Objective To discuss the status of cesarean section in Shao Xing area, to investigate the indications of cesarean section rate and to study the possibility and feasibility for decreasing it. Methods All pregnant women and obstetricians of seven hospitals were asked to answer a designed questionaire, then the indications of cesarean section were appraised by the experts. Results The average cesarean section rate was 46.1%, the indications for cesarean section were as followed: cephalopelvic disproportion, fetal distress, social factors, proper indications for cesarean section were 74.0%. Conclusions The cesarean section rate can be decreased to 30% and less with the current standard of practice.

Objective To establish the diagnostic criteria for polypoidal choroidal vasculopathy (PCV) based on spectral-domain optical coherence tomography (SD OCT) by evaluating the sensitivity and specificity of SD OCT in differentiating PCV from wet age-related macular degeneration (wAMD).Methods The clinical data were reviewed for 62 patients (63 eyes) with the initial diagnosis of PCV or wAMD between August,2012 and June,2016.Twenty-four patients (25 eyes) were diagnosed to have PCV and 38 (38 eyes) had wAMD based on findings by fundus photography,fluorescein angiography (FFA) and indocyanine green angiography (ICGA).Among the 6 features of SD OCT,namely a sharp RPED peak,double-layer sign,multiple RPED,an RPED notch,a hyporeflecfive lumen representing polyps,and hyperreflecfive intraretinal hard exudates,findings of the first two features and at least one of the other features sufficed the diagnosis of PCV;in the absence of the first two features,the diagnosis of PCV was also made when at least 3 of the other features were present simultaneously.The sensitivity and specificity of SD OCT-based diagnosis were estimated by comparison with the gold standard ICGA-based diagnosis.Results In the 25 eyes with an established diagnosis of PCV,23 eyes (92.0％) met the diagnostic criteria based on SD OCT findings;in the 38 eyes with the diagnosis of wAMD,only 4 eyes (10.5％) met the criteria.The sensitivity and specificity of SD OCT-based diagnosis of PCV was 92.0％ and 89.5％,respectively.Conclusions We established the diagnostic criteria for PCV based on SD OCT findings with a high sensitivity and specificity.SD OCT shows a strong capacity for differentiating PCV from wAMD.

With the rapid development and widespread application of artificial intelligence(AI)technology,it has brought convenience to people's lives and work,while bringing a series of ethical challenges such as lack of transparency,privacy leakage,limited autonomy in decision-making,and blurred responsibility attribution.By comparing the ethical risk governance of the application of AI in the medical field,this paper systematically analyzed 30 policy regulations issued by 10 countries and international organizations,revealing the consensus and differences in ethical governance of medical AI internationally.The results showed that transparency,fairness and justice,non-harm,privacy protection,freedom and autonomy,responsibility,and people-oriented principles were seven internationally recognized ethical principles,providing important guidance for building a safe,trustworthy,and humane-respecting medical AI ecosystem.In addition,this paper deeply compared the risk assessment methods in the guidelines of China,the United States,and the European Union,as well as found differences in risk types,risk grading,and risk assessment process standards.These differences not only reflect diversities in different cultural,legal backgrounds,and regulatory concepts,but also highlight the necessity of strengthening international cooperation in the context of globalization.Therefore,it is recommended to develop ethical risk governance standards and norms for medical AI that applicable to China's national conditions.Based on drawing on international experience,proactively carry out risk assessments,reduce ethical challenges,and promote the healthy and rational application of medical AI technology.

Objective To establish the diagnostic criteria for polypoidal choroidal vasculopathy (PCV) based on spectral-domain optical coherence tomography (SD OCT) by evaluating the sensitivity and specificity of SD OCT in differentiating PCV from wet age-related macular degeneration (wAMD).Methods The clinical data were reviewed for 62 patients (63 eyes) with the initial diagnosis of PCV or wAMD between August,2012 and June,2016.Twenty-four patients (25 eyes) were diagnosed to have PCV and 38 (38 eyes) had wAMD based on findings by fundus photography,fluorescein angiography (FFA) and indocyanine green angiography (ICGA).Among the 6 features of SD OCT,namely a sharp RPED peak,double-layer sign,multiple RPED,an RPED notch,a hyporeflecfive lumen representing polyps,and hyperreflecfive intraretinal hard exudates,findings of the first two features and at least one of the other features sufficed the diagnosis of PCV;in the absence of the first two features,the diagnosis of PCV was also made when at least 3 of the other features were present simultaneously.The sensitivity and specificity of SD OCT-based diagnosis were estimated by comparison with the gold standard ICGA-based diagnosis.Results In the 25 eyes with an established diagnosis of PCV,23 eyes (92.0％) met the diagnostic criteria based on SD OCT findings;in the 38 eyes with the diagnosis of wAMD,only 4 eyes (10.5％) met the criteria.The sensitivity and specificity of SD OCT-based diagnosis of PCV was 92.0％ and 89.5％,respectively.Conclusions We established the diagnostic criteria for PCV based on SD OCT findings with a high sensitivity and specificity.SD OCT shows a strong capacity for differentiating PCV from wAMD.

Objective:The aim is to construct an evaluation framework for clinical research benefits,and provide a reference for the formulate of evaluation standards for clinical research benefits.Methods:The Delphi method was used to carry out expert consultation,and the mean,score of importance,coefficient of variation and coordination,etc.of evaluation indicators were summarized and calculated,to screen evaluation indicators for clinical research benefits.Results:Twenty-three experts in this field were selected for correspondence,and their enthusiasm was 100%in both rounds,the authority coefficients were≥0.90,and Kendall's coefficients of concordance were<0.25(P<0.001).By referring to the mean and coefficient of variation of the indicators,as well as combining them with expert suggestions,an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators,5 secondary indicators,and 8 tertiary indicators.Conclusion:The evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits,as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.

【Objective:】 To deeply understand the current situation and hotspots of drug clinical trials risk management in China. 【Methods:】 Co-word analysis and social network analysis were used to sort out the study results of risk management in drug clinical trials in China. 【Results:】 The trend of risk research of drug clinical trials in China was generally on the rise. The research hotspots focused on four areas: drug supervision and pharmacovigilance, risk management of drug clinical trial institutions, ethical review of drug clinical trials, and risk management of drug clinical trials. 【Conclusion:】 In the future, China should gradually improve the risk management system and supervision system of drug clinical trials, explore to establish a risk-based quality management and ethical review system of drug clinical trials, and enhance the risk assessment and coping ability of institutions.

【Objective:】 To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China. 【Methods:】 The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China, and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks. 【Results:】 The risk categories of drug clinical trials were divided into 5 parts, namely drug clinical trial institution management, ethics committee management, clinical trial designs, researchers, and subjects, involving 13 main risk influencing factors and 21 specific risk points. 【Conclusion:】 By strengthening the construction of drug clinical trial institutions and ethical management capabilities, optimizing research protocol design, enhancing researchers’ awareness and ability, and establishing a subject management system to improve the quality of drug clinical trials.

Conducting ethical review of investigator-initiated trials （IIT） is one of the important links to ensure the quality of research projects. Currently， the quality of ethical review for IIT projects is greatly influenced by the personal factors of committee members， which to some extent affects the ethical review committee’s judgments of research risks and benefits. Based on the previously developed Risk-Benefit Assessment Scale for Clinical Research， this paper established an ethical review decision-making pathway based on risk-benefit assessment， that is， proposed the “four-step method” for ethical review risk-benefit assessment， including evaluating the research benefits， assessing the research risks， constructing a risk-benefit matrix， and establishing an ethical review pathway. The “four-step method” helps to reduce the impact of committee members’ subjective/intuitive judgments on the quality of ethical review， assists in promoting the implementation of multi-center ethical review policy， narrows the gap in the quality of ethical review among different medical institutions， and provides clearer guidance for the risk judgments of scientific research management and ethical review departments.

OBJECTIVE: To evaluate the value of fundus autofluorescence (FAF) imaging combined with spectral domain optical coherence tomography (SD-OCT) in diagnosis, prognostic assessment and follow-up observation of acute Vogt-KoyanagiHarada (VKH) disease. METHODS: Clinical data were collected from 12 patients (23 eyes) with acute VKH disease treated in our hospital from May, 2018 to November, 2019, including detailed medical history, best corrected visual acuity (BCVA), and results of slit lamp biomicroscopy, fundus photography, SD-OCT, fundus fluorescein angiography (FFA) and FAF imaging.SDOCT and FAF imaging were repeated after a course of treatment and in follow-up examination, and the results were compared with those at the time of admission. RESULTS: VKH disease involved both eyes in 11 patients (91.7%).Fundus photography showed optic disc edema in 16 eyes (69.6%), and multiple retinal neuroepithelial detachment was detected by SD-OCT in all the involved eyes (100%).IN all the eyes, FFA revealed small and dense fluorescein leakage in the early stage and fluorescein accumulation in advanced stages of VHK disease to form multiple dye pooling in the areas of serous detachment.Hyperauto fluorescence was a common finding in FAF imaging (100%), and the area involved was consistent with that of fluorescein accumulation shown by FAF imaging.Ten eyes (43.5%) showed patches of relative hypoautofluorescence in the hyperauto fl uorescence areas, and granular hyperauto fl uorescence was found in the lesions in 4 eyes (17.4%).During the remission period of VKH disease, FAF imaging showed normal finding in 8 eyes (34.8%) and reduced areas (by 55.2%) and intensity (by 46.5%) of hyperautofluorescence in 9 eyes (39.1%).In 6 eyes (26.1%), only a few hyperautofluorescent spots scattered in the macula were observed.SD-OCT demonstrated significantly reduced (by 69.5% on average) or even disappearance of subretinal fluid in the eyes.The fluorescence intensity in FAF imaging showed a significant positive correlation with the volume of subretinal fluid detected by SD-OCT ( CONCLUSIONS The combination of fluorescein angiography, FAF imaging and SD-OCT can significantly improve the diagnostic accuracy of VKH disease.FAF imaging combined with SD-OCT provides an effective and noninvasive modality for evaluation of remission and monitoring the changes in VKH disease.
Acute Disease ; Fluorescein Angiography ; Follow-Up Studies ; Humans ; Retinal Detachment/diagnostic imaging* ; Tomography, Optical Coherence ; Uveomeningoencephalitic Syndrome/diagnostic imaging*

Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.