1.Challenges, countermeasures, and key points of ethics review in investigator-initiated clinical trials of unlisted products
Honglei NIAN ; Jihong LI ; Jiyin ZHOU
Chinese Medical Ethics 2025;38(1):31-39
Investigator-initiated clinical trials (IIT) are an important part of scientific and technological activities involving human study participants. Among them, high-quality IIT can be used to support the marketing and registration application of drugs, medical devices, and other products when conditions permit. Currently, there is a huge gap between IIT and industry-initiated clinical trials. The use of unlisted products in IIT has problems, such as lack of regulatory support, insufficient research funding support, the need to improve the ability of clinical research management departments, the weakness of professional clinical research teams, and the difficulty of ethics review to match the demands. The challenges could be addressed by improving regulations and conducting pilot trials on a small scale, guaranteeing adequate research funding, strengthening the construction of clinical research management systems, building professional clinical research teams, ensuring the quality of ethical reviews and strict follow-up reviews, shifting from ethical reviews to a system for protecting research participants, and reinforcing training for researchers. Ethics committees should strictly review key points, such as the risk-benefit ratio, informed consent, research funding, compensation for damages, qualifications and equipment of research team members, and management of conflict of interest.
3.Expert consensus on imaging diagnosis and analysis of early correction of childhood malocclusion.
Zitong LIN ; Chenchen ZHOU ; Ziyang HU ; Zuyan ZHANG ; Yong CHENG ; Bing FANG ; Hong HE ; Hu WANG ; Gang LI ; Jun GUO ; Weihua GUO ; Xiaobing LI ; Guangning ZHENG ; Zhimin LI ; Donglin ZENG ; Yan LIU ; Yuehua LIU ; Min HU ; Lunguo XIA ; Jihong ZHAO ; Yaling SONG ; Huang LI ; Jun JI ; Jinlin SONG ; Lili CHEN ; Tiemei WANG
International Journal of Oral Science 2025;17(1):21-21
Early correction of childhood malocclusion is timely managing morphological, structural, and functional abnormalities at different dentomaxillofacial developmental stages. The selection of appropriate imaging examination and comprehensive radiological diagnosis and analysis play an important role in early correction of childhood malocclusion. This expert consensus is a collaborative effort by multidisciplinary experts in dentistry across the nation based on the current clinical evidence, aiming to provide general guidance on appropriate imaging examination selection, comprehensive and accurate imaging assessment for early orthodontic treatment patients.
Humans
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Malocclusion/diagnostic imaging*
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Child
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Consensus
4.Construction of a prognostic model of future asthma exacerbation risk in adults combined with novel biomarkers
Li ZHANG ; Liang LI ; Mei ZHOU ; Qianyun ZHOU ; Qin LIU ; Mei LIANG ; Jihong TANG ; Xiaofeng FU
International Journal of Laboratory Medicine 2025;46(4):435-442
Objective To construct a prognostic model of future asthma exacerbation risk in adults by com-bining novel biomarkers of serum chitinase-3-like protein 1(YKL-40),dipeptidyl peptidase-4(DPP4)and conventional predictors.Methods Patients with asthma in the non-acute exacerbation phase were recruited from the People's Hospital of Yubei District of Chongqing,from March 2022 to May 2023.Baseline clinical da-ta collected included medical history,forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC),percentage of predicted forced expiratory volume in the first second(FEV1%pred),blood eosinophil count(EOS),blood neutrophil count(NEU),fractional exhaled nitric oxide(FeNO),serum YKL-40,and ser-um DPP4,etc.The patients were followed for one year to gather data on asthma acute exacerbations and their timings as defined in this study.A COX proportional hazards regression model was used to construct a prog-nostic model for future asthma exacerbations,with internal validation and results presentation.Results A to-tal of 224 patients with asthma completed the study.During the one-year follow-up period,102 patients experi-enced acute exacerbations as defined in this study.Based on univariate COX regression,stepwise regression for variable selection,clinical significance,and model simplicity,asthma control test(ACT)score group,number of asthma exacerbations in the past year group,log10(YKL-40),log10(FeNO),log10(EOS),and FEV1%pred were the following predictors were included in the final model.The overall C-statistic of the model was 0.795(95%CI:0.754-0.836),the area under the curve at the 52-week follow-up was 0.879(95%CI:0.834-0.924),and the Brier score at the 52-week follow-up was 0.142(95%CI:0.117-0.168).The calibration curve was close to a slope of 1,and bootstrap validation suggested good stability of the prediction model.The model was presented using a Nomogram and a dynamic scoring table in a web APP,which can be used to predict the risk of asthma exacerbations within 52 weeks for individual patients.Conclusion The prediction model based on serum YKL-40,EOS,FeNO,the number of asthma exacerbation in the past year group,FEV1%pred and ACT scores group can accurately predict the probability of acute attacks in 52 weeks of asthma patients.
5.Gluteal tendinitis and primary coxarthrosis may lead to iliotibial band syndrome:a Mendelian randomization study
Chen YAO ; Wenjia LI ; Ruiming PANG ; Jihong ZHOU
Journal of Southern Medical University 2024;44(9):1821-1830
Objective To analyze the causal relationship of gluteal tendinitis and primary coxarthrosis with the occurrence of iliotibial band syndrome using Mendelian randomization.Methods The GWAS data of gluteal tendinitis,primary coxarthrosis and iliotibial band syndrome were screened for high correlation single-nucleotide polymorphisms(SNPs).Mendelian randomization analysis was performed using random-effects inverse variance weighting(IVW),MR-Egger regression,and weighted median method to determine whether gluteal tendinitis and primary coxarthrosis were causally related with iliotibial band syndrome.Heterogeneity test,multiple validity test and sensitivity analysis,and clinical data analysis were used to verify the reliability of the results.Results Both gluteal tendinitis[IVW:OR(95%CI)=1.32(1.03-1.68),P=0.026]and primary coxarthrosis[IVW:OR(95%CI)=1.40(1.06-1.84),P=0.017]was positively correlated with iliotibial band syndrome.Conclusion Gluteal tendinitis and primary coxarthrosis may increase the risk of iliotibial band syndrome.
6.Exploration of the misunderstandings,challenges,and countermeasures of exemption from ethical review from the perspective of medical and health institutions
Honglei NIAN ; Hui JIANG ; Jihong LI ; Min LIU ; Jiyin ZHOU
Chinese Medical Ethics 2024;37(4):408-414
In the implementation of exemption from ethical review,medical institutions equate exemption from ethical review with no ethical review or simple review,misunderstand the scope of exemption from ethical review,confuse the concepts of de-identification and anonymization,and equate privacy with personal information.The implementation faced challenges such as the coordination of conditions for exempt review with other regulations,the lack of clear decision-making subjects for exempting from ethical review,the legality and compliance of using general informed consent for biological samples and information data,as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review.Measures such as improving relevant laws and regulations,perfecting the construction and management of information databases and biological sample libraries,strengthening the project management and process supervision of exemption from ethical review,and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.
7.Strolling through the glorious years of Alveolar Surgery, bravely stepping onto the path of practice and innovation
Yiming WANG ; Yang XUE ; Jihong ZHAO ; Jian PAN ; Duohong ZOU ; Nianhui CUI ; Wei ZHANG ; Qizhang WANG ; Zhizheng LI ; Yuqiong ZHOU ; Kaijin HU
Chinese Journal of Stomatology 2024;59(4):301-311
This article summarizes and organizes relevant publications in journals, along with a review of medical history, systematically summarizing the development process of dental alveolar surgery in China. The initial establishment phase (1935—1952) marked the starting point of Chinese Alveolar Surgery. Despite the impact of wars, it laid the foundation for subsequent research and practice. During the early development phase (1953—1966), the "Chinese Journal of Stomatology" was founded, which promoted the development of Alveolar Surgery. Research focused on tooth extraction methods and complications. Tooth Transplantation and Preprosthetic Surgery gradually began to take off. The stagnant phase (1967—1977) occurred due to the interruption of international exchanges, leading to an almost complete halt in the development of Alveolar Surgery. Entering the rapid catch-up phase (1978—1985), Alveolar Surgery scholars in China began striving to overcome the stagnation of the previous decade. While some progress was made, no significant innovative achievements emerged. In the scientific development phase (1986—2010), clinical research, basic experiments, and paper writing in modern Chinese Alveolar Surgery began to adhere to scientific standards with the rise of experimental medicine. The exploration and innovation stage (2011—2023) is the current development phase, during which Chinese Aveolar Surgery has reached its peak, making substantial progress in technology, clinical practices, and basic research, gradually reaching or even surpassing international advanced levels. Looking back at the development history in China, we can find the wisdom and hard work of the older generation of Alveolar Surgery scholars. However, contemporary challenges and issues, such as standardizing technology, promoting clinical practices, and talent cultivation, need to be addressed by present-day Alveolar Surgery professionals as they forge ahead.
8.Gluteal tendinitis and primary coxarthrosis may lead to iliotibial band syndrome:a Mendelian randomization study
Chen YAO ; Wenjia LI ; Ruiming PANG ; Jihong ZHOU
Journal of Southern Medical University 2024;44(9):1821-1830
Objective To analyze the causal relationship of gluteal tendinitis and primary coxarthrosis with the occurrence of iliotibial band syndrome using Mendelian randomization.Methods The GWAS data of gluteal tendinitis,primary coxarthrosis and iliotibial band syndrome were screened for high correlation single-nucleotide polymorphisms(SNPs).Mendelian randomization analysis was performed using random-effects inverse variance weighting(IVW),MR-Egger regression,and weighted median method to determine whether gluteal tendinitis and primary coxarthrosis were causally related with iliotibial band syndrome.Heterogeneity test,multiple validity test and sensitivity analysis,and clinical data analysis were used to verify the reliability of the results.Results Both gluteal tendinitis[IVW:OR(95%CI)=1.32(1.03-1.68),P=0.026]and primary coxarthrosis[IVW:OR(95%CI)=1.40(1.06-1.84),P=0.017]was positively correlated with iliotibial band syndrome.Conclusion Gluteal tendinitis and primary coxarthrosis may increase the risk of iliotibial band syndrome.
9.Clinical characteristics and prognosis of acute B-lymphoblastic leukemia complicated with chemotherapy-induced peripheral neuropathy in children
Xinyu ZHOU ; Jihong TANG ; Xiao XIAO ; Jun FENG ; Letian YANG ; Huan XU ; Yinyin WU
Basic & Clinical Medicine 2024;44(10):1394-1399
Objective To summarize the characteristics of chemotherapy-induced peripheral neuropathy(CIPN)in children with acute B-lymphoblast leukemia(B-ALL)and to identify the influencing factors and prognosis of CIPN.Methods The clinical data of 60 children with B-ALL admitted to the 29th Ward of the Department of Hematology and Oncology,Children's Hospital Affiliated to Soochow University from June 2020 to December 2023 who received chemotherapy and had finished chemotherapy for 6 months were retrospectively reviewed.Results There were 37 cases of B-ALL combined with CIPN;the incidence of CIPN was 61.7% .Increasing age of onset was a risk factor for CIPN in children[OR=1.209,95% CI(1.023-1.428),P=0.026]with the highest incidence of sensory nerve dysfunction(78.4% ).Electromyography indicated that B-ALL combined with CIPN was multiple peripheral neurogenic lesions with certain reversibility.In the induction stage of chemotherapy,13 cases(35.1% )showed CIPN,accounting for the highest proportion.The CIPN improvement rate 6 months after chemotherapy was 67.6%,the age of onset[OR=2.418,95% CI(0.212-2.106),P=0.018]and the severity of CIPN[OR=203.394,95% CI(2.29-18 065.04). P=0.02]were risk factors for poor prognosis of children with CIPN.The older the age of onset was,the higher the severity of CIPN and worse prognosis were found.Conclusions Children with B-ALL complicated with CIPN are reversible multiple peripheral nerve lesions,and the occurrence and outcome of CIPN is potentially related to individual differences of children.
10.The impact of patient gratitude on nurse creativity:testing the mediating role of job satisfaction and the moderating role of safety climate
Huiqin JIA ; Jihong WANG ; Yubo LI ; Mingjian ZHOU
Modern Hospital 2024;24(7):1026-1030
Objective This study aims to explore the impact of patient gratitude on nurse creativity and examine the me-diating role of job satisfaction and the moderating role of safety climate.Methods In May 2023,a questionnaire survey was con-ducted among all nurses in two county-level public hospitals in Yangquan City,using the Patient Gratitude Scale,Creativity Scale,Job Satisfaction Scale,and Safety Climate Scale.A total of 448 valid questionnaires were collected.Mediation and moder-ation effects were tested using SPSS 20.0 and Model 4 and Model 7 in the Process v3.0 plugin.Results Patient gratitude showed a significant positive correlation with job satisfaction and creativity(r=0.558,0.591,P<0.01),and job satisfaction showed a significant positive correlation with creativity(r=0.581,P<0.01).Job satisfaction partially mediated the relationship between patient gratitude and creativity(mediation effect value=0.1850,95%confidence interval[0.1190:0.2484]),ac-counting for 34.76%of the total effect.Safety climate moderated the relationship between patient gratitude and job satisfaction(β=-0.048,P<0.05).Conclusion Patient gratitude has a positive impact on nurse creativity through job satisfaction.Ad-ditionally,safety climate moderates the relationship between patient gratitude and job satisfaction.

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