OBJECTIVE To investigate the job mo bility of cl inical research coordinators （CRCs） and clinical research associates（CRAs）in Chongqing ，and to explore the feasible methods to improve the job stability of CRCs and CRAs. METHODS Questionnaire survey was conducted to investigate the job mobility of 200 CRCs and CRAs working in 22 drug clinical trial institutions of Chongqing. The contents included basic information ，job mobility ，and reasons for mobility. RESULTS & CONCLUSIONS Totally 178 valid questionnaires were recovered ，with an efficient recovery rate of 89.00％，of which 110 were recovered from CRCs and 68 were recovered from CRAs. Among the surveyed CRCs and CRAs ，the age distribution was mainly 20-30 years old ，accounting for 87.27％ and 82.35％ of the respective population respectively. The overall educational degree of CRAs were slightly higher than those of CRCs. The majors and previous work experience were mainly related to medicine ；the proportion of other non-medicine-related professions who switched to CRCs was higher than that of CRAs. Totally 88.18％ had CRC working experience within 3 years；after having 1-＜3 years of work experience ，50.00％ had worked in 2 or more work units. Totally 64.70％ had CRA working experience within 3 years；after having 1-＜3 years of work experience ，70.37％ had worked in 2 or more work units. CRCs handled 5.38 items of clinical trials and completed 1.22 items on average ；CRAs handled 7.47 items and completes 2.04 items on average. Main reasons of CRCs and CRAs for job-hopping included low salary below expectations，few promotion opportunities ，and too much workload ，accounting for 83.64％/80.88％，45.45％/39.71％，31.82％/ 26.47％，respectively. As an important part of clinical trials ，CRCs and CRAs had high job mobility. It is suggested to establish a unified industry standard ，standardize the management rights and responsibilities of CRCs and CRAs ，optimize the working mode of CRCs and CRAs ，and improve professional identity and sense of belonging ，so as to improve the job stability of relevant

ObjectiveTo analyze the changing trend of cerebrovascular disease burden in Minhang District of Shanghai from 1996 to 2021， and to provide scientific evidence for government to formulate targeted cerebrovascular disease prevention and control strategies. MethodsMortality， years of life lost（YLL）， years of lived with disability（YLD） and disability⁃adjusted life years（DALY） were used to evaluate the burden of cerebrovascular diseases in Minhang District. Joinpoint linear regression was used to analyze the trend of disease burden. ResultsFrom 1996 to 2021， the YLL rate of cerebrovascular diseases in Minhang District showed a downward trend （whole population： APC=-1.69%， t=-6.9， P<0.05）， The YLD rate of cerebrovascular diseases showed a slow upward trend （whole population： APC=1.17%， t=3.5， P<0.05）， The DALY rate of cerebrovascular diseases showed a downward trend， and fluctuated since 2003 （whole population： APC= -1.43%， t=-5.6， P<0.05）. The YLL rate of cerebrovascular diseases in men was higher than that in women， and the YLD rate of cerebrovascular diseases in women was higher than that in men. After 2014， the DALY of cerebrovascular diseases in men was higher than that in women. With the increase of age， the burden of cerebrovascular diseases increased， and the burden of disease increased significantly in the age group above 70. ConclusionThe burden of cerebrovascular diseases in Minhang District is at a high level， and there are differences in age， gender and other aspects. Measures such as screening， intervention and rehabilitation need to be improved to reduce disability and premature death caused by cerebrovascular diseases and to reduce the burden of cerebrovascular diseases on individuals， families and society.

Background::Although existing mycological tests (bronchoalveolar lavage [BAL] galactomannan [GM], serum GM, serum (1,3)-β-D-glucan [BDG], and fungal culture) are widely used for diagnosing invasive pulmonary aspergillosis (IPA) in non-hematological patients with respiratory diseases, their clinical utility in this large population is actually unclear. We aimed to resolve this clinical uncertainty by evaluating the diagnostic accuracy and utility of existing tests and explore the efficacy of novel sputum-based Aspergillus assays. Methods::Existing tests were assessed in a prospective and consecutive cohort of patients with respiratory diseases in West China Hospital between 2016 and 2019 while novel sputum assays (especially sputum GM and Aspergillus-specific lateral-flow device [LFD]) in a case-controlled subcohort. IPA was defined according to the modified European Organization for Research and Treatment of Cancer/Mycoses Study Group criteria. Sensitivity and specificity were computed for each test and receiver operating characteristic (ROC) curve analysis was performed. Results::The entire cohort included 3530 admissions (proven/probable IPA = 66, no IPA = 3464) and the subcohort included 127 admissions (proven/probable IPA = 38, no IPA = 89). Sensitivity of BAL GM (≥1.0 optical density index [ODI]: 86% [24/28]) was substantially higher than that of serum GM (≥0.5 ODI: 38% [39/102]) ( χ2 = 19.83, P < 0.001), serum BDG (≥70 pg/mL: 33% [31/95]) ( χ2 = 24.65, P < 0.001), and fungal culture (33% [84/253]) ( χ2 = 29.38, P < 0.001). Specificity varied between BAL GM (≥1.0 ODI: 94% [377/402]), serum GM (≥0.5 ODI: 95% [2130/2248]), BDG (89% [1878/2106]), and culture (98% [4936/5055]). Sputum GM (≥2.0 ODI) had similar sensitivity (84% [32/38]) (Fisher’s exact P = 1.000) to and slightly lower specificity (87% [77/89]) ( χ2 = 5.52, P = 0.019) than BAL GM (≥1.0 ODI). Area under the ROC curve values were comparable between sputum GM (0.883 [0.812-0.953]) and BAL GM (0.901 [0.824-0.977]) ( P = 0.734). Sputum LFD had similar specificity (91% [81/89]) ( χ2 = 0.89, P = 0.345) to and lower sensitivity (63% [24/38]) ( χ2 = 4.14, P = 0.042) than BAL GM (≥1.0 ODI), but significantly higher sensitivity than serum GM (≥0.5 ODI) ( χ2 = 6.95, P = 0.008), BDG ( χ2 = 10.43, P = 0.001), and fungal culture ( χ2 = 12.70, P < 0.001). Conclusions::Serum GM, serum BDG, and fungal culture lack sufficient sensitivity for diagnosing IPA in respiratory patients. Sputum GM and LFD assays hold promise as rapid, sensitive, and non-invasive alternatives to the BAL GM test.

Objective:To explore the effect of restrictive perineal incision evaluation combined with prone flexion delivery on reducing the perineal incision rate.Methods:The convenient sampling method was used to select 440 primiparas who delivered naturally in Wuxi People's Hospital Affiliated to Nanjing Medical University from June to November 2020 as research objects. According to the random number table method, the primiparas were divided into the observation group and the control group, with 220 cases in each group. The observation group was scored item by item according to the Restrictive Perineotomy Assessment Scale, and the indications of perineotomy were strictly performed according to the final score. The control group judged whether to undergo perineotomy according to subjective experience. The prone flexion delivery was used in both groups and the delivery outcomes of the two groups were compared.Results:The perineal incision rate of the observation group was lower than that of the control group, and the difference was statistically significant ( P<0.01) . The perineal laceration degree of the observation group was less than that of the control group, and the difference was statistically significant ( P< 0.05) . The rate of poor perineal wound healing in the observation group was lower than that in the control group, and the difference was statistically significant ( P<0.05) . The degree of postpartum perineal pain in the observation group was less than that in the control group, and the difference was statistically significant ( P<0.01) . There was no statistically significant difference in the incidence of neonatal asphyxia between the two groups ( P>0.05) . There was no neonatal injury in the two groups. Conclusions:Construction and application of Restrictive Perineotomy Assessment Scale avoid midwives to judge based on subjective experience and improve the accuracy of perineotomy assessment. The combination with prone flexion delivery can further reduce the rate of perineotomy and poor healing rate of postpartum perineal wound and reduce postpartum perineal pain, which is an effective method to improve postpartum perineal outcome and ensure the safety of mother and children.

OBJECTIVE： To summarize the problems and countermeasures which the construction of drug clinical trial institutions face after China Food and Drug Administration （CFDA） join in ICH， and its effects on clinical study management in China. METHODS： Combined with the experience on Good Clinical Practice （GCP） in our hospital during recent years， reviewing related content of ICH-GCP， the differences between China’s GCP （CFDA-GCP） and ICH-GCP， the problems faced by drug clinical trial institutions after joining in ICH， and the thinking of China’s clinical research were discussed. RESULTS & CONCLUSIONS： There were differences between CFDA-GCP and ICH-GCP in the management concept of clinical drug trials， the structure and function of ethical committees， the protection of the rights and interests of subjects， the choice of researchers and research institutions， management requirements of experimental drugs and the management of documents and data. After joining in ICH， the current organization and management structure， system and standard operating procedures， ethics committee， GCP training and continuing education， professional quality control system， experimental drug management， data management and information system construction and upgrading， clinical research coordinator management and other aspects of the drug clinical trial institutions were far from the requirements of ICH. The standardization of drug clinical trial institutions in China can be further promoted by revising regulations and guidelines， formulating standard operating procedures in line with ICH-GCP， building standardized ethics committees， implementing GCP training and continuing education， improving quality control system and drug management in clinical trials， strengthening hardware and software construction and clinical coordinator management， etc. At the same time， problems such as fewer full-time personnel and weak implementation of the system can be improved by strengthening project management， improving the quality of employees and building normal cross-regional cooperation.

OBJECTIVE： To provide references for improving the standard operating procedures of drug management in clinical trials and drug management in clinical trials. METHODS： According to Good Clinical Practice （GCP）， Data On-site Verification Points of Drugs Clinical Trial， Qualification Examination Rules of Drug Clinical Trial Institution， based on the quality control project carried out in our hospital since July 2016， the matters needing attention in the non-standard operation and key process of drug management in clinical trial were summarized， and the improvement measures were discussed. RESULTS & CONCLUSIONS： Non-standard drug management is a high-incidence link of non-standard operation in the trial process. Among them， the acceptance， distribution and use of drugs are the three links with the highest incidence of non-standard operation of drug management in the trial process. Therefore， when formulating the relevant management system， each institution should pay attention to it according to its own situation； such as， when accepting drugs in clinical trials， attention should be paid to checking the intact degree of drug packaging； drugs transported in cold chain should also be checked for temperature records and rejected in case of over-temperature； the copies of the waybill should be kept in file with the original to avoid fading of the thermosensitive paper； whether the relevant characteristics of the control drugs and placebos meet the requirements. Institutions can standardize the key links of drug management in the trial process， the time of project establishment， project start-up， quality control and supervision， formulate and constantly improve the relevant drug management system and standard operating procedures （SOP）. For example， when starting a project， attention should be paid to the participation of drug administrators in the training and signature of start-up meeting， whether the design of the form is complete， standardized and operable. It is necessary for clinical trial institutions to pay attention to the standardization and precision of drug management and the key links in clinical trials.

Objective To investigate the effect of comprehensive nursing intervention and evaluate its role in the entire clinical course of in the treatment of children with severe burns. Methods A total of 60 children with 1-5 years old with clinical diagnosis of severe burns were randomly divided into experimental group and control group by random digits table method, 30 cases in each group. The control group received routine burn care. The experimental group received comprehensive nursing interventions on the basis of routine burn care and the intervention time covered the entire course of treatment. During hospitalization, the recovery and family social system were evaluated by anxiety scales and social support scales combined with the cure rate and hospitalization of children. Results Before intervention, the score of Anxiety Rating Scale was high in both groups of families, while Social Support Scale was lower, the difference was not statistically significant between the two groups (P>0.05). After intervention, the score of Anxiety Rating Scale and was Social Support Scale were (52.31±7.81), (31.52± 5.48)points in the experimental group, and (62.51 ± 6.52), (23.62 ± 5.62) points in the control group, and there were significant differences (t=5.491 3, 5.512 5, P<0.01). The length of stay was (18.34±3.58) d in the experimental group, and (21.82 ± 4.23) d in the control group, and there was significant difference(t=3.439 6, P<0.05). The cure rate was 93.33%(28/30) in the experimental group, and 56.67%(17/30) in the control group, and there was significant difference(χ2=10.755 6, P<0.05). Conclusions The comprehensive nursing intervention can provide comprehensive refinement of the overall care in children and their families, promote physical and psychological rehabilitation of children with severe burns, and repair their family and social support systems. The comprehensive nursing intervention has far-reaching implications for the rehabilitation of children with severe burns.

Objective To develop an evaluation index system of reputation for higher medical insti-tutions and to test its reliability and validity. Methods Using literature method and small-group discussion to collect the evaluation indexes, the data was collected by the questionnaire survey and the 1 493 effective questionnaires were collected with effective recovery rates of 61.90%. And the exploratory and confirmatory factor analysis methods were conducted to develop evaluation index system with using the SPSS 17.0 soft-ware for statistics analysis. Results The evaluation index system of reputation for higher medical institutions included six dimensionalities: social responsibility, opinion direction, social image, management quality, emotional attract and environmental facility. The Cronbachs’a coefficients of evaluation index system were greater than 0.7, RMSEA is 0.063<0.08, χ2/df is 3.933<5, therefore, the structural equation model fitting was good and evaluation index system had good validity. Conclusion This article has developed an evalu-ation index system of reputation for higher medical institutions, which has a good reliability and validity. To test the model’s reliability and validity, the suggestion that the future research will be performed between more other medical universities has been given.

Objective To investigate the effect of COX￣2 inhibitor celecoxib on radiosensitity of irradiation￣resistant cell line CNE￣2R of nasopharyngeal carcinoma and the potential mechanism. Methods Via exposing to a series of X￣ray (2, 4, 6, 8 Gy, 3 times for each dose), radio￣resistant cell subline CNE￣2R was established from human nasopharyngeal carcinoma cell CNE￣2.Radiosensitivity was detected by clone formation assay.CNE￣2R and CNE￣2 cell lines were exposed to 25, 50, 75 μmol.L-1 celecoxib, respectively.Western blotting was used to detect the protein expression of COX￣2.Clone formation assay was performed to measure the survival fraction of CNE￣2 and CNE￣2R after radiotherapy alone or radiotherapy combined with 30 μmol.L-1 celecoxib treatment.Flow cytometry was used to measure influence of radiotherapy alone or radiotherapy combined with 30 μmol.L￣1celecoxib treatment on cell apoptosis.Number of residual γ￣H2AX foci was observed by immunofluorescence assay. Results The colony forming assay demonstrated that the values of SF2, D0 , Dq , and N of CNE￣2R cell subline [(0.81±0.05), (2.15±0.07) Gy, (2.94±0.08) Gy, (3.91±0.07), respectively] was significant higher than those of CNE￣2 cell line [(0.61±0.08), (1.47±0.06) Gy, (1. 68 ± 0. 10) Gy, (3. 13 ± 0. 05), respectively]. The expression of COX￣2 protein was significantly downregulated with increasing celecoxib concentration.Surviving fraction was decreased in both CNE￣2 and CNE￣2R cell lines after irradiation.After radiotherapy combined with celecoxib, apoptosis rates of CNE￣2 and CNE￣2R cell lines [(13.10±0.63)%, (5.30±0.75)%] were higher than those of the corresponding control groups [(4.90±0.71)%, (1.82±0.82)%].Celecoxib increased radiosensitivity in nasopharyngeal carcinoma CNE￣2R and CNE￣2 cell lines.The number of residual γ￣H2AX foci after irradiation was increased by celecoxib pretreatment.The difference was statistically significant (P<0.05). Conclusion Celecoxib can enhance radiosensitivity of radio￣resistant cell subline CNE￣2R of human nasopharyngeal carcinoma in vitro.