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.The role of establishing the concept of"liver and pancreas co-management"in the treatment of pancreatic diseases
Kongyuan WEI ; Canitano NICOLA ; Shuo WANG ; Zipeng LU ; Kuirong JIANG ; Zhenhua MA ; Zheng WU ; Qingyong MA ; Marchegiani GIOVANNI ; Hackert THILO ; Zheng WANG
Chinese Journal of Surgery 2026;64(1):79-82
With the continuous development of new surgical technology, new equipment and new concepts, the research focused in the field of surgery is also in constant change. Among them, there are still confusion and controversies in the current clinical practice when facing the one-stop proposition of benefit population screening, advantageous surgical indication decision-making, surgical intervention timing selection, postoperative complication prediction and management. Therefore, our team tries to analyze whether the concept of"co-management of liver and pancreas"exists in clinical practice from the aspects of anatomy, physiology, histology and embryology of liver and pancreas, as well as the interaction between liver and pancreas, and explore the relationship between liver and pancreas in anatomy and tissue embryonic development, and the relationship between the concept of"co-management of liver and pancreas"and pancreatitis and pancreatic tumors as well as the concept of “co-management of liver and pancreas” applied in neoadjuvant chemoradiotherapy, and attempts to establish a new treatment pathway for pancreatic diseases based on this concept, in order to provide a new idea, new scheme and new possibility for the clinical research of pancreatic diseases and pancreatic surgery.
3.The role of establishing the concept of"liver and pancreas co-management"in the treatment of pancreatic diseases
Kongyuan WEI ; Canitano NICOLA ; Shuo WANG ; Zipeng LU ; Kuirong JIANG ; Zhenhua MA ; Zheng WU ; Qingyong MA ; Marchegiani GIOVANNI ; Hackert THILO ; Zheng WANG
Chinese Journal of Surgery 2026;64(1):79-82
With the continuous development of new surgical technology, new equipment and new concepts, the research focused in the field of surgery is also in constant change. Among them, there are still confusion and controversies in the current clinical practice when facing the one-stop proposition of benefit population screening, advantageous surgical indication decision-making, surgical intervention timing selection, postoperative complication prediction and management. Therefore, our team tries to analyze whether the concept of"co-management of liver and pancreas"exists in clinical practice from the aspects of anatomy, physiology, histology and embryology of liver and pancreas, as well as the interaction between liver and pancreas, and explore the relationship between liver and pancreas in anatomy and tissue embryonic development, and the relationship between the concept of"co-management of liver and pancreas"and pancreatitis and pancreatic tumors as well as the concept of “co-management of liver and pancreas” applied in neoadjuvant chemoradiotherapy, and attempts to establish a new treatment pathway for pancreatic diseases based on this concept, in order to provide a new idea, new scheme and new possibility for the clinical research of pancreatic diseases and pancreatic surgery.
4.Recommendations for Standardized Reporting of Systematic Reviews and Meta-Analysis of Animal Experiments
Qingyong ZHENG ; Donghua YANG ; Zhichao MA ; Ziyu ZHOU ; Yang LU ; Jingyu WANG ; Lina XING ; Yingying KANG ; Li DU ; Chunxiang ZHAO ; Baoshan DI ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(4):496-507
Animal experiments are an essential component of life sciences and medical research. However, the external validity and reliability of individual animal studies are frequently challenged by inherent limitations such as small sample sizes, high design heterogeneity, and poor reproducibility, which impede the effective translation of research findings into clinical practice. Systematic reviews and meta-analysis represent a key methodology for integrating existing evidence and enhancing the robustness of conclusions. Currently, however, the application of systematic reviews and meta-analysis in the field of animal experiments lacks standardized guidelines for their conduct and reporting, resulting in inconsistent quality and, to some extent, diminishing their evidence value. To address this issue, this paper aims to systematically delineate the reporting process for systematic reviews and meta-analysis of animal experiments and to propose a set of standardized recommendations that are both scientific and practical. The article's scope encompasses the entire process, from the preliminary preparatory phase [including formulating the population, intervention, comparison and outcome (PICO) question, assessing feasibility, and protocol pre-registration] to the key writing points for each section of the main report. In the core methods section, the paper elaborates on how to implement literature searches, establish eligibility criteria, perform data extraction, and assess the risk of bias, based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, in conjunction with relevant guidelines and tools such as Animal Research: Reporting of in Vivo Experiments (ARRIVE) and a risk of bias assessment tool developed by the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). For the presentation of results, strategies are proposed for clear and transparent display using flow diagrams and tables of characteristics. The discussion section places particular emphasis on how to scientifically interpret pooled effects, thoroughly analyze sources of heterogeneity, evaluate the impact of publication bias, and cautiously discuss the validity and limitations of extrapolating findings from animal studies to clinical settings. Furthermore, this paper recommends adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to comprehensively grade the quality of evidence. Through a modular analysis of the entire reporting process, this paper aims to provide researchers in the field with a clear and practical guide, thereby promoting the standardized development of systematic reviews and meta-analysis of animal experiments and enhancing their application value in scientific decision-making and translational medicine.
5.Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method
Tengfei LI ; Qingyong ZHENG ; Jianguo XU ; Yiyi LI ; Yongjia ZHOU ; Caihua XU ; Mingyue ZHANG ; Jiexiang TIAN ; Gang WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(1):101-111
Animal experiments are essential tools in biomedical research, serving as a bridge between basic research and clinical trials. Systematic reviews and meta-analyses (SRs/MAs) of animal experiments are crucial methods for integrating evidence from animal experiment, which can facilitate the translation of findings into clinical research, reduce translational risks, and promote resource integration in basic research. With the continuous development of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, its application in SRs/MAs of animal experiments has gained increasing attention. This article first outlines the principles and specific applications of the GRADE methodology in SRs/MAs of animal experiments, including qualitative descriptive systematic reviews, meta-analyses, and network meta-analyses. It then deeply analyzes the misuse of the GRADE methodology in practice, including incorrect evidence grading, improper classification of evidence, misapplication in qualitative systematic reviews, inconsistencies between the documentation of the upgrading and downgrading process and results, and inappropriate use for making recommendations. Furthermore, this article comprehensively discusses the factors influencing the grading of evidence certainty in SRs/MAs of animal experiments, including the impact of bias risk, indirectness, inconsistency, imprecision, and publication bias on evidence downgrading, as well as the role of large effect sizes and cross-species consistency in evidence upgrading. Finally, in response to the issues discussed, improvement strategies are proposed, including further research and optimization of the GRADE methodology for SRs/MAs of animal experiments, the development of reporting guidelines tailored to the characteristics of SRs/MAs in animal experiment research, and enhanced professional training for researchers in the GRADE methodology. This article aims to improve the quality of evidence in SRs/MAs of animal experiments, strengthen their reliability in clinical decision-making, and promote the more efficient translation of findings from animal experiment research into clinical practice.
6.Expression and significance of α7 nicotinic acetylcholine receptor on thymic T follicular helper cells in myasthenia gravis
Meng WANG ; Menghao YANG ; Xinzheng CUI ; Zirui SUN ; Chenshuo SHI ; Zhiwen ZHANG ; Lixiang ZHENG ; Qingyong ZHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(12):1771-1776
Objective To investigate the expression of α7 nicotinic acetylcholine receptor (α7nAChR) in thymic T follicular helper cells (TFH) and its significance in patients with myasthenia gravis (MG). Methods Fifteen MG patients who underwent surgical treatment at the Myasthenia Gravis Comprehensive Diagnosis and Treatment Center of Henan Provincial People’s Hospital from June 2022 to June 2023 were selected as a MG group, including 7 males and 8 females, aged 12-30 years. Twelve patients who underwent partial thymectomy to optimize surgical field exposure during cardiac surgery at Fuwai Central China Cardiovascular Hospital from June 2022 to June 2023 were selected as a control group, including 5 males and 7 females aged 20-35 years. Thymus single cell suspension was obtained by grinding the thymus tissue, and flow cytometry was used to detect the expression of α7nAChR in TFH cells. The thymus cell suspension was purified using density gradient centrifugation, followed by immunomagnetic bead separation to obtain CD4+T cells. CXCR5 antibody and coupled magnetic beads were added to isolate TFH cells. Real-time fluorescent polymerase chain reaction and Western blotting were performed to further investigate the expression of α7nAChR in TFH cells. Results Compared with the control group, the proportion of thymic TFH cells in the MG group was significantly increased (P<0.05), along with significantly decreased mRNA and protein expression levels of α7nAChR within these cells (P<0.01). Conclusion The findings suggest that there is a reduced expression of α7nAChR within thymic TFH cells in MG patients, leading to weakened immunosuppressive function which may indirectly contribute to disease onset and progression.
7.The application of modified pancreatic duct stone classification in chronic pancreatitis
Xue YANG ; Wanxing DUAN ; Shuai WU ; Jinpeng ZHAO ; Wanzhen WEI ; Qingyong MA ; Hao SUN ; Zheng WU ; Zheng WANG
Chinese Journal of Digestive Surgery 2025;24(5):591-598
Chronic pancreatitis is a chronic inflammatory disease characterized by progre-ssive fibrosis of pancreatic tissue. Its pathological features primarily include parenchymal fibrosis, intraductal stone formation or calcification deposits, as well as segmental stenosis and dilation of the pancreatic duct. Prolonged chronic inflammatory stimulation not only leads to progressive pancreatic dysfunction but may also trigger the formation of pancreatic pseudocysts and even malignant transformation. In the comprehensive treatment of chronic pancreatitis, the core clinical goals are the removal of pancreatic duct stones, restoration of unobstructed pancreatic duct drainage, and preservation of residual pancreatic function. Traditional treatment strategies have been based on the principle of progressive intervention and early surgical management. In recent years, with advancements in extracorporeal shock wave lithotripsy, the application of new techniques such as endoscopic retrograde cholangiopancreatography combined with laser lithotripsy under direct cholan-gioscopic visualization, and improvements in pancreas-preserving surgical approaches, the debate over the superiority of progressive intervention versus early surgical treatment has intensified. Against this backdrop, the treatment mode of Xi′an Jiaotong University Pancreatic Disease Center (hereinafter referred to as "Western Pancreas") has emerged, emphasizing a personalized, multimodal treatment strategy based on different types of pancreatic duct stones. The treatment mode of "Western Pancreas" integrates lithotripsy, endoscopic treatment, and surgical interventions to optimize patient outcomes. By conducting a comprehensive analysis of domestic and international pancreatic duct stone classi-fication systems and drawing from our team′s clinical experience in managing over a thousand cases of chronic pancreatitis, the authors have further refined and proposed a classification system for pancreatic duct stones under the treatment mode of "Western Pancreas". This refinement aims to enhance the overall diagnostic and therapeutic standards for chronic pancreatitis.
8.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(10):an overview and case study of quality assessment tools
Qingyong ZHENG ; Caihua XU ; Yongjia ZHOU ; Xiao TANG ; Mengjun ZHANG ; Jinzhi QI ; Ming LIU ; Ya GAO ; Feng SUN ; Jinhui TIAN
Chinese Journal of Pharmacoepidemiology 2025;34(10):1113-1126
Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.
9.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(10):an overview and case study of quality assessment tools
Qingyong ZHENG ; Caihua XU ; Yongjia ZHOU ; Xiao TANG ; Mengjun ZHANG ; Jinzhi QI ; Ming LIU ; Ya GAO ; Feng SUN ; Jinhui TIAN
Chinese Journal of Pharmacoepidemiology 2025;34(10):1113-1126
Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.
10.The application of modified pancreatic duct stone classification in chronic pancreatitis
Xue YANG ; Wanxing DUAN ; Shuai WU ; Jinpeng ZHAO ; Wanzhen WEI ; Qingyong MA ; Hao SUN ; Zheng WU ; Zheng WANG
Chinese Journal of Digestive Surgery 2025;24(5):591-598
Chronic pancreatitis is a chronic inflammatory disease characterized by progre-ssive fibrosis of pancreatic tissue. Its pathological features primarily include parenchymal fibrosis, intraductal stone formation or calcification deposits, as well as segmental stenosis and dilation of the pancreatic duct. Prolonged chronic inflammatory stimulation not only leads to progressive pancreatic dysfunction but may also trigger the formation of pancreatic pseudocysts and even malignant transformation. In the comprehensive treatment of chronic pancreatitis, the core clinical goals are the removal of pancreatic duct stones, restoration of unobstructed pancreatic duct drainage, and preservation of residual pancreatic function. Traditional treatment strategies have been based on the principle of progressive intervention and early surgical management. In recent years, with advancements in extracorporeal shock wave lithotripsy, the application of new techniques such as endoscopic retrograde cholangiopancreatography combined with laser lithotripsy under direct cholan-gioscopic visualization, and improvements in pancreas-preserving surgical approaches, the debate over the superiority of progressive intervention versus early surgical treatment has intensified. Against this backdrop, the treatment mode of Xi′an Jiaotong University Pancreatic Disease Center (hereinafter referred to as "Western Pancreas") has emerged, emphasizing a personalized, multimodal treatment strategy based on different types of pancreatic duct stones. The treatment mode of "Western Pancreas" integrates lithotripsy, endoscopic treatment, and surgical interventions to optimize patient outcomes. By conducting a comprehensive analysis of domestic and international pancreatic duct stone classi-fication systems and drawing from our team′s clinical experience in managing over a thousand cases of chronic pancreatitis, the authors have further refined and proposed a classification system for pancreatic duct stones under the treatment mode of "Western Pancreas". This refinement aims to enhance the overall diagnostic and therapeutic standards for chronic pancreatitis.

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