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.

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.

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.

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.

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.

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.

Objective To investigate the risk factors for bronchopulmonary dysplasia(BPD)in twin preterm infants with a gestational age of<34 weeks,and to provide a basis for early identification of BPD in twin preterm infants in clinical practice.Methods A retrospective analysis was performed for the twin preterm infants with a gestational age of<34 weeks who were admitted to 22 hospitals nationwide from January 2018 to December 2020.According to their conditions,they were divided into group A(both twins had BPD),group B(only one twin had BPD),and group C(neither twin had BPD).The risk factors for BPD in twin preterm infants were analyzed.Further analysis was conducted on group B to investigate the postnatal risk factors for BPD within twins.Results A total of 904 pairs of twins with a gestational age of<34 weeks were included in this study.The multivariate logistic regression analysis showed that compared with group C,birth weight discordance of>25%between the twins was an independent risk factor for BPD in one of the twins(OR=3.370,95%CI:1.500-7.568,P<0.05),and high gestational age at birth was a protective factor against BPD(P<0.05).The conditional logistic regression analysis of group B showed that small-for-gestational-age(SGA)birth was an independent risk factor for BPD in individual twins(OR=5.017,95%CI:1.040-24.190,P<0.05).Conclusions The development of BPD in twin preterm infants is associated with gestational age,birth weight discordance between the twins,and SGA birth.

OBJECTIVE: To investigate whether the combination of chemotherapy with staged Chinese herbal medicine (CHM) therapy could enhance health-related quality of life (QoL) in non-small-cell lung cancer (NSCLC) patients and prolong the time before deterioration of lung cancer symptoms, in comparison to chemotherapy alone. METHODS: A prospective, double-blind, randomized, controlled trial was conducted from December 14, 2017 to August 28, 2020. A total of 180 patients with stage I B-IIIA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM (chemo+CHM) group (120 cases) or chemotherapy combined with placebo (chemo+placebo) group (60 cases) using stratified blocking randomization. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life-Core 30 Scale (QLQ-C30) was used to evaluate the patient-reported outcomes (PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC. Adverse events (AEs) were assessed in the safety analysis. RESULTS: Out of the total 180 patients, 173 patients (116 in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses. The initial mean QLQ-C30 Global Health Status (GHS)/QoL scores at baseline were 57.16 ± 1.64 and 57.67 ± 2.25 for the two respective groups (P>0.05). Compared with baseline, the chemo+CHM group had an improvement in EORTC QLQ-C30 GHS/QoL score at week 18 [least squares mean (LSM) change 17.83, 95% confidence interval (CI) 14.29 to 21.38]. Conversely, the chemo+placebo group had a decrease in the score (LSM change -13.67, 95% CI -22.70 to -4.63). A significant between-group difference in the LSM GHS/QoL score was observed, amounting to 31.63 points (95% CI 25.61 to 37.64, P<0.001). The similar trends were observed in physical functioning, fatigue and appetite loss. At week 18, patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group (P<0.001). The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio (HR)=0.33, 95% CI 0.23 to 0.48, P<0.0010], physical functioning (HR=0.43, 95% CI 0.25 to 0.75, P=0.0005), fatigue (HR=0.47, 95% CI 0.30 to 0.72, P<0.0001) and appetite loss (HR=0.65, 95% CI 0.42 to 1.00, P=0.0215). The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group (9.83% vs. 15.79%, P=0.52). CONCLUSION The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy, which is worthy of further clinical research. (Registry No. NCT03372694).
Humans ; Carcinoma, Non-Small-Cell Lung/surgery* ; Male ; Middle Aged ; Female ; Lung Neoplasms/pathology* ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Chemotherapy, Adjuvant ; Patient Reported Outcome Measures ; Quality of Life ; Aged ; Postoperative Period ; Prospective Studies

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

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.