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.Optimization of immune scheme for SARS-CoV-2 RBD recombinant protein vaccine based on P.pastoris and the effect of different adjuvants on neutralizating antibody titer
Heng WANG ; Jinfang JIANG ; Ke LIU ; Qingqing MA
International Journal of Laboratory Medicine 2024;45(1):69-78
Objective To optimize the immune scheme of SARS-CoV-2 RBD recombinant protein vaccine based on P.pastoris,and investigate the effect of different adjuvants on neutralizating antibody(NAb)titer,in order to provide reference for the continuous optimization research of SARS-CoV-2 vaccine.Methods The RBD protein was selected and the corresponding gene fragment was synthesized,which was constructed into the pPICZαA plasmid,and the plasmid was integrated into the genome of P.pastoris after linear transforma-tion for recombinant expression.The obtained recombinant protein vaccine was combined with different adju-vants to immunize mice to evaluate its immunogenicity.Results Both the target proteins wtRBD and Delta RBD were able to achieve satisfactory overexpression through the P.pastoris system.Compared with the 42 d interval,the IgG antibody titer at the 28 d interval increased by 1.8 times(44 923 vs.80 507).After 3 doses of immunization at an interval of 28 d,the geometric mean titer of NAb for Delta variant was 2.5 times higher than that at an interval of 42 days(2 191 vs.891).After immunization with Delta RBD recombinant protein vaccine combined with aluminum adjuvant,the NAb geometric mean titer for Delta variants reached 32 255(2 167-88 084).When using 5 μg or 30 μg Delta RBD immunization,the NAb titers of the aluminum adju-vant+CpG adjuvant group were about 10 times higher than those of the aluminum adjuvant group alone.Af-ter the third immunization,there was no significant difference in Delta RBD specific IgG titers between the 5 μg antigen group and the 30 μg antigen group(P>0.05).Conclusion Both wtRBD and Delta RBD prepared based on P.pastoris could be used as effective antigens,with three doses of vaccine administered at a 28 day in-terval being the most effective.The combined immunization of Delta RBD recombinant protein with aluminum adjuvant+CpG adjuvant could obtain higher titers of NAb to exert immune effects on SARS-CoV-2 and its va-riants,providing some reference for the continuous optimization research of SARS-CoV-2 vaccines.
3.Analysis on Nutritional Status of Vitamin D Among Adults of 6 Ethnic Minority Groups Native to Yunnan Province
Nan ZHANG ; Yanling YANG ; Qingqing WAN ; Jiang ZHAO ; Min PENG ; Xiao ZHU ; Zhitao LIU ; Qiang ZHANG
Journal of Kunming Medical University 2024;45(2):105-111
Objective To assess the nutritional status of vitamin D and associated factors among adults of six ethnic minority groups native to Yunnan Province,and provide evidence for policy making.Methods Between May 2019 and August 2020,a total of 690 adults were selected from Jinuo,Bulang,Jingpo,Deang,Achang and Pumi ethnic groups according to the sex and age composition in the 6th national census.A questionnaire survey and an anthropometric examination were conducted by trained health workers,and serum 25(OH)D levels were determined with high-performance liquid chromatography-tandem mass spectrometry.Results The median of serum 25(OH)D was 28.7(P25~P75∶24.3~33.8)ng/mL,and the prevalence of vitamin D sufficiency,insufficiency and deficiency were 44.2%、47.5%and 8.3%,respectively.There were significant differences in serum 25(OH)D levels among the six ethnic groups(χ2=139.29,P<0.01).Multivariate logistic regression showed that ethnic groups living in higher latitude areas(Pumi,Jingpo,Deang,and Achang),women,and those whose BMI≥24.0 were more likely to be vitamin D insufficient or deficient.Conclusion More than half of the ethnic adults suffer from vitamin D malnutrition which also varies across ethnicities.Further surveillance and interventions among key areas and populations are needed.
4.Status quo and challenges of continuing medical education for general practitioners in China: suggestions based on the concept of people centered and integrated health care
Xin CHEN ; Jianli GE ; Shasha GENG ; Qingqing LI ; Yingqian ZHU ; Xiaotong GUO ; Hua JIANG
Chinese Journal of General Practitioners 2024;23(4):384-388
Continuing medical education for general practitioners is an important measure to upgrade the quality of primary health care services in China, which is still facing various challenges and need to be further developed and improved. This article analyzes the status quo and existing problems of continuing medical education for general practitioners in China, and proposes suggestions based on the concept of people centered and integrated health care (PCIC), including faculty development, training contents, assessment methods, and experience learning, to provide references for the improvement of continuing medical education for general practitioners.
5.Correlation between gene polymorphisms of coagulation factor Ⅻ rs1801020 and resistin rs1862513 and unexplained recurrent spontaneous abortion
Cong WANG ; Qingqing JIANG ; Xue JIANG ; Jiahui SUN ; Ying LUO ; Yi ZHANG
International Journal of Laboratory Medicine 2024;45(1):6-11
Objective To investigate the correlation between gene polymorphisms of coagulation factor Ⅻ(FⅫ)rs1801020 and resistin rs1862513 and unexplained recurrent spontaneous abortion(URSA).Methods A total of 189 patients diagnosed with URSA and 191 healthy postpartum women during the same period were selected from the obstetric clinic of Changning Maternity and Infant Health Hospital from January 2020 to December 2022.The probe PCR was used to detect gene polymorphisms of rs1801020 and rs1862513 in peripheral blood,and the differences in genotype distribution between the groups were observed.Results The frequencies of geno-types and alleles for F Ⅻ rs1801020 in the URSA-A group were 4.9%(CC),35.7%(CT),59.5%(TT),22.7%(C),and 77.3%(T),respectively.In the control A group,the frequencies were 8.0%(CC),47.1%(CT),44.9%(TT),31.5%(C)and 68.5%(T).The frequencies of genotypes and alleles for resistin rs1862513 in the URSA-B group were 11.3%(CC),47.3%(CG),41.4%(GG),34.9%(C)and 65.1%(G).In the control B group,the frequencies were 10.2%(CC),34.1%(CG),55.7%(GG),27.3%(C)and 72.7%(G).There was no significant difference in genotype frequency of the two loci(P>0.05),but there was a sig-nificant difference in allele frequency(P<0.05).The distribution frequency of F Ⅻ rs1801020 T allele in the URSA group was higher than that in the control group(X2=6.32,OR=1.567,95%CI:1.100-2.238,P=0.012).The distribution frequency of resistin rs1862513 G allele in URSA group was lower than that in con-trol group(X2=4.96,OR=1.433,95%CI:1.050-1.969,P=0.026).The mutation of F Ⅻ rs1801020 C to T was a risk factor for the occurrence of URSA,while the mutation of rs1862513 C to G was a protective factor for the occurrence of URSA(P<0.05).The combined genotype analysis showed that compared to the popu-lation carrying the rs1801020 CC+rs1862513 CC genotype combination,the population carrying the rs1801020 TT+rs1862513 CG genotype had a significantly higher risk of URSA(OR=5.684,95%CI:1.210-30.920,P=0.035).Conclusion FⅫ rs1801020 T allele may increase the risk of URSA and resistin rs1862513 G al-lele may the risk of URSA.People with rs1801020 TT+rs1862513 CG genotype combination is more likely to develop URSA than those with rs1801020 CC+rs1862513 CC genotype combination.
6.Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fracture with kyphotic deformity in the elderly (version 2024)
Jian CHEN ; Qingqing LI ; Jun GU ; Zhiyi HU ; Shujie ZHAO ; Zhenfei HUANG ; Tao JIANG ; Wei ZHOU ; Xiaojian CAO ; Yongxin REN ; Weihua CAI ; Lipeng YU ; Tao SUI ; Qian WANG ; Pengyu TANG ; Mengyuan WU ; Weihu MA ; Xuhua LU ; Hongjian LIU ; Zhongmin ZHANG ; Xiaozhong ZHOU ; Baorong HE ; Kainan LI ; Tengbo YU ; Xiaodong GUO ; Yongxiang WANG ; Yong HAI ; Jiangang SHI ; Baoshan XU ; Weishi LI ; Jinglong YAN ; Guangzhi NING ; Yongfei GUO ; Zhijun QIAO ; Feng ZHANG ; Fubing WANG ; Fuyang CHEN ; Yan JIA ; Xiaohua ZHOU ; Yuhui PENG ; Jin FAN ; Guoyong YIN
Chinese Journal of Trauma 2024;40(11):961-973
The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.
7.Caries status and its influencing factors among first-grade primary school students in Shanghai
Ying YU ; Fangyu YI ; Hao ZHANG ; Qingqing WENG ; Xiaoli ZENG ; Jin YU ; Yiwei JIANG ; Huning WANG ; Ying ZHANG
Academic Journal of Naval Medical University 2024;45(10):1310-1315
Objective To investigate the oral health status of the first-grade primary school students in Shanghai and analyze its influencing factors.Methods In 2021,Huangpu,Xuhui,Jiading,and Jing'an districts were selected in Shanghai by random sampling method.The first-grade students of 8 primary schools in these 4 districts were enrolled by random cluster sampling.Oral clinical examinations and questionnaires were conducted according to the criteria of the Fourth National Oral Health Epidemiological Survey.EpiData 3.1 software was used to create the database.SPSS 26.0 software was applied for statistical analysis.Chi-square test was used to compare the caries prevalence between groups,and two independent samples non-parametric test was used to compare the decayed,missing and filled teeth(DMFT)between groups.Multifactorial logistic regression model was used to analyzse the influencing factors of caries.Results A total of 824 informed consent forms and questionnaires were collected,of which 764 were completed,with an effective rate of 92.7%.The total caries prevalence of the participating students was 65.6%(501/764),and the mean DMFT was 3.24±3.47.A total of 2 473 carious teeth were found in the participating students,and 671 teeth were filled,with a filling rate of 27.1%.There were 7.91±2.76 permanent teeth erupted per student,and 56.3%(430/764)of the students had all 4 first permanent molars erupted.Multivariate logistic regression showed that eating sweets>3 times a day(P=0.030),eating regularly before bedtime(P=0.001),and parents'cognition of kids'poor oral health status(P=0.025)were the influencing factors for the detection of caries in children.Conclusion The first-grade primary school students in Shanghai have high prevalence of caries.Eating sweets>3 times a day,eating regularly before bedtime,and parents'cognition of kids'poor oral health status(P<0.05)are the influencing factors for the detection of caries in children.
8.Visual analysis of neonatal hospice care based on Web of Science database
Sishan JIANG ; Tingwei LUO ; Na ZHANG ; Yuqiong XIANG ; Qingqing XIA ; Zhiqiang ZHANG ; Lihui ZHU
Chinese Journal of Modern Nursing 2024;30(4):487-494
Objective:To conduct visual analysis of neonatal hospice care based on Web of Science database and explore the research hotspots and frontiers, so as to provide reference for the development of neonatal hospice care in China.Methods:The literatures related to neonatal hospice care included in the core collection of Web of Science from 1991 to 2023 were retrieved and screened. CiteSpace 6.1.R6 was used for visual analysis from the aspects of author, country/region, institution, journal co-citation frequency, keyword knowledge map and so on.Results:A total of 1 452 articles were included, and the number of articles was on the rise. The United States, the United Kingdom and Canada occupied the core position of neonatal hospice care related research. Research hotspots included hospice care for different stages and types of diseases, key links in neonatal intensive care unit hospice care, innovation in neonatal hospice care service models, the needs and psychological support strategies of family members and medical staff. The forefront of research focused on the role and challenges of healthcare professionals in hospice care, disease diagnosis and ethical dilemmas related to decision-making.Conclusions:China can learn from international research hotspots and frontiers to explore the applicability of different hospice service models, enrich research types, strengthen guidance at the level of laws and policies, improve education and training systems and build a neonatal hospice service system that conforms to national conditions and culture in China.
9.A scoping review of application of sedentary behavior interventions in patients with chronic diseases
Yulu JIANG ; Qingqing WANG ; Mingcan ZONG ; Xianhua LI
Chinese Journal of Modern Nursing 2024;30(13):1800-1808
Objective:To conduct a scoping review on the application of sedentary behavior intervention in chronic disease patients and identify the delivery carriers, intervention time, intervention content and intervention results, so as to provide guidance for health care personnel to carry out relevant intervention research.Methods:Literature was systematically searched in PubMed, Embase, CINAHL, Cochrane Library, China National Knowledge Infrastructure and Wanfang data from establishment of the databases to June 15, 2023. The included literatures were screened, summarized and analyzed.Results:A total of 25 articles were included, among which the delivery carriers of sedentary behavior intervention included offline guidance, wearable device monitoring, telephone follow-up, mobile phone applications, email and website platform. The most common intervention implementers were rehabilitation therapists, followed by nurses, doctors and psychologists. Intervention durations ranged from 4 weeks to 3 years. Behavioral intervention strategies covered eight aspects, including providing information about behavioral consequences, goal setting, action planning, obstacle identification/problem-solving, behavioral feedback, exploring social support, motivational rewards and restructuring the physical environment. The types of outcome indicators for intervention included sedentary time, physical activity time, physiological indicators, psychological indicators, feasibility evaluation and safety evaluation. The results showed that sedentary behavior intervention not only reduced sedentary behavior in patients with chronic diseases, but also affected their quality of life and self-efficacy.Conclusions:Sedentary behavior intervention has positive effects on sedentary behavior, physical activity, physical health and mental health of patients with chronic diseases. Future research should strengthen the development and application of mobile phone applications and strengthen environmental intervention to further improve the intervention effect.
10.Strategies of geriatric management for elderly patients with multimorbidity based on concept of people centered integrated care
Xin CHEN ; Yang LI ; Jianli GE ; Shasha GENG ; Qingqing LI ; Yingqian ZHU ; Hua JIANG
Chinese Journal of General Practitioners 2024;23(11):1210-1215
Multimorbidity management for the elderly is a big challenge for China′s healthcare system and the people centered integrated care (PCIC) is a new concept in health care reform, and the application of the PCIC in multimorbidity management can better improve the health servece for elderly patients. This article applies SWOT analysis to assess the internal strengths and weaknesses as well as external opportunities and threats of applying the PCIC to the geriatric management of multimorbidity; also proposes strategies of geriatric management for elderly patients with Chinese characteristics based on concept of PCIC. The proposed stretegies optimize the personalized assessment with the digital technology, promotes the management with close-knit healthcare system, and strengthen the role of primary medical institutions to improve the long-term management mechanism of multimorbidity.

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