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.Effects of biapenem on the blood concentration of sodium valproate in patients with severe infections:a re-trospective study
Xiaohua CHOU ; Qian ZHANG ; Zhidong LIU ; Daoli JIANG
China Pharmacy 2025;36(24):3079-3083
OBJECTIVE To analyze the effects of biapenem on the blood concentration of sodium valproate (VPA) in patients with severe infections. METHODS A retrospective collection of patient data was conducted, encompassing individuals admitted to our hospital from January 2021 to May 2024 who were treated with biapenem for severe infections and concurrently or sequentially administered VPA for the prevention or treatment of epilepsy. The effects of various factors on the blood concentration of VPA, including the combination of biapenem, the sequence of biapenem administration, the number of days of biapenem combination, the dosage of biapenem, and the time after biapenem discontinuation. RESULTS A total of 70 patients with 117 VPA blood concentration results were included in this study. When VPA was used alone, no statistically significant difference was observed in the steady-state blood concentrations of VPA between patients who received biapenem first and those who received it later (P> 0.05). There was no statistically significant difference between the steady-state concentration of VPA in patients who received biapenem in combination for 1 to 3 days and those who did not receive the combination therapy (P>0.05). The steady-state concentration of VPA in patients not receiving biapenem combination therapy was significantly higher than that of the patients who received combination therapy for 4 to 7 days and more than 7 days (P<0.001). With the prolonged duration of combination therapy, the blood concentration of VPA gradually decreased (P<0.001). However, no statistically significant difference was observed between the group receiving combination therapy for more than 7 days and the group receiving it for 4 to 7 days (P> 0.05). After 1 to 3 days of combination therapy, no statistically significant differences in VPA blood concentrations were observed among patients with different discontinuation times of biapenem (P>0.05). The blood concentration of VPA in patients who received combination therapy for more than 3 days was significantly lower than those who discontinued biapenem 4 to 7 days or more than 7 days after more than 3 days of combination therapy(P<0.001). There was no statistically significant difference in VPA blood concentrations between patients receiving a daily biapenem dose >1.0 g and those receiving a daily dose <1.0 g (P>0.05). CONCLUSIONS The concomitant administration of biapenem for 1-3 days has a minimal impact on the blood concentration of VPA. In patients receiving combination therapy for longer than 3 days, VPA blood concentrations return to baseline levels chouxiaoh@163.com within 4-7 days after biapenem discontinuation.
3.Key Issues,Innovative Paradigms and Realization Paths of Modernized Performance Management in Public Hospitals under the Perspective of Benchmarking Theory
Peiwen WANG ; Mengyun SUI ; Xiaohua JIANG ; Minna CHENG ; Yan SHI ; Chen FU ; Su XU
Chinese Health Economics 2024;43(7):66-68,85
Objective:Based on the benchmarking theory,to elaborate the key issues,paradigm innovations and realization paths of modernized performance management in China's public hospitals,and to provide policy recommendations for the government and hospitals.Methods:Literature/document collection,expert consultation and prototyping were used as methodological support.Results:Hospital performance management lacks management standards,multivariate dynamic indicator systems and realization tools;the digital governance model of"digital technology+management system"has not been established;and horizontal and vertical comparisons among geographic regions,hospitals,departments,and disease types based on standards have not been realized.Innovative paradigms include the establishment of a standard paradigm based on the smallest functional units such as disease types,indexes,bed days,operators,doctors,etc.;the construction of a dynamic index library,the mining of different combinations of indexes and their internal relationships,and the establishment of an evaluation paradigm;the establishment of a longitudinal evaluation of disease types,the evaluation of"specialties,hospitals,and industries",and the positioning of internal functions of hospitals,resource efficiency and the application of healthcare quality evaluation.It creates a multivariate,multidimensional,dynamic evaluation method and visualized evaluation tool and realization path based on big data.Conclusion:It is needed to emancipate the mind to further enhance the cognitive level of digital governance,innovate the paradigm to accelerate the construction of modernized performance management system in public hospitals,and build a platform to promote the application of modernized performance management system in public hospitals.
4.Expert consensus on clinical application of 177Lu-prostate specific membrane antigen radio-ligand therapy in prostate cancer
Guobing LIU ; Weihai ZHUO ; Yushen GU ; Zhi YANG ; Yue CHEN ; Wei FAN ; Jianming GUO ; Jian TAN ; Xiaohua ZHU ; Li HUO ; Xiaoli LAN ; Biao LI ; Weibing MIAO ; Shaoli SONG ; Hao XU ; Rong TIAN ; Quanyong LUO ; Feng WANG ; Xuemei WANG ; Aimin YANG ; Dong DAI ; Zhiyong DENG ; Jinhua ZHAO ; Xiaoliang CHEN ; Yan FAN ; Zairong GAO ; Xingmin HAN ; Ningyi JIANG ; Anren KUANG ; Yansong LIN ; Fugeng LIU ; Cen LOU ; Xinhui SU ; Lijun TANG ; Hui WANG ; Xinlu WANG ; Fuzhou YANG ; Hui YANG ; Xinming ZHAO ; Bo YANG ; Xiaodong HUANG ; Jiliang CHEN ; Sijin LI ; Jing WANG ; Yaming LI ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2024;31(5):844-850,封3
177Lu-prostate specific membrane antigen(PSMA)radio-ligand therapy has been approved abroad for advanced prostate cancer and has been in several clinical trials in China.Based on domestic clinical practice and experimental data and referred to international experience and viewpoints,the expert group forms a consensus on the clinical application of 177Lu-PSMA radio-ligand therapy in prostate cancer to guide clinical practice.
5.Key Issues,Innovative Paradigms and Realization Paths of Modernized Performance Management in Public Hospitals under the Perspective of Benchmarking Theory
Peiwen WANG ; Mengyun SUI ; Xiaohua JIANG ; Minna CHENG ; Yan SHI ; Chen FU ; Su XU
Chinese Health Economics 2024;43(7):66-68,85
Objective:Based on the benchmarking theory,to elaborate the key issues,paradigm innovations and realization paths of modernized performance management in China's public hospitals,and to provide policy recommendations for the government and hospitals.Methods:Literature/document collection,expert consultation and prototyping were used as methodological support.Results:Hospital performance management lacks management standards,multivariate dynamic indicator systems and realization tools;the digital governance model of"digital technology+management system"has not been established;and horizontal and vertical comparisons among geographic regions,hospitals,departments,and disease types based on standards have not been realized.Innovative paradigms include the establishment of a standard paradigm based on the smallest functional units such as disease types,indexes,bed days,operators,doctors,etc.;the construction of a dynamic index library,the mining of different combinations of indexes and their internal relationships,and the establishment of an evaluation paradigm;the establishment of a longitudinal evaluation of disease types,the evaluation of"specialties,hospitals,and industries",and the positioning of internal functions of hospitals,resource efficiency and the application of healthcare quality evaluation.It creates a multivariate,multidimensional,dynamic evaluation method and visualized evaluation tool and realization path based on big data.Conclusion:It is needed to emancipate the mind to further enhance the cognitive level of digital governance,innovate the paradigm to accelerate the construction of modernized performance management system in public hospitals,and build a platform to promote the application of modernized performance management system in public hospitals.
6.Key Issues,Innovative Paradigms and Realization Paths of Modernized Performance Management in Public Hospitals under the Perspective of Benchmarking Theory
Peiwen WANG ; Mengyun SUI ; Xiaohua JIANG ; Minna CHENG ; Yan SHI ; Chen FU ; Su XU
Chinese Health Economics 2024;43(7):66-68,85
Objective:Based on the benchmarking theory,to elaborate the key issues,paradigm innovations and realization paths of modernized performance management in China's public hospitals,and to provide policy recommendations for the government and hospitals.Methods:Literature/document collection,expert consultation and prototyping were used as methodological support.Results:Hospital performance management lacks management standards,multivariate dynamic indicator systems and realization tools;the digital governance model of"digital technology+management system"has not been established;and horizontal and vertical comparisons among geographic regions,hospitals,departments,and disease types based on standards have not been realized.Innovative paradigms include the establishment of a standard paradigm based on the smallest functional units such as disease types,indexes,bed days,operators,doctors,etc.;the construction of a dynamic index library,the mining of different combinations of indexes and their internal relationships,and the establishment of an evaluation paradigm;the establishment of a longitudinal evaluation of disease types,the evaluation of"specialties,hospitals,and industries",and the positioning of internal functions of hospitals,resource efficiency and the application of healthcare quality evaluation.It creates a multivariate,multidimensional,dynamic evaluation method and visualized evaluation tool and realization path based on big data.Conclusion:It is needed to emancipate the mind to further enhance the cognitive level of digital governance,innovate the paradigm to accelerate the construction of modernized performance management system in public hospitals,and build a platform to promote the application of modernized performance management system in public hospitals.
7.Key Issues,Innovative Paradigms and Realization Paths of Modernized Performance Management in Public Hospitals under the Perspective of Benchmarking Theory
Peiwen WANG ; Mengyun SUI ; Xiaohua JIANG ; Minna CHENG ; Yan SHI ; Chen FU ; Su XU
Chinese Health Economics 2024;43(7):66-68,85
Objective:Based on the benchmarking theory,to elaborate the key issues,paradigm innovations and realization paths of modernized performance management in China's public hospitals,and to provide policy recommendations for the government and hospitals.Methods:Literature/document collection,expert consultation and prototyping were used as methodological support.Results:Hospital performance management lacks management standards,multivariate dynamic indicator systems and realization tools;the digital governance model of"digital technology+management system"has not been established;and horizontal and vertical comparisons among geographic regions,hospitals,departments,and disease types based on standards have not been realized.Innovative paradigms include the establishment of a standard paradigm based on the smallest functional units such as disease types,indexes,bed days,operators,doctors,etc.;the construction of a dynamic index library,the mining of different combinations of indexes and their internal relationships,and the establishment of an evaluation paradigm;the establishment of a longitudinal evaluation of disease types,the evaluation of"specialties,hospitals,and industries",and the positioning of internal functions of hospitals,resource efficiency and the application of healthcare quality evaluation.It creates a multivariate,multidimensional,dynamic evaluation method and visualized evaluation tool and realization path based on big data.Conclusion:It is needed to emancipate the mind to further enhance the cognitive level of digital governance,innovate the paradigm to accelerate the construction of modernized performance management system in public hospitals,and build a platform to promote the application of modernized performance management system in public hospitals.
8.Key Issues,Innovative Paradigms and Realization Paths of Modernized Performance Management in Public Hospitals under the Perspective of Benchmarking Theory
Peiwen WANG ; Mengyun SUI ; Xiaohua JIANG ; Minna CHENG ; Yan SHI ; Chen FU ; Su XU
Chinese Health Economics 2024;43(7):66-68,85
Objective:Based on the benchmarking theory,to elaborate the key issues,paradigm innovations and realization paths of modernized performance management in China's public hospitals,and to provide policy recommendations for the government and hospitals.Methods:Literature/document collection,expert consultation and prototyping were used as methodological support.Results:Hospital performance management lacks management standards,multivariate dynamic indicator systems and realization tools;the digital governance model of"digital technology+management system"has not been established;and horizontal and vertical comparisons among geographic regions,hospitals,departments,and disease types based on standards have not been realized.Innovative paradigms include the establishment of a standard paradigm based on the smallest functional units such as disease types,indexes,bed days,operators,doctors,etc.;the construction of a dynamic index library,the mining of different combinations of indexes and their internal relationships,and the establishment of an evaluation paradigm;the establishment of a longitudinal evaluation of disease types,the evaluation of"specialties,hospitals,and industries",and the positioning of internal functions of hospitals,resource efficiency and the application of healthcare quality evaluation.It creates a multivariate,multidimensional,dynamic evaluation method and visualized evaluation tool and realization path based on big data.Conclusion:It is needed to emancipate the mind to further enhance the cognitive level of digital governance,innovate the paradigm to accelerate the construction of modernized performance management system in public hospitals,and build a platform to promote the application of modernized performance management system in public hospitals.
9.Key Issues,Innovative Paradigms and Realization Paths of Modernized Performance Management in Public Hospitals under the Perspective of Benchmarking Theory
Peiwen WANG ; Mengyun SUI ; Xiaohua JIANG ; Minna CHENG ; Yan SHI ; Chen FU ; Su XU
Chinese Health Economics 2024;43(7):66-68,85
Objective:Based on the benchmarking theory,to elaborate the key issues,paradigm innovations and realization paths of modernized performance management in China's public hospitals,and to provide policy recommendations for the government and hospitals.Methods:Literature/document collection,expert consultation and prototyping were used as methodological support.Results:Hospital performance management lacks management standards,multivariate dynamic indicator systems and realization tools;the digital governance model of"digital technology+management system"has not been established;and horizontal and vertical comparisons among geographic regions,hospitals,departments,and disease types based on standards have not been realized.Innovative paradigms include the establishment of a standard paradigm based on the smallest functional units such as disease types,indexes,bed days,operators,doctors,etc.;the construction of a dynamic index library,the mining of different combinations of indexes and their internal relationships,and the establishment of an evaluation paradigm;the establishment of a longitudinal evaluation of disease types,the evaluation of"specialties,hospitals,and industries",and the positioning of internal functions of hospitals,resource efficiency and the application of healthcare quality evaluation.It creates a multivariate,multidimensional,dynamic evaluation method and visualized evaluation tool and realization path based on big data.Conclusion:It is needed to emancipate the mind to further enhance the cognitive level of digital governance,innovate the paradigm to accelerate the construction of modernized performance management system in public hospitals,and build a platform to promote the application of modernized performance management system in public hospitals.
10.Key Issues,Innovative Paradigms and Realization Paths of Modernized Performance Management in Public Hospitals under the Perspective of Benchmarking Theory
Peiwen WANG ; Mengyun SUI ; Xiaohua JIANG ; Minna CHENG ; Yan SHI ; Chen FU ; Su XU
Chinese Health Economics 2024;43(7):66-68,85
Objective:Based on the benchmarking theory,to elaborate the key issues,paradigm innovations and realization paths of modernized performance management in China's public hospitals,and to provide policy recommendations for the government and hospitals.Methods:Literature/document collection,expert consultation and prototyping were used as methodological support.Results:Hospital performance management lacks management standards,multivariate dynamic indicator systems and realization tools;the digital governance model of"digital technology+management system"has not been established;and horizontal and vertical comparisons among geographic regions,hospitals,departments,and disease types based on standards have not been realized.Innovative paradigms include the establishment of a standard paradigm based on the smallest functional units such as disease types,indexes,bed days,operators,doctors,etc.;the construction of a dynamic index library,the mining of different combinations of indexes and their internal relationships,and the establishment of an evaluation paradigm;the establishment of a longitudinal evaluation of disease types,the evaluation of"specialties,hospitals,and industries",and the positioning of internal functions of hospitals,resource efficiency and the application of healthcare quality evaluation.It creates a multivariate,multidimensional,dynamic evaluation method and visualized evaluation tool and realization path based on big data.Conclusion:It is needed to emancipate the mind to further enhance the cognitive level of digital governance,innovate the paradigm to accelerate the construction of modernized performance management system in public hospitals,and build a platform to promote the application of modernized performance management system in public hospitals.

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