elevated triglycerides and low triiodothyronine: Key risk factors for coronary artery calcification in patients with schizophrenia.

OBJECTIVE: Coronary artery calcification (CAC) is a well-established independent predictor of coronary heart disease, and patients with schizophrenia have significantly higher rates compared to the general population. We performed this study to examine the population-specific risk factors associated with CAC in patients with schizophrenia. METHODS: In this cross-sectional study, patients with schizophrenia who underwent low-dose chest CT scans between January 2020 and December 2021 were analyzed. Ordinary CAC scores and results of routine blood tests were obtained. Logistic regression was used to calculate the odds ratio (OR) for potential risk factors in patients with and without CAC, while the negative binomial additive model was used to explore the dose-response relationship between risk factors and CAC score. RESULTS: Of the 916 patients, 233 (25.4 %) had CAC, while 683 (74.6 %) did not. After adjusting for confounding factors, higher triglyceride levels (OR = 1.20, 95 % confidence interval (CI): 1.04 to 1.38, p = 0.013) and low triiodothyronine levels (OR = 0.50, 95 % CI: 0.29 to 0.84; p = 0.010) were identified as risk factors for CAC. Both triglycerides (p = 0.021) and triiodothyronine (p = 0.010) were also found to have significant dose-response relationships with CAC scores according to the negative binomial additive model in the exploratory analysis. CONCLUSIONS: This study highlights elevated serum triglycerides and decreased triiodothyronine levels as population-specific risk factors for CAC in patients with schizophrenia, suggest the need for close monitoring of CAC in patients with schizophrenia and further prospective trials to provide additional evidence on this topic.

Potential causal links between long-term ambient particulate matter exposure and cardiovascular mortality: New evidence from a large community-based cohort in South China.

BACKGROUND: Cardiovascular disease (CVD) mortality is associated with long-term particulate matter (PM) exposure. However, evidence from large, highly-exposed population cohort and observational-data-based causal inference approaches remains limited. AIMS: We examined the potential causal links between PM exposure and the CVD mortality in South China. METHODS: 580,757 participants were recruited during 2009-2015 and followed up through 2020. Satellite-based annual concentrations of PM2.5, PM10, and PMcoarse (i.e., PM10 - PM2.5) at 1 km2 spatial resolution were estimated and assigned to each participant. Marginal structural Cox models with time-varying covariates, adjusted using inverse probability weighting, were developed to evaluate the association between prolonged PM exposure and CVD mortality. RESULTS: For overall CVD mortality, the hazard ratios and 95% confidence interval for each 1 µg/m3 increase in the annual average concentration of PM2.5, PM10, and PMcoarse were 1.033 (1.028-1.037), 1.028 (1.024-1.032), and 1.022 (1.012-1.033), respectively. All three PMs were linked to a higher mortality risk for myocardial infarction and ischemic heart disease (IHD). The mortality risk of chronic IHD and hypertension was linked to PM2.5 and PM10. Significant association between PMcoarse and other heart disease mortality was also observed. The older, women, less-educated participants, or inactive participants exhibited particularly higher susceptibility. Participants who were generally exposed to PM10 concentrations below 70 µg/m3 were more vulnerable to PM2.5-, PM10- and PMcoarse-CVD mortality risks. CONCLUSION: This large cohort study provides evidence for the potential causal links between increased CVD mortality and ambient PM exposure, as well as socio-demographics linked to the highest vulnerability.

Trajectories of Efficacy and Cognitive Function During Electroconvulsive Therapy Course in Young Adults with Treatment-Resistant Depression.

Objective: Little is known about the effectiveness and cognitive side-effects of electroconvulsive therapy (ECT) in young adults with treatment-resistant depression (TRD). The primary aim of this prospective longitudinal observational trial was to examine the clinical features and cognitive outcomes of young adults with TRD undergoing ECT. Methods: Changes in depressive symptoms and objective and subjective cognitive function were assessed using repeated evaluation at baseline, after each ECT session, and at one-month follow-up using the Montgomery-Äsberg Depression Rating Scale (MADRS) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Forward Digital Span Test (FDST), and part of the Columbia Subjective Side Effects Schedule. Results: Of 41 inpatients, 35 (85.4%) and 12 (29.3%) met the criteria for response and remission after ECT, respectively. The greatest clinical improvements occurred during the first 3-4 ECT sessions. While 34 patients reported subjective cognitive impairment increased with ECT, immediate and delayed memory (RBANS) significantly increased after ECT, consistent with FDST results. Objective cognition significantly improved during follow-up, but subjective cognition remained impaired. Conclusion: ECT is effective in young adults with TRD. Although subjective cognitive impairment increased during treatment, objective cognitive impairments were not observed.

Potential causal links between long-term ambient particulate matter exposure and cerebrovascular mortality: Insights from a large cohort in southern China.

Cohort studies conducted in North America and Europe have linked cerebrovascular mortality to long-term exposure to particulate matter (PM). However, limited evidence from large cohorts in high-exposure areas and the traditional approach of association assessment may cause residual confounding issues. In this study, we aimed to investigate the causal links between cerebrovascular mortality and long-term exposure to PM2.5, PM10, and PM2.5-10 in an ongoing cohort study with 580,757 participants in southern China. Using satellite-based estimates of PM concentration at a 1-km2 spatial resolution, we assigned exposure levels to each participant and used the marginal structural Cox model to assess the association between PM exposure and cerebrovascular mortality while accounting for time-varying covariates. We also explored the potential modification effects of sociodemographic and behavioral factors on the PM-health associations. Adjusted hazard ratios (HR) for overall cerebrovascular mortality were 1.041 (95% confidence interval (CI): 1.034-1.049) and 1.032 (95% CI: 1.026-1.038) for each 1 µg/m3 increase in PM2.5, and PM10, respectively. Similar trends were observed in the mortality risk from stroke and ischemic stroke, with HRs ranging from 1.040 to 1.069 and 1.025 to 1.052, respectively, across 2 p.m. exposures. The impact of PM exposure was generally more apparent among women, participants with primary school diplomas and below, and the subgroup under low-exposure. Multiple sensitivity analyses confirmed the robustness of the results. In conclusion, this sizable prospective cohort study hypothesizes causal links between long-term PM exposure and cerebrovascular mortality, particularly among vulnerable participants, supporting the rationale for reducing PM concentration in China to reduce cerebrovascular mortality.

HRCT quantitative analysis of airway remodeling and airway trapping in the small airway asthma phenotype and its correlation with pulmonary function.

OBJECTIVES: We aimed to explore whether large airway remodeling and small airway structural changes exist in subjects with small airway asthma phenotype and to evaluate the relationships between quantitative high-resolution computed tomography (qHRCT) parameters and lung function. METHODS: We enrolled 15 subjects with small airway asthma phenotype and 18 healthy controls. The two groups were matched by age, sex and body square area (BSA) with propensity score matching (PSM). Pulmonary function and qHRCT parameters [wall thickness (WT), wall area (WA), lumen area (LA), wall area percentage (WA%) of the 4th-6th generations in the right upper lobe apical segmental bronchus (RB1), adjusted by BSA, WT/BSA, WA/BSA, and LA/BSA, relative volume change -860 HU to -950 HU (RVC-860 to -950) and the expiration to inspiration ratio of mean lung density (MLDE/I)) were compared between the groups. Correlation analysis was employed to assess the relationship between qHRCT parameters and pulmonary function. RESULTS: The small airway asthma phenotype had significantly higher WA%, RVC-860 to -950 and MLDE/I and lower LA/BSA than the healthy control. Additionally, we found moderate to strong correlations between impulse oscillation (IOS) indices and WA6% and WT6/BSA. No significant correlation was found between bronchial parameters and air trapping parameters (p > 0.05). CONCLUSIONS: Combining physiological tests with imaging approaches can lead to better evaluation of small airway disfunction (SAD) in asthmatic patients. Additionally, despite nonexistent airflow obstruction in patients with small airway asthma phenotype, large airway remodeling and small airway structural changes may appear simultaneously in the early stage of disease.

Potential Gains in Health-Adjusted Life Expectancy by Reducing Burden of Noncommunicable Diseases in 188 Countries: A Population-Based Study.

OBJECTIVES: This article quantifies the potential gains in health-adjusted life expectancy for people aged 30 to 70 years (HALE[30-70]) by examining the reductions in disability in addition to premature mortality from noncommunicable diseases (NCDs). METHODS: We extracted data from the Global Burden of Disease Study 2019 for 4 major NCDs (cancers, cardiovascular diseases, chronic respiratory diseases, and diabetes mellitus) in 188 countries from 2010 to 2019. Estimates of the potential gains in HALE[30-70] were based on a counterfactual analysis involving 3 alternative future scenarios: (1) achieve Sustainable Development Goals target 3.4 but do not make any progress on disability reduction, (2) achieve Sustainable Development Goals target 3.4 and eliminate NCD-related disability, and (3) eliminate all NCD-related mortality and disability. RESULTS: In all scenarios, the high-income group has the greatest potential gains in HALE[30-70], above the global average. For all specific causes, potential gains in HALE[30-70] decrease as income levels fall. Across these 3 scenarios, the potential gains in HALE[30-70] globally of reducing premature mortality for 4 major NCDs are 3.13 years, 4.53 years, and 7.32 years, respectively. In scenario A, all income groups have the greatest potential gains in HALE[30-70] from diabetes and chronic respiratory diseases. In scenarios B and C, the high-income group has the greatest potential gains in HALE[30-70] from cancer intervention, and the other income groups have the greatest potential gains in HALE[30-70] from cardiovascular diseases intervention. CONCLUSION: Reducing premature death and disability from 4 major NCDs at once and attaching equal importance to each lead to a sizable improvement in HALE[30-70].

Violent behavior and the network properties of psychopathological symptoms and real-life functioning in patients with schizophrenia.

Objective: To assess the interplay among psychopathological symptoms and real-life functioning, and to further detect their influence with violent behavior in patient with schizophrenia. Methods: A sample of 1,664 patients with post-violence assessments and their propensity score-matched controls without violence from a disease registration report system of community mental health service in Guangdong, China, were studied by network analysis. Ising-Model was used to estimate networks of psychopathological symptoms and real-life functioning. Then, we tested whether network properties indicated the patterns of interaction were different between cases and controls, and calculated centrality indices of each node to identify the central nodes. Sensitivity analysis was conducted to examine the difference of interaction patterns between pre-violence and post-violence assessments in violence cases. Results: Some nodes in the same domain were highly positive interrelations, while psychopathological symptoms were negatively related to real-life functioning in all networks. Many symptom-symptom connections and symptom-functioning connections were disconnected after the violence. The network density decreased from 23.53% to 12.42% without statistical significance (p = 0.338). The network structure, the global network strength, and the global clustering coefficient decreased significantly after the violence (p < 0.001, p = 0.019, and p = 0.045, respectively). Real-life functioning had a higher node strength. The strength of sleeping, lack of spontaneity and flow of conversation, and preoccupation were decreased in post-violence network of patients. Conclusion: The decreasing connectivity may indicate an increased risk of violence and early warning for detecting violence. Interventions and improving health state based on nodes with high strength might prevent violence in schizophrenia patients.

Influencing factors of multiple adverse outcomes among schizophrenia patients using count regression models: a cross-sectional study.

BACKGROUND: Schizophrenia patients have increased risks of adverse outcomes, including violent crime, aggressiveness, and suicide. However, studies of different adverse outcomes in schizophrenia patients are limited and the influencing factors for these outcomes need clarification by appropriate models. This study aimed to identify influencing factors of these adverse outcomes by examining and comparing different count regression models. METHODS: This study included schizophrenia patients who had at least one follow-up record in the Guangdong Mental Health Center Network Medical System during 2020. Three types of adverse outcomes were included: a) aggressiveness with police dispatch or violent crime, b) aggressiveness without police dispatch, and c) self-harm or suicide attempts. The incidence density of these adverse outcomes was investigated using the Poisson, negative binomial (NB), zero-inflated Poisson (ZIP), and zero-inflated negative binomial (ZINB) models, accordingly. The best model was chosen based on goodness-of-fit tests. We further analyzed associations between the number of occurrences of adverse outcomes and sociodemographic, clinical factors with the best model. RESULTS: A total of 130,474 schizophrenia patients were enrolled. Adverse outcomes rates were reported to be less than 1% for schizophrenia patients in 2020, in Guangdong. The NB model performed the best in terms of goodness-of-fit and interpretation when fitting for the number of occurrences of aggressiveness without police dispatch, whereas the ZINB models performed better for the other two outcomes. Age, sex, and history of adverse outcomes were influencing factors shared across these adverse outcomes. Higher education and employment were protective factors for aggressive and violent behaviors. Disease onset aged ≥ 18 years served as a significant risk factor for aggressiveness without police dispatch, and self-harm or suicide attempts. Family history of mental diseases was a risk factor for self-harm or suicide attempts individually. CONCLUSIONS: NB and ZINB models were selected for fitting the number of occurrences of adverse outcomes among schizophrenia patients in our studies. Influencing factors for the incidence density of adverse outcomes included both those shared across different types and those individual to specific types. Therefore, comprehensive and customized tools in risk assessment and intervention might be necessary.

Improved Safety of Hybrid Electroconvulsive Therapy Compared With Standard Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Parallel-Group Pilot Trial.

Objectives: ECT is a rapid and effective treatment for depression. While efficacy is often remarkable over the initial 3-4 sessions, the efficacy of later sessions is less rapid, and the side-effects, especially cognitive impairment limit its use. To preliminarily compare the efficacy and acceptability of a novel hybrid-ECT (HECT) protocol for patients with major depressive disorder (MDD) with standard ECT, we conducted this pilot trial. Methods: Thirty patients were randomly assigned to ECT or HECT. Both arms received three ECT sessions (phase 1) but, in phase 2, the HECT arm received low-charge electrotherapy instead of ECT. The primary outcome was the change in 24-item Hamilton depression rating scale (HAMD-24) scores between baseline and the end of treatment. Cognitive function was assessed by repeatable battery for the assessment of neuropsychological status (RBANS), Stroop color word, and orientation recovery tests (ORT). Safety was measured by the drop-out rate and adverse events (AEs). Four visits were conducted at baseline, post-phase 1, post-phase 2, and at 1-month follow-up. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/), identifier: ChiCTR1900027701. Results: Patients in both arms showed significant within-group improvements in HAMD-24, but the between-group differences were non-significant. Participants in the HECT arm outperformed ECT patients for most cognitive tests at the end of treatment or at follow-up. There was a significantly lower AE rate and shorter ORT in phase 2 of the HECT ar. Conclusion: In this pilot trial, HECT was associated with fewer AEs and better cognitive function including executive and memory function, but its possible similar antidepressive efficacy needs to be further investigated in future.

Tenofovir is superior to entecavir in reducing HCC for patients with HBV-related compensated cirrhosis at high HCC risk scores.

Background: Both tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are known to reduce the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). This study aimed to compare the difference in HCC risk reduction between TDF and ETV in treatment-naïve patients with CHB-related compensated cirrhosis. Methods: Patients with compensated cirrhosis initially treated with TDF or ETV at nine Chinese hospitals between June 2014 and March 2021 were enrolled in this retrospective study. The cumulative HCC incidence rates for the two drugs were compared for the entire cohort, and a subgroup analysis was performed according to the HCC risk scores. Propensity score matching (PSM) was used to control confounding biases. Results: The analysis included 1453 patients (TDF group, n = 188; ETV group, n = 1265). Ninety-five patients developed HCC, with a median follow-up period of 26.1 months. The 3-year HCC incidence was 2.0% in the TDF group and 7.5% in the ETV group (log-rank p = 0.005). TDF treatment was associated with a lower risk of HCC than ETV treatment [hazard ratio (HR) = 0.222, 95% confidence interval (CI), 0.070-0.702, p = 0.010] but was similar after PSM (HR = 0.483, 95% CI, 0.144-1.626, p = 0.240; log-rank p = 0.230). However, subgroup analysis showed that the cumulative HCC incidence was lower in the TDF group than in the ETV group among patients with a modified PAGE-B score (mPAGE-B) ⩾9, either before or after PSM (log-rank p = 0.048 and p = 0.023, respectively). Conclusion: Among patients with an mPAGE-B score ⩾9, TDF is associated with a lower HCC incidence than ETV in patients with CHB-related compensated cirrhosis.

Regional years of life lost, years lived with disability, and disability-adjusted life-years for severe mental disorders in Guangdong Province, China: a real-world longitudinal study.

BACKGROUND: To understand the magnitude and spatial-temporal distribution of the regional burden attributable to severe mental disorders is of great essential and high policy relevance. The study aimed to address the burden of severe mental disorders by evaluating the years of life lost, years lived with disability, and disability-adjusted life-years (DALYs) in Guangdong, China. METHODS: We undertook a longitudinal study based on a multicenter database established by the Health Commission of Guangdong, involving a total of 21 prefectures and four economic regions in the Guangdong province. A total of 520,731 medical records from patients with severe mental disorders were collected for 2010-2020. Data were analyzed via an integrated evaluation framework by synthesizing prevalence estimates, epidemiological adjustment as well as comorbidity assessment to develop internally consistent estimates of DALY. DALY changes during 2010-2020 were decomposed by population growth and aging and further grouped by Socio-demographic Index (SDI). DALYs were projected to 2030 by the weighted median annualized rate of change in 2010-2020. RESULTS: In 2010-2020, the average DALYs for severe mental disorders reached 798,474 (95% uncertainty interval [UI]: 536,280-1,270,465) person-years (52.2% for males, and 47.8% for females). Severe mental disorders led to a great amount of disease burden, especially in Guangzhou, Shenzhen, and Foshan cities. Schizophrenia and mental retardation with mental disorders were the two leading sources of the burden ascribed to severe mental disorders. Population growth and aging could be accountable for the increasing burden of severe mental disorders. Economic regions with higher SDI carried a greater burden but had lower annualized rates of change in DALYs. The overall burden of severe mental disorders is projected to rise modestly over the next decade. CONCLUSIONS: The findings urge prioritization of initiatives focused on public mental health, prevention strategies, health resources reallocation, and active involvement of authorities to effectively address the anticipated needs.

Machine learning directed discrimination of virgin and recycled poly(ethylene terephthalate) based on non-targeted analysis of volatile organic compounds.

The use of non-decontaminated recycled poly(ethylene terephthalate) (PET) in food packages arouses consumer safety concerns, and thus is a major obstacle hindering PET bottle-to-bottle recycling in many developing regions. Herein, machine learning (ML) algorithms were employed for the discrimination of 127 batches of virgin PET and recycled PET (rPET) samples based on 1247 volatile organic compounds (VOCs) tentatively identified by headspace solid-phase microextraction comprehensive two-dimensional gas chromatography quadrupole-time-of-flight mass spectrometry. 100% prediction accuracy was achieved for PET discrimination using random forest (RF) and support vector machine (SVM) algorithms. The features of VOCs bearing high variable contributions to the RF prediction performance characterized by mean decrease Gini and variable importance were summarized as high occurrence rate, dominant appearance and distinct instrument response. Further, RF and SVM were employed for PET discrimination using the simplified input datasets composed of 62 VOCs with the highest contributions to the RF prediction performance derived by the AUCRF algorithm, by which over 99% prediction accuracy was achieved. Our results demonstrated ML algorithms were reliable and powerful to address PET adulteration and were beneficial to boost food-contact applications of rPET bottles.

Task-Aware Sampling Layer for Point-Wise Analysis.

Sampling, grouping, and aggregation are three important components in the multi-scale analysis of point clouds. In this paper, we present a novel data-driven sampler learning strategy for point-wise analysis tasks. Unlike the widely used sampling technique, Farthest Point Sampling (FPS), we propose to learn sampling and downstream applications jointly. Our key insight is that uniform sampling methods like FPS are not always optimal for different tasks: sampling more points around boundary areas can make the point-wise classification easier for segmentation. Towards this end, we propose a novel sampler learning strategy that learns sampling point displacement supervised by task-related ground truth information and can be trained jointly with the underlying tasks. We further demonstrate our methods in various point-wise analysis tasks, including semantic part segmentation, point cloud completion, and keypoint detection. Our experiments show that jointly learning of the sampler and task brings better performance than using FPS in various point-based networks.

The Effect of M-Health-Based Core Stability Exercise Combined with Self-Compassion Training for Patients with Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study.

INTRODUCTION: Nonspecific chronic low back pain (NCLBP) is a leading contributor to disease burden worldwide, and the management of NCLBP has always been a problem. This study is designed to explore the feasibility and efficacy of m-health-based core stability exercise (CSE) combined with self-compassion training (SCT) and compare it with m-health-based CSE alone for the management of NCLBP. METHODS: This study is a pilot, patient-blinded randomized controlled trial. Participants with NCLBP were randomized into an intervention group and a control group. All the participants received m-health-based CSE, but those in the intervention group also received SCT before CSE. The intervention took place weekly on Saturday or Sunday for 4 weeks in total. Patients self-assessed their outcomes by filling out electronic questionnaires at 4 and 16 weeks after the start of the study. The primary outcome metrics for these questionnaires were back pain disability (based on the Roland-Morris Disability Questionnaire, RMDQ) and Pain intensity (Numeric Rating Scale, NRS; current pain, worst pain, average pain). The secondary outcome metrics were anxiety (GAD-7,7-item Generalized Anxiety Disorder scale), Depression Symptoms (PHQ-9,Patient Health Questionnaire-9), pain catastrophizing (PCS, Pain Catastrophizing Scale) and Self-efficiency (PSEQ, Pain Self-Efficiency Questionnaire). RESULTS: A total of 37 patients comprising 28 (75.7%) females completed the study, with 19 patients in the intervention group and 18 in the control group. The mean (SD) patient age was 35.2 (11.1) years. For all primary outcomes, although there were no significant differences between groups, we found that participants in the intervention group improved function and pain earlier. The RMDQ score changed by - 1.771 points (95% CI - 3.768 to 0.227) from baseline to 4 weeks in the control group and by - 4.822 points (95% CI - 6.752 to - 2.892) in the intervention group (difference between groups, - 3.052 [95% CI - 5.836 to - 0.267]). Also, the RMDQ score changed by - 3.328 points (95% CI - 5.252 to - 1.403) from baseline to 16 weeks in the control group and by - 5.124 points (95% CI - 7.014 to - 3.233) in the intervention group (difference between groups - 1.796 [95% CI - 4.501 to 0.909]). A similar pattern was found in the NRS scores. For secondary outcomes, the intervention group was superior to the control group in for GAD-7 (intervention difference from CSE along at week 16, - 2.156 [95% CI - 4.434 to - 0.122; P value for group effect was 0.030]). At the end of treatment, the improvement in PCS in the intervention group was significant (difference in PCS score at week 4, - 6.718 [95% CI - 11.872 to - 1.564]). We also found significant changes in PCS in the control group (- 6.326 [95% CI, - 11.250 to - 1.401]) at the 16-week follow-up. As for PSEQ, there were no apparent differences between the two groups. There were no adverse events relented to study participation. CONCLUSIONS: The pilot study is feasible to deliver, and our results indicate that participants in the group of m-health-based CSE combined with SCT may experience faster relief from pain intensity and back disability than those in the group of m-health-based CSE alone. TRIAL REGISTRATION: ChiCTR2100042810.

The impact of chronic low back pain on people's life quality and social economy is increasing year by year. Helping patients self-manage low back pain through a biological-psycho-social model seems to be an effective management approach, but the lack of connectivity between disciplines limits the development of multidisciplinary collaboration. Mindfulness-related therapy (self-compassion training) has been proven to be effective in chronic pain, and exercise therapy is widely used in rehabilitation medicine. In this study, these two programs were combined. We also used mobile health technology in the study, which brings a lot of convenience for research. The results of the study showed that the efficacy of the combined group seemed to be more obvious and worthy of further study.

Bayesian two-stage design for phase II oncology trials with binary endpoint.

In phase II oncology trials, two-stage design allowing early stopping for futility and/or efficacy is frequently used. However, this design based on frequentist statistical approaches could not guarantee a high posterior probability of attending the pre-specified clinically interesting rate from a Bayesian perspective. Here, we proposed a new Bayesian design enabling early terminating for efficacy as well as futility. In addition to the clinically uninteresting and interesting response rate, a prior distribution of response rate, the minimum posterior threshold probabilities and the lengths of the highest posterior density intervals were specified in the design. Finally, we defined the feasible design with the highest total effective predictive probability. We studied the properties of the proposed design and applied it to an oncology trial as an example. The proposed design ensured that the observed response rate fell within prespecified levels of posterior probability. The proposed design provides an alternative design to single-arm two-stage trials.

Clinical implications of concentration of alveolar nitric oxide in asthmatic and non-asthmatic subacute cough.

Asthma is an important cause of subacute cough. The concentration of alveolar nitric oxide (CANO) is a sensitive inflammatory indicator in peripheral airways, and it has received much less attention than the fraction of exhaled nitric oxide (FeNO50). The main objective of this study was to explore the correlation between CANO and clinical parameters in asthmatic and non-asthmatic subacute cough, which might promote understanding of the clinical utility of CANO in these special patient populations. 155 patients with subacute cough were included consecutively, of which 25 were diagnosed as asthmatic. Data for demographic characteristics, FeNO50, CANO, baseline spirometry, bronchial provocation test (or bronchodilation test) and response dose ratio (RDR) were collected. Differences between the asthmatic and non-asthmatic groups were analyzed. Spearman's correlation coefficient (ρ) was used to evaluate the correlation between FeNO50, CANO and other clinical parameters. In patients with subacute cough, baseline CANO values did not differ between asthmatic and non-asthmatic patients (4.4(1.3, 11.4) versus 4.0(2.1, 6.8) ppb,P> 0.05). Besides, CANO exhibited a stronger association with pulmonary function parameters when compared with FeNO50. For asthmatic subacute cough, CANO was inversely correlated with FEV1/FVC (ρ= -0.69,P< 0.01) and small airway parameters including MEF25 (ρ= -0.47,P< 0.05) and MMEF (ρ= -0.45,P< 0.05). For non-asthmatic subacute cough, CANO was inversely correlated with MEF25 (ρ= -0.19,P< 0.05) and RDR (ρ= -0.21,P< 0.05). In subacute cough, asthmatic and non-asthmatic patients had similar values of baseline CANO. In both asthmatic and non-asthmatic subacute cough, CANO exhibited a stronger association with pulmonary function parameters when compared with FeNO50. A low CANO value in non-asthmatic subacute cough corresponded to a higher value of RDR, which implied a stronger tendency towards airway responsiveness.

The Value of Impulse Oscillometric Parameters and Quantitative HRCT Parameters in Differentiating Asthma-COPD Overlap from COPD.

PURPOSE: To evaluate the value of impulse oscillometry (IOS) and quantitative HRCT parameters for differentiating asthma-COPD overlap (ACO) in COPD patients. PATIENTS AND METHODS: We enrolled 44 controls and 66 COPD patients, divided into the pure COPD group (n=40) and the ACO group (n=26). Spearman correlation analysis was utilized to assess the relationship between the quantitative HRCT and IOS parameters. A binary logistic regression analysis was performed to analyze the associations between the different variables and the risk of ACO. Receiver operating characteristic (ROC) curves were employed to identify the optimal cutoff and assess the diagnostic value of relative volume change -856 HU to -950 HU (RVC-856 to -950), decrease in the resistance from 5 Hz to 20 Hz (R5-R20) and their combination in predicting ACO. Bootstrapping validation was used to evaluate the internal validation. The concordance index (C-index) and calibration plot were calculated to assess the discrimination and calibration of the prediction model. RESULTS: Binary logistic regression analysis indicated that RVC-856 to -950 and the IOS parameters (R5-R20, R5, X5) were independently correlated with a higher risk of developing ACO after adjusting for age, sex, body mass index (BMI), history of smoking, exacerbation and atopy or allergic rhinitis. A correlation analysis showed a good correlation between the pulmonary function parameters and RVC-856 to -950, with a weaker correlation with the % area of low attenuation (LAA%) in ACO patients. Combining RVC-856 to -950 and R5-R20 to predict ACO, the AUC was 0.909, and the optimal cutoff value was >-0.62 for RVC-856 to -950 and >0.09 for R5-R20. Good calibration and favorable discrimination were displayed with a higher C-index. CONCLUSION: More serious small airway impairment exists in ACO patients. The combination of RVC-856 to -950 and R5-R20 could be applied to differentiate ACO from COPD patients.