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.Pre-operative risk assessment of hepatocellular carcinoma recurrence in liver transplant recipients by non-invasive detection of pre-existing genetic lesions
Suqin YANG ; Sunbin LING ; Jianhua LI ; Yan WANG ; Jiapei WANG ; Qiwei HUANG ; Fanming LIU ; Yiqi ZHUANG ; Yingyu ZHENG ; Rui WANG ; Zhe YANG ; Xiaoping ZHENG ; Kai WANG ; Zhikun LIU ; Jun CHEN ; Jianguo WANG ; Haiyang XIE ; Lin ZHOU ; Leiming CHEN ; Guoqiang CAO ; Dandan CHEN ; Junfang JI ; Bin ZHAO ; Chao JIANG ; Di LU ; Xuyong WEI ; Hangjin JIANG ; Qiaonan SHAN ; Hengbo SHI ; Yong-Zhen XU ; Shusen ZHENG ; Zhengxin WANG ; Shengda LIN ; Xiao XU
Clinical and Molecular Hepatology 2026;32(2):884-903
Background/Aims:
Liver transplantation (LT) following total hepatectomy is a life-saving treatment for hepatocellular carcinoma (HCC). The HCC recurrence after LT hinders the effectiveness of the procedure. The objective of this study is to develop a pre-operative risk stratification model based on a liquid biopsy.
Methods:
We conducted a comprehensive multi-omics study of 260 HCC patients from three centers, including clinical data, low-coverage whole-genome sequencing of cell-free DNA (cfDNA) from plasma, as well as whole-exome, single-nucleus RNA, and spatial transcriptomics from matched tumor and non-tumor tissues.
Results:
We identified cfDNA-derived copy number alteration (CNA) signatures associated with post-transplant recurrence. By integrating cfDNA-derived CNA profiles with single-cell transcriptomic data, we traced recurrence-associated cfDNA to a distinct subpopulation of malignant cells within the primary tumor. These cells were embedded in a pro-metastatic microenvironment of specialized endothelial subtypes and cancer-associated fibroblasts. Notably, most recurrence-associated lesions were detectable in cfDNA prior to liver transplantation (LT). Building on these insights, we developed the ZJU Criteria based on CNA fragments and tumor markers, a pre-LT risk prediction tool that integrates conventional clinical factors with cfDNA-derived CNA signatures, and validated it using internal and independent external cohorts.
Conclusion
Our findings suggest that post-transplant recurrence commonly originates from advanced subclones that emerge late during tumor evolution. The ZJU Criteria provides an accurate, non-invasive strategy that significantly improves pre-LT risk stratification and clinical decision-making for patients with HCC.
3.Construction features and practical applications of an intelligent morning meeting management platform in the radiology department
Weiwei LIU ; Haichang XING ; Jianguo WANG
Chinese Journal of Radiological Health 2026;35(3):455-459
Objective To investigated how morning meetings are conducted in radiology departments across different levels of hospitals in Shandong Province. It also explored the role of an intelligent morning meeting platform in supporting digital management of radiology departments. Methods This study was conducted through the Shandong Provincial Regional Medical Center Alliance. A questionnaire survey was administered to 241 hospitals of different grades to assess their morning meeting practices. Based on the findings, an intelligent and process-oriented management model suitable for the regional context was summarized and developed, leading to the construction of an intelligent morning meeting management platform. A comparative analysis was then performed in our hospital's radiology department. Key management indicators were compared before and after using the platform. These indicators included: weekly frequency of morning meetings, number of meeting types, staff attendance rate, rate of electronic management of meeting materials, proportion of case discussions that met teaching requirements, and staff satisfaction. Results The intelligent morning meeting management platform integrates multiple functions. These functions included morning meeting management, case management, archiving of meeting materials, quality control management, electronic attendance tracking, and online meetings across multiple hospital campuses. After the platform was implemented in the radiology department, all key indicators improved significantly. Specifically, weekly meeting frequency, number of meeting types, attendance rate, rate of electronic management of meeting materials, proportion of case discussions meeting teaching requirements, and staff satisfaction were all significantly higher than before implementation (all P<0.05). Conclusion The application of the intelligent morning meeting management platform can digitize, standardize, and make traceable the morning meetings in radiology departments.It significantly improves the efficiency and quality of these meetings. It also effectively enhances the digital management level of radiology departments. This study aimed to investigate the current operation of morning meetings in radiology departments at different levels of hospitals in Shandong Province, and to explore the role of the intelligent morning meeting platform in the digital management of radiology departments.
4.Analysis of the Interactive Effects between Diagnosis-Intervention Packet and Pre-Hospitalization Mode
Songsong TAN ; Yun SHU ; Jingjing WU ; Yuanzheng WANG ; Lisha SU ; Song HE ; Changhui LI ; Yan ZHA ; Daishun LIU ; Jianguo ZHU
Chinese Hospital Management 2025;45(7):25-29
Objective Under the operation background of Diagnosis-Intervention Packet(DIP),whether there is interaction between reducing medical cost and average length of stay combined with pre-hospitalization mode,and whether there is difference between different departments and diseases in interaction.Methods Based on real-world data from 71 453 patients admitted to Guizhou Provincial People's Hospital from July to December 2021,a two-way analysis of variance was employed.When the interaction effect was statistically significant,parameter estimation was used to determine the magnitude and direction of the interaction effect,followed by subgroup analyses by department and disease.Results Without adjustment,both total medical costs and average length of stay exhibited a negative interaction effect(P<0.05).Subgroup analyses revealed that in terms of total medical costs,the effect size for the surgical system was 0.18%,lower than that for the internal medicine system(0.70%);for core diseases,it was 6.62%,lower than that for comprehensive diseases(7.71%).Regarding average length of stay,the effect size for the surgical system was 0.55%,better than that for the internal medicine system(0.22%);for core diseases,it was 8.70%,higher than that for comprehensive diseases(2.90%).Conclusion The combination of DIP payment reform and pre-admission management model demonstrates a synergistic effect,effectively reducing patients' medical costs and length of stay.This effect is influenced by disease complexity and the standardization of diagnostic and treatment processes.
5.Factors influencing cognitive impairment of residents in drinking water-borne endemic fluorosis areas
Wenbo LYU ; Ying LIU ; Xin WANG ; Chao ZHANG ; Yunzhu LIU ; Qingbo WANG ; Xirui FENG ; Shuaifei YANG ; Jianguo FENG ; Yanmei YANG ; Yanhui GAO
Chinese Journal of Endemiology 2025;44(5):345-351
Objective:To gain a understanding of the occurrence of cognitive impairment among residents in drinking water-borne endemic fluorosis (drinking water-borne fluorosis) areas, and to study its influencing factors.Methods:In March 2023, a cluster sampling method was used to select local residents aged 18 and above from the drinking water-borne fluorosis areas in Jishan County, Shanxi Province as survey subjects. General demographic data were collected through face-to-face surveys, and a random urine sample was collected once to determine urinary fluoride level. Cognitive function was assessed using the mini-mental state examination (MMSE), and the survey subjects were divided into a cognitive impairment group ( < 27 points) and a control group (27 - 30 points) based on the MMSE scores. A multiple logistic regression model and a decision tree model based on chi-squared automatic interaction detector were constructed to analyze the factors affecting cognitive impairment, and the model fitting effect was evaluated using receiver operating characteristic (ROC) curve.Results:A total of 3 301 subjects were included in the survey, including 2 081 females and 1 220 males. There were 1 515 subjects < 60 years old and 1 786 subjects ≥60 years old, with urinary fluoride level [ M ( Q1, Q3)] of 2.92 (1.78, 4.54) mg/L. There were 1 939 cases in the cognitive impairment group and 1 362 cases in the control group, with a detection rate of 58.74% (1 939/3 301) for cognitive impairment; and the differences in gender, age, education level, marital status, annual household income, alcohol consumption, smoking distribution, and urinary fluoride level between the two groups were statistically significant ( P < 0.05). The results of multiple logistic regression analysis showed that female, ≥60 years, and urinary fluoride > 4.54 mg/L were risk factors for cognitive impairment [ OR (95% CI): 1.25 (1.01, 1.54), 2.66 (2.26, 3.14), 1.32 (1.06, 1.65), P < 0.05]. Education level of primary school or above, annual household income≥12 000 yuan, and mild alcohol consumption were protective factors for cognitive impairment [ OR (95% CI): 0.15 (0.09, 0.25), 0.58 (0.48, 0.68), 0.67 (0.51, 0.87), P < 0.05]. The analysis results of the decision tree model showed that age had the greatest impact on the occurrence of cognitive impairment, followed by annual household income, education level, and urinary fluoride. The areas under the ROC curves of the multiple logistic regression and decision tree model were 0.72 and 0.70 ( P < 0.001), respectively, indicating good model fitting performance. Conclusion:The detection rate of cognitive impairment in residents of drinking water-borne fluorosis areas is relatively high, and age, annual household income, education level, and urinary fluoride are all influencing factors for occurrence of cognitive impairment.
6.Analysis of the Interactive Effects between Diagnosis-Intervention Packet and Pre-Hospitalization Mode
Songsong TAN ; Yun SHU ; Jingjing WU ; Yuanzheng WANG ; Lisha SU ; Song HE ; Changhui LI ; Yan ZHA ; Daishun LIU ; Jianguo ZHU
Chinese Hospital Management 2025;45(7):25-29
Objective Under the operation background of Diagnosis-Intervention Packet(DIP),whether there is interaction between reducing medical cost and average length of stay combined with pre-hospitalization mode,and whether there is difference between different departments and diseases in interaction.Methods Based on real-world data from 71 453 patients admitted to Guizhou Provincial People's Hospital from July to December 2021,a two-way analysis of variance was employed.When the interaction effect was statistically significant,parameter estimation was used to determine the magnitude and direction of the interaction effect,followed by subgroup analyses by department and disease.Results Without adjustment,both total medical costs and average length of stay exhibited a negative interaction effect(P<0.05).Subgroup analyses revealed that in terms of total medical costs,the effect size for the surgical system was 0.18%,lower than that for the internal medicine system(0.70%);for core diseases,it was 6.62%,lower than that for comprehensive diseases(7.71%).Regarding average length of stay,the effect size for the surgical system was 0.55%,better than that for the internal medicine system(0.22%);for core diseases,it was 8.70%,higher than that for comprehensive diseases(2.90%).Conclusion The combination of DIP payment reform and pre-admission management model demonstrates a synergistic effect,effectively reducing patients' medical costs and length of stay.This effect is influenced by disease complexity and the standardization of diagnostic and treatment processes.
7.Ecological adaptations of body weight and blood biochemical parameters in wild Macaca mulatta brevicaudus
Baozhen LIU ; Jun WANG ; Ruiping SUN ; Chengfeng WU ; Xinyuan ZHAO ; Jianguo ZHAO ; Jingli YUAN
Chinese Journal of Comparative Medicine 2025;35(8):67-77
Objective To determine the body weights and blood physiological and biochemical indicators in the Macaca mulatta brevicaudus(M.m.brevicaudus),to provide a reference for the breeding of experimental animals.Methods A total of 180 wild M.m.brevicaudus(female and male)from the South Bay Macaque Reserve in Lingshui were selected as the research subjects.Body weights were measured using electronic scales and blood samples were collected.Routine blood indicators(red blood cell count,hemoglobin,white blood cell count,and platelet count)were detected using an automated blood cell analyzer,and biochemical indicators(alanine aminotransferase,aspartate aminotransferase,glucose,blood urea nitrogen)were measured using an automated biochemical analyzer.Data were analyzed using SPSS 18.0 software for descriptive statistics,and differences in body weights and blood indicators between sexes and age groups were compared using t-tests.Results Adult male wild M.m.brevicaudus were significantly heavier than females(P<0.05);however,there were no significant differences in complete blood cell counts between female and male macaques(P>0.05).In terms of blood biochemical indicators,lactate dehydrogenase and total bilirubin levels differed significantly between female and male M.m.brevicaudus(P<0.05),but there were no significant differences in any other biochemical indicators.Conclusions This study established baseline data on the body weights and blood physiological and biochemical indicators of wild M.m.brevicaudus,providing a reference for their future breeding as experimental animals.
8.Comparative study of five coma assessment scales in prognosis prediction of patients with severe stroke
Dongyang HU ; Xiaochen HAN ; Sheng YAO ; Jianguo LIU ; Hairong QIAN ; Jiatang ZHANG
Chinese Journal of Cerebrovascular Diseases 2025;22(1):15-22,37
Objective To compare the predictive effectiveness of the Glasgow coma scale(GCS),GCS-pupils scale(GCS-P),Glasgow-Pittsburgh coma scale(GPCS),full outline of unresponsiveness scale(FOUR),and coma recovery scale-revised(CRS-R)in forecasting the prognosis of severe stroke patients.Methods A prospective,consecutive cohort of severe stroke patients admitted to the Department of Neurology,First Medical Center of Chinese PLA General Hospital from September 2021 to April 2024 was enrolled.Demographic and clinical data were collected,including age,sex,length of hospital stay,diagnosis(severe ischemic stroke,severe cerebral hemorrhage,aneurysmal subarachnoid hemorrhage),medical history(hypertension,diabetes,coronary artery disease),smoking and drinking habits,vital signs upon admission(temperature,pulse,respiration,blood pressure),neurological examination findings(including speech and brainstem reflexes)at admission,head imaging results(CT,MRI)within 24 h of admission to assess the presence of brain herniation,and whether intubation occurred within 24 h of admission.Patients underwent GCS,GCS-P,GPCS,FOUR,and CRS-R scoring within 8h of admission.Telephone follow-up was conducted at 6 months post-stroke to assess outcomes using the modified Rankin scale(mRS),with mRS scores of 0-2 classified as the good prognosis group and 3-6 as the poor prognosis group.The receiver operating characteristic(ROC)curve was used to assess the prognostic prediction value of the five scales for poor outcomes at 6 months.The area under the ROC curve(AUC)was calculated,and pairwise comparisons of AUC were performed using the Delong test.Results A total of 179 severe stroke patients were enrolled,including 116 males and 63 females.The group consisted of 132 patients with severe ischemic stroke,30 with severe intracerebral hemorrhage,and 17 with aneurysmal subarachnoid hemorrhage.At 6months,126patients had a poor prognosis and 53 had a good prognosis.(1)There were statistically significant differences in age,temperature,pulse,history of coronary artery disease,smoking and drinking habits,presence of speech impairment,abnormal brainstem reflexes,brain herniation,intubation within 24 h of admission,and GCS,GCS-P,GPCS,FOUR,and CRS-R scores between the poor and good prognosis groups(all P<0.05).(2)ROC analysis revealed that the AUC(95%CI)for predicting poor outcomes at 6 months in severe stroke patients for GCS,GCS-P,GPCS,FOUR,and CRS-R were 0.808(0.742-0.863),0.815(0.750-0.869),0.828(0.765-0.880),0.841(0.780-0.892),and 0.831(0.768-0.883),respectively.Sensitivities were 76.98%,78.57%,82.54%,84.13%,and 82.54%,and specificities were 73.58%,73.58%,67.92%,71.70%,and 73.58%,respectively.The FOUR had the highest AUC,with an optimal cutoff value of 13.(3)Pairwise comparisons of AUC showed a statistically significant difference between the FOUR and GCS(the difference value of AUC is 0.034,95%CI 0.004-0.064,Z=2.194,P=0.028),but no significant differences were observed between other scales(all P>0.05).Conclusion Compared to GCS,GCS-P,GPCS,and CRS-R,FOUR may provide more valuable prognostic information for severe stroke patients.
9.Ecological adaptations of body weight and blood biochemical parameters in wild Macaca mulatta brevicaudus
Baozhen LIU ; Jun WANG ; Ruiping SUN ; Chengfeng WU ; Xinyuan ZHAO ; Jianguo ZHAO ; Jingli YUAN
Chinese Journal of Comparative Medicine 2025;35(8):67-77
Objective To determine the body weights and blood physiological and biochemical indicators in the Macaca mulatta brevicaudus(M.m.brevicaudus),to provide a reference for the breeding of experimental animals.Methods A total of 180 wild M.m.brevicaudus(female and male)from the South Bay Macaque Reserve in Lingshui were selected as the research subjects.Body weights were measured using electronic scales and blood samples were collected.Routine blood indicators(red blood cell count,hemoglobin,white blood cell count,and platelet count)were detected using an automated blood cell analyzer,and biochemical indicators(alanine aminotransferase,aspartate aminotransferase,glucose,blood urea nitrogen)were measured using an automated biochemical analyzer.Data were analyzed using SPSS 18.0 software for descriptive statistics,and differences in body weights and blood indicators between sexes and age groups were compared using t-tests.Results Adult male wild M.m.brevicaudus were significantly heavier than females(P<0.05);however,there were no significant differences in complete blood cell counts between female and male macaques(P>0.05).In terms of blood biochemical indicators,lactate dehydrogenase and total bilirubin levels differed significantly between female and male M.m.brevicaudus(P<0.05),but there were no significant differences in any other biochemical indicators.Conclusions This study established baseline data on the body weights and blood physiological and biochemical indicators of wild M.m.brevicaudus,providing a reference for their future breeding as experimental animals.
10.Evaluation of the efficacy and safety of multi-center fecal microbiota transplantation for treatment of functional constipation: A retrospective real-world study
Long LI ; Le WANG ; Gongjing GUO ; Yunhe FAN ; Jianguo SHI ; Xiaogang YUAN ; Xiushan DONG ; Lei LIU ; Ning LI ; Qiyi CHEN
Chinese Journal of Gastrointestinal Surgery 2025;28(3):288-295
Objective:To evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for treating functional constipation, analyze the incidence of, and factors that influence, adverse events, and provide scientific evidence for optimizing FMT treatment.Methods:This retrospective, multicenter, single-arm, pre–post real-world study included 1529 patients with functional constipation from four clinical centers. Eligibility criteria comprised meeting the diagnostic criteria for functional constipation, having undergone at least one FMT treatment, complete pre- and post-treatment data available, and age ≥18 years. Patients who had received other interventions affecting gut function within 1 month before treatment and those with severe organic diseases or immune deficiencies were excluded. Applying the above criteria yielded 1529 eligible patients with functional constipation from four medical centers (1405 from the Shanghai Tenth People's Hospital Affiliated to Tongji University, 20 from the Central Hospital of Wuhan, 67 from the Shanxi Bethune Hospital and 37 from the Longgang District People's Hospital of Shenzhen). The study cohort comprised 746 male (48.8%) and 783 female patients (51.2%) of mean age (51.4 ± 17.4) years, mean body mass index (26.4 ± 4.9) kg/m2, and mean duration of disease (15.0 ± 8.3) years. The primary outcomes were the incidence, types, and severity of adverse reactions during treatment, and their impact on patients' quality of life. Secondary outcomes included: (1) the efficacy of FMT in treating constipation. This was assessed based on changes in Patient Assessment of Constipation Symptoms (PAC-SYM) scores, where higher score indicates worse symptom. (2) Subjective satisfaction, evaluated through questionnaires or rating scales, reflecting patients' acceptance of and satisfaction with the treatment, with scores ranging from 1 to 5, where higher scores indicated greater satisfaction. Paired t-tests and Wilcoxon signed-rank tests were used to evaluate changes in symptom scores and biochemical indicators before and after treatment. Logistic regression was performed to analyze factors influencing adverse events, and subgroup analyses to explored differences in efficacy between patient groups.Results:In this cohort of 1529 patients with functional constipation, adverse reactions were primarily mild to moderate (1048/1529,68.5%). They comprised fever in 54 patients (3.5%), dizziness or fatigue in 218 (14.3%), throat discomfort in 806 (52.7%), nausea and vomiting in 166 (10.9%), and abdominal distension or pain in 415 (27.1%). According to multivariate logistic regression analysis, PAC-SYM scores were associated with the rate of adverse reactions, higher scores indicating a lower risk (OR = 0.958, 95% CI: 0.923–0.993, P=0.021). Among the 1529 patients, 274 (17.9%) underwent two or more treatment courses. After one treatment course, the patients' PAC-SYM scores decreased from (37.7 ± 3.2) pre-treatment to (23.7 ± 8.6) (mean difference 14.0 ± 9.1). PAC-SYM scores decreased by (20.7 ± 7.7) after two courses of FMT, and by (19.4 ± 6.3) after three courses. After treatment, 50.7%(775/1529) of patients reported satisfaction scores of ≥4. Adverse reactions impacted satisfaction; specifically, dizziness/fatigue, throat discomfort, and abdominal distension/pain were significantly associated with satisfaction (all P < 0.05). Conclusions:FMT achieved good relief of symptoms of functional constipation and multiple treatment courses have a cumulative effect. Adverse reactions, mainly dizziness/fatigue, throat discomfort, and abdominal distension/pain, had significant negative impacts on patient satisfaction.

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