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.

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.

Objectives:To develop modified prehospital stroke scales and to evaluate their predictive value for in-hospital acute large vessel occlusion (LVO) stroke.Methods:Patients admitted to Dongtai People's Hospital due to non-stroke-related diseases and activated the in-hospital stroke green channel due to suspected stroke symptoms during hospitalization from January 2015 to December 2022 were included retrospectively. According to the final imaging diagnosis, they were divided into LVO group and non-LVO group. The five prehospital stroke scales included Field Assessment Stroke Triage for Emergency Destination (FAST-ED), Rapid Arterial Occlusion Evaluation (RACE), Los Angeles Motor Scale (LAMS), Cincinnati Prehospital Stroke Severity Scale (CPSSS), and Prehospital Acute Stroke Severity Scale (PASS). Multivariate logistic regression analysis was used to determine independent predictive factors of LVO in patients with in-hospital stroke, and incorporating them into the prehospital stroke scale to develop modified scales. The receiver operating characteristic (ROC) curve was used to evaluate the predictive performance of the modified scales. Results:A total of 174 patients with in-hospital stroke were enrolled, including 92 males (52.9%), aged 65.7±11.9 years. Fifty-four patients (31.0%) had LVO, and 59 (33.9%) had a surgical history within 3 days before the onset of stroke, mainly cardiopulmonary surgeries. Multivariate logistic regression analysis showed that atrial fibrillation (odds ratio 2.940, 95% confidence interval 1.387-6.230; P=0.005) and recent history of cardiopulmonary surgery (odds ratio 6.861, 95% confidence interval 2.437-11.315; P<0.001) were the independent predictive factors of LVO in patients with in-hospital stroke. According to the β coefficient and ROC curve, they were assigned a score of 1 and included in the prehospital stroke scale. The area under the curve of the modified scale for predicting LVO (mRACE: 0.917; mFAST-ED: 0.865; mPASS: 0.859; mCPSSS: 0.853; mLAMS: 0.907) was significantly higher than the corresponding original scale (RACE: 0.888; FAST-ED: 0.820; PASS: 0.786; CPSSS: 0.810; LAMS: 0.859) (all P<0.05). Conclusion:The modified scales based on the prehospital stroke scales can significantly improve the predictive value of in-hospital acute LVO stroke compared to the original prehospital stroke scales.

With the rapid development of population aging in various countries around the world,the health and elderly care industry has been paid high attention.The standardization of smart health and elderly care technology and services is particularly important.This paper firstly reviewed the policies related to healthy elderly care in China.By analyzing the industrial standards and provincial standards issued,this paper focused on the policies proposed by the Shanghai Municipal Government for the standardization of smart health and elderly care,as well as the researches on the standard system and the construction of standard families.Shanghai group standards in the field of smart health and elderly care were summarized,including the guidelines for the construction of standard systems,elderly care service platforms,community elderly cafeterias,portable health monitoring terminals,indoor sports services,and home-based elderly care safety monitoring.A series of case analyses of the standardized implementation of the above aspects were also provided.Through standardization research and practice in recent years,it has been fully demonstrated that the standard research plays an important leading role in the field of smart health and elderly care.

Objective To investigate the effect of obstructive sleep apnea(OSA)on behavioral problems in children and the association between them.Methods A simple random sampling method was used to select 100 children aged 4 to 12 years for the case group.All of them were diagnosed with OSA through overnight polysomnography at the Sleep Medicine Center,West China Fourth Hospital,Sichuan University between October 2022 and October 2023.An additional 100 children without snoring symptoms and clinically evaluated and confirmed as not having OSA were enrolled as the control group.General demographic data of the participants were collected.The Caregiver Report Form of the Achenbach Child Behavior Checklist(CBCL)was used for behavioral problem assessment,and polysomnography data were collected.The chi-square/t test was used to analyze the inter-group differences in general data,the total score of behavioral problems,and scores for each dimension.Linear regression was performed to analyze the relationship between OSA and the total score for children's behavioral problems and those for the different dimensions.Logistic regression was applied to analyze the relationship between the obstructive apnoea-hypopnea index(OAHI)and behavioral problems in children with OSA.A logistic regression model integrating the OAHI×sex interaction term was constructed to evaluate the moderating effect of sex on the association between OAHI and behavioral problems.Results No significant differences were observed in general demographic data between the case and control groups.The total score for behavioral problems and those for each dimension were higher in the case group than those in the control group,with the total score of the case group being 24.60±1.55 and that of the control group being 8.85±0.75(P<0.001).The results of the linear regression analysis showed a positive association between OSA and both the total score for behavioral problems(b=16.01;95%CI,12.56-19.47)and those for each dimension.The results of the logistic regression analysis showed that,after adjusting for covariates,OAHI was a risk factor for behavioral problems in children with OSA(odds ratio[OR]=1.17;95%CI,1.04-1.31).After stratification by sex and adjustment for covariates,the OR value of the effect of OAHI on behavioral problems was slightly higher in female participants(1.57)than that in male participants(1.21).The interaction effect analysis showed that sex moderated the association between OAHI and behavioral problems(OR=1.64;95%CI,1.02-2.64;P=0.04).Conclusion Children with OSA are prone to developing behavioral problems.OAHI is a risk factor for behavioral problems in children with OSA,with a potentially greater effect observed in girls.

Objective To investigate the efficacy and safety of compound cantharidis capsule combined with pemetrexed and platinum-based drugs in the treatment of elderly patients with advanced lungadenocarcinoma.Methods A total of 80 patients with advanced lung adenocarcinoma were retro-spectively selected as the study subjects.According to the treatment regimen,they were divided into chemotherapy group(treated with pemetrexed and platinum-based drugs)and traditional Chinese med-icine combined with chemotherapy group(treated with compound cantharidis capsule combined with-pemetrexed and platinum-based drugs),with 40 cases in each group.The short-term efficacy,serum tumor marker[carcinoembryonic antigen(CEA),carbohydrate antigen 72-4(CA72-4),carbohydrate antigen 125(CA125)]levels,and the incidence of adverse reactions were observed and compared between the two groups.The patients were followed up,and the progression-free survival(PFS)and overall survival(OS)of the two groups were recorded.Results The objective response rate(ORR)and disease control rate(DCR)in the traditional Chinese medicine combined with chemotherapy group were higher than those in the chemotherapy group,with statistically significant differences(P＜0.05).After treatment,the serum CEA,CA72-4 and CA125 levels in both groups were lower than those before treatment,and the levels in the traditional Chinese medicine combined with chemotherapy group were lower than those in the chemotherapy group,with statistically significant differences(P＜0.05).There was no statistically significant difference in the incidence of grade 3 to 4 adverse reac-tions between the two groups(P＞0.05).The progression-free survival rate and overall survival rate in the traditional Chinese medicine combined with chemotherapy group were higher than those in the chemotherapy group,with statistically significant differences(P＜0.05).Conclusion Compound cantharidis capsule combined with pemetrexed and platinum-based drugs can significantly improve the ORR and DCR,reduce serum tumor marker levels,prolong the survival of patients with ad-vanced lung adenocarcinoma,and has good safety.

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.

Objective To explore the value of dual-phase enhanced CT radiomics in predicting post-acute pancreatitis diabetes mellitus(PPDM-A).Methods A total of 145 patients with acute pancreatitis(AP)were retrospectively collected,including 62 patients in PPDM-A group and 83 patients in non-PPDM-A group.The patients were randomly divided into training set and test set at a ratio of 7︰3,the pancreatic parenchyma in arterial phase and venous phase was delineated and the radiomics features were extracted.Vari-ance threshold method,univariate selection method and least absolute shrinkage and selection operator(LASSO)were used to screen radiomics features.The prediction performance of the model was evaluated by the area under the curve(AUC).The DeLong test was used to compare the prediction efficiency between the models,and the calibration curve and decision curve were used to evaluate the prediction efficiency of the model.Results The AUC of arterial phase model,venous phase model,combined arterial venous phase model,clinical model and radiomics combined clinical model in the training set were 0.845,0.792,0.829,0.656 and 0.862,respec-tively.The DeLong test results showed that only the difference between the radiomics combined clinical model and the clinical model in the training set and the test set was statistically significant(P<0.05).The decision curve showed that the radiomics combined clinical model had high clinical practicability in a certain range,and the calibration curve showed that the radiomics combined clinical model had the best fitting degree with the actual observation value.Conclusion Based on the dual-phase enhanced CT radiomics combined clinical model,PPDM-A can be predicted more accurately,and it can provide a certain reference value for the clinical development of per-sonalized treatment programs.

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.

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.