1.Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies
Qingyong ZHENG ; Yongjia ZHOU ; Tengfei LI ; Jianguo XU ; Chen TIAN ; Hui LIU ; Min TIAN ; Ziyu ZHOU ; Caihua XU ; Yating CUI ; Junfei WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2026;46(1):138-148
Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.
2.A Survey on the Perceived Experience and Acceptance of Intrapartum Ultrasound as a Novel Method for Labor Progress Assessment
Xinjuan CHEN ; Jinhui CUI ; Liping OUYANG ; Ling LI ; Jianhui FAN ; Ping LI
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(3):535-540
ObjectiveTo investigate the perceived experience and acceptance of intrapartum ultrasound (IPUS) as a novel method for labor progress assessment among pregnant women. MethodsFrom February 2023 to December 2024, a total of 180 pregnant women admitted to the Labor Ward of Lingnan Hospital, the Third Affiliated Hospital of Sun Yat-sen University, who were planned for vaginal trial of labor , were accessed for labor progress using IPUS and vaginal examination (VE) after the onset of labor and prior to the initiation n of labor analgesia. A self-designed questionnaire was used to investigate the women's perceived experiences with both examination methods and their acceptance of IPUS. The pain intensity associated with the examinations was evaluated using the visual analogue pain scale (VAS). Differences in the women's experiences and pain intensity between the two labor progress assessment methods were compared. ResultsThe acceptance rate of IPUS was 96.67% (174/180), with the remaining 6 cases undecided. Over 60% of the pregnant women reported IPUS assessment as comfortable and none of them felt discomfort, whereas 32.8% felt uncomfortable with VE (χ2=196.02, P<0.001). Nearly two-thirds of the pregnant women believed that VE would cause psychological distress, while none reported such effect with IPUS (χ2=261.52, P<0.001). Approximately 77.78% (140/180) of the pregnant women believed that IPUS could reduce their fear of vaginal delivery and enhance their confidence if it replaced VE. The VAS score for IPUS [0 (0, 2)] was significantly lower than that for VE [4 (4, 6)] (Z=-14.62, P<0.001). Further stratified analysis showed that over 90% (164/180) of the pregnant women found IPUS painless, with no moderate or severe pain reported, compared to 43.33% (78/180) experienced moderate or severe pain with VE (P<0.001). ConclusionAs a novel approach for labor progress assessment, IPUS not only alleviates the pain and discomfort associated with traditional VE and reduces the fear of childbirth but also enhances women's confidence in delivery, thereby achieving a high level of acceptance among parturient women in China.
3.T1WI deep learning models for evaluating brain injury of neonatal hyperbilirubinemia
Jingwei CUI ; Yongchao NIU ; Beichen XIE ; Chang LIU ; Jinhui DUAN ; Qin XUE ; Ruifang YAN
Chinese Journal of Medical Imaging Technology 2025;41(3):394-398
Objective To observe the value of T1WI deep learning models for evaluating brain injury of neonatal hyperbilirubinemia(NHB).Methods Totally 106 NHB(defined as newborns with neonatal behavioral neurological assessment≤37,NHB group)and 119 non-NHB newborns(control group)in center A,as well as 34 NHB and 18 non-NHB newborns in center B were collected.ROI was delineated based on bilateral globus pallidus on T1WI.A total of 690 slices were obtained by preprocessing data of center A and then were divided into training set(n=552)and test set(n=138)at a ratio of 8∶2.ResNet18,DenseNet121 and EfficientNetB0 models was established,respectively.External validation was performed based on data of center B.Receiver operating characteristic curves were drawn,area under the curves(AUC)were calculated to evaluate the performance of models for assessing NHB brain injuries compared with traditional visual analysis.Results The AUC of ResNet18 model for evaluating NHB brain injury was 0.910-0.990,significantly higher than that of DenseNet121 model(0.710-0.820)and EfficientNetB0 model(0.640-0.740)(all P<0.001).The accuracy,sensitivity and precision of ResNet18 model for evaluating NHB brain injury were all higher than those of visual analysis(all P<0.05),while no significant difference of specificity was found between the above two(P>0.05).Conclusion T1WI ResNet18 model showed excellent performance and generalization ability for evaluating NHB brain injury.
4.Biomechanical Comparison of Different Repair Methods for Inferior Pole Fracture of the Patella
Yulin XU ; Yuangui TANG ; Yongkang CUI ; Yuchuan LIU ; Tao WANG ; Wanyin QI ; Jinhui LIU ; Cheng LIANG
Journal of Medical Biomechanics 2025;40(1):100-105
Objective To conduct a comparative study on the biomechanical performance of using sutures for repairing inferior pole patellar fractures.Methods Compared to the normal patellar structure(Group A),four repair methods,namely,'Krackow'suture(Group B),"Kessler"fixation(Group C),'8-figure'mesh method(Group D),and modified suture bridge(Group E)were adopted.The static stiffness and dynamic stability of inferior pole patellar fractures fixed by each repair method were measured at 30°,60°,and 90° knee flexion.Results The stiffness at all flexion angles in Group E was closer to that in Group A,compared to other repair groups,followed by Group B,then Group D,and finally Group C.After the first cycle,at 30° knee flexion,Group C showed the greatest displacement,while Groups B and E had slightly larger displacements than the Group A,and the displacement of Group D was smaller than that of Group A.At 60° and 90° knee flexion,the displacement in all repair groups was smaller than that of Group A.After 200 cycles in the subsequent three cycles,displacement changes in all repair groups were smaller than those in Group A.Conclusions All repair methods were effective.In terms of biomechanical fixation performance,the modified suture bridge was superior to the'Krackow'suture and'8-figure'mesh,with Kessler fixation being the least effective.However,factors such as the injury severity,incision location,and surgical time should be comprehensively considered in actual clinical use,and it is recommended that the repair method should be selected in the following order:E,B,D,and C.
5.Clinical efficacy of endoscopic lumbar interbody fusion versus minimally invasive transforaminal lumbar interbody fusion in the treatment of lumbar disc herniation in older adult patients
Ming JIN ; Jinhui ZHAO ; Jiangong CUI
Chinese Journal of Primary Medicine and Pharmacy 2025;32(5):681-687
Objective:To investigate the clinical efficacy of endoscopic lumbar interbody fusion (Endo-LIF) versus minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in the treatment of lumbar disc herniation in older adult patients. Methods:The medical records of 120 older adult patients with lumbar disc herniation who underwent surgical treatment at Tunliu Hospital, The Second People's Hospital of Changzhi from January 2021 to January 2023 were retrospectively collected. According to different surgical methods, the patients were divided into the Endo-LIF group and the MIS-TLIF group, with 60 patients in each group. Surgery-related indicators, Visual Analog Scale score, Oswestry Disability Index score, the Japanese Orthopaedic Association score, imaging indicators, complications, and patient satisfaction were compared between the two groups.Results:Patients in the Endo-LIF group had shorter surgery duration [(76.29 ± 8.35) minutes vs. (80.85 ± 9.15) minutes, t = -11.93, P < 0.001], less intraoperative bleeding [(31.37 ± 4.57) mL vs. (45.47 ± 6.26) mL, t = -9.66, P < 0.001], shorter postoperative bed rest duration [(1.02 ± 0.54) days vs. (2.51 ± 0.83) days, t = -5.49, P = 0.042], and shorter hospital stay [(5.25 ± 1.67) days vs. (7.43 ± 2.82) days, t = -5.16, P = 0.039] compared with the MIS-TLI group. The Endo-LIF group had more intraoperative fluoroscopy sessions [(7.62 ± 2.63) times vs. (6.91 ± 1.84) times, t = 8.53, P < 0.001] compared with the MIS-TLI group. There were no statistically significant differences in Visual Analog Scale score, Oswestry Disability Index score, or Japanese Orthopaedic Association score between the two groups before and after intervention (all P > 0.05). There were no significant differences in intervertebral height index and range of motion of the affected segments between the two groups before and after intervention (both P > 0.05). The incidence of complications did not differ significantly between the two groups ( P > 0.05). However, patient satisfaction was higher in the Endo-LIF group compared with the MIS-TLI group [91.67% (55/60) vs. 78.33% (13/60), χ2 = 4.18, P = 0.041]. Conclusions:The postoperative recovery indicators at 3 months were comparable between the Endo-LIF and MIS-TLI procedures; however, the surgical indicators for the Endo-LIF procedure were more favorable. Therefore, Endo-LIF is recommended for older adult patients with lumbar disc herniation.
6.Study on transmission characteristics and genetic variation of carbapenem-resistant Klebsiella pneumonia based on whole genome sequencing
Jiachen LI ; Yanying CHEN ; Yanlei GE ; Jinrui HU ; Xiaoli DU ; Jinyue LIU ; Huan XING ; Pengfang GAO ; Xiao HAN ; Yuelong LI ; Yating TANG ; Juan LI ; Zhigang CUI ; Jinhui ZHANG ; Haijian ZHOU ; Aiying DONG
Chinese Journal of Preventive Medicine 2025;59(6):892-900
Objective:To analyze the short-term hospital-based transmission characteristics and gene variation of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) by genome-wide technique to provide evidence for transmission control. Methods:The experimental strain was derived from all the CRKP isolated in Affiliated Hospital of North China University of Science and Technology from October 2022 to December 2023. Strain identification and drug susceptibility were tested with VITEK 2-Compact automatic bacterial identification drug susceptibility analyzer or disk method, and the results were interpreted through whole genome sequencing. The ST type, carbapenem resistance gene, virulence factor, and O serotype of the collected strains were analyzed.Results:Among the 115 strains of CRKP, 94 strains were isolated from the intensive care unit (ICU), accounting for 81.7%, and 21 strains were isolated from the non-intensive care unit (NICU), accounting for 18.3%. The 115 strains of CRKP can be divided into 11 ST types, of which ST11 type was the most (54.8%, 63/115), followed by ST15 type (22.6%, 26/115) and ST5492 type (15.7%, 18/115). Type ST5492 was a new clonal group in the region. The 115 strains of CRKP could be divided into 7 O serotypes, most of which were O2a type(32.2%,37/115), followed by O5 type(30.4%,35/115) and O1 type(27.8%,32/115). The resistance genes of carbapenem antibiotics showed that there were 107 strains carrying the blaKPC-2 gene, one strain with the blaNDM-1 gene, and one strain with both the blaKPC-2 and blaNDM-13 genes. Virulence genes were detected in 55 CRKP strains (47.8%, 55/115), among which six strains detected peg-344, iucA, iroB, rmpA, and rmpA2 virulence genes (5.2%, 6/115). Four virulence genes ( peg-344, iucA, rmpA, and rmpA2) were detected in 34 strains (29.6%, 34/115). Three virulence genes ( iucA, iroB and rmpA) were detected in two strains (1.7%, 2/115). Three virulence genes ( peg-344, iucA and rmpA) were detected in one strain (0.8%, 1/115). IucA and rmpA virulence genes were detected in 12 strains (10.4%, 12/115). KPC-2_ST11_O2a, KPC-2_ST15_O1 and KPC-2_ST5492_O5 were dominant clones, and their distribution was mainly in the intensive care unit. The whole genome sequence analysis showed that there were three dominant clones, among which ST11 clones were subdivided into three dominant O serotypes, all of which were mainly in the intensive care unit. Conclusion:The popular strain in the hospital of CRKP is a KPC-2_ST11 clone group carrying iucA, rmpA/rmpA2, with cross-department transmission and mutation. ST5492 is a newly-launched clone type. The intensive care unit of hvKP carrying five virulence genes, including peg-344, should be alert to the epidemic risk of CR-hvKP outbreak.
7.ResNet-Vision Transformer based MRI-endoscopy fusion model for predicting treatment response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: A multicenter study.
Junhao ZHANG ; Ruiqing LIU ; Di HAO ; Guangye TIAN ; Shiwei ZHANG ; Sen ZHANG ; Yitong ZANG ; Kai PANG ; Xuhua HU ; Keyu REN ; Mingjuan CUI ; Shuhao LIU ; Jinhui WU ; Quan WANG ; Bo FENG ; Weidong TONG ; Yingchi YANG ; Guiying WANG ; Yun LU
Chinese Medical Journal 2025;138(21):2793-2803
BACKGROUND:
Neoadjuvant chemoradiotherapy followed by radical surgery has been a common practice for patients with locally advanced rectal cancer, but the response rate varies among patients. This study aimed to develop a ResNet-Vision Transformer based magnetic resonance imaging (MRI)-endoscopy fusion model to precisely predict treatment response and provide personalized treatment.
METHODS:
In this multicenter study, 366 eligible patients who had undergone neoadjuvant chemoradiotherapy followed by radical surgery at eight Chinese tertiary hospitals between January 2017 and June 2024 were recruited, with 2928 pretreatment colonic endoscopic images and 366 pelvic MRI images. An MRI-endoscopy fusion model was constructed based on the ResNet backbone and Transformer network using pretreatment MRI and endoscopic images. Treatment response was defined as good response or non-good response based on the tumor regression grade. The Delong test and the Hanley-McNeil test were utilized to compare prediction performance among different models and different subgroups, respectively. The predictive performance of the MRI-endoscopy fusion model was comprehensively validated in the test sets and was further compared to that of the single-modal MRI model and single-modal endoscopy model.
RESULTS:
The MRI-endoscopy fusion model demonstrated favorable prediction performance. In the internal validation set, the area under the curve (AUC) and accuracy were 0.852 (95% confidence interval [CI]: 0.744-0.940) and 0.737 (95% CI: 0.712-0.844), respectively. Moreover, the AUC and accuracy reached 0.769 (95% CI: 0.678-0.861) and 0.729 (95% CI: 0.628-0.821), respectively, in the external test set. In addition, the MRI-endoscopy fusion model outperformed the single-modal MRI model (AUC: 0.692 [95% CI: 0.609-0.783], accuracy: 0.659 [95% CI: 0.565-0.775]) and the single-modal endoscopy model (AUC: 0.720 [95% CI: 0.617-0.823], accuracy: 0.713 [95% CI: 0.612-0.809]) in the external test set.
CONCLUSION
The MRI-endoscopy fusion model based on ResNet-Vision Transformer achieved favorable performance in predicting treatment response to neoadjuvant chemoradiotherapy and holds tremendous potential for enabling personalized treatment regimens for locally advanced rectal cancer patients.
Humans
;
Rectal Neoplasms/diagnostic imaging*
;
Magnetic Resonance Imaging/methods*
;
Male
;
Female
;
Middle Aged
;
Neoadjuvant Therapy/methods*
;
Aged
;
Adult
;
Chemoradiotherapy/methods*
;
Endoscopy/methods*
;
Treatment Outcome
8.T1WI deep learning models for evaluating brain injury of neonatal hyperbilirubinemia
Jingwei CUI ; Yongchao NIU ; Beichen XIE ; Chang LIU ; Jinhui DUAN ; Qin XUE ; Ruifang YAN
Chinese Journal of Medical Imaging Technology 2025;41(3):394-398
Objective To observe the value of T1WI deep learning models for evaluating brain injury of neonatal hyperbilirubinemia(NHB).Methods Totally 106 NHB(defined as newborns with neonatal behavioral neurological assessment≤37,NHB group)and 119 non-NHB newborns(control group)in center A,as well as 34 NHB and 18 non-NHB newborns in center B were collected.ROI was delineated based on bilateral globus pallidus on T1WI.A total of 690 slices were obtained by preprocessing data of center A and then were divided into training set(n=552)and test set(n=138)at a ratio of 8∶2.ResNet18,DenseNet121 and EfficientNetB0 models was established,respectively.External validation was performed based on data of center B.Receiver operating characteristic curves were drawn,area under the curves(AUC)were calculated to evaluate the performance of models for assessing NHB brain injuries compared with traditional visual analysis.Results The AUC of ResNet18 model for evaluating NHB brain injury was 0.910-0.990,significantly higher than that of DenseNet121 model(0.710-0.820)and EfficientNetB0 model(0.640-0.740)(all P<0.001).The accuracy,sensitivity and precision of ResNet18 model for evaluating NHB brain injury were all higher than those of visual analysis(all P<0.05),while no significant difference of specificity was found between the above two(P>0.05).Conclusion T1WI ResNet18 model showed excellent performance and generalization ability for evaluating NHB brain injury.
9.Study on transmission characteristics and genetic variation of carbapenem-resistant Klebsiella pneumonia based on whole genome sequencing
Jiachen LI ; Yanying CHEN ; Yanlei GE ; Jinrui HU ; Xiaoli DU ; Jinyue LIU ; Huan XING ; Pengfang GAO ; Xiao HAN ; Yuelong LI ; Yating TANG ; Juan LI ; Zhigang CUI ; Jinhui ZHANG ; Haijian ZHOU ; Aiying DONG
Chinese Journal of Preventive Medicine 2025;59(6):892-900
Objective:To analyze the short-term hospital-based transmission characteristics and gene variation of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) by genome-wide technique to provide evidence for transmission control. Methods:The experimental strain was derived from all the CRKP isolated in Affiliated Hospital of North China University of Science and Technology from October 2022 to December 2023. Strain identification and drug susceptibility were tested with VITEK 2-Compact automatic bacterial identification drug susceptibility analyzer or disk method, and the results were interpreted through whole genome sequencing. The ST type, carbapenem resistance gene, virulence factor, and O serotype of the collected strains were analyzed.Results:Among the 115 strains of CRKP, 94 strains were isolated from the intensive care unit (ICU), accounting for 81.7%, and 21 strains were isolated from the non-intensive care unit (NICU), accounting for 18.3%. The 115 strains of CRKP can be divided into 11 ST types, of which ST11 type was the most (54.8%, 63/115), followed by ST15 type (22.6%, 26/115) and ST5492 type (15.7%, 18/115). Type ST5492 was a new clonal group in the region. The 115 strains of CRKP could be divided into 7 O serotypes, most of which were O2a type(32.2%,37/115), followed by O5 type(30.4%,35/115) and O1 type(27.8%,32/115). The resistance genes of carbapenem antibiotics showed that there were 107 strains carrying the blaKPC-2 gene, one strain with the blaNDM-1 gene, and one strain with both the blaKPC-2 and blaNDM-13 genes. Virulence genes were detected in 55 CRKP strains (47.8%, 55/115), among which six strains detected peg-344, iucA, iroB, rmpA, and rmpA2 virulence genes (5.2%, 6/115). Four virulence genes ( peg-344, iucA, rmpA, and rmpA2) were detected in 34 strains (29.6%, 34/115). Three virulence genes ( iucA, iroB and rmpA) were detected in two strains (1.7%, 2/115). Three virulence genes ( peg-344, iucA and rmpA) were detected in one strain (0.8%, 1/115). IucA and rmpA virulence genes were detected in 12 strains (10.4%, 12/115). KPC-2_ST11_O2a, KPC-2_ST15_O1 and KPC-2_ST5492_O5 were dominant clones, and their distribution was mainly in the intensive care unit. The whole genome sequence analysis showed that there were three dominant clones, among which ST11 clones were subdivided into three dominant O serotypes, all of which were mainly in the intensive care unit. Conclusion:The popular strain in the hospital of CRKP is a KPC-2_ST11 clone group carrying iucA, rmpA/rmpA2, with cross-department transmission and mutation. ST5492 is a newly-launched clone type. The intensive care unit of hvKP carrying five virulence genes, including peg-344, should be alert to the epidemic risk of CR-hvKP outbreak.
10.Biomechanical Comparison of Different Repair Methods for Inferior Pole Fracture of the Patella
Yulin XU ; Yuangui TANG ; Yongkang CUI ; Yuchuan LIU ; Tao WANG ; Wanyin QI ; Jinhui LIU ; Cheng LIANG
Journal of Medical Biomechanics 2025;40(1):100-105
Objective To conduct a comparative study on the biomechanical performance of using sutures for repairing inferior pole patellar fractures.Methods Compared to the normal patellar structure(Group A),four repair methods,namely,'Krackow'suture(Group B),"Kessler"fixation(Group C),'8-figure'mesh method(Group D),and modified suture bridge(Group E)were adopted.The static stiffness and dynamic stability of inferior pole patellar fractures fixed by each repair method were measured at 30°,60°,and 90° knee flexion.Results The stiffness at all flexion angles in Group E was closer to that in Group A,compared to other repair groups,followed by Group B,then Group D,and finally Group C.After the first cycle,at 30° knee flexion,Group C showed the greatest displacement,while Groups B and E had slightly larger displacements than the Group A,and the displacement of Group D was smaller than that of Group A.At 60° and 90° knee flexion,the displacement in all repair groups was smaller than that of Group A.After 200 cycles in the subsequent three cycles,displacement changes in all repair groups were smaller than those in Group A.Conclusions All repair methods were effective.In terms of biomechanical fixation performance,the modified suture bridge was superior to the'Krackow'suture and'8-figure'mesh,with Kessler fixation being the least effective.However,factors such as the injury severity,incision location,and surgical time should be comprehensively considered in actual clinical use,and it is recommended that the repair method should be selected in the following order:E,B,D,and C.

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