1.Application of multi-reader multi-case design in evaluating artificial intelligence-assisted imaging diagnostic trials
Huiqin WAN ; Man XIANG ; Zhemin PAN ; Yingyi QIN ; Qian HE ; Jia HE
Academic Journal of Naval Medical University 2025;46(4):504-510
Objective To evaluate the clinical efficacy of artificial intelligence(AI)-assisted imaging diagnostic trials using multi-reader multi-case(MRMC)design,so as to provide a scientific basis for clinical evaluation of imaging diagnostic trials.Methods The MRMC design,widely used in imaging diagnostic trials,was adopted in this study.The Obuchowski-Rockette(OR)method of MRMC design was detailed,including model construction and test methods.A case study was conducted,collecting imaging data of 200 subjects from 3 hospitals,with 133 cases of rib fractures and 68 cases of non-rib fractures.Three radiologists reviewed all CT images of the subjects.The area under curve(AUC)value,sensitivity and specificity in detecting rib fractures between 2 reading modalities(radiologists with AI assistance vs radiologists reading independently)were compared.Results The AI-assisted reading group had an AUC value of 0.958,while the radiologist-independent reading group had an AUC value of 0.902,showing a significant difference(P<0.001).The overall sensitivity and specificity of the AI-assisted reading group were 0.970 and 0.946,respectively;while the sensitivity and specificity of the radiologist-independent reading group were 0.838 and 0.966,respectively.The difference of sensitivity between groups was 0.131(95%confidence interval[CI]0.091-0.171),and the difference of specificity was-0.020(95%CI-0.059-0.020),indicating a significant difference in sensitivity but not in specificity between AI-assisted and radiologist-independent reading groups.Both groups had positive likelihood ratios(+LR)greater than 10 and negative likelihood ratios(-LR)less than 0.2,with positive predictive values approaching 1,suggesting that the diagnostic accuracy of the AI-assisted imaging diagnostic trials was high.Conclusion The AI-assisted reading method demonstrates a significant advantage in enhancing diagnostic efficiency,not only improving the diagnostic accuracy and detection rate of rib fractures,but also improving the work efficiency of radiologists and optimizing hospital services.
2.Sample size estimation of radiological diagnostic tests in multireader multicase design
Man XIANG ; Huiqin WAN ; Zhemin PAN ; Qian HE ; Yingyi QIN ; Jia HE
Academic Journal of Naval Medical University 2025;46(5):693-698
Objective To estimate the sample size of radiological diagnostic tests in multireader multicase(MRMC)design,and to explore the numbers of readers and cases under 3 different inference situations:random-reader random-case,fixed-reader random-case,and random-reader fixed-case.Methods The images of 114 participants(45 cases diagnosed as aortic coarctation by the gold standard)in the Van Dyke dataset were used,and 5 radiologists read these images under 2 different magnetic resonance imaging(MRI)sequences(Spin-echo and Cine MRI)to obtain the pre-experiment data.Then Obuchowski-Rockette method was used to estimate sample size.Results The mean area under curve(AUC)of aortic coarctation determined by radiologists was 0.941(95%confidence interval[CI]0.899-0.983)with the Spin-echo MRI sequence,and 0.897(95%CI 0.837-0.957)with the Cine MRI sequence.When the effect size was 0.044 and the number of readers was 5,we needed 337 participants for random-reader random-case,162 participants for fixed-reader random-case,and 282 participants for random-reader fixed-case.Conclusion In MRMC design,we need both the number of readers and cases;the larger the number of readers,the smaller the cases required.We need more samples under the situation of random-reader random-case,when the number of readers is≥5.
3.Establishment of a LC-MS/MS method for detecting gamma-aminobutyric acid in plasma and its clinical application
Jia-qian QIN ; Lei CAO ; Ying-fei PENG ; Fang-jun CHEN ; Bai-shen PAN ; Bei-li WANG ; Wei GUO
Fudan University Journal of Medical Sciences 2025;52(5):708-716
Objective To establish a stable liquid chromatography-tandem mass spectrometry(LC-MS/MS)method for detecting gamma-aminobutyric acid(GABA)in plasma,and to evaluate the value of GABA detection in the diagnosis of sleep disorders.Methods GABA was detected using a UPLC Xevo TQs system.The method was pre-validated and its performance was verified to establish a reference range for healthy individuals.The difference in plasma GABA levels between apparently healthy individuals and patients with sleep disorders was compared.Results We employed deuterated compounds as isotopic internal standards and utilized an Amide chromatographic column for separation.The mobile phase was 0.050%formic acid in water and 90%acetonitrile in water containing 0.175%formic acid and 5 mmol/L ammonium acetate with gradient elution in the column temperature of 35℃.The linear range for the detection of GABA by LC-MS/MS was 0.05-10.00 μmol/L,with a lower limit of quantification of 0.02 μmol/L,the inter-day CV<3.00%and intra assay CV<4.00%,respectively,and the recovery rate was 101.06%-109.02%.The reference ranges for plasma GABA were established by analyzing 300 healthy controls stratified by age:18-34 years(0.08-0.15 μmol/L),35-49 years(0.10-0.20 μmol/L),and≥50 years(0.12-0.23 μmol/L).Then plasma GABA was used as a biomarker for auxiliary diagnosis of sleep disorders in analyzing 221 patients and 300 healthy controls,which revealed that AUC values were 0.510(P=0.850),0.686(P=0.002),and 0.890(P<0.001)in the groups of 18-34 years,35-49 years,and≥50 years,respectively,with optimal cut-off values of 0.09,0.10 and 0.11 μmol/L.Conclusion A reliable LC-MS/MS method for detecting GABA has been established,which can detect plasma GABA levels sensitively and accurately and can be used in assisting the clinical diagnosis of sleep disorders.
4.Performance analysis of the double-check standard process for ultrasound reports in health examinations
Zhuqing JIA ; Jingfeng CHEN ; Qian QIN ; Suying DING
Chinese Journal of Health Management 2025;19(6):452-456
Objective:To explore the application effect of double-check standard process for ultrasound reports in health examinations.Method:A historical control study design was used in this study. A total of 11 909 health examination ultrasound reports from the Health Center of the First Affiliated Hospital of Zhengzhou University from February to April in 2021 were selected by systematic sampling method, the double-check standard process was adopted in those reports. The existing problems were categorized, organized and analyzed, and relevant measures for continuous quality improvement were formulated. Then, 13 939 and 15 833 health examination ultrasound reports from February to April in 2022 and 2023 respectively were selected for effect analysis.Results:Compared with those in February to April in 2021, the overall (double-check), initial check and secondary check ultrasound report accuracy rates in February to April in 2023 increased by 5.73%, 3.07% and 1.99%, respectively ( χ2=132.58, 46.80, 127.44, all P<0.001). In terms of trend changes, from February to April 2021 to February to April 2023, the error rates of the following five issues all showed a declining trend: misspellings, inconsistencies between descriptions and conclusion, need for doctor′s signature on the report, missing images, and errors in thyroid/breast color Doppler grading ( χ2=98.93, 30.13/14.59, 3.98, 14.6, all P<0.05). The error rate of ultrasound reports after continuous quality improvement was significantly lower than before. Conclusion:The double-check standard process for ultrasound reports in health examinations can effectively improve the quality of health examination ultrasound reports.
5.Performance analysis of the double-check standard process for ultrasound reports in health examinations
Zhuqing JIA ; Jingfeng CHEN ; Qian QIN ; Suying DING
Chinese Journal of Health Management 2025;19(6):452-456
Objective:To explore the application effect of double-check standard process for ultrasound reports in health examinations.Method:A historical control study design was used in this study. A total of 11 909 health examination ultrasound reports from the Health Center of the First Affiliated Hospital of Zhengzhou University from February to April in 2021 were selected by systematic sampling method, the double-check standard process was adopted in those reports. The existing problems were categorized, organized and analyzed, and relevant measures for continuous quality improvement were formulated. Then, 13 939 and 15 833 health examination ultrasound reports from February to April in 2022 and 2023 respectively were selected for effect analysis.Results:Compared with those in February to April in 2021, the overall (double-check), initial check and secondary check ultrasound report accuracy rates in February to April in 2023 increased by 5.73%, 3.07% and 1.99%, respectively ( χ2=132.58, 46.80, 127.44, all P<0.001). In terms of trend changes, from February to April 2021 to February to April 2023, the error rates of the following five issues all showed a declining trend: misspellings, inconsistencies between descriptions and conclusion, need for doctor′s signature on the report, missing images, and errors in thyroid/breast color Doppler grading ( χ2=98.93, 30.13/14.59, 3.98, 14.6, all P<0.05). The error rate of ultrasound reports after continuous quality improvement was significantly lower than before. Conclusion:The double-check standard process for ultrasound reports in health examinations can effectively improve the quality of health examination ultrasound reports.
6.Establishment of a LC-MS/MS method for detecting gamma-aminobutyric acid in plasma and its clinical application
Jia-qian QIN ; Lei CAO ; Ying-fei PENG ; Fang-jun CHEN ; Bai-shen PAN ; Bei-li WANG ; Wei GUO
Fudan University Journal of Medical Sciences 2025;52(5):708-716
Objective To establish a stable liquid chromatography-tandem mass spectrometry(LC-MS/MS)method for detecting gamma-aminobutyric acid(GABA)in plasma,and to evaluate the value of GABA detection in the diagnosis of sleep disorders.Methods GABA was detected using a UPLC Xevo TQs system.The method was pre-validated and its performance was verified to establish a reference range for healthy individuals.The difference in plasma GABA levels between apparently healthy individuals and patients with sleep disorders was compared.Results We employed deuterated compounds as isotopic internal standards and utilized an Amide chromatographic column for separation.The mobile phase was 0.050%formic acid in water and 90%acetonitrile in water containing 0.175%formic acid and 5 mmol/L ammonium acetate with gradient elution in the column temperature of 35℃.The linear range for the detection of GABA by LC-MS/MS was 0.05-10.00 μmol/L,with a lower limit of quantification of 0.02 μmol/L,the inter-day CV<3.00%and intra assay CV<4.00%,respectively,and the recovery rate was 101.06%-109.02%.The reference ranges for plasma GABA were established by analyzing 300 healthy controls stratified by age:18-34 years(0.08-0.15 μmol/L),35-49 years(0.10-0.20 μmol/L),and≥50 years(0.12-0.23 μmol/L).Then plasma GABA was used as a biomarker for auxiliary diagnosis of sleep disorders in analyzing 221 patients and 300 healthy controls,which revealed that AUC values were 0.510(P=0.850),0.686(P=0.002),and 0.890(P<0.001)in the groups of 18-34 years,35-49 years,and≥50 years,respectively,with optimal cut-off values of 0.09,0.10 and 0.11 μmol/L.Conclusion A reliable LC-MS/MS method for detecting GABA has been established,which can detect plasma GABA levels sensitively and accurately and can be used in assisting the clinical diagnosis of sleep disorders.
7.Stains:recent research progress for endometriosis
Xian QIN ; Qian WANG ; Jia HOU ; Dongmei XU
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(5):488-494
Defined as a common gynecologic en-docrine disease,endometriosis is characterized by the presence of endometrium outside of the uterus cavity,affecting about 10%to 15%of reproductive-aged women worldwide.Moreover,Asian women tend to have a nine-fold increased risk of endome-triosis compared with their white counterparts in Europe and the United States.Endometriosis not only causes chronic pelvic pain,dysmenorrhea,painful sex and other pain symptoms,but also leads to infertility,pushing the patients into a state of fatigue,high sensitivity and anxiety,thus reduc-ing their quality of life.As the aging of Chinese pop-ulation intensifies and the women's childbearing age delays,it is highly urgent to find solutions to those gynecological endocrine diseases such as en-dometriosis,which hamper women's fertility.In re-cent years,studies have shown that patients with endometriosis have abnormal serum lipid metabo-lism and an increased risk of cardiovascular diseas-es.At the same time,as a type of cholesterol-lower-ing drug,statins can inhibit the progression of en-dometriosis at the cellular and animal levels.Also,a few clinical studies have exhibited that statins ex-ert a positive effect on the treatment of endometri-osis.Therefore,this article aims to review the re-searches regarding the relationship between endo-metriosis and the cardiovascular disease,as well as the research progress of statin therapy on endome-triosis based on the level of cells,animals and hu-man beings.
8.Mechanism of ginkgo flavonoid aglycone against doxorubicin-induced cardiotoxicity
Ying CAI ; Li QIAN ; Kailiang WANG ; Qin LI ; Chunhua LIU ; Jia SUN ; Jie PAN ; Yongjun LI ; Yuan LU
China Pharmacy 2024;35(6):659-664
OBJECTIVE To investigate the potential mechanism of the effect of ginkgo flavone aglycone (GA) against doxorubicin (DOX)-induced cardiotoxicity. METHODS The male ICR mice were randomized into control group (CON group), model group (DOX group) and GA+DOX group (GDOX group), with 12 mice in each group. The DOX group was injected with DOX solution at a dose of 3 mg/kg via tail vein every other day, and the GDOX group was given GA suspension intragastrically at a dose of 100 mg/kg every day+DOX solution at a dose of 3 mg/kg via tail vein every other day, for 15 consecutive days. After the end of administration, the serum levels of aspartate aminotransferase(AST), creatine kinase(CK), creatine kinase isoenzyme(CK- MB) and lactate dehydrogenase(LDH) in mice were detected in each group. Based on the metabolomics method, UHPLC-Q- Exactive Orbitrap HRMS method was used; based on principal component analysis (PCA) and orthogonal partial least squares- discriminant analysis (OPLS-DA), the differentially expressed metabolites (DEMs) were screened using the criteria of variable importance in the projection≥1, fold change of peak area>1 and P<0.05; biological analysis was conducted based on databases such as HMDB and PubChem. RESULTS Compared with CON group, serum levels of AST, CK, CK-MB and LDH were increased significantly in DOX group (P<0.05); compared with DOX group, the serum levels of the above indicators (except for CK-MB) were decreased significantly in GDOX group (P<0.05). PCA and OPLS-DA showed that myocardial tissue samples of CON group, DOX group and GDOX group were isolated completely. After database matching, 37 common DEMs were identified, among which 17 DEMs were significantly up-regulated in the DOX group and significantly down- regulated in the GDOX group, and 8 DEMs were significantly down-regulated in the DOX group and significantly up-regulated in the GDOX group; pathway enrichment involved the biosynthesis of unsaturated fatty acids, arachidonic acid metabolism, linoleic acid metabolism, taurine and hypotaurine metabolism; the key metabolites in the above pathways included docosahexaenoic acid, arachidonic acid, phosphatidylcholine (16∶0/18∶3) and taurine. CONCLUSIONS GA may regulate the biosynthesis of unsaturated fatty acids, arachidonic acid metabolism and other metabolic pathways by acting on the core metabolites such as docosahexaenoic acid and arachidonic acid, thus alleviating the cardiotoxic effects of DOX.
9.Correlation between the level of NT-proBNP and cardiorespiratory fitness of individuals following acute high altitude exposure
Ping-Ping LI ; Xiao-Wei YE ; Jie YANG ; Zhe-Xue QIN ; Shi-Zhu BIAN ; Ji-Hang ZHANG ; Xu-Bin GAO ; Meng-Jia SUN ; Zhen LIU ; Hai-Lin LYU ; Qian-Yu JIA ; Yuan-Qi YANG ; Bing-Jie YANG ; Lan HUANG
Medical Journal of Chinese People's Liberation Army 2024;49(9):998-1003
Objective To investigate the correlation between the level of N-terminal pro-Brain natriuretic peptide(NT-proBNP)and cardiorespiratory fitness following acute exposure to high altitude.Methods Forty-six subjects were recruited from the Second Affiliated Hospital of Army Medical University in June 2022,including 19 males and 27 females.After completing cardiopulmonary exercise test(CPET),serological detection of myocardial cell-related markers,and multiple metabolites at a plain altitude(300 meters above sea level),all subjects flew to a high-altitude location(3900 meters above sea level).Biomarker testing and CPET were repeated on the second and third days after arrival at high altitude.Changes in serum biomarker and key CPET indicators before and after rapid ascent to high altitude were compared,and the correlation between serum levels of various myocardial cell-related markers and metabolites and high altitude cardiorespiratory fitness was analyzed.Results Compared with the plain altitude,there was a significant decrease in maximal oxygen uptake after rapid ascent to high altitude[(25.41±6.20)ml/(kg.min)vs.(30.17±5.01)ml/(kg.min),P<0.001].Serum levels of NT-proBNP,Epinephrine(E),plasma renin activity(PRA),angiotensin Ⅱ(Ang Ⅱ),angiotensin-converting enzyme 2(ACE2)and leptin(LEP)significantly increased,with all differences being statistically significant(P<0.05)after acute high altitude exposure.In contrast,no statistically significant differences were observed for creatine kinase MB(CK-MB),cardiac troponin I(cTnI),myoglobin(Myo)and norepinephrine(NE)(P>0.05).Correlation analysis showed a significant negative correlation between NT-proBNP at plain altitude(r=-0.768,P<0.001)and at high altitude(r=-0.791,P<0.001)with maximal oxygen uptake at high altitude.Multivariate linear regression analysis indicated that maximal oxygen uptake at plain altitude(t=2.069,P=0.045),NT-proBNP at plain altitude(t=-2.436,P=0.020)and at high altitude(t=-3.578,P=0.001)were independent influencing factors of cardiorespiratory fitness at high altitude.Conclusion Cardiorespiratory fitness significantly decreases after rapid ascent to high altitude,and the baseline NT-proBNP level at plain altitude is closely related to cardiorespiratory fitness at high altitude,making it a potential predictor indicator for high altitude cardiorespiratory fitness.
10.Iodine Nutrition,Thyroid-stimulating Hormone,and Related Factors of Postpartum Women from three Different Areas in China:A Cross-sectional Survey
Yun Xiao SHAN ; Yan ZOU ; Chun Li HUANG ; Shan JIANG ; Wen Wei ZHOU ; Lan Qiu QIN ; Qing Chang LIU ; Yan Xiao LUO ; Xi Jia LU ; Qian De MAO ; Min LI ; Yu Zhen YANG ; Chen Li YANG
Biomedical and Environmental Sciences 2024;37(3):254-265
Objective Studies on the relationship between iodine,vitamin A(VA),and vitamin D(VD)and thyroid function are limited.This study aimed to analyze iodine and thyroid-stimulating hormone(TSH)status and their possible relationships with VA,VD,and other factors in postpartum women. Methods A total of 1,311 mothers(896 lactating and 415 non-lactating)from Hebei,Zhejiang,and Guangxi provinces were included in this study.The urinary iodine concentration(UIC),TSH,VA,and VD were measured. Results The median UIC of total and lactating participants were 142.00 μg/L and 139.95 μg/L,respectively.The median TSH,VA,and VD levels in all the participants were 1.89 mIU/L,0.44 μg/mL,and 24.04 ng/mL,respectively.No differences in the UIC were found between lactating and non-lactating mothers.UIC and TSH levels were significantly different among the three provinces.The rural UIC was higher than the urban UIC.Obese mothers had a higher UIC and a higher prevalence of excessive TSH.Higher UICs and TSHs levels were observed in both the VD deficiency and insufficiency groups than in the VD-sufficient group.After adjustment,no linear correlation was observed between UIC and VA/VD.No interaction was found between vitamins A/D and UIC on TSH levels. Conclusion The mothers in the present study had no iodine deficiency.Region,area type,BMI,and VD may be related to the iodine status or TSH levels.

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