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 analyze the clinical characteristics of patients with myeloproliferative neoplasms (MPN) complicated with portal hypertension and evaluate the efficacy of ruxolitinib treatment.Methods:A total of 42 patients with MPN complicated with portal hypertension and 84 patients with MPN without portal hypertension who were admitted to the Department of Hematology of the Zhongshan Hospital, Fudan University from January 2018 to December 2023 were retrospectively included. The clinical characteristics of the two groups were compared. The MPN combined with portal hypertension group was divided into the ruxolitinib group ( n=18) and the traditional treatment group ( n=24) according to different treatment methods. The baseline characteristics and therapeutic effects of the two groups were compared. Results:Compared with patients with MPN without portal hypertension, patients with MPN combined with portal hypertension were younger (median age 49 years vs 63 years), and were more common in females [54.76%(23/42) vs 41.67%(35/84)]. The proportion of JAK2V617F mutation was higher [88.09%(37/42) vs 70.23%(59/84)], and the incidence of portal vein thrombosis was higher [57.14%(24/42) vs 1.19%(1/84)]. The incidence of gastrointestinal bleeding was high [45.24%(19/42) vs 4.76%(4/84)], and the hemoglobin and platelet counts were lower (all P<0.05). In terms of MPN classification, the proportions of PrePMF (5/18) and Post-ET-MF (4/18) were relatively high in the ruxolitinib group, while the proportions of essential thrombocythemia (ET) [41.67%(10/24)] and polycythemia vera (PV) [25.00%(6/24)] were relatively high in the traditional treatment group. The distribution of driver genes showed that the JAK2V617F mutation rate in the ruxolitinib group was higher than that in the traditional treatment group (all P<0.05). The proportion of patients with spleen volume reduction ≥35%(SVR35) in the ruxolitinib group was 4/18, and that in the traditional treatment group was 8.33%(2/24), with no statistically significant difference ( P=0.21). The portal vein diameter in the ruxolitinib group decreased compared with the baseline [(14.2±2.1)mm vs (16.5±2.8)mm, P=0.02], while no improvement was observed in the traditional treatment group. Conclusions:Ruxolitinib can effectively improve the portal vein diameter of patients with MPN complicated with portal hypertension.

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 analyze the clinical characteristics of patients with myeloproliferative neoplasms (MPN) complicated with portal hypertension and evaluate the efficacy of ruxolitinib treatment.Methods:A total of 42 patients with MPN complicated with portal hypertension and 84 patients with MPN without portal hypertension who were admitted to the Department of Hematology of the Zhongshan Hospital, Fudan University from January 2018 to December 2023 were retrospectively included. The clinical characteristics of the two groups were compared. The MPN combined with portal hypertension group was divided into the ruxolitinib group ( n=18) and the traditional treatment group ( n=24) according to different treatment methods. The baseline characteristics and therapeutic effects of the two groups were compared. Results:Compared with patients with MPN without portal hypertension, patients with MPN combined with portal hypertension were younger (median age 49 years vs 63 years), and were more common in females [54.76%(23/42) vs 41.67%(35/84)]. The proportion of JAK2V617F mutation was higher [88.09%(37/42) vs 70.23%(59/84)], and the incidence of portal vein thrombosis was higher [57.14%(24/42) vs 1.19%(1/84)]. The incidence of gastrointestinal bleeding was high [45.24%(19/42) vs 4.76%(4/84)], and the hemoglobin and platelet counts were lower (all P<0.05). In terms of MPN classification, the proportions of PrePMF (5/18) and Post-ET-MF (4/18) were relatively high in the ruxolitinib group, while the proportions of essential thrombocythemia (ET) [41.67%(10/24)] and polycythemia vera (PV) [25.00%(6/24)] were relatively high in the traditional treatment group. The distribution of driver genes showed that the JAK2V617F mutation rate in the ruxolitinib group was higher than that in the traditional treatment group (all P<0.05). The proportion of patients with spleen volume reduction ≥35%(SVR35) in the ruxolitinib group was 4/18, and that in the traditional treatment group was 8.33%(2/24), with no statistically significant difference ( P=0.21). The portal vein diameter in the ruxolitinib group decreased compared with the baseline [(14.2±2.1)mm vs (16.5±2.8)mm, P=0.02], while no improvement was observed in the traditional treatment group. Conclusions:Ruxolitinib can effectively improve the portal vein diameter of patients with MPN complicated with portal hypertension.

Geriatric depression in the elderly is becoming one of the most common psychiatric disorders affecting older people's mental and physical health.However, there is currently no systematic review on animal models for geriatric depression.Therefore, this paper analyzes and summarizes the animal models commonly used in geriatric depression studies and the application of antidepressants in geriatric depression models based on relevant national and international literature of recent years, aiming to provide insights on research approaches and considerations on study methods for geriatric depression.

Objective:To distinguish the differences between Olibanum and Myrrha by using modern analytical methods such as Differential Scanning Calorimeter (DSC) and Fourier Transform InfraRed (FT-IR). Methods:By collecting Olibanum and Myrrha in different growing areas and different processed prosecures, this paper to analizes the influence of temperature increase and its speed , as well as the particle size on the DSC experiment. The DSC method was used to perform a differential thermal map of Olibanum and Myrrha scanning and analysis; FT-IR was used to scan and analyze 20 batches of Olibanum and Myrrha. Results:TThe results of DSC analysis showed that the DSC experimental condition ranged between 30-600 ℃; the speed of temperature increase was 30 ℃/min; the particle size was 100 mesh. The DSC spectra of of Olibanum and Myrrha were significantly different. Only the processed products of frankincense had endothermic peak near 297 ℃, and there was no characteristic peak in this temperature range. Their exothermic peaks are close at 326 ℃, but their enthalpy values are quite different. The position of endothermic peak near 100 ℃ is close to the size of peak shape. FT-IR test showed that the absorption peaks of Olibanum and Myrrha at wave numbers 2 925, 1 710, 1 454, 1 371, 1 242, 1 029 cm -1 appeared, and the positions of strong peaks were also similar. The intensity of the characteristic peak of Myrrha wave number 1 029 cm -1 is greater than that of Olibanum. Conclusion:The DSC spectra of Olibanum and Myrrha are significantly different, and the difference between the two FT-IR spectra is small. Differential scanning Calorimetry is an effective, fast, and simple way to identify resinous Chinese medicinal materials, and is worthy of further popularization.

Objective:To analyze the risk factors of bronchopulmonary dysplasia(BPD)in very preterm infants(VPI), and to provide scientific basis for the prevention and treatment of BPD in VPI.Methods:A prospective multicenter study was designed to collect the clinical data of VPI in department of neonatology of 28 hospitals in 7 regions from September 2019 to December 2020.According to the continuous oxygen dependence at 28 days after birth, VPI were divided into non BPD group and BPD group, and the risk factors of BPD in VPI were analyzed.Results:A total of 2 514 cases of VPI including 1 364 cases without BPD and 1 150 cases with BPD were enrolled.The incidence of BPD was 45.7%.The smaller the gestational age and weight, the higher the incidence of BPD( P<0.001). Compared with non BPD group, the average birth age, weight and cesarean section rate in BPD group were lower, and the incidence of male infants, small for gestational age and 5-minute apgar score≤7 were higher( P<0.01). In BPD group, the incidences of neonatal respiratory distress syndrome(NRDS), hemodynamically significant patent ductus arteriosus, retinopathy of prematurity, feeding intolerance, extrauterine growth restriction, grade Ⅲ~Ⅳ intracranial hemorrhage, anemia, early-onset and late-onset sepsis, nosocomial infection, parenteral nutrition-associated cholestasis were higher( P<0.05), the use of pulmonary surfactant(PS), postnatal hormone exposure, anemia and blood transfusion were also higher, and the time of invasive and non-invasive mechanical ventilation, oxygen use and total hospital stay were longer( P<0.001). The time of starting enteral nutrition, cumulative fasting days, days of reaching total enteral nutrition, days of continuous parenteral nutrition, days of reaching 110 kcal/(kg·d) total calorie, days of reaching 110 kcal/(kg·d) oral calorie were longer and the breastfeeding rate was lower in BPD group than those in non BPD group( P<0.001). The cumulative doses of amino acid and fat emulsion during the first week of hospitalization were higher in BPD group( P<0.001). Multivariate Logistic regression analysis showed that NRDS, invasive mechanical ventilation, age of reaching total enteral nutrition, anemia and blood transfusion were the independent risk factors for BPD in VPI, and older gestational age was the protective factor for BPD. Conclusion:Strengthening perinatal management, avoiding premature delivery and severe NRDS, shortening the time of invasive mechanical ventilation, paying attention to enteral nutrition management, reaching whole intestinal feeding as soon as possible, and strictly mastering the indications of blood transfusion are very important to reduce the incidence of BPD in VPI.

Objective:To explore the interobserver variabilities in the delineation of the target volume using simulation three-dimensional computed tomography (3DCT) between the supine and prone positions for external-beam partial breast irradiation (EB-PBI) after breast-conserving surgery (BCS).Methods:Twenty-seven breast cancer patients who were scheduled to receive EB-PBI after BCS from July 2016 to April 2017 were enrolled in this study. All patients underwent axial 3DCT simulation scanning in the supine and prone positions during free breathing. Based on two different simulation 3DCT acquired, the gross target volume (TB) formed by using surgical clips and the clinical target volume (CTV) were delineated by five radiologists using specific guidelines. The following parameters including the target volume, coefficient of variations (COV) and matching degree (MD) were calculated to analyze the interobserver variability. Twenty-seven breast cancer patients who were scheduled to receive EB-PBI after BCS from July 2016 to April 2017 were enrolled in this study.Results:Whether in the supine or prone position, the interobserver variabilities for TB and CTV were statistically significant ( P<0.001, P=0.001, P<0.001, P=0.001). And the intersection of CTV in the prone position was 5.79 cm 3 greater than that in the supine position ( P=0.011). The interobserver variability of COV CTV in the prone positionwas significantly lower than that in the supine position ( P=0.014). And the interobserver variabilities of MDTB TB and MDTB CTV in the prone positionwere statistically greater than those in the supine position, respectively ( P<0.001, P= 0.001). Conclusions:When delineating the target volume of EB-PBI in the prone position, the interobsever variability can be reduced compared with that in the supine position. Hence, it is more reasonable to carry out EB-PBI in the prone position in free breathing.

Objective:To assess the feasibility of delayed-enhancement MRI in contouring the lumpectomy cavity (LC) for patients with invisible seroma or a low cavity visualization score (CVS≤2) in the excision cavity after breast-conserving surgery (BCS).Methods:Twenty-six patients with stage T 1-2N 0M 0 who underwent prone radiotherapy after BCS were recruited. The LC delineated on CT simulation images was denoted as LC CT. The LCs delineated on T 2WI, as well as on different delayed phases (2-, 5-and 10-minute) of delayed-enhancement T 1WI were defined as LC T2, LC 2T1, LC 5T1 and LC 10T1, respectively. Subsequently, the volumes and locations of the LCs were compared between CT simulation images and different sequences of MR simulation images using deformable image registration. Results:The volumes of LC T2, LC 2T1, LC 5T1 and LC 10T1 were all larger than that of LC CT. A statistical significance was found between the volume of LC CT and those of LC 2T1 or LC 5T1, respectively (both P<0.05). The conformal index (CI), degree of inclusion (DI), dice similarity coefficient (DSC) and the distance between the center of mass of the targets (COM) of LC CT-LC 10T1 were better than those of LC CT-LC T2, LC CT-LC 2T1 and LC CT-LC 5T1, however, there was no statistical difference among them (all P>0.05). Conclusions:It is feasible to delineate the LC based on prone delayed-enhancement MR simulation images in patients with low CVS after BCS. Meanwhile, the LCs derived from prone delayed-enhancement T 1WI of 10-minute are the most similar with those derived from prone CT simulation scans using titanium clips, regardless of the volumes and locations of LCs.

Objective To investigate the effect of the overexpression of Krüppel-like factor 6 (KLF6)towards the apoptosis of human lens epithelial cells (HLECs) induced by ultraviolet B (UVB) radiation.Methods The eukaryotic expression plasmid pEGFP-C2-KLF6 which was successfully constructed were transfected into HLECs,followed by the detection of KLF6 level by using Western blot,and then companied by UVB stimulation.Cell viability was measured by methyl thiazolyl tetrazolium (MTT) assay.The morphology of the cells was observed by using hematoxylin-eosin staining method.The cell damage was examined by Live/Dead staining.The apoptotic markers bax and bcl-2 were detected by Western blot.Quantitative apoptotic levels were measured with the apoptosis detection kit;the expression level of reactive oxygen species (ROS) was analyzed by DCFH-DA probe.Results The cell viability of the 0.5 μg transfection group and the 1.0 μg transfection group was significantly lower than that of the blank vector control group (both at P＜0.05).In high KLF6 expression group,the cells were sparse,long and narrow in size and shape,and the cytoplasm was concentrated.The cells in the normal control group were green living cells with stable morphology and even quantity.The number of red dead cells was increased significantly in the KLF6 highexpression group.After UVB irradiation,the apoptosis value,relative bax expression,bax/bcl-2 ratio and ROS expression of HLECs cells in the KLF6 high-expression group were all higher than those in the blank vector control group,with statistically significant differences between them (all at P＜0.05).Conclusions Overexpression of KLF6 can exacerbate apoptosis of HLECs caused by UVB,by regulating the expression of apoptosis-related proteins and promoting the accumulation of ROS in the endoplasmic reticulum.Down-regulation of KLF6 expression by biological tools may play a protective role on LECs to a certain extent.