1.Importation and analysis of data from a multi-center randomized controlled clinical research on total knee arthroplasty based on REDCap system
Yu LIU ; Pei-hua CAO ; Chang-hai DING
Fudan University Journal of Medical Sciences 2025;52(1):119-127
Objective To introduce how to import and analyze data using the Research Electronic Data Capture(REDCap)system,taking a multi-center randomized controlled clinical research of total knee arthroplasty as an example.Methods Various tools within the REDCap system,including data import tools,data export functions,reports and statistics,project dashboards,and coding manuals,were used to systematically process and analyze the multi-center randomized controlled clinical trial data for total knee arthroplasty.Initially,electronically collected clinical data were adjusted and standardized,then uploaded in bulk to the system using the REDCap data import tool.Subsequently,the data were organized through REDCap's data export feature,and basic descriptive statistical analysis was performed using its reporting and statistical functions to ensure data quality and completeness.Results An electronic data collection and management platform for clinical research on knee osteoarthritis wase successfully created by the REDCap system.The platform enabled real-time data collection from multiple centers,and ensured data accuracy and consistency through built-in data management and quality control mechanisms.With the statistical analysis features of REDCap,the research team could monitor the progress of data in real time,conduct effective quality assessments,and perform dynamic analysis for further in-depth statistical evaluations.Conclusion The REDCap system can be used not only to build a new clinical research project,but also to import and analyze data that has been previously digitized of ongoing clinical researches into the system,which improved the scientificity of data management and research efficiency.
2.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
3.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
4.Importation and analysis of data from a multi-center randomized controlled clinical research on total knee arthroplasty based on REDCap system
Yu LIU ; Pei-hua CAO ; Chang-hai DING
Fudan University Journal of Medical Sciences 2025;52(1):119-127
Objective To introduce how to import and analyze data using the Research Electronic Data Capture(REDCap)system,taking a multi-center randomized controlled clinical research of total knee arthroplasty as an example.Methods Various tools within the REDCap system,including data import tools,data export functions,reports and statistics,project dashboards,and coding manuals,were used to systematically process and analyze the multi-center randomized controlled clinical trial data for total knee arthroplasty.Initially,electronically collected clinical data were adjusted and standardized,then uploaded in bulk to the system using the REDCap data import tool.Subsequently,the data were organized through REDCap's data export feature,and basic descriptive statistical analysis was performed using its reporting and statistical functions to ensure data quality and completeness.Results An electronic data collection and management platform for clinical research on knee osteoarthritis wase successfully created by the REDCap system.The platform enabled real-time data collection from multiple centers,and ensured data accuracy and consistency through built-in data management and quality control mechanisms.With the statistical analysis features of REDCap,the research team could monitor the progress of data in real time,conduct effective quality assessments,and perform dynamic analysis for further in-depth statistical evaluations.Conclusion The REDCap system can be used not only to build a new clinical research project,but also to import and analyze data that has been previously digitized of ongoing clinical researches into the system,which improved the scientificity of data management and research efficiency.
5.Experts consensus on standard items of the cohort construction and quality control of temporomandibular joint diseases (2024)
Min HU ; Chi YANG ; Huawei LIU ; Haixia LU ; Chen YAO ; Qiufei XIE ; Yongjin CHEN ; Kaiyuan FU ; Bing FANG ; Songsong ZHU ; Qing ZHOU ; Zhiye CHEN ; Yaomin ZHU ; Qingbin ZHANG ; Ying YAN ; Xing LONG ; Zhiyong LI ; Yehua GAN ; Shibin YU ; Yuxing BAI ; Yi ZHANG ; Yanyi WANG ; Jie LEI ; Yong CHENG ; Changkui LIU ; Ye CAO ; Dongmei HE ; Ning WEN ; Shanyong ZHANG ; Minjie CHEN ; Guoliang JIAO ; Xinhua LIU ; Hua JIANG ; Yang HE ; Pei SHEN ; Haitao HUANG ; Yongfeng LI ; Jisi ZHENG ; Jing GUO ; Lisheng ZHAO ; Laiqing XU
Chinese Journal of Stomatology 2024;59(10):977-987
Temporomandibular joint (TMJ) diseases are common clinical conditions. The number of patients with TMJ diseases is large, and the etiology, epidemiology, disease spectrum, and treatment of the disease remain controversial and unknown. To understand and master the current situation of the occurrence, development and prevention of TMJ diseases, as well as to identify the patterns in etiology, incidence, drug sensitivity, and prognosis is crucial for alleviating patients′suffering.This will facilitate in-depth medical research, effective disease prevention measures, and the formulation of corresponding health policies. Cohort construction and research has an irreplaceable role in precise disease prevention and significant improvement in diagnosis and treatment levels. Large-scale cohort studies are needed to explore the relationship between potential risk factors and outcomes of TMJ diseases, and to observe disease prognoses through long-term follw-ups. The consensus aims to establish a standard conceptual frame work for a cohort study on patients with TMJ disease while providing ideas for cohort data standards to this condition. TMJ disease cohort data consists of both common data standards applicable to all specific disease cohorts as well as disease-specific data standards. Common data were available for each specific disease cohort. By integrating different cohort research resources, standard problems or study variables can be unified. Long-term follow-up can be performed using consistent definitions and criteria across different projects for better core data collection. It is hoped that this consensus will be facilitate the development cohort studies of TMJ diseases.
6.Expert Consensus on the Technical Process for Preoperative Three-Dimensional Planning of Total Hip Arthroplasty Using a Dual Fluoroscopic Imaging System(2024 Version)
Juan WANG ; Huiwu LI ; Pei YANG ; Li CAO ; Yunsu CHEN ; Eryou FENG ; Zhenpeng GUAN ; Wei HUANG ; Pengfei LEI ; Chunbao LI ; Pingyue LI ; Xiaoming LI ; Zhitao RAO ; Hua TIAN ; Peijian TONG ; Fei WANG ; Guangji WANG ; Liao WANG ; Wei WANG ; Yayi XIA ; Peng XU ; Qi YAO ; Tengbo YU ; Guoqiang ZHANG ; Zongke ZHOU ; Kunzheng WANG ; Tsungyuan TSAI ; Zhiyong HOU
Journal of Medical Biomechanics 2024;39(6):1016-1025
Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.
7.Expert Consensus on the Technical Process for Preoperative Three-Dimensional Planning of Total Hip Arthroplasty Using a Dual Fluoroscopic Imaging System(2024 Version)
Juan WANG ; Huiwu LI ; Pei YANG ; Li CAO ; Yunsu CHEN ; Eryou FENG ; Zhenpeng GUAN ; Wei HUANG ; Pengfei LEI ; Chunbao LI ; Pingyue LI ; Xiaoming LI ; Zhitao RAO ; Hua TIAN ; Peijian TONG ; Fei WANG ; Guangji WANG ; Liao WANG ; Wei WANG ; Yayi XIA ; Peng XU ; Qi YAO ; Tengbo YU ; Guoqiang ZHANG ; Zongke ZHOU ; Kunzheng WANG ; Tsungyuan TSAI ; Zhiyong HOU
Journal of Medical Biomechanics 2024;39(6):1016-1025
Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.
8.Precise application of Beichaihu and Nanchaihu in classical formulas.
Yu-Ping SHE ; Pei-Pei ZHANG ; Jing-Yan HU ; Yong-Hua GUO ; Qian CAO ; Xiang YIN ; Xiu-Hua HU ; Ting ZHAO ; Feng-Bo LIU ; Yuan ZHANG ; Sheng-Li WEI
China Journal of Chinese Materia Medica 2023;48(3):681-688
To maintain the precision and stability of the efficacy of classical formulas, this study compared the origins and specifications of Bupleuri Radix and revealed the precise application regularity of Bupleurum chinense(Beichaihu) and Bupleurum scorzonerifolium(Nanchaihu) in classical formulas. The efficacy and indications of formulas with Bupleuri Radix as the sovereign drug in the Treatise on Cold Damage and Miscellaneous Diseases(Shang Han Za Bing Lun) were investigated. The difference in the efficacy of Bupleuri Radix as well as the differences in the chemical composition, and liver-protecting and lipid-lowering effects of the decoctions of Beichaihu and Nanchaihu were analyzed with LC-MS technology based on the CCl_4-induced liver injury model in mice and sodium oleate-induced HepG2 hyperlipidemia cell model. The results showed that seven classical formulas with Bupleuri Radix as the sovereign drug in the Treatise on Cold Damage and Miscellaneous Diseases were mainly used in the treatment of digestive, metabolic, immune, circulatory, and other diseases. Bupleuri Radix mainly played the functions of protecting the liver, benefiting the gallbladder, and lowering the lipid, and had different focuses in different formulas. There were 14 differential components in the decoctions of Beichaihu and Nanchaihu, and the chemical structures of 11 components were identified, including 10 saponins and one flavonoid. The results of the liver-protecting efficacy experiment showed that compared with the Nanchaihu decoction, Beichaihu decoction could reduce the serum aspartate aminotransferase(AST) activity in liver injury model mice(P<0.01). The results of the lipid-lowering efficacy experiment proved that Beichaihu and Nanchaihu decoctions both showed highly significant differences in lowering the total cholesterol(TC) and triglyceride(TG) content in HepG2 cells(P<0.01), and Nanchaihu decoction was superior to Beichaihu decoction in lowering the lipid. The results of this study preliminarily proved that there were differences in chemical composition, and liver-protecting and lipid-lowering effects of Beichaihu and Nanchaihu decoctions, indicating that it was necessary to determine the precise origin of Bupleuri Radix in the clinical formulation of traditional Chinese medicine. The study provides a scientific basis for both precise clinical medication and purpose-based accurate quality evaluation of traditional Chinese medicine in clinical application.
Animals
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Mice
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Liver
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Aspartate Aminotransferases
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Bupleurum
9.Clinical Characteristics of Children with Hemophagocytic Syndrome with Different EB Virus DNA Loads.
Jiao-Jiao HUANG ; Nan-Du LUO ; Zuo-Chen DU ; Jia-Hong YAN ; Jin-Hua MA ; Xiu-Li CAO ; Zhi-Xu HE ; Pei HUANG ; Yan CHEN
Journal of Experimental Hematology 2023;31(1):261-267
OBJECTIVE:
To analyze the clinical characteristics of hemophagocytic syndrome (HLH) children with different EB virus (EBV) DNA loads, and to explore the relationship between differential indicators and prognosis.
METHODS:
Clinical data of 73 children with HLH treated in our hospital from January 2015 to April 2022 were collected. According to EBV DNA loads, the children were divided into negative group (≤5×102 copies/ml), low load group (>5×102-<5×105 copies/ml) and high load group (≥5×105copies/ml). The clinical symptoms and laboratory indexes of the three groups were compared, and the ROC curve was used to determine the best cut-off value of the different indexes. Cox regression model was used to analyze the independent risk factors affecting the prognosis of children, and to analyze the survival of children in each group.
RESULTS:
The proportion of female children, the swelling rate of liver and spleen lymph nodes and the involvement rate of blood, liver, circulation and central nervous system in the high load group were higher than those in the negative group. The incidence of disseminated intravascular coagulation(DIC) and central nervous system(CNS) involvement in the high load group were higher than those in the low load group. The liver swelling rate and circulatory system involvement rate in the low load group were higher than those in the negative group(P<0.05). PLT counts in the high load group were significantly lower than those in the negative group, and the levels of GGT, TBIL, CK-MB, LDH, TG, SF, and organ involvement were significantly higher than those in the negative group. The levels of CK, LDH, SF and the number of organ involvement in the high load group were significantly higher than those in the low load group. The levels of GGT and TBIL in low load group were significantly higher than those in negative group. In terms of treatment, the proportion of blood purification therapy in the high and low load group was significantly higher than that in the negative group(P<0.01). ROC curve analysis showed that the best cut-off values of PLT, LDH, TG and SF were 49.5, 1139, 3.12 and 1812, respectively. The appellate laboratory indicators were dichotomized according to the cut-off value, and the differential clinical symptoms were included in the Cox regression model. Univariate analysis showed that LDH>1139 U/L, SF>1812 μg/L, dysfunction of central nervous system, number of organ damage, DIC and no blood purification therapy were the risk factors affecting the prognosis of children (P<0.05); Multivariate analysis shows that PLT≤49.5×109/L and dysfunction of central nervous system were risk factors affecting the prognosis of children (P<0.05). Survival analysis showed that there was no significant difference in the survival rate among the three groups.
CONCLUSION
The incidence of adverse prognostic factors in children with HLH in the EBV-DNA high load group is higher, and there is no significant difference in the survival rate of the three groups after blood purification therapy. Therefore, early identification and application of blood purification therapy is of great significance for children with HLH in the high load group.
Humans
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Child
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Female
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Lymphohistiocytosis, Hemophagocytic
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Retrospective Studies
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Risk Factors
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DNA
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Prognosis
10.Antimicrobial susceptibility of Gram-positive organisms:Results from China antimicrobial resistance surveillance trial(CARST)program,2021-2022
Yun LI ; Bo ZHENG ; Feng XUE ; Xiu-Zhen ZHANG ; Yun-Jian HU ; Yu-Fen JIN ; Jian-Hong ZHAO ; Shi-Yang PAN ; Wei GUO ; Feng ZHAO ; Yun-Song YU ; Xuan CAI ; Wen-En LIU ; De-Hua LIU ; Ying FEI ; Jia-Yun LIU ; Feng-Yan PEI ; Ling MENG ; Ping JI ; Jin TANG ; Kai XU ; Lei ZHU ; Cun-Wei CAO ; He-Ping XU ; Shan WANG ; Lan-Qing CUI ; Jia ZHANG ; Yao-Yao LIU
The Chinese Journal of Clinical Pharmacology 2023;39(23):3509-3524
Objective To investigate the Gram-positive coccus resistance in nationwide's tertiary hospitals and understand the trend of antimicrobial resistance.Methods All the clinical isolates were collected from 19 hospitals and the minimal inhibitory concentrations(MICs)were tested using agar/broth dilution method recommended.Results A total of 1 974 pathogenic Gram-positive coccus from 19 tertiary hospitals in 19 cities nationwide over the period from July 2021 to June 2022 were studied.Based on the MIC results,the prevalence of methicillin resistant Stapylococcus aureus(MRSA)and methicillin resistant Stapylococcus epidermidis(MRSE)were 36.4%and 79.9%respectively.No vancomycin insensitivity Staphylococcus was detected.Staphylococcus aureus were 100%susceptibility to linezolid and teicoplanin.Antibiotic resistance rate of Enterococcus faecalis and Enterococcus faecium to ampicillin were 3.1%and 92.9%.The detectation rate of vancomycin resistant Enterococcus(VRE)was 1.6%.Nonsusceptibility rate of Enterococcus faecalis to linezolid was 32.2%,two consecutive monitoring rises and nonsusceptibility rate of Enterococcus faecium(12.5%)was also significantly increased.The prevalence of penicillin non-susceptible Streptococcus pneumoniae(PNSSP)was 0.8%based on non-meningitis and parenteral administration criterion,decrease of nearly 30 percentage points from the previous surveillance.While for cases of oral penicillin,the rate was 71.8%,showing similar to last time.The results indicated that the number of strains with higher MIC value of penicillin(MIC ≥4 mg·L-1)decreased significantly.There were no significant differences of resistance rates of Stapylococcus aureus,Stapylococcus epidermidis,Enterococcus faecalis,Enterococcus faecium and Streptococcus pneumoniae among various groups such as different department,age,or specimen source.Conclusion VRE detection ratio stablized at a relatively low level.The number of Streptococcus pneumoniae with higher MIC value of penicillin decreased significantly compared with the previous monitoring.The increase of linezolidin-insensitive Enterococcus was noteworthy.

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