1.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution, providing a basis for optimizing the training system for committee members, improving the quality of ethical review, and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation, a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it, ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system, a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide, comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators (ethics and professional knowledge, ethics review ability, communication and expression ability, moral integrity and work style) and 39 secondary indicators (familiarity with the content of clinical trial-related laws and regulations, ability to complete project ethics review and identify ethical defects in research protocols within a short period of time, ability to judge the scientific value of clinical research, etc.). The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge, ethical norms, review efficiency, risk judgment, and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training, qualification certification, and standardized management of ethics committees.
2.CT-guided fine-needle assisted localization for puncturing difficult lung or liver lesions
Jian ZHANG ; Zhongbao TAN ; Zhenhai DI ; Xuequn MAO ; Rong ZOU ; Qingqing WANG ; Zhuang HAN
Chinese Journal of Interventional Imaging and Therapy 2024;21(8):482-485
Objective To observe the feasibility and safety of CT-guided fine-needle assisted localization for puncturing difficult lung or liver lesions.Methods Data of 30 patients with single difficult lung or liver lesion,i.e.lesion located at difficult part for puncturing or deep lesion with diameter of 0.5-2.0 cm who underwent CT-guided 22G needle assisted localization before puncturing were retrospectively analyzed.The success rate of fine-needle assisted localization,the success rate of the first-time puncturing and the occurrence of complications were recorded.Results Among 30 difficult lesions,there were 27 lung lesions and 3 hepatic lesions,with a mean diameter of(1.0±0.4)cm.Assisted localization of difficult lesions were successfully performed with 22G needle under CT guidance at the edge of lesion,1 cm adjacent to lesion or at the puncture path,with success rate of fine-needle assisted localization of 100%,and no obvious complication happened.The followed operations included preoperative localization of 14 lung nodules,biopsy of 10 lung nodules and 3 liver nodules,as well as microwave ablation of 3 liver nodules,with the success rate of the first-time puncturing of 100%.Mild pneumothorax was observed in 3 cases(3/27,11.11%)of difficult lung lesions after biopy.No other obvious complication occurred.Conclusion CT-guided fine-needle assisted localization for percutaneous puncturing difficult lung or liver lesions was feasible and safe.
3.Risk factors analysis for tibial fracture in patients with congenital anterolateral bowing of the tibia
Shulang JIAN ; Qingqing MAO ; Siyu XU ; Guanghui ZHU ; Kun LIU ; Qian TAN ; Ge YANG ; Zexi JIANG ; Xiaoyu ZHOU ; Haibo MEI
Chinese Journal of Orthopaedics 2023;43(17):1164-1173
Objective:To explore the risk factors associated with tibia fractures in children with congenital anterolateral bowing of the tibia (ALBT).Methods:A retrospective analysis was conducted on data from 87 children diagnosed with ALBT at the Children's Hospital of Hunan Province from January 2012 to January 2020. The collected data included age at initial diagnosis, affected limb side, whether there was a concomitant type I neurofibromatosis, whether there was a concomitant fibular pseudoarthrosis, whether there was concomitant ankle joint deformity, whether there was bone cystic change in the region of tibial bowing deformity, location of the apex of the bowing deformity, diameter of the tibial bowing deformity on the affected side, diameter on the healthy side in the same plane as the tibial bowing deformity, angle of lateral bending deformity of the tibia, angle of anterior bending deformity of the tibia, occurrence of tibia fracture, history of trauma before fracture, location of fracture, and age at the time of fracture. The follow-up endpoint was January 2023. Receiver operating characteristic (ROC) curves were used to determine the optimal cutoff values for the angles of lateral and anterior bending deformity of the tibia and the ratio of cross-sectional areas. The correlation between the above factors and tibial fractures in children was analyzed by single factor survival analysis, and the indicators with statistical significance were included in multivariate Cox proportional risk regression analysis to determine the risk factors for tibial fractures in children with ALBT.Results:Of the 87 children diagnosed with ALBT, the median age at initial diagnosis was 14.0 months (range, 1-93 months), with 42 males and 45 females, 44 left-sided and 43 right-sided cases. The median follow-up time for non-fracture cases was 42.0 months (range, 1-124 months). At the last follow-up, 43 children had experienced fractures, while 44 had not. The average time to fracture-free survival was 70.3 months, the median fracture-free survival time was 55.0 months, and the median survival time without fractures was 42.0 months. The ROC curve results indicated a cutoff value of 25.55° for the lateral bending angle of the tibia and 32.63° for the anterior bending angle of the tibia, with no statistically significant significance for the cross-sectional area ratio [AUC=0.54, 95% CI (0.42, 0.66), P=0.530]. Single-factor analysis of fracture-free survival suggested that there were statistically significant differences in the intergroup fracture-free survival rates of four factors: lateral bending angle of the tibia (χ 2=7.06, P=0.008), anterior bending angle of the tibia (χ 2=8.96, P=0.003), history of trauma (χ 2=18.26, P<0.001), and tibial bone cystic change (χ 2=4.30, P=0.038). The results of the multivariate Cox proportional hazards regression analysis showed that a lateral bending angle of the tibia≥25.55° ( HR=2.73, P=0.007), tibial bone cystic change ( HR=2.35, P=0.018), and history of trauma ( HR=2.65, P=0.004) were all positively correlated with fractures. Conclusion:The main risk factors for tibia fractures in children with ALBT include trauma, tibial bowing deformity with concomitant bone cystic change, and lateral bending angle of the tibia≥25.55°.
4.Development and validation of interpersonal emotion regulation questionnaire for healthcare workers
Qingqing ZHANG ; Xiaohong MAO ; Xinying LIU ; Shanshan LIU ; Chunyan ZHU
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(2):171-176
Objective:To develop the interpersonal emotion regulation questionnaire for healthcare workers and examine its reliability and validity.Methods:Based on the theory of social regulatory cycle (SRC), literatures review and semi-structured interview were used to form the item pool of the scale.Through expert consultation, project analysis and the exploratory factor analysis, the scale items were screened, and the interpersonal emotion regulation questionnaire for healthcare workers was initially formed.The convenient sampling method was adopted to select 619 healthcare workers from multiple hospitals in Anhui province to conduct the formal survey to test the reliability and validity of the questionnaire and confirmatory factor analysis (CFA) using the SPSS 24.0 and Mplus 8.0 software.Results:There were 18 items and four dimensions including emotion identification, motivation, regulation strategy and implementation strategy process in the interpersonal emotion regulation questionnaire for healthcare workers.The results of CFA showed that the questionnaire fitted the data with well construct validity.The correlation coefficients between each dimension and the scale were 0.830-0.932.The Cronbach’s α coefficient of the overall questionnaire was 0.962, the split-half reliability was 0.880 and the test-retest reliability was 0.786.The score of total questionnaire was significantly positively correlated with the score of emotional intelligence ( r=0.680, P<0.001) and empathic ability ( r=0.554, P<0.001), and was significantly negatively correlated with the doctor-patient relationship ( r=-0.353, P<0.001). Conclusion:The interpersonal emotion regulation questionnaire for healthcare workers has satisfactory reliability and validity, which can be used to measure the ability of interpersonal emotion regulation in healthcare workers.
5.Leaky Gut Plays a Critical Role in the Pathophysiology of Autism in Mice by Activating the Lipopolysaccharide-Mediated Toll-Like Receptor 4-Myeloid Differentiation Factor 88-Nuclear Factor Kappa B Signaling Pathway.
Fang LI ; Haoran KE ; Siqi WANG ; Wei MAO ; Cexiong FU ; Xi CHEN ; Qingqing FU ; Xiaori QIN ; Yonghua HUANG ; Bidan LI ; Shibing LI ; Jingying XING ; Minhui WANG ; Wenlin DENG
Neuroscience Bulletin 2023;39(6):911-928
Increased intestinal barrier permeability, leaky gut, has been reported in patients with autism. However, its contribution to the development of autism has not been determined. We selected dextran sulfate sodium (DSS) to disrupt and metformin to repair the intestinal barrier in BTBR T+tf/J autistic mice to test this hypothesis. DSS treatment resulted in a decreased affinity for social proximity; however, autistic behaviors in mice were improved after the administration of metformin. We found an increased affinity for social proximity/social memory and decreased repetitive and anxiety-related behaviors. The concentration of lipopolysaccharides in blood decreased after the administration of metformin. The expression levels of the key molecules in the toll-like receptor 4 (TLR4)-myeloid differentiation factor 88 (MyD88)-nuclear factor kappa B (NF-κB) pathway and their downstream inflammatory cytokines in the cerebral cortex were both repressed. Thus, "leaky gut" could be a trigger for the development of autism via activation of the lipopolysaccharide-mediated TLR4-MyD88-NF-κB pathway.
Mice
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Animals
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NF-kappa B
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Myeloid Differentiation Factor 88/metabolism*
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Lipopolysaccharides/pharmacology*
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Toll-Like Receptor 4/metabolism*
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Autistic Disorder/metabolism*
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Signal Transduction/physiology*
6.Impact of obstructive sleep apnea on nonalcoholic fatty liver disease
Qingqing XU ; Haiying TANG ; Jingwei MAO
Journal of Clinical Hepatology 2021;37(1):192-195
Obstructive sleep apnea (OSA) may induce chronic intermittent hypoxia, which may lead to the disorders of multiple systems and organs and even sudden cardiac death in severe cases. Besides respiratory, cardiovascular, endocrine, and metabolic diseases, OSA is also closely associated with nonalcoholic fatty liver disease (NAFLD). This article briefly describes the current status of OSA and NAFLD, introduces the impact of OSA on NAFLD, and reviews the mechanisms of OSA in NAFLD. It is pointed out that clarifying the mechanisms of OSA in affecting NAFLD and discovering potential prevention and treatment targets for NAFLD from the aspect of OSA are of great significance in delaying and even blocking the progression of NAFLD.
7.BRICS report of 2020: The bacterial composition and antimicrobial resistance profile of clinical isolates from bloodstream infections in China
Yunbo CHEN ; Jinru JI ; Chaoqun YING ; Zhiying LIU ; Qing YANG ; Haishen KONG ; Yuanyuan DAI ; Jiliang WANG ; Haifeng MAO ; Hui DING ; Yongyun LIU ; Yizheng ZHOU ; Hong LU ; Youdong YIN ; Yan JIN ; Hongyun XU ; Lixia ZHANG ; Lu WANG ; Haixin DONG ; Zhenghai YANG ; Fenghong CHEN ; Donghong HUANG ; Guolin LIAO ; Pengpeng TIAN ; Dan LIU ; Yan GENG ; Sijin MAN ; Baohua ZHANG ; Ying HUANG ; Liang GUO ; Junmin CAO ; Beiqing GU ; Yanhong LI ; Hongxia HU ; Liang LUAN ; Shuyan HU ; Lin ZHENG ; Aiyun LI ; Rong XU ; Kunpeng LIANG ; Zhuo LI ; Donghua LIU ; Bo QUAN ; Qiang LIU ; Jilu SHEN ; Yiqun LIAO ; Hai CHEN ; Qingqing BAI ; Xiusan XIA ; Shifu WANG ; Jinhua LIANG ; Liping ZHANG ; Yinqiao DONG ; Xiaoyan QI ; Jianzhong WANG ; Xuefei HU ; Xiaoping YAN ; Dengyan QIAO ; Ling MENG ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2021;14(6):413-426
Objective:To investigate the bacterial composition and antimicrobial resistance profile of clinical isolates from bloodstream infections in China.Methods:The clinical bacterial strains isolated from blood culture were collected during January 2020 to December 2020 in member hospitals of Blood Bacterial Resistant Investigation Collaborative System (BRICS). Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical Laboratory Standards Institute(CLSI, USA). WHONET 5.6 was used to analyze data.Results:During the study period, 10 043 bacterial strains were collected from 54 hospitals, of which 2 664 (26.5%) were Gram-positive bacteria and 7 379 (73.5%) were Gram-negative bacteria. The top 10 bacterial species were Escherichia coli (38.6%), Klebsiella pneumoniae (18.4%), Staphylococcus aureus (9.9%), coagulase-negative Staphylococci (7.5%), Pseudomonas aeruginosa (3.9%), Enterococcus faecium (3.3%), Enterobacter cloacae (2.8%), Enterococcus faecalis (2.6%), Acinetobacter baumannii (2.4%) and Klebsiella spp (1.8%). The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant coagulase-negative Staphylococcus aureus were 27.6% and 74.4%, respectively. No glycopeptide- and daptomycin-resistant Staphylococci were detected. More than 95% of Staphylococcus aureus were sensitive to rifampicin and SMZco. No vancomycin-resistant Enterococci strains were detected. Extended spectrum β-lactamase (ESBL) producing Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis were 48.4%, 23.6% and 36.1%, respectively. The prevalence rates of carbapenem-resistance in Escherichia coli and Klebsiella pneumoniae were 2.3% and 16.1%, respectively; 9.6% of carbapenem-resistant Klebsiella pneumoniae strains were resistant to ceftazidime/avibactam combination. The prevalence rate of carbapenem-resistance in Acinetobacter baumannii was 60.0%, while polymyxin and tigecycline showed good activity against Acinetobacter baumannii. The prevalence rate of carbapenem-resistance of Pseudomonas aeruginosa was 23.2%. Conclusions:The surveillance results in 2020 showed that the main pathogens of bloodstream infection in China were gram-negative bacteria, while Escherichia coli was the most common pathogen, and ESBL-producing strains declined while carbapenem-resistant Klebsiella pneumoniae kept on high level. The proportion and the prevalence of carbapenem-resistant Pseudomonas aeruginosa were on the rise slowly. On the other side, the MRSA incidence got lower in China, while the overall prevalence of vancomycin-resistant Enterococci was low.
8.Progress in research of allergen detection methods
Jie MAO ; Qingqing LU ; Xin ZENG ; Ping LI ; Shengjie SHI ; Jing LI ; Zhenhua ZHU ; Xiaobing XIE ; Qun LU
Chinese Journal of Preventive Medicine 2021;55(1):123-129
Allergic diseases have continued to increase year by year causing serious physical and mental injury to patients, families and individuals. This increase has been driven by conventional environmental and nutritional changes but is also created by the continual introduction of food additives into the diet and novel interior decoration materials into the living space. The causes of allergic diseases are complex and diverse, and the medical laboratory often is not be able to identify the allergic trigger; this creates a difficult environment to identify the appropriate clinical treatment for disease prevention and control. Physicians must be able to identify these triggers to help patients avoid the underlying allergenic cause of their disease. This can only be done by actively knowing a patient′s medical history, identifying the clinical manifestations of hypersensitivity and utilizing confirmatory testing as an important clinical tool in identifying the allergic source.
9.Progress in research of allergen detection methods
Jie MAO ; Qingqing LU ; Xin ZENG ; Ping LI ; Shengjie SHI ; Jing LI ; Zhenhua ZHU ; Xiaobing XIE ; Qun LU
Chinese Journal of Preventive Medicine 2021;55(1):123-129
Allergic diseases have continued to increase year by year causing serious physical and mental injury to patients, families and individuals. This increase has been driven by conventional environmental and nutritional changes but is also created by the continual introduction of food additives into the diet and novel interior decoration materials into the living space. The causes of allergic diseases are complex and diverse, and the medical laboratory often is not be able to identify the allergic trigger; this creates a difficult environment to identify the appropriate clinical treatment for disease prevention and control. Physicians must be able to identify these triggers to help patients avoid the underlying allergenic cause of their disease. This can only be done by actively knowing a patient′s medical history, identifying the clinical manifestations of hypersensitivity and utilizing confirmatory testing as an important clinical tool in identifying the allergic source.
10.Mental health and related influencing factors among rural elderly in 14 poverty state counties of Chongqing, Southwest China: a cross-sectional study.
Yin YANG ; Hui DENG ; Qingqing YANG ; Xianbin DING ; Deqiang MAO ; Xiaosong MA ; Bangzhong XIAO ; Zhaohui ZHONG
Environmental Health and Preventive Medicine 2020;25(1):51-51
BACKGROUND:
China has the largest elderly population in the world; little attention has been paid to the mental health of elderly in areas of extreme poverty. This is the first study to investigate the mental health of the rural elderly in poverty state counties in Chongqing and was part of the Chongqing 2018 health literacy promotion project.
METHODS:
In 2019, a cross-sectional study was conducted to investigate the mental health status of the rural elderly in fourteen poverty state counties of Chongqing, in which a total of 1400 elderly aged ≥ 65 years were interviewed, where mental health status was measured by the ten-item Kessler10 (K10) scale. Ordered multivariate logistic regression was performed to evaluate the influencing factors related to mental health of the elderly in these areas.
RESULTS:
The average score of K10 in 14 poverty state counties was 17.40 ± 6.31, 47.6% was labeled as good, 30.2% was moderate, 17.0% was poor, and lastly 5.1% was bad, and the mental health status of the elderly in the northeastern wing of Chongqing was better than the one in the southeastern wing of Chongqing. A worse self-rated health was the risk factor for mental health both in the northeastern and southeastern wings of Chongqing (all P < 0.001). Lower education level (OR (95% CI) = 1.45 (1.12-1.87), P = 0.004) was a risk factor in the northeastern wing, whereas older age (OR (95% CI) = 1.33 (1.13-1.56), P = 0.001) was a risk factors in the southeastern wing.
CONCLUSIONS
The results showed that mental health of the elderly in poverty state counties was poor, especially in the southeastern wing of Chongqing. Particular attention needs to be paid to the males who were less educated, older, and single; female with lower annual per capital income; and especially the elderly with poor self-rated health.
Aged
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Aged, 80 and over
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China
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Cross-Sectional Studies
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Female
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Health Policy
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Humans
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Logistic Models
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Male
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Mental Health
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statistics & numerical data
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Multivariate Analysis
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Rural Population
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statistics & numerical data
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Socioeconomic Factors

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