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.Expert consensus on orthodontic treatment of protrusive facial deformities.
Jie PAN ; Yun LU ; Anqi LIU ; Xuedong WANG ; Yu WANG ; Shiqiang GONG ; Bing FANG ; Hong HE ; Yuxing BAI ; Lin WANG ; Zuolin JIN ; Weiran LI ; Lili CHEN ; Min HU ; Jinlin SONG ; Yang CAO ; Jun WANG ; Jin FANG ; Jiejun SHI ; Yuxia HOU ; Xudong WANG ; Jing MAO ; Chenchen ZHOU ; Yan LIU ; Yuehua LIU
International Journal of Oral Science 2025;17(1):5-5
Protrusive facial deformities, characterized by the forward displacement of the teeth and/or jaws beyond the normal range, affect a considerable portion of the population. The manifestations and morphological mechanisms of protrusive facial deformities are complex and diverse, requiring orthodontists to possess a high level of theoretical knowledge and practical experience in the relevant orthodontic field. To further optimize the correction of protrusive facial deformities, this consensus proposes that the morphological mechanisms and diagnosis of protrusive facial deformities should be analyzed and judged from multiple dimensions and factors to accurately formulate treatment plans. It emphasizes the use of orthodontic strategies, including jaw growth modification, tooth extraction or non-extraction for anterior teeth retraction, and maxillofacial vertical control. These strategies aim to reduce anterior teeth and lip protrusion, increase chin prominence, harmonize nasolabial and chin-lip relationships, and improve the facial profile of patients with protrusive facial deformities. For severe skeletal protrusive facial deformities, orthodontic-orthognathic combined treatment may be suggested. This consensus summarizes the theoretical knowledge and clinical experience of numerous renowned oral experts nationwide, offering reference strategies for the correction of protrusive facial deformities.
Humans
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Orthodontics, Corrective/methods*
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Consensus
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Malocclusion/therapy*
;
Patient Care Planning
;
Cephalometry
3.Expert consensus on the prevention and treatment of enamel demineralization in orthodontic treatment.
Lunguo XIA ; Chenchen ZHOU ; Peng MEI ; Zuolin JIN ; Hong HE ; Lin WANG ; Yuxing BAI ; Lili CHEN ; Weiran LI ; Jun WANG ; Min HU ; Jinlin SONG ; Yang CAO ; Yuehua LIU ; Benxiang HOU ; Xi WEI ; Lina NIU ; Haixia LU ; Wensheng MA ; Peijun WANG ; Guirong ZHANG ; Jie GUO ; Zhihua LI ; Haiyan LU ; Liling REN ; Linyu XU ; Xiuping WU ; Yanqin LU ; Jiangtian HU ; Lin YUE ; Xu ZHANG ; Bing FANG
International Journal of Oral Science 2025;17(1):13-13
Enamel demineralization, the formation of white spot lesions, is a common issue in clinical orthodontic treatment. The appearance of white spot lesions not only affects the texture and health of dental hard tissues but also impacts the health and aesthetics of teeth after orthodontic treatment. The prevention, diagnosis, and treatment of white spot lesions that occur throughout the orthodontic treatment process involve multiple dental specialties. This expert consensus will focus on providing guiding opinions on the management and prevention of white spot lesions during orthodontic treatment, advocating for proactive prevention, early detection, timely treatment, scientific follow-up, and multidisciplinary management of white spot lesions throughout the orthodontic process, thereby maintaining the dental health of patients during orthodontic treatment.
Humans
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Consensus
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Dental Caries/etiology*
;
Dental Enamel/pathology*
;
Tooth Demineralization/etiology*
;
Tooth Remineralization
4.Expert consensus on early orthodontic treatment of class III malocclusion.
Xin ZHOU ; Si CHEN ; Chenchen ZHOU ; Zuolin JIN ; Hong HE ; Yuxing BAI ; Weiran LI ; Jun WANG ; Min HU ; Yang CAO ; Yuehua LIU ; Bin YAN ; Jiejun SHI ; Jie GUO ; Zhihua LI ; Wensheng MA ; Yi LIU ; Huang LI ; Yanqin LU ; Liling REN ; Rui ZOU ; Linyu XU ; Jiangtian HU ; Xiuping WU ; Shuxia CUI ; Lulu XU ; Xudong WANG ; Songsong ZHU ; Li HU ; Qingming TANG ; Jinlin SONG ; Bing FANG ; Lili CHEN
International Journal of Oral Science 2025;17(1):20-20
The prevalence of Class III malocclusion varies among different countries and regions. The populations from Southeast Asian countries (Chinese and Malaysian) showed the highest prevalence rate of 15.8%, which can seriously affect oral function, facial appearance, and mental health. As anterior crossbite tends to worsen with growth, early orthodontic treatment can harness growth potential to normalize maxillofacial development or reduce skeletal malformation severity, thereby reducing the difficulty and shortening the treatment cycle of later-stage treatment. This is beneficial for the physical and mental growth of children. Therefore, early orthodontic treatment for Class III malocclusion is particularly important. Determining the optimal timing for early orthodontic treatment requires a comprehensive assessment of clinical manifestations, dental age, and skeletal age, and can lead to better results with less effort. Currently, standardized treatment guidelines for early orthodontic treatment of Class III malocclusion are lacking. This review provides a comprehensive summary of the etiology, clinical manifestations, classification, and early orthodontic techniques for Class III malocclusion, along with systematic discussions on selecting early treatment plans. The purpose of this expert consensus is to standardize clinical practices and improve the treatment outcomes of Class III malocclusion through early orthodontic treatment.
Humans
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Malocclusion, Angle Class III/classification*
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Orthodontics, Corrective/methods*
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Consensus
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Child
5.Expert consensus on orthodontic treatment of patients with periodontal disease.
Wenjie ZHONG ; Chenchen ZHOU ; Yuanyuan YIN ; Ge FENG ; Zhihe ZHAO ; Yaping PAN ; Yuxing BAI ; Zuolin JIN ; Yan XU ; Bing FANG ; Yi LIU ; Hong HE ; Faming CHEN ; Weiran LI ; Shaohua GE ; Ang LI ; Yi DING ; Lili CHEN ; Fuhua YAN ; Jinlin SONG
International Journal of Oral Science 2025;17(1):27-27
Patients with periodontal disease often require combined periodontal-orthodontic interventions to restore periodontal health, function, and aesthetics, ensuring both patient satisfaction and long-term stability. Managing these patients involving orthodontic tooth movement can be particularly challenging due to compromised periodontal soft and hard tissues, especially in severe cases. Therefore, close collaboration between orthodontists and periodontists for comprehensive diagnosis and sequential treatment, along with diligent patient compliance throughout the entire process, is crucial for achieving favorable treatment outcomes. Moreover, long-term orthodontic retention and periodontal follow-up are essential to sustain treatment success. This expert consensus, informed by the latest clinical research and practical experience, addresses clinical considerations for orthodontic treatment of periodontal patients, delineating indications, objectives, procedures, and principles with the aim of providing clear and practical guidance for clinical practitioners.
Humans
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Consensus
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Orthodontics, Corrective/standards*
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Periodontal Diseases/complications*
;
Tooth Movement Techniques/methods*
;
Practice Guidelines as Topic
6.Development and application of core competence assessment index system among drug clinical trial quality control personnel
Yu CHEN ; Qingqing JIANG ; Guo YE ; Weiran MAO ; Yuanyuan YIN ; Mengjuan ZHANG ; Pu SUN ; Xia CHEN
China Pharmacy 2025;36(24):3023-3028
OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work, responsibilities, and role positioning of quality management personnel in drug clinical trials, a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions, ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions, comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%, with Kendall’s W coefficients of 0.256 and 0.277 (P<0.001 for both), and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators, covering individual professional competence, communication skills, implementation condition verification, informed consent process review, clinical trial execution monitoring, adverse event disposal, reporting and documentation, trial record examination, trial report auditing, and inspection of other tasks, and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents (P<0.05). Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice (GCP) requirements (0.34-point gap), familiarity with national and institutional clinical trial inspection priorities (0.24-point gap),etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies, highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.
7.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.
8.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.
9.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.
10.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.

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