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.The impact of different experienced radiologists on the diagnostic efficiency of MRI protocol for prostate cancer
Qian ZHANG ; Lei SHEN ; Maolin XU ; Jiangdong CHU ; Yue CHEN ; Yu ZHANG
Journal of Practical Radiology 2024;40(8):1320-1324
Objective To compare the diagnostic efficacy of biparametric magnetic resonance imaging(bp-MRI)and multiparametric magnetic resonance imaging(mp-MRI)for prostate cancer among radiologists with different levels of experience.Methods A retrospective analysis was conducted on MRI data of 112 suspected prostate cancer patients.Six radiologists(2 in the primary,intermediate,and advanced groups)used the bp-MRI and mp-MRI protocol scores to analyze the diagnostic efficacy.Results The area under the curve(AUC)of diagnostic efficacy in the advanced group of the bp-MRI protocol was greater than that in the intermediate group(P=0.024),and the intermediate group was greater than that in the primary group(P=0.046).The intermediate group of the mp-MRI protocol was greater than the primary group(P=0.043),while there was no difference between the intermediate and advanced groups(P=0.221).As the experience of the radiologists increased,sensitivity also increased,but there was no significant change in specificity.There was no difference between the two protocols in the advanced group(AUC=0.826-0.866;P>0.05);while the mp-MRI protocol performance was better in the primary and intermediate groups(AUC=0.705-0.815;P<0.05).Conclusion Experienced radiologists can choose the bp-MRI protocol,while inexperienced radiologists are more suitable for the mp-MRI protocol.Based on the accumulated experience of radiologists,protocol optimization and adjustment can be carried out at appropriate times.
3.Guideline for the diagnosis and treatment of chronic refractory wounds in orthopedic trauma patients (version 2023)
Yuan XIONG ; Bobin MI ; Chenchen YAN ; Hui LI ; Wu ZHOU ; Yun SUN ; Tian XIA ; Faqi CAO ; Zhiyong HOU ; Tengbo YU ; Aixi YU ; Meng ZHAO ; Zhao XIE ; Jinmin ZHAO ; Xinbao WU ; Xieyuan JIANG ; Bin YU ; Dianying ZHANG ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Qikai HUA ; Mengfei LIU ; Yiqiang HU ; Peng CHENG ; Hang XUE ; Li LU ; Xiangyu CHU ; Liangcong HU ; Lang CHEN ; Kangkang ZHA ; Chuanlu LIN ; Chengyan YU ; Ranyang TAO ; Ze LIN ; Xudong XIE ; Yanjiu HAN ; Xiaodong GUO ; Zhewei YE ; Qisheng ZHOU ; Yong LIU ; Junwen WANG ; Ping XIA ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Dongliang WANG ; Fengfei LIN ; Jiangdong NI ; Aiguo WANG ; Dehao FU ; Shiwu DONG ; Lin CHEN ; Xinzhong XU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Yingze ZHANG ; Xiaobing FU ; Guohui LIU
Chinese Journal of Trauma 2023;39(6):481-493
Chronic refractory wound (CRW) is one of the most challengeable issues in clinic due to complex pathogenesis, long course of disease and poor prognosis. Experts need to conduct systematic summary for the diagnosis and treatment of CRW due to complex pathogenesis and poor prognosis, and standard guidelines for the diagnosis and treatment of CRW should be created. The Guideline forthe diagnosis and treatment of chronic refractory wounds in orthopedic trauma patients ( version 2023) was created by the expert group organized by the Chinese Association of Orthopedic Surgeons, Chinese Orthopedic Association, Chinese Society of Traumatology, and Trauma Orthopedics and Multiple Traumatology Group of Emergency Resuscitation Committee of Chinese Medical Doctor Association after the clinical problems were chosen based on demand-driven principles and principles of evidence-based medicine. The guideline systematically elaborated CRW from aspects of the epidemiology, diagnosis, treatment, postoperative management, complication prevention and comorbidity management, and rehabilitation and health education, and 9 recommendations were finally proposed to provide a reliable clinical reference for the diagnosis and treatment of CRW.
4.Expression and clinical significance of GBP1 in pulmonary tuberculosis
Guomin Ye ; Shijie Shen ; Bo Zhang ; Siqi Deng ; Zhen Feng ; Weimin Li ; Wanjiang Zhang ; Chuangfu Chen ; Jiangdong Wu
Acta Universitatis Medicinalis Anhui 2023;58(2):214-218
Objective:
To investigate the expression pattern,underlying function and clinical significance of Guanylate-binding protein 1 ( GBP1) in pulmonary tuberculosis ( pTB) .
Methods:
Immunohistochemical staining was applied to detect the expression of GBP1 in pTB specimensand control samples. Combined with Gene Expression Omnibus ( GEO) datasets ,including GSE83456 and GSE34608,receiver operating characteristic ( ROC) curve was depicted to assess the diagnostic value of GBP1 in pTB.Then,the correlation between GBP1 and related regulatory factors was analyzed by protein-protein interaction network ( PPI) ; Finally,the potential molecular mechanism of GBP1 in pTB was probed by Gene Set Enrichment Analysis( GSEA) .
Results:
Compared with the control group,GBP1 was significantly overexpressed in human pTB samples,including lung tissue and blood.The positive rate of GBP1 protein in pTB was 73. 9% . ROC curve analysis revealed that GBP1 might have important value in early diagnosis of pTB.GSEA analysis suggested that the hyper-expression of GBP1 was closely related to the host inflammatory response,IFN-γ/ α signaling pathway and TNF-α/ IL-6 signal transduction.
Conclusion
GBP1 is highly expressed in pTB tissues and is involved in the process of inflammatory response and host anti-tuberculosis infection ; GBP1 may be used as an early diagnostic marker or therapeutic target for pTB.
5.Construction of core competence evaluation index system for thoracic specialist nurses based on post competence
Luyu CHEN ; Fengjuan LIU ; Jiangdong WANG ; Mi DING ; Hongli QIU ; Huimin ZHANG
Chinese Journal of Modern Nursing 2023;29(18):2415-2421
Objective:To establish a core competence evaluation index system for thoracic specialist nurses.Methods:From April to September 2022, based on the iceberg model of post competence, the primary evaluation index system of core competence of thoracic specialist nurses was developed through literature review and semi-structured interview. The core competence evaluation index system for thoracic specialist nurses was determined through three rounds of letter consultation with 20 experts by Delphi method.Results:The effective recovery rates of the three rounds of expert inquiry questionnaires were 100.0% (20/20), 95.0% (19/20) and 100.0% (19/19), respectively. The expert authority coefficients were 0.925, 0.958 and 0.968, and the Kendall's concordance coefficients were 0.270, 0.235 and 0.184, respectively ( P<0.01). Finally, a core competency evaluation index system for thoracic specialist nurses was formed, including 6 first level indicators, 18 second level indicators and 68 third level indicators. Conclusions:The core competency evaluation index system for thoracic specialist nurses constructed based on post competence in this study is certain scientific, reliable and practical, which can provide a basis for the training and assessment of thoracic specialist nurses.
6.Expert consensus on diagnosis, prevention and treatment of perioperative lower extremity vein thrombosis in orthopedic trauma patients (2022 edition)
Wu ZHOU ; Faqi CAO ; Ruiyin ZENG ; Baoguo JIANG ; Peifu TANG ; Xinbao WU ; Bin YU ; Zhiyong HOU ; Jian LI ; Jiacan SU ; Guodong LIU ; Baoqing YU ; Zhi YUAN ; Jiangdong NI ; Yanxi CHEN ; Dehao FU ; Peijian TONG ; Dongliang WANG ; Dianying ZHANG ; Peng ZHANG ; Yunfei ZHANG ; Feng NIU ; Lei YANG ; Qiang YANG ; Zhongmin SHI ; Qiang ZHOU ; Junwen WANG ; Yong WANG ; Chengjian HE ; Biao CHE ; Meng ZHAO ; Ping XIA ; Liming XIONG ; Liehu CAO ; Xiao CHEN ; Hui LI ; Yun SUN ; Liangcong HU ; Yan HU ; Mengfei LIU ; Bobin MI ; Yuan XIONG ; Hang XUE ; Ze LIN ; Yingze ZHANG ; Yu HU ; Guohui LIU
Chinese Journal of Trauma 2022;38(1):23-31
Lower extremity deep vein thrombosis (DVT) is one of the main complications in patients with traumatic fractures, and for severe patients, the DVT can even affect arterial blood supply, resulting in insufficient limb blood supply. If the thrombus breaks off, pulmonary embolism may occur, with a high mortality. The treatment and rehabilitation strategies of thrombosis in patients with lower extremity fractures have its particularity. DVT in traumatic fractures patients has attracted extensive attention and been largely studied, and the measures for prevention and treatment of DVT are constantly developing. In recent years, a series of thrombosis prevention and treatment guidelines have been updated at home and abroad, but there are still many doubts about the prevention and treatment of DVT in patients with different traumatic fractures. Accordingly, on the basis of summarizing the latest evidence-based medical evidence at home and abroad and the clinical experience of the majority of experts, the authors summarize the clinical treatment and prevention protocols for DVT in patients with traumatic fractures, and make this consensus on the examination and assessment, treatment, prevention and preventive measures for DVT in patients with different fractures so as to provide a practicable approach suitable for China ′s national conditions and improve the prognosis and the life quality of patients.
7.Interpretation of the guidelines for neoadjuvant therapy of pancreatic cancer in China(2020 edition)
Jiangdong QIU ; Ruizhe ZHU ; Hao CHEN ; Taiping ZHANG
Chinese Journal of Surgery 2021;59(3):232-236
Pancreatic cancer is a highly malignant tumor in the digestive system.The role of neoadjuvant therapy in pancreatic cancer has been highlighted with the understanding of pancreatic cancer biological behavior and popularization of comprehensive treatment.Therefore,Study group of Pancreatic Surgery in China Society of Surgery of Chinese Medical Association and Pancreatic Disease Committee of China Research Hospital Association has formulated the guidelines for neoadjuvant therapy of pancreatic cancer in China(2020 edition).This guidelines elaborated key issues of the neoadjuvant therapy of pancreatic cancer,and provided reference for clinical practice.This article aims to interpret the guidelines about the preparation before neoadjuvant therapy, indication, regimen selection, therapeutic effect evaluation and surgery strategy, with further discussion about controversial issues of neoadjuvant therapy in pancreatic cancer.
8.Interpretation of the guidelines for neoadjuvant therapy of pancreatic cancer in China(2020 edition)
Jiangdong QIU ; Ruizhe ZHU ; Hao CHEN ; Taiping ZHANG
Chinese Journal of Surgery 2021;59(3):232-236
Pancreatic cancer is a highly malignant tumor in the digestive system.The role of neoadjuvant therapy in pancreatic cancer has been highlighted with the understanding of pancreatic cancer biological behavior and popularization of comprehensive treatment.Therefore,Study group of Pancreatic Surgery in China Society of Surgery of Chinese Medical Association and Pancreatic Disease Committee of China Research Hospital Association has formulated the guidelines for neoadjuvant therapy of pancreatic cancer in China(2020 edition).This guidelines elaborated key issues of the neoadjuvant therapy of pancreatic cancer,and provided reference for clinical practice.This article aims to interpret the guidelines about the preparation before neoadjuvant therapy, indication, regimen selection, therapeutic effect evaluation and surgery strategy, with further discussion about controversial issues of neoadjuvant therapy in pancreatic cancer.
9. Expert consensus on emergency surgery management for traumatic orthopedics under prevention and control of novel coronavirus pneumonia
Jing LIU ; Hui LI ; Wu ZHOU ; Guohui LIU ; Yingze ZHANG ; Baoguo JIANG ; Peifu TANG ; Guodong LIU ; Xinbao WU ; Zhi YUAN ; Fang ZHOU ; Tianbing WANG ; Zhongguo FU ; Zhiyong HOU ; Jiacan SU ; Bin YU ; Zengwu SHAO ; Tian XIA ; Liming XIONG ; Yue FANG ; Guanglin WANG ; Peng LIN ; Yanxi CHEN ; Jiangdong NI ; Lei YANG ; Dongliang WANG ; Chengjian HE ; Ximing LIU ; Biao CHE ; Yaming LI ; Junwen WANG ; Ming CHEN ; Meng ZHAO ; Faqi CAO ; Yun SUN ; Bobin MI ; Mengfei LIU ; Yuan XIONG ; Hang XUE ; Liangcong HU ; Yiqiang HU ; Lang CHEN ; Chenchen YAN
Chinese Journal of Trauma 2020;36(2):111-116
Since December 2019, novel coronavirus pneumonia (NCP) has been reported in Wuhan, Hubei Province, and spreads rapidly to all through Hubei Province and even to the whole country. The virus is 2019 novel coronavirus (2019-nCoV), never been seen previously in human, but all the population is generally susceptible. The virus spreads through many ways and is highly infectious, which brings great difficulties to the prevention and control of NCP. Based on the needs of orthopedic trauma patients for emergency surgery and review of the latest NCP diagnosis and treatment strategy and the latest principles and principles of evidence-based medicine in traumatic orthopedics, the authors put forward this expert consensus to systematically standardize the clinical pathway and protective measures of emergency surgery for orthopedic trauma patients during prevention and control of NCP and provide reference for the emergency surgical treatment of orthopedic trauma patients in hospitals at all levels.
10.Effect of eNOS gene G894T mutation on the ability of vascular endothelial cells to produce nitric oxide and its significance
Liwen ZHENG ; Wanchun WANG ; Xinzhan MAO ; Jiangdong NI ; Jianwei WEI ; Ding CHEN ; Ding LI ; Minzhi MAO
Journal of Chinese Physician 2019;21(5):677-681,687
Objective To investigate the relationship between vascular endothelial cell nitric oxide synthase (eNOS) gene polymorphism and the pathogenesis of avascular femoral head necrosis (ANFH).Methods The eNOS full-length CDS fragments,containing 894G or 894T separately,was subcloned into lentiviral expression vector,and then infect the human umbilical vein endothelial cells (HUVEC).The contents of nitric oxide NO and cyclic guanosine monophosphate (cGMP) in cell culture supernatant were detected in a time-dependent manner.The luciferase-labeled reporter plasmid pNF-κB-luc was co-transfected with the reference control plasmid pRL-TK into HUVEC cells infected with LV-eNOS-894G,LV-eNOS-894T,and control lentivirus (LV-NC) for 48 h.The luciferase activity of each group was detected.The expression of nuclear factor (NF)-κB protein and eNOS protein in HUVEC cells were detected by Western blot assay.The HUVEC cells in each group were co-cultured with hFOB1.19 cells,and the concentration of alkaline phosphatase (ALP) or osteocalcin (OCN) in the supernatant were detected at different time points.Results The contents of NO and cGMP in the cell culture supernatant of the full-length lentivirus expressing eNOS gene (containing 894G or 894T) were significantly higher than that in the empty cell group and the empty vector group,and the contents of NO and cGMP in the cell culture supernatant of the 894G group were significantly higher than that of 894T group (P < 0.01).Compared with blank cells,the expression levels of NF-κB/p65 protein and eNOS protein were significantly increased in cells expressing eNOS,and the expression of NF-κB/p65 protein in 894G group was significantly increased than 894T group,but there was no difference in eNOS protein expression between the 894G and 894T groups;each group of HUVEC cells were co-cultured with hFOB1.19 osteoblasts,and at each of the same time points,the concentrations of ALP and OCN in the cell culture supernatant expressing lentivirus were significantly higher than that in the empty cell group and the empty vector group,and the ALP and OCN concentrations in the cell culture supernatant of the 894G group were significantly higher than those in the 894T group.Conclusions The eNOS gene exon G894T mutation reduces the levels of nitric oxide and cGMP produced by vascular endothelial cells through the eNOS-NO pathway,affecting the expression levels of NF-κB/p65 protein and eNOS protein,and reducing osteoblast activity,and blood supply to blood vessels.It may be one of the pathogenic mechanisms leading to femoral head necrosis.


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