1.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
Chunyan GUO ; Yi ZHANG ; Yuxin YANG ; Yuguang LIANG ; Qian DING ; Qian WANG ; Chengyue ZHANG ; Yu SUN ; Peng GUO
China Pharmacy 2026;37(9):1206-1210
OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis (RCA) in a problem-oriented manner combined with knowledge-attitude-practice (KAP) theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group, and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials, while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge, attitude and practice on the basis of routine pharmaceutical services, according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products, as well as the incidences of minor and major protocol violations, were all significantly lower in the observation group than in the control group ( P <0.001). The main types of protocol violations in both groups included missed/under-/over-dosing of medications, non-adherence to administration time, failure to adjust dosage as required, and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations, the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group ( P <0.001, P <0.001, P =0.025). However, there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups ( P >0.05). CONCLUSIONS Pharmaceutical services led by pharmacists, based on problem-oriented RCA and combined with KAP theory, can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials, thereby safeguarding the safety and rights of study participants.
2.Relationship between stressors and job burnout: Moderating role of job well-being
Jie WU ; Fengmin CHENG ; Ruotong YI ; Weiqian YU ; Chunyan LIU ; Mengyu OU
Journal of Environmental and Occupational Medicine 2025;42(7):833-839
Background Enhancing the sense of honor and belonging among medical staff is a key component of establishing a modern hospital management system. Compared to medical staff at general hospitals, medical staff at oncology hospitals are more prone to job burnout, yet few studies in China have focused on job burnout among employees in oncology hospitals. Objective To propose a hypothetical model in which job well-being moderates the relationship between stressors and occupational burnout, to explore how stressors influence burnout and potential moderating role of job well-being, and to provide better understanding of job burnout and motivate employees based on the double-edge sword effect of stressors. Methods A cross-sectional survey was conducted in May 2022 at a tertiary oncology specialty hospital in Chongqing, China. A total of 1 898 medical staff were recruited. Data were collectedthrough four scales including a general information questionnaire, Maslach Burnout Inventory-Human Service Survey, Work Stressor Scale, and Occupational Well-being Scale for Medical Staff. Independent sample t-tests and one-way ANOVA were used for univariate comparisons of job burnout. Pearson correlation analysis was employed to examine the relationships between job burnout, stressors, and job well-being. Hierarchical linear regression was conducted to identify factors influencing job burnout and to examine potential moderating role of job well-being in the relationship between stressors and job burnout. Results A total of 2 123 questionnaires were distributed, with 1 898 valid responses, yielding an effective response rate of 89.4%. The prevalence of job burnout was 60.1%. The correlation coefficient was 0.717 (P<0.001) between stressors and burnout, −0.784 (P<0.05) between job well-being and burnout, and −0.744 (P<0.001) between stressors and job well-being. The quadratic stressors showed a statistically significant effect on burnout (β=0.404, P<0.01). Job well-being positively moderated the relationship between the linear stressors and burnout (β=1.289, P<0.001) and negatively moderated the relationship between the quadratic stressors and job burnout (β=−0.571, P<0.01), explaining 7.1% of the variance. Conclusion Job burnout prevalence is relatively high among employees in oncology hospitals. There is a curvilinear relationship between stressors and job burnout, with job well-being moderating this relationship. From a practical perspective, it is recommended to establish a tiered stress alert system to monitor employees’ stress levels and prevent prolonged exposure to high-pressure conditions. Additionally, improving employees’ job well-being through institutional incentives and developmental support can enhance its moderating role in mitigating the adverse effects of stressors on job burnout. Meanwhile, fostering coordinated responses between organizations and individuals is crucial for strengthening mental health management systems, thereby supporting a healthy, stable, and sustainable development of the healthcare workforce.
3.Correlation of parent-child relationships with junior high school students bullying behaviors and social cohesion
YOU Lijun, LOU Chaohua, YU Chunyan, LIAN Qiguo, FANG Yuhang, TU Xiaowen, ZUO Xiayun
Chinese Journal of School Health 2025;46(8):1134-1137
Objective:
To examine the association between parent-child relationships and bullying behaviors among junior high school students, and to explore the moderating effect of community cohesion, so as to provide evidences for bullying intervention strategies.
Methods:
From November to December 2017, a cluster sampling method was used to survey 1 589 students in grades 6- 8 from three junior high schools in Jing an District,Shanghai. Anonymous electronic questionnaires collected data on parent-child relationships, community cohesion, and bullying behaviors. Multivariate Logistic regression analyzed the associations and moderation effects.
Results:
The prevalence of bullying behaviors among junior high school students was 7.80%. Spearman correlation analysis revealed negative associations between both parent-child relationships ( r =-0.13) and community cohesion ( r =-0.10) with bullying behaviors, while parent-child relationships positively correlated with community cohesion ( r =0.29) (all P <0.01). Junior high school students with positive parent-child relationships and higher perceived community cohesion showed lower risks of bullying behaviors ( OR=0.51, 95%CI =0.36-0.72; OR=0.58, 95%CI =0.45-0.76), with a significant interaction effect between the two factors (all P <0.05).
Conclusions
Positive parent-child relationships and community cohesion are negatively associated with bullying behaviors in middle school students. Supportive family relationships help reduce bullying, while stronger community cohesion enhances the protective effect of positive parent-child relationships against bullying.
4.Genetic detection for hereditary cancer syndrome among general population
Xinning CHEN ; Li ZHANG ; Li YU ; Huiqin JIANG ; Fei HUANG ; Chunyan ZHANG ; Baishen PAN ; Beili WANG ; Wei GUO
Chinese Journal of Clinical Medicine 2025;32(4):627-633
Objective To examine the significance of susceptible gene detection for hereditary cancer syndrome (HCS) among general population. Methods A total of 2 928 individuals undergoing routine health examinations in Healthcare Center of Zhongshan Hospital, Fudan University, from September 2021 to April 2024 were enrolled retrospectively. Next generation sequencing was employed to identify susceptible genes for HCS. American College of Medical Genetics and Genomics (ACMG) guideline was used to analyze the pathogenicity of variants. Clinical data, imagings, follow-up data were also collected. Results The overall mutation rate of HCS panel was 3.59% (105/2 928), with 0.61% (18/2 928) for MutY DNA glycosylase (MUTYH), 0.27% (8/2 928) for breast cancer susceptibility gene 1/2 (BRCA1/2) and 0.23% (7/2 928) for mismatch repair (MMR) genes. Conclusions Healthy individuals carrying tumor susceptible genes usually lack the relevant clinical phenotypes. Whether comprehensive testing needs to be carried out among healthy people remains to be further explored.
5.Association of parent-child connectedness and peers romantic behaviors with romantic relationships of secondary vocational school students
XU Simin, ZUO Xiayun, FANG Yuhang, YU Chunyan, LIAN Qiguo, LOU Chaohua, ZHENG Yujia, TU Xiaowen
Chinese Journal of School Health 2025;46(10):1422-1426
Objective:
To explore the association between parent-child connectedness and romantic relationships of secondary vocational school students and the moderating effect of peers romantic behavior, providing scientific basis for family and school health education.
Methods:
From March to April 2021,2 426 students from six secondary vocational and technical schools in Shanghai and Shaanxi Province were selected to conduct the survey by combining convenience sampling and cluster sampling.Electronic questionnaires were used to collect data on students family characteristics,oneself and peer romantic behaviors, and parent-child bonding. The t-test was employed for inter group comparisons, and binary Logistic regression analysis was conducted to examine the relationship between parent-child bonding levels, peer romantic behavior, and the romantic behavior of secondary vocational students.
Results:
The mother-child connection (2.63±0.77) was higher than that of father-child connection (2.48±0.78), with statistically significant difference ( t =6.83, P <0.01). Multivariable Logistic regression showed that overall father-child connectedness was negatively associated with students romantic relationships( OR =0.86,95% CI =0.76-0.97, P =0.02)and was only associated to girls romantic relationships when stratified by gender( OR =0.79,95% CI =0.66-0.93, P =0.01). Peers romantic relationships were positively associated with students romantic relationships ( OR =3.19-5.12, all P <0.01), and there was a moderating effect of the association between maternal connectedness and boys romantic relationships ( OR =1.67, 95% CI =1.05-2.66, P =0.03). Among boys without romantic peers, mother-child connectedness was negatively associated with their romantic relationships ( OR = 0.60 , 95% CI =0.36-0.99, P <0.05). In the total sample of Shanghai and girls of Shaanxi, father-child connectedness was negatively correlated with the romantic relationships of secondary vocational school students ( OR =0.84,0.65,95% CI =0.71-1.00,0.50-0.85,both P <0.05). Peer romantic relationships exhibited a negative moderating effect on the influence of mother-child connectedness on the romantic relationships of males in Shanghai ( OR =1.91, 95% CI =1.03-3.57, P <0.05).
Conclusions
The father-daughter connectedness is negatively correlated with girls romantic behavior, and peer romantic behavior weakens the correlation between mother-child connectedness and boys romantic behavior. Efforts should be made to enhance the parent-child connectedness of secondary vocational students and their ability to cope with peer influence, providing proper guidance for adolescents heterosexual interactions.
6.Evidence summary for risk management of breast and ovarian cancers in carriers of breast cancer susceptibility gene 1/2 mutations
Zhixiang SUN ; Pingpin WEN ; Xiaoli ZHANG ; Chunyan LIU ; Xinyu YANG ; Yu XIAO ; Jing FU
Journal of Clinical Medicine in Practice 2025;29(10):83-88
Objective To systematically search,evaluate,and summarize the evidence for risk management of breast and ovarian cancers in carriers of breast cancer susceptibility gene 1/2(BRCA1/2)mutations.Methods A systematic search was conducted in BMJ Best Practice,UpTo-Date,the National Guideline Clearinghouse(NGC),the National Institute for Health and Care Ex-cellence(NICE),the Scottish Intercollegiate Guidelines Network(SIGN),the Guidelines Interna-tional Network(GIN),the New Zealand Guidelines Group(NZGG),the Canadian Medical Associa-tion Infobase(CMA InfoBase),the Registered Nurses' Association of Ontario(RNAO),the National Comprehensive Cancer Network(NCCN),Cancer Care Ontario(CCO),the Medlive website,the American Society of Clinical Oncology(ASCO),the European Society for Medical Oncology(ESMO),the American Cancer Society(ACS),the American College of Obstetricians and Gynecologists(ACOG),the Joanna Briggs Institute(JBI),the Cochrane Library,PubMed,Web of Science,Em-base,CINAHL,ProQuest,ClinicalTrials.gov,China National Knowledge Infrastructure,Wanfang Data,VIP Database,and SinoMed for evidence related to risk management of breast and ovarian canc-ers in BRCA1/2 mutation carriers,including clinical decisions,guidelines,systematic reviews,expert consensus,and evidence summaries.The search period was from the inception of each database to September 20,2024.Results A total of 14 articles were included,comprising 1 clinical decision,8 guidelines,and 5 expert consensus documents.Based on five themes-risk assessment,risk moni-toring,risk-reducing surgery,pharmacologic prevention,and health guidance,a total of 24 pieces of evidence were summarized.Conclusion The evidence summarization process in this study is standardized,and the summarized evidence is relatively comprehensive.Healthcare professionals should comprehensively consider patients' individual characteristics,family history,personal prefer-ences,and the accessibility of healthcare resources to achieve effective prevention and control of he-reditary tumor risks.
7.Construction and evaluation of a nomogram for preoperative prediction of microvascular invasion and vascular encirulation of tumor cell nests in double-positive hepatocellular carcinoma
Jiyun ZHANG ; Xueqin ZHANG ; Qi QU ; Jifeng JIANG ; Chunyan GU ; Yixing YU ; Tao ZHANG
Chinese Journal of Hepatobiliary Surgery 2025;31(11):811-816
Objective:A nomogram model for predicting double positivity of microvascular invasion (MVI) and vascular endothelial-to-mesenchymal transition (VETC) in patients with hepatocellular carcinoma (HCC) was constructed and its predictive performance was evaluated.Methods:A retrospective analysis was conducted on 326 HCC patients who were treated at the Third People's Hospital of Nantong and the First Affiliated Hospital of Soochow University from January 2013 to June 2023, including 240 males and 86 females, with an average age of (58.7±9.0) years. The 326 patients were randomly divided into a training set ( n=228) and a test set ( n=98) at a ratio of 7: 3 using the random number table method. The training set was divided into a double-positive group ( n=54) and a control group ( n=174) based on whether the HCC patients were double positive for MVI and VETC. Univariate and multivariate logistic regression analyses were performed to identify the influencing factors of double positivity of microvascular invasion in HCC patients, and a nomogram for predicting double positivity of microvascular invasion patterns was constructed based on the multivariate. The predictive performance and clinical net benefit of the nomogram were evaluated using the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis. Results:There were statistically significant differences in alpha-fetoprotein, gamma-glutamyl transferase, and phosphatidylinositol proteoglycan between the two groups (all P<0.05). Multivariate logistic regression analysis showed that LI-RADS category ( OR=8.58, 95% CI: 1.87-39.38), intratumoral hemorrhage ( OR=2.16, 95% CI: 1.14-4.07), and intratumoral arteries ( OR=2.59, 95% CI: 1.19-5.64) were all influencing factors of double positivity of microvascular invasion patterns in HCC patients (all P<0.05). Based on the multivariate results, a nomogram was constructed. In the training set, the area under the ROC curve for predicting double positivity of microvascular invasion patterns in HCC patients was 0.769 (95% CI: 0.720-0.814). In the test set, the area under the ROC curve for predicting double positivity of microvascular invasion patterns in HCC patients was 0.756 (95% CI: 0.622-0.850). The calibration curve showed a good fit between the predicted model and the ideal curve. Decision curve analysis showed that the clinical applicability was good when the threshold was 0.01-0.80 in the training set and 0.01-0.65 in the test set. Conclusion:The nomogram model based on LI-RADS category, intratumoral hemorrhage, and intratumoral arteries can effectively predict double positivity of microvascular invasion patterns in HCC patients and has good clinical applicability.
8.Meta-analysis of the diagnostic value of 18F-FDG PET/CT in postoperative recurrence or metastasis of ovarian cancer patients with elevated CA125 levels
Chunyan MIAO ; Dapai LIU ; Fu GAO ; Chengcheng YU ; MANFEIDA·MAIMAITI ; Wutao PU ; Luhua XIA
China Medical Equipment 2025;22(5):33-37
Objective:To systematically review the diagnostic value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography(18F-FDG PET/CT)on recurrence or metastasis of patients with ovarian cancer whose postoperative serum carbohydrate antigen 125(CA125)occurred abnormal elevation.Methods:A systematic search was conducted in foreign databases,including PubMed,Embase,Cochrane Library(Central)and Web of Science(SCI-Expanded),as well as Chinese databases,such as China National Knowledge Infrastructure(CNKI),VIP Network,Wanfang Database,and China Biology Medicine(CBM),for the studies that were published between January 2010 and January 2023 on the diagnostic value of 18F-FDG PET/CT on recurrence or metastasis of patients with ovarian cancer whose postoperative serum CA125 levels occurred abnormal elevation.The quality of the included studies was assessed by using the QUADAS-2 quality evaluation tool in Review Manager 5.4 software.The effective data were extracted,and effect quantities were merged,and heterogeneity test was conducted through Meta-Disc 1.4 software.Publication bias of the included studies was tested by using Stata 14.0 software.Results:A total of seven literatures were involved in this research,and 290 patients with ovarian cancer were included to conduct heterogeneity test,which revealed I2 values all were greater than 50%.Therefore,the a fixed-effect model was used to merge effect quantity.The results demonstrated that the diagnostic accuracy was higher,and the sensitivity,specificity,positive likelihood ratio,negative likelihood ratio,and diagnostic odds ratio(DOR)of the mergement were respectively 0.95(95%CI:0.91-0.98),0.83(95%CI:0.70-0.92),4.84(95%CI:2.82-8.31),0.07(95%CI:0.04-0.13)and 73.53(95%CI:28.00-187.90).The area under curve(AUC)value of receiver operating characteristic curve(AUC)was 0.9527,and the diagnostic accuracy of 18F-FDG PET/CT for metastasis or recurrence in patients with ovarian cancer,whose postoperative serum CA125 levels occurred elevation,reached to 95.27%.Publication bias testing showed there was no evidence of publication bias.Conclusion:18F-FDG PET/CT exhibits higher accuracy in diagnosing recurrence or metastasis in patients with ovarian cancer whose postoperative serum CA125 levels occurred elevation,which can sensitively and accurately confirmed postoperative recurrence or metastasis of patients with ovarian cancer,and early find the lesions of metastasis or recurrence of ovarian cancer.
9.Effect of surface treatment on dentin rebonding after laser non-destructive removal of zirconia prosthesis
LI Xiaoting ; JIANG Lei ; LU Zhicen ; CAI Chunyan ; YU Hao
Journal of Prevention and Treatment for Stomatological Diseases 2025;33(3):195-202
Objective:
To investigate the changes of dentin surface and the effects of different surface treatments on the rebonding effect following non-destructive restoration removal by an Er:YAG laser and to provide reference for oral clinical operation
Methods:
This study was approved by the ethics review committee of the unit. Using computer-aided design and computer-aided manufacturing (CAD/CAM) technology, 102 zirconia specimens (4 mm × 4 mm × 1.5 mm) were fabricated. In total, 110 impacted third molar teeth were extracted, and 102 dentine blocks (4 mm × 4 mm × 2 mm) were prepared. The zirconia specimen and dentin blocks were bonded with resin cement before removal with an Er: YAG laser. Three disassembled dentin blocks were randomly selected, and the components of dentin surface elements were analyzed by energy dispersive X-ray spectroscopy (EDX). The removed dentin blocks were randomly divided into three groups (n = 33) based on the different surface treatments: control group (no treatment), sandblasting group (50 μm, Al2O3 sandblasting), and laser irradiation group (Er: YAG laser irradiation, parameters were set to 10 Hz, 60 mJ, 0.6 W). Three dentin blocks were randomly selected in each group for scanning electron microscopy (SEM) observation, and the residual resin on dentin surface of remaining 30 dentin blocks in each group were observed under an optical microscope at 20 times magnification. Scores were obtained using the adhesive remnant index (ARI) method. Three groups of dentin blocks (n = 30) that underwent different surface treatments were rebonded with resin cement according to standard procedures and then divided into two subgroups for aging (n = 15). One subgroup was subjected to a 37 ℃ water bath for 24 h, and the other subgroup was subjected to 5 000 thermal cycles after a 37 ℃ water bath for 24 h, and the micro-shear bonding strength of each group was measured. The microshear bonding strength of each group was measured, and fracture modes were analyzed. The differences of dentine surface ARI between the three groups, as well as the inter-group differences in fracture mode, and bonding strength, and the intra-group differences before and after aging were compared between the three groups.
Results:
When zirconia was removed by Er: YAG laser, there was no obvious damage on the dentin surface, but C and Si elements in dentin increased significantly. After different surface treatments, the ARI scores of the sandblasting and laser irradiation groups were lower than those of the control group (P<0.05), while ARI was not significantly different between the sandblasting and laser irradiation groups (P>0.05). The dentin surface morphology was also different. There was a large amount of residual resin on the dentin surface of the control group. In the sandblasting group, the residual resin was lower, the dentin surface was rough, and the dentin tubules were visible. A large amount of residual resin was observed on the dentin surface of the laser irradiation group. After 24 h of water bath at 37 ℃, the bonding strengths of the control group, sandblasting group, and laser irradiation group were (6.13 ± 2.40) MPa, (9.39 ± 2.00) MPa, and (5.85 ± 1.44) MPa, respectively, and the bonding strength of the sandblasting group was significantly higher than that of the other two groups (P<0.05). After being subjected to 24 h of water bath at 37 ℃ and 5 000 thermal cycles, the bonding strengths of the control group, sandblasting group, and laser irradiation group were (5.39 ± 0.83) MPa, (8.45 ± 1.20) MPa and (4.84 ± 1.43) MPa, respectively. The bonding strength of the sandblasting group was significantly higher than that of the other two groups (P<0.05). There was no significant difference between the control group, sandblasting group, and laser irradiation group before and after 5 000 thermal cycles following 24 h of water bath at 37 ℃ (P>0.05). In the control group, sandblasting group, and laser irradiation group, cohesive fracture was not observed. The fracture mode was mainly adhesive fracture. Before and after 5 000 thermal cycles, the frequency of mixed fracture in the sandblasting group was significantly higher than that in the other two groups (P<0.05).
Conclusion
Er: YAG laser removal of zirconia does not damage dentin, but a large amount of resin remains on the dentin surface after removal. The sandblasting process can effectively remove these residual resins, thereby improving the dentine rebonding effect.
10.Impact of peer dating behavior and cohabitation with parents on sexual behaviors among secondary vocational school students
JIA Xin, FANG Yuhang, JIN Yan, ZUO Xiayun, YU Chunyan, LIAN Qiguo, LI Lihe, HONG Ping, TU Xiaowen
Chinese Journal of School Health 2025;46(5):657-661
Objective:
To understand the moderating effect of cohabitation with parents on the association between peer dating behavior and sexual behaviors among secondary vocational school students, so as to provide a scientific basis for preventing sexual behaviors among secondary vocational school students.
Methods:
From March to April 2021, an electronic questionnaire survey was conducted among 3 180 students from 6 vocational schools in Shanghai (urban, suburban, exurban) and Shaanxi (Shangluo, Ankang, Baoji) using cluster sampling. Spearman correlation analysis was used to investigate the relationship of cohabitation with parents, peer dating behavior and sexual behaviors among secondary vocational school students. Binary Logistic regression analysis was performed to investigate the role of cohabitation with parents on peer dating behavior and sexual behaviors among secondary vocational students.
Results:
There was a significant negative between cohabitation with parents and sexual ( r =-0.04); and there was a positive correlation between peer dating behavior and sexual behaviors ( r =0.24), as well as cohabitation with parents and peer dating behavior ( r =0.04)( P <0.05). Multivariable Logistic regression analysis showed an association between peer dating behavior and the occurrence of sexual behaviors ( OR=2.79-12.95, P <0.05). Cohabitation with parents played a moderating role in the association between peer dating behavior and sexual behaviors, and a signification interaction was found between cohabitation with parents and reporting that a small part or about half of their peers had dating behavior ( OR =0.48, P <0.05).
Conclusions
The more peers dating behavior are associated with a higher risk of sexual behaviors among secondary vocational school students, and cohabitation with parents can partly reduce this risk. School and family sexuality education for secondary vocational students should be strengthened to improve their interpersonal skills and decision-making, and ability to resist peer pressure, so as to reduce their risk of sexual behaviors.


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