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.

[Objective] To explore the clinical significance and application value of establishing a database for red blood cell alloantibody detection. [Methods] Patients who were scheduled for blood transfusion in our hospital from January 1, 2020 to May 1, 2024 were selected as the research subjects. A red blood cell alloantibody detection database was established using Microsoft Office Excel software to register the detection data of patients' alloantibodies and antibodies of undetermined specificity (AUS). A retrospective analysis was conducted on the clinical characteristics, antibody distribution, antibody decay and repeat positivity of the patients in the database. The LISS-IAT method was routinely used for antibody screening and identification. [Results] Among the alloantibodies, the Rh blood group system had the highest detection rate, followed by antibodies of the MNS blood group system and the Lewis blood group system. The predominant antibody in the Rh blood group system was anti-E. In the univariate analysis, the positivity of antibody was significantly associated with the patient's gender, age, blood transfusion history, pregnancy history and type of disease (all P<0.001). In the database, 48 patients experienced antibody decay, accounting for 15.24%(48/315), with an average time span of antibody decay ranging from 22 to 1 324 days. Six cases showed repeat positivity after decay, which were related to blood transfusions. The shortest interval between blood transfusions that led to antibody repeat positivity was 3 days, and the longest interval was 427 days. Among 58 cases with AUS, 3 converted into alloantibodies, among which 2 were anti-E and 1 was anti-Lea. [Conclusion] Establishing a red blood cell alloantibody detection database is an effective way to guide ambiguous cross-matching in clinical practice and is also an effective measure for the management of transfusion risks.

Objective:To conduct meta analysis to compare the effect of complete resection with or without postoperative radiotherapy (PORT) on survival in stage Ⅲ(N 2) non-small cell lung cancer (NSCLC). Methods:Relevant studies of the efficacy of PORT for stage Ⅲ(N 2) NSCLC were searched from Wanfang Data, PubMed, and Cochrane Library from January 2006 to January 2022. Literature screening, extraction of information and assessment of the risk of bias of the included literature was carried out by two independent researchers. Meta analysis was performed using R4.0.3 software. Results:A total of 12 publications consisting of 2992 patients were included, 1479 cases in the PORT group and 1513 cases in the control group. PORT improved the overall survival (OS) and disease free survival (DFS) compared to the control group. Fixed-effects model meta analysis of 6 randomized controlled trials showed that PORT did not significantly reduce the risk of death ( HR=0.98, 95% CI: 0.80-1.20). Fixed-effects model meta analysis of 6 retrospective studies showed that PORT improved prognosis ( HR=0.68, 95% CI: 0.59-0.79). PORT could improve OS of patients with multiple (station) metastasis of ipsilateral mediastinum and / or submandibular lymph nodes ( HR=0.89, 95% CI: 0.80-0.99). Conclusions:PORT could improve OS and DFS in stage Ⅲ(N 2) NSCLC. A trend towards benefit can be observed in the subgroup with multiple/multi-station N2 metastasis.

BACKGROUND: Lung cancer is the most common malignancy world-wide. There are a variety of immune infiltrating cells in tumor microenvironment, which is an important component of tumor immunity and has clinical significance for the prognosis of patients. CD45RO is a surface marker of memory T cells. The expression of CD45RO⁺ tumor infiltrating lymphocytes (TILs) is associated with the prognosis of many tumors. The purpose of this study was to evaluate the relationship between the density of CD45RO⁺ TILs in tumor and stromal area and the clinical characteristics of patients with non-small cell lung cancer (NSCLC) and its impact on the prognosis of patients. We aimed to explore the clinical value of CD45RO⁺ TILs and programmed cell death ligand 1 (PD-L1) as prognostic markers. METHODS: Multiple fluorescent immunohistochemical staining was used to stain the tissue microarray chips of 167 patients with NSCLC, marking CD45RO, cytokeratin (CK) and PD-L1. Using artificial intelligence image recognition technology and tumor cell-specific CK staining, divide the tumor and stromal area in the tissue, evaluate the density of CD45RO⁺ TILs in the tumor and stromal area, and the expression level of PD-L1 in tumor cells. The non-parametric test was used to analyze the relationship between CD45RO⁺ TILs and the clinical characteristics of patients, and the Kaplan-Meier method and Cox risk ratio model were used to analyze the relationship between CD45RO⁺ TILs independently or in combination with PD-L1 and tumor prognosis. RESULTS: The density of CD45RO⁺ TILs was significantly associated with patient age, smoking, tumor stage, and pathological type. Single-factor survival analysis showed that NSCLC (P=0.007) stromal region and lung adenocarcinoma (LUAD) (P<0.001) with CD45RO⁺ TILs high density had better OS. Multivariate survival analysis showed that the high density of CD45RO⁺ TILs in the stromal region of NSCLC (HR=0.559, 95%CI: 0.377-0.829, P=0.004) and lung adenocarcinoma (HR=0.352, 95%CI: 0.193-0.641, P=0.001) were independent prognostic factors for overall survival time (OS). Combined with PD-L1 score of tumor cells in tumor tissues and infiltration score of CD45RO⁺ TILs in all tumor tissues, the patients were divided into 4 groups: patients with PD-L1⁺/CD45RO⁺ had the longest disease-free survival (DFS) time, and patients with PD-L1⁺/CD45RO- had the shortest DFS time. Multivariate Cox regression analysis showed that PD-L1⁺/CD45RO- was an independent prognostic factor for DFS and had a higher risk of poor prognosis compared to the other three groups (HR=2.221, 95%CI: 1.258-3.919, P=0.006). CONCLUSIONS In tumor tissues, the density of CD45RO⁺ TILs, as well as the combination of CD45RO⁺ TILs and PD-L1 in tumor areas, significantly correlated with clinicopathological features and prognosis of NSCLC, which can be used as a new prognosis marker.

Objective: To construct the BCMA-CAR using the B-cell maturation antigen (BCMA) specific ligand APRIL as antigen binding region and to validate the effect of BCMA-CAR modified T cells (BCMA-CAR-T) on myeloma cells. Methods: The BCMA-CAR was constructed using the BCMA specific ligand APRIL as antigen binding domain and 4-1BB as the costimulatory domain. The specific cytotoxicity against BCMA⁺ myeloma cell lines and primary multiple myeloma (MM) cells in vitro were evaluated. In addition, BCMA⁺ myeloma xenograft mouse model was established to assess the anti-tumor effect of BCMA-CAR-T cell therapy in vivo. Results: BCMA-CAR-T cells could specifically kill BCMA⁺ myeloma cell lines (For BCMA-CAR-T cells, BCMA⁺ cells are almost undetectable in the E∶T ratio of 1∶4) and MM patients’ bone marrow mononuclear cells (the proportion of residual cells in BCMA-CAR-T and vector-T groups was 16.0% vs 66.85%, P=0.003) with significant degranulation (CAR-T and vector-T cells cocultured with MM1.S, H929 and U266 had degranulation levels of 33.30% vs 5.62%, 16.97% vs 2.95% and 25.87% vs 2.97%, respectively, P<0.001) and cytokines release (P<0.01) in vitro. In a human BCMA⁺ myeloma xenograft mouse model, BCMA-CAR-T cells could significantly prolong the survival of mice (The median survival time of mice treated with BCMA-CAR-T and vector-T cells was 87.5 days and 67.5 days, respectively, P<0.001) . Conclusion The ligand-based BCMA-CAR-T cells could be a promising strategy for BCMA⁺ multiple myeloma treatment.

The aim of the research is to study the prevalence and antimicrobial resistance of Campylabocter jejuni isolated from poultry in Jiangsu Province.A total of 753 samples from poultry meat and cloacal swabs were investigated,after the pure culture and the polymerase chain reaction of the mapA gene,207 isolates were examined for antimicrobial resistance by using K-B method according to World Health Organization.Results showed that all isolates performed different degree of antimicrobial resistance except meropenem,gentamycin,kanamycin,florfenicol and fosfomycin,the resistance rates of 194 strains to trimethoprim,norfloxacin,ceftriaxone and tetracycline were 100％,84.02％,80.9％ and 79.4％ respectively,1 strain isolated from Xuzhou was resistant to 92.6 ％ antibiotics.The multi-drug resistance appeared and the advantage of drug-resistant spectrum was LIN/CTX/CRO/NOR/CIP/T/TE,the resistant type focused on 40％-60％.The research provided evidence for surveillance of the antimicrobial resistance of C.jejuni and highlighted the need to employ more prudent use of critically important antimicrobial.

Objective To verify the simulation effect by the performance of pedal and reaction tasks in aviation emergency simulation on ground and to evaluate the subjects' psychological stress response by heart rate variability (HRV).Methods Twenty-seven male subjects participated in the reaction task,the pedal task and the comprehensive tasks.In pedal task,subjects applied force on pedals with the feedback of force indication and the force curves were recorded.Subjects were asked to respond colored lights of reaction task in defined time (1 s) in reaction task.A safe-level current stimulus was applied on subject's wrist in case of wrong or prolonged response happened.Comprehensive task was the integration of pedal and reaction tasks.ECG signals were recorded at pre-task baselines before the task and in the tasks.The reaction rate,reaction accuracy and the performance of pedal task were all calculated.Results The subjects' reaction rate in the comprehensive tasks was faster than that in the reaction task (t=5.16,P＜0.05),while the accuracy was lower than that in the reaction task (t=1.97,P＜0.05).The performance of pedal force in the comprehensive task was the lowest (t=2.43,P＜0.05).Subjects' heart rate was significantly different among the pre-task,pedal task and comprehensive task (F=42.33,P＜0.05).HR was the lowest in the pre-task and the highest in comprehensive task.Standard deviation of the NN intervals,root mean square of successive difference of the NN intervals had different distribution in 3 tasks (x2 =25.85,38.00,P＜0.05).The high frequency power,low frequency normalized unit and high frequency normalized unit showed significantly different among tasks (x2=19.18,26.96,24.00,P＜0.05).Standard deviation of the NN intervals,root mean square of successive difference of the NN intervals was the highest in pre-task and the lowest in comprehensive task.Conclusions The comprehensive task brings changes on the behavioristics of subjects.The HRV index verifies the raising of subjects' psychological stress in comprehensive task,and the aviation emergency that simulated on ground would induce subjects' fear mood to a certain extent.

Objective To verify the simulation effect by the performance of pedal and reaction tasks in aviation emergency simulation on ground and to evaluate the subjects' psychological stress response by heart rate variability (HRV).Methods Twenty-seven male subjects participated in the reaction task,the pedal task and the comprehensive tasks.In pedal task,subjects applied force on pedals with the feedback of force indication and the force curves were recorded.Subjects were asked to respond colored lights of reaction task in defined time (1 s) in reaction task.A safe-level current stimulus was applied on subject's wrist in case of wrong or prolonged response happened.Comprehensive task was the integration of pedal and reaction tasks.ECG signals were recorded at pre-task baselines before the task and in the tasks.The reaction rate,reaction accuracy and the performance of pedal task were all calculated.Results The subjects' reaction rate in the comprehensive tasks was faster than that in the reaction task (t=5.16,P＜0.05),while the accuracy was lower than that in the reaction task (t=1.97,P＜0.05).The performance of pedal force in the comprehensive task was the lowest (t=2.43,P＜0.05).Subjects' heart rate was significantly different among the pre-task,pedal task and comprehensive task (F=42.33,P＜0.05).HR was the lowest in the pre-task and the highest in comprehensive task.Standard deviation of the NN intervals,root mean square of successive difference of the NN intervals had different distribution in 3 tasks (x2 =25.85,38.00,P＜0.05).The high frequency power,low frequency normalized unit and high frequency normalized unit showed significantly different among tasks (x2=19.18,26.96,24.00,P＜0.05).Standard deviation of the NN intervals,root mean square of successive difference of the NN intervals was the highest in pre-task and the lowest in comprehensive task.Conclusions The comprehensive task brings changes on the behavioristics of subjects.The HRV index verifies the raising of subjects' psychological stress in comprehensive task,and the aviation emergency that simulated on ground would induce subjects' fear mood to a certain extent.

Objective To discuss the clinical value of strain rate imaging in quantitatively evaluating segmental myocardial function of left ventricle in latent autoimmune diabetes in adult(LADA).Methods Thirty LADA without complication(LADA group),30 LADA patients with hypertension and normal geometric left ventricle(LADA+NLVH group)and 30 healthy people(control group)were enrolled.All patients had normal ejection fraction,normal fractional shortening and no cardiac symptoms.The strain rate in systolic,early and later diastolic periods were obtained from 3 consecutive heartbeats in 16 segments respectively.The parameters were quantitatively analyzed between the three groups.Results Compared with the control group,all of the measured parameter of LADA and LADA+NLVH were significantly lower(P＜0.05 or P＜0.01).Although the mean strain rate in early and later diastolic periods decreased significantly in LADA+NLVH group than in LADA group(P＜0.05),there was no significant difference in the mean systolic strain rate between the two groups (P＞0.05).Conclusions Strain rate imaging provides a sensitive and accurate tool to assess the left ventricular myocardial performance in patients with LADA.