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.

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.

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.

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.

Integrating evidence from animal experiments is a critical component of biomedical research, providing essential prior information for in-depth investigations of disease mechanisms and new drug development. Animal models have played an irreplaceable role in simulating human diseases. However, the integration of evidence from animal experiments has faced numerous challenges, including insufficient emphasis, significant heterogeneity in study designs, high publication bias, and discrepancies with clinical research practices. This paper first identifies existing issues in the original research evidence from animal experiments, such as the selection and applicability of animal models, considerations in the design of experimental studies, and factors influencing the translation of animal experimental evidence. It then discusses various methods for integrating this evidence, including systematic review and meta-analysis, overview of systematic review/umbrella review, scoping review, and evidence mapping, while highlighting recent advancements in their application. Finally, the paper addresses the main challenges currently encountered in the integration of evidence from animal experiments and proposes targeted improvement strategies aimed at enhancing the efficiency of translating research outcomes into clinical practice and promoting the advancement of evidence-based medicine. By continuously optimizing original experimental research protocols and evidence integration practices, this work aims to establish a more efficient and scientific environment for the synthesis of evidence from animal experiments, ultimately contributing to clinical trials and human health.

Triple-negative breast cancer(TNBC)can benefit from immunotherapy because of its higher tumor mutational burden(TMB)and tumor-infiltrating lymphocytes.Although immunotherapy has made breakthroughs as an important treatment strategy for TNBC,recent clinical data suggest that a proportion of patients exhibit resistance to immunotherapy,or those who are ef-fective in treatment experience further recurrence or progression.The main reason for these poor prognosis is complex internal or ex-ternal immune escape mechanisms,which may be caused by abnormal antigen presentation,immunosuppressive tumor microenviron-ment,interactions with other immune checkpoints,and abnormal activation of tumor cell signaling.However,the research on the re-sistance mechanism of TNBC immunotherapy is still incomplete.This article will provide a review of the challenges faced by immuno-therapy and the potential mechanisms of TNBC develops resistance to immunotherapy.

Objective:To introduce the stereotactic cardiac radioablation (SCRA) based on the stereotactic body radiotherapy (SBRT), and comprehensively evaluate the new approach by short-term effectiveness and safety.Methods:Patients with ventricular arrhythmia (VA) were evaluated and included in this clinical trial, who were immobilized by vacuum bag and performed simulation with 4-dimensional computed tomography (4DCT). In this study, the planning target volume (PTV) was set as the target to design a SBRT plan using volumetric modulated arc therapy (VMAT), which was evaluated by dose parameters such as R 50%, homogeneity index and conformity index, etc. The results of Holter and echocardiography were monitored during the follow-up and compared with the data before treatment. Results:Three subjects with ventricular tachycardia (VT) and one with premature ventricular contraction (PVC) received the same prescription of 25 Gy in a single fraction. The average volume of PTV was 71.4 cm 3(60.3-89.4 cm 3). The average time of beam delivery was 12.0 min (4.5-21.0 min). And the short-term follow-up lasted for an average of 18 weeks (14-25 weeks), which showed significant decrease in both VT and PVC load without complications. Conclusion:This study reports the implementation method of SCRA and proves its short-term effectiveness and safety, but the effects and standards of the key radiotherapy techniques still need to be explored.

In recent years, neoadjuvant chemotherapy has been increasingly applied to the treatment of locally advanced or early-stage breast cancer patients, and has improved the pathological state and stage of the disease to a certain extent, which makes the decision-making of postmastectomy radiotherapy after neoadjuvant chemotherapy in breast cancer patients more complex. Existing guidelines have pointed out that patients with positive axillary lymph nodes after neoadjuvant chemotherapy are recommend for postmastectomy radiotherapy. However, postmastectomy radiotherapy is still controversial in patients with pathological complete remission or pathologically lymph node-negative after neoadjuvant chemotherapy. Radiotherapy can improve the local control rate and overall survival rate of patients, but some patients will have a series of adverse reactions after radiotherapy. Therefore, it is very important to find patients who can benefit from postmastectomy radiotherapy after neoadjuvant chemotherapy. This article reviews the research progress of postmastectomy radiotherapy for breast cancer patients with pathological complete remission or pathologically lymph node-negative after neoadjuvant chemotherapy.

Objective:To investigate the emergency surgical strategies for patients with acute abdomen during the Corona Virus Disease 2019 (COVID-19) outbreak.Methods:The retrospective and descriptive study was conducted. The clinical data of 20 patients with acute abdomen who were admitted to the Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 18, 2020 and February 10, 2020 were collected. There were 13 males and 7 females, aged from 25 to 82 years, with an average age of 57 years. All the patients with emergency surgeries received pulmonary computed tomography (CT) examination before surgery, and completed nucleic acid detection in throat swab if necessary. Patients excluded from COVID-19 underwent regular anesthesia, suspected and confirmed cases were selected a proper anesthesia based on their medical condition and surgical procedure. Patients excluded from COVID-19 underwent emergency surgeries following the regular procedure, suspected and confirmed cases underwent emergency surgeries following the three-grade protection.Observation indicators: (1) surgical situations; (2) postoperative situations. Measurement data with normal distribution were represented as average (range). Count data were described as absolute numbers.Results:(1) Surgical situations: of the 20 patients with acute abdomen, 16 patients were excluded from COVID-19, and 4 were not excluded. All the 20 patients underwent emergency abdominal surgeries successfully, of whom 2 received surgeries under epidural anesthesia (including 1 with open appendectomy, 1 with open repair of duodenal bulbar perforation), 18 received surgeries under general anesthesia (including 9 with laparoscopic repair of duodenal bulbar perforation, 3 with open partial enterectomy, 3 with laparoscopic appendectomy, 1 with laparoscopic left hemicolectomy, 1 with laparoscopic right hemicolectomy, 1 with cholecystostomy). The operation time of patients was 32-194 minutes, with an average time of 85 minutes. The volume of intraoperative blood loss was 50-400 mL, with an average volume of 68 mL. (2) Postoperative situations: 16 patients excluded from COVID-19 preopratively were treated in the private general ward postoperatively. One of the 16 patients had fever at the postoperative 5th day and was highly suspected of COVID-19 after an emergency follow-up of pulmonary CT showing multiple ground-glass changes in the lungs. The patient was promptly transferred to the isolation ward for treatment, and results of nucleic acid detection in throat swab showed double positive. Medical history described by the patient showed that the patient and family members were residents of Wuhan who were not isolated at home during the epidemic. There was no way to confirm whether they had a history of exposure to patients with COVID-19. Medical staffs involved in this case did not show COVID-19 related symptoms during 14 days of medical observation. The other 15 patients recovered well postoperatively. The 4 patients who were not excluded from COVID-19 preoperatively based on medical history and results of pulmonary CT examination were directly transferred to the isolation ward for treatment postoperatively. They were excluded from COVID-19 for two consecutive negative results of nucleic acid detection in the throat swab and recovered well. Two of the 20 patients with acute abdomen had postoperative complications. One had surgical incision infection and recovered after secondary closure following opening incision, sterilizing and dressing, the other one had intestinal leakage and was improved after conservative treatment by abdominal drainage. There was no death in the 20 patients with acute abdomen.Conclusions:Patients with acute abdomen need to be screened through emergency forward. Patients excluded from COVID-19 undergo emergency surgeries following the regular procedure, and patients not excluded from COVID-19 undergo emergency surgeries following the three-grade protection. The temperature, blood routine test and other laboratory examinations are performed to monitor patients after operation, and the pulmonary CT and throat nucleic acid tests should be conducted if necessary. Patients excluded from COVID-19 preopratively are treated in the private general ward postoperatively, and they should be promptly transferred to the isolation ward for treatment after being confirmed. Patients who are not excluded from COVID-19 preoperatively based on medical history should be directly transferred to the isolation ward for treatment postoperatively.

Objective: To investigate the incidence and risk factors of peripartum mood disorder (PPMD) in order to improve clinical prevention and intervention of this condition. Methods: This was a prospective cohort study recruiting first-trimester pregnant women (<13 gestational weeks) from Beijing Daxing Maternal and Child Care Hospital from October 1, 2016 to December 31, 2017. Zung Self-rating Anxiety Scale (SAS) and Zung Self-rating Depression Scale (SDS) were used to evaluate the anxiety and depression status in the second and third trimesters, respectively. Their life styles, social and environmental factors exposure during pregnancy were also collected. Statistical analysis was conducted using Chi-square test, student's t test, Mann-Whitney U test and multivariate logistic regression. Results: (1) A total of 478 subjects were enrolled in early pregnancy and 460 (96.2%) and 431 (90.2%) of them completed SAS and SDS assessment in the second and third trimesters, respectively, and 413 (86.4%) of the subjects finished both assessments on two occasions. (2) The prevalence of anxiety and depression was 7.1% (30/425) and 13.9% (59/425) in the second trimester, and 11.2% (44/392) and 21.5% (84/390) in the third. The incidence of anxiety and depression in the third trimester was 7.7% (26/336) and 9.6% (30/313). (3) Cross-sectional data analysis showed that prolonged television watching was a risk factor of anxiety in the second (OR=1.216, 95%CI: 1.055-1.402) and third (OR=1.166, 95%CI: 1.044-1.303) trimester, while exercise was a protect factor (OR=0.238, 95%CI: 0.105-0.541; OR=0.432, 95%CI: 0.212-0.879). Pregnant women with longer sleeping time had lower risks of depression in the second trimester (OR=0.725, 95%CI: 0.554-0.950); those who did exercise had lower risks of depression in the third trimester (OR=0.450, 95%CI: 0.252-0.803). (4) Longitudinal-data analysis revealed that longer television watching time in the second trimester was a risk factor for anxiety (OR=1.264, 95%CI: 1.117-1.432) and depression (OR=1.119, 95%CI: 1.005-1.246) in the third trimester. Conclusions The prevalence of anxiety and depression in the third trimester is higher than that in the second trimester. The incidence of depression is higher than that of anxiety in the third trimester. Prolonged television viewing time in the second trimester is a risk factor for both anxiety and depression in the third trimester.