Objective:To make clear the duties of the clinical research coordinators (CRC) and evaluate any inadequacies in their management and training in the industry, ideas for ameliorating the construction of the CRC team and the promotion of clinical trial quality should be suggested.Methods:Drawing from the author′s experience in CRC management and a literature review, this paper assessed the current state of CRC work and management, and provides advice on how to improve CRC management.Results:In China, the CRC domain lacked a unified standard and access mechanism, leading to inconsistent levels of basic quality and business ability among CRC offerings within the sector.In order to maintain a steady CRC personnel team and promote the quality of clinical trials, it was essential to improve the training of CRC professionals, determine their career development paths, arrange different levels and fields of CRC training, adjust wages and appraisals, and take other suitable measures.Conclusions:It is proposed that the top medical organizations in China collaborate with sponsors and site management organizations to create a standardized and unified CRC occupational admission system and assessment criteria, in order to enhance the capacity and standard of CRC and addressing China′s increasing demand for clinical trials.

Objective:To provide evidence for medical institutions to explore the standardized management in Investigator Initiated Trials (IIT) through understanding the problems and providing suggestions of IIT management in the past 10 years.Methods:The publication year, region, content, existing problems, and suggestions were abstracted and analyzed by Bibliometric analysis.Results:58 studies were included in the analysis from 12 regions, and the top three regions were Shanghai, Beijing, and Guangdong Province. There were 10 items of IIT management, including management status, ethical management, process management, information management, contract management, approval management, human genetic resource management, researcher management, multi-center management, and methodology system management. The problems and suggestions of each item of IIT management were summarized respectively.Conclusions:The imperfect supervision system of IIT has brought great difficulties to the management department. Medical institutions should clarify management points and risk points from the item of IIT management and take targeted measures to actively promote high-quality IIT research.

Objective To explore the content and psychometric properties of sarcopenia measurements for older adults. Methods Using the International Classification of Functioning,Disability and Health(ICF)linking and coding rules,a content analysis were conducted on the seven types of measurement tools for geriatric sarcopenia,including Strength,Assistance with walking,Rising from a chair,Climbing stairs,and Falls(SARC-F);Ishii Test;Mini Sar-copenia Risk Assessment-7(MSRA-7);6-minute walk test(6MWT);Barthel Index(BI);Short Physical Perfor-mance Battery(SPPB);and World Health Organization Disability Assessment Schedule 2.0(WHODAS 2.0),and psychometric property was explored. Results The seven measurement tools can be categorized into body functions and structures,activities and participation,and comprehensive categories.ICF coding for SARC-F involved muscle power functions(b730),walking(d450),changing basic body position(d410),etc.Ishii Test involved muscle power functions(b730)and weight maintenance functions(b530).MSRA-7 involved walking(d450),involuntary movement reaction functions(b755),muscle endurance functions(b740),etc.ICF coding for 6MWT involved walking(d450).SPPB involved changing basic body position(d410),control voluntary movement functions(b760),and walking(d450).BI in-volved eating(d550),drinking(d560),washing oneself(d510),caring for body parts(d520),etc.WHODAS 2.0 involved attention functions(b140),acquiring skills(d155),communication-receiving-verbal messages(d310),community life(d910),etc.SARC-F was low to medium in sensitivity,and medium to excellent in specificity.Ishii Test was medium to good in sensitivity,average to good in specificity,and good in diagnostic performance.MSRA-7 was medium to good in sensitivity,average in specificity,and average to medium in diagnostic perfor-mance,while MSRA-5 was average to good in sensitivity,average in specificity,and medium in diagnostic per-formance.6MWT was average to medium in sensitivity,and average in specificity.SPPB was average in sensitiv-ity,average to medium in specificity,and average to excellent in diagnostic performance.BI was good in reliabili-ty,and WHODAS 2.0 was excellent in reliability. Conclusion The measurement tools for sarcopenia can be categorized into body functions and structures,activities and participation,and comprehensive assessment tools combining the above.The psychometric properties of the sev-en measurement tools are low to excellent in sensitivity and average to excellent in specificity.

Objective:To assess the effectiveness and feasibility of carrier detection for Spinal muscular atrophy (SMA) by using digital PCR assay.Methods:Peripheral blood samples were collected from 214 pregnant women who were routinely screened for SMA carriers, of which 204 were randomly selected samples and 10 were samples with known copy numbers of SMN1 exons 7 and 8. Samples with known copy numbers of SMN1 exons 7 and 8 were randomly mixed into the experiment to validate the performance of the digital PCR assay. The copy numbers of SMN1 exons 7 and 8 and SMN2 exons 7 and 8 in peripheral blood samples were detected by digital PCR assay. The results of SMN1 exons 7 and 8 were compared with those of the quantitative PCR method to assess the reliability and clinical performance of the digital PCR assay. Results:Among the 204 random samples, digital PCR has detected five samples with simultaneous heterozygous deletion of SMN1 exons 7 and 8, three samples with heterozygous deletion of SMN1 exon 8 only, and 196 samples with no deletion of SMN1 exons 7 and 8. Ten samples with known SMN1 exons 7 and 8 copy numbers were detected with the expected values. The digital PCR test results were fully consistent with that of the quantitative PCR. Conclusion:The results of digital PCR for the detection of copy number variation of SMN1 exons 7 and 8 were consistent with qPCR. Digital PCR assay was able to clearly distinguish the copy number of the target genes, therefore can be used for SMA carrier screening. Moreover, it can also detect copy number of SMN2 exons 7 and 8, which can provide more information for genetic counseling.

The new-generation non-invasive prenatal screening technology (NIPT2.0) is a new method successfully realized in recent years based on high-throughput sequencing to synchronously and accurately detect fetal chromosomal aneuploidies, microdeletion/microduplication syndromes and dominantly inherited monogenic disorders. NIPT2.0 can circumvent the shortcomings of previous non-invasive prenatal screening techniques (NIPT and NIPT Plus) including incapability to detect fetal monogenic disorders, insufficient accuracy of detection and low positive predictive values for certain chromosomal abnormalities (in particular trisomy 13, sex chromosomal abnormalities, and small-segment microdeletions and microduplication syndromes). How to apply NIPT2.0 reasonably and normatively to maximize its clinical value has become an issue which requires clarification. The Reproductive Health Branch of the Chinese Maternal and Child Health Care Association has organized experts to fully discuss and jointly drafted this consensus, which has put forwards suggestions over the clinical application strategy for NIPT2.0, including the scope of application, target disease, pre-test consultation, clinical application pathway, post-test genetic counseling and intervention, quality control and limitations, for the reference by peers, with a view to standardize its application and provide better clinical service.

Objective:The cluster analysis method was applied to evaluate the scientific research performance evaluation index system of departments in an obstetrics and gynecology hospital, and analyze the weaknesses of scientific research work of various departments, to provide a basis for the improvement of scientific research strength of departments.Methods:On the basis of the scientific research performance evaluation index system of departments in the obstetrics and gynecology hospital, the indicators and weights of the system were optimized through expert consultation, and the scientific research values from 2019 to 2021 were brought into the optimized scientific research performance evaluation index system to calculate the scientific research scores of each department, and then the cluster analysis method was applied to evaluate the index system.Results:Before and after the optimization of the scientific research performance evaluation index system of departments, the conformity with the discipline classification was 76.00% and 96.67% respectively ( P=0.039). In total of 30 departments were clustered into 4 categories: excellent (7), good (7), medium (4), and concerned (12). The average score of the total scientific research performance evaluation indicators of the 4 categories of departments was 15.022. The highest average score was for papers and monographs, and the lowest was for awards. Conclusions:This study applied the cluster analysis method to evaluate the scientific research performance evaluation index system of departments in the obstetrics and gynecology hospital and replaced quantitative indicators with quality indicators. It will optimize and improve the hospital hierarchical management methods, provide data support and classified guidance for the scientific research development of different categories of departments, and provide a reference basis for hospitals to formulate scientific research management policies such as achievement transformation, award, industry standard guidelines, etc.

Abnormal activation and secretion of pancreatic enzymes in pancreatic acinar cells is one of the important pathogeneses of acute pancreatitis (AP) and can directly damage the pancreatic tissue to accelerate disease progression and induce severe AP. At present, the drugs inhibiting the abnormal activation and secretion of pancreatic enzymes tend to have an unsatisfactory effect in clinical practice, and therefore, it is of great importance to search for new therapeutic targets. This article summarizes the pathological events of abnormal activation and secretion of pancreatic enzymes (cytoplasmic calcium overload, colocalization of lysosomes and zymogen granules, organelle injury, obstructed apical secretion of trypsin, and increased basal secretion of trypsin), collects the molecular mechanisms of related events, and discusses the role of abnormal activation and secretion of pancreatic enzymes in the early stage of AP, so as to provide ideas for the development of targeted drugs in the future.

Objective:To understand the cognition of scientific research integrity of the authors of scientific and technological papers in a grade A tertiary hospital, the necessity and relevant needs of carrying out scientific research integrity construction, and provide a reference for improving the construction of relevant scientific research integrity system in the hospital.Methods:A questionnaire was used to survey 746 people who had published scientific and technological papers in a grade A tertiary hospital from 2016 to 2021, and the influencing factors of scientific research integrity cognition and construction were analyzed via a generalized linear model.Results:The overall awareness rate of scientific research integrity cognition of scientific papers was 76.72%, and the overall necessity rate of scientific research integrity construction was 77.75%. Generalized linear model analysis showed that other degrees refer to a doctor's degree, associate senior title, intermediate title, refer to junior title, or no title were negatively correlated with the cognition of scientific research integrity ( P<0.05), other ages refer to ≤30 years old, middle-level and above positions refer to no position, postgraduate mentor refer to non-postgraduate mentor, senior title refer to junior title or no title, postgraduate, nursing, administrative and research personnel refer to medical technology and pharmacy personnel, and presiding projects refer to no presiding project experience were positively related to scientific research integrity cognition ( P<0.05). Bachelor′s degree and no degree refer to doctor′s degree, associate senior and intermediate titles refer to junior title or no title were negatively related to the necessity of scientific research integrity construction ( P<0.05), middle level and above positions refer to no position, postgraduate, nursing and research personnel refer to medical technology and pharmacy personnel, were positively related to the necessity of scientific research integrity construction ( P<0.05). Behaviors with less than 60% cognition of scientific research integrity included the ethical problems of artificial intelligence, the ethical problems of stem cells, the problems of human genetic resources, and the definition of unauthorized human living drug and medical technology experiments. Conclusions:The hospital will take publicity and education as the basis, system norms as the criteria, daily supervision as the starting point, evaluation system as the core, carry forward the spirit of scientists, improve and implement the construction of the hospital's scientific research integrity system and supervision system, strengthen the integrity management of the whole process of scientific research activities, and guide medical personnel to practice excellent scientific research style and style of study.

Objective : To investigate the changes of liver renin⁃angiotensin (RAS) system as well as its relationship with liver function in endotoxemia rats. Methods : Totally 90 rats were randomly divided into control group and 2 , 4 , 8 , 12 , 24 , 48 , 72 h and 7 d after injection group , which were prepared for sepsis model by tail vein injection of LPS except for the control group. Animals in the control group were collected samples at 8 h after injection , while animals in the model group were collected samples at each time points (2 , 4 , 8 , 12 , 24 , 48 , 72 h and 7 d) . Heart blood was collected to measure liver markers alanine amine aminotransferase ( ALT) , aspartate aminotransferase (AST) , lactate dehydrogenase (LDH) , RAS markers renin⁃angiotensin (PRA) , angiotensin converting enzyme (ACE) and angiotensin Ⅱ (Ang Ⅱ ) . Liver tissues were extracted to observe the pathology characteristics and detect PRA , ACE , Ang Ⅱ and angiotensin type 1 receptor ( AT1R) mRNA. Results : The levels of AST , ALT and LDH in the model group gradually increased after LPS injection , and AST and LDH in the model group were higher than those in the control group at 4 ~ 48 h , ALT in the model group was higher than that in the control group at 2 to 48 h , and the differences were statistically significant (P < 0. 05) . The circle and liver PRA level in the model group increased rapidly after injection , which was higher than that in the control group at 2 to 48 h. The circle and liver levels of ACE and Ang Ⅱ increased after injection too , which were both higher than those in the control group at 2 to 28 h , and the difference was statistically significant ( P < 0. 05 ) . The expression of AT1R mRNA in the model group gradually increased after injection , which was higher than that in the control group at 4 to 48 h , and the difference was statistically significant ( P < 0. 05 ) . Conclusion Liver function damage caused by endotoxemia may be related to the activation of local RAS in the liver.

Objective:Delphi method and weighted average method are used to establish the evaluation index system of basic and clinical scientific research projects respectively, to provide support for screening high-quality projects, to avoid the disadvantages of " one size fits all" , and promote the transformation of project management from quantity and restatement to quality and results, in order to release the innovative vitality of talents and produce more high-quality results.Methods:Using the methods of literature review and expert interview, form the questionnaire of evaluation indicators for the conclusion of basic and clinical scientific research projects, then carry out two rounds of expert consultation with Delphi method, evaluate the authority of experts with authority coefficient, form the second round of questionnaire after analysis and discussion according to the results from the first round of expert consultation, screen and determine the evaluation indicators again in the same way. After two rounds of discussion, the evaluation index system of basic and clinical scientific research projects was developed, and the weighted average method and product method were used to calculate the weight and combination weight.Results:After two rounds of consultation, the evaluation index system for the conclusion of basic scientific research projects was finally established, with 2 first-class indicators, 12 second-class indicators and 33 third-class indicators, and the evaluation index system for the conclusion of clinical scientific research projects had 2 first-class indicators, 10 second-class indicators and 33 third-class indicators. In the second round, the authority coefficient of basic and clinical experts was 0.8, indicating that the authority of experts in this study was high. 29 basic and clinical projects concluded from 2018 to 2020 were selected to verify the index system.Conclusions:The index system formed in this study will be used to classify and evaluate the conclusion evaluation of basic scientific research projects and clinical scientific research projects. In the next step, the weight of the index system will be adjusted to make it more realistic and highlight high-quality achievements, guide the project leader to pay more attention to quality and results, and conduct follow-up evaluation at different stages.