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.Analysis of factors affecting depressive disorders after rehabilitation therapy in elderly stroke patients
Qin HAN ; Xiuli HAN ; Weiran CHEN
Tianjin Medical Journal 2024;52(6):639-642
Objective To investigate and analyze factors affecting depressive disorders in elderly stroke patients after rehabilitation treatment.Methods A total of 1 100 elderly stroke patients receiving rehabilitation treatment in the three hospitals(Beijing Electric Power Hospital of State Grid Corporation,Beijing Fengtai Hospital of Integrative Medicine and Beijing Daxing Hospital of Integrative Medicine)were selected as the study subjects.General data were collected,and patients were surveyed using the daily life ability scale(BI),family care scale and social support scale(SSRS),according to the Hamilton Depression Scale(HAMD)to determine whether patients developed depressive disorders.Multivariate Logistic regression analysis were used to analyze influencing factors of depressive disorders in elderly stroke patients after rehabilitation treatment.Results A total of 1 100 survey questionnaires were issued and 1 073 were retrieved,with an effective rate of 97.5%,and among them,386 cases(36.0%)were diagnosed with depressive disorder,and 687 cases(64.0%)without depressive disorder.There were significant differences in the incidence of depression between patients with different ages,complications,per capita family income,BI score,family caring degree and SSRS score(P<0.05).Multivariate Logistic regression analysis showed that advanced age(OR=1.337,95%CI:1.014-1.763),complication(OR=3.214,95%CI:1.365-7.569),lower per capita monthly family income(OR=2.263,95%CI:1.137-4.503),lower BI score(OR=1.872,95%CI:1.158-3.026),average family caring degree(OR=2.639,95%CI:1.200-5.802)and lower SSRS score(OR=1.557,95%CI:1.044-2.322)were risk factors for depression in elderly stroke patients after rehabilitation treatment(P<0.05).Conclusion More attention should be given to elderly stroke patients to improve family care and social support,thus reducing the risk of depressive disorders after rehabilitation.
3.Clinical effect of multi-modality image fusion combined with intraoperative fluorescein sodium in the treatment of brain metastases from lung cancer
Zhong WANG ; Xiaojun ZHANG ; Ruijian ZHANG ; Zhitong HAN ; Weiran YANG ; Wenbo YANG ; Yunzhao CHEN ; Dong XING ; Junqing WANG ; Yuhui SONG
Clinical Medicine of China 2024;40(6):447-455
Objective:To explore the application and clinical efficacy of functional neural navigation multimodal image fusion technology combined with intraoperative fluorescein sodium in the surgery of lung cancer brain metastases.Methods:Forty patients with lung cancer and brain metastasis admitted to the Department of Neurosurgery of Inner Mongolia Autonomous Region People's Hospital from January 2020 to January 2024 were collected as the observation group. Another 40 patients with lung cancer brain metastases who underwent microscopic resection at Inner Mongolia Autonomous Region People's Hospital from January 2016 to December 2019 were selected as the control group. All patients received head CT examination, head MRI examination, MRI enhanced sequence and MRA, MRV and DWI sequence scanning before operation. Functional neural navigation system was used to perform preoperative multi-modal image fusion to realize three-dimensional display of tumor lesions, and display the position relationship between tumor and functional areas, conduction bundles and large blood vessels, so as to make preoperative navigation plan. After conducting a fluorescein sodium allergy test on the patient before surgery, a small dose of fluorescein sodium (2 mg/kg) was intravenously injected during the operation. During the operation, neuro navigation was combined with fluorescein sodium to perform tumor resection by displaying the boundary between tumor tissue and normal brain tissue under a Pentero 900 Zeiss microscope 560 fluorescence mode. Both groups collected tumor tissue samples for pathological classification and immunohistochemical analysis, comparing and analyzing differences in tumor resection degree, postoperative occurrence of new neurological dysfunction, postoperative muscle strength improvement, changes in KPS scores before and after surgery, and the occurrence of complications. The metric data that conforms to normal distribution is represented by xˉ± s, and the comparison of means between two groups is conducted using independent sample t-test. Calculate the percentage based on the count data, and compare the inter group rates using the χ2 test. P<0.05 indicates statistical significance of the difference. Results:Compared with the control group, the total tumor resection rate of observation group (75.0% (30/40) ) and KPS score of 3 months after surgery (82.5% (33/40)) were better than those of the control group (52.5% (21/40) and 60% (24/40)), and the differences were statistically significant ( χ2 value was 4.94 and 4.38, P values were 0.026 and 0.036). The rate of postoperative new neurological dysfunction in the observation group (22.5% (9/40)) was lower than that in the control group (45.0% (18/40)), and the difference between the two groups was statistically significant ( χ2=4.53, P=0.033). The length of hospital stay ((21.48±3.23) days), operation time ((216.65±56.76) points) and complication rate (37.5% (15/40)) in observation group were lower than those in control group ((22.43±2.34) days, (225.62±37.68) points, 45.0% (18/40)). However, the difference was not statistically significant ( t/ χ2 values were 1.51, 0.83, and 0.46, respectively; P values were 0.136, 0.408, and 0.496, respectively). The 12-month survival rate of observation group (67.5%(27/45) respectively was significantly higher than that of control group (40.0%(16/40) respectively, and the difference was statistically significant ( χ2=6.08, P=0.014). Conclusion:Functional neural navigation multimodal image fusion technology combined with intraoperative fluorescein sodium can accurately locate the tumor and determine the boundary relationship between the tumor and normal brain tissue during lung cancer brain metastasis surgery, improve tumor resection rate, enhance patient quality of life, and ultimately improve patient prognosis without increasing the risk of related complications.
4.Portable spirometer-based pulmonary function test willingness in China: A nationwide cross-sectional study from the "Happy Breathing Program"
Weiran QI ; Ke HUANG ; Qiushi CHEN ; Lirui JIAO ; Fengyun YU ; Yiwen YU ; Hongtao NIU ; Wei LI ; Fang FANG ; Jieping LEI ; Xu CHU ; Zilin LI ; Pascal GELDSETZER ; Till B?RNIGHAUSEN ; Simiao CHEN ; Ting YANG ; Chen WANG
Chinese Medical Journal 2024;137(14):1695-1704
Background::Understanding willingness to undergo pulmonary function tests (PFTs) and the factors associated with poor uptake of PFTs is crucial for improving early detection and treatment of chronic obstructive pulmonary disease (COPD). This study aimed to understand willingness to undergo PFTs among high-risk populations and identify any barriers that may contribute to low uptake of PFTs.Methods::We collected data from participants in the "Happy Breathing Program" in China. Participants who did not follow physicians’ recommendations to undergo PFTs were invited to complete a survey regarding their willingness to undergo PFTs and their reasons for not undergoing PFTs. We estimated the proportion of participants who were willing to undergo PFTs and examined the various reasons for participants to not undergo PFTs. We conducted univariable and multivariable logistic regressions to analyze the impact of individual-level factors on willingness to undergo PFTs.Results::A total of 8475 participants who had completed the survey on willingness to undergo PFTs were included in this study. Out of these participants, 7660 (90.4%) were willing to undergo PFTs. Among those who were willing to undergo PFTs but actually did not, the main reasons for not doing so were geographical inaccessibility ( n = 3304, 43.1%) and a lack of trust in primary healthcare institutions ( n = 2809, 36.7%). Among the 815 participants who were unwilling to undergo PFTs, over half ( n = 447, 54.8%) believed that they did not have health problems and would only consider PFTs when they felt unwell. In the multivariable regression, individuals who were ≤54 years old, residing in rural townships, with a secondary educational level, with medical reimbursement, still working, with occupational exposure to dust, and aware of the abbreviation "COPD" were more willing to undergo PFTs. Conclusions::Willingness to undergo PFTs was high among high-risk populations. Policymakers may consider implementing strategies such as providing financial incentives, promoting education, and establishing community-based programs to enhance the utilization of PFTs.
5.Comparison of the biomechanical effects of cervical fusion surgery between using a cervical interfacet self-locking cage and a Zero-profile anterior cervical interbody fusion device
Ziyao DING ; Kexin CHEN ; Weiran SHI
Chinese Journal of Spine and Spinal Cord 2024;34(9):960-968
Objectives:To compare the biomechanical effects on the cervical spine between the insertion of a cervical interfacet self-locking cage(CILC)for anterior cervical interbody fusion and the insertion of a Zero-profile anterior cervical interbody fusion device(Zero-P)through the finite element method.Methods:Extracting the thin-layer cervical CT scan data of a 24-year-old male volunteer,and excluding any history of cervical spine trauma,surgery,cervical spondylosis,and imaging-diagnosed cervical spine deformities.Establishing a three-dimensional finite element model(blank model)of the normal lower cervical spine.The validity of the model was verified by comparing the range of motion(ROM)with those reported in previous studies.Based on this model,finite element models were constructed for single-segment posterior CILC insertion and fusion and Zero-P insertion and fusion.The surgical segment was set as the C4/5 segment,and CILC and Zero-P were implanted respectively to fuse and construct model.The lower endplate of the C7 vertebral body was fixed,and an axial load of 73.6N was applied to simulate the head's weight.A 1.0N·m torque was applied to the upper surface of the C2 vertebral body to simulate the overall movement of the C2-C7 finite element models,including flexion,extension,lateral bending,and axial rotation.The ROM of the segment and the stress changes in the adjacent segment intervertebral discs and facet joints were analyzed in all four motion directions for the blank model,CILC model,and Zero-P model.Results:The ROMs of the established three-dimensional finite element model of the lower cervical spine in all motion directions were consistent with previously published studies,therefore its validity was verified.Compared with the blank mod-el,the ROMs in all directions of the fusion segment was significantly reduced in both the CILC and Zero-P models.The ROM of the adjacent segments and the peak stress in the intervertebral discs and facet joints of the adjacent segments were higher in all motion directions compared with the blank model,with no significant difference in the degree of ROM increase between the CILC and Zero-P models.The peak stress increase in the intervertebral discs of adjacent segments in the CILC model was smaller than that in the Zero-P model.In the CILC model,the peak stress values of the C3/4 segment during flexion,extension,lateral bending,and rotation increased from pre-fixation values of 2.181,3.358,3.636,and 3.950MPa to post-fixation values of 2.532,3.881,4.463,and 4.917MPa,respectively.The peak stress values of the C5/6 segment during flexion,extension,lateral bending,and rotation increased from pre-fixation values of 1.558,3.996,3.778,and 3.660 MPa to post-fixation values of 1.864,4.131,4.183,and 4.266MPa,respectively.In the Zero-P model,the peak stress values of the C3/4 segment during flexion,extension,lateral bending,and rotation increased from preoperative values of 2.181,3.358,3.636,and 3.950MPa to 2.977,4.241,4.654,and 5.509MPa,respectively.The peak stress values of the C5/6 segment during flexion,extension,lateral bending,and rotation increased from pre-fixation values of 1.558,3.996,3.778,and 3.660MPa to post-fixation values of 2.314,5.214,4.469,and 4.739MPa,respectively.The peak stress increase in the adjacent facet joints in all motion directions was greater in the CILC model than in the Zero-P model.Conclusions:CILC insertion results in less impact on adjacent segment disc stress compared to Zero-P and provides reliable fixation,making it a suitable option for treating adjacent segment disease after cervical surgery.
6.Investigation on home blood pressure monitoring among hypertensive patients
FAN Qiqi ; CHEN Ciyu ; SUN Xiaoning ; WU Weiran ; WANG Juan
Journal of Preventive Medicine 2023;35(11):948-952
Objective :
To investigate the status and influencing factors of home blood pressure monitoring (HBPM) among hypertensive patients, so as to provide the evidence for building and maintaining HBPM among hypertensive patients.
Methods:
Hypertensive patients hospitalized in the First Affiliated Hospital of Guangdong Pharmaceutical University were sampled from July to December 2022, and subjects' general data, HBPM behaviors and cognition were collected using self-designed questionnaires. In addition, factors affecting regular HBPM were identified using a multivariable logistic regression model.
Results:
Totally 440 questionnaires were allocated, and 422 valid questionnaires were recovered, with an effective recovery rate of 95.91%. The respondents included 234 males (55.45%) and 188 females (44.55%), and had a median age of 70 (interquartile range, 15) years. There were 239 respondents with regular HBPM (56.64%). Of 422 respondents, 68 had good cognition of blood pressure monitoring (16.11%), and 79.15% did not think regular changes of their blood pressure within 24 hours, while 72.04% did not think it necessary to measure blood pressure more than twice a day. Multivariable logistic regression analysis showed that recommendation of regular blood pressure monitoring by healthcare workers (OR=4.341, 95%CI: 2.493-7.560), number of blood pressure measurements according to real circumstances (OR=3.858, 95%CI: 1.358-10.961), recording of measurement results (OR=4.945, 95%CI: 1.863-13.129), provision of data to doctors at admission (OR=2.023, 95%CI: 1.173-3.488) and good cognition of blood pressure monitoring (good, OR=11.939, 95%CI: 3.972-35.886; general, OR=9.681, 95%CI: 5.157-18.172) resulted in a high possibility of regular HBPM among respondents.
Conclusion
Hypertensive patients with recommendation of regular blood pressure monitoring by healthcare workers, number of blood pressure measurements according to real conditions, recording of blood pressure measurement results, provision of blood pressure to doctors at admission and good cognition of blood pressure monitoring are more likely to have regular HBPM.
7.Application of toxicant and drug detection in 895 patients with clinical poisoning diseases
Zhenyu XIA ; Zhengshen MAO ; Jinsong ZHANG ; Hao SUN ; Hong SUN ; Weiran XIE ; Lili JIANG ; Li ZHANG ; Xueli JI ; Feng CHEN
Chinese Journal of Emergency Medicine 2023;32(2):186-191
Objective:To explore the diagnostic value of the toxicant and drug detection in clinical poisoning diseases and analyze the clinical characteristics of patients with positive poison test.Methods:This study was a multicenter retrospective cohort study. Sampling and clinical information data were collected between October 1, 2020 and September 30, 2022 from 41 tertiary hospitals in and around Jiangsu province. The clinical characteristics of patients with positive toxicology tests were analyzed, and the correlation between the drug sampling situation and the test results was analyzed..Results:A total of 895 patients with clinical diagnosis or suspected poisoning were enrolled in this study. Among them, 652 patients had positive results, accounting for 72.85%. Among all positive patients, 506 patients were exposed to a single poison and 147 patients were exposed to multiple poisons. The top three poisons were pesticide herbicides (202 cases, 30.98%), sedative and psychotropic drugs (151 cases, 23.16%), and pesticide insecticides (97 cases, 14.88%). Among 541 patients with clear exposure history, the positive rate was 78.19%, and among 354 patients with unclear exposure history, the positive rate was 64.69%. The top three poisons (drugs) of patients with unclear exposure history were sedative and psychotropic (82, 12.58%), herbicide (26, 3.99%), and rodenticide (22, 3.37%). Patients who admitted to hospital for unexplained consciousness disorder, abnormal blood coagulation function and multiple organ dysfunction were more likely to obtain positive poison test results.Conclusions:There is uncertainty in the exposure history of poisoning diseases, so it is necessary to improve the detection of toxic substances as soon as possible. Toxicant testing should be considered when patients have impaired consciousness, abnormal coagulation function and multiple organ dysfunction.
8.Analysis of epidemiology and clinical characteristics of patients with poisons purchase online
Meng LI ; Jinsong ZHANG ; Qifang SHI ; Lili JIANG ; Weiran XIE ; Zhengsheng MAO ; Feng CHEN ; Hao SUN
Chinese Journal of Emergency Medicine 2023;32(2):198-202
Objective:To explore the clinical characteristics of poisoned patients with poisons purchase online.Methods:A retrospective case-control study was conducted on poisoned patients purchased poisons online from 1st January 2021 to 31th May 2022 in the Emergency Department of the First Affiliated Hospital of Nanjing Medical University. The clinical data including sex, age, way of medical treatment, cause of poisoning, exposure routes, category of toxic drugs, gastric lavage, toxic detection and prognosis of patients were collected and compared with those patients obtained poisons at stores as the control group.Results:Totally 318 poisoned patients were included in this study, of which 44 (13.8%) were obtained poisons online. Compared with the patients obtained poisons at stores, the patients obtained poisons online were younger ( P<0.001), and had higher proportion of suicide intention ( P=0.006), more oral route exposure ( P=0.029), and more proportions of receiving gastric lavage before transfer to the hospital ( P=0.001). Pesticides and fertilizers with organic heterocycles were the main types of poisons in the online group, and there was no statistical difference in the distribution of poisons compared with the control group. Mixed drug poisoning was the leading cause in both online group (27.8%) and control group (38.8%) in drug overdose poisoned types, followed by dextromethorphan (16.7%) and estazolam (15.5%) in the online group. Conclusions:Young people are the main group getting poisons through the Internet. Health education should be strengthened for this group, and online shopping platforms should pay attention to the poisoning risk of potential overdose drugs or poisons transactions.
9.A study of the influence of the level of transvaginal birth experience on the timing of postpartum lactation initiation
Fangxiang DONG ; Yanna GUAN ; Xi CHEN ; Yaqi FENG ; Huiying SI ; Jingjing CHEN ; Jing XIN ; Weiran LI ; Fang WEI ; Qing CHEN ; Hongjing SU
Chinese Journal of Practical Nursing 2023;39(19):1505-1511
Objective:To investigate the current status of women′s level of birth experience and lactation initiation time and explore the effect of level of birth experience on lactation initiation time.Methods:This was a cross-sectional study. A convenience sampling method was used to select 622 maternal cases attending the Affiliated Hospital of Jining Medical College from November, 2020 to January, 2021, and the distribution of their labor experience level and lactation initiation time was investigated by questionnaire and follow-up assessment.Results:There were 622 women with transvaginal deliveries who had lactation initiation times of more than 72 h in 241 cases (38.75%). The scores for each dimension of the Childbirth Experience Questionnaire (CEQ) were (49.63 ± 8.58)points, and the scores for each dimension of CEQ were perceived safety, professional support, involvement and self-efficacy in descending order. The results of the correlation analysis showed that there was a negative correlation between the scores on each dimension of CEQ and the total score and lactation initiation time ( r values were -0.436 to -0.146, all P<0.01). Stratified regression analysis showed that after controlling for age, number of births, gestational weeks of labour, illness during pregnancy and labour analgesia as the underlying variables affecting lactation initiation time, the scores for self-efficacy, involvement, perceived safety and professional support in the CEQ all affected lactation initiation time after delivery ( t values were -6.76 to -2.02, all P<0.05). Conclusions:The birth experience and lactation of women who deliver via vaginal birth need to be taken into account. The more negative the birth experience, the longer the lactation initiation time. The women′s involvement in the birth process, their own competence, perceived safety and level of professional support are all valid influencing indicators of lactation initiation time.
10.Technical specification for orthodontic transmission straight wire technique
Jiuxiang LIN ; Lili CHEN ; Bing HAN ; Si CHEN ; Weiran LI ; Zuolin JIN ; Bing FANG ; Yuxing BAI ; Lin WANG ; Jun WANG ; Hong HE ; Yuehua LIU ; Min HU ; Jinlin SONG ; Yang CAO ; Yannan SUN ; Xiaomo LIU ; Jieni ZHANG ; Yunfan ZHANG
Chinese Journal of Stomatology 2023;58(12):1217-1226
Malocclusion is an oral disease with a high prevalence. The goal of orthodontic treatment is health, aesthetics, function and stability. The transmission straight wire appliance and technique is an innovative orthodontic system with independent intellectual property rights invented by Professor Jiuxiang Lin′s team based on decades of clinical experience, which provides a new solution for the non-surgical correction of skeletal malocclusions, especially class Ⅲ malocclusion, and it is also a good carrier for the implementation of the concept of healthy orthodontics. Due to the lack of guidelines, how to implement standardized application of transmission straight wire technique remains a problem to be solved. This technical specification was formed by combining the guidance from Professor Jiuxiang Lin and joint revision by a number of authoritative experts from the Orthodontic Special Committee, Chinese Stomatological Association, with reference to relevant literatures, and combined with abundant clinical experience of many experts. This specification aims to provide reference to standardize the clinical application of transmission straight wire technique, so as to reduce the risk and complications, and finally to improve the clinical application level of this technique.


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